Pricing and Reimbursement Handbook

Transcription

1 Pharmaceuticals & Healthcare Europe Pricing and Reimbursement Handbook 1 st edition

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3 Pricing and Reimbursement Handbook 1st edition Editor Thilo Räpple Authors Magdalena Bąkowska Réka Berekméri-Varró Helga Bíró Stefan Brandt Annabelle Bruyndonckx Ariadna Casanueva Roberto Cursano Natasja De Splenter Thomas Devred Michaela Drábková Julia Gillert Milena Hoffmanová Patrik Kastner Paulina Kieszkowska-Knapik Daniel Larcher John Leadley Montserrat Llopart Sergei Lomakin Misha lutje Beerenbroek Eleonora Mzhavanadze Ester Navas Cecilia Pastor Frank Pflüger Thilo Räpple Peter Reinert Emma Runia Caroline Treiman Alexey Trusov Eline van Nimwegen Agata Wolinska

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5 Table of Contents Introduction...iii Austria... 2 Belgium Czech Republic France Germany Hungary Italy The Netherlands Poland Russia Spain Sweden Switzerland United Kingdom European Pricing and Reimbursement Handbook i

6 ii Baker & McKenzie

7 Introduction Introduction The pharmaceuticals sector has always been of worldwide importance. During the past years, industry sales have steadily and significantly increased. In 2010, global spending on prescription drugs topped USD800 billion, with Europe accounting for about 30 percent of this turnover. This continued increase in sales is among the factors linked to the development of new and progressively effective medicines. While innovation in the pharmaceutical industry is usually welcomed by all stakeholders, it inevitably comes at the expense of having higher medicine prices and growing health-related expenditures. Against this backdrop, many EU countries have endeavored on the one hand to support their respective pharmaceutical industry by creating an environment which incentivizes innovation, and on the other hand maintain a healthcare system that is within financial reach of their citizens. To this end, all EU member states have adopted laws that limit public expenditures on medicinal products. Governments have also established detailed rules and practices regarding the pricing and reimbursement of such products. Since the EU has not harmonized the healthcare systems of its member states, differences across the reimbursement and pricing environment of Europe are set to remain. This means that pharmaceutical companies will continue to be faced with as many healthcare systems as there are national markets in the EU. This book provides a snapshot from a helicopter perspective of the pricing and reimbursement practices of the various European member states where Baker & McKenzie has an office. It is not, however, meant to be a detailed and conclusive resource of the legal framework governing the pharmaceutical industry of the different countries in Europe. European Pricing and Reimbursement Handbook iii

8 Introduction Most chapters in this book are written in bilingual format, with English and the native version for each country. I trust that this will be very helpful for lawyers and professionals who need to understand the fundamentals of the pricing and reimbursement systems of the countries covered in this book. Thilo Räpple October 2011 iv Baker & McKenzie

9 Pricing and Reimbursement Handbook 1st edition Editor Thilo Räpple European Pricing and Reimbursement Handbook 1

10 Österreich Österreich Daniel Larcher / Agata Wolinska 1. Welche Arzneimittel werden in welchen Verfahren von den Krankenkassen rückerstattet? In Österreich werden Arzneimittel entweder ganz oder überhaupt nicht rückerstattet. Der Antrag auf Rückerstattung ist beim Hauptverband der österreichischen Sozialversicherungsträger zu stellen. Alle im Erstattungskodex (EKO) enthaltenen Medikamente werden von den Krankenkassen übernommen. Der Erstattungskodex wird vom Hauptverband der Sozialversicherungsträger (HVB) herauszugeben. Allgemeines Das österreichische Gesundheitssystem ist als Sozialversicherungssystem organisiert. Gemäß dem Allgemeinen Sozialversicherungsgesetz (ASVG) muss allen Patienten ausreichende medizinische und medikamentöse Behandlung gewährleistet werden, solange sie angemessen ist. Die Rückerstattung erfolgt in Form von Sachleistungen. Grundsätzlich sind alle ordnungsgemäß registrierten Arzneimittel erstattungsfähig, solange keine therapeutische Alternative besteht. In Österreich ist die Rückerstattung von Kosten für Medikamente nach einem Boxen-System organisiert ( 31 ASVG). Es gibt weiters auch eine negative Liste ( no box ), in der Medikamente genannt sind, die jedenfalls vom Patienten selbst zu bezahlen sind oder deren Kosten nur in Ausnahmefällen von der Krankenkasse übernommen werden. Die Arzneimittel, die erstattungsfähig sind, sind im EKO, der sich in 3 Boxen ( rote Box, gelbe Box, grüne Box ) gliedert, zu finden. In der roten Box sind die Medikamente, für deren Aufnahme in den EKO ein Antrag gestellt wurde, zeitlich befristet aufgelistet. Die gelbe Box beinhaltet im dunkelgelben Bereich jene Arzneimittel, 2 Baker & McKenzie

11 Austria Austria Daniel Larcher and Agata Wolinska 1. Which pharmaceutical products are reimbursed by the NHS, under what procedures? In Austria, pharmaceuticals are either fully reimbursed or not reimbursed at all. The application for reimbursement needs to be filed with the Main Association of Austrian Social Security Institutions (HVB). A list of pharmaceuticals, the Erstattungskodex (EKO), published by the HVB, enumerates pharmaceuticals qualified for general reimbursement. All reimbursable pharmaceuticals are enumerated in the EKO. General Overview Austria is organized in a social health insurance (SHI) system. According to the Austrian Social Insurance Law (ASVG), patients must be granted all necessary forms of medicinal and medical treatment in a sufficient and appropriate way as long as adequacy of resources is guaranteed. In Austria, reimbursement of pharmaceuticals is characterized by reimbursement in kind. On a very general level, all duly registered pharmaceuticals are reimbursable by SHI for certain diseases as long as there is no treatment alternative. In Austria there are two lists: the positive List (EKO) and a negative list (not reimbursable pharmaceuticals). The EKO has three main segments: the red box, the yellow box (sub grouped by light yellow), and the green box. The red box includes newly launched pharmaceuticals and all pharmaceuticals that apply for reimbursement. The yellow box includes pharmaceuticals fulfilling certain criteria, for example, a specific disease or age group. Head physicians of the HVB may authorize a reimbursement of pharmaceuticals in the red and the yellow boxes. In the subgroup of the light yellow box, the exante approval is replaced by a possible ex-post volume control of the prescribing doctor. The green box includes pharmaceuticals European Pricing and Reimbursement Handbook 3

12 Austria die einen wesentlichen zusätzlichen therapeutischen Nutzen für die Patienten aufweisen und die aus medizinischen und/oder gesundheitsökonomischen Gründen nicht in die grüne Box aufgenommen wurden. Für Arzneimittel, die in den dunkelgelben oder roten Bereich fallen, werden die Kosten von den Krankenversicherungsträgern nur bei Vorliegen der ärztlichen Bewilligung des chef- und kontrollärztlichen Dienstes der Krankenkasse übernommen. Für einzelne Medikamente aus der gelben Box, deren Aufnahme sich auf eine bestimmte Verwendung bezieht (hellgelber Bereich), akzeptiert der Hauptverband anstelle der ärztlichen Bewilligung des chef- und kontrollärztlichen Dienstes eine nachfolgende Kontrolle der Einhaltung der bestimmten Verwendung anhand der Dokumentation des behandelnden Arztes. Arzneimittel aus der grünen Box dürfen allgemein oder unter bestimmten Voraussetzungen in der als frei verschreibbar angegebenen Menge abgegeben werden und sind voll erstattungsfähig. Für ärztlich verschriebene, erstattungsfähige Arzneimittel ist ein pauschaler Selbstbehalt in Form der Rezeptgebühr in Höhe von EUR 5,10 zu entrichten. Kosten von nicht verschriebenen Medikamenten müssen vom Patienten selbst getragen werden. Zuständige Behörden Die Entscheidung, ob ein Arzneimittel erstattungsfähig ist oder nicht, liegt beim Hauptverband der österreichischen Sozialversicherungsträger. Dieser ist auch für die Herausgabe des EKO zuständig. Als beratendes Gremium bei der Herausgabe des EKO ist die Heilmittel-Evaluierungs-Kommission (HEK) eingerichtet. Die HEK besteht aus 20 Mitgliedern, die von verschiedenen österreichischen Körperschaften öffentlichen Rechts nominiert wurden. 10 Mitglieder davon sind die Repräsentanten der Krankheitsfonds. Der HVB entscheidet auf Grundlage der Empfehlung der HEK. Gegen die Entscheidung des HVB kann bei 4 Baker & McKenzie

13 Austria qualifying for automatic reimbursement. These can be prescribed by any contract physician. In addition to the positive list, there is the negative one ( no box ), which includes pharmaceuticals (i.e., nicotine replacement drugs, nootropics, medical wines, contraceptives, obesity treatment drugs, some homoeopathic products, and pharmaceuticals used to stimulate or increase the sexual drive) that are in general excluded from reimbursement. If pharmaceuticals are reimbursed, patients have to pay out-of pocket a fixed prescription fee amounting to EUR Furthermore, selfmedication has to be paid directly by patients. Competent authorities The Main Association of Austrian Social Security Institutions (HVB) decides whether a pharmaceutical should be reimbursed or not. Furthermore, the HVB publishes the EKO. The Pharmaceutical Evaluation Board (HEK) is the consultant of the HVB. After hearing the HEK, the HVB takes a decision. The HEK consists of 20 experts nominated by several Austrian public bodies, 10 of which are representatives of the sickness funds. The Independent Pharmaceutical Commission (UHK) is established at the Federal Ministry Of Health (BMG) and functions as court of appeal against HVB s decisions. European Pricing and Reimbursement Handbook 5

14 Austria der Unabhängigen Heilmittelkommission (UHK), die beim Bundesministerium für Gesundheit eingerichtet ist, Beschwerde erhoben werden. Bundesministerium für Gesundheit (BMG) Preiskommission (PK) Unabhängige Heilmittelkommission Hauptverband der Sozialversicherungsträger (HVB) Heilmittel-Evaluierungs- Kommission (HEK) Verfahren Um in die Liste erstattungsfähiger Arzneimittel (gelber oder grüner Bereich des EKO) aufgenommen zu werden, muss der Zulassungsinhaber einen Antrag an den HVB stellen. Dieser hat ua Angaben darüber zu enthalten, ob das Arzneimittel in einem anderen EU-Mitgliedstaat auf dem Markt ist. In diesem Fall ist der Fabrikoder Depotabgabepreis (FAB/DAP), zu dem das Medikament in anderen EU-Mitgliedstaaten abgegeben wird, anzugeben. Über Beschwerden des Antragstellers entscheidet die UHK. Über Streichungen aus dem EKO, Änderungen der Bereichszugehörigkeit (rot, gelb, grün) uä entscheidet der HVB. Auch dagegen kann an die UHK Beschwerde erhoben werden. 6 Baker & McKenzie

15 Austria Federal Ministry Of Health (BMG) Pricing Committee (PK) Independent Drug Commission (UHK) Main Association of Austrian Security Institutions (HVB) Pharmaceutical Evaluation Board (HEK) Procedure In order to apply for reimbursement, the holder of a market authorization needs to send an application for the inclusion of the pharmaceutical into the EKO to the HVB. The application needs to contain information, whether the pharmaceutical is on the market in other EU member states and if so, the ex-factory or wholesale prices (FAP/DAP) of the pharmaceutical in each of these countries have to be submitted. The UHK decides in case of appeal. Decisions on delisting, on the change of the insertion of a pharmaceutical into a box, or on any restrictions in the wake of new pharmacological, medical-therapeutic, or economic findings can be made by the HVB. The manufacturer has the right to comment or complain against any such decision to the UHK. European Pricing and Reimbursement Handbook 7

16 Austria 2. Gibt es eine Preiskontrolle für Arzneimittel? Zum Fabrik- oder Depotabgabepreis (FAP/DAP) des Herstellers werden die jeweiligen Aufschläge (Großhandels- und Apothekenaufschlag) und die Mehrwertsteuer gerechnet. Der FAP/DAP kann vom vertriebsberechtigten Unternehmen frei festgelegt werden, wobei das BMG über diesen Preis informiert wird. Für Arzneimittel, die in den EKO aufgenommen werden sollen, wird der Preis anhand des EU-Durchschnittspreises festgelegt. Dieser Durchschnittspreis bildet den maximal möglichen FAP/DAP für erstattungsfähige Medikamente. Die gemäß dem Preisgesetz festgesetzten Höchstpreise sind in monatlichen in Veröffentlichungen des BMG festgehalten. Für die Überwachung der Einhaltung der Höchstpreise nach dem Preisgesetz sind die Bezirksverwaltungsbehörden zuständig. 3. Wie erfolgt die Preisbildung für Arzneimittel? Für die Preisbildung ist in Österreich zwischen internem und externem Preisvergleich zu unterscheiden. Der EU-Durchschnittspreis gilt nur für Arzneimittel des roten Bereichs. Durch die geringe Anzahl von chef- und kontrollärztlichen Genehmigungen für Arzneimittel aus dem roten Bereich hat der EU- Durchschnittspreis keine wirtschaftliche Bedeutung erlangt. Im gelben Bereich des Erstattungskodex stellt der EU-Durchschnittspreis die Obergrenze dar, und im grünen Bereich muss dieser darunter liegen. Spezielle Regelungen gelten unter anderem für krankenhausexklusive Arzneimittel und Nicht-verschreibungspflichtige Arzneimittel (OTC- Produkte). Interner Preisvergleich Diese Methode wird bei der Anmeldung eines Arzneimittels zur Aufnahme in den EKO angewandt. Zulassungsinhaber, die einen 8 Baker & McKenzie

17 Austria 2. Is there a direct price control on pharmaceutical products? In Austria, a wholesale mark-up and a pharmacy mark-up plus VAT are added to the ex-factory price. In case that the pharmaceutical is on the market in other EU member states, the average price of those EUmember states is the maximum ex-factory or wholesale price (FAP/DAP) in Austria. The BMG publishes the maximum prices monthly in accordance with the Austrian Pricing Law (Preisgesetz). The Austrian district administrative authorities are responsible for abidance of the maximum prices. 3. What are the pricing procedures, if any, under which the prices for pharmaceutical products are determined? In Austria, internal and external price referencing plays an important role in the pricing procedure of pharmaceuticals applying for reimbursement. A special way of pricing is used for Hospital-only medicines (HOM). The average EU price is only relevant for pharmaceuticals enumerated in the red box. Concerning the prices of pharmaceuticals in the yellow box, the average EU price is the maximum price. Pharmaceuticals which are found in the green box must not be priced more than the average EU price. Pricing of HOM and over-the-counter pharmaceuticals (OTC), inter alia, follows specific rules. Internal price referencing Internal price referencing is applied in course of the application for inclusion in the EKO. Manufacturers of pharmaceuticals that apply for inclusion in the EKO have to submit a comparison of the European Pricing and Reimbursement Handbook 9

18 Austria solchen Antrag an den HVB stellen, müssen diesem unter anderem einen Preisvergleich mit identischen Arzneimitteln und/oder therapeutisch gleichwertigen Produkten innerhalb des Landes anschließen. Externer Preisvergleich Der EU-Durchschnittspreis gilt nur für Arzneimittel des roten Bereichs. Dieser wird mittels eines externen Preisvergleichs ermittelt. Dafür verantwortlich ist die Preiskommission (PK), die beim BMG eingerichtet ist. Ein Zulassungsinhaber, der möchte, dass sein Medikament im EKO steht, hat im Zuge der Anmeldung beim HVB Angaben darüber zu machen, ob das Medikament in anderen EU- Ländern schon auf dem Markt ist und falls ja, zu welchem Preis (FAP/DAP). Dafür ist ein von der PK entwickeltes Formular zu verwenden. Diese Meldungen dienen der PK als Basis für ihre Berechnungen. Das Österreichische Bundesinstitut für Gesundheitswesen (OBIG) ist für die Überprüfung der vom Antragsteller gemachten Angaben verantwortlich. Verglichen wird anhand derselben Wirkstoffe, derselben Dosierung und ähnlicher Packungsgröße. Krankenhausexklusive Arzneimittel Der Erwerb von Arzneimitteln durch Krankenhäuser hat mittels öffentlicher Ausschreibung zu erfolgen. Pharmaunternehmen teilen ihre Preislisten dem BMG mit. Das BMG setzt den Preis in Höhe des Fabriksabgabepreises fest. In den Krankenhäusern werden die Arzneimittel dann höchstens zu diesem Preis abgegeben. 4. Wie werden öffentliche Ausgaben für Arzneimittel kontrolliert (Referenzpreissysteme, Zuzahlungen, Rückerstattungen, wertorientierte Preisbildung, Risikoteilung etc.)? Die Preisbildung für Medikamente erfolgt nach dem Referenzsystemsiehe Frage Baker & McKenzie

19 Austria ex-factory prices of comparable pharmaceuticals in Austria. The potential sales of the pharmaceuticals may also be taken into consideration. External price referencing External price referencing is applied at the ex-factory price level. The holder of a market authorization applying for inclusion of a pharmaceutical to the EKO has to provide information, including whether the product is on the market in other EU member states and if so, the ex-factory and wholesale prices of the pharmaceutical in all current EU Member States have to be submitted. To do this, the companies have to use a standard form, which was developed by the Pricing Committee (PK). Public authorities for health care (GÖG/ÖBIG) may be asked by the PK to check the prices submitted by the industry on a random basis. The prices are compared per unit with the same ingredients, the same pack size and the same dosage. Hospital-only medicines Pharmaceutical companies submit their price application at the BMG. The BMG then sets the prices at ex-factory price level. Hereafter, the hospitals can purchase the pharmaceuticals at the maximum ex-factory price level. The committees purchase HOM via tendering processes and individual negotiations. 4. What instruments are used to control public expenditure on pharmaceutical products (reference pricing, co-payment, payback, value-based pricing, risk-sharing arrangements, etc.)? Reference pricing is relevant in the procedure of pricing (see question 3). In Austria, patients have to pay a flat rate fee per prescription (out-of pocket payments). All pharmaceuticals enumerated in the EKO are fully reimbursable. The prescription fee currently amounts to EUR European Pricing and Reimbursement Handbook 11

20 Austria Im österreichischen Rückerstattungssystem müssen Patienten eine Pauschale in Form der Rezeptgebühr begleichen. Alle im EKO aufgelisteten Medikamente sind voll erstattungsfähig und werden daher von den Krankenkassen bezahlt. Der Patient muss jedoch einen pauschalen Selbstbehalt in Form der Rezeptgebühr in Höhe von EUR 5,10 entrichten, welcher jährlich um die Inflationsrate angepasst wird. Diese Erscheinungsform der Zuzahlung (Selbstbeteiligung) stellt für den Patienten keinen Anreiz dar, günstigere Medikamente oder generell Alternativen zum verschriebenen Arzneimittel zu wählen. Die Rezeptgebühr wird jährlich an die Inflation angepasst. Die Rezeptgebühr wird von den Apotheken einbehalten und an die Krankenkassen weitergeleitet. Die Möglichkeit der Rezeptgebührbefreiung besteht für Personen mit anzeigepflichtigen, übertragbaren Krankheiten und Personen mit besonderer sozialer Schutzbedürftigkeit (zb Personen, deren Nettoeinkommen einen bestimmten Richtsatz nicht übersteigt, Bezieher von Mindestpensionen). 5. Gibt es eigene Regelungen für Generika, zb schnellere Genehmigungen, geringere Zulassungsgebühren usw? Ist der Preis von Generika gesetzlich festgelegt? Generika sind Arzneimittel, sich an ein seit Jahren bewährtes Medikament anlehnen und den gleichen Wirkstoff wie das seit Jahren bekannte Ursprungsprodukt haben. Der Preis wird gemäß den Regelungen des EKO festgelegt. Es wird diskutiert, ob sich die Einführung einer niedrigeren Rezeptgebühr für Generika lohnt. 6. Gibt es Anreize für innovative Arzneimittel? Gesetzlich sind keine speziellen Anreize für innovative Arzneimittel vorgesehen. 12 Baker & McKenzie

21 Austria 5.10 and is annually adjusted according to the inflation rate. Patients do not have to pay any other additional payments for reimbursable pharmaceuticals. This form of co-payment (fixed co-payments) does not give any incentives for patients to opt for cheaper pharmaceuticals or treatment alternatives. The pharmacies collect the prescription fee on behalf of the sickness funds and pass it on to them. The prescription fee is adjusted annually according to inflation. Socially disadvantaged people such as old-age pensioners with an income below a certain threshold and people with communicable diseases like tuberculosis or HIV are exempt from prescription fees. 5. Is there a specific policy for generic pharmaceutical products (for instance, fast track approval, lower registration fees, etc.)? Is the price of generic products fixed by law? Generics are defined as products containing bio-equivalent substances of off-patent original brands. There are no separate pricing rules. Generics are usually included in the green box. In principle, generic substitution is not relevant in Austria. There is an ongoing discussion in Austria whether a lower prescription fee for generic products makes sense. 6. What incentives exist for innovative pharmaceutical products? There are no specific incentives set forth under Austrian law. 7. Are hospitals allowed to run public tenders on pharmaceutical products? If so, what are the rules governing the pricing proposal of the pharmaceutical companies? In principle, contracting authorities in the public sectors are required to put out to tender all works, services and supply contracts that European Pricing and Reimbursement Handbook 13

22 Austria 7. Sind Krankenhäuser zu öffentlichen Ausschreibungen für Arzneimittel verpflichtet? Wenn ja, welche Regelungen gelten für Gebote? Grundsätzlich müssen Beteiligte im öffentlichen Bereich alle entgeltlichen Arbeits-, Dienst- und Versorgungsverträge ausschreiben (Vergaberecht). Als öffentliche Auftraggeber im Gesundheitsbereich sind Krankenhäuser zur Einhaltung des Vergaberechts verpflichtet. Öffentliche Ausschreibungen für Arzneimittel sind sehr komplex, da an diesem Verfahren viele unterschiedliche Akteure beteiligt sind (Behörden, Ministerien, Hersteller). Abgesehen davon kommen unterschiedliche Bundes- oder Landesgesetze zur Anwendung. Der Bieter hat sich an den vorgeschriebenen Text der Ausschreibungsunterlagen zu halten. Die darin geforderten Unterlagen sind dem Angebot beizulegen. Im Angebot sind ua Name (Firma, Geschäftsbezeichnung) und Preise zu nennen. 8. Besteht ein Unterschied zwischen der Rückerstattung von Kosten für Arzneimitteln, die in Arztpraxen verschrieben wurden und solchen, die in Krankenhäusern verschrieben wurden? In Österreich werden alle Arzneimittel, die im EKO aufgelistet sind, voll rückerstattet. Patienten müssen nur einen pauschalen Selbstbehalt in Form der Rezeptgebühr in Höhe von EUR 5,10 entrichten. Der EKO ist nur für Medikamente, die im Rahmen von Behandlungen außerhalb eines Krankenhauses verschrieben werden, relevant. Alle Arzneimittel, die im Zuge einer Behandlung in einem Krankenhaus benötigt werden, sind vom Spitalskostenbeitrag abgedeckt. 14 Baker & McKenzie

23 Austria provide for a pecuniary consideration to be paid to the contractor (Federal Act on Public Procurement). Therefore, public hospitals even have to run public tenders on pharmaceutical products. Pharmaceutical tendering is a complex process which involves several steps/routes as well as stakeholders (agencies, ministries and manufacturers). Apart from that, various laws are applicable, depending on whether the contract was awarded within the sphere of the Federation (Bund) or of the states (Länder). The content of the bid is prescribed in the published tender. Any information required has to be attached. The offer has to include, inter alia, names and prices. 8. Is there a difference between reimbursement of pharmaceutical products prescribed by physicians in private practice and those prescribed in a hospital? In Austria, all pharmaceuticals that are included in the EKO are fully reimbursable. For those pharmaceuticals, patients have to pay a flat rate fee per prescription. The pharmaceuticals used in hospital care are included in the diagnosis related remuneration system of hospitals, i.e., there is no separate reimbursement of pharmaceuticals in hospitals. 9. Can a pharmaceutical product that is used for an indication for which it is not approved (i.e., off-label use) be reimbursed? If yes, what are the conditions? Yes, under certain conditions. Firstly, no use of any alternative registered pharmaceutical product must be available. Secondly, offlabel use has to be a therapeutical necessity. In such case, Head physicians of the HVB may authorize a reimbursement. European Pricing and Reimbursement Handbook 15

24 Austria 9. Wird ein zulassungsüberschreitend angewendetes Arzneimittel rückerstattet? Falls ja, unter welchen Voraussetzungen? Unter off-label use (zulassungsüberschreitende Anwendung) wird die Anwendung eines an sich zugelassenen Arzneimittels außerhalb der von der Zulassung gedeckten Anwendungsgebiete oder Verabreichungsarten verstanden. Grundsätzlich besteht die Möglichkeit, dass in Österreich nicht oder anders zugelassene Arzneimittel rückerstattet werden. Die Behandlung mit einem solchen Medikament muss therapeutisch notwendig sein, und es darf keine alternative, erfolgversprechende Therapiemöglichkeit mit zugelassenen Medikamenten bestehen (Richtlinie über die ökonomische Verschreibweise von Heilmitteln - RÖV). In diesem Fall ist eine chef- und kontrollärztliche Bewilligung und somit Rückerstattung möglich. 16 Baker & McKenzie

25 Belgium Belgium Annabelle Bruyndonckx and Natasja De Splenter Executive Summary: How are National Health Services ( NHS ) organized in your country? The Belgian health system is based on the principle of social insurance characterized by horizontal solidarity (between healthy and sick people) and vertical solidarity (based to a large extent on the labor incomes) and without risk selection. Responsibilities for health policy are shared between the federal level and the federated entities (regions and communities). While the federal level is mainly responsible for the regulation and financing of compulsory health insurance, the financing of hospital budgets and heavy medical equipment (e.g., CT and MRI scanners), and the registration of medicinal products and their price control, the federated entities are mainly responsible for health promotion and prevention, maternity and child health services, different aspects of elderly care, home care and palliative care. Compulsory health insurance is organized through six private, nonprofit-making national associations of sickness funds, and one public national association sickness fund (the so called mutualities, in French mutualités and in Dutch mutualiteiten ). The major responsibilities of the sickness funds are to reimburse health services benefits and to represent their members at the National Institute for Health and Disability Insurance (NIHDI RIZIV-INAMI). The National Institute for Health and Disability Insurance (hereafter the NIHDI ) is a public social security institution accountable to the Minister of Social Affairs and Public Health. It is responsible for the general organization and financial management of the compulsory health care and benefits insurance. It is the Health Care Department within the NIHDI that is in charge of the administrative and financial management of the compulsory health insurance and which European Pricing and Reimbursement Handbook 17

26 Belgium determines the reimbursement criteria, establishes and monitors the budget, informs the healthcare providers, among other functions. The budget for public expenditures on pharmaceutical products is determined by the NIHDI General Council. At the proposal of the Minister of Social Affairs and Public Health, the budget is then deliberated and approved by the government. As the budget may underestimate real pharmaceutical expenditure, a buffer system funded by the pharmaceutical industry ensures that the budget is maintained in balance in case of excessive pharmaceutical public expenditure. 1. Which pharmaceutical products are reimbursed by the NHS, under what procedures? Pharmaceutical products do not automatically qualify for reimbursement. The main legislations regulating the reimbursement of pharmaceutical products are the Act of 14 July 1994 on the compulsory insurance system and the Royal Decree of 21 December 2001 concerning the procedures, terms and conditions for contribution by compulsory insurance for health care and benefits towards costs of pharmaceutical specialties. Only pharmaceutical products included on the positive list of reimbursement (i.e., appendix to Royal Decree of 21 December 2001) are covered by the compulsory health insurance. As soon as market authorization is granted, the pharmaceutical company 1 can submit its drug reimbursement request file to the Drug 1 It should be noted that pursuant to article 96 of the Royal Decree of 21 December 2001, the Minister of Social Affairs and Public Health has the power to bring pharmaceutical products in the reimbursement system and this even if the marketing authorization holder did not submit any drug reimbursement file. However, if a pharmaceutical product is designated as orphan pharmaceutical or if the company requests reimbursement status as Class 1 product, and if the product is going through the centralized approval procedure under Regulation (EC) 726/2004 on the authorization and 18 Baker & McKenzie

27 Belgium Reimbursement Committee (in French CRM, Commission de Remboursement des Médicaments ; in Dutch CTG, Commissie voor Tegemoetkoming Geneesmiddelen ). The reimbursement request file shall notably include the clinical evidences, the price requested for the product, budget impact estimate and for products for which the company claims Class 1 (added therapeutic value), an estimate of cost-effectiveness ratio. The applicant must also include in the reimbursement request file a proposal regarding the reimbursement conditions. The reimbursement pathway procedure slightly varies with the Class claim. Class 1 is restricted to pharmaceuticals with a significant therapeutic improvement in comparison with existing alternatives; Class 2 is for pharmaceuticals without a significant therapeutic improvement in comparison with existing alternatives and that do not belong to class 3; and Class 3 includes generics and pharmaceutical products registered on the basis of a bibliographic application 2. As a general rule, the experts of the NIHDI must prepare an assessment report within 60 days of the filing of the request, describing and critically assessing the evidences presented in the drug reimbursement request file ( day 60 -report). The assessment report is then presented at a CRM/CTG meeting. Based on the assessment report and the discussions during the meeting, the CRM/CTG prepares a preliminary reimbursement proposal ( day 120 -proposal). The supervision of pharmaceutical products and establishing a European Medicines Agency, the reimbursement application can be submitted as soon as the Committee for Pharmaceutical Products for Human Use (CHMP) issued a positive opinion. 2 For the sake of completeness, the classes 2 and 3 are divided into subclasses based on the: price and proposed reimbursement basis; importance of the product in medical practice in relation to therapeutic and social needs; budgetary implications for the health insurance system; and the relation between the costs for the health insurance system and the therapeutic value. If the applicant considers that its product offers added therapeutic value, it introduces a claim for Class 1. European Pricing and Reimbursement Handbook 19

28 Belgium drug reimbursement proposals are appraised by NIHDI experts and the CRM/CTG members and subsequently voted during CRM/CTG meeting. The reimbursement proposals are as a general rule based on the following criteria: the therapeutic value of the product expressed in three classes (see above); the price and reimbursement basis proposed by the applicant; the value of the product in the medical practice in relation to the therapeutic and social needs; the budgetary impact on health care expenditures; and the relation between the health care cost and the therapeutic value of the product. The motivated positive or negative reimbursement proposal is then transferred to the Minister of Social Affairs and Public Health within 150 days of the filing of the drug reimbursement request file. The Minister of Social Affairs and Public Health, who is allowed to deviate form the reimbursement proposal, must take a final decision within 30 days. The procedure must take no more than 180 days, which could be suspended in certain circumstances. A final positive reimbursement decision generally contains the reimbursement modalities necessary for its implementation: The reimbursement basis: it generally equals the pharmacy retail price; The reimbursement conditions: conditions limiting the access to reimbursement, e.g., age range, preliminary diagnostic examinations, maximum dosage, etc.; The category of reimbursement: the category defines the level of cost-sharing for the patients. There are five categories (A, B, C, Cs and Cx) conferring various percentages of reimbursement by the national health insurance 3. 3 A distinction is made between: category A (pharmaceutical products for serious and long term illnesses which are fully (100 percent reimbursed); category B (socially and medically useful pharmaceutical products which reimbursement level ranges between 75 percent and 85 percent); category C (socially and medically less useful pharmaceutical products which reimbursement level is 50 percent); category Cs (pharmaceutical products 20 Baker & McKenzie

29 Belgium The reimbursement decision comes into force the first day of the month that follows a ten-day period after its publication in the Belgian Official Journal (Moniteur belge-belgische Staatsblad). From that day usually only on remittance of a medical prescription, the patient pays only the co-payment. The reimbursement decision can be subject to a reappraisal procedure which will revise or confirm the pharmaceutical product reimbursement modalities. Reappraisals are either individual or collective and are usually triggered by budget impact or uncertainty concerns. Class 1 pharmaceutical products are systematically reappraised as the assessment of the added therapeutic value is often based on factors with surrounding uncertainty. Individual reappraisal usually takes place between 18 and 36 months after the positive decision. 2. Is there a direct price control on pharmaceutical products? In Belgium, as a general rule, all pharmaceutical products are subject to price control. 3. What are the pricing procedures, if any, under which the price for pharmaceutical products is determined? In Belgium, several procedures for determining the prices of pharmaceutical products exist. The main procedures for determining prices are set out in the following decrees: Two Ministerial Decrees dated 29 December 1989: used in certain chronic illnesses e.g., antihistamines and vaccines which reimbursement level is 40 percent); and category Cx (contraceptives and antispasmodics which reimbursement level is 20 percent). Pharmaceutical products with no reimbursement and that are thus fully paid by patients are sometimes referred as category D pharmaceutical products. European Pricing and Reimbursement Handbook 21

30 Belgium o the first deals with pharmaceutical products that are reimbursed under the national health insurance system; o the second deals with other pharmaceutical products, of which at least one pharmaceutical form is subject to prescription; The Ministerial Decree dated 20 April 1993 which deals with other pharmaceutical products and which contains a general price control mechanism not limited to pharmaceutical products; The Ministerial Decree dated 2 April 1996 concerning the maximum sales prices and the maximum margins for wholesale and dispensing; The Ministerial Decree of 5 May 2006 which contains a separate procedure for establishing prices for generic products and pharmaceutical products registered on the basis of a bibliographic application. The Ministry of Economic Affairs is the competent authority for setting the maximum ex-factory price of all pharmaceutical products. There are two pricing committees, one for reimbursed pharmaceutical products (the Pricing Committee for Pharmaceutical Products) and one for non reimbursed pharmaceutical products (the Price Regulation Commission). Price setting and price increases require the prior approval of the Minister of Economic Affairs to whom an application must be sent containing information as to the applicant, including its financial situation, the relevant product and the elements which may justify the proposed price or price increase, including the manufacturing cost and a comparison with the prices applicable in other EU countries. Prior to any decision, the Minister must consult one of the pricing committees. 22 Baker & McKenzie

31 Belgium The decision of the Minister must be sent to the applicant within: 90 days (which may be extended to sixty days in very exceptional cases) for prescription only pharmaceutical products; 45 days for parallel imported and distributed pharmaceutical products; and 60 days for OTC pharmaceutical products as from the receipt of the complete application. In the absence of any decision within the required period, the applicant may apply the maximum price or the price increase as requested. The price set by the Minister of Economic Affairs is a maximum exfactory price. The main criteria considered for setting the maximum prices are: ex-factory prices in other European countries; prices of similar products in Belgium; manufacturer s personnel, overhead, and administrative costs; and manufacturer s investments in research and development. In Belgium, regulated price cuts for old pharmaceuticals are applied: pharmaceutical products containing an active component that has been reimbursed for more than 12 years are reduced by 17 percent (ex-factory level); once the active component is reimbursed for more than 15 years, the applied pharmacy retail price (PRP) and the corresponding reimbursement basis are reduced by an additional 2.41 percent (ex-factory level). 4. What instruments are used to control public expenditure on pharmaceutical products (reference pricing, co-payment, payback, value-based pricing, risk-sharing arrangements, etc.)? To reduce expenditure on pharmaceuticals, several measures have been undertaken. These include notably a further reduction in prices for products within the reference price system (i.e., the basis of reimbursement of an original pharmacological product for which there is a less expensive version [often a generic or a copy ] is decreased). In addition to that, reimbursement agreements with the NIHDI (Agreements) can be concluded in very specific situations and under European Pricing and Reimbursement Handbook 23

32 Belgium specific conditions, one of them being that a negative reimbursement opinion has been issued. Agreements have been so far rather exceptional 4. This could however change in the future, since the recent reform in the system seems to have triggered a new wave of interest for the Agreements. 5. Is there a specific policy for generic pharmaceutical products (for instance, fast track approval, lower registration fees, etc.)? Is the price of generic products fixed by law? The Ministerial Decree of 5 May 2006 contains a separate procedure for establishing prices for generic products and pharmaceutical products registered on the basis of a bibliographic application. The pharmaceutical company must notify 30 days before marketing the product, the proposed ex-factory price to the Price Regulation Commission. The decision of the Price Regulation Commission must be sent to the applicant within 30 days. In the absence of any decision within the required period, the applicant may apply the maximum price as requested. In 2007, a simplified administrative reimbursement procedure was introduced for certain generic pharmaceutical products, pharmaceutical products registered on the basis of a bibliographic application, and parallel import pharmaceutical products. Under this procedure, a decision for reimbursement must be taken within 60 days (subject to suspension) and without the involvement of the CRM/CTG. Also, in Belgium, the possibility of generic prescription, the so-called International Non Proprietary Name (INNN) prescription, was introduced. Physicians can still prescribe specific branded pharmaceutical products, but must however meet certain targets of generic prescription. For generic prescription, pharmacists must as a general rule dispense the cheapest product. 4 To date eight Agreements have been concluded. 24 Baker & McKenzie

33 Belgium 6. What incentives exist for innovative pharmaceutical products? The act of 30 March 1994 relating to social measures has introduced a system of price-volume agreements for innovative medical products to be concluded between the government and pharmaceutical companies. Under this act, price increases of certain products could be granted provided that the pharmaceutical companies would undertake to maintain the annual expenses of the health care insurance within limits to be defined and to reimburse any additional expenses incurred for health insurance. In addition, when the innovative product is going through the centralized approval procedure under Regulation (EC) 726/2004 on the authorization and supervision of pharmaceutical products and establishing a European Medicines Agency, the price application can be submitted as soon as the Committee for Pharmaceutical Products for Human Use (CHMP) issues a positive opinion. 7. Are hospitals allowed to run public tenders on pharmaceutical products? If so, what are the rules governing the pricing proposal of the pharmaceutical companies? Yes, hospitals are allowed to run public tenders and must follow the legal procedure applicable to public tenders. For maximum pricing the same rules as the ones described under question 3 are applicable. At the end of 2006, the legal basis was established for a new procedure (designed for the modification of reimbursement conditions for pharmaceuticals) based on the principles of public tendering, the so-called kiwi model. In general terms, an indirect competitive benefit is offered to the pharmaceutical company, by means of a lower co-payment for the patients for its pharmaceutical product(s), offering the lowest cost for the treatment (from the health insurance and patient perspective). The Minister of Social Affairs launched two of these procedures (for simvastatin and amlodipin) without any success. European Pricing and Reimbursement Handbook 25

34 Belgium 8. Is there a difference between reimbursement of pharmaceutical products prescribed by physicians in private practice and those prescribed in a hospital? On 1 July 2006, a new financing system was introduced for pharmaceutical products dispensed in hospitals, according to which hospitals receive a fixed reimbursement sum for pharmaceuticals dispensed during a patient stay, independent of the real expenditure for that patient. Hospitalized patients are only charged a fixed daily amount of EUR0.62 for dispensed reimbursed pharmaceuticals, while non-reimbursed pharmaceuticals are always charged in full. The Minister for Social Affairs is responsible for determining the exceptions. 9. Can a pharmaceutical product that is used for an indication for which it is not approved (i.e., off-label use) be reimbursed? If yes, what are the conditions? No. 26 Baker & McKenzie

35

36 Czech Republic Česká republika Patrik Kastner, Milena Hoffmanová a Michaela Drábková Shrnutí: Jak je ve vaší zemi organizována veřejná zdravotní péče? Česká veřejná zdravotní péče je upravena mimo jiné zákonem č. 48/1997 Sb., o veřejném zdravotním pojištění, v platném znění (dále jen zákon o veřejném zdravotním pojištění ), a cenovým předpisem Ministerstva zdravotnictví 2/2009/FAR (dále jen cenový předpis ), vydaným na základě zákona č. 265/1991 Sb., o působnosti orgánů České republiky v oblasti cen, a zákona č. 526/1990 Sb., o cenách. Výše uvedené právní předpisy stanovují hlavní pravidla pro úhradu a stanovení cen léčivých přípravků v České republice. 1. Které léčivé přípravky jsou hrazeny z veřejného zdravotního pojištění, jakými postupy? Postupy a typy léčivých přípravků hrazených z veřejného zdravotního pojištění jsou stanoveny zákonem o veřejném zdravotním pojištění. Primární kompetenci, především v oblasti stanovení maximálních cen a úhrad léčivých přípravků, má Státní ústav pro kontrolu léčiv (dále jen SÚKL ). Do cenové regulace léčivých přípravků je však zapojeno i Ministerstvo zdravotnictví ČR. Při poskytování ambulantní péče zahrnují léčivé přípravky hrazené z veřejného zdravotního pojištění léčivé přípravky obsahující léčivé látky uvedené v příloze 2 zákona o veřejném zdravotním pojištění, u nichž vydal SÚKL rozhodnutí o jejich úhradě v souladu s příslušnými právními předpisy. Z veřejného zdravotního pojištění jsou dále hrazeny individuálně připravované léčivé přípravky, radiofarmaka a transfuzní přípravky, a to ve výši stanovené opatřením obecné povahy vydaným SÚKLem. Při poskytování ústavní péče jsou v závislosti na míře a závažnosti onemocnění z veřejného zdravotního pojištění plně hrazeny léčivé přípravky, individuálně připravované léčivé přípravky, radiofarmaka a 28 Baker & McKenzie

37 Czech Republic Czech Republic Patrik Kastner, Milena Hoffmanová and Michaela Drábková Executive Summary: How are National Health Services (NHS) organized in your country? Czech NHS are regulated, among other things, by Act No. 48/1997 Coll., on Public Health Insurance, as amended ( Public Health Insurance Act ) and Price Regulation of the Ministry of Health 2/2009/FAR ( Price Regulation ) issued on the basis of Act No. 265/1991 Coll., on Competence of the Czech Republic Authorities in the Area of Prices and Act No. 526/1990 Coll., on Prices. The preceding legal regulations stipulate main rules for the reimbursement and pricing of pharmaceutical products in the Czech Republic. 1. Which pharmaceutical products are reimbursed by the NHS, under what procedures? The procedures and type of pharmaceutical products reimbursed by the NHS are stipulated by the Public Health Insurance Act. The primarily competent authority, especially in the area of setting of maximum prices and reimbursement of the pharmaceutical products, is the State Institute for Drug Control ( Institute ). Nevertheless, the Czech Ministry of Health also participates in the area of price regulation of the pharmaceutical products. When providing outpatient care, pharmaceutical products reimbursed by the NHS include pharmaceutical products containing active substances listed in Annex 2 to the Public Health Insurance Act, regarding which the Institute issued a decision on their reimbursement pursuant to applicable legal regulations. Moreover, individually prepared pharmaceutical products, radiopharmaceuticals and transfusion products are reimbursed by the NHS in the amount set by a measure of general nature issued by the Institute. European Pricing and Reimbursement Handbook 29

38 Czech Republic transfuzní přípravky, které jsou nejméně ekonomicky náročné, tj. pacienti se na úhradě výše uvedených položek vůbec nepodílejí. S výhradou vysoce inovativních přípravků (viz bod 6 níže) se rozhodnutí o úhradě léčivého přípravku nevydává na omezenou dobu. SÚKL je nicméně povinen nejméně jednou ročně kontrolovat, zda stanovená výše a podmínky úhrady léčivého přípravku odpovídají příslušným zákonům. Při stanovení výše a podmínek úhrady léčivého produktu zařadí SÚKL léčivý přípravek do referenční skupiny. Referenční skupiny jsou skupiny léčivých přípravků, které jsou z terapeutického hlediska v zásadě zaměnitelné, mají stejnou nebo podobnou účinnost a bezpečnost a obdobné klinické využití. Seznam referenčních skupin stanoví Ministerstvo zdravotnictví ČR prováděcí vyhláškou. Základní úhrada léčivého přípravku se pak rovná základní úhradě pro referenční skupinu, do které byl daný léčivý přípravek zařazen. Základní úhrada je úhrada za obvyklou denní terapeutickou dávku léčivých látek obsažených v léčivých přípravcích a je stejná pro celou referenční skupinu. Základní úhrada v referenční skupině je stanovena jako: (a) nejnižší cena pro konečného spotřebitele připadající na denní terapeutickou dávku léčivého přípravku zařazeného do referenční skupiny, zjištěná v kterémkoliv státě Evropské unie (EU) u léčivého přípravku dostupného v České republice; dostupný léčivý přípravek znamená léčivý přípravek, jehož podíl na celkovém objemu prodeje v zásadě zaměnitelných léčivých přípravků na trhu v České republice v uplynulém kalendářním čtvrtletí dosáhl nejméně 3 procent, pokud se nejedná o první až třetí generický léčivý přípravek k léčivé látce uvedený na český trh; pro účely stanovení základní úhrady se zahraniční cena pro konečného spotřebitele upraví o případné rozdíly ve výši daní nebo obchodních přirážek mezi státem, kde byla cena zjištěna, a Českou republikou; 30 Baker & McKenzie

39 Czech Republic When providing inpatient care, pharmaceutical products, individually prepared pharmaceutical products, radiopharmaceuticals and transfusion products that are less economically challenging depending on the extent and severity of the illness are fully reimbursed by the NHS, i.e., patients do not participate in the reimbursement of the preceding items at all. Subject to highly innovative pharmaceutical products (please see point 6 below), the decision on reimbursement of a pharmaceutical product is not issued for a limited time period. Nevertheless, the Institute is obligated to revise compliance of set amount and conditions of reimbursement of a pharmaceutical product with applicable laws at least once a year. When setting the amount and conditions of the reimbursement of a pharmaceutical product, the Institute includes the pharmaceutical product in a reference group. Reference groups are groups of pharmaceutical products that are, in general, therapeutically interchangeable, have similar or close efficacy and safety and similar clinical use. A list of reference groups is established by the Czech Ministry of Health in an implementing regulation. The baseline reimbursement of the pharmaceutical product is then equal to the baseline reimbursement for the reference group in which the pharmaceutical product was included. The baseline reimbursement is the reimbursement for the ordinary daily therapeutic dose of the active substances contained in the pharmaceutical products, and is the same for the entire reference group. The baseline reimbursement in a reference group is set at: (a) the lowest final consumer price attributable to the daily therapeutic dose of the pharmaceutical product included in the reference group, as ascertained in any country of the European Union (EU) for a pharmaceutical product available in the Czech Republic; available pharmaceutical product means the pharmaceutical product which accounted for at least European Pricing and Reimbursement Handbook 31

40 Czech Republic (b) (c) denní náklady jiné terapie, pokud je z hlediska účinnosti a efektivity nákladů srovnatelná s použitím léčivého přípravku podle bodu (a) a tyto skutečnosti jsou SÚKLu v době stanovení základní úhrady známy, s přihlédnutím k potřebné době terapie léčivým přípravkem a potřebné době srovnatelné terapie; cena pro konečného spotřebitele vyplývající z cenové soutěže, pokud je tato cena nižší než cena zjištěná podle bodu (a) nebo (b); (d) nejvyšší cena pro konečného spotřebitele obsažená v písemném ujednání učiněném ve veřejném zájmu mezi zdravotní pojišťovnou a držitelem rozhodnutí o registraci, výrobcem nebo dovozcem, pokud je taková cena nižší než cena podle bodu (a), (b) nebo (c) a pokud je ujednání učiněno ve vztahu ke všem dodávkám daného léčivého přípravku na český trh. 2. Existuje u léčivých přípravků přímá cenová kontrola? Podle příslušných právních předpisů je přímá cenová kontrola prováděná ze strany SÚKLu omezena na léčivé přípravky hrazené z veřejného zdravotního pojištění. Přímá cenová kontrola se nicméně vztahuje jak na léčivé přípravky na lékařský předpis, tak i na volně prodejná léčiva. Při stanovení cen se nerozlišuje mezi léčivými přípravky podávanými pacientům v rámci ošetřovatelské péče poskytované doma, resp. mimo nemocniční zařízení a léčivými přípravky podávanými pacientům v nemocnicích v České republice. 3. Na základě jakých cenových postupů je stanovena cena léčivých přípravků? Podle cenového předpisu podléhají veškeré léčivé přípravky hrazené z veřejného zdravotního pojištění (i) regulaci maximální cenou léčivého 32 Baker & McKenzie

41 Czech Republic 3 percent of the total sales of essentially interchangeable pharmaceutical products with one active substance in the previous calendar quarter if it is not first to third generic pharmaceutical product to the active essence launched to the Czech market; for the purposes of setting the baseline reimbursement, the foreign price for the end consumer is adjusted for any differences in the amounts of taxes and margins between the country in which it was established and the Czech Republic; (b) (c) the daily cost of another therapy if the same is comparable in efficacy and cost effectiveness to the use of a pharmaceutical product pursuant to letter (a) and such facts are known to the Institute when the baseline reimbursement is set, taking into account the required time of therapy by the pharmaceutical product and the required time of the comparable therapy; the final consumer price resulting from price competition, if such price is lower than that identified pursuant to letters (a) or (b); (d) the highest final consumer price contained in a written arrangement made in the public interest between the health insurance company and the market authorization holder, manufacturer or importer if such price is lower than that pursuant to letters (a), (b), or (c) and if the arrangement is made with respect to all supplies of the pharmaceutical product to the Czech market. 2. Is there a direct price control on pharmaceutical products? Pursuant to applicable legal regulations, the direct price control performed by the Institute is limited to the pharmaceutical products reimbursed by the NHS. Nevertheless, the direct price control applies both in case of prescription and OTC pharmaceutical products. European Pricing and Reimbursement Handbook 33

42 Czech Republic přípravku, (ii) regulaci věcným usměrňováním ceny a (iii) regulaci maximální obchodní přirážkou, tj. maximální přirážkou, kterou si může distributor přičíst k ceně účtované subjektem uvádějícím zboží na trh v ČR. Pravidla pro stanovení maximální ceny Maximální cenu léčivého přípravku stanoví SÚKL takovým způsobem, aby nepřekračovala: (a) (b) (c) průměr výrobních cen konkrétního léčivého přípravku v zemích referenčního koše, pokud je daný léčivý přípravek na trhu nejméně ve třech zemích referenčního koše; tato podmínka je splněna také tehdy, když daný léčivý přípravek není na trhu nejméně ve třech zemích referenčního koše, ale držitel rozhodnutí o registraci, dovozce nebo distributor požádá o to, aby byla namísto ceny konkrétního léčivého přípravku použita cena nejlevnějšího generika; průměr tří nejnižších výrobních cen konkrétního léčivého přípravku v ostatních členských státech EU v případě, že není uplatněn postup podle bodu (a) výše; nebo výrobní cenu terapeuticky nejbližšího srovnatelného léčivého přípravku dostupného v České republice, a pokud žádné takové léčivé přípravky neexistují, nejnižší výrobní cenu nejbližšího srovnatelného přípravku v členských státech EU, v případě, že není uplatněn postup podle bodu (a) nebo (b) výše. Země referenčního koše jsou stanoveny prováděcí vyhláškou Ministerstva zdravotnictví č. 92/2008 Sb. Regulace věcným usměrňováním ceny Pravidla pro výpočet věcného usměrňování ceny jsou stanovena cenovým předpisem. Tato pravidla se týkají pouze individuálně připravovaných léčivých přípravků, radiofarmak a transfuzních 34 Baker & McKenzie

43 Czech Republic There are no differences between pricing of pharmaceutical products that are delivered to patients in the community and the pricing of pharmaceutical products delivered to patients in hospitals in the Czech Republic. 3. What are the pricing procedures, if any, under which the price for pharmaceutical products is determined? According to the Price Regulation, all pharmaceutical products reimbursed by the NHS are subject to (i) regulation by maximum price of a pharmaceutical product; (ii) regulation by a matter-of-fact price; and (iii) regulation by maximum distribution margin, i.e., maximum mark-up which may be added by a distributor on the top of the price charged by an entity launching goods on the market in the Czech Republic. Rules for setting maximum price The maximum price of a pharmaceutical product is set by the Institute in such a way that the price does not exceed: (a) (b) an average of manufacturing prices of the particular pharmaceutical product in the reference countries, provided that the given pharmaceutical product is marketed in at least three reference countries; this condition is also met if the given pharmaceutical product is not marketed in at least three reference countries but the market authorization holder, importer or a distributor requests that the price of the cheapest generic pharmaceutical product in a reference country is used instead of the price of the particular pharmaceutical product; an average of three lowest manufacturing prices of the particular pharmaceutical product in other member states of the EU, in case that the procedure pursuant to letter (a) above cannot be applied; or European Pricing and Reimbursement Handbook 35

44 Czech Republic přípravků, které splňují podmínky dále stanovené cenovým předpisem. Maximální obchodní přirážka Maximální obchodní přirážka, tj. maximální přirážka, kterou mohou všichni účastníci v rámci distribučního řetězce přičíst k základní ceně, za kterou produkt dodává výrobce/dovozce první osobě oprávněné distribuovat nebo podávat takový produkt v České republice (bez zahrnutí obchodní přirážky a DPH), je stanovena Ministerstvem zdravotnictví jako procento vypočtené ze základu představovaného cenou daného produktu skutečně uplatněnou výrobcem/dovozcem (bez DPH). Maximální distribuční marže činí od 5 do 36 procent v závislosti na základní ceně produktu (čím vyšší je základní cena, tím nižší je distribuční marže). V případech, kdy se na distribučním řetězci v České republice podílí více osob, nesmí celkový úhrn jednotlivých marží použitých takovými osobami přesáhnout stanovenou maximální marži. Upozorňujeme, že další pravidla (týkající se například nulové marže nebo informační povinnosti subjektů podílejících se na distribuci léčivých přípravků vůči jejich zákazníkům) jsou stanovena příslušnými právními předpisy. Cena léčivého přípravku může být stanovena jako cena pro konečného spotřebitele. Pokud není léčivý přípravek hrazen v plné výši, může být po konečném spotřebiteli požadována úhrada poměrné části ceny takového léčivého přípravku. V případech stanovených příslušným zákonem je navíc použita výrobní cena. V případech stanovených příslušným zákonem se dále uplatní limit stanovující maximální část ceny hrazené z veřejného zdravotního pojištění. Obecně nepodléhá regulace cen žádným časovým omezením. 36 Baker & McKenzie

45 Czech Republic (c) manufacturing price of therapeutically nearest comparable pharmaceutical product available in the Czech Republic, and if there are no such pharmaceutical products, the lowest manufacturing price of therapeutically nearest comparable product in the member states of the EU, in case that the procedures pursuant to letter (a) or (b) above cannot be applied. The reference countries are determined by the implementing regulation of Ministry of Health No. 92/2008 Coll. Regulation by a matter-of-fact price The rules for calculation of a matter-of-fact price are stipulated by the Price Regulation. These rules relate only to individually-prepared pharmaceutical products, radiopharmaceuticals and transfusion products that meet the conditions further determined by the Price Regulation. Maximum distribution margin The maximum distribution margin, i.e., the maximum mark-up which may be added by all participants in the distribution chain on top of the base price for which the product is supplied by the manufacturer/importer to the first person authorized to distribute or dispense such product in the Czech Republic (the distribution margin and VAT not included), is set by the Ministry of Health as percentage points calculated from the base as represented by the product s price actually applied by the manufacturer/importer (without VAT). Maximum distribution margin varies from 5 to 36 percent depending on the base price of the product (the higher the base price, the lower the rate of distribution margin). In cases where there are several persons taking part in the distribution chain within the Czech Republic, the sum of individual margins applied by such persons cannot exceed the stipulated maximum margin. European Pricing and Reimbursement Handbook 37

46 Czech Republic 4. Jaké nástroje se používají ke kontrole veřejných výdajů na léčivé přípravky (např. stanovení referenčních cen, spoluúčast na úhradě, vrácení úhrad, stanovení cen v závislosti na hodnotě a ujednání o sdílení rizik)? Nejčastěji používanými nástroji pro kontrolu veřejných výdajů na léčivé přípravky zahrnují maximální ceny a výše úhrady léčivých přípravků a spoluúčast na úhradě. Dále mohou být sjednány systémy bonusů, dohody o ceně/objemu a ujednání o sdílení rizika, ovšem ty se nevyskytují tak často jako nástroje uvedené v předchozí větě. 5. Existuje konkrétní předpis o generických léčivých přípravcích (například rychlejší schvalovací proces, nižší registrační poplatky)? Je cena generických přípravků stanovena právním předpisem? Podle aplikovatelného práva platí, že se v případě generických léčivých přípravků neuplatní žádný specifický postup (tj. neuplatní se zrychlený registrační proces a poplatky za registraci jsou stejné jako v případě inovativních léčivých přípravků). Cena generických léčivých přípravků není jako taková pevně stanovena právem. Pokud však na český trh vstupuje první generický léčivý přípravek k inovativnímu léčivému přípravku, jehož cena je regulována prostřednictvím maximální ceny, stanoví SÚKL jeho maximální cenu tak, aby byla o 25 procent nižší, než je maximální cena inovativního léčivého přípravku, ledaže je cena generického léčivého přípravku stanovená v souladu s pravidly uvedenými v bodě 3 výše nebo cena navrhovaná žadatelem nižší. V případě druhého generického léčivého přípravku se jeho maximální cena dále snižuje o 10 procent. Podobně platí, že v případě stanovení výše a podmínek úhrady prvního generického léčivého přípravku k inovativnímu léčivému přípravku se základní úhrada celé referenční skupiny (viz bod 1 výše), do níž byl 38 Baker & McKenzie

47 Czech Republic Please note that further rules (e.g., regarding zero margin or information obligation of entities involved in the distribution of pharmaceutical products vis-à-vis their customers) are stipulated by applicable legal regulations. The price of a pharmaceutical product may be determined as the public price for an end consumer. The end consumer may be required to pay a proportional part of the price of the pharmaceutical product, unless the pharmaceutical product is reimbursed in full. Moreover, the manufacturing price is applied in cases determined by applicable law. Additionally, a cap fixing the maximum part of the public price reimbursed by the NHS applies in cases determined by applicable law. In general, the price regulation is not subject to any time limits. 4. What instruments are used to control public expenditure on pharmaceutical products (e.g., reference pricing, co-payment, payback, value-based pricing and risk-sharing arrangements)? The instruments mostly used to control public expenditure on pharmaceutical products comprise maximum and reimbursement prices of pharmaceutical products and co-payments. Additionally, bonus schemes, price/value agreements and risk-sharing arrangements may be concluded, although they do not appear as often as the instruments mentioned in the preceding sentence. European Pricing and Reimbursement Handbook 39

48 Czech Republic generický léčivý přípravek zařazen SÚKLem, snižuje nejméně o 25 procent (v závislosti na ceně generického léčivého přípravku), pokud nejsou splněny specifické podmínky stanovené zákonem o veřejném zdravotním pojištění. Základní úhrada příslušné referenční skupiny se obdobně dále snižuje o 10 procent, pokud SÚKL stanovuje výši a podmínky úhrady druhého generického léčivého přípravku. 6. Jaké existují pobídky u inovativních léčivých přípravků? U vysoce inovativních léčivých přípravků platí odlišná pravidla úhrady z veřejného zdravotního pojištění. SÚKL v souladu se zákonem o veřejném zdravotním pojištění rozhodne o výši a podmínkách dočasné úhrady vysoce inovativního přípravku, u něhož nebyl dosud v průběhu jeho použití v klinické praxi získán dostatek informací ohledně jeho nákladové efektivity nebo výsledků léčby; SÚKL ovšem takové rozhodnutí vydá pouze tehdy, je-li to ve veřejném zájmu, pokud dostupné informace dostatečně prokazatelně dokládají přínos takového vysoce inovativního přípravku pro léčbu a také pokud léčivý přípravek splňuje všechny další podmínky nezbytné ke stanovení výše a podmínek úhrady z veřejného zdravotního pojištění a zároveň je hrazen z veřejných prostředků nejméně v jedné zemi referenčního koše. Výše a podmínky úhrady jsou stanoveny na dobu 12 měsíců a mohou být třikrát obnoveny. 7. Mohou nemocnice vyhlašovat výběrová řízení na dodávku léčivých přípravků? Pokud ano, jakými pravidly se řídí cenová nabídka farmaceutických společností? Ano, mohou. Některé nemocnice jsou dokonce povinny vyhlašovat výběrová řízení na léčivé přípravky, jelikož využívají veřejné zdroje k výkonu svých činností a jsou považovány za veřejné zadavatele ve smyslu zákona č. 137/2006 Sb., o veřejných zakázkách, v platném znění (dále jen zákon o veřejných zakázkách ). Zákon o veřejných zakázkách 40 Baker & McKenzie

49 Czech Republic 5. Is there a specific policy for generic pharmaceutical products (for instance, fast track approval, lower registration fees)? Is the price of generic products fixed by law? Pursuant to applicable law, no specific policy applies in case of generic pharmaceutical products (i.e., there is no fast track approval in place and the registration fees are the same as in case of the innovative pharmaceutical products). The price of the generic pharmaceutical products is not as such fixed by law. Nevertheless, if that first generic pharmaceutical product for an innovative pharmaceutical product whose price is regulated by the maximum price enters the Czech market, the Institute shall determine its maximum price so that it is 25 percent lower than the maximum price of the innovative pharmaceutical product, unless the maximum price of the generic pharmaceutical product determined in compliance with the rules specified in point 3 above or the price proposed by the applicant is lower. In case of a second generic pharmaceutical product, its maximum price shall be further lowered by 10 percent. Similarly, in case of setting the amount and conditions of the reimbursement of the first generic pharmaceutical product for an innovative pharmaceutical product, the baseline reimbursement of the whole reference group (please see point 1 above), in which the generic pharmaceutical product was included by the Institute, shall be cut by at least 25 percent (depending on the price of the generic pharmaceutical product), unless specific conditions stipulated by the Public Healthcare Insurance Act are met. Likewise, the baseline reimbursement of the relevant reference group shall be further lowered by 10 percent if the amount and conditions of the reimbursement of a second generic pharmaceutical product are set by the Institute. European Pricing and Reimbursement Handbook 41

50 Czech Republic rozlišuje několik druhů veřejných zakázek a stanoví odlišná pravidla pro každou z nich. Co se týká nemocnic, které nejsou povinny vyhlašovat výběrová řízení na léčivé přípravky, neexistuje v České republice žádný právní předpis, který by jim bránil vyhlašovat soukromá výběrová řízení na léčivé přípravky. Tato soukromá výběrová řízení však musí být v souladu s pravidly obchodní veřejné soutěže stanovenými zákonem č. 513/1991 Sb., obchodní zákoník, v platném znění (dále jen obchodní zákoník ). Pravidla pro cenové nabídky farmaceutických firem pak vyplývají z požadavků stanovených nemocnicemi vyhlašujícími výběrová řízení. Taková výběrová řízení, jak již bylo zmíněno výše, musí splňovat pravidla vymezená zákonem o veřejných zakázkách nebo případně obchodním zákoníkem. Farmaceutické společnosti však musí postupovat v souladu s pravidly zakazujícími omezování hospodářské soutěže. 8. Je rozdíl mezi úhradou léčivých přípravků předepsaných lékaři majícími soukromou praxi a léčivými přípravky předepsanými v nemocnici? Ne, není. Pro oba případy platí stejná pravidla. 9. Může být hrazen léčivý přípravek, který je použit pro jinou indikaci, než pro kterou byl schválen (tzv. použití off-label )? Pokud ano, za jakých podmínek? Ano, může. Podle zákona o veřejném zdravotním pojištění může SÚKL rozhodnut o úhradě registrovaného léčivého přípravku pro offlabel použití v případě, že je použití takového přípravku dostatečně opodstatněno současným vědeckým poznáním a je jedinou variantou léčby nebo je ve srovnání s již dostupnou terapií nákladově efektivnější. 42 Baker & McKenzie

51 Czech Republic 6. What incentives exist for innovative pharmaceutical products? In case of highly innovative pharmaceutical products, different rules apply regarding their reimbursement by the NHS. In compliance with the Public Healthcare Insurance Act, the Institute shall decide on the amount and conditions of temporary reimbursement of a highly innovative pharmaceutical product in respect of which there is not sufficient level of information on its cost effectiveness or results of therapy during its use in the clinical practice; however the Institute shall issue such decision only if it is in the public interest, the available information is sufficient grounds evidencing the benefit of the highly innovative pharmaceutical product for the therapy, and it also complies with all other conditions necessary for determination of the amount and conditions of reimbursement by the NHS and, at the same time, the highly innovative pharmaceutical product is reimbursed from the public funds at least in one of the reference countries. The amount and conditions of the reimbursement are stipulated for the period of 12 months and may be renewed three times. 7. Are hospitals allowed to run public tenders on pharmaceutical products? If so, what are the rules governing the pricing proposal of the pharmaceutical companies? Yes. Some hospitals are even obligated to run public tenders on the pharmaceutical products since they use public funds to perform their activities and are considered public contracting authorities within the meaning of Act No. 137/2006 Coll., on Public Procurement, as amended ( Public Procurement Act ). The Public Procurement Act differentiates several categories of public procurements and stipulates different rules for each of them. European Pricing and Reimbursement Handbook 43

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53 Czech Republic As to the hospitals not legally bound to run public tenders, no legal regulation preventing them from running the private public tenders on pharmaceutical products exists in the Czech Republic. These private public tenders, however, must comply with the rules of the commercial public competition stipulated in Act No. 513/1991 Coll., the Commercial Code, as amended ( Commercial Code ). The rules for the pricing proposals of the pharmaceutical companies then follow from the requisites stipulated by the hospitals running the public tenders. Such public tenders, as already mentioned above, must observe the rules determined by the Public Procurement Act or by the Commercial Code, as applicable. Nevertheless, the pharmaceutical companies need to adhere with the rules prohibiting limitation of competition. 8. Is there a difference between reimbursement of pharmaceutical products prescribed by physicians in private practice and those prescribed in a hospital? No. The same rules apply in both cases. 9. Can a pharmaceutical product that is used for an indication for which it is not approved (i.e., off-label use) be reimbursed? If yes, what are the conditions? Yes. Pursuant to the Public Healthcare Insurance Act, the Institute may decide on the reimbursement of a registered pharmaceutical product for off-label use in case that use of such pharmaceutical product is sufficiently justified by the current state of knowledge and the use of the pharmaceutical product is the only option of therapy or the use is cost effective in comparison with the available therapy. European Pricing and Reimbursement Handbook 45

54 France France Thomas Devred Résumé introductif : Comment l Assurance Maladie est-elle organisée dans votre pays? Les prix des médicaments et de certains dispositifs médicaux sont fixés en France seulement pour ceux de ces produits qui sont admis au remboursement et qui sont destinés au circuit ville (délivrance aux patients en ville par les pharmacies). Cependant, les prix des médicaments et des dispositifs médicaux destinés au circuit hospitalier (délivrance aux patients hospitalisés) sont indirectement contrôlés au travers de mécanismes de facturation mis en place entre les hôpitaux publics ou les cliniques privées et l Assurance Maladie ( AM ). La réglementation française prévoit des procédures accélérées à la fois pour les génériques et pour les médicaments innovants. 1. Quels sont les médicaments qui sont remboursés par l AM, et selon quelles procédures? Seuls les médicaments (innovants ou génériques, OTC si prescrits ou médicaments soumis à prescription) et les dispositifs médicaux qui ont été admis au remboursement sur la base des opinions médicoéconomiques des Commissions compétentes de la Haute Autorité de Santé ( HAS ) peuvent être remboursés par les organismes de la Sécurité Sociale dans le cadre de l AM. Au sein de la HAS, la Commission de la Transparence est compétente pour l évaluation des critères de remboursement pour les médicaments, et la Commission Nationale d Evaluation des Dispositifs Médicaux et des Technologies de Santé est compétente pour les dispositifs médicaux. Le critère le plus important pour l évaluation des médicaments et des dispositifs médicaux est le Service Médical Rendu ( SMR ). 46 Baker & McKenzie

55 France France Thomas Devred Executive Summary: How are National Health Services ( NHS ) organized in your country? Prices for pharmaceutical products and certain medical devices are fixed in France only for those products which are admitted to reimbursement and intended to be delivered to patients in town by pharmacies. However, prices of pharmaceuticals and medical devices intended to be delivered to patients staying in public hospitals or private clinics are indirectly controlled through the invoicing system implemented between such hospitals and clinics and the Assurance Maladie ( AM the French Health Insurance National Program or French NHS). French regulations provide for fast-track procedures for both generics and innovative products. 1. Which pharmaceutical products are reimbursed by the NHS, under what procedures? Only pharmaceutical products (innovative and generics, OTC if prescribed and prescription-only pharmaceuticals) and medical devices which have been admitted to reimbursement upon the economic and scientific opinions of the competent Commissions of the Haute Autorité de Santé ( HAS High Health Agency) can be reimbursed by the Social Security organizations in the framework of the AM. Within the HAS, the Transparency Commission is competent for assessing the reimbursement criteria for pharmaceuticals and the Commission for the evaluation of medical devices and health technologies is competent for medical devices. European Pricing and Reimbursement Handbook 47

56 France Il y a plusieurs niveaux de SMR. Les produits pour lesquels la Commission compétente estime dans son opinion que le SMR est insuffisant seront exclus du remboursement. Les produits apportant un SMR suffisant seront remboursés selon différents taux. Plus le niveau de SMR est important, plus le taux de remboursement augmente. Par exemple, les produits pour lesquels la Commission compétente considère que le SMR est au niveau le plus important pourront être remboursés à 100 % par l AM ; les produits dont le SMR est évalué à un niveau moyen ne seront que partiellement remboursés par l AM (et les patients pourront obtenir le remboursement de la partie non couverte par l AM au travers des complémentaires-santé des assureurs du secteur privé). Ce système s applique aux médicaments et aux dispositifs médicaux délivrés aux patients par les pharmacies de ville, et les taux de remboursement s appliquent au prix public (voir les Sections 2 et 3 ci-dessous sur la notion de prix public et sur le système de l AM pour les produits délivrés ou implantés aux patients dans les hôpitaux publics ou les cliniques privées). Une fois les médicaments ou dispositifs médicaux admis au remboursement sur la base de l opinion favorable de la Commission compétente de la HAS, leurs prix sont fixés dans une convention avec le Comité Economique des Produits de Santé ( CEPS ). La décision finale (portant sur l admission au remboursement, la fixation du prix et la détermination du taux de remboursement) est prise par les ministres compétents et publiée au Journal Officiel. Cette décision doit être prise dans un délai de 180 jours à compter de la date de réception du dossier complet soumis par le fabricant du médicament ou du dispositif médical à l appui de sa demande d inscription au remboursement. En principe, les produits sont admis au remboursement pour cinq ans. A l issue de chaque période quinquennale, les fabricants doivent présenter une demande de renouvellement, qui donnera lieu à une nouvelle évaluation du SMR. Cependant, au gré des diverses politiques gouvernementales mises en œuvre pour le financement de l AM, les produits peuvent être retirés de la liste des produits 48 Baker & McKenzie

57 France The most important criteria for the assessment of both pharmaceuticals and medicals devices is the Service Médical Rendu ( SMR Medical Benefit provided by the product to the patients). There are various levels of SMR. Products for which the competent Commission considers in its opinion that the SMR is not sufficient will be excluded from reimbursement. Products offering a sufficient SMR will be reimbursed at various rates. The higher the SMR level is, the more important the reimbursement rate becomes. For example, products for which the competent Commission considers the SMR is at the best level will be 100 percent reimbursed through the AM; products with a mid-level SMR will be partly reimbursed through the AM (and patients can get reimbursed for the part not covered by the AM by their private health insurers). This system applies to pharmaceuticals and medical devices delivered to patients in town by pharmacies, and the reimbursement rate applies to the public price (please see below Sections 2 and 3 the notion of public price and the system applying to the AM coverage of products delivered or implemented to patients in public hospitals or private clinics). Once pharmaceuticals or medical devices are admitted to reimbursement upon the positive opinion of the competent Commissions of the HAS, their prices are fixed in an agreement with the Comité Economique des Produits de Santé ( CEPS Economic Committee for Health Products). The final decision (including the admission to reimbursement, the determination of the price and the reimbursement rate) is taken by the competent Ministries and published in the French Official Journal. This decision must be taken with 180 days from the receipt of the complete dossier submitted by the pharmaceutical or medical device manufacturer for its application for reimbursement. In principle, the products are admitted to reimbursement for five years. At the end of each five-year period, manufacturers must submit an application for renewal, which will trigger a new assessment of the SMR. However, depending of the various governmental political European Pricing and Reimbursement Handbook 49

58 France remboursables, ou leur prix ou taux de remboursement peuvent être baissés, à tout moment. 2. Existe-t-il un contrôle direct sur les prix des médicaments? Les prix des médicaments ou des dispositifs médicaux qui ne sont pas admis au remboursement sont librement fixés selon la loi du marché. Les prix des médicaments ou des dispositifs médicaux qui sont admis au remboursement et qui sont destinés au circuit ville sont fixés dans une convention négociées par leur fabricant avec le CEPS, et sont remboursés sur la base d un taux prédéterminé qui s applique au prix public (voir la section 3 ci-dessous). Les prix des médicaments ou des dispositifs médicaux, qu ils soient ou non admis au remboursement, et qui sont destinés au circuit hospitalier, sont en principe libres. Toutefois, les prix auxquels les hôpitaux ou cliniques achètent les médicaments ou dispositifs médicaux auprès de leurs fabricants sont indirectement contrôlés, puisque les conditions dans lesquelles l AM couvre les hôpitaux ou cliniques de leurs dépenses sont réglementées par le mécanisme de la T2A (les patients ne payent pas les produits utilisés pour leur traitement en séjour hospitalier et n ont dès lors pas à en demander le remboursement, les hôpitaux ou cliniques achètent ces produits et les coûts afférents sont pris en charge par l AM au travers du système de la T2A). En application du système de la T2A, chaque prestation de soin fournie aux patients par les hôpitaux ou cliniques est l objet d un classement au sein de diverses catégories de prestation de soins et les coûts globaux supportés par les hôpitaux ou cliniques pour fournir une prestation sont évalués et prédéterminés pour chaque catégorie de soins. La prise en charge des coûts supportés par les hôpitaux ou les cliniques n est assurée par l AM que dans la limite de ces coûts prédéterminés. Ces catégories de prestation de soin et les coûts associés sont appelés GHS et couvrent globalement tous les coûts supportés par les hôpitaux ou cliniques pour fournir les prestations aux patients (consultation d un médecin, chirurgien, chambre d hôpital, 50 Baker & McKenzie

59 France strategies for the funding of the AM, products can be withdrawn for the list of reimbursable products, or their price or reimbursement rates can be decreased at any time. 2. Is there a direct price control on pharmaceutical products? Prices of pharmaceuticals or medical devices which are not admitted to reimbursement are free and fixed following the law of the market. Prices of pharmaceuticals or medical devices which are admitted to reimbursement and which are delivered to patients in town by pharmacies are fixed by an agreement negotiated between their manufacturers and the CEPS, and are reimbursed on the basis of a predetermined rate which applies to the public price (please see Section 3 below). Prices of pharmaceuticals or medical devices, whether admitted to reimbursement or not, which are delivered to patients staying in public hospitals or private clinics are free in principle. However, prices at which hospitals or clinics purchase pharmaceuticals or medicals devices from their manufacturers are indirectly controlled since the conditions under with the AM covers the related costs for hospitals and clinics are regulated through the T2A system (patients do not pay for products used for their treatment within hospitals or clinics and thus do not have to seek reimbursement; hospitals and clinics purchase such products and their related expenses are covered by the AM through the T2A system). Under the T2A system, each medical service which can be provided to patients by hospitals or clinics is predetermined in various categories of medical services and the global cost incurred by hospitals or clinics to provide the related medical service to the patients is assessed and predetermined. Hospital and clinics will only be covered by the AM at the level of this predetermined cost. Such medical services categories and their predetermined costs are called GHS and includes globally all the costs incurred by hospitals or clinics to provide the medical services to the patients (doctor consultation, surgeon, hospital bedroom, nurse, European Pricing and Reimbursement Handbook 51

60 France infirmière, analyses médicales, et médicaments et dispositifs médicaux). En conséquence, sous le régime de la T2A, les hôpitaux et les cliniques sont contraints de gérer leurs propres budgets et les coûts qu ils engagent pour fournir les prestations de soins à leurs patients puisque l AM ne prend en charge ces coûts que dans la limite des GHS correspondants. Dès lors, les hôpitaux et les cliniques doivent négocier les prix d achats des médicaments et des dispositifs médicaux au regard des GHS correspondants dans l objectif d équilibrer leurs budgets. A titre dérogatoire, certains médicaments ou dispositifs médicaux considérés comme très innovants ou très coûteux peuvent demeurer temporairement en dehors du système de la T2A et exclus des GHS. Dans ce cas, un tarif de remboursement est fixé avec le CEPS pour ces produits, et l AM ne remboursera les hôpitaux ou les cliniques que dans la limite de ce tarif (l AM remboursera directement le coût de ces produits, en plus de la prise en charge des GHS). Il en découle que les prix sont encore plus indirectement contrôlés, puisque les hôpitaux ou les cliniques n acceptent jamais d acheter ce type de produit à un prix supérieur au tarif de remboursement. 3. Quelles sont, le cas échéant, les procédures applicables à la fixation des prix des médicaments? Le champ d application des procédures de fixation de prix est limité aux prix des médicaments et de certains dispositifs médicaux qui sont (i) admis au remboursement et qui sont (ii) destinés au circuit ville (à l exclusion des produits destinés au circuit hospitalier). Les prix pour ces produits sont des prix fixes (et non des prix forfaitaires délimitant la prise en charge de l AM). Les prix sont fixés dans une convention entre chaque fabricant et le CEPS. Les critères les plus importants sont les prévisions de volume globales pour le marché français, les prix déjà fixés pour les produits concurrents dans le même domaine thérapeutique et l Amélioration du Service Médical Rendu ( ASMR voir la Section 1 ci-dessus : le SMR du produit dont le prix est discuté avec le CEPS est comparé 52 Baker & McKenzie

61 France medical analysis, and pharmaceuticals and medical devices). As a consequence, under the T2A regime, hospitals and clinics must manage their own budget and the costs they incur to provide the medical services to their patient since the AM covers only those costs in the limit of the corresponding GHS. Therefore, hospitals and clinics must negotiate the purchase prices of pharmaceuticals and medical devices with regard to the corresponding GHS for costefficiency purposes. By way of exception, some pharmaceuticals or medical devices which are considered as very innovative or which are very expensive can remain temporarily out of the scope of the T2A system and excluded from GHS. In such a case, a reimbursement tariff is predetermined with the CEPS for such products, and the AM will reimburse hospitals and clinics at the level of this reimbursement tariff (i.e., will take directly in charge the cost of the concerned product, in addition to the GHS coverage). As a consequence, prices are more indirectly controlled for those products since hospitals or clinics never purchase such products from their manufacturers at a price higher than the reimbursement tariff. 3. What are the pricing procedures, if any, under which the price for pharmaceutical products is determined? Pricing procedures in France are limited in scope to prices of pharmaceuticals and of certain medical devices which are (i) admitted to reimbursement and (ii) intended to be delivered to patients in town by pharmacies (i.e., to the exclusion of products delivered to patients staying in hospitals or clinics). Prices for those products are fixed prices (as opposed to capped prices limiting the AM coverage). Prices are fixed by an agreement between each manufacturer and the CEPS. The most important criteria are the volume forecasts globally for the French market, the prices already fixed for competitors products in the same therapeutic area, and the Amélioration du Service Médical Rendu ( ASMR Improvement of the SMR, please see above Section 1: the SMR of the product which the price is discussed European Pricing and Reimbursement Handbook 53

62 France avec le SMR des produits concurrents déjà admis au remboursement, si le SMR du produit est meilleur que celui des produits concurrents, la Commission de la Transparence au sein de la HAS peut attribuer au produit un niveau d ASMR et le CEPS peut consentir à un prix supérieur). Le prix fixé dans la convention avec le CEPS est le prix fabricant (à savoir le prix auquel le fabricant vend le produit aux grossistesrépartiteurs). Toutefois, les marges des grossistes-répartiteurs et des pharmacies sont plafonnées par la réglementation sur la Sécurité Sociale, de sorte que le prix public auquel les patients achètent le produit en pharmacie (et sur lequel le taux de remboursement s applique) est aussi fixé de manière systématique. La convention de prix entre le fabricant et le CEPS doit être conclue dans le délai de 180 jours visé à la Section 1 ci-dessus. 4. Quels sont les instruments de contrôle des dépenses publiques en ce qui concerne les médicaments? Mises à part les stratégies politiques desquelles peuvent découler à tout moment des décisions contraignantes de baisse de prix pour certaines catégories de médicaments pour limiter autant que possible le déficit de l AM, l instrument utilisé pour contrôler les dépenses publiques relatives aux médicaments est la convention de prix avec le CEPS. Dans la convention avec le CEPS, des volumes sont établis pour fixer des plafonds pour les ventes du médicament concerné par son fabricant. A la fin de chaque année, si les ventes excédent les plafonds, le fabricant est alors obligé de reverser une partie de l excédant (calculée sur la base du chiffre d affaires réalisé au titre des ventes du médicament et en considération des plafonds) au travers de paiements directs à l AM. 54 Baker & McKenzie

63 France with the CEPS is compared to the SMR of the competitors products previously admitted to reimbursement; if the SMR of the product is better than the SMR of its competitors, the Transparency Commission at the HAS can consider that the medical benefit for patients is improved and thus the CEPS can agree on a higher price). The price fixed in the CEPS agreement is the manufacturing price (the price at which the manufacturer will sell the products to wholesalers). However, the margins of both the wholesalers and the pharmacies are capped by the Social Security regulations for pharmaceutical products, such that the public price at which patients purchase the product from pharmacies (and on which the reimbursement rates apply) is also systematically fixed. The pricing agreement must be entered into between the CEPS and the manufacturer within the 180-day time period mentioned in Section 1 above. 4. What instruments are used to control public expenditure on pharmaceutical products (reference pricing, co-payment, payback, value-based pricing, risk-sharing arrangements, etc.)? Except for any political strategy which could trigger mandatory decisions decreasing the prices of certain categories of product at any time to limit as much as possible the deficit of the AM, the instrument used to control public expenditure is the pricing agreement with the CEPS. In the CEPS agreement, volumes are determined to fix a cap for the sales of the concerned product by its manufacturer. At the end of each year, if the sales exceed such cap, the manufacturer is then obliged to make back payments (calculated on the basis of the annual sales turnover of the manufacturer and the cap) directly to the AM. European Pricing and Reimbursement Handbook 55

64 France 5. Existe-t-il des mesures spéciales pour les génériques? Le prix des génériques est-il réglementé? Oui, les génériques bénéficient d une procédure accélérée. Ces produits ne tombent pas dans le champ d application de la procédure d évaluation avec la Commission de la Transparence. Dans la mesure où le médicament de référence (à savoir le produit princeps innovant) est déjà admis au remboursement, on considère qu il n y pas besoin d évaluer le SMR des génériques, puisque ces derniers en sont la copie. Les procédures de fixation des prix auprès du CEPS sont également conduites plus rapidement. 6. Quelles sont les mécanismes d incitation en faveur des médicaments innovants? Il existe une procédure accélérée pour la fixation du prix des médicaments innovants (entendus dans la plupart des cas comme les produits pour lesquels la Commission de la Transparence a attribué l un des trois meilleurs niveaux d ASMR). Pour ces produits, le fabricant est habilité à proposer un prix au CEPS au plus tard un mois après l avis de la Commission de la Transparence. Si le CEPS ne réagit pas en faisant une contre-proposition de prix dans les deux semaines, alors le prix initialement proposé par le fabricant est réputé être accepté par le CEPS et celui-ci doit signer la convention de prix dans les 48 heures. Le prix initialement proposé par le fabricant doit correspondre aux prix qui pourraient déjà avoir été fixés dans les autres grands pays européens (Allemagne, Espagne, Italie et Royaume-Uni). 56 Baker & McKenzie

65 France 5. Is there a specific policy for generic pharmaceutical products (for instance, fast track approval, lower registration fees, etc.)? Is the price of generic products fixed by law? Yes, generics benefit from a fast-track approval. Such products do not fall in the scope of the assessment procedure with the Transparency Commission. To the extent that the reference product (i.e., the innovative princeps ) is already admitted to reimbursement, it is considered that there is no need to assess the SMR of the generics since the latter are copies of the reference product. Pricing procedures with the CEPS are also achieved faster. 6. What incentives exist for innovative pharmaceutical products? There is a fast-track pricing procedure for innovative pharmaceuticals (defined, in the most general cases, as the products for which the Transparency Commission is of the opinion that the ASMR is ranked within one of the three best levels). For such products, the manufacturer is entitled to address a price proposal to the CEPS at the latest one month after the date of the Transparency opinion. If the CEPS does not revert to the manufacturer with another price proposal within the two weeks following the initial proposal of the manufacturer, then the price initially proposed by the manufacturer is considered as tacitly accepted by the CEPS and the pricing agreement must be signed with such price by the CEPS in 48 hours. The price initially proposed by the manufacturer must be consistent with the prices which could have already been fixed in the other major European countries (Germany, Italy, Spain and UK). European Pricing and Reimbursement Handbook 57

66 France 7. Les hôpitaux sont-ils habilités à lancer des appels d offres pour leur approvisionnement en médicaments? Dans l affirmative, quels sont les règles gouvernant les prix dans les offres des fabricants? En vertu de la réglementation française des marches publics, les hôpitaux sont obligés de lancer des appels d offres pour les marchés générant des commandes de médicaments de plus de 4000 EUR. En pratique, les offres soumises par les fabricants seront présentées en considération des GHS ou des tarifs de remboursement (voir la Section 2). 8. Existe-t-il une différence entre le remboursement des médicaments prescrits par les médecins libéraux en ville les ceux qui sont prescrits au sein des hôpitaux? Oui. Un médicament prescrit par un médecin liberal en ville sera delivré au patient par une pharmacie. Le patient ne payera pas la partie du prix public prise en charge par l AM, grâce au réseau de transmission électronique qui a été développé en France (chaque patient est titulaire d une Carte Vitale, une carte électronique l identifiant par son numéro de Sécurité Sociale et permettant au pharmacien de se connecter au réseau de transmission électronique de l AM pour obtenir paiement auprès de l AM directement). Le patient pourrait devoir payer la partie du prix qui n est pas prise en charge par l AM, s il n a pas souscrit à une complémentaire-santé auprès d un assureur privé pour le couvrir de cette partie du prix, ou si l assureur privé n est pas relié à la pharmacie par réseau électronique (auquel cas, le patient doit payer la pharmacie et est remboursé ultérieurement pas l assureur privé). A l hôpital, les patients ne payent rien en ce qui concerne les médicaments, si ces médicaments leur sont délivrés par la pharmacie intérieure de l hôpital. 58 Baker & McKenzie

67 France 7. Are hospitals allowed to run public tenders on pharmaceutical products? If so, what are the rules governing the pricing proposal of the pharmaceutical companies? Pursuant to French rules governing public procurement contracts, hospitals are obliged to run public tenders for the supply of pharmaceuticals or medical devices which will trigger purchase orders of more than EUR4,000. In practice, offers presented by manufacturers in bid procedures will be based on the GHS or the reimbursement tariff (please see Section 2). 8. Is there a difference between reimbursement of pharmaceutical products prescribed by physicians in private practice and those prescribed in a hospital? Yes. A pharmaceutical product prescribed by a physician in private practice will be delivered to the patient by the pharmacy. The patient will not pay the portion of the public price which is covered by the AM, thanks to the electronic transmission system which is implemented in France (each patient has a Carte Vitale, i.e., an electronic card identifying the patient with his/her social security number and allowing the pharmacist to use the AM electronic network in order to get paid directly by the AM). The patient may have to pay to the pharmacist the portion of the price which is not covered by the AM, if he/she has not subscribed a health insurance policy with a private health insurer covering this portion, or if the private health insurer has not implemented any electronic system with the pharmacy (in which case the patient pays the pharmacy and is reimbursed later by the private insurer). At the hospital, patients do not pay anything as far as prices of pharmaceuticals are concerned, to the extent that such pharmaceuticals are delivered by the internal pharmacy of the hospital. European Pricing and Reimbursement Handbook 59

68 France 9. Un médicament utilisé dans une indication hors- AMM peut-il être remboursé? Sous quelles conditions? Non, sauf si le fabricant a convenu préalablement d un accord spécifique avec l AM. 60 Baker & McKenzie

69 France 9. Can a pharmaceutical product that is used for an indication for which it is not approved (i.e. off-label use) be reimbursed? If yes, what are the conditions? No, except if the manufacturer has reached a specific agreement with the AM. European Pricing and Reimbursement Handbook 61

70 Germany Deutschland Thilo Räpple & Frank Pflüger Erstattung Und Preissetzung Von Arzneimitteln Die Gesetzliche Krankenversicherung (GKV) wurde in Deutschland 1883 eingeführt. Ihre fundamentalen Prinzipien gelten bis heute. Es handelt sich um ein beitragsfinanziertes öffentlich- bzw. sozialrechtliches Versicherungssystem. Die wesentlichen gesetzlichen Regelungen sind im Fünften Sozialgesetzbuch (SGB V) zusammengefasst. Für weite Teile der Bevölkerung besteht Versicherungspflicht (abhängig Beschäftigte unterhalb bestimmter Einkommensgrenzen, Bezieher von Erwerbsersatzeinkünften, Studierende, Rentner etc.). Bestimmte Familienangehörige sind mitversichert. Nur ca. 13% der Bevölkerung ist nicht über die GKV krankenversichert und hält meistenteils private Versicherungspolicen. Das GKV-Budget für Arzneimittel beträgt 2011 ca. 30 Mrd. Euro. Die Versorgung der GKV-Versicherten mit Arzneimitteln geschieht als Sachleistung. Das heißt, die Versicherten haben einen Anspruch auf Arzneimittelversorgung gegen die GKV. Diese bedient sich der involvierten Leistungserbringer, nämlich (Vertrags-)Ärzten, Apotheken sowie Krankenhäuser, um Arzneimittel auf Kosten der GKV zu verordnen, abzugeben bzw. anzuwenden. Nur bei Privatversicherten gilt dagegen der konträre Grundsatz der Kostenerstattung, d.h. diese Patienten zahlen die Arzneimittel (bzw. die damit durchgeführten Therapien) zunächst grundsätzlich selbst und beantragen Erstattung bei ihren (privaten) Versicherern. 1. Welche pharmazeutischen Produkte werden seitens des nationalen Gesundheitswesens zurückerstattet und nach welchen Verfahren? In Deutschland ist jedes Pharmaunternehmen frei, die Preise für seine Arzneimittel nach eigenem Ermessen festzulegen. Von den Kostenträgern (Gesetzliche und Private Krankenversicherung) werden indes grundsätzlich nur zugelassene apotheken- und 62 Baker & McKenzie

71 Germany Germany Thilo Räpple & Frank Pflüger Executive Summary: How are National Health Services (NHS) organized in your country? The statutory (or public) health insurance was introduced in Germany in the year Its fundamental doctrines have been in place ever since and remain until the present day. This health insurance is a universal insurance plan governed by public (social) law and funded on the basis of contributions paid by its members. Its essential statutory regulations are set forth in a legislation referred to as the 5th Social Code Book (SGB V). For major portions of the population, membership in the public health insurance is compulsory (employees whose wages do not surpass certain thresholds, individuals entitled to certain income replacement benefits, students, pensioners, etc.). Certain family members are included in the insurance coverage. Just about 13 percent of the population is not insured with the public health insurance. They mostly hold insurance contracts with private insurance companies. The budget of the public health insurance allocated to drugs (medicinal products) amounted to about EUR30 billion in The provision of drugs within the public health insurance works on the basis of a service in kind. This means, the insured individuals have a claim against the public health insurance to the extent that they be provided and treated with medications. The public health insurance retains certain medical service providers, namely office-based physicians (associated with the public insurers), pharmacies, and hospitals for prescribing, dispensing and administering drugs at the expense of the public health insurance. Only for privately insured patients, the opposing principle of cost reimbursement applies. This means, as a general rule, such patients pay for the drugs (and the according treatments) themselves and then seek recovery (reimbursement) of the incurred expenses from their (private) insurers. European Pricing and Reimbursement Handbook 63

72 Germany verschreibungspflichtige Arzneimittel erstattet; OTC-Präparate werden von den Kostenträgern grundsätzlich nicht erstattet ( Erstattung hier untechnisch dahingehend zu verstehen, dass Kosten von der GKV übernommen werden). Auch bei Vorliegen dieser Voraussetzungen sind bestimmte Präparate von der (GKV-) Leistungspflicht ausgeschlossen, wie z.b. sog. Lifestylepräparate oder (bei Erwachsenen) Mittel gegen Erkältungskrankheiten. Im ambulanten Bereich ist Voraussetzung der Kostenübernahme eine ärztliche Verordnung. Diese löst die Kostenübernahme/Erstattung aus. Es bedarf daher grds. keiner Genehmigung einer individuellen Arzneimittelversorgung durch eine bestimmte Behörde. Bei besonders teuren Arzneimitteln oder unsicherer Indikation stellen Ärzte bzw. Versicherte jedoch oft Kostenübernahmeanfragen bei den zuständigen Krankenkassen. Der Status als kostentragungsfähiges Arzneimittel ist nicht zeitlich limitiert. Als Behörden fungieren bei in der gesetzlichen Krankenversicherung (GKV) die vorerwähnten Krankenkassen. Es gibt z.z. noch ca. 150 davon. Ca. 90% der deutschen Bevölkerung sind dort versichert. Die Krankenkassen sind in erster Linie Versicherungsträger. Behördliche Befugnisse üben die Krankenkassen indirekt durch ihre Verbände auf Länder- und Bundesebene aus. Z.B. legt der Spitzenverband für bestimmte Arzneimittel maximale Kostenübernahmebeträge fest (sog. Festbeträge, s.u.). 2. Gibt es eine direkte Preiskontrolle für pharmazeutische Produkte? Bestimmte OTC sind ausnahmsweise in der GKV kostentragungsfähig. Die entsprechenden Präparate werden von einem quasi-untergesetzgeberischen Gremium, dem sog. Gemeinsamen Bundesausschuss (GBA), listenmäßig festgelegt. Über Apotheken abgegebene und zulasten der GKV verordnete Arzneimittel unterliegen der sog. Arzneimittelpreisverordnung. Dieses Gesetz regelt jedoch keine Preise sondern nur (Maximal-)Aufschläge, die in den Handelsstufen (Großhändler und Apotheke) auf die Abgabepreise der pharmazeutischen Unternehmer aufgeschlagen werden dürfen. Für 64 Baker & McKenzie

73 Germany 1. Which pharmaceutical products are reimbursed by the NHS, under what procedures? In Germany, pharmaceutical companies are free to determine the prices of their drugs according to their discretion. As a general rule, payers (public and private health insurers) have to reimburse only drugs approved for the market which have the status of prescriptiononly and pharmacy-bound medicinal products. OTC s are in general not eligible for reimbursement (in the present context, reimbursement is not to be understood as an equivalent of the technical term Kostenerstattung but rather in the sense of cost coverage by public health insurers). Even with the aforementioned conditions met, certain medicinal products are exempt from reimbursement (by public health insurers), such as so-called lifestyle drugs (for adults) or drugs against coughs and sneezes. In the outpatient sector, the precondition of reimbursement is a prescription made out by a physician. Such prescription triggers reimbursement. Hence, as a general rule, there is no need for obtaining approval of individual prescriptions from specific authorities. Nevertheless, when prescribing particularly expensive drugs and/or in case of questionable indications, physicians and/or insured patients often make prior inquiries for cost coverage with the competent public health insurer. The status as a reimbursable drug is not subject to any time limitations. If speaking of authorities the various public health insurers may be understood as working in such capacity. At present, there are still about 150 of such insurers in Germany, providing insurance coverage for approximately 90 percent of the population. They primarily operate as insurance carriers. Yet indirectly they exercise powers associated with authorities through their associations on state and federal levels. For example, the federal leading association of public health insurers determines maximum reimbursement sums for certain categories of drugs (so-called fixed amounts). European Pricing and Reimbursement Handbook 65

74 Germany den Verbrauch in Krankenhäusern bestimmte und an Krankenhäuser gelieferte Arzneimittel sind nicht der Arzneimittelpreisverordnung unterstellt. Für Krankenhausgroßpackungen gelten regelmäßig spezielle Abgabepreise. 3. Was sind die etwaigen Preisfestsetzungsverfahren für Arzneimittel? GKV-Versicherte erhalten kostenübernahmepflichtige Arzneimittel als Sachleistung in der Apotheke gegen Vorlage der Verordnung (eine Rezeptgebühr von i.d.r einigen Euro ist zuzuzahlen). Die Apotheken stellen die Arzneimittel (über Abrechnungsstellen) den Krankenkassen in Rechnung. Die pharmazeutischen Unternehmer wiederum verkaufen (direkt oder zwischengeschaltet über Großhändler) den Apotheken die Arzneimittel. Es erfolgt daher keine unmittelbare Vergütung der pharmazeutischen Unternehmer durch die Krankenkassen. Der Verkauf durch die pharmazeutischen Unternehmer erfolgt zu einem bundeseinheitlichen Abgabepreis. Auf diesen Preis dürfen Großhändler und Apotheken jeweils eine gesetzlich limitierte Marge aufschlagen. Der Abgabepreis selbst ist grds. nicht Gegenstand einer behördlichen Preisfestsetzung. Eine gewisse Ausnahme stellen sog. Rabattverträge dar. Dies sind Vereinbarung, in denen (regelmäßig nach öffentlicher Ausschreibung) zwischen Kassen und den bezuschlagten pharmazeutischen Unternehmern die bevorzugte Verordnung der vertragsgegenständlichen Arzneimittel sowie eine Rabattierung derselben gegenüber den Kassen geregelt wird. Als weitere Ausnahme ist für bestimmte neue und innovative Arzneimittel eine Aushandlung von erstattungsfähigen Preisen auf Basis einer Kosten-Nutzen- Bewertung vorgesehen. Eine Preiskontrolle findet für die GKV statt, indem durch eine Vielzahl von Mechanismen auf unterschiedliche Weise kostenübernahmefähige Maximalbeträge fixiert werden. Dies geschieht (außer indirekt Maximalbeträge fixiert werden. Dies geschieht (außer indirekt durch vorerwähnte Rabattverträge) z.b. durch sog. Festbeträge (wirksoffgruppenbezogen behördlich fixierte Erstattungshöchstbeträge), zeitlich begrenzte Preismoratorien (automatische Weiterleitung von Preiserhöhungen 66 Baker & McKenzie

75 Germany 2. Is there a direct price control on pharmaceutical products? Certain OTCs are exceptionally eligible for reimbursement by the public health insurance. The affected drugs are included in a list maintained by an organization called Federal Joint Committee (in German abbreviated GBA) which factually operates as a subordinate legislative body. Drugs dispensed by pharmacies and prescribed at the expense of the public health insurance are subject to the so-called Drug Prices Regulation (in German abbreviated AMPreisV). This piece of legislation does not set forth any actual prices, however. Rather, it regulates the (maximum) mark-ups which may be charged in the distribution chain (i.e., by the wholesalers and pharmacies) on top of the sales prices of the pharmaceutical companies. Drugs destined for consumption in, and supplied to, hospitals do not fall under the AMPreisV. For bulk packs delivered to hospitals, special prices usually apply. 3. What are the pricing procedures, if any, under which the prices for pharmaceutical products are determined? Patients insured with the public health insurance receive drugs subject to compulsory reimbursement in the form of benefits in kind, against presentation of the pertaining prescriptions in a pharmacy (a copayment of several Euros has to be paid out of the patients pockets). The pharmacies invoice the dispensed drugs (through special clearing organizations) to the public health insurers. In turn, the pharmaceutical companies sell those drugs to the pharmacies (either directly or through intermediary wholesalers). Thus, there are no direct payments by public health insurers to pharma companies. The sale of the drugs by pharma companies is based on a uniform sales price consistent all over Germany. Wholesalers and pharmacies may charge their mark-ups, the amounts of which are limited by law, on top of this sales price. The sales price itself is, as a general rule, not subject to a specific price fixing by authorities. In a certain sense, European Pricing and Reimbursement Handbook 67

76 Germany als Rabatte an die GKV) oder sog. Zwangsrabatte (von pharmazeutsichen Unternehmen zugunsten der GKV nachzulassende Pflichtabschläge i.h.v. 6, 10 oder 16%). 4. Welche Instrumente werden zur Kontrolle der staatlichen Ausgaben für pharmazeutische Produkte verwendet (Referenzpreise, Selbstbehalte, Rückzahlungen, wertbasierte Preise, Risikoaufteilung, etc.)? Im Sozialgesetzbuch V (SGB V) sind eine Reihe von Erstattungsregeln festgelegt, mit denen die Ausgaben der Krankenkassen für Arzneimittel begrenzt werden sollen. Zum einen sind für eine Vielzahl von Arzneimitteln Festbeträge festgelegt; dies sind Maximalbeträge, die die Krankenversicherung für bestimmte Wirkstoffe erstattet. Sofern der Preis für ein Arzneimittel höher als der Festbetrag liegt, muss der Patient eine entsprechende Zuzahlung leisten. Festbeträge können für Gruppen von Arzneimitteln mit (1) denselben Wirkstoffen, (2) pharmakologisch-therapeutisch vergleichbaren Wirkstoffen, insbesondere mit chemisch verwandten Stoffen und (3) therapeutisch-vergleichbarer Wirkung, insbesondere Arzneimittelkombinationen festgelegt werden. Darüber hinaus wurden für alle pharmazeutischen Unternehmer im SGB V Zwangsrabatte festgelegt, die sich bis auf 16% summieren können. Ein neues Instrument zur Kostenkontrolle in Deutschland ist die Kosten-Nutzen- Bewertung von Arzneimitteln. Im Rahmen dieses Verfahrens muss ein pharmazeutischer Unternehmer einen sogenannten Zusatznutzen nachweisen, um einen erhöhten Erstattungspreis erlangen zu können. Neben diesen Preisinstrumenten, die sich direkt auf den Preis des pharmazeutischen Unternehmers auswirken, gibt es gesetzliche Maßnahmen, mit denen die Verordnung von Arzneimittel durch Ärzte kontrolliert und beschränkt werden kann, einschließlich der Anordnung von sogenannten Arzneimittelregressen. Patienten müssen grundsätzlich für die Verordnung von verschreibungspflichtigen Arzneimitteln eine Zuzahlung leisten. Die Zuzahlung beträgt 10% des Arzneimittelpreises, mindestens aber Euro 5,-- und höchstens Euro 68 Baker & McKenzie

77 Germany however, an exception to this rule has been established in connection with so-called rebate agreements. The subject matter of such agreements, concluded between public health insurers and selected pharmaceutical companies (and very often awarded as a result of public tender procedures), relates to the preferred prescription/dispensing of the drugs included in the contractual medication plans as well as the grant of discounts (rebates) on the sale of such drugs. As a further exception, for specific new and innovative drugs, mechanisms are being introduced which put in place price negotiations based on a preceding benefit assessment. There is certainly an element of price control exercised to the benefit of the public health insurers (and inter alia implemented by GBA) based on a multitude of legal mechanisms functioning in different operational modes. These mechanisms (apart from the aforementioned rebate agreements) are conceived and implemented, for example, in the form of fixed amounts (capped reimbursable maximum amounts determined by organizations associated with the public insurers), temporary price freeze regulations (causing profits generated by raised price to be automatically passed on to the public insurers), and socalled compulsory rebates (i.e., mandatory discounts of 6, 10, or 16 percent imposed on pharmaceutical companies). 4. What instruments are used to control public expenditure on pharmaceutical products (reference pricing, co-payment, payback, value-based pricing, risk-sharing arrangements, etc.)? Social Act V (SGB V) sets out a number of reimbursement rules which are aimed to limit the expenditure of public health insurances for medicinal products. Firstly, for a number of drugs, fixed amounts have been established; these are maximum amounts which the public health insurance reimburses for certain active ingredients. In case the price for a drug is higher than the fixed amount, the patient is forced to make a co-payment. Fixed amounts may be established for groups of medicinal products with (1) identical active ingredients, (2) pharmacologically and therapeutically comparable active ingredients, in particular chemically related substances, and/or (3) substances with European Pricing and Reimbursement Handbook 69

78 Germany 10,--. Es gibt Ausnahmen von der Zuzahlungspflicht (z.b. Kinder bis 18, Präparate 30% unter Festbetrag, Rabattarzneimittel u.a). 5. Gibt es eine spezielle Richtlinie für Generika (beispielsweise Fast Track Zulassung, tiefere Registrationsgebühren, etc.)? Wird der Preis für Generika gesetzlich festgelegt? Es gibt in Deutschland kein Gesetz, das staatlichen Stellen oder Krankenversicherungen erlauben würde, Arzneimittelpreise festzulegen. Ein solches Gesetz wäre nach geltender Rechtsprechung verfassungswidrig. Dieser Grundsatz gilt für innovative Arzneimittel und Generika. Allerdings ist insbesondere mit dem Verfahren der frühen Nutzenbewertung ( 35a SGB V) ein Instrument eingeführt worden, mit dem der Erstattungspreis für ab 2011 neu in den Markt eingeführte Arzneimittel im Wege der Verhandlung bzw. im Wege eines Schiedsspruchs festgelegt werden kann. Außerdem gelten für alle grundsätzlich erstattungsfähigen Arzneimittel, die bereits oben unter Ziffer 4 erwähnten Instrumente zur Regulierung des Erstattungspreises. Ferner gibt es unterschiedliche Zwangsrabattabschläge für innovative Arzneimittel und Generika. 6. Welche Anreize bestehen für innovative pharmazeutische Produkte? Für die Entwicklung und den Vertrieb von innovativen Arzneimitteln gibt es keine gesetzlichen Anreize. Generell wird man jedoch sagen können, dass der Gesetzgeber tendenziell versucht, die Erstattung von innovativen Arzneimitteln weniger zu beschränken als diejenigen von Generika. 7. Dürfen Spitäler öffentliche Ausschreibungen für pharmazeutische Produkte machen? Falls ja, welche Regeln bestehen für die Preisofferten der pharmazeutischen Unternehmen? 70 Baker & McKenzie

79 Germany comparable therapeutic effect, in particular combination drugs. Furthermore, pharma companies have to pay compulsory rebates to the health insurances which might amount to up to 16 percent. A new instrument for cost control in Germany is the cost-benefit evaluation for drugs. Within the framework of this procedure, a pharma company must prove a so-called additional benefit of its product in order to be granted a favorable reimbursement price. In addition to these price instruments which directly affect the reimbursable price set by the pharmaceutical company, there are other legal measures with which the prescription of drugs through physicians is controlled and limited; physicians may even be subject to damage claims. Patients are generally required to make a co-payment for the prescription of each Rx product. The co-payment is 10 percent of the price of the drug; the minimum is EUR5 and the maximum is EUR10. There are exceptions from the obligation of co-payment (e.g., children until the age of 18, pharmaceutical with a price 30 percent below fixed price, rebated medicines, etc.). 5. Is there a specific policy for generic pharmaceutical products (for instance, fast track approval, lower registration fees, etc.)? Is the price of generic products fixed by law? There is no law in Germany which allows public bodies or health insurances to set the prices for medicinal products. Such a law would be against the constitution according to case law. This principle applies to innovative drugs and generics as well. However, the procedure of the early benefit evaluation (para. 35 a SGB V) introduces an instrument with which the reimbursement price for medicinal products which are introduced on the market since 2011 can be set by way of negotiation or decision. Furthermore, all instruments for controlling the reimbursement price which are mentioned above under no. 4 apply in general to all reimbursable medicinal products. Finally, there are different compulsory rebates for innovative medicines and generics. European Pricing and Reimbursement Handbook 71

80 Germany Es ist Krankenhäusern nicht verwehrt, öffentliche Ausschreibungen für Arzneimittel durchzuführen. Wenn bestimmte Einkaufsschwellen überschritten werden, müssen sogar Ausschreibungsverfahren durchgeführt werden. Allerdings ist die Ausschreibung durch Krankenhäuser in der Praxis eher selten. Denn sehr häufig bieten Pharmaunternehmen Krankenhäuser Arzneimittel ohnehin zu einem sehr günstigen Preis an, um die Chancen zu erhöhen, dass der Patient nach der Entlassung aus dem Krankenhaus von einem niedergelassenen Arzt mit demselben Präparat auf Kosten der Krankenkassen weiter behandelt wird. Auf der Ebene der Krankenversicherung sind Ausschreibungen hingegen mittlerweile üblich und führen zu drastischen Marktverschiebungen und der Verdrängung von Wettbewerbern. 8. Besteht ein Unterschied zwischen dem Rückerstattungspreis für pharmazeutische Produkte, die durch Ärzte in privaten Praxen und solchen die in Spitälern verschrieben werden? Arzneimittel, die in einem Krankenhaus abgegeben werden, unterliegen grundsätzlich nicht der Erstattung. Denn die Kosten für Arzneimittel, die ein Patient im Krankenhaus erhält, werden über pauschale Krankenhausentgelte für die Behandlung von Patienten abgedeckt. Eine Ausnahme gibt es nur für die Verordnung von Arzneimitteln im Rahmen der beschränkt zulässigen ambulanten Behandlung von Patienten. In diesem Fall ist die Erstattung der Arzneimittel vergleichbar mit derjenigen durch Arzneimittel in niedergelassener Praxis. 9. Kann ein pharmazeutisches Produkt, das für eine Indikation angewendet wird, für das es nicht zugelassen ist (d.h. Off-label-Use) durch die obligatorische Krankenversicherung bezahlt werden? Falls ja, unter welchen Voraussetzungen? Krankenkassen müssen grundsätzlich nur zugelassene Arzneimittel 72 Baker & McKenzie

81 Germany 6. What incentives exist for innovative pharmaceutical products? Incentives for the development and the distribution of innovative medicines are not available. Generally, it can, however, be said that the German legislator intends to restrict the reimbursement of innovative medicines less than the reimbursement of generics. 7. Are hospitals allowed to run public tenders on pharmaceutical products? If so, what are the rules governing the pricing proposal of the pharmaceutical companies? Hospitals are not prevented from initiating public procurement procedures for medicinal products. In case certain purchase levels are exceeded, such procurement procedures are even compulsory. In practice, hospitals initiate billing processes quite rarely. This is because pharma companies very often offer hospitals pharmaceutical products for a comparatively low price in order to increase the chances that the physician in private practice continues to treat the patient after leaving the hospital with the same medicine at the cost of the health insurances. At the level of the health insurances, public procurement procedures have meanwhile become usual and lead to drastic changes in the market and suppression of competitors. 8. Is there a difference between reimbursement of pharmaceutical products prescribed by physicians in private practice and those prescribed in a hospital? Medicinal products which are supplied in hospitals are generally not subject to reimbursement. This is because the costs for medicines which a patient receives in the hospital are covered by lump sum payments for the treatment of patients in a hospital. An exception applies only for the prescription of medicines in case of outpatient treatments by hospitals which are, however, possible only to a limited extent. In this case, the reimbursement of medicinal product is European Pricing and Reimbursement Handbook 73

82 Germany erstatten. Bei zugelassenen Arzneimitteln muss die Anwendung im Bereich der zugelassenen Indikation erfolgen. Die Erstattung von Arzneimitteln für die Anwendung im Rahmen eines Off-Label-Use ist nur ausnahmsweise erstattungsfähig. Von der Rechtsprechung sind 3 Voraussetzungen entwickelt worden, nämlich schwerwiegende Erkrankung, keine anderweitige anerkannte Therapie verfügbar, ausreichende Belege für eine Aussicht auf einen Behandlungserfolg. Was den Nachweis für die Therapieaussichten anbetrifft, gehen Gerichte davon aus, dass Studien die Wirksamkeit des Präparats in der Off-Label-Indikation nachweisen müssen, die Zulassungsstudien gleichwertig sind. Das heißt, es muss sich möglichst um eine randomisierte, placebokontrollierte und doppelblind durchgeführte Studie handeln. Beweiserleichterungen für den Nachweis der Wirksamkeit gibt es bei lebensbedrohlichen oder regelmäßig tödlich verlaufenden Erkrankungen. Die Rechtsprechung ist sehr differenziert und muss im Einzelfall überprüft werden. 74 Baker & McKenzie

83 Germany comparable with a reimbursement of a product which is prescribed by a physician in private practice. 9. Can a pharmaceutical product that is used for an indication for which it is not approved (i.e., off-label use) be reimbursed? If yes, what are the conditions? Health insurances are generally only required to reimburse approved products. Furthermore, approved products need to be applied within the label, i.e., the approved indication. The reimbursement of medicinal products for off-label use is only possible in exceptional cases. The courts have developed three requirements, namely: serious disease; no other acknowledged therapy available; and sufficient proof for the chances of a treatment success. As to the proof of the therapy chances, courts require the provision of clinical studies which give evidence of the efficacy of the medicine in the off-label indication and which meet the standards of an approval study. This means the study must be a randomized, placebo-controlled study which is performed in a double blinded format. Studies with lower scientific evidence can be sufficient in case of life-threatening diseases or diseases which usually end fatal. The case law is quite differentiated and needs to be checked in each individual case. European Pricing and Reimbursement Handbook 75

84 Hungary Magyarország Dr. Bíró Helga és Dr. Berekméri-Varró Réka Gyógyszerkészítmények társadalombiztosítási támogatása és árazása Összefoglaló: Hogyan épül fel, illetve hogyan működik a társadalombiztosítási támogatási rendszer? A gyógyszerek társadalombiztosítási támogatásának finanszírozására az Egészségbiztosítási Alapból kerül sor. A Költségvetési törvény, amely meghatározza a Magyar Köztársaság éves pénzügyi-gazdasági tervét tartalmazza az adott évben gyógyszertámogatásra fordítható összeg felső határát. Az egyes készítmények társadalombiztosítási támogatásba történő befogadásáról az Országos Egészségbiztosítási Pénztár (OEP) dönt. Az OEP-en belül annak szakosított főosztálya, az Ártámogatási Főosztály foglalkozik a gyógyszerár-támogatással kapcsolatos eljárások lefolytatásával. 1. Mely gyógyszerkészítmények, és milyen eljárások keretében részesülnek társadalombiztosítási támogatásban? A vonatkozó jogszabályok szerint egy gyógyszer kizárólag a forgalomba hozatali engedély jogosultja vagy annak meghatalmazottja kérelmére részesíthető társadalombiztosítási támogatásban abban az esetben, ha: annak biztonságosságát és hatásosságát a hatáskörrel rendelkező hatóság elismerte és forgalomba hozatalát engedélyezte; terápiás felhasználás szempontjából gazdaságosan és célszerűen rendelkezésre áll; felhasználásának költséghatékonysága igazolt, valamint támogatásához a szükséges társadalombiztosítási forrás rendelkezésre áll, illetve biztosítható; a forgalomba hozatali engedély jogosultja, illetve meghatalmazottja kötelezettséget vállal a támogatással történő forgalmazásra és készletben tartásra; és a 76 Baker & McKenzie

85 Hungary Hungary Helga Bíró and Réka Berekméri-Varró Executive Summary: How are National Health Services (NHS) organized in your country? Pharmaceutical products are reimbursed from the Health Insurance Fund. The Budget Act determines the annual financial and economic plan of the Republic of Hungary, and establishes the maximum amount that may be spent on the reimbursement of pharmaceutical products in a given year. The Health Insurance Fund Administration (OEP) decides whether to include individual pharmaceutical products into reimbursement. The Reimbursement Department of the OEP conducts procedures relating to the reimbursement of pharmaceutical products. 1. Which pharmaceutical products are reimbursed by the NHS, under what procedures? Pursuant to the relevant legal provisions, a pharmaceutical product may be included in reimbursement only at the request of the marketing authorization holder or its representative and only if: the competent authority has verified its safety and efficacy and authorized its marketing; it is available in an economic and reasonable manner for the purposes of therapeutic use; the cost-effectiveness of its use is proven; the necessary health insurance funding is available or can be ensured; the marketing authorization holder or its representative undertakes the obligation to distribute the product with reimbursement or keep the product in stock; and the entity requesting inclusion in reimbursement undertakes to comply with the relevant legal provisions relating to insurance costs. The OEP makes a formal decision in relation to the inclusion of pharmaceutical products in reimbursement, the reimbursement category, method, rate or amount as well as the starting date of European Pricing and Reimbursement Handbook 77

86 Hungary befogadást kérő vállalja a biztosítói költségekre vonatkozó szabályok betartását. Az OEP formális határozatot hoz a gyógyszerek támogatásba való befogadásáról, a támogatás kategóriájáról, módszeréről, mértékéről vagy összegéről, valamint az árhoz nyújtott társadalombiztosítási támogatás kezdőnapjáról. Az OEP-nek főszabály szerint a kérelem beérkezésétől számítva 90 nap áll rendelkezésére a határozat meghozatalára, azonban ez a határidő a jogszabályban meghatározott esetekben 60 napra rövidül, így például abban az esetben, ha a gyógyszer társadalombiztosítási támogatásba való befogadási kérelme már támogatott hatóanyagú készítmény új generikumára vonatkozik. Az OEP határozata ellen fellebbezésnek helye nincs, annak bírósági felülvizsgálata kérhető. Az OEP a gyógyszereket a jogszabályban meghatározott következő támogatási kategóriákba sorolhatja be: (a) 100 százalékos támogatási kategória (különkeretes gyógyszer), amely esetében a beteg semmit nem fizet a gyógyszerért; (b) (c) (d) (e) kiemelt, indikációhoz kötött támogatási kategória, amely esetében a beteg dobozonként 300 forintot (kb. 1 Euro) fizet a gyógyszerért; emelt, indikációhoz kötött támogatási kategória, amely esetében 90 százalékos, 70 százalékos, vagy 50 százalékos a támogatás, átlagon felüli támogatási kategória, amely esetben a gyógyszer ún. normatív 80 százalékos támogatásban részesül, átlagos támogatási kategória, amely esetben a gyógyszer ún. normatív 55 százalékos támogatásban részesül; 78 Baker & McKenzie

87 Hungary reimbursement. As a general rule, the OEP has 90 days to deliver its decision from the date of its receipt of the request for inclusion. However, this deadline is reduced to 60 days in certain cases as prescribed by the relevant laws, for example if the request for inclusion in reimbursement concerns a new generic of an already reimbursed active ingredient. No appeal may be brought against the decision of the OEP in the administrative proceeding; however, the decision may be subject to review by the courts. The OEP may categorize pharmaceutical products in the following reimbursement categories: (a) (b) (c) (d) (e) (f) (g) 100 percent reimbursement category (pharmaceutical product with a special budget) wherein the patient is not required to pay anything for the product; special reimbursement category that is contingent on an indication, where the patient must pay HUF300 (approx. EUR1) per packaging unit of the product; increased reimbursement category that is contingent on an indication, where the reimbursement rate is 90 percent, 70 percent or 50 percent; the above average reimbursement category, where the product is reimbursed at a so-called normative rate of 80 percent; average reimbursement category where the product is reimbursed at a so-called normative rate of 55 percent; below average reimbursement category where the product is reimbursed at a so-called normative rate of 25 percent; as well as category without reimbursement value (0 percent). European Pricing and Reimbursement Handbook 79

88 Hungary (f) átlag alatti támogatási kategória, amely esetben a gyógyszer ún. normatív 25 százalékos támogatásban részesül, valamint (g) támogatási érték nélküli kategória (0 százalék). A fenti (c) (f) pontok esetében tehát a beteg által fizetendő térítési díj az adott gyógyszerre az OEP által meghatározott támogatáson felüli összeg. A gyógyszerek támogatására az OEP a következő támogatási módszereket alkalmazhatja: százalékos mértékű támogatás; meghatározott (fix) összegű támogatás (hatóanyag alapú fix összegű támogatás vagy terápiás fix elven működő támogatás); támogatásvolumen-szerződés; közbeszerzés útján beszerzett, speciális támogatású gyógyszerekre kötött szerződés; illetve meghatározott összeggel vagy százalékosan csökkentett támogatás. Az egyes támogatási kategóriákban valamennyi fenti támogatási módszer alkalmazható. 2. Létezik-e hatósági árszabályozás a gyógyszerkészítmények piacán? A nem támogatott gyógyszerek árát a gyártó és a gyógyszer forgalmazói szabadon határozzák meg, ezen gyógyszerek tekintetében hatósági árkontroll nincs Magyarországon. A támogatott gyógyszerek ára azonban több tényezőtől függ. Egyrészt, bár a gyártó a gyógyszerbefogadási eljárás során szabadon határozhatja meg a gyógyszer termelői árát, azonban a gyártó az eljárás során az OEP-el történő egyeztetések eredményeképpen és a befogadás érdekében az ajánlat csökkentésére kényszerülhet. Továbbá, jogszabály alapján a generikus termék piacon való megjelenését követően képzett fix támogatási csoport esetében az első generikum termelői ára legalább 40 százalékkal alacsonyabb kell, hogy legyen az elsőként támogatásba bevont termék árától. Az ez után a támogatási rendszerbe kerülő második készítmény ehhez képest további legalább 20 százalékkal, a harmadik készítmény további 10 százalékkal alacsonyabb termelői áron, a további három belépő az utolsó belépőhöz képest 5 százalékkal alacsonyabb termelői áron fogadható be. Az árkontroll eszközeiként 80 Baker & McKenzie

89 Hungary In case of points (c) - (f) above, the price payable by the patient equals the amount in excess of the amount of reimbursement determined by the OEP. The OEP may apply the following reimbursement methods for the reimbursement of pharmaceutical products: percentage reimbursement; fixed reimbursement (active ingredient-based fixed reimbursement or therapeutic fixed reimbursement; subsidy-volume agreement; agreement on pharmaceutical products with special reimbursement procured through public procurement; as well as reimbursement decreased by a fixed amount or a certain percentage. These reimbursement methods may be used in any reimbursement category. 2. Is there a direct price control on pharmaceutical products? Manufacturers and distributors of non-reimbursed pharmaceutical products are free to determine the price of such pharmaceutical products, i.e., there is no price control with respect to these products in Hungary. However, the price of reimbursed pharmaceutical products depends on many factors. On the one hand, although the manufacturer is free to determine the manufacturing price of the pharmaceutical product in the course of the procedure for inclusion in reimbursement, the manufacturer may be forced to decrease its proposed price during the procedure as a result of negotiations with the OEP in order to ensure that its product is included in reimbursement. Further, pursuant to the relevant legal provisions, in case of fixed reimbursement groups that are established after the market release of a generic product, the price of the first generic product must be at least 40 percent lower than the price of the first product in the group that has been included in reimbursement. The manufacturing price of the second generic product must be at least 20 percent lower than that of the first generic product previously included in reimbursement. The manufacturing price of the third generic product must be at least 10 percent lower than the manufacturing price of the second generic product, whereas the manufacturing price of the subsequent three generic entrants must European Pricing and Reimbursement Handbook 81

90 Hungary figyelembe kell venni a lenti 4. pont (c) és (d) alpontjaiban írt korlátokat is. Jogszabály a gyógyszer árától függő, degresszív skálán megállapított maximum nagykereskedelmi és kiskereskedelmi árréseket határoz meg támogatott gyógyszerek esetében. A befogadási eljárás során az OEP által elfogadott termelői árhoz hozzáadják a jogszabály által meghatározott maximum nagykereskedelmi és kiskereskedelmi árrést és ez lesz az ún. közfinanszírozás alapjául szolgáló ár. Az OEP által a befogadási eljárás során meghatározott támogatási kulcsok alkalmazásával kerül kiszámításra a közfinanszírozás alapjául szolgáló ár figyelembevételével a támogatás összege, valamint a beteg által fizetendő térítési díj. Ennek megfelelően, a támogatás mértéke az ATC csoportonként kategorizált gyógyszerek közfinanszírozás alapjául elfogadott árának az adott csoportban maximálisan adható százalékos támogatási kulcsnak megfelelően számított 80, 55, 25, 0 százalékának megfelelő összeg, emelt támogatási kategóriába tartozó gyógyszerek esetében 90, 70, 50 százalékának megfelelő összeg, kiemelt támogatási kategória és különkeretes gyógyszerek esetében 100 százalékának megfelelő összeg. Ezek az adatok minden támogatott gyógyszer esetében hozzáférhetők az OEP honlapján is. Bár a jogszabály támogatott termékek esetében is maximált nagy- és kiskereskedelmi árrésről rendelkezik, egy külön törvényi szabály miatt a gyógyszertárak támogatott termékek esetében sem közvetlenül, sem közvetett módon nem térhetnek el az OEP által a befogadási eljárásban megállapított támogatási összegtől és térítési díjtól. Fekvőbeteg ellátás keretében történő gyógyszerfelhasználás esetén a gyógyszer beszerzési ára és a finanszírozás tekintetében a 7. és 8. pontokban foglaltakat kell figyelembe venni. 3. Ismertesse, hogy milyen eljárások keretében történik a gyógyszerkészítmények árának megállapítása, amennyiben vannak ilyen eljárások. 82 Baker & McKenzie

91 Hungary be 5 percent lower than each previous entrant. The limitations set out in section 4 (c) and (d) below are further instruments of price control. In case of reimbursed pharmaceutical products, the relevant legal provisions provide for maximum wholesale and retail price margins that are determined on the basis of the product price on a digressive scale. In the course of the procedure for inclusion in reimbursement, the maximum wholesale and retail price margin is added to the manufacturing price accepted by the OEP and as a result the so-called price serving as the basis for reimbursement is determined. The amount of reimbursement and the price to be paid by the patient is calculated by applying the reimbursement rate determined by the OEP in the procedure for inclusion in reimbursement to the price serving as the basis of reimbursement. Accordingly, the amount of reimbursement equals the maximum percentage of the price serving as the basis for reimbursement that may be applied in the given reimbursement category, i.e., 80, 55, 25, 0 percent of the price; 90, 70, 50 percent of the price in case of the increased reimbursement category; and 100 percent of the price in case of the special reimbursement category and in case of pharmaceutical products with a special budget. This information is also published on the website of the OEP in relation to every reimbursed pharmaceutical product. Although the relevant laws provide maximum wholesale and retail price margins in case of reimbursed products, a separate legal provision sets out that pharmacies may neither directly nor indirectly deviate from the amount of reimbursement and the price to be paid by the patient determined by the OEP in the course of the procedure for inclusion in reimbursement. In case of administration of pharmaceutical products in the course of in-patient care, sections 7 and 8 are applicable in relation to the price and the financing of such products. European Pricing and Reimbursement Handbook 83

92 Hungary A gyógyszerkészítmények árának megállapítására nincsen külön eljárás Magyarországon. Amint a fenti 2. pontban is hivatkoztunk rá, a nem támogatott gyógyszerek ára tekintetében nincsen hatósági kontroll. Támogatott készítmények esetében pedig a termelői ár az OEP-el való egyeztetés során kerül megállapításra a támogatás megállapítására irányuló eljárásban. Így az OEP egy eljárásban dönt a támogatás alapjául szolgáló árról, a támogatás mértékéről és a módjáról, amint azt az 1. kérdésre adott válaszban részletesen kifejtettük. 4. Milyen eszközöket alkalmaznak a gyógyszerkészítményekre fordított közkiadások csökkentésére? (például referencia-árazás, betegek hozzájárulása a gyógyszer árához, gyártói visszafizetési kötelezettség, érték-alapú árazás és kockázat-megosztáson alapuló megállapodások)? Magyarországon a Kormány sokrétű intézkedéseket vezetett be a gyógyszerkiadások ellenőrzése és lehetőség szerinti csökkentése érdekében. A gyógyszer támogatás-politika intézkedései közé tartozik különösen: (a) (b) a támogatásba befogadás költséghatékonysági kritériumokhoz kötött; bizonyos ún. indikációhoz kötött gyógyszerek kivételével a betegek is hozzájárulnak a gyógyszerek árához (Eü 90, 70, 50 százalékos, normatív 80 százalékos, 55 százalékos és 25 százalékos támogatási kulcsok alkalmazása); (c) referencia árazás alkalmazása a generikus termék megjelenését követően a fix támogatási csoportba sorolt termékek esetében, valamint a fix támogatási csoportok és a referencia árak negyedévenkénti újraképzése a gyártói árajánlatok alapján. A generikus készítmények piacra lépését követően alkalmazott hatóanyag alapú fix támogatási 84 Baker & McKenzie

93 Hungary 3. What are the pricing procedures, if any, under which the price for pharmaceutical products is determined? In Hungary, there is no separate procedure under which the price for pharmaceutical products is determined. As referred to in section 2 above, there is no price control with respect to non-reimbursed pharmaceutical products. In case of reimbursed pharmaceutical products, the manufacturing price is determined in the course of the procedure for inclusion in reimbursement as a result of negotiations with the OEP. Therefore, the OEP determines the price serving as basis for reimbursement as well as the amount and method of reimbursement in one procedure as detailed in section 1 above. 4. What instruments are used to control public expenditure on pharmaceutical products (e.g., reference pricing, co-payment, payback, value-based pricing and risk-sharing arrangements)? In Hungary, a variety of measures have been introduced to control and possibly even lower public expenditure on pharmaceutical products. These measures include especially the following: (a) (b) (c) the inclusion in reimbursement depends on the costeffectiveness of the pharmaceutical product; except for certain pharmaceutical products the reimbursement of which is contingent on their indication, patients must also contribute to the price of the product (application of reimbursement rates of 90, 70, 50 or 80 percent, 55 percent and 25 percent); the application of reference pricing in case of pharmaceutical products of fixed reimbursement groups after the market release of generic products, as well as the reestablishment of fixed reimbursement groups and reference prices quarterly. As regards to active ingredient-based fixed reimbursement groups established after the market entry of generic European Pricing and Reimbursement Handbook 85

94 Hungary csoportban a referenciaárazás azt jelenti, hogy az adott csoportban meghatározott (fix) összegű támogatás alapja a referencia készítménynek a közfinanszírozás alapjául elfogadott ára. A terápiás fix elven működő támogatás összegének meghatározása a jogszabályban meghatározott számítási módszerek alkalmazásával történik. Az OEP a támogatásból kizárja azt a gyógyszert, amelynek az ára hatóanyag alapú fix csoport esetén 30 százalékkal meghaladja a referencia készítmény árát. Terápiás fix csoport esetében az OEP akkor zárja ki a készítményt, ha az ára 60 százalékkal meghaladja a csoportba tartozó gyógyszerek napi terápiás költsége egyszerű számtani átlagát; (d) (e) az OEP félévente újraképezi a legalább már egy éve kialakításra került fix csoportokat és a gyártók árajánlata alapján meghatározza az ún. preferált referencia ársávba tartozó gyógyszerek körét. Preferált referencia ársávba tartozik egy gyógyszer, ha a napi terápiás költsége a referencia gyógyszer napi terápiás költségétől legfeljebb 5 százalékkal magasabb. Az ilyen gyógyszerek a referenciaárhoz nyújtott fix összegű támogatást kapják. A referencia ársávba nem tartozó gyógyszerek a referencia gyógyszer árához nyújtott támogatás összegénél 15 százalékkal alacsonyabb támogatást kapnak; nemzetközi referenciaárazás alkalmazása, amely alapján az OEP évente legalább egy alkalommal felülvizsgálatot tart a legmagasabb támogatáskiáramlást generáló, fix támogatású gyógyszerek körében és azok árát az EGT államokban ténylegesen forgalomban lévő ugyanazon vagy azonos hatóanyagú gyógyszer árával összehasonlítja. Ha a gyógyszer ára az összehasonlítás eredményeképpen 20 százalékkal magasabb, mint az EGT államokban forgalmazott három legalacsonyabb termelői árú gyógyszer árának számtani átlaga, akkor az OEP a támogatásból kizárja; 86 Baker & McKenzie

95 Hungary products, reference pricing means that the price of the reference product serving as the basis of reimbursement is the basis of the fixed reimbursement applied within the fixed reimbursement group. The amount of the therapeutic fixed subsidy is determined via calculation methods prescribed by the relevant legal provisions. In case of active ingredientbased fixed reimbursement groups, the OEP excludes a pharmaceutical product from reimbursement if its price exceeds the price of the reference product by 30 percent or more. In case of therapeutic fixed reimbursement groups, the OEP excludes a pharmaceutical product if its price exceeds the average daily therapeutic cost of the pharmaceutical products that belong to the reimbursement group by 60 percent or more; (d) (e) the OEP twice a year reestablishes those fix reimbursement groups which were created at least a year earlier and based on price offers of manufacturers, the OEP determines the medicinal products that belong to the so-called preferred reference price range. A medicinal product may belong to the preferred reference price range if its daily therapeutic cost is not more than 5 percent higher than the daily therapeutic cost of the reference medicinal product. Medicinal products that belong to the preferred reference price range get the reimbursement amount of the reference product. Medicinal products that do not belong to the preferred reference price range get a reimbursement amount which is 15 percent lower than the reimbursement of the reference product; the application of international reference pricing, according to which the OEP reviews pharmaceutical products that belong to a fixed reimbursement group and generate the highest public expenditure and compares the prices of these products to the prices of other products that are marketed in the EEA and that contain the same or a similar active ingredient. If it is established that the price of a product is at least 20 percent higher than the average price of the three lowest price European Pricing and Reimbursement Handbook 87

96 Hungary (f) (g) (h) támogatás-volumen szerződések (tehát a gyártó és az OEP közötti kockázatmegosztáson alapuló szerződések) alkalmazása, melyek legfeljebb négy évre köthetőek. A szerződéseken alapuló befizetési kötelezettség az esetek nagy részében az értékesítési volumen, illetve a támogatás kiáramlás nagyságától függ. Az OEP innovatív készítmények esetében a támogatásba történő befogadás során erőteljesebben veszi figyelembe azt is, hogy a támogatott terápia mennyire hatékony. Befizetési kötelezettség pedig olyan esetben is megállapítható, ha a szerződésben a gyártó által vállalt terápiaeredményességi mutató nem teljesül, amely esetben a befizetés mértéke függ az eredményesség elmaradásának hatására előálló becsült költségtől. Befizetési kötelezettség megállapítható akkor is, ha a kezeléshez kapcsolódóan biztosított, beteg-együttműködést (compliance) fokozó tevékenység szerződésben rögzített kritériumainak nem felel meg a gyártó; gyártói befizetési kötelezettség a gyógyszerkasszába, amely alapján a támogatott gyógyszer forgalomba hozatali engedélyének jogosultja az általa forgalmazott támogatott gyógyszerek támogatás kiáramlása után számított 20 százalékos adót köteles fizetni. A gyógyszercégek kötelesek továbbá ún. sávos befizetést teljesíteni, ha az adott évben a tervezett gyógyszerkassza hiánya lép fel. Ezen kívül a gyógyszercégek kötelesek külön adót fizetni orvoslátogatók foglalkoztatása esetén, amely adó mértéke jelenleg éves szinten orvoslátogatónként 10 millió forint (kb euró); az orvosok felírási szokásainak a figyelemmel kísérése, amely alapján az OEP félévenként ellenőrzi, hogy az orvosok által felírt és a betegek által kiváltott gyógyszerek hogyan viszonyulnak a Kormány által meghatározott, terápiához kapcsolódó támogatási célértékekhez. Amennyiben az orvos felírásai meghaladják a célértéket, az OEP az orvosnál ellenőrzést tarthat. Ha háziorvosok és gyógyszertárak a 88 Baker & McKenzie

97 Hungary products marketed in the EEA the OEP excludes the product from reimbursement; (f) (g) (h) the application of subsidy-volume agreements (i.e., risk sharing agreements between the OEP and the manufacturer) that can be concluded for a maximum period of four years. In most cases, the contractual payback obligation depends on the volume of sales or the total amount of reimbursement. In case of innovative pharmaceutical products, the effectiveness of the subsidized therapy is of more importance to the OEP when deciding whether to include the product into reimbursement. A payback obligation can be prescribed if the level of therapeutic efficacy provided for in the agreement is not achieved in case of which the amount of the payback obligation depends on the estimated cost that accrued as a result of inefficiency. A payback obligation may also be prescribed if the manufacturer fails to comply with the criteria provided in the agreement that relate to the activity aimed at the enhancement of patient compliance during the treatment; payback obligation of manufacturers, according to which each marketing authorization holder of reimbursed pharmaceutical products is obliged to pay a tax that amounts to 20 percent of the amount of the reimbursement relating to a given reimbursed product that it markets. Pharmaceutical companies must also comply with a band-based payment obligation to cover the overspend of the health insurance budget. Further, pharmaceutical companies are also obliged to pay a separate tax if they employ medical sales representatives, the amount of which is currently HUF 10 million (approx. EUR37,000) per year per medical sales representative; surveillance of the prescription habits of physicians based on which the OEP reviews how the quantity of pharmaceutical products prescribed by physicians and purchased by patients relate to the subsidy targets relating to certain therapies that European Pricing and Reimbursement Handbook 89

98 Hungary felírás, illetve a gyógyszer kiadása során a gyógyszerkassza számára megtakarítást érnek el, akkor juttatásban részesülnek. 5. Létezik-e külön szabályozás generikus gyógyszerkészítményekre (például gyorsított befogadási eljárás, alacsonyabb eljárási díjak, stb.)? A generikus termékek árait jogszabály rögzíti? A generikus gyógyszerkészítmények társadalombiztosítási támogatásba történő befogadása egyszerűsített eljárásrendben történik, illetve az OEP 90 nap helyett 60 napon belül dönt a készítmény befogadásáról. Egyszerűsített eljárás esetén az engedélyezési eljárásért fizetendő igazgatási szolgáltatási díj is alacsonyabb, mint a normál eljárásrendben. Így a generikus gyógyszerkészítmények befogadási eljárásáért fizetendő díj forint (kb euró) a normál eljárásrend esetén fizetendő 1,5 millió forint (kb euró) helyett. Speciális szabályok hiányában a generikus készítmények árának meghatározása tekintetében visszautalunk a fenti 2. pontban részletesen kifejtettekre. 6. Milyen módszerekkel ösztönzik az innovatív gyógyszerkészítmények piacra lépését? Az innovatív gyógyszereket gyártó gyógyszercégek a jogszabályban meghatározott mértékű adókedvezményre jogosultak a Magyarországon folytatott kutatás-fejlesztési tevékenységük után. A kedvezmény a cégek által támogatással forgalmazott készítmények után fizetendő 20 százalékos adó, valamint a cégek által foglalkoztatott orvoslátogatók után fizetendő adó tekintetében vehető igénybe. 7. Kórházak kiírhatnak-e nyilvános pályázatokat gyógyszerkészítmények beszerzésére? Amennyiben igen, milyen szabályok vonatkoznak a gyógyszergyárak által tett árajánlatokra? A közbeszerzési törvény hatálya alá tartozó állami és önkormányzati egészségügyi intézmények törvényben meghatározott értékhatárt 90 Baker & McKenzie

99 Hungary are determined by the Government every six months. If the quantity of pharmaceutical products prescribed by a physician exceeds the target value, the OEP may conduct an investigation of the physician. Physicians or pharmacies may receive a premium if they manage to save on public expenditure on pharmaceutical products in the course of prescribing or selling such products. 5. Is there a specific policy for generic pharmaceutical products (for instance, fast track approval, lower registration fees, etc.)? Is the price of generic products fixed by law? Generic pharmaceutical products are included in reimbursement in the course of a simplified procedure. In a simplified procedure, the OEP decides whether to include the product within 60 instead of 90 days. The administrative fee for simplified procedures is also lower. Thus, the administrative fee payable for the procedure for inclusion of generic pharmaceutical products into reimbursement is HUF300,000 (approx. EUR1,100) instead of HUF1.5 million (approx. EUR5,600) which is payable in case of a normal procedure. As there are no special provisions concerning the regulation of the price of generic products, we refer back to the general rules detailed in section 2 above. 6. What incentives exist for innovative pharmaceutical products? Pharmaceutical companies that produce innovative products are entitled to tax benefits for their research and development activities performed in Hungary. Such companies may deduct the benefit from the 20 percent tax payable in relation their reimbursed products as well as the tax payable in relation to medical sales representatives employed by them. European Pricing and Reimbursement Handbook 91

100 Hungary meghaladó gyógyszerbeszerzései esetén mind a pályáztatás, mind az ajánlatok kiválasztásának folyamatára a közbeszerzési törvényt kell alkalmazni. A pályázati kiírásnak megfelelő gyógyszercégek, illetve nagykereskedők pályázhatnak az ilyen tendereken, az árajánlatot a pályázat körülményei és üzleti szempontok alapján szabadon határozzák meg. Külön jogszabályban rendezett speciális közbeszerzési szabályok vonatkoznak az OEP által meghatározott bizonyos nagy költségigényű gyógyszerekre (ún. különkeretes gyógyszerek). Az ilyen gyógyszerek beszerzésére az OEP éves költségvetési keretet alakít ki és külön szerződést köt a gyógyszerek beszerzésére a gyógyszercéggel, valamint a gyógyszert felhasználó kijelölt egészségügyi intézményekkel. 8. Van különbség a magánpraxisban dolgozó orvosok által felírt gyógyszerkészítmények és a kórházban rendelt gyógyszerkészítmények ártámogatása között? Támogatással történő gyógyszer rendelésére jogosult valamennyi orvos, aki az OEP-el finanszírozási szerződést kötött. Így, a finanszírozási szerződés keretei között nemcsak az állami vagy önkormányzati fenntartású egészségügyi intézményekben dolgozó orvosok írhatnak fel támogatott gyógyszert a betegnek, hanem a magán egészségügyi intézmények orvosai vagy a magánpraxist folytató orvosok is. A kórházakban a beteg a fekvőbeteg ellátás keretében minden szükséges gyógyszert ingyen kap. Az állami vagy önkormányzati fenntartású kórházakban nyújtott egészségügyi ellátások finanszírozása az ún. HBCs (homogén beteg csoportok) modell alapján történik, ami azt jelenti, hogy a diagnózisokat költségigény és szakmai homogenitás alapján listába sorolják és azokhoz a kezelés költségigényét tükröző súlyszámokat rendelnek, ezek pedig magukban foglalják az ellátáshoz szükséges gyógyszer és gyógyászati segédeszköz költségeket is. Az OEP-el kötött finanszírozási 92 Baker & McKenzie

101 Hungary 7. Are hospitals allowed to run public tenders on pharmaceutical products? If so, what are the rules governing the pricing proposal of the pharmaceutical companies? If public healthcare institutions falling under the scope of the act on public procurement procure pharmaceutical products at a value that exceeds the threshold provided by law, the act on public procurement must be applied to the tendering procedure and the selection of the suitable pricing proposal. Pharmaceutical companies and wholesalers that comply with the criteria set out in the call for tender may participate in such tenders and are free to determine the content of their proposal based on the circumstances of the tender and other commercial considerations. Special provisions on public procurement apply to certain costintensive pharmaceutical products (so-called pharmaceutical products with a special budget) determined by the OEP. The OEP establishes an annual budget and concludes a separate agreement with the pharmaceutical company as well as the healthcare institutions that administer the product for the procurement of such pharmaceutical products. 8. Is there a difference between reimbursement of pharmaceutical products prescribed by physicians in private practice and those prescribed in a hospital? Reimbursed pharmaceutical products may be prescribed by any physician who has previously concluded a financing agreement with the OEP. Therefore, not only physicians who work for public healthcare institutions but also physicians who work in private practice or for private healthcare institutions may prescribe reimbursed pharmaceutical products within the framework of the financing agreement. European Pricing and Reimbursement Handbook 93

102 Hungary szerződésük keretei között bizonyos ellátásokat a magán egészségügyi intézmények is elszámolhatnak a fenti rendszerben. 9. Részesülhet-e társadalombiztosítási támogatásban az olyan gyógyszerkészítmény, amelyet nem az engedélyezett alkalmazási területen alkalmaznak (azaz az indikáción túl alkalmazott gyógyszer)? Amennyiben igen, melyek ennek a feltételei? Magyarországon csak törzskönyvezett gyógyszerek és csak törzskönyvezett indikációban történő felírás esetén támogathatóak. 94 Baker & McKenzie

103 Hungary In hospitals, patients receive all necessary pharmaceutical products for free as part of in-patient care. Healthcare services in public healthcare institutions are financed on the basis of the model of so-called diagnosis related groups according to which the different types of diagnoses are grouped according to their cost and professional homogeneity. These groups are categorized according to the costs related to them which contain the costs of pharmaceutical products and therapeutic medical devices necessary for the treatment. Private healthcare institutions may finance certain healthcare services through the above-mentioned system within the framework of their financing agreement concluded with the OEP. 9. Can a pharmaceutical product that is used for an indication for which it is not approved (i.e., off-label use) be reimbursed? If yes, what are the conditions? In Hungary, only those pharmaceutical products may be reimbursed for which a marketing authorization has been obtained and only if they are used for an indication for which they are approved. European Pricing and Reimbursement Handbook 95

104 Italy Italia Roberto Cursano Introduzione: Com è organizzato il Servizio Sanitario Nazionale ( SSN ) in Italia? L obiettivo del SSN è quello di offrire ai cittadini un assistenza sanitaria uniforme su tutto il territorio, comprendente sia l assistenza da parte dei medici di base convenzionati con il SSN, sia l assistenza ospedaliera, che il rimborso dei farmaci ritenuti essenziali per la tutela della salute. Il funzionamento del SSN è organizzato su base regionale attraverso le Aziende Sanitarie Locali (ASL) ed è finanziato sia attraverso il gettito di tributi nazionali che attraverso tributi regionali. A partire dal 2004 la competenza a regolare il settore farmaceutico è stata trasferita dal Ministero del Salute all Agenzia Italiana del Farmaco (AIFA), ente pubblico sottoposto al controllo del Ministero della Salute. All AIFA sono state, tra l altro, trasferite tutte le funzioni in materia di autorizzazione all immissione in commercio (AIC) dei farmaci e di determinazione del prezzo, monitoraggio e vigilanza sul prezzo degli stessi. In proposito, all interno del SSN sono individuate tre classi di rimborsabilità di farmaci: la classe A, comprendente i farmaci a totale carico del SSN, la classe H, comprendente i farmaci rimborsati dal SSN da dispensarsi in ambito ospedaliero, e la classe C comprendente i farmaci a carico del cittadino. Per quanto concerne i farmaci rimborsati dal SSN, specifiche procedure di negoziazione del prezzo tra le società titolari dell AIC e l AIFA sono previste dalla legge e dai regolamenti applicabili. 96 Baker & McKenzie

105 Italy Italy Roberto Cursano Executive Summary: How are National Health Services (NHS) organized in your country? The objective of the Italian National Health Service (Servizio Sanitario Nazionale SSN) is to provide citizens with uniform health care throughout the country, including both assistance by doctors affiliated with the SSN, and hospital care, as well as the reimbursement of drugs deemed essential for health protection. The operation of the SSN is organized on a regional basis through the local health authorities (Aziende Sanitarie Locali ASL) and is funded both by the proceeds of national taxes and by regional taxes. In 2004, the power to regulate the pharmaceutical sector was transferred from the Ministry of Health to the Italian Pharmaceutical Agency (Agenzia Italiana del Farmaco AIFA), a public institution under the supervision of the Ministry of Health. In addition, AIFA was assigned all functions relating to the drugs marketing authorization (MA) and the determination of the price, monitoring and supervision of pharmaceutical prices. In this respect, within the SSN three classes of reimbursement of drugs have been identified: Class A, which includes drugs to be charged to the SSN; Class H, which includes drugs reimbursed by the SSN to be dispensed by hospitals; and Class C which includes drugs to be paid for by the individual. As regards drugs reimbursed by the SSN, specific procedures for price negotiation between the pharmaceutical companies and AIFA are provided for by law and relevant regulations. European Pricing and Reimbursement Handbook 97

106 Italy La determinazione del prezzo dei farmaci rimborsabili da parte del SSN risente, inevitabilmente, della necessità di realizzare un contenimento della spesa farmaceutica. Per questo motivo, sia a livello nazionale che a livello locale, negli ultimi anni si sono applicati alcuni strumenti volti a realizzare un risparmio di spesa da parte del SSN, quali il payback, il reference pricing, nonché il sistema di distribuzione diretta. Tuttavia, è opportuno precisare che tutte le norme in materia di prezzo dei farmaci e di contenimento della spesa, ivi incluse le norme che disciplinano i margini spettanti ai soggetti operanti nella catena di distribuzione dei farmaci sono stati soggetti negli ultimi anni a continue modifiche normative, determinate dal necessità di realizzare risparmi di spesa (si veda ad esempio il decreto-legge 28 aprile 2009, numero 39, adottato ai fini di reperire fondi necessari a fronteggiare l emergenza terremoto a L Aquila). 1. Quali sono i prodotti farmaceutici che sono rimborsati dal SSN, secondo quali procedure? Ai fini della rimborsabilità da parte del SSN, i farmaci sono suddivisi nelle seguenti classi: (a) (b) (c) la classe A comprende i farmaci che, ritenuti essenziali per assicurare i Livelli Essenziali di Assistenza ai cittadini, sono completamente a carico del SSN; la classe H, comprende i farmaci essenziali e interamente rimborsati dal SSN, di esclusivo uso ospedaliero; la classe C, infine, include farmaci che sono ad esclusivo carico del cittadino. Il sistema di rimborsabilità è basato sulla valutazione della gravità della patologia e sui relativi benefici terapeutici apportati dal farmaco, nonché sul rapporto costi-efficacia. 98 Baker & McKenzie

107 Italy The pricing of medicines reimbursed by the SSN is inevitably influenced by the need to contain pharmaceutical expenditure. For this reason, in recent years both on a national and local level, methods to contain SSN expenditure have been introduced, such as payback, reference pricing and a direct distribution system. However, please note that all drug price regulations and expenditure containment including regulation concerning the percentage relating to pharmaceutical distributors, which in recent years have been subject to constant legislative changes, due to the need to contain pharmaceutical expenditure (for example, Decree-Law No. 39 of 28 April 2009, implemented in order to raise emergency funds necessary to cope with the earthquake in L Aquila). 1. Which pharmaceutical products are reimbursed by the NHS, under what procedures? For the purposes of SSN reimbursement, drugs are divided into three categories: (a) (b) (c) Class A includes drugs that are considered essential to ensure basic levels of service to the citizens, and are fully paid for by the SSN. Class H includes essential drugs fully reimbursed by the SSN for hospital use only. Class C includes drugs whose cost is entirely borne by the citizen. The reimbursement system is based on an assessment of the severity of the disease and the therapeutic benefits of the drug as well as on a cost-efficiency basis. AIFA is the competent authority for the supervision, establishment and monitoring of drug prices. In particular, the Pricing and Reimbursement Committee, which exists within AIFA, is the body European Pricing and Reimbursement Handbook 99

108 Italy L AIFA è l autorità competente in materia di vigilanza, fissazione e controllo dei prezzi dei farmaci. In particolare, il Comitato Prezzi e Rimborso (CPR), operante presso l AIFA medesima, è l organo deputato a negoziare con le società farmaceutiche il prezzo di rimborso dei farmaci a carico del SSN; in questa attività è supportato dall Osservatorio Nazionale sull impiego dei Medicinali ( OSMED ) che opera un costante monitoraggio sull uso e sull efficacia dei farmaci. Le negoziazioni si concludono con un accordo in cui sono determinate le condizioni di ammissione alla rimborsabilità nonché i prezzi dei farmaci. Detto accordo è approvato dalla Commissione tecnico scientifica (CTS) e, quindi, sottoposto all esame del Consiglio di Amministrazione dell AIFA per la delibera di definitiva approvazione. Successivamente, l elenco dei medicinali rimborsati dal SSN è pubblicato sulla Gazzetta Ufficiale ed è soggetto ad aggiornamento ogni sei mesi. L AIFA provvede entro il 30 settembre di ogni anno, o semestralmente nel caso di sfondamento del tetto di spesa sanitaria e farmaceutica fissato dalla legge, a redigere l elenco dei farmaci rimborsabili dal SSN, sulla base dei criteri di costo e di efficacia, in modo da assicurare su base annua il rispetto dei livelli di spesa programmata. 2. C è un controllo diretto dei prezzi sui prodotti farmaceutici? Il tipo di controllo dei prezzi dei farmaci esercitato da parte dell AIFA dipende dalla classe di appartenenza dei farmaci medesimi. L AIFA esercita un controllo stretto sui prezzi dei farmaci di fascia A e H dal momento che il prezzo di questi è determinato attraverso negoziazioni tra l AIFA medesima e la società farmaceutica (si veda il punto 1). Sui medicinali di classe C, il cui prezzo è liberamente determinato del titolare dell AIC, l AIFA controlla che gli aumenti di prezzo avvengano con frequenza non inferiore a due anni (negli anni 100 Baker & McKenzie

109 Italy responsible for the negotiation with pharmaceutical companies on the price of drugs reimbursed by the SSN. This activity is supported by the National Observatory on the use of Medicines (Osservatorio Nazionale sull impiego dei Medicinali OsMED ), which constantly monitors the use and effectiveness of drugs. The negotiations conclude with an agreement which contains certain conditions for reimbursement and pharmaceutical prices. This agreement is approved by the Technical and Scientific Commission (TSC) and, is subsequently submitted to the AIFA Board of Directors for the resolution of a final approval. Subsequently, the list of drugs reimbursed by the NHS is published in the Official Gazette and is updated every six months. By 30 September of each year, or if the maximum expenditure established by law is crossed, every six months, AIFA must draw up a list of drugs reimbursed by the SSN, based on the cost-effective criteria, to ensure compliance with the annual level of planned expenditure. 2. Is there a direct price control on pharmaceutical products? The type of pharmaceutical price control carried out by AIFA depends on the class of the pharmaceuticals. AIFA maintains strict controls on the prices of pharmaceuticals in Classes A and H since the prices of these are determined through negotiations between the AIFA and the pharmaceutical companies (see Response 1). For Class C pharmaceuticals, whose prices are freely determined by the pharmaceutical companies, AIFA ensures that price increases occur with a frequency of no less than two years (odd years), that the increases do not exceed inflation, and that they are scheduled to take place in January. European Pricing and Reimbursement Handbook 101

110 Italy dispari), e che l incremento non superi l inflazione programmata e avvenga nel mese di gennaio. 3. Quali sono le procedure in base alle quali si determina il prezzo dei prodotti farmaceutici? La fissazione del dispari), e che l incremento non superi l inflazione programmata e avvenga nel mese di gennaio. prezzo avviene a livello nazionale ed è pubblicata sulla Gazzetta Ufficiale. Per i medicinali di classe A e H, in base alla Legge 24 Novembre del 2003, n. 326 e secondo la deliberazione CIPE del 01/02/01, è previsto un processo di negoziazione del prezzo tra l AIFA e la società titolare dell AIC, che può svolgersi anche attraverso modalità on line. La procedura prevede: (a) una richiesta di determinazione del prezzo del farmaco all AIFA; (b) una descrizione del farmaco relativa al rapporto costo/efficacia; (c) una descrizione relativa agli effetti benefici del farmaco. Il prezzo definito al termine della procedura negoziale, è valido per un periodo di ventiquattro mesi, fatte salve le diverse clausole contrattuali. Allo scadere del contratto questo verrà rinnovato automaticamente se le parti nulla disporranno entro 90 giorni dalla scadenza del contratto stesso. Ulteriori modalità di aggiornamento del prezzo possono essere determinati dalle parti. Al prezzo così determinato debbono aggiungersi l IVA e le quote di spettanza per gli operatori della distribuzione. Si noti che secondo la legge italiana i margini del prezzo finale del farmaco da corrispondersi a grossisti e a farmacisti sono fissati ai 102 Baker & McKenzie

111 Italy 3. What are the pricing procedures, if any, under which the price for pharmaceutical products is determined? Prices are fixed at national level and are published in the Official Gazette. According to Law No. 326 of 24 November 2003, and according to CIPE ( Comitato Interministeriale per la Programmazione Economica ) resolution of 2 January 2001, for drugs in Classes A and H, there is a process of price negotiation between the pharmaceutical company and AIFA, which may also take place online. The procedure involves: (a) (b) (c) an application to AIFA to determine the price of the drug; a description of the drug on a cost-effective basis; a description of the drug s beneficial effects. The price determined at the end of the negotiation procedure is valid for a period of 24 months, subject to various contractual clauses. Upon expiration, the contract will be renewed automatically if the parties do not make any amendments to the original contract, within 90 days of the expiration date. Additional procedures to update prices can be determined by the parties. VAT and the amount due to distributors are added to the determined price. Note that, under Italian law the final price percentages to be paid by drug wholesalers and pharmacists are established in accordance with Legislative Decree No. 78, 31 May 2010, article 11, paragraph 6, at a minimum of 3 percent and percent respectively. However, the SSN retains 1.82 percent of the sales price when compensating pharmacies for the payment of reimbursed drugs. Legislative measures are currently being analyzed in order to modify the system to determine percentages due to the sector of the drugs distribution. European Pricing and Reimbursement Handbook 103

112 Italy sensi dell articolo 11, comma 6, D.L. 31 maggio 2010, n. 78, nella misura minima, rispettivamente del 3 per cento e del 30,35 per cento. Tuttavia, il SSN nel procedere alla compensazione di quanto dovuto al farmacista a titolo di pagamento dei farmaci rimborsati, trattiene l 1,82 per cento sul prezzo delle vendite. Attualmente sono allo studio misure legislative volte a modificare il sistema di determinazione dei margini dovuti al settore della distribuzione dei farmaci. 4. Quali strumenti sono utilizzati per controllare la spesa pubblica relativa ai prodotti farmaceutici (prezzi di riferimento, co-payment, rimborso, value pricing basato su accordi di condivisione del rischio, ecc)? Gli strumenti utilizzati al fine del contenimento della spesa pubblica farmaceutica sono i seguenti: (a) Distribuzione diretta La distribuzione diretta, è una forma di erogazione (diretta) del farmaco al paziente. Consiste nell erogazione del farmaco al paziente attraverso le strutture dell Azienda Sanitaria; queste acquistano i farmaci secondo le condizioni di norma previste per il SSN e li distribuiscono, mediante le proprie strutture, direttamente ai pazienti per il consumo al proprio domicilio. In questo modo, le ASL che acquistano i farmaci direttamente dalle ditte produttrici, realizzano un risparmio medio del 50 per cento. (b) Prezzo di riferimento Il sistema del prezzo di riferimento è uno strumento di contenimento della spesa farmaceutica che fissa il prezzo di rimborso da parte del SSN dei medicinali non coperti da brevetto. Il prezzo è determinato prendendo come riferimento il prezzo più basso tra i farmaci appartenenti alla stessa area terapeutica, tra loro equivalenti. La scelta di avvalersi del 104 Baker & McKenzie

113 Italy 4. What instruments are used to control public expenditure on pharmaceutical products (e.g., reference pricing, co-payment, payback, value-based pricing and risk-sharing arrangements)? The instruments used in order to limit public pharmaceutical expenditure are as follows: (a) Direct distribution Direct distribution is a form of (direct) disbursement of drugs to the patient. It consists of the disbursement of drugs to the patient in accordance with health authorities which acquire the pharmaceuticals from the SSN and distribute them through their own structures directly to the patients for home consumption. In this way, the health authorities that purchase drugs directly from manufacturers achieve average savings of 50 percent. (b) Reference pricing Reference pricing is a procedure which limits pharmaceutical expenditure by fixing the SSN reimbursement price at that of unpatented drugs. The price is determined with reference to the lowest price among drugs belonging to the same therapeutic area, including their equivalents. The choice to use the reference pricing system may also be carried out at a regional level. (c) Payback Using the payback system, the SSN expects restitution from pharmaceutical companies of 6.83 percent, calculated on an annual basis. This system is optional, since pharmaceutical companies can, as an alternative to payback, make a price European Pricing and Reimbursement Handbook 105

114 Italy meccanismo del reference pricing può essere adottata anche dalle Regioni. (c) Payback Attraverso il sistema di payback si prevede la restituzione da parte delle società farmaceutiche al SSN del 6,83 per cento del prezzo del farmaco, calcolato su base annuale. Tale sistema è facoltativo in quanto le società farmaceutiche possono, in alternativa al payback, operare una riduzione del prezzo del farmaco pari al 6,83 per cento al pubblico. Il motivo per cui le società farmaceutiche aderiscono normalmente al payback è dato dalla necessità di impedire che una riduzione del prezzo operata per il contenimento della spesa pubblica in Italia possa poi influire sulla determinazione del prezzo da parte di altri paesi dell Unione europea che usino il prezzo italiano come prezzo di riferimento per la determinazione del prezzo dei farmaci nel proprio paese. Nei casi in cui, nonostante le misure predisposte, si verifichi un superamento della soglia del 13,3 per cento della spesa sanitaria pubblica previsto dalla legge, le società farmaceutiche, i grossisti, i farmacisti e le regioni devono rimborsare l eccedenza al SSN. 5. C è una politica specifica per i prodotti farmaceutici generici (ad esempio, l approvazione accelerata e una quota d iscrizione inferiore)? Il prezzo dei prodotti generici è stabilito dalla legge? Per il farmaco generico è prevista una procedura abbreviata di AIC. In base a quanto previsto nel Budget previsionale del 2011 pubblicato dall AIFA, la fissazione del prezzo dei medicinali generici sarà quello corrispondente al prezzo definito in sede negoziale oppure, nel caso 106 Baker & McKenzie

115 Italy reduction of 6.83 percent of the pharmaceutical products to the public. Pharmaceutical companies generally adhere to payback due to the need to prevent price cuts resulting from public spending cuts in Italy since this may also affect pricing in other European Union countries which use Italian pricing as a reference for drug prices in their country. In the event that, despite the adopted measures, the threshold of public health expenditure required by law is exceeded by 13.3 percent, pharmaceutical companies, wholesalers, pharmacists and regions must repay the excess to the SSN. 5. Is there a specific policy for generic pharmaceutical products (for instance, fast track approval, and lower registration fees)? Is the price of generic products fixed by law? For the generic drugs, there is a shortened MA procedure. In accordance with the budget provisions forecast for 2011 published by the AIFA, the pricing of generic drugs will be equal to the price established by negotiation or, if the price of the drug has not yet been negotiated, an average price reduction equal to 40 percent shall apply. 6. What incentives exist for innovative pharmaceutical products? In order to encourage research and development of innovative pharmaceuticals, the Italian authorities established a fund in order to assign a price premium to producers of drugs which prove to be genuinely innovative. For these drugs, the opportunity to be included in the reimbursement system is also provided, if they are considered to be of significant interest to the SSN. European Pricing and Reimbursement Handbook 107

116 Italy in cui il prezzo del farmaco non sia stato ancora negoziato con le medesime, si applicherà una riduzione media di prezzo pari al 40 per cento. 6. Quali incentivi esistono per prodotti farmaceutici innovativi? Al fine di incentivare la ricerca e lo sviluppo è stato istituito un Fondo per i farmaci innovativi con lo scopo di assegnare un premio di prezzo in favore del produttore di farmaci che risultino essere effettivamente innovativi. Per tali farmaci è, altresì, prevista la possibilità di essere inclusi nel sistema di rimborso nel caso in cui siano considerati di interesse rilevante per il SSN. 7. Gli ospedali sono autorizzati ad eseguire appalti pubblici sui prodotti farmaceutici? Se si, quali sono le regole che disciplinano la proposta dei prezzi delle case farmaceutiche? Gli ospedali possono bandire procedure per l affidamento di appalti pubblici per la somministrazione di farmaci ai pazienti. E necessario che il bando di gara sia redatto in modo dettagliato sì da identificare compiutamente il farmaco e valutare l offerta presentata dalla società farmaceutica sia da un punto di vista economico, sia tecnico. L offerta dell impresa farmaceutica deve essere conforme al bando di gara ai capitolati speciali e tecnici adottati dalla stazione appaltante che, normalmente aggiudica la gara in base al criterio dell offerta economicamente più vantaggiosa o del prezzo più basso. 8. C è una differenza di rimborso tra i farmaci prescritti dai medici in uno studio privato e in un ospedale? Si, soltanto i medici di base e gli ospedali convenzionati con il SSN possono prescrivere farmaci rimborsabili dal SSN. 108 Baker & McKenzie

117 Italy 7. Are hospitals allowed to run public tenders on pharmaceutical products? If so, what are the rules governing the pricing proposal of the pharmaceutical companies? Hospitals may carry out public tenders to determine how to supply the pharmaceutical products. The public tender notice must be prepared in detail in order to fully identify the drug and evaluate the offer made by the pharmaceutical company from both an economic and technical perspective. The pharmaceutical company s offer must comply with the tender notice and with the specific technical conditions adopted by the awarding authority, which normally awards the tender to the most economically advantageous offer or on the basis of the lowest price. 8. Is there a difference between reimbursement of pharmaceutical products prescribed by physicians in private practice and those prescribed in a hospital? Yes, only doctors and hospitals affiliated with the SSN can prescribe drugs reimbursed by the SSN. 9. Can a pharmaceutical product that is used for an indication for which it is not approved (i.e., off-label use) be reimbursed? If yes, what are the conditions? Pursuant to Law No. 648 of 2 December 1996, off-label drugs are reimbursed by the SSN if the following conditions are met: (a) (b) (c) Lack of alternative drugs; Product safety; and Inclusion in an ad hoc list prepared by AIFA. European Pricing and Reimbursement Handbook 109

118 Italy 9. Può essere rimborsato un prodotto farmaceutico utilizzato in modo diverso rispetto all autorizzazione di immissione in commercio che ha ottenuto (uso offlabel)? Se si, quali sono le condizioni? I farmaci off-label sono ammessi al rimborso del SSN ai sensi della legge 2 dicembre 1996, n. 648, se sono rispettate le seguenti condizioni: (a) (b) (c) assenza di farmaci alternativi; sicurezza del prodotto; inclusione del farmaco in un elenco ad hoc predisposto dall AIFA. 110 Baker & McKenzie

119 The Netherlands The Netherlands Misha lutje Beerenbroek, Emma Runia and Eline van Nimwegen Executive Summary: How are National Health Services (NHS) organized in your country? In the Netherlands pharmaceutical products bought by patients at pharmacies will in principle be reimbursed if these products are registered in the Drugs Reimbursement System. Most pharmaceutical products administered in (contracted) hospitals/private clinics are fully reimbursed as well. Also products used off-label will in principle be reimbursed. Furthermore, the maximum prices producers may ask for registered pharmaceutical products (including generic products) are fixed. 1. Which pharmaceutical products are reimbursed by the NHS, under what procedures? The reimbursement system makes a distinction between pharmaceutical products bought by patients at pharmacies and pharmaceutical products administered in a hospital/private clinic. Pharmacies The reimbursement of pharmaceutical products that are prescribed by family doctors and bought at pharmacies is regulated in the Drugs Reimbursement System (DRS) ( Geneesmiddelenvergoedingssysteem ), which forms part of the Care Insurance Act ( Zorgverzekeringsswet ). Only pharmaceutical products that are registered in the DRS and therefore listed in the annexes of the Care Insurance Regulations ( Regeling zorgverzekering ) will in principle be reimbursed by the mandatory basic health insurance. However, health insurers may choose what products from the DRS they reimburse, taking into account that they must at least reimburse one pharmaceutical product per active European Pricing and Reimbursement Handbook 111

120 The Netherlands ingredient. Furthermore, health insurers may determine the length of time that products can be reimbursed. To become registered in the DRS, pharmaceutical products need to be reviewed and approved by the Healthcare Insurance Board ( College voor zorgverzekeringen ) based on therapeutic value and costs. Registered products in the DRS are subdivided into two groups: (a) (b) Annex 1A of the Care Insurance Regulations lists products that are substitutable. The products on this list are clustered based on therapeutic comparability. Farmatec, part of the Ministry of Public Health, Welfare and Sports, determines the maximum reimbursements of the different products based on the prices of comparable pharmaceutical products on a reference date. In general, the limits are set on the price of the lowest priced product in the cluster. The limits are published monthly in the Government Gazette. If the price of a pharmaceutical product exceeds the reimbursement limit, patients need to pay for the excess themselves. Annex 1B of the Care Insurance Regulations lists products that are not substitutable. For these products, no reimbursement limits exist. Hospitals/Private Clinics The reimbursement of pharmaceutical products forms part of the overall reimbursement of hospital care. Based on the Diagnosis Treatment Combination ( Diagnosebehandelingcombinatie ), the hospital charges one price for all stages from diagnosis by a medical specialist until possible hospital treatment, including the use of pharmaceutical products. Hospital care is divided into two segments. Segment A lists around 66 percent of all treatments. Fixed average fees apply to the different (clustered) product groups in this segment, which are fully reimbursed 112 Baker & McKenzie

121 The Netherlands by insurers. Moreover, for treatments in private clinics and the like the fixed fees in this segment also count as maximum fees. Segment B lists around 34 percent of all treatments, mostly (nonurgent) treatments that occur in a regular manner. For this segment, the rates are formed through negotiations and agreements between insurers and hospitals. However, insurers are not required to enter into agreements with all hospitals. Treatments in contracted hospitals will be fully reimbursed. For treatments in non-contracted hospitals the standard price list of the hospital in question applies. In that case, patients need to contact their insurer first to check whether and to what extent the particular treatment will be reimbursed. In case hospitals prescribe so-called expensive pharmaceutical products, they get 80 percent of these listed products reimbursed by insurers. However, this does not have any influence on patients situations. 2. Is there a direct price control on pharmaceutical products? The Medicine Prices Act ( Wet geneesmiddelenprijzen ) establishes maximum prices producers may ask for registered pharmaceutical products. Accordingly, there is no price control on non-registered pharmaceutical products. 3. What are the pricing procedures, if any, under which the price for pharmaceutical products is determined? The maximum prices producers may ask hospitals and pharmacies for registered pharmaceutical products are determined based on the numerical average of the prices of comparable products present on the price lists of four reference countries as indicated in the Reference Price Lists Medicines Regulations ( Regeling referentieprijslijsten geneesmiddelen ): Belgium, Germany, France and the United Kingdom. European Pricing and Reimbursement Handbook 113

122 The Netherlands The maximum prices are determined by Farmatec and can be found in the Maximum Medicine Prices Regulations ( Regeling maximumprijzen geneesmiddelen ). Twice a year, Farmatec examines whether there is a cause to reassess the maximum prices and if so, it publishes a new, amended draft of the Regulations. Based on this draft, interested parties may express their opinions within six weeks. After that period, the Regulations will be changed (possibly but not necessarily in accordance with the expressed opinions). Interested parties may lodge an appeal against these changed Regulations. 4. What instruments are used to control public expenditure on pharmaceutical products (e.g., reference pricing, co-payment, payback, value-based pricing, and risk-sharing arrangements)? The Minister of Public Health, Welfare and Sports has taken several measures to control public expenditure. (a) (b) There is a policy to assess critically whether to allow new pharmaceutical products in the insurance package. Pharmacies now charge lower prices to patients and insurers as a result of the fact that negotiations take place between the Ministry, pharmacies, producers of generic pharmaceutical products and insurers. (c) Maximum prices are established (as described above under 2). (d) (e) (f) When buying in pharmacies, patients pay the excess if a product exceeds the maximum price (as described above under 2). The clustering of products and the accompanying maximum reimbursement are established (as described above under 1). There is the possibility of preferential policies (as described below under 5). 114 Baker & McKenzie

123 The Netherlands (g) Doctors are increasing their use of an electronic prescription system. (h) Achievement funding that results in negotiations between hospitals and insurers about the costs of certain expensive pharmaceutical products is introduced (as described above under 1). 5. Is there a specific policy for generic pharmaceutical products (for instance, fast track approval, lower registration fees)? Is the price of generic products fixed by law? Insurers may apply a preferential policy with regard to generic products, based on which insurers may decide to only reimburse these products instead of branded products. However, the application of such preferential policies is not mandatory for insurers. Furthermore, the maximum prices as explained under 2 and 3 above also apply to generic products. 6. What incentives exist for innovative pharmaceutical products? In principle, incentives for innovative pharmaceutical products exist in the Netherlands, but only in the initial research/pre-competitive phase (when the products are not on the market yet). 7. Are hospitals allowed to run public tenders on pharmaceutical products? If so, what are the rules governing the pricing proposal of the pharmaceutical companies? If a hospital can be deemed a regulatory organization as described in Directive 2004/18/EC (as implemented in the Tendering Rules for Public Works Contracts Decree ( Besluit aanbestedingsregels voor overheidsopdrachten ), it is obliged to run public tenders. Whether a hospital is a regulatory organization depends on the following: European Pricing and Reimbursement Handbook 115

124 The Netherlands (a) (b) Does the hospital provide for non-commercial needs of public interest? Does the hospital depend upon the government with regard to financing and supervision? If the above questions can be answered positively, the hospital can be deemed a regulatory organization and is therefore obliged to run public tenders if the tender exceeds a certain value. If (one of) the questions cannot be answered positively or the value of the tender does not exceed a certain value, the hospital is allowed, but not obliged to run public tenders. In case hospitals run public tenders, pricing proposals of pharmaceutical companies are assessed based on either the lowest price or the most economically advantageous tender. 8. Is there a difference between reimbursement of pharmaceutical products prescribed by physicians in private practice and those prescribed in a hospital? Reference is made to section 1 above. 9. Can a pharmaceutical product that is used for an indication for which it is not approved (i.e. off-label use) be reimbursed? If yes, what are the conditions? In general, pharmaceutical products registered in the DRS will be reimbursed in case of off-label use. However, if a pharmaceutical product is listed in Annex 2 of the Care Insurance Regulations, it will only be reimbursed if additional conditions (e.g., with regard to age, indication, medical history) apply to the patient. 116 Baker & McKenzie

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126 Poland Polska Paulina Kieszkowska-Knapik i Magdalena Bąkowska Podsumowanie: W jaki sposób zorganizowany jest system opieki zdrowotnej w Polsce? 1 stycznia 2012 wejdzie w życie ustawa z dnia 12 maja 2011 r. o refundacji leków, środków spożywczych specjalnego przeznaczenia żywieniowego oraz wyrobów medycznych (Dz. U. nr 122, poz. 696). Ustawa w sposób zasadniczy zmienia system refundacji w Polsce w stosunku do obecnie funkcjonujących rozwiązań. Poniższe opracowanie oparte zostało na zapisach nowej ustawy. Podmiotem finansującym świadczenia opieki zdrowotnej w Polsce jest Narodowy Fundusz Zdrowia ( NFZ ) podległy Ministrowi Zdrowia. Refundowane mogą być leki, środki spożywcze specjalnego przeznaczenia żywieniowego oraz wyroby medyczne. Objęcie refundacją następuje w drodze decyzji Ministra Zdrowia, który jednocześnie ustala dla produktu refundowanego urzędową cenę zbytu. Ceny i marże na produkty refundowane mają w Polsce charakter cen i marż sztywnych. Ceny pozostałych produktów kształtowane są dowolnie przez ich producentów. Przepisy przewidują całkowity budżet na refundację w wysokości nie wyższej niż 17 procent sumy środków publicznych przeznaczonych na finansowanie świadczeń gwarantowanych w planie finansowym NFZ. W celu ochrony tego budżetu oraz zmniejszenia publicznych wydatków na refundację wprowadzono instrumenty takie jak obowiązek zwrotu kwoty przekroczenia (pay back), instrumenty dzielenia ryzyka i inne. 1. Jakie produkty finansowane są ze środków publicznych, w oparciu o jakie procedury? W Polsce refundacji ze środków publicznych podlegają leki, środki spożywcze specjalnego przeznaczenia żywieniowego oraz wyroby 118 Baker & McKenzie

127 Poland Poland Paulina Kieszkowska-Knapik and Magdalena Bąkowska Executive Summary: How are National Health Services (NHS) organized in your country? On 1 January 2012 the act of 12 May 2011 on reimbursement of drugs, food products for special dietary purposes and medical devices (Journal of Laws no. 122, item 696) will come into force. The act introduces fundamental changes to the reimbursement system in Poland currently in force. This monograph has been based on the provisions of the new act. The entity financing healthcare services in Poland is the National Health Fund ( Fund ) subordinate to the Minister of Health. Reimbursed products can be drugs, food products for special dietary purposes and medical devices. The reimbursement status is granted by way of decision of the Minister of Health, who also sets the official selling price of the product. Prices and margins on reimbursed products in Poland are fixed. Prices for other products are determined freely by their manufacturers. The regulations provide for an overall reimbursement budget of up to 17 percent of the sum of the public funds allocated for financing the guaranteed services under the Fund s financial plan. To secure the budget and decrease the public expenditure on reimbursement, certain instruments have been introduced, namely the payback obligation, risk-sharing instruments and others. 1. Which pharmaceutical products are reimbursed by the NHS, under what procedures? In Poland, reimbursed products can be: drugs, food products for special dietary purposes and medical devices. A product may be reimbursed if: European Pricing and Reimbursement Handbook 119

128 Poland medyczne. Refundowany może być produkt, który: (a) (b) w przypadku leków - jest dopuszczony do obrotu lub pozostaje w obrocie (z odstępstwem dla leków off-label oraz z importu docelowego); w przypadku wyrobu medycznego jest wprowadzony do obrotu i do używania; w przypadku środka spożywczego specjalnego przeznaczenia żywieniowego jest wprowadzony do obrotu; jest dostępny na rynku; (c) posiada kod identyfikacyjny EAN lub inny kod odpowiadający kodowi EAN. Objęty refundacją nie może natomiast zostać: (a) (b) (c) produkt w stanach klinicznych, w których możliwe jest skuteczne jego zastąpienie poprzez zmianę stylu życia pacjenta; lek dostępny na podstawie recepty, który posiada swój odpowiednik OTC, chyba że wymaga stosowania dłużej niż 30 dni w określonym stanie klinicznym; lek z importu docelowego wymieniony w odpowiednim rozporządzeniu Ministra Zdrowia. Przepisy przewidują następujące kategorie dostępności refundacyjnej: (a) dostępny w aptece na receptę (w całym zakresie zarejestrowanych wskazań i przeznaczeń bądź we wskazaniu określonym stanem klinicznym); (b) stosowany w ramach programu lekowego; 120 Baker & McKenzie

129 Poland (a) (b) (c) in the case of drugs it is authorized for marketing or is marketed (with an exception for off-label drugs and namedpatient basis import); in the case of medical devices if it is authorized for marketing and use; and in the case of food products for special dietary purposes if it is marketed; it is available on the market; it has an EAN or another code equivalent to EAN. Unlike the above products, the following may not be reimbursed: (a) (b) (c) a product in clinical conditions in which it is possible to effectively replace such a product by changing the patient s lifestyle; prescription drug which has an OTC counterpart, unless it requires administration for more than 30 days in a specific clinical condition; drug obtained by way of named-patient basis import, specified in an applicable ordinance of the Minister of Health. The law provides for the following reimbursement availability category: (a) (b) (c) available in the pharmacy against the prescription (within the whole scope of registered indications and intended uses or for indications specified by a given clinical condition); used within the scope of a drug program; used in chemotherapy (within the whole scope of registered indications and intended uses or for indications specified by a given clinical condition); European Pricing and Reimbursement Handbook 121

130 Poland (c) (d) stosowany w ramach chemioterapii (w całym zakresie zarejestrowanych wskazań i przeznaczeń bądź we wskazaniu określonym stanem klinicznym); stosowany w ramach udzielania świadczeń gwarantowanych innych niż wyżej wymienione. Organem właściwym do wydania decyzji o objęciu produktu refundacją jest Minister Zdrowia. Poza Ministrem Zdrowia w procedurze refundacyjnej uczestniczą Agencja Oceny Technologii Medycznych ( AOTM ) oraz Rada Przejrzystości. Decyzja refundacyjna wydawana jest na okres 5, 3 lub 2 lat, przy czym okres jej obowiązywania nie może przekraczać okresu wyłączności rynkowej. Po upływie ustalonego terminu decyzja o objęciu refundacją wygasa i konieczne jest złożenie nowego wniosku do Ministra Zdrowia. Możliwe jest też skrócenie terminu obowiązywania decyzji refundacyjnej w drodze decyzji Ministra Zdrowia wydanej na wniosek podmiotu, którego produkt został objęty refundacją. Wniosek taki nie jest jednak dla Ministra Zdrowia wiążący i w przypadkach określonych w przepisach może on odmówić wydania decyzji o skróceniu refundacji. 2. Czy ceny produktów kontrolowane są bezpośrednio? Kontrolą cen objęte są w Polsce tylko produkty refundowane. Dla tych produktów ustalana jest w drodze decyzji refundacyjnej urzędowa cena zbytu, obejmująca podatek od towarów i usług. Ustawa wprowadza dla produktów refundowanych również urzędowe marże hurtowe (w wysokości 5 procent liczonej od urzędowej ceny zbytu) oraz detaliczne (według stawek procentowo-kwotowych określonych w ustawie). Zarówno urzędowe ceny zbytu, jak i urzędowe marże hurtowe i detaliczne, mają charakter cen i marż sztywnych. Urzędowa marża hurtowa może być jednak dzielona pomiędzy przedsiębiorców prowadzących obrót hurtowy. 122 Baker & McKenzie

131 Poland (d) used within the scope of providing guaranteed services other than the above-listed. The decision to cover a given product with reimbursement rests with the Minister of Health. The other entities involved in the reimbursement procedure are: the Health Technology Assessment Agency ( Agency ) and the Transparency Council. A reimbursement decision may be issued for five, three or two years, provided that the validity period of the decision shall not exceed the market exclusivity period. With an applicable lapse of time, the reimbursement decision terminates and a new reimbursement motion has to be filed to the Minister of Health. There is a possibility of shortening the term of the reimbursement decision, by way of decision of the Minister of Health issued at the request of the entity whose product is subject to reimbursement. However, such a motion is not binding on the Minister, who may refuse issuing the decision on shortening the reimbursement in the circumstances described in the law. 2. Is there a direct price control on pharmaceutical products? The price control in Poland covers the reimbursed products only. The official selling price including VAT is established for these products by reimbursement decision. Also, official wholesale margins (5 percent of the official selling price) and retail margins (according to amount/percentage rates determined by law) on reimbursed products are set in the law. Both the official selling prices and official wholesale and retail margins are fixed. An official wholesale margin may be, however, shared by the entrepreneurs conducting the wholesale. Prices for non-reimbursable products may be determined freely by their manufacturers. European Pricing and Reimbursement Handbook 123

132 Poland Ceny produktów nieobjętych refundacją kształtowane są dowolnie przez ich producentów. 3. Jak wygląda procedura ustalania cen? Urzędowa cena zbytu określana jest w decyzji refundacyjnej. Minister Zdrowia ustala urzędową cenę zbytu przy uwzględnieniu: (a) stanowiska Komisji Ekonomicznej (utworzonej przy Ministrze Zdrowia); (b) (c) rekomendacji Prezesa AOTM, w szczególności wyników analizy stosunku kosztów do uzyskanych efektów zdrowotnych; konkurencyjności cenowej: biorąc pod uwagę równoważenie interesów świadczeniobiorców i przedsiębiorców zajmujących się wytwarzaniem lub obrotem produktami, możliwości płatnicze podmiotu zobowiązanego do finansowania świadczeń ze środków publicznych oraz działalność naukowo-badawczą i inwestycyjną wnioskodawcy w zakresie związanym z ochroną zdrowia na terytorium Polski oraz w innych państwach członkowskich Unii Europejskiej (UE) lub Europejskiego Porozumienia o Wolnym Handlu (EFTA). Od urzędowej ceny zbytu naliczana jest sztywna marża hurtowa w wysokości 5 procent, a następnie sztywna marża detaliczna według stawek procentowo-kwotowych określonych w ustawie. Cena danego produktu refundowanego dla pacjenta jest więc taka sama w każdej aptece i równa się urzędowej cenie zbytu określonej w decyzji refundacyjnej, powiększonej o marżę hurtową i detaliczną. 124 Baker & McKenzie

133 Poland 3. What are the pricing procedures, if any, under which the price for pharmaceutical products is determined? An official selling price is determined by reimbursement decision. The Minister of Health sets the official selling price taking into consideration: (a) (b) (c) position of the Economic Commission (a body established with the Minister of Health); recommendation of the President of the Agency, with special emphasis on the analysis of the relation between the incurred costs and the achieved health effects; price competitiveness; taking into account a balance between the interests of patients and entrepreneurs manufacturing or trading in the products, the financial means of the entity responsible for financing services with public funds, as well as R&D and investment operations of the applicant in the scope connected with the healthcare in Poland and in other European Union (EU) member states or the members of the European Free Trade Association (EFTA). The official selling price is the basis for calculation of a fixed wholesale margin amounting to five percent, and then a fixed retail margin according to percentage/amount rates specified by law. The price for a given reimbursed product to be paid by the patient is, therefore, the same at every pharmacy and equals the official selling price specified by reimbursement decision, plus the wholesale and retail margin. Reimbursed products are dispensed to patients: free of charge; against a lump sum charge; against payment of 30 percent or 50 percent of their financing limit, up to the level of the financing limit as European Pricing and Reimbursement Handbook 125

134 Poland Produkty refundowane wydawane są pacjentom: bezpłatnie, za odpłatnością ryczałtową, za odpłatnością w wysokości 30 procent albo 50 procent ich limitu finansowania, do wysokości limitu finansowania wyznaczonego dla danej grupy limitowej (ustalanej w oparciu o wskazane w ustawie kryteria). Oznacza to, iż NFZ refunduje aptece koszt zakupu leku do wysokości wyznaczonego limitu, zaś nadwyżkę zobowiązany jest pokryć pacjent. Cena ustalana jest na czas obowiązywania decyzji refundacyjnej (patrz powyżej). Jej ewentualne podwyższenie albo obniżenie następuje w drodze zmiany decyzji o objęciu refundacją. Nieco inne zasady obowiązują świadczeniodawców nabywających produkty w celu realizacji świadczeń gwarantowanych. 4. Jakie instrumenty stosowane są w celu kontroli publicznych wydatków na leki (np. reference pricing, współpłacenie przez pacjenta, tzw. pay back, value based pricing i instrumenty dzielenia ryzyka)? Przepisy przewidują następujące instrumenty służące ochronie publicznych wydatków na refundację: (a) (b) współpłacenie przez pacjenta (patrz pkt 3 powyżej); tzw. pay back - w przypadku przekroczenia całkowitego budżetu na refundację, podmiot, który uzyskał decyzję o objęciu refundacją, zwraca do NFZ kwotę proporcjonalną do udziału kosztów refundacji swojego produktu w przekroczeniu w danej grupie limitowej. Kwota ta wyliczana jest w ramach danej grupy limitowej w oparciu o podany w ustawie wzór. Obowiązku zwrotu kwoty przekroczenia nie stosuje się w przypadku ustalenia w decyzji refundacyjnej instrumentów dzielenia ryzyka; 126 Baker & McKenzie

135 Poland determined for a given limit group (established on the basis of the criteria indicated in the law). It means that the Fund reimburses the pharmacy the cost of the drug s purchase up to an established limit and the payment of the balance is the responsibility of the patient. The price is established for the term of the reimbursement decision (see above). It may be increased or decreased at a later date by way of amendment to the reimbursement decision. Slightly different rules apply to healthcare services providers purchasing the products for the purpose of providing guaranteed healthcare services. 4. What instruments are used to control public expenditure on pharmaceutical products (e.g., reference pricing, co-payment, payback, value-based pricing, and risk-sharing arrangements)? The law provides for the following instruments of control of public expenditure for reimbursement: (a) (b) (c) co-payment by the patient (see point 3 above); pay back where the overall budget for reimbursement has been exceeded, an entity which was granted a reimbursement decision, pays back to the Fund an amount which corresponds to its product s reimbursement share in the amount by which the budget was exceeded for a given limit group. The amount is calculated for a given limit group with the mathematical formula indicated in the law. The pay back is not applicable where the reimbursement decision provides for risk-sharing instruments; risk-sharing instruments may be specified in the reimbursement decision, and if so specified, they release an entity which was granted the decision from the payback obligation. European Pricing and Reimbursement Handbook 127

136 Poland (c) Instrumenty dzielenia ryzyka mogą zostać określone w treści decyzji refundacyjnej, a ich ustalenie wyłącza obowiązek zwrotu kwoty przekroczenia (pay back). 5. Czy obowiązuje specyficzna polityka dla produktów generycznych (np. szybsza procedura refundacyjna, niższe opłaty od wniosków itp.)? Czy cena produktów generycznych jest ustalana w drodze ustawy? Przepisy ustawy nie przewidują wprost ułatwień dla produktów generycznych, takich jak przyspieszona procedura refundacyjna czy niższe opłaty od wniosków. W trakcie prac nad ustawą w Senacie zgłoszono jednak poprawkę, zgodnie z którą producenci produktów generycznych mają zostać zwolnieni z instytucji pay-back. Również uzasadnienie projektu ustawy wskazuje na zamiar ułatwienia pacjentom dostępu do generyków. Jednocześnie należy podkreślić, że dotychczasowa praktyka Ministra Zdrowia na gruncie obecnie obowiązującego stanu prawnego (który również formalnie nie różnicował produktów referencyjnych i generycznych) wskazywała na protekcjonistyczne traktowanie tych ostatnich, co zostało wytknięte Polsce przez Komisję Europejską. Ceny urzędowe ustalane są dla leków generycznych na tej samej zasadzie, co dla leków oryginalnych, a więc tylko w przypadku objęcia ich refundacją, w drodze decyzji Ministra Zdrowia. 6. Jakie zachęty stosowane są wobec producentów leków innowacyjnych? Zgodnie z przepisami Minister Zdrowia ustalając cenę urzędową dla leków refundowanych bierze pod uwagę działalność naukowobadawczą i inwestycyjną wnioskodawcy w zakresie związanym z ochroną zdrowia na terytorium Polski oraz w innych państwach członkowskich UE lub Europejskiego Porozumienia o Wolnym Handlu (EFTA). Poza tym przepisy nie przewidują zachęt ani ułatwień dla innowacyjnych produktów leczniczych. 128 Baker & McKenzie

137 Poland 5. Is there a specific policy for generic pharmaceutical products (for instance, fast track approval, lower registration fees)? Is the price of generic products fixed by law? The law does not provide in express terms facilitation for generic pharmaceutical products such as fast track approval or lower registration fees for applications. During the legislation procedure an amendment has been proposed to exclude the generic pharmaceutical companies from the pay back mechanism. Also the justification to the draft law indicates for the intention to facilitate the patients access to the generic products. It should be stressed that also the existing practice of the Minister of Health in the current regulatory environment (under which also reference and generic pharmaceutical products are not officially differentiated) has been such that the latter were treated in a protectionist way, which has been pointed out to Poland by the European Commission. Official prices for generic drugs are determined in the same manner as official prices for original drugs, e.g., only in case they are covered by reimbursement, by way of decision of the Minister of Health. 6. What incentives exist for innovative pharmaceutical products? In accordance with the law, when establishing the official price for reimbursed products, the Minister of Health takes into account the R&D and investment operations of the applicant in the scope connected with the healthcare in Poland and in other EU member states or the members of the European Free Trade Association (EFTA). Except for that the law does not provide for facilitation or incentives for innovative pharmaceutical products. European Pricing and Reimbursement Handbook 129

138 Poland 7. Czy szpitale przeprowadzają przetargi publiczne na zakup leków? Jeżeli tak, to jakie zasady rządzą ofertami cenowymi składanymi przez firmy farmaceutyczne? Zakup produktów leczniczych przez szpitale podlega ustawie o zamówieniach publicznych. Na rynku szpitalnym ceny produktów refundowanych mają charakter cen maksymalnych, a nie sztywnych, nie mogą jednak przekraczać urzędowej ceny zbytu stanowiącej podstawę limitu w danej grupie limitowej. 8. Czy istnieje różnica pomiędzy refundacją leków przepisywanych przez lekarza w ramach prywatnej praktyki a tych przepisywanych w szpitalu? Ustawa nie wprowadza rozróżnienia pomiędzy refundacją leków przepisywanych w szpitalu oraz w lecznictwie otwartym. W czasie pobytu w szpitalu pacjent otrzymuje jednak leki bezpłatnie, podczas gdy zakupując lek w aptece musi dopłacić kwotę przekraczającą limit finansowania przez NFZ. 9. Czy możliwa jest refundacja produktu leczniczego we wskazaniu, które nie zostało zarejestrowane (tj. offlabel)? Jeżeli tak, to jakie są warunki? Dany produkt leczniczy może być refundowany poza zarejestrowanymi wskazaniami (off-label) tylko w ramach programu lekowego mającego na celu zwalczanie chorób nowotworowych oraz chemioterapii, jeżeli jest to niezbędne dla ratowania życia i zdrowia pacjentów oraz w brak innych możliwych do zastosowania w danym stanie klinicznym procedur medycznych finansowanych ze środków publicznych. Zgodę na finansowanie leku off-label może wydać Minister Zdrowia po zasięgnięciu opinii Rady Przejrzystości oraz konsultanta krajowego w odpowiedniej dziedzinie medycyny, przy uwzględnieniu określonych w ustawie kryteriów. 130 Baker & McKenzie

139 Poland 7. Are hospitals allowed to run public tenders on pharmaceutical products? If so, what are the rules governing the pricing proposal of the pharmaceutical companies? The purchase of medicinal products by hospitals is subject to the law on public tenders. The prices for reimbursed products on the hospital market are maximum and not fixed; they cannot however exceed the official selling price which constitutes the limit in the given limit group. 8. Is there a difference between reimbursement of pharmaceutical products prescribed by physicians in private practice and those prescribed in a hospital? The law does not differentiate between the reimbursement of drugs prescribed in the hospital and outpatient. However, when in hospital, the patient receives the drugs free of charge, whereas when buying in a pharmacy, he/she is obliged to pay the amount exceeding the reimbursement limit. 9. Can a pharmaceutical product that is used for an indication for which it is not approved (i.e. off-label use) be reimbursed? If yes, what are the conditions? A given pharmaceutical product may be reimbursed as an off-label drug prescribed only within the framework of a drug program designated for the elimination of malignant diseases and chemotherapy, if it is necessary to save patients lives and health and in the absence of other medical procedures which can be used in a given clinical condition, as financed from public funds. The consent to the financing of an off-label drug may be given by the Minister of Health based on: an opinion of the Transparency Council and the national consultant in the relevant field of medicine, and the criteria specified by the law. European Pricing and Reimbursement Handbook 131

140 Russia РОССИЯ Алексей Трусов, Сергей Ломакин, Элеонора Мжаванадзе Введение: Как в России организована Государственная система здравоохранения («ГСЗ»)? Российская система здравоохранения полагается, в основном, на государственные и муниципальные учреждения здравоохранения и основана на бюджетной (государственной и муниципальной) и страховой модели финансирования. Управление ею осуществляет Министерство здравоохранения и социального развития Российской Федерации (далее «Минздравсоцразвития»). Краеугольным камнем финансирования здравоохранения в России является принимаемая ежегодно Программа государственных гарантий оказания гражданам Российской Федерации медицинской помощи (далее «Государственная программа»). Она определяет виды и условия оказания медицинской помощи, нормативы объема медицинской помощи, нормативы финансовых затрат на единицу объема медицинской помощи, подушевые нормативы финансового обеспечения, порядок формирования и структуру тарифов на медицинскую помощь, а также предусматривает критерии качества и доступности медицинской помощи, предоставляемой гражданам Российской Федерации на ее территории бесплатно. В рамках Государственной программы гарантируется следующая медицинская помощь: первичная медико-санитарная помощь; скорая, в том числе специализированная (санитарноавиационная), медицинская помощь; специализированная, в том числе высокотехнологичная, медицинская помощь. 132 Baker & McKenzie

141 Russia Russia Alexey Trusov, Sergei Lomakin and Eleonora Mzhavanadze Executive Summary: How are National Health Services ( NHS ) organized in your country? Russian system of healthcare relies mainly on state and municipally owned healthcare institutions and is based on budget (state and municipal) and insurance model of funding. It is being managed by the Russian Ministry of Healthcare and Social Development ( MOH ). The cornerstone of financing of healthcare in Russia is the Program of State Guarantees of Medical Treatment to Russian Citizens (the State Program ) which is adopted annually. It defines types and conditions of medical treatment, standards of scope of medical aid, standards of financial expenses per specific item of medical aid, per capita standards of financial expenses, formation procedure and structure of tariffs of medical aid, and also provides criteria of quality and accessibility of medical aid provided free of charge to the citizens of Russia within its territory. The following medical aid is granted for free within the State Program: (a) (b) (c) primary medical aid; emergency call service, including specialized medical aid (i.e., air-medical aid); specialized, including high-tech, medical aid. Budget financing for procurement of medicines covers, inter alia, the following: (a) (b) additional medical aid (medical aid by district doctors) specialized medical aid (in relevant specialized medical institutions adopted by MOH) European Pricing and Reimbursement Handbook 133

142 Russia Бюджетное финансирование приобретения лекарственных препаратов покрывает, в частности, следующее: 1) дополнительную медицинскую помощь (оказание медицинской помощи участковыми врачами); 2) специализированную медицинскую помощь (в соответствующих специализированных медицинских учреждениях, одобренных Минздравсоцразвития); 3) высокотехнологичную медицинскую помощь (в соответствующих специализированных государственных учреждениях согласно государственному заданию Минздравсоцразвития); 4) программу «7 нозологий» (см. информацию ниже); 5) программу оказания дополнительной лекарственного обеспечения малообеспеченным гражданам и другим категориям, определенным в соответствующем законе (т.e., ветеранам, участниками Великой отечественной войны, инвалидам и пр.) в форме обеспечения лекарственными средствами (по утвержденному Минздравсоцразвития перечню), оказания медицинской помощи и санитарно-курортного лечения. Медицинское страхование в России включает в себя два уровня: Обязательное медицинское страхование («ОМС»), которое является неотъемлемой частью Государственной программы и Добровольное медицинское страхование («ДМС»). ОМС основано на следующих принципах: универсальный характер, что означает равенство прав на получение медицинского обслуживания вне зависимости от возраста, пола, статуса и состояния здоровья; государственный характер, что означает обеспечение государством рационального использования средств на ОМС и исполнение обязательств перед застрахованными лицами; 134 Baker & McKenzie

143 Russia (c) (d) (e) high-tech medical aid (in relevant specialized medical institutions in accordance with state assignment formulated by MOH) seven nosologies program (see more details below) additional medicinal supply program to low-income citizens and other categories specified in the relevant law (i.e., veterans, participants in World War II, disabled persons, etc.) in the form of providing medicines (under approved by MOH list), medical aid and sanatorium-resort therapy. Medical insurance in Russia includes two levels: Mandatory medical insurance ( OMS ), which is an integral part of the State Program, and Voluntary medical insurance ( DMS ). OMS is based on the following principles: (a) (b) (c) universal character, which means the equality of right for obtaining medical aid despite age, gender, status, state of health; governmental nature, which means the state provides rational use of OMS funds and fulfillment of its obligations before insured individuals; non-commercial character, which means all sums are addressed for the system of OMS and medical institutions. OMS guarantees Russian citizens the right to obtain free of charge medical and pharmaceutical aid within the scope of particular programs of OMS. OMS covers primary medical aid, specialized medical aid (excluding high-tech medical aid), and the list of relevant medical aid and supply of medicines in case of particular diseases (the list as integral part of the OMS may be altered from year to year). Payments for OMS are mandatory and for the most part are done by the employers. European Pricing and Reimbursement Handbook 135

144 Russia некоммерческий характер, что все суммы в ее рамках предназначаются для системы ОМС и медицинских учреждений. ОМС гарантирует российским гражданам право на получение бесплатной медицинской и лекарственной помощи в рамках определенных программ ОМС. ОМС покрывает расходы на первичную медицинскую помощь, специализированную медицинскую помощь (исключая высокотехнологичную медицинскую помощь), а также перечень соответствующей медицинской помощи и обеспечения лекарственными средствами в случае возникновения определенных заболеваний (перечень представляет собой неотъемлемую часть ОМС и может каждый год корректироваться). Платежи по ОМС являются обязательными и в основном производятся за счет работодателей. Система ДМС является по отношению к ОМС дополнительной и предусматривает под собой большее покрытие в части медицинского обслуживания, однако требует отдельного приобретения. На настоящий момент данный вид страхования обычно приобретается работодателями в качестве дополнительной льготы для работников. 1. Какая фармацевтическая продукция финансируется за счет ГСЗ, какова процедура? Лекарственное обеспечение в России в рамках упомянутых во Введении механизмов организовано путем осуществления закупок лекарственных препаратов для государственных и муниципальных нужд, регулируемых общими правилами осуществления закупок для государственных и муниципальных нужд в России, установленных в Федеральном законе 94-ФЗ «О размещении заказов на поставки товаров, выполнение работ, оказание услуг для государственных и муниципальных нужд» от 21 июля 2005 г. (с изменениями и дополнениями). 136 Baker & McKenzie

145 Russia DMS system is supplementary to the OMS, provides greater coverage in terms of medical services, but needs to be separately purchased. For the moment, this type of insurance is usually purchased by the employers as an additional benefit for the employees. 1. Which pharmaceutical products are reimbursed by the NHS, under what procedures? Medicinal supply in Russia within the mechanisms mentioned in the Executive Summary above is organized on the basis of state/municipal purchases of medicinal preparations, governed by the general rules of state/municipal procurement in Russia, namely Federal Law No. 94- FZ On Placement of Orders for the Supply of Goods, Performance of Works, and Rendering of Services for State and Municipal Needs, dated 21 July 2005, as amended. The medicinal preparations, which are subject to purchasing for budgetary funds, are specified in lists established by Russian state bodies. The medicinal preparations in these lists are mentioned by international no-proprietarily names (INNs). These lists are developed by the relevant state bodies as their internal function, i.e., a company may not apply within a formal procedure to have its product listed. Similarly, time period during which a medicine is purchased by the state is also not set and decisions on this matter, as the practice shows, may be made by Russian governmental authority rather unexpectedly. Prices of medicinal preparations purchased within state/municipal procurement are not specifically regulated and are defined in accordance with the rules of state/municipal procurement in Russia. For example, medicinal preparations are usually bought for state/municipal needs during open auctions in the electronic form so that a bidder with the lowest price bid wins the auction. At the same time, if the state regulation of prices applies to a medicinal preparation generally (for discussion of this matter please refer to questions 2 and 3 below), it will equally apply to it within state/municipal purchases. European Pricing and Reimbursement Handbook 137

146 Russia Лекарственные препараты, которые приобретаются за счет бюджетных средств, определены в перечнях, установленных российскими государственными органами. Лекарственные препараты в данных перечнях упоминаются под международными непатентованными наименованиями (МНН). Данные перечни разрабатываются соответствующими государственными органами согласно их внутренним функциям, т.е. организация не может в рамках официальной процедуры обратиться за включением своих товаров в перечень. Подобным образом также не установлен временной период, в течение которого лекарственный препарат приобретается государством, а решения по данному вопросу, как показывает практика, может быть принято российскими государственными органами достаточно неожиданно. Цены на лекарственные препараты, приобретаемые в рамках закупок для государственных и муниципальных нужд, никак отдельно не регулируются и устанавливаются в соответствии с правилами об осуществлении таких закупок. Например, лекарственные препараты обычно приобретаются для государственных и муниципальных нужд в ходе открытых аукционов в электронной форме таким образом, что их участник, предложивший самую низкую цену, выигрывает аукцион. В то же время, государственное регулирование цен, установленное в отношении определенных лекарственных препаратов (для получения комментариев по данному поводу см. вопросы 2 и 3 ниже), будет в равной степени применимо к таким лекарственным препаратам и в рамках их закупок для государственных и муниципальных нужд. В осуществлении государственных закупок участвуют различные государственные и муниципальные органы. Наиболее важно то, что Минздравсоцразвития организует аукционы по закупке лекарственных препаратов в раках программы «7 нозологий». За организацию государственных закупок для реализации программы обеспечения необходимыми лекарствами (известную 138 Baker & McKenzie

147 Russia Different state bodies are involved in running state/municipal purchases. Most importantly, the MOH organizes auctions to purchase medicinal preparations within seven nosologies program. Regional authorities are responsible for organization of state purchases to run the program of supply with necessary medicines (known under Russian abbreviations of DLO or ONLS program). Certain minor quantities of medicinal preparations are purchased using budgetary funds by healthcare institutions themselves. Purchased medicinal preparations are then given or administered to the patients in accordance with the conditions of each relevant program free of charge (please refer to question 3 below). 2. Is there a direct price control on pharmaceutical products? Yes, there is a direct price control on certain pharmaceutical products in Russia. 3. What are the pricing procedures, if any, under which the price for pharmaceutical products is determined? Prices of medicinal preparations included on the Essential Drugs List (EDL), adopted by the Russian Government, are subject to state regulation and control in Russia. The EDL refers to the medicines by their INNs and medicinal form so that any medicinal reparation with matching INN and medicinal form falls within the state regulation of prices. The state regulation of prices of medicinal preparations included in the EDL is effected through the following measures: (a) (b) state registration of the maximum manufacturer s prices of medicinal preparations (done at the federal level); and establishing maximum wholesale and retail trade margins applied to the prices of these medicinal preparations (done at the regional level). European Pricing and Reimbursement Handbook 139

148 Russia под российскими аббревиатурами ДЛО или ОНЛС) отвечают региональные органы власти. Самими учреждениями здравоохранения за счет бюджетных средств также приобретается небольшие количества лекарственных препаратов. Приобретенные лекарственные препараты затем бесплатно выдаются пациентам или применяются к ним в соответствии с условиями каждой соответствующей программы (см. вопрос 3 ниже). 2. Существует ли в России прямое ценовое регулирование фармацевтической продукции? Да, в России на определенную фармацевтическую продукцию существует прямое ценовое регулирование. 3. Какова методика ценообразования, согласно которой определяется цена на фармацевтическую продукцию (если таковая имеется)? Цены на лекарственные препараты, включенные в Перечень жизненно необходимых и важнейших лекарсвтенным препаратов (ЖНВЛП), принятый Правительством России, подлежат в России государственному регулированию и контролю. ЖНВЛП перечисляет лекарственные препараты по их МНН и лекарственной форме таким образом, что любой лекарственный препарат с подходящим МНН и лекарственной формой подпадает под государственное регулирование цен. Государственное регулирование цен на лекарственные препараты, включенные в ЖНВЛП, осуществляется посредством принятия следующих мер: государственной регистрации предельных отпускных цен производителей на лекарственные препараты (осуществляется на федеральном уровне); и 140 Baker & McKenzie

149 Russia The manufacturers of EDL medicinal preparations in Russia are obliged to register maximum manufacturer s prices of EDL medicinal preparations they manufacture, and EDL medicinal preparations may not be imported and circulate in the Russian market until and unless their maximum manufacturer s price is registered. For the purposes of registration of the maximum manufacturer s prices, the manufacturers or their representatives must submit to the MOH an application, stating, most importantly, a request for the registration of maximum manufacturer s price and a calculation of this price to substantiate the request. In case of local manufacturers, this calculation allows to take into account the cost structure of the manufacturing, whereas in case of foreign manufacturers, the calculation needs to show the price of the relevant medicinal preparations in certain reference countries and the weighted average importation price of this medicinal preparation into Russia (if it was imported prior to registration of the price). In addition, the maximum manufacturer s price being registered is limited by the already registered prices of analogous medicinal preparations (by INN, medicinal form and dosage, however, if the differences in dosage may be removed by calculating a price per unit). After the price is registered, it becomes the maximum allowed price for sales made by the manufacturers (both Russian and foreign) to the distributors in Russia. With respect to the foreign medicinal preparations, the registered maximum manufacturer s prices serve as a constraint on their importation price. The importation price (foreign manufacturer) or sale price (local manufacturer) may of course be lower than the registered maximum manufacturer s price. However, whenever a price decrease is considered, it needs to be kept in mind that this decrease may affect the future registrations of the maximum manufacturer s price of this medicinal preparation. The maximum manufacturer s price registrations do not have a validity term and apply to any sales unless re-registered or the relevant medicinal preparation ceases to have EDL status. In case of Russian European Pricing and Reimbursement Handbook 141

150 Russia установление максимальной оптовой и розничной торговых надбавок, применяемых к ценам на данные лекарственные препараты (осуществляется на региональном уровне). Производители лекарственных препаратов, включенных в ЖНВЛП, обязаны зарегистрировать в России предельную отпускную цену включенных в ЖНВЛП лекарственных препаратов, которые они производят, причем включенные в ЖНВЛП лекарственные препараты не могут быть импортированы или выпущены на российский рынок до тех пор, пока их предельная отпускная цена не будет зарегистрирована. Для целей регистрации предельной отпускной цены производители или их представители должны представить в Минздравсоцразвития заявление, в котором указано, главным образом, требование о государственной регистрации предельной отпускной цены и расчет данной цены для обоснования требования. В случае с локальными производителями данный расчет позволяет учесть структуру затрат на производство, тогда как в случае с иностранными производителями в расчетах должны быть указаны цены на соответствующие лекарственные препараты в определенных государствах сравнения, а также средневзвешенную цену ввоза этих лекарственных препаратов в Россию (в случае если они ввозились до регистрации цены на них). В дополнение к изложенному, регистрируемая предельная отпускная цена производителя ограничивается уже зарегистрированными ценами на аналогичные лекарственные препараты (по МНН, лекарственной форме и дозировке, а при наличии разницы в дозировке она может быть устранена путем расчета цены за единицу). После того как цена была зарегистрирована, она становится максимально разрешенной ценой для продажи лекарственных 142 Baker & McKenzie

151 Russia manufacturers, the maximum manufacturer s prices may be reregistered once a year. In addition, the maximum manufacturer s prices may be re-registered whenever something changes with respect to the preparation itself (e.g. manufacturer changes its name). However, in practice, for foreign manufacturers, any such reregistration may mean the price either remains the same or becomes lower. The maximum wholesale and retail trade margins for medicines included on the EDL are established by regional governmental authorities. These margins are established as percentages and are calculated using the actual sale price of the medicine of the Russian manufacturer or actual importation price. Prices for other medicines (i.e. those not included on the EDL) and medical products are no longer regulated. However, some regional authorities did not abolish the maximum margins they established for other medicines or for medical devices under the previous rules and, therefore, may attempt to enforce them. 4. What instruments are used to control public expenditure on pharmaceutical products (reference pricing, co-payment, payback, value-based pricing, risk-sharing arrangements, etc.)? The most important mechanism used to control expenses of state/municipal budgets for purchases of medicinal preparations is the budgetary system itself, when no budget expense may be performed until and unless it is set forth in a budget. For the purchase of medicinal preparations, it means that they will be purchased within a sum of money allocated for such purpose. Therefore, changes to the funding of any given state/municipal program usually happen when the relevant budget is approved. For practical reasons, there are cases wherein the Russian state urgently increases budget funding for the purchases of medicinal preparations, but this is done to avoid state program failure. European Pricing and Reimbursement Handbook 143

152 Russia препаратов производителями (как российскими, так и иностранными) дистрибьюторам в России. В отношении иностранных лекарственных препаратов, зарегистрированные предельные отпускные цены производителей служат ограничением цены их ввоза. Цена ввоза (иностранного производителя) или продажи (локального производителя) может, несомненно, быть ниже зарегистрированной предельной отпускной цены производителя. Однако при рассмотрении возможности снижения цены, необходимо учитывать, что это может затронуть будущие регистрации предельных отпускных цен производителей на данные лекарственные препараты. Зарегистрированные предельные отпускные цены производителей не имеют срока действия и применимы к любым продажам до тех пор, пока они не были перерегистрированы или же пока соответствующие лекарственные препараты не исключены из ЖНВЛП. В случае с российскими производителями предельные отпускные цены производителей могут быть перерегистрированы один раз в год. В дополнение к изложенному максимальные отпускные цены могут быть перерегистрированы всякий раз, когда что-либо изменяется в самих препаратах (например, если производитель изменяет наименование препарата). Однако на практике для иностранных производителей любая такая перерегистрация может означать либо сохранение уровня цен, либо его понижение. Максимальные оптовые и розничные торговые надбавки на препараты, включенные в ЖНВЛП, устанавливаются региональными государственными органами. Такие надбавки устанавливаются в виде процентов и рассчитываются с использованием фактической отпускной цены препарата, установленной российским производителем, или же фактической цены ввоза. Цены на иные лекарственные средства (не включенные в ЖНВЛП) и медицинские изделия более не регулируются. Однако некоторые региональные органы власти не отменяли 144 Baker & McKenzie

153 Russia The effectiveness of state/municipal budget expenditures is achieved through the state regulation of prices of EDL medicinal preparations, but most importantly through the instruments of state/municipal procurement, e.g. auctions. 5. Is there a specific policy for generic pharmaceutical products (for instance, fast track approval, lower registration fees, etc.)? Is the price of generic products fixed by law? The only specific mechanism established for reproduced medicinal preparations in Russia (the term is roughly equal to generic though in Russia, it means any registration of the same medicine [by INN or a combination of INNs and medicinal form] in Russia following the original registration) is that they may be subject to expedited expert examination within the procedure of their state registration as medicinal preparations. The expedited expert examination allows submission of openly published data on clinical trials of the medicinal preparation together with the results of bioequivalence or therapeutic equivalence study. At the same time, it is not clearly stated whether this information replaces any documents, e.g. data on pre-clinical and/or clinical trials within the application dossier. In addition, the timing of expert examinations is shortened within the expedited expert examination, but it is important to note that complete state registration procedure both for the original and reproduced medicinal preparations should not take longer than 210 working days. The price of reproduced medicinal preparations in Russia is not fixed by law simply due to the fact that they are reproduced, at the same time, state regulation of prices of EDL medicines applies equally to reproduced medicinal preparations. European Pricing and Reimbursement Handbook 145

154 Russia максимальных торговых набавок, которые они установили в отношении иных лекарственных средств и медицинских изделий по ранее действовавшим правилам, и, следовательно, могут пытаться обеспечить их соблюдение. 4. Какие инструменты используются для контроля государственных расходов на приобретение фармацевтической продукции (цены сравнения, софинансирование, возвратная оплата, ценообразование на основе ценности, соглашения о разделе рисков и пр.)? Наиболее важным механизмом, используемым для контроля над расходованием государственных и муниципальных бюджетов на закупку лекарственных препаратов, является сама бюджетная система, - когда никакие бюджетные расходы не могут осуществляться до тех пор, пока они не предусмотрены в бюджете. В части закупки лекарственных препаратов это означает, что она будет осуществлена в рамках суммы, которая выделена для таких целей. В этой связи изменение финансирования любой государственной или муниципальной программы обычно происходит при принятии соответствующего бюджета. На практике имеются случаи, когда российское правительство срочно поднимает бюджетное финансирование для закупки лекарственных препаратов, однако это осуществляется для избежания срыва государственной программы. Эффективность расходования государственных и муниципальных бюджетов достигается через государственное регулирование цен на включенные в ЖНВЛП лекарственные препараты, но самое главное через инструмент государственных и муниципальных закупок, т.е. через аукционы. 146 Baker & McKenzie

155 Russia 6. What incentives exist for innovative pharmaceutical products? We are not aware of any incentives for innovative pharmaceutical products established in Russia. The government promotes innovation in Russia. Proof of that is the Skolkovo project, a high-tech research hub near Moscow, as well as the localization of medicine production such as through the pharmaceuticals clusters initiative. However, we have not yet known any incentives on innovative medicines either economic or administrative. 7. Are hospitals allowed to run public tenders on pharmaceutical products? If so, what are the rules governing the pricing proposal of the pharmaceutical companies? Yes, most, if not all Russian state or municipally owned hospitals are allocated budget funds for purchasing of medicinal preparations, and they are allowed to run state/municipal procurement tenders for purchase of medicinal preparations. State/municipal procurement organized by them is subject to the same general rules as described above and the default mode of purchasing in this case is again open auctions in electronic form. 8. Is there a difference between reimbursement of pharmaceutical products prescribed by physicians in private practice and those prescribed in a hospital? Usually, only physicians employed in hospitals may issue prescriptions for medicinal preparations, provided to the patients within the state/municipal programs of medicinal supply. At the same time, private practicing physicians who: (a) work under agreement with a regional healthcare authority and/or a territorial Mandatory Medical Insurance Fund; European Pricing and Reimbursement Handbook 147

156 Russia 5. Имеются ли специальные положения, регулирующие генериковую фармацевтическую продукцию (например, ускоренное одобрение, более низкие регистрационные сборы и пр.)? Фиксирована ли цена на генериковую фармацевтическую продукцию законом? Единственным специальным механизмом, установленным в России для воспроизведенных лекарственных препаратов (термин примерно соответствующий по значению понятию термину генерик, хотя в России он означает любую регистрацию того же лекарственного средства [по МНН или по сочетанию МНН и лекарственной формы], осуществленную в России после оригинальной регистрации), состоит в том, что они могут подлежать ускоренной процедуре экспертизы в рамках процедуры их государственной регистрации в качестве лекарственных препаратов. Ускоренная процедура экспертизы позволяет представлять информацию, полученную при проведении клинических исследований лекарственных препаратов и опубликованная в специализированных печатных изданиях, а также документы, содержащие результаты исследования биоэквивалентности и (или) терапевтической эквивалентности лекарственного препарата. И в то же время явно не указано, заменяет ли такая информация какие-либо документы, например, данные о доклинических и/или клинических исследованиях в рамках регистрационного досье. Помимо этого, срок проведения экспертиз в рамках ускоренной процедуры экспертизы сокращен, однако важно учитывать, что полная процедура государственной регистрации как для оригинальных, так и для воспроизведенных лекарственных препаратов не может превышать 210 рабочих дней. 148 Baker & McKenzie

157 Russia (b) deliver medical aid within the program of rendering state social aid; and (c) deliver medical aid to individuals who have right to receive pharmaceutical products free of charge and with discount are empowered to also issue prescriptions in this context. However, as we understand, privately practicing physicians in Russia are quite rare. Therefore, those qualified to issue prescriptions within the state/municipal programs of medicinal supply should even be rarer, if any exist at all. 9. Can a pharmaceutical product that is used for an indication for which it is not approved (i.e. off-label use) be reimbursed? If yes, what are the conditions? No, Russian law regulates supply of pharmaceutical products only in accordance with their approved indications. European Pricing and Reimbursement Handbook 149

158 Russia Российское законодательство не регулирует цены на воспроизведенные лекарственные препараты лишь в силу того факта, что они являются воспроизведенными. В то же время государственное регулирование цен на лекарственные препараты, включенные в ЖНВЛП, в равной степени применяется и к воспроизведенным лекарственным препаратам. 6. Какие льготы существуют для инновационных фармацевтических препаратов? Нам не известно ни о каких установленных в России льготах для инновационных фармацевтических препаратов. Россия поощряет инновации, доказательством чему является проект «Сколково» - высокотехнологичный исследовательский центр недалеко от Москвы, а также проекты по локализации производств лекарственных средств, например через инициативу создания фармацевтических кластеров. Несмотря на это, мы пока не осведомлены ни о каких льготах на инновационные лекарственные средства - ни экономических, ни административных. 7. Разрешено ли больницам проводить публичные тендеры на закупку фармацевтической продукции? Если да, то каковы правила, регулирующие предложение цен фармацевтическими компаниями? Да, большинству, если не всем российским государственным и муниципальным больницам выделяются бюджетные средства для приобретения лекарственных препаратов и им разрешено проводить тендеры для целей закупки лекарственных препаратов для государственных и муниципальных нужд. Организованные ими закупки для государственных и муниципальных нужд регулируется теми же общими правилами, которые описаны выше, а способом приобретения продукции по 150 Baker & McKenzie

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160 Russia умолчанию в таких случаях также является проведение открытых аукционов в электронной форме. 8. Существует ли разница в порядке возмещения расходов на приобретение фармацевтической продукции, назначенной частными практикующими врачами или больницей? Обычно выдавать рецепты на лекарственные препараты, предоставляемые пациентам в рамках государственных и муниципальных программ лекарственного обеспечения, вправе только врачи, работающие в больницах. И в то же время, частные практикующие врачи, которые: работают по договору с региональным органом здравоохранения и/или территориальном Фонде обязательного медицинского страхования; предоставляют медицинскую помощь в рамках программы оказания государственной социальной помощи; и предоставляют медицинскую помощь лицам, которые имеют право на получение фармацевтической продукции бесплатно или со скидкой, также уполномочены выдавать рецепты в данной связи. Однако, насколько мы понимаем, частные практикующие врачи в России встречаются довольно редко. Исходя из вышеизложенного, те их них, которые имеют квалификацию для выдачи рецептов в рамках государственных или муниципальных программ лекарственного обеспечения, являются еще большей редкостью, если вообще существуют. 152 Baker & McKenzie

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162 Russia 9. Могут ли быть возмещены расходы на покупку фармацевтической продукции, которая используется не в соответствии с показаниями к применению (т.е. за пределами инструкции)? Если да, то каковы условия? Нет. Российское законодательство регулирует обеспечение фармацевтической продукцией только для использования в соответствии с установленными показаниями. 154 Baker & McKenzie

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164 Spain España Montserrat Llopart, Cecilia Pastor, Ester Navas, Ariadna Casanueva Resumen: Cómo está organizado el Servicio Nacional de Salud en España? El Sistema Nacional de Salud (en adelante, SNS ) incluye el conjunto de prestaciones sanitarias públicas así como las estructuras y servicios puestos al servicio de la salud de los ciudadanos. En España existe un sistema de financiación selectiva de los medicamentos, que tiene en cuenta la valoración de la utilidad terapéutica del medicamento y el grado de innovación 1. Asimismo, incorpora sistemas de control del gasto público en medicamentos a través de un sistema de precios de referencia y del establecimiento de descuentos obligatorios para los medicamentos. La decisión sobre financiación y precio de un medicamento se adopta de manera centralizada a nivel nacional. No obstante, la gestión de las prestaciones incluidas en el SNS corresponde a las 17 Comunidades Autónomas. Los ciudadanos únicamente abonan parte del coste de los medicamentos dispensados a través de oficinas de farmacia, estando exentos de pago ciertos grupos de población. 1. Qué medicamentos son reembolsados y de acuerdo con qué procedimiento? Una vez que un medicamento ha obtenido la autorización de comercialización, y con carácter previo a su puesta en el mercado, la Dirección General de Farmacia y Productos Sanitarios del Ministerio de Sanidad, Política Social e Igualdad ( Ministerio de Sanidad ) inicia 1 Ley 29/2006, de 26 de julio, de Garantías y Uso Racional del Medicamento y Productos Sanitarios ( Ley 29/2006 ) y su normativa de desarrollo. 156 Baker & McKenzie

165 Spain Spain Montserrat Llopart, Cecilia Pastor, Ester Navas y Ariadna Casanueva Executive Summary: How are the National Health Services organized in your country? The National Health System (SNS) includes the entire gamut of public health benefits, as well as the structures and services placed at the service of citizens health. Spain has a system for the selective financing of medicines, which takes into account the assessment of the therapeutic usefulness of the medicine and its degree of innovation. 12 Spain also controls public spending on medicines through a reference price system and the establishment of mandatory discounts for medicines. Decision-making on financing and pricing of medicines is centralized at national level. Nevertheless, the 17 Autonomous Communities manage the benefits included in the NHS. Citizens pay only part of the cost of the medicines dispensed through pharmacies, though certain groups of the public are exempt from payment. 1. Which pharmaceutical products are reimbursed by the NHS, under what procedures? Once a medicine has obtained the marketing authorization and before it is placed on the market, the General Directorate of Pharmacy and Medical Devices of the Ministry of Health, Social Policy, and Equality (the Ministry of Health ) begins the financing procedure 2, 3 12 Law 29/2006, of July 26, on Guarantees and the Rational Use of Medicines and Medical Devices ( Law 29/2006 ) and the regulations which implement it. 23 Article 89 of Law 29/2006. European Pricing and Reimbursement Handbook 157

166 Spain de oficio el procedimiento de financiación 2, 4 en el que se determina si dicho medicamento estará incluido o no en la prestación farmacéutica del SNS. Los medicamentos autorizados para hacer publicidad dirigida al público en general no se incluyen en la financiación pública. Los criterios que debe tener en cuenta el Ministerio de Sanidad para determinar la inclusión o no de un medicamento en la prestación farmacéutica del SNS son los siguientes: a) gravedad, duración y secuelas de las distintas patologías para las que resulten indicados; b) necesidades específicas de ciertos colectivos; c) valor terapéutico y social del medicamento y beneficio clínico incremental del mismo teniendo en cuenta su relación coste-efectividad; d) racionalización del gasto público destinado a prestación farmacéutica e impacto presupuestario en el SNS; e) existencia de medicamentos u otras alternativas terapéuticas para las mismas afecciones a menor precio o inferior coste de tratamiento y; f) el grado de innovación del medicamento. Dentro del procedimiento de financiación se decide, en primer lugar, la inclusión o no en la prestación farmacéutica del SNS y, en caso afirmativo, se establece su precio. 2. Existe un control directo del precio de los medicamentos? Este punto se trata en el tercer apartado. 3. Cuáles son los procedimientos para la fijación de precios de medicamentos? Los medicamentos incluidos en la prestación farmacéutica del SNS están sujetos a un sistema de fijación de precios. El resto de medicamentos tienen precio libre. 24 Artículo 89 de la Ley 29/ Baker & McKenzie

167 Spain in which the Ministry of Health will establish whether or not said medicine shall be included within the products covered by the SNS. Medicines authorized to be advertised to the general public shall not be included in the public financing system. The Ministry of Health s criteria in determining whether or not to include a medicine within the products covered by the SNS are the following: (a) the seriousness, duration, and long-term effects of the different pathologies for which the medicine is indicated; (b) the specific needs of certain groups of patients; (c) the therapeutic and social usefulness of the medicine and its increased clinical benefit, considering its cost-effectiveness relation; (d) rationalization of the public expense for providing pharmaceutical coverage and the impact on the SNS s budget; (e) the existence of medicines or other therapeutic alternatives for the same ailments at a lower price or lower cost of treatment; and (f) the degree of innovation of the medicine. Within the financing procedure, it will first be decided whether or not the medicine is to be covered by the SNS and, if so, the price will be established. 2. Is there direct price control on pharmaceutical products? This point is covered in question three below. 3. What are the pricing procedures, if any, under which the price for pharmaceutical products is determined? Medicines included in the SNS s pharmaceutical coverage are subject to a pricing system. All other medicines may be freely priced. The laboratory may submit a price proposal. The Interministry Commission on Medicine Prices, under the Ministry of Health, is the body entrusted with setting the maximum industrial price. The decision must be based on the criteria indicated in the response to Question 1 above and must take into account the price of the medicine in the European Union Member-States which are not subject to special European Pricing and Reimbursement Handbook 159

168 Spain El laboratorio puede presentar su propuesta de precio. La Comisión Interministerial de Precios de los Medicamentos, dependiente del Ministerio de Sanidad, es el órgano encargado de determinar el precio industrial máximo. Su decisión debe basarse en los criterios señalados en la pregunta 1 y tener en cuenta el precio de los medicamentos en los Estados Miembros de la Unión Europea que, sin estar sujetos a regímenes excepcionales o transitorios en materia de propiedad industrial, hubiesen incorporado a su ordenamiento jurídico la legislación comunitaria. Asimismo, la Comisión Interministerial de Precios de los Medicamentos tiene en cuenta los informes sobre utilidad terapéutica de los medicamentos elaborados por la AEMPS, así como los informes que pueda elaborar el Comité de Coste- Efectividad de los Medicamentos y Productos Sanitarios (pendiente de creación). El Ministerio de Sanidad establece el precio de venta al público de los medicamentos mediante la agregación al precio industrial máximo de los márgenes de comercialización establecidos para los distribuidores y oficinas de farmacias. La relación de medicamentos y productos sanitarios incluidos en la prestación farmacéutica del SNS puede ser objeto de revisión, de acuerdo con la evolución de los criterios de uso racional, conocimientos científicos, aparición de nuevos medicamentos de mayor utilidad terapéutica o aparición de efectos adversos que hagan variar la relación beneficio/riesgo. Actualmente, las decisiones sobre financiación y precio de medicamentos incluyen la exigencia de una revisión anual del precio autorizado. El plazo para la resolución del procedimiento sobre la inclusión o no de un medicamento en la prestación farmacéutica del SNS, y en su caso, la fijación del precio es de 90 días. En el supuesto de que el Ministerio de Sanidad solicite al laboratorio información o documentación adicional, el plazo se amplía otros 90 días adicionales. 160 Baker & McKenzie

169 Spain or temporary regimes with respect to intellectual property and have incorporated Community legislation in their legal systems. Furthermore, the Interministry Commission on Medicine Prices takes into account the reports on the therapeutic usefulness of the medicines prepared by the Spanish Medicines and Medical Devices Agency, as well as any reports prepared by the Committee on Cost-Effectiveness of Medicines and Medical Devices (pending creation). The Ministry of Health establishes the public sale price of medicines by adding the profit margins of distributors and pharmacies to the maximum industrial price. The SNS may review the list of medicines and medical devices included in its pharmaceutical coverage, in keeping with the rational use of scientific knowledge, the appearance of medicines with a greater therapeutic usefulness, or the appearance of adverse effects which alter the benefit/risk relationship. Currently, the decisions on financing and medicine prices include the requirement of an annual review of the authorized price. The SNS has 90 days to resolve on whether or not to include a medicine in its pharmaceutical coverage and, if so, to establish its price. If the Ministry of Health requests additional information or documentation, the deadline is extended for another 90 days. 4. What instruments are used to control public expenditure on pharmaceutical products (reference pricing, co-payment, payback, value based pricing, risk-sharing arrangements, etc.)? There is a reference price system to control pharmaceutical expenses. It establishes the maximum amount by which covered presentation of medicines in each group are financed. European Pricing and Reimbursement Handbook 161

170 Spain 4. Cuáles son los instrumentos para controlar el gasto farmacéutico (precios de referencia, copago )? Existe un sistema de precios de referencia como sistema de control del gasto farmacéutico, por el que se establece la cuantía máxima con la que se financian las presentaciones de medicamentos incluidas en cada uno de los conjuntos que se determinen. El sistema de precios de referencia se basa en el establecimiento de conjuntos de medicamentos que incluyen la totalidad de las presentaciones de medicamentos financiados que tengan el mismo principio activo e idéntica vía de administración, entre las que debe existir, al menos, una presentación de medicamento genérico o medicamento biosimilar. Pueden crearse conjuntos una vez hayan transcurrido 10 años desde la fecha de la autorización inicial de comercialización del medicamento de referencia en España, u 11 en el caso de haber sido autorizada una nueva indicación. El precio de referencia se fija, para cada conjunto, en base al coste/tratamiento/día menor de las presentaciones de medicamentos en él agrupadas por cada vía de administración, calculados según la dosis diaria definida. Pueden fijarse umbrales mínimos para estos precios, en ningún caso inferiores a EUR1,00 de precio industrial. Los medicamentos incluidos en un conjunto no podrán superar el precio de referencia de dicho conjunto. La determinación de los conjuntos y sus precios de referencia, así como la revisión de los precios de referencia de los conjuntos ya determinados se realizará, a la mayor brevedad posible, cuando concurran los requisitos previstos en la legislación para la determinación de un nuevo conjunto o revisión de los existentes, y como mínimo una vez al año. Además del sistema de precios de referencia, también existe un sistema de copago en España, por el cual los pacientes abonan un porcentaje del coste del medicamento que adquieren a través de la 162 Baker & McKenzie

171 Spain The reference price system is based on groups of medicines which include all covered medicines with the same active principle and the same means of administration, with at least one generic or biosimilar medicine in the group. Groups may be created starting 10 years from the initial authorization date for sale in Spain, or 11 if a medicine has been approved for a new indication. The reference price for each group is established based on the cost/treatment/day of the medicines in the group for each means of administration, calculated according to the defined daily dose. Minimum thresholds may be established, but the industrial price of a medicine may not be lower than EUR1.00. Medicines included in a group may not exceed the reference price for the group. The groups and their reference prices and the review of reference prices will be determined as soon as possible after the legal requirements to determine a new group or review those in existence are met, but at least once a year. Beyond the reference price system, there is also a co-payment system in Spain, under which patients pay a percentage of the cost of the SNS-covered medicine which they acquire through pharmacies. There are two types of contributions: (i) the normal contribution, generally applicable, paid by patients when the medicine is dispensed at a pharmacy (40 percent of the public sale price) and (ii) the reduced contribution (10 percent of the public sale price), but here the total amount of the contribution may not exceed EUR2.64 per container, for example, for medicines for the treatment of chronic or serious illnesses. Also, pensioners and similar groups, as well as patients under treatment for on-the-job accidents or occupational illnesses, are not subject to co-payment. European Pricing and Reimbursement Handbook 163

172 Spain oficina de farmacia con cargo a la prestación farmacéutica del SNS. Existen dos tipos de aportaciones: (i) la aportación normal que es la que con carácter general corresponde satisfacer a los pacientes en el momento de la dispensación en oficina de farmacia: 40 por ciento sobre el precio de venta al público; y (ii) la aportación reducida: un 10 por ciento sobre el precio de venta al público, sin que el importe total de la aportación pueda exceder de EUR2,64 por envase, por ejemplo en el caso de medicamentos para el tratamiento de enfermedades crónicas o graves. Por otra parte, los pensionistas y colectivos asimilados, y los pacientes sujetos a tratamientos derivados de accidentes de trabajo y enfermedad profesional no están sujetos a copago. Finalmente, mediante el Real Decreto Ley 8/2010, el Gobierno estableció un descuento del 7 5 por ciento sobre el precio de los medicamentos cuya compra, con cargo al SNS, se lleve a cabo a través de los servicios de farmacia de los hospitales, de los centros de salud y de las estructuras de atención primaria (4 por ciento en el caso de medicamentos huérfanos). Dicho porcentaje de descuento fue incrementado en agosto de 2011 (Real Decreto Ley 9/2011) al 15 por ciento en relación con los medicamentos de uso humano respecto de los que no exista genérico o biosimilar autorizado en España, incluidos los de uso hospitalario, para los que hayan transcurrido 10 años desde la fecha en que se hubiese adoptado la decisión de financiar con fondos públicos, u 11 en el caso de haber sido autorizada una nueva indicación, con la excepción de aquellos medicamentos que cuenten con protección de patente de producto en todos los Estados miembros de la Unión Europea que, sin estar sujetos a regímenes excepcionales o transitorios en materia de propiedad industrial, hubiesen incorporado a su ordenamiento jurídico la legislación comunitaria correspondiente, y siempre que esta circunstancia se acredite por el titular de la autorización de comercialización 5. 5 Las deducciones el 7,5% y del 15% no son aplicables a los medicamentos genéricos. 164 Baker & McKenzie

173 Spain Finally, by means of Royal Decree 8/2010, the Government established a discount of 7.5 percent on the price of medicines (4 percent for orphan drugs) which are purchased at the expense of the SNS through the pharmacy services of hospitals, healthcare centers, and primary care facilities. In August 2011, Royal Decree 9/2011 increased this discount to 15 percent for medicines for human use, including medicines for hospital use, when there is no authorized generic or biosimilar product in Spain 10 years after the decision to finance them with public funds, or 11 if a new indication is authorized. The exceptions are medicines patented in all the European Union member states which are not subject to special or temporary regimes with respect to intellectual property and have incorporated Community legislation in their legal systems. This must be verified by the holder of the authorization to market Is there a specific policy for generic pharmaceutical products (for instance, fast track approval, lower registration fees, etc.)? Is the price of generic products fixed by law? Article 90.2 of Law 29/2006 states that to establish the price of generic medicines, the Interministry Commission on Medicine Prices must establish the economic criteria to apply. Using those criteria, the Ministry of Health will determine the maximum industrial price of generic medicines. This should entail an accelerated procedure to approve financing and the pricing of generic medicines. However, to date the Interministry Commission on Medicine Prices has not established the above-mentioned economic criteria. 36 The 7.5 percent and 15 percent deductions are not applicable to generics. European Pricing and Reimbursement Handbook 165

174 Spain 5. Existe alguna política específica para medicamentos genéricos (por ejemplo, un procedimiento rápido de aprobación, unas tasas reducidas de registro, etc.)? Se fija el precio de los medicamentos genéricos por ley? El artículo 90.2 de la Ley 29/2006 establece que, para la fijación del precio de los medicamentos genéricos, la Comisión Interministerial de Precios de los Medicamentos deberá establecer los criterios económicos a aplicar, y el Ministerio de Sanidad será quien, de acuerdo con dichos criterios, determine el precio industrial máximo de los medicamentos genéricos. Ello debería suponer un procedimiento acelerado para la aprobación de la financiación y precio de los medicamentos genéricos. Sin embargo, a esta fecha la Comisión Interministerial de Precios no ha fijado dichos criterios. En el año 2010 y atendiendo a las necesidades de contención y reducción del gasto público farmacéutico como consecuencia del contexto económico, el Gobierno acordó reducir el precio industrial máximo de los medicamentos genéricos de uso humano financiados por el SNS (Real Decreto-Ley 4/2010): (i) (ii) Para los medicamentos genéricos incluidos en el sistema de precios de referencia, la reducción se aplicó mediante un escalado (del 0 por ciento al 30 por ciento) según la diferencia porcentual existente entre el precio de referencia y el precio de venta al público del medicamento genérico. Para los medicamentos genéricos no incluidos en el sistema de precios de referencia, la reducción fue del 30 por ciento. No obstante, se fijó como precio mínimo de venta al público resultante de los anteriores descuentos el importe de EUR3, Baker & McKenzie

175 Spain In 2010, addressing the need to contain and reduce public spending on pharmaceuticals as a consequence of the current economic climate, the Government approved the reduction of the maximum industrial price of generic medicines for human use financed by the SNS (Royal Decree-Law 4/2010): (i) (ii) For generic medicines included in the reference price system, a scale of reduction (of from 0 percent to 30 percent) was applied according to the percentage difference between the reference price and the sale price to the relevant public. For generic medicines not included in the reference price system, the discount was 30 percent. Nevertheless, the minimum sale price to the public of the above discounts was established at EUR What incentives exist for innovative pharmaceutical products? In the development of the provisions of Article 93.2 of Law 29/2006, the Ministry of Health approved Order SPI/3052/2010, of November 26, which regulates certain aspects of the reference price system and the situations, requirements, procedures, and effects of the declaration of pharmaceutical innovation with therapeutic interest (the Order ). The Order establishes that to classify a medicine as having pharmaceutical innovation with therapeutic interest, at least one of the following requirements must be met: European Pricing and Reimbursement Handbook 167

176 Spain 6. Qué incentivos existen para los medicamentos innovadores? En desarrollo de lo establecido en el Artículo 93.2 de la Ley 29/2006, el Ministerio de Sanidad aprobó la Orden SPI/3052/2010, de 26 de noviembre, en la que se regulan los supuestos, requisitos, procedimiento y efectos de la declaración de innovación galénica de interés terapéutico (en adelante, Orden ). La Orden establece que para declarar un medicamento como innovación galénica de interés terapéutico debe concurrir, al menos, alguno de los siguientes requisitos: Que el medicamento se presente por primera vez bajo una vía de administración diferente a la autorizada y que esta nueva vía suponga una mejora significativa en la utilidad terapéutica del producto, basada en su eficacia, seguridad o utilidad en poblaciones especiales. Que, aun presentándose bajo una vía de administración ya autorizada, se demuestre que la novedad incorporada en el medicamento añade una mejora significativa en la utilidad terapéutica del producto, basada en su eficacia, seguridad o utilidad en poblaciones especiales. La consecuencia de que un medicamento sea declarado innovación galénica es que queda excluido del sistema de precios de referencia durante un período de 5 años computables desde la fecha de entrada en vigor de la Orden Ministerial que determine el conjunto correspondiente a su principio activo y precio de referencia. En el supuesto de que la citada calificación sea posterior a la creación del conjunto correspondiente al principio activo y precio de referencia, el plazo de exclusión de cinco años se computará desde la fecha de la declaración de innovación galénica, debiendo reponerse, a partir de ese momento, el precio que el medicamento tuviera con anterioridad a la creación de aquel conjunto. 168 Baker & McKenzie

177 Spain (i) (ii) The medicine is presented for the first time with a manner of administering it different from that for which it was authorized, and this new manner represents a significant improvement in the therapeutic usefulness of the product, based on its effectiveness, safety, or usefulness in special populations. Even for medicines administered in the same manner as that approved, it can be demonstrated that the innovation in the medicine adds a significant improvement in the therapeutic usefulness of the product, based on its effectiveness, safety, or usefulness in special populations. The consequence of a medicinal product being qualified as a pharmaceutical innovation is that such medicinal product is excluded from the price reference system for five years as of the date of entry into force of the Ministry Order that determines the group corresponding to its active ingredient together with the reference price. If the qualification of the product as a pharmaceutical innovation takes place after the group corresponding to its active ingredient and the reference price have been determined, the five-year period shall start from the date of qualification of the medicine as a pharmaceutical innovation, and the price of the medicinal product prior to the creation of that group shall be reinstated. 7. Are hospitals allowed to run public tenders on pharmaceutical products? If so, what are the rules governing the pricing proposal of the pharmaceutical companies? Public entities usually contract their supplies by public tender (Law 30/2007, of October 30, on Contracting with the Public Sector). Within the framework of public tenders, the maximum price at which a pharmaceutical company may offer its medicines is the maximum industrial price approved by the Ministry of Health. European Pricing and Reimbursement Handbook 169

178 Spain 7. Están autorizados los hospitales a convocar concursos para el suministro de medicamentos? Si es así, cuáles son las reglas que regulan las ofertas de precios de las compañías farmacéuticas? El concurso público es el sistema habitual de contratación de los suministros por las entidades públicas (Ley 30/2007, de 30 de octubre, de Contratos del Sector Público). En el marco de los concursos públicos el precio máximo al que la compañía farmacéutica puede ofrecer sus medicamentos es el precio industrial máximo aprobado por el Ministerio de Sanidad. Cada vez es más habitual que las Consejerías o Servicios de Salud de las Comunidades Autónomas negocien con los laboratorios de forma centralizada las condiciones de compra de los medicamentos para todos los hospitales bajo su dependencia, a través de los sistemas de homologación de proveedores. En estas negociaciones centralizadas, las Comunidades Autónomas suelen obtener precios inferiores a los precios industriales máximos y, posteriormente, los hospitales dependientes de dicha Comunidad Autónoma negocian descuentos adicionales por volumen de compra. 8. Existe alguna diferencia entre el reembolso de los medicamentos prescritos por un facultativo en el ejercicio de la medicina privada y aquellos prescritos en la práctica pública? Únicamente están financiados los medicamentos prescritos a través de receta oficial por facultativos en el marco de la práctica pública de la medicina, es decir, dentro del SNS. Los medicamentos prescritos por facultativos en el ejercicio de la medicina privada no están financiados. 170 Baker & McKenzie

179 Spain It is becoming more usual for government departments and health services of the different autonomous communities to negotiate the purchase conditions for medicines with laboratories in a centralized fashion for all the hospitals within their sphere, using supplier authorization systems. In these centralized negotiations, the autonomous communities usually get prices lower than the maximum industrial prices. Subsequently, the hospitals in a given autonomous community negotiate additional discounts due to purchase volume. 8. Is there a difference between reimbursement of pharmaceutical products prescribed by physicians in private practice and those prescribed in a hospital? Only medicines prescribed on the official prescription form by a physician working in the public sector, that is, within the SNS, are financed. Medicines prescribed by private physicians are not financed. 9. Can a pharmaceutical product that is used for an indication for which it is not approved (i.e. off-label use) be reimbursed? If yes, what are the conditions? Basically, medicines are financed only for their authorized uses. However, there is no general supervisory system for the prescription of medicines by indication. In certain cases, an approval is required in order to ensure the rational use of medicines. This involves supervising the indication for which the medicine is prescribed. The approvals require that the healthcare professional justify the specific need for the medicine before prescribing it and submit the prescription and therefore the financing for the same to prior supervision by the healthcare administration. European Pricing and Reimbursement Handbook 171

180 Spain 9. Puede reembolsarse un medicamento utilizado para una indicación diferente a las aprobadas (por ejemplo, uso fuera de las indicaciones autorizadas)? Si la respuesta es sí, bajo qué condiciones? En principio, los medicamentos están financiados únicamente para las indicaciones autorizadas. Sin embargo, no existe un sistema general de control de la prescripción de un medicamento por indicación. En determinados casos, se establece la exigencia de un visado, para asegurar el uso racional de los medicamentos, lo que incluye un control de la indicación prescrita. Estos visados exigen que el profesional sanitario justifique la necesidad específica del medicamento antes de su prescripción y somete dicha prescripción, y por tanto también su financiación, al previo control de la administración sanitaria. 172 Baker & McKenzie

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182 Sweden Sverige Stefan Brandt och Caroline Treiman Sammanfattning: Hur är läkemedelsförmånerna organiserade i Sverige? I Sverige subventionerar staten vissa läkemedel för att kostnaderna för den enskilde patienten inte skall bli alltför höga. Detta kallas för läkemedelsförmåner. Vilka läkemedel som skall omfattas av läkemedelsförmånerna och till vilket pris bestäms av den statliga myndigheten Tandvårds- och läkemedelsförmånsverket, TLV. Den som marknadsför ett läkemedel, vanligen ett läkemedelsföretag, kan ansöka hos TLV om att ett läkemedel skall omfattas av läkemedelsförmånerna till ett visst pris. Samtliga receptbelagda läkemedel kan omfattas av läkemedelsförmånerna. För receptfria läkemedel gäller dock vissa begränsningar. Receptfria läkemedel för rökavvänjning, vissa utvärtes läkemedel och naturläkemedel kan inte omfattas av läkemedelsförmånerna. 1. Vilka läkemedel omfattas av läkemedelsförmånerna och enligt vilka principer? Läkemedelsförmånerna regleras i lagen (2002:160) om läkemedelsförmåner m.m. Samtliga receptbelagda läkemedel och de flesta icke-receptbelagda läkemedel 1 kan omfattas av läkemedelsförmånerna under 2 förutsättning att : 1 Med läkemedel avses läkemedel som omfattas av läkemedelslagen (1992:859) och som är avsedda för människor, se 2 lag (2002:160) om läkemedelsförmåner m.m. 2 Undantag gäller för läkemedel för rökavvänjning, naturläkemedel och vissa utvärtes läkemedel godkända av Läkemedelsverket, som inte kan omfattas av 174 Baker & McKenzie

183 Sweden Sweden Stefan Brandt and Caroline Treiman Executive Summary: How are National Health Services ( NHS ) organized in your country? In order to avoid excessive costs for individual patients, certain pharmaceuticals are reimbursed in Sweden by the state. This is called the Pharmaceutical Benefits. The Dental and Pharmaceutical Benefits Agency, TLV, is the central government agency that determines whether a pharmaceutical product shall be reimbursed by the state, and sets the price for that pharmaceutical. The marketer of a pharmaceutical, usually a pharmaceutical company, may apply for a pharmaceutical to be included in the Pharmaceutical Benefits to a certain price. Whereas all prescription pharmaceuticals may be included in the Pharmaceutical Benefits, non-prescription pharmaceuticals are subject to certain limitations. Non-prescription pharmaceuticals for antismoking, certain pharmaceuticals for external use, and homeopathic pharmaceuticals can not be included in the Pharmaceutical Benefits. 1. Which pharmaceutical products are reimbursed by the NHS, under what procedures? The Pharmaceutical Benefits are governed by the Act (2002:160) on Pharmaceutical Benefits, etc. All prescription pharmaceuticals and almost all non- prescription pharmaceuticals may be included in the Pharmaceutical Benefits, provided: (a) that the costs of using the pharmaceutical appear reasonable from the medical, humanitarian and economic aspects; and European Pricing and Reimbursement Handbook 175

184 Sweden (a) kostnaderna för användning av läkemedlet framstår som rimliga från medicinska, humanitära och samhällsekonomiska synpunkter, och (b) det inte finns andra tillgängliga läkemedel eller behandlingsmetoder som, enligt en avvägning mellan avsedd effekt och skadeverkningar, är att bedöma som väsentligt mer ändamålsenliga. 3 Vilka läkemedel som skall omfattas av läkemedelsförmånerna och till vilket pris bestäms av TLV. Den som marknadsför ett läkemedel, vanligen ett läkemedelsföretag, kan ansöka hos TLV om att ett läkemedel skall omfattas av läkemedelsförmånerna till ett visst pris. 4 Merparten av de läkemedel som finns på den svenska läkemedelsmarknaden omfattas av läkemedelsförmånerna. I vissa fall är subventionen begränsad, t.ex. med subvention endast för vissa patientgrupper eller en viss användning. Ett beslut om subvention gäller vanligtvis tills vidare, men TLV kan besluta om tidsbegränsad subvention. TLV får på eget initiativ besluta att ett läkemedel inte längre skall omfattas av läkemedelsförmånerna. Dessutom kan TLV på begäran av den som marknadsför ett läkemedel besluta att läkemedlet inte längre skall omfattas av läkemedelsförmånerna. 5 förmånerna, se Läkemedelsförmånsverkets föreskrifter (LFNFS 2003:4) om receptfria läkemedel enligt lagen (2002:160) om läkemedelsförmåner m.m. Förutom läkemedel omfattas även vissa varor och förbrukningsartiklar av läkemedelsförmånerna, se 18 lag (2002:160) om läkemedelsförmåner m.m lag (2002:160) om läkemedelsförmåner m.m., 2 hälso- och sjukvårdslagen (1982:763); samt 4 Läkemedelsförmånsverkets föreskrifter (LFNFS 2003:2 och LFNFS 2003:4) om receptfria läkemedel enligt lagen (2002:160) om läkemedelsförmåner m.m. 4 8 lag (2002:160) om läkemedelsförmåner m.m. 5 11, 12 lag (2002:160) om läkemedelsförmåner m.m. 176 Baker & McKenzie

185 Sweden (b) that there are no other available pharmaceuticals or treatment methods which after overall consideration of the intended effects and harmful effects, can be judged as significantly more suitable for the purpose. The TLV determines whether a pharmaceutical product shall be included in the Pharmaceutical Benefits and sets the price for that pharmaceutical. The marketer of a pharmaceutical, usually a pharmaceutical company, may apply for a pharmaceutical to be included in the Pharmaceutical Benefits to a certain price. Most of the pharmaceuticals available on the Swedish pharmaceutical market are included in the Pharmaceutical Benefits. In some cases, the reimbursement is limited, for instance, with reimbursement available only for certain groups of patients or for a particular use. The TLV s decision to include a pharmaceutical in the Pharmaceutical Benefits is usually valid until further notice, but the TLV may decide that a pharmaceutical shall be included for a limited time. The TLV may decide that a pharmaceutical included in the Pharmaceutical Benefits shall no longer be included. If requested by the marketer of a pharmaceutical, the TLV shall decide that a pharmaceutical shall no longer be included in the Pharmaceutical Benefits. The Pharmaceutical Benefits imply a reduction of the individual patient s costs for pharmaceuticals included in the Pharmaceutical Benefits. The reduction is calculated based on the total cost of pharmaceuticals that the individual who is entitled to benefits buys in one year, commencing on the date of the first purchase. The reimbursement is granted upon each purchase, based on the total cost of pharmaceuticals purchased prior to that date and the pharmaceuticals purchased on that occasion. No reimbursement shall be granted as long as the total cost does not exceed SEK900. When the total cost exceeds that amount, a reimbursement shall be granted as follows: European Pricing and Reimbursement Handbook 177

186 Sweden Läkemedelsförmånerna innebär en reducering av den enskilde patientens kostnader för läkemedel som omfattas av läkemedelsförmånerna. Kostnadsreduceringen beräknas på den sammanlagda kostnaden för de läkemedel som den enskilde köper under ett år räknat från det första inköpstillfället. Så länge den sammanlagda kostnaden inte överstiger 900 kronor lämnas ingen kostnadsreducering. När den sammanlagda kostnaden överstiger detta belopp, utgör kostnadsreduceringen: 50 procent av den del som överstiger 900 kronor men inte kronor, 75 procent av den del som överstiger kronor men inte kronor, 90 procent av den del som överstiger kronor men inte kronor, samt hela den del av den sammanlagda kostnaden som överstiger kronor. 6 Läkemedelsförmånerna omfattar normalt sett bara läkemedel som används i öppenvård, där patienten själv betalar för läkemedelskostnaden. Inom slutenvård svarar landstingen i regel för hela kostnaden. Läkemedelsförmånerna omfattar normalt sett bara läkemedel som används i öppenvård, där patienten själv betalar för läkemedelskostnaden. Inom slutenvård svarar landstingen i regel för hela kostnaden. 2. Finns det en direkt priskontroll av läkemedel? Läkemedel som inte omfattas av läkemedelsförmånerna är inte föremål för någon priskontroll. 6 5 lag (2002:160) om läkemedelsförmåner m.m. 178 Baker & McKenzie

187 Sweden (a) (b) (c) (d) 50 percent of the portion exceeding SEK900 but less than SEK1, percent of the portion exceeding SEK1,700 but less than SEK3, percent of the portion exceeding SEK3,300 but less than SEK4, percent of total cost exceeding SEK4,300 The Pharmaceutical Benefits normally only include drugs used in outpatient care, where the patient pays for the medical expenses. For inpatient care, the county councils usually pay the full cost. 2. Is there a direct price control on pharmaceutical products? Pharmaceuticals which are not included in the Pharmaceutical Benefits are not subject to any price control. However, for such pharmaceuticals which are included in the Pharmaceutical Benefits, the TLV generally sets the purchase price and the sales price to be applied by pharmacies. Exemptions apply with respect to pharmaceuticals that are not exchangeable with generics. A pharmacy may buy such pharmaceuticals at prices lower than the purchase price which has been decided by the TLV. Moreover, a pharmacy may also purchase and sell parallel imported pharmaceuticals, which are exchangeable, at prices lower than the purchase price and selling price established by the TLV. In addition, special provisions apply with respect to so-called extempore pharmaceuticals, i.e., pharmaceuticals which are manufactured in pharmacies for a certain patient, and non-approved pharmaceuticals which are subject to marketing authorization for specific reasons. The TLV may decide that such pharmaceuticals shall be included in the Pharmaceutical Benefits without a determined sales price. European Pricing and Reimbursement Handbook 179

188 Sweden För läkemedel som omfattas av läkemedelsförmånerna beslutar TLV i regel om det inköpspris och försäljningspris som skall tillämpas av apoteken. 7 Undantag gäller för läkemedel som inte är utbytbara mot generiska läkemedel. Ett apotek får köpa in sådana läkemedel till priser som understiger det inköpspris som TLV har fastställt. Ett apotek får även köpa in och sälja parallellimporterade läkemedel, som är utbytbara, till priser som understiger det inköpspris respektive försäljningspris som TLV har fastställt. 8 Vidare gäller särskilda regler för så kallade extemporeläkemedel dvs. läkemedel som tillverkas på apotek för viss patient och icke godkända läkemedel som erhållit tillstånd att säljas av särskilda skäl. TLV kan besluta att sådana läkemedel skall omfattas av läkemedelsförmånerna utan att ett försäljningspris fastställs för läkemedlen Enligt vilka procedurer, om några, fastställs priset för läkemedel? När TLV beslutar om att ett läkemedel skall omfattas av läkemedelsförmånerna och fastställer priset för läkemedlet, beaktar TLV bl.a. kostnadseffektivitetsprincipen. Det betyder att TLV väger nyttan mot kostnaden av ett läkemedel. Vidare beaktar TLV den så kallade behovs- och solidaritetsprincipen. De som har de största medicinska behoven skall erhålla större del av vårdens resurser än andra patientgrupper. TLV tar också hänsyn till människovärdesprincipen vilken innebär att vården skall respektera alla människors lika värde lag (2002:160) om läkemedelsförmåner m.m., samt 4 Läkemedelsförmånsverkets föreskrifter (LFNFS 2003:2) om receptfria läkemedel enligt lagen (2002:160) om läkemedelsförmåner m.m. 8 7a och 7b lag (2002:160) om läkemedelsförmåner m.m lag (2002:160) om läkemedelsförmåner m.m Hälso- och sjukvårdslag (1982:763) och 15 lag (2002:160) om läkemedelsförmåner m.m. 180 Baker & McKenzie

189 Sweden 3. What are the pricing procedures, if any, under which the price for pharmaceutical products is determined? When the TLV determines that a pharmaceutical shall be included in the Pharmaceutical Benefits, and sets a price for that pharmaceutical, the TLV considers the cost-effectiveness principle. This means that the TLV weighs the benefits against the cost. Furthermore, the TLV takes into account the so-called need and solidarity principle. Those with the greatest medical need shall be entitled to a larger part of the healthcare resources than other patient groups. The TLV also takes into account the principle of human dignity, which means that the healthcare must respect human equality. Price means the purchase price and sale price to be applied by outpatient pharmacies. A question of changing a previously set price may not only be raised by the TLV, it may also be raised by the TLV at the request of the marketer of a pharmaceutical, or at the request of a county council. The party that requests the change shall also be entitled to participate in deliberations with the TLV. If deliberations are not requested, the TLV may set the new price based on available information. 4. What instruments are used to control public expenditure on pharmaceutical products (reference pricing, co-payment, payback, value-based pricing, risk-sharing arrangements, etc.)? The public expenditure on pharmaceutical products is controlled, inter alia, due to the fact that not all pharmaceuticals are included in the Pharmaceutical Benefits. Only such pharmaceuticals shall be included where the cost of using the pharmaceuticals appear reasonable from the medical, humanitarian and economic aspects. In addition, the TLV may decide that a pharmaceutical shall be subject to so-called limited reimbursement. See further under question 1. European Pricing and Reimbursement Handbook 181

190 Sweden Med pris avses det inköpspris och försäljningspris som skall tillämpas av öppenvårdsapoteken. 11 En fråga om ändring av ett tidigare fastställt pris får, förutom på eget initiativ av TLV, tas upp av TLV på begäran av den som marknadsför läkemedlet eller av ett landsting. Den som begär ändringen har även rätt till överläggningar med TLV. Om överläggningar inte begärs, eller om överläggningarna inte leder till en överenskommelse, kan TLV fastställa det nya priset på grundval av tillgänglig utredning Vilka instrument används för att kontrollera de offentliga utgifterna för läkemedel (referensprissättning, co-payment, återbetalning, värdebaserad prissättning, riskdelningsarrangemang, etc.)? De offentliga utgifterna för läkemedel kontrolleras bl.a. genom att alla läkemedel inte subventioneras i Sverige. Endast sådana läkemedel där kostnaderna för användning är rimliga ur en medicinsk, humanitär och samhällsekonomisk synvinkel skall omfattas av läkemedelsförmånerna. TLV kan även besluta att ett läkemedel skall omfattas av så kallad begränsad subvention. Se närmare under fråga Finns det en specifik policy för generiska läkemedel (t.ex. snabbt godkännande, lägre registreringskostnader, etc.)? Finns det ett lagstadgat fast pris för generiska produkter? Det finns särskilda regler om generiskt utbyte som innebär att om ett läkemedel som omfattas av läkemedelsförmånerna har förskrivits, och det finns läkemedel som är utbytbara mot det läkemedlet, skall ett öppenvårdsapotek byta ut det förskrivna läkemedlet mot det tillgängliga läkemedel som har lägst fastställt försäljningspris lag (2002:160) om läkemedelsförmåner m.m lag (2002:160) om läkemedelsförmåner m.m. 182 Baker & McKenzie

191 Sweden 5. Is there a specific policy for generic pharmaceutical products (for instance, fast track approval, lower registration fees, etc.)? Is the price of generic products fixed by law? There are special provisions regarding generic substitution which imply that if a pharmaceutical included in the Pharmaceutical Benefits has been prescribed and there is one or more less expensive, substitutable pharmaceuticals available at the pharmacy where the prescription is dispensed, the pharmaceutical shall be substituted with the least expensive pharmaceutical available. However, a pharmaceutical shall not be substituted if the prescriber has objected to the substitution on medical grounds. Nor shall the pharmaceutical be substituted if the patient pays the difference between the price set for the prescribed pharmaceutical and the corresponding price for the least expensive substitutable pharmaceutical available. If another substitutable pharmaceutical is available, the pharmaceutical may be substituted with that pharmaceutical if the patient pays the difference between the price set for that pharmaceutical and the corresponding price for the least expensive substitutable pharmaceutical. 6. What incentives exist for innovative pharmaceutical products? An important incentive is the patent, which implies a time-limited exclusive right to manufacture, market and commercialize an invention. There is no specific incitement within the reimbursement system. European Pricing and Reimbursement Handbook 183

192 Sweden Ett läkemedel får dock inte bytas ut om den som utfärdat receptet på medicinska grunder har motsatt sig ett utbyte, eller om patienten betalar mellanskillnaden mellan det försäljningspris som fastställts, för det förskrivna läkemedlet, och det lägsta försäljningspris för det utbytbara läkemedel som finns tillgängligt. Om något annat utbytbart läkemedel finns tillgängligt, kan utbyte ske mot detta läkemedel, om patienten betalar hela kostnaden för det läkemedlet Vilka incitament finns för innovativa läkemedel? Ett viktigt incitament utgörs av patent, vilket innebär en tidsbegränsad ensamrätt att producera, marknadsföra och kommersialisera en uppfinning. Det finns inga särskilda incitament inom systemet för läkemedelsförmåner. 7. Är det tillåtet för sjukhus att upphandla läkemedel? Om så, vilka bestämmelser reglerar läkemedelsföretagens prisförslag? Ja, läkemedel som används på sjukhus upphandlas och prissätts i allmänhet enligt lagen (2007:1091) om offentlig upphandling. 8. Skiljer sig reglerna om subvention åt beträffande läkemedel som förskrivs av läkare inom den privata och den allmänna sjukvården? Nej, samma regler om subvention gäller oavsett om ett läkemedel förskrivs av en läkare inom den privata eller den allmänna sjukvården. 9. Kan ett läkemedel som används för en indikation som det inte är godkänt för subventioneras? Under vilka omständigheter? Ja, TLV kan besluta att så kallade extemporeläkemedel, dvs. läkemedel som tillverkas på apotek för viss patient, skall omfattas av läkemedelsförmånerna trots att ett försäljningspris inte har fastställts lag (2002:160) om läkemedelsförmåner m.m. 184 Baker & McKenzie

193 Sweden 7. Are hospitals allowed to run public tenders on pharmaceutical products? If so, what are the rules governing the pricing proposal of the pharmaceutical companies? Yes, pharmaceuticals used in hospitals are in general procured according to the Act (2007:1091) on Public Procurement. 8. Is there a difference between reimbursement of pharmaceutical products prescribed by physicians in private practice and those prescribed in a hospital? No, the same provisions regarding reimbursement apply regardless of whether a pharmaceutical is prescribed by physicians in private practice or in a hospital. 9. Can a pharmaceutical product that is used for an indication for which it is not approved (i.e. off-label use) be reimbursed? If yes, what are the conditions? Yes, the TLV can decide that so-called extempore pharmaceuticals, i.e. pharmaceuticals which are manufactured in pharmacies for a certain patient, shall be included in the Pharmaceutical Benefits even if no price has been set for the pharmaceutical. The same applies with respect to non-approved pharmaceuticals which have been granted marketing authorization for special reasons, for instance, licenses, i.e. pharmaceuticals for which an application for marketing authorization has been filed. European Pricing and Reimbursement Handbook 185

194 Sweden för läkemedlet. 14 Detsamma gäller icke-godkända läkemedel som medgivits tillstånd till försäljning av särskilda skäl lag (2002:160) om läkemedelsförmåner m.m lag (2002:160) om läkemedelsförmåner m.m., samt 5 läkemedelslagen (1992:859). 186 Baker & McKenzie

195

196 Switzerland Schweiz Peter Reinert Zusammenfassung: Wie ist das nationale Gesundheitssystem organisiert? Jede in der Schweiz wohnhafte Person hat sich grundsätzlich bei einer anerkannten Schweizer Krankenkasse zu versichern. Schweizer Krankenkassen sind privatrechtlich organisiert, haben aber gewissen gesetzlichen Mindestansprüchen zu genügen und unterstehen der Aufsicht der Bundesbehörden. Das schweizerische Recht legt fest, welche Arzneimittel, Medizinprodukte und medizinischen Leistungen seitens der obligatorischen Krankenversicherung zu ersetzen sind. Die durch die obligatorische Krankenversicherung zu ersetzenden Kosten für Arzneimittel werden vom Bundesamt für Gesundheit ( BAG ) nach Konsultation der Eidgenössischen Arzneimittelkommission ( EAK ) festgelegt. Neben der obligatorischen Krankenversicherung können die Krankenkassen auch weitere Policen anbieten, welche von der obligatorischen Krankenversicherung nicht gedeckte Leistungen abdecken und Kosten von Arzneimitteln und Medizinprodukten bezahlen, die in der obligatorischen Versicherung nicht ersetzt werden müssen und dürfen. Für diese überobligatorische Versicherung setzen die Behörden keinen Rückvergütungspreis fest. 1. Welche pharmazeutischen Produkte werden seitens des nationalen Gesundheitswesens zurückerstattet und nach welchen Verfahren? Arzneimittel werden auf Gesuch hin vom BAG nach Anhörung der EAK in die sogenannte Spezialitätenliste ( SL ) aufgenommen, Medizinprodukte in die Liste der Mittel und Gegenstände ( MiGeL ). Ein Arzneimittel muss von Swissmedic zugelassen worden sein, um in die SL aufgenommen zu werden. Ein Arzneimittel wird in die entsprechende Liste zum Preis aufgenommen, den der Gesuchsteller verlangte, sofern das pharmazeutische Produkt wirksam, zweckmässig und zu diesem Preis wirtschaftlich ist. Ein pharmazeutisches Produkt 188 Baker & McKenzie

197 Switzerland Switzerland Peter Reinert Executive Summary: How are National Health Services ( NHS ) organized in your country? Every Swiss resident basically has to be covered by a recognized Swiss health insurance company. While the Swiss health insurance companies are private entities, they have to comply with certain legal requirements and are subject to the supervision of federal authorities. Swiss law states in detail what pharmaceuticals, medical devices and healthcare services have to be paid by the mandatory health insurance. The prices for pharmaceuticals are set by the Federal Office for Public Health ( Bundesamt für Gesundheit ; BAG ) after consultation with the Federal Pharmaceutical Commission ( Eidgenössische Arzneimittelkommission ; EAK ). The health insurance companies are free to offer additional insurance policies that cover the costs of additional pharmaceuticals, medical devices and healthcare services that do not have to and must not be covered by the mandatory insurance. No reimbursement price is set by the authorities for this extra mandatory insurance coverage. 1. Which pharmaceutical products are reimbursed by the NHS, under what procedures? Pharmaceuticals are, upon application, listed by the BAG after hearing the EAK, in the so-called List of Specialties ( Spezialitätenliste ; SL ), and medical devices in the List for Medical Products and Medical Devices ( Liste der Mittel und Gegenstände ; MiGeL ). To be listed in the SL, a pharmaceutical needs to be approved by Swissmedic. A pharmaceutical is so listed at the price requested by the applicant provided that the pharmaceutical is efficient, purposive and economic at the requested price. A pharmaceutical is economic if the indicated effect is secured with an as low as possible financial expense. In practice, price negotiations are common. European Pricing and Reimbursement Handbook 189

198 Switzerland gilt als wirtschaftlich, wenn es die indizierte Heilwirkung mit möglichst geringem finanziellem Aufwand gewährleistet. In der Praxis sind Verhandlungen über den Rückvergütungspreis üblich. Der vom BAG festgesetzte Vergütungspreis entspricht dem Höchstpreis, den die Krankenkassen unter der obligatorischen Versicherung erstatten müssen und dürfen. 2. Gibt es eine direkte Preiskontrolle für pharmazeutische Produkte? Die direkte Preiskontrolle ist auf diejenigen Produkte beschränkt, die in der obligatorischen Krankenversicherung rückerstattungspflichtig sind. Die Preise für weitere Produkte werden nicht kontrolliert. 3. Was sind die etwaigen Preisfestsetzungsverfahren für Arzneimittel? Der Zulassungsinhaber eines Arzneimittels kann dem BAG beantragen, das Arzneimittel in die SL aufzunehmen. Ein seitens der Swissmedic zugelassenes Arzneimittel, das für die medizinische Behandlung von grosser Bedeutung ist, kann auch ohne Gesuch in die SL aufgenommen werden. Das BAG evaluiert das Arzneimittel und unterbreitet sein Ergebnis der EAK, welche ihrerseits dem BAG Antrag stellt. Das BAG verfügt durch anfechtbare Verfügung über die Aufnahme in die SL, wobei diese mit Bedingungen und Auflagen verbunden werden kann. Für die Preisfestsetzung werden die folgenden Kriterien verwendet: (i) der Fabrikabgabepreis des Arzneimittels in Deutschland, Dänemark, Grossbritannien, den Niederlanden, Frankreich und Österreich und allenfalls weiteren Ländern; der Fabrikabgabepreis darf in der Regel den durchschnittlichen Fabrikabgabepreis, abzüglich Mehrwertsteuer dieses Arzneimittels in den Vergleichsländern nicht überschreiten, (ii) die Wirksamkeit des Arzneimittels im Verhältnis zu anderen Arzneimitteln gleicher Indikation und ähnlicher Wirkungsweise und 190 Baker & McKenzie

199 Switzerland The reimbursement price is fixed by the BAG and constitutes the maximum price that the health insurance companies do have to and may reimburse under the mandatory insurance. 2. Is there a direct price control on pharmaceutical products? Direct price control is limited to those products that are reimbursed by the mandatory health insurance. Prices for other products are not controlled. 3. What are the pricing procedures, if any, under which the price for pharmaceutical products is determined? The market authorization holder of a pharmaceutical may apply to the BAG to list the pharmaceutical in the SL. A pharmaceutical which is of great relevance to the medical treatment and for which a Swiss marketing authorization exists, can also be listed in the SL without any application. The BAG evaluates the drug and submits its evaluation to the EAK which, in turn, submits a proposal to the BAG. The BAG then decides by appealable order about the listing in the SL and can order the listing under specific conditions. Criteria that are used to fix the prices of pharmaceuticals are: (i) their ex-factory price in Germany, Denmark, Great Britain, The Netherlands, France and Austria and possibly other countries; the exfactory price must in general, not exceed the average ex-factory price of this pharmaceutical in the reference countries minus any applicable VAT; (ii) the efficacy of the pharmaceutical as compared to other pharmaceuticals with the same indication or a similar mode of action; and (iii) the daily treatment costs as compared to the daily treatment costs of pharmaceuticals of identical indication or similar mode of action. European Pricing and Reimbursement Handbook 191

200 Switzerland (iii) die Kosten pro Tag oder Kur im Verhältnis zu den Kosten von Arzneimitteln gleicher Indikation oder ähnlicher Wirkungsweise. Der vom BAG festgesetzte Vergütungspreis entspricht dem festgesetzten Fabrikabgabepreis zuzüglich eines in der massgebenden Verordnung festgesetzten Vertriebsanteils. Der daraus resultierende Preis stellt den maximalen Rückvergütungspreis dar. Dieser Höchstpreis wird alle drei Jahre, bei Patentablauf sowie immer dann überprüft, wenn eine Indikationserweiterung oder eine Limitierungsänderung erfolgt. Die anwendbare Verordnung hält fest, dass das BAG die Zulassungsinhaberin zur Rückerstattung der seit der Aufnahme erzielten Mehreinnahmen an die gemeinsame Einrichtung der Krankenkassen verpflichten kann, sofern der bei der Aufnahme des Arzneimittels in die SL dem verfügten Höchstpreis zugrunde gelegte Fabrikabgabepreis den bei der ersten Überprüfung der Wirtschaftlichkeit ermittelten Fabrikabgabepreis um mehr als 3 Prozent übersteigt und die dadurch erzielten Mehreinnahmen mindestens CHF betragen. Es ist allerdings fraglich, ob diese Verpflichtung gesetzmässig und damit durchsetzbar ist. 4. Welche Instrumente werden zur Kontrolle der staatlichen Ausgaben für pharmazeutische Produkte verwendet (Referenzpreise, Selbstbehalte, Rückzahlungen, wertbasierte Preise, Risikoaufteilung, etc.)? Obwohl in der Schweiz wohnhafte Personen mit tieferen Einkommen von kantonalen Zuschüssen zu ihren Krankenkassenprämien profitieren können, werden keine öffentlichen Gelder direkt in das Krankenversicherungssystem bezahlt. Trotzdem besteht ein hoher politischer Druck, die Krankenkassenprämien auf einem angemessenen Niveau zu halten und das BAG hat begonnen, mit den Zulassungsinhabern tiefere Rückerstattungspreise auszuhandeln, sofern gewisse Umsatzwerte überschritten werden. Ob diese Praxis mit dem anwendbaren Recht übereinstimmt, ist jedoch fraglich. 192 Baker & McKenzie

201 Switzerland The reimbursement price that is set by the BAG fixes the ex-factory price and increases it by the distribution surcharge set by statutory law, thereby setting the maximum price to be reimbursed. This maximum price is reassessed every three years, at the time of patent expiry and whenever there is an extension of the indication or a change of the limitation. The relevant ordinance states that if, after the first price reassessment, the ex-factory price which formed the basis when the pharmaceutical was listed in the SL exceeds the price after the first reassessment by more than three percent and if the additional income exceeds CHF20,000, the BAG can ask the marketing authorization holder to pay the additional income resulting from such price difference to the common institution of the health insurance companies. It is, however, questionable whether this obligation is valid and enforceable. 4. What instruments are used to control public expenditure on pharmaceutical products (reference pricing, co-payment, payback, value-based pricing, risk-sharing arrangements, etc.)? Even though Swiss residents with lower income can benefit from cantonal subsidies to their health insurance premium, no public funds are paid into the health insurance system. Nevertheless, there is high political pressure to keep the health insurance premium at an adequate level and the BAG started to negotiate lower reimbursement prices with market authorization holders if certain turnover thresholds are exceeded. Whether this practice is in line with applicable law is, however, questionable. 5. Is there a specific policy for generic pharmaceutical products (for instance, fast track approval, lower registration fees, etc.)? Is the price of generic products fixed by law? When assessing whether a generic pharmaceutical product is economic, the lower costs for the development when compared to the European Pricing and Reimbursement Handbook 193

202 Switzerland 5. Gibt es eine spezielle Richtlinie für Generika (beispielsweise Fast Track Zulassung, tiefere Registrationsgebühren, etc.)? Wird der Preis für Generika gesetzlich festgelegt? Bei der Prüfung der Frage, ob ein Generikum wirtschaftlich ist, sind die tieferen Entwicklungskosten im Vergleich zum Originalpräparat zu berücksichtigen. Je nach Umfang des schweizerischen Umsatzes des Originalpräparates und seiner Co-Marketing Arzneimittel während der vier Jahre vor Patentablauf, muss der Fabrikabgabepreis eines Generikums mindestens 20 bis 50 Prozent tiefer als der Fabrikabgabepreis des relevanten Originalpräparates, gemessen an der Basis des durchschnittlichen Auslandpreises im Zeitpunkt des Patentablaufes in der Schweiz sein. Patienten müssen üblicherweise einen Selbstbehalt in Höhe von 10 Prozent des Rückerstattungspreises eines Arzneimittels, allerdings nur bis zu einer bestimmten Franchise, bezahlen. Für Originalpräparate, für die in der SL damit austauschbare Generika aufgeführt sind, deren Höchstpreise mindestens 20 Prozent tiefer sind als der Höchstpreis des entsprechenden Originalpräparates, erhöht sich der Selbstbehalt auf 20 Prozent. Der Rückerstattungspreis für Generika wird nicht gesetzlich festgesetzt, sondern ebenfalls im Einzelfall durch das BAG. 6. Welche Anreize bestehen für innovative pharmazeutische Produkte? Bei der Festsetzung des Rückerstattungspreises ist bei Arzneimitteln, die einen medizinisch-therapeutischen Durchbruch darstellen oder einen therapeutischen Fortschritt bringen, ein Innovationszuschlag für die Dauer von höchstens 15 Jahren zu gewähren. In diesem Zuschlag sind die Kosten für Forschung und Entwicklung angemessen zu berücksichtigen. 194 Baker & McKenzie

203 Switzerland original preparation are taken into consideration. Depending on the Swiss market turnover of the original preparation and its co-marketing pharmaceuticals during the four years prior to patent expiry, the exfactory price of the generic pharmaceutical product needs to be at least 20 percent to 50 percent lower than the ex-factory price of the relevant original preparation measured on the basis of the average price level abroad at the time the patent expired in Switzerland. Patients generally have to make a co-payment of 10 percent of the reimbursement price of a pharmaceutical but limited to a certain amount. For original preparations for which generic pharmaceutical products are listed in the SL with a reimbursement price that is at least 20 percent lower than that of the original preparation, the co-payment increases to 20 percent. The reimbursement price of generic products is not fixed by law but also by the BAG in the individual case. 6. What incentives exist for innovative pharmaceutical products? When fixing the reimbursement price, an innovation surcharge for the duration of a maximum of 15 years is granted in case of pharmaceuticals which trigger a medical therapeutic break-through or a therapeutic progress. This surcharge also has to take into consideration the adequate costs for research and development. 7. Are hospitals allowed to run public tenders on pharmaceutical products? If so, what are the rules governing the pricing proposal of the pharmaceutical companies? Hospitals are basically allowed to run public tenders on pharmaceutical products and, depending on the public procurement rules, even would have an obligation to do so even though in practice this still hardly ever happens. European Pricing and Reimbursement Handbook 195

204 Switzerland 7. Dürfen Spitäler öffentliche Ausschreibungen für pharmazeutische Produkte machen? Falls ja, welche Regeln bestehen für die Preisofferten der pharmazeutischen Unternehmen? Spitäler dürfen grundsätzlich öffentliche Ausschreibungen über pharmazeutische Produkte durchführen und hätten je nach anwendbaren öffentlichen Vergaberegeln gar eine Verpflichtung, dies zu tun, obwohl dies in der Praxis kaum je geschieht. Es bestehen keine speziellen Regeln betreffend Preisvorschlägen der Pharmaunternehmen. Diese müssen sich aber bewusst sein, dass das BAG bei einer Preisüberprüfung den Umstand, dass ein Verkauf unter dem Fabrikabgabepreis stattfand, welcher Grundlage des Rückerstattungspreises bildete, mitberücksichtigen dürfte. 8. Besteht ein Unterschied zwischen dem Rückerstattungspreis für pharmazeutische Produkte, die durch Ärzte in privaten Praxen und solchen die in Spitälern verschrieben werden? Nein. 9. Kann ein pharmazeutisches Produkt, das für eine Indikation angewendet wird, für das es nicht zugelassen ist (d.h. Off-label-Use) durch die obligatorische Krankenversicherung bezahlt werden? Falls ja, unter welchen Voraussetzungen? Die obligatorische Krankenversicherung kann ausnahmsweise die Kosten für ein Arzneimittel übernehmen, wenn dieses für eine Indikation abgegeben wird, für welche es keine Zulassung besitzt (sog. Off-Label-Use) oder das noch keine Schweizer Zulassung besitzt, aber legal in die Schweiz eingeführt wurde. Voraussetzung ist, dass ein sogenannter Behandlungskomplex vorliegt und dass für eine Krankheit, die für die versicherte Person tödlich verlaufen oder schwere und chronische gesundheitliche Probleme nach sich ziehen 196 Baker & McKenzie

205 Switzerland There are no specific rules governing the pricing proposals of the pharmaceutical companies even though they have to be aware that if they sell pharmaceuticals far below the ex-factory price that forms the basis of the reimbursement price, the BAG might take that into consideration when reassessing the reimbursement price. 8. Is there a difference between reimbursement of pharmaceutical products prescribed by physicians in private practice and those prescribed in a hospital? No. 9. Can a pharmaceutical product that is used for an indication for which it is not approved (i.e. off-label use) be reimbursed? If yes, what are the conditions? The mandatory health insurance exceptionally has to cover the costs of a pharmaceutical product that is used for an indication for which it is not approved, or if a pharmaceutical has not yet been granted the Swiss marketing authorization but has been imported in compliance with the law. This is the case if a so-called treatment complex exists or if there is no effective alternative treatment method available for a disease which can trigger the death or severe and chronic health problems of the insured person. In such a case, the pharmaceutical product needs to have high therapeutic (curative and palliative) benefit. Case law is rather restrictive in this respect. European Pricing and Reimbursement Handbook 197

206 Switzerland kann, wegen fehlender therapeutischer Alternativen keine andere wirksame Behandlungsmethode verfügbar ist. Allerdings muss das Arzneimittel in diesem Fall einen hohen therapeutischen (kurativen oder palliativen) Nutzen haben. Die Kostenübernahme bildet in der Praxis die Ausnahme und wird restriktive gehandhabt. 198 Baker & McKenzie

207 United Kingdom United Kingdom John Leadley and Julia Gillert How are National Health Services ( NHS ) organized in your country? The United Kingdom s National Health Service (NHS) was established in 1948 to be free at the point of delivery. This principle remains at the core of the NHS over 60 years on; access to NHS services is based on clinical need, not an individual s ability to pay and so NHS services are free of charge to the 62 million people who are resident in the UK. The only exceptions to this are for some charges sanctioned by parliament for the application of a set charge for some prescriptions in England, and capped charges for some dentistry and optical services. The NHS is funded centrally by taxation and controlled by the Department of Health (DoH), of which the head is the Secretary of State for Health who reports directly to the UK s Prime Minister. The devolved administrations of Scotland, Wales and Northern Ireland run their local NHS services separately, but in England, the Department of Health controls 10 Strategic Health Authorities (SHAs), which oversee all NHS activities. In turn, each SHA supervises all the NHS trusts in its area. The organization of the NHS in England is currently in a state of flux due to the major structural reforms proposed in the Health and Social Care Bill and its prolonged path through parliament towards becoming law. Now due to come into law in the next two years, the Health and Social Care Bill will result in the abolition of SHAs and make general practitioners (GPs) largely responsible for commissioning via consortia. Drugs and other supplies comprise around 20 percent of the annual budget of the NHS, and the UK is one of the few markets in the world where pharmaceutical manufacturers have freedom of pricing for new active substances. However, more generally the Government, which through the NHS accounts for over 80 percent of drug spending in the European Pricing and Reimbursement Handbook 199

208 United Kingdom UK, runs a voluntary Pharmaceutical Price Regulation Scheme (PPRS) under which the prices of branded (on-patent) medicines are indirectly controlled by the regulation of the profits pharmaceutical companies made on their sales to the NHS. The current PPRS is due to expire in 2013 and the Government is planning to implement a new value-based medicine pricing system to replace it for new active substances. 1. Which pharmaceutical products are reimbursed by the NHS, under what procedures? The National Institute for Health and Clinical Excellence (NICE) is an independent organization responsible for making recommendations to the NHS on the use of new and existing medicines (branded and unbranded), procedures, and treatments in terms of the impact and cost of each intervention on health. It uses a measure called a qualityadjusted life year (QALY), where one QALY is the equivalent of one year in perfect health. NICE generally considers a treatment to be cost-effective if it costs less than GBP20,000 per QALY; treatments costing GBP20,000 - GBP30,000 are subject to debate and those costing over GBP30,000 are authorized only very rarely. Currently, around 40 percent of drugs new to the UK market are evaluated by NICE every year. NICE recently introduced end-of-life criteria to increase flexibility when assessing certain innovative new drugs, recognizing that R&D costs are higher for these drugs, which target a small percentage of the population. Therefore, no threshold for end-of-life economic value is set. The NHS is legally obliged to fund drugs recommended by NICE but a negative NICE appraisal does not prohibit the NHS from funding any drugs or treatments. Clinicians can prescribe any licensed drug if the relevant trust is willing to pay for it - thus, if NICE has not recommended the use of a particular treatment on the NHS, the trust can still make its own decision on whether to fund it, either generally 200 Baker & McKenzie

209 United Kingdom or in specific cases. NICE does not negotiate drug prices; this responsibility rests with the DoH. NICE may review and make recommendations of any medicine. However, decisions on reimbursement and drug prices are settled differently by the various responsible bodies depending on whether the product is branded or unbranded. A. Branded medicines Branded medicines (defined as medicines with a proprietary name) comprise approximately 80 percent of NHS drugs costs. The prices of branded medicines are indirectly controlled by the PPRS. The PPRS is a voluntary, non-statutory agreement made between the DoH and the branded pharmaceutical industry, represented by the Association of the British Pharmaceutical Industry (ABPI). The current scheme is the 2009 agreement, the latest in a line of previous agreements between the DoH and the ABPI lasting for up to five years each, stretching back to There are also reserve statutory powers behind the PPRS voluntary scheme that may be used to control the prices of medicines. Both the 2009 PPRS and the statutory scheme are administered by DoH staff in the Medicines, Pharmacy and Industry - Pricing and Supply branch. The PPRS involves two key methods of controlling drug prices: a) Profit control After allowing for R&D expenditure, caps (up to 29.4 percent) are imposed. Therefore, a company may adjust the prices of new drugs within its portfolio, provided its overall profit on sales to the NHS does not exceed its cap. The scheme requires companies with annual NHS sales of over GBP35 million to submit annual data on sales, costs, assets, and profitability and to repay the excess where profits exceed the agreed threshold. It also requires companies to seek DoH approval for increases in prices, which is only given if the reasons for European Pricing and Reimbursement Handbook 201

210 United Kingdom the application meet criteria for increases as agreed when the relevant company entered the scheme. As acknowledged by the Parliamentary Office of Science and Technology, it can be difficult in practice to estimate the relevant portion of a multinational company s profits and the DoH is rarely repaid any excess profits, further motivating the DoH s drive to cut prices (see the section on Price cuts, below). The ABPI argues that due to the price cuts of recent years, companies profitability levels are lower and thus excesses rarely arise. It has also been argued by the industry that the payment of excess profits is administratively burdensome and that price cuts are to be preferred. b) Price cuts Price cuts are negotiated across all drugs, regardless of whether they are deemed cost effective by NICE (though older drugs are often particularly targeted). The current PPRS for instance, is delivering an overall price cut of 5 percent over its five years. A consequence of the PPRS is that the UK has a national list of drug prices. This is widely used by other countries as a reference for setting their own prices. The Office of Fair Trading (OFT) estimates that up to 25 percent of world pharmaceuticals sales reference UK prices to some extent. As a result, companies are particularly cautious in agreeing to any reduction in the UK list price of a drug as this can have an effect on the profits made on sales elsewhere in the world. Successive price cuts and exchange rate movements mean that the UK, from traditionally having among the highest prices in Europe, currently has among the lowest. In 2007, the OFT published a study of the PPRS that found that some branded drugs prescribed in large volumes were up to 10 times more expensive than substitutes that deliver similar clinical benefits. The OFT argued that where drug prices are out of line with value, the NHS is not making effective use of its funds, and that the mechanisms to control profits and price cuts do not reflect a drug s value to the NHS. The current PPRS is due to expire at the end of 2013 and, partially in response to the OFT report, the Government is planning to replace it 202 Baker & McKenzie

211 United Kingdom with a value-based pricing system to apply to new active substances based on the market from 1 January The new focus on value-based pricing links the price of a drug to costeffectiveness based on clinical evidence, and builds on innovations introduced in the current PPRS involving patient access schemes. Some existing medicines may also be included within the value-based pricing system. For existing branded medicines already covered by the current PPRS, a successor scheme will be required but the details have not yet been agreed. B. Unbranded medicines Generic medicines (defined as medicines marketed with no brand name) and proprietary medicines not covered by the PPRS are reimbursed under the Drug Tariff, through which the Department of Health reimburses pharmacists the cost of dispensing the listed medicines, which accounts for about 80 percent of prescriptions by volume, but only around 20 percent of the overall cost of medicines. 2. Is there a direct price control on pharmaceutical products? The price controls applying to pharmaceutical products in the UK apply specifically to products reimbursed by the NHS (though the prices of non-reimbursed products are subject to any other applicable restrictions under UK and European competition rules). Branded medicines are subject either to the voluntary but indirect control of the current PPRS s caps on profits from products sold to the NHS and price cuts on those products, or to the DoH s set prices under the Drug Tariff, which are continually reviewed. Non-branded medicines are also subject to the prices under the Drug Tariff. 3. What are the pricing procedures, if any, under which the price for pharmaceutical products is determined? A. Branded medicines European Pricing and Reimbursement Handbook 203

212 United Kingdom All products subject to the PPRS are indirectly regulated on an ongoing basis according to the principles of the PPRS, i.e., that companies profitability on products sold to the NHS is within agreed parameters. For all PPRS regulated products where the company and the DoH are unable to reach agreement on the price of a product, a company may decide to refer the issue to the PPRS dispute resolution procedure. From 2014, the prices of products containing new active ingredients will be established according to their cost-effectiveness under the new value-based pricing system to be introduced. Under the current PPRS, the rules for setting the prices of products (where price represents the maximum public price that will be reimbursed) are as follows: a) New active substances New products introduced following the granting of an EU or UK new active substance marketing authorization from the appropriate licensing authority may be priced at the discretion of the company on entering the market and negotiations over pricing and reimbursement are not required. Line extensions relating to such new substances and applied for within five years of that product, granted on the basis of an abridged application, may also be priced at the discretion of the company provided that the application to market the line extension has been submitted to the appropriate licensing authority within five years of the grant of the original authorization of the new product. However, increased strengths of existing formulations may not be priced at a level greater than pro rata to existing formulations. There are various conditions to this freedom of pricing, as follows: If forecast sales of any new product in any one year of the first five years following launch are expected to exceed GBP20 million, a company must inform the DoH of both 204 Baker & McKenzie

213 United Kingdom the price and the anticipated level of sales in each of the first five years. If a company considers that the rapid uptake of a new product will cause the company to exceed the upper margin of tolerance for that company s profitability permitted under the PPRS (MOT), then it is obliged to inform the DoH immediately and negotiate a reduction in profitability for the current year to the upper level of the MOT. Similarly, the DoH will negotiate a reduction in profitability if it has reason to believe that the rapid uptake of a new product will cause a company to exceed the upper MOT. A company wishing to introduce a product to the UK market should give the DoH a minimum of four weeks notice before the intended date of introduction. The company may give such notice prior to receipt of the marketing authorization in order to avoid patient access delays. b) New products (but where the active ingredient is not new) In reaching a decision on the acceptability of a price for a new product that is not introduced following the granting of an EU or UK new active substance marketing authorization, the DoH may take into account factors such as: The price of other presentations of the same medicine or comparable products Forecast sales and the effect on the NHS drugs bill The clinical need for the product Any exceptional costs European Pricing and Reimbursement Handbook 205

214 United Kingdom B. Unbranded medicines The DoH sets prices (where price represents the maximum public price that will be reimbursed) for the Drug Tariff according to the type of product involved. The Drug Tariff is produced monthly by the Pharmaceutical Directorate of the NHS Business Services Authority (NHSBSA) Prescription Services for the Secretary of State, and is supplied on a monthly basis primarily to pharmacists and prescribing healthcare professionals. The Drug Tariff provides information on what will be paid to contractors for NHS Services including both reimbursement (e.g., the cost of drugs and appliances supplied against an NHS Prescription form) and remuneration (e.g., professional fees/allowances which are paid to pharmacists as part of the NHS pharmacy contract). The vast majority of commonly prescribed products are listed in part VIII of the Drug Tariff, which is divided into various categories: a) Category A is for generic medicines that are widely available from key suppliers. The price is based on a weighted average of the prices listed by two wholesalers and two generic manufacturers. In the weighted formula, the wholesaler prices have a weighting of two, the prices from the other suppliers have a weighting of one. b) Category C items are based on the list price for a particular brand or manufacturer s product. The Drug Tariff is annotated with an indication of which product forms the basis for the reimbursement price. c) Category E products are those that can be extemporaneously dispensed with the reimbursement price based on the costs of the ingredients required to dispense the product. d) Category M was launched in 2005 for the most readily available generics drugs and is used to adjust the reimbursement prices of over 500 medicines. The DoH uses 206 Baker & McKenzie

215 United Kingdom information gathered from manufacturers on volumes and prices of products sold together with information from the NHSBSA Prescription Services on dispensing volumes to calculate margins in the supply chain and to set the reimbursement price for these products. The prices are adjusted every three months in light of information from manufacturers. Where a prescription has been written generically but the item is not listed in Part VIII of the Drug Tariff, reimbursement will be based on the manufacturer or supplier s list price for the endorsed product. 4. What instruments are used to control public expenditure on pharmaceutical products (reference pricing, co-payment, payback, value-based pricing, risk-sharing arrangements, etc.)? The UK does not use reference pricing to set its reimbursement prices, though it is used as a reference by other countries employing such a system (see the answer to question 1, above). The NHS has increasingly been entering into one-off risk-sharing arrangements, and the successor scheme to the current PPRS from 2014 is to be based upon value-based pricing for new active substances. For both branded and unbranded medicines, the Government operates a patient co-payment system (in the form of prescription charges, currently set at GBP7.40 per item) for patients in England only, a claw back system operated by the Government for community pharmacies and discounting to hospital pharmacies. Children, the elderly, those in receipt of benefits, pregnant women, and the sufferers of certain diseases (e.g., cancer) are not required to pay the charge. Prescription charges have been abolished in other parts of the UK. European Pricing and Reimbursement Handbook 207

216 United Kingdom 5. Is there a specific policy for generic pharmaceutical products (for instance, fast track approval, lower registration fees, etc.)? Is the price of generic products fixed by law? The price of generic products is not fixed by law per se in the UK. However, the basic NHS reimbursement prices of generic products are set out in part VIII of the Drug Tariff. As prices in the market are constantly changing, there is an agreed mechanism in place to increase and decrease the reimbursement prices for medicines at regular intervals (varying from monthly to quarterly, depending upon the classification of the product concerned). The UK Government consulted in early 2010 on plans to introduce generic substitution in NHS prescriptions but later abandoned these plans, stating that the national plans to enforce generic substitution were too prescriptive. However, UK medical students are taught to prescribe by reference to a product s international non-proprietary name (INN) to enable pharmacists to dispense the most cost-effective generic version of a product. This practice tends to remain common among prescribing healthcare professionals; recent NHS figures indicate that in 2008 over 80 percent of prescribed items were by INN in England. Furthermore, local trusts run schemes to incentivize prescribers to switch patients to cheaper generic medicines, or to introduce new patients to generic medicines rather than more expensive brand-name products. Computer programs have also been introduced for use by prescribers to indicate generic alternatives to GPs at the point of prescription. 6. What incentives exist for innovative pharmaceutical products? Currently, innovative pharmaceutical products are subject to the system of NICE review and voluntary submission to the PPRS, although ad hoc risk-sharing arrangements are increasingly being entered into for certain innovative products across the NHS. From 2014, however, the PPRS is to be replaced for products containing 208 Baker & McKenzie

217 United Kingdom new active substances by a new value-based pricing system that the DoH is promising will provide incentives for innovative products. 7. Are hospitals allowed to run public tenders on pharmaceutical products? If so, what are the rules governing the pricing proposal of the pharmaceutical companies? For hospital medicines (i.e. secondary care), the use of tenders has been standard in the NHS for a number of years, particularly for products at the end of their lifecycle. Such tenders lead to local discounting arrangements being set up between NHS trusts and companies, which are not usually publicly disclosed. A typical tender may relate to the supply of products traditionally manufactured inhouse within the NHS such as chemotherapy drugs but which, due to increasing demand, are now being outsourced to commercial compounding service providers. A more recent trend, however, is for tenders to be run for newly launched cancer medicines. All such tenders follow UK and EU procurement requirements. With the exception of vaccines, tendering is not carried out for nonhospital medicines (i.e. primary care); although there have been incidents of local trusts starting to launch tenders in primary care, to date they have all so far been successfully challenged. However, the ABPI reports that in some NHS regions, consultancies are being retained to engage with companies to broker discussions and arrangements on tenders for medicines in both primary and secondary care, and value-added service provision. The ABPI does not support tendering for on-patent medicines in either primary or secondary care medicines, arguing that not only does tendering undermine the PPRS, it also restricts the availability of patented medicines, presents a risk to patient safety through a onesize fits all approach, curtails clinician choice by emphasizing cost over individual patient needs, and undermines ongoing investments in innovation. European Pricing and Reimbursement Handbook 209

218 United Kingdom 8. Is there a difference between reimbursement of pharmaceutical products prescribed by physicians in private practice and those prescribed in a hospital? There is no difference for NHS patients, except that those in a hospital are not required to make the co-payment for their products (i.e., they do not have to pay any prescription charge, even if they are eligible to pay within the community). 9. Can a pharmaceutical product that is used for an indication for which it is not approved (i.e. off-label use) be reimbursed? If yes, what are the conditions? Yes, where, as is most likely in such cases, the indication does not appear in the Drug Tariff, the relevant local trust (or, following the entering into law of the Health and Social Care Bill, GP commissioning consortia) has the authority to make decisions on which products and indications are reimbursed, either generally or in specific cases. As off-label prescribing is relatively common in palliative care treatment, the local nature of the decision-making regarding reimbursement has led to particular controversy, with terminally-ill patients in one area permitted certain drugs while those in another area are refused the same treatment. However, it has been announced that in an attempt to save the NHS money in the long term, and to better regulate the pricing and reimbursement of unlicensed medical products for named individuals (i.e., specials ), a Specials Tariff will be published in November 2011 alongside the Drug Tariff. 210 Baker & McKenzie

219 Contributing Offices Contributing Offices Office phone numbers and addresses may change from time to time. Please refer to for current contact information. Austria - Vienna Diwok Hermann Petsche Rechtsanwälte GmbH Schottenring Vienna Austria Tel: Fax: Belgium - Antwerp Baker & McKenzie CVBA Meir Antwerp, Belgium Tel: Fax: Belgium - Brussels Baker & McKenzie LLP 149 Avenue Louise Eighth Floor 1050 Brussels, Belgium Tel: Fax: Czech Republic - Prague Baker & McKenzie v.o.s. Praha City Center Klimentská Prague 1, Czech Republic Tel: Fax: European Pricing and Reimbursement Handbook 211

220 Contributing Offices France - Paris Baker & McKenzie SCP 1 rue Paul Baudry Paris, France Tel: Fax: Germany - Berlin Baker & McKenzie LLP Friedrichstraße 88/Unter den Linden Berlin, Germany Tel: Fax: Germany - Dusseldorf Baker & McKenzie LLP Neuer Zollhof Dusseldorf, Germany Tel: Fax: Germany - Frankfurt Baker & McKenzie LLP Bethmannstrasse Frankfurt/Main, Germany Tel: Fax: Germany - Munich Baker & McKenzie LLP Theatinerstrasse Munich, Germany Tel: Fax: Hungary - Budapest Martonyi és Kajtár Attorneys at Law Andrássy-út Budapest, Hungary Tel: Fax: Italy - Milan Baker & McKenzie Milano StP 3 Piazza Meda Milan, Italy Tel: Fax: Italy - Rome Baker & McKenzie Roma StP Viale di Villa Massimo, Rome, Italy Tel: Fax: The Netherlands - Amsterdam Baker & McKenzie Amsterdam N.V. Claude Debussylaan MD Amsterdam P.O. Box CS Amsterdam, The Netherlands Tel: Fax: Poland - Warsaw Baker & McKenzie Gruszczynski & Partners Attorneys at Law LP Rondo ONZ Warsaw, Poland Tel: Fax: Baker & McKenzie

221 Contributing Offices Russia - Moscow Baker & McKenzie - CIS, Limited Sadovaya Plaza, 11th Floor 7 Dolgorukovskaya Street Moscow , Russia Tel: Fax: Russia - St. Petersberg Baker & McKenzie - CIS, Limited BolloevCenter, 2nd Floor 4A Grivtsova Lane St. Petersburg Russia Tel: Fax: Spain - Barcelona Baker & McKenzie Barcelona S.L. Avda. Diagonal, 652, Edif. D, 8 th floor Barcelona, Spain Tel: Fax: Spain - Madrid Baker & McKenzie Madrid S.L. Paseo de la Castellana Madrid Tel: Fax: ; Sweden - Stockholm Baker & McKenzie Advokatbyrå KB Postal Address: P.O. Box 180 SE Stockholm, Sweden Other deliveries: Vasagatan 7, Floor 8 (Reception) SE Stockholm, Sweden Tel: Fax: Switzerland - Geneva Baker & McKenzie Geneva Rue Pedro-Meylan Geneva, Switzerland Tel: Fax: Switzerland - Zurich Baker & McKenzie Zurich Holbeinstrasse 30 P.O. Box 8034 Zurich Switzerland Tel: Fax: UK - London Baker & McKenzie LLP 100 New Bridge Street London EC4V 6JA UK Tel: Fax: European Pricing and Reimbursement Handbook 213

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