Competentes en Medicamentos

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1 VIII Encuentro de Autoridades Competentes en Medicamentos de los Países Iberoamericanos (EAMI) de Mayo 2010 Madrid MARTIN TERBERGER Jefe de la Unidad de Productos Farmacéuticos

2 Nuevas iniciativas legislativas europeas en farmacovigilancia y lucha contra los medicamentos falsificados.

3 Medicinas Falsificadas - Counterfeit Medicines What is the matter at stake? What legal changes are proposed?

4 Risk Appraisal From lifestyle to life-saving drugs From illegal to legal supply chain

5 The new risk profile has consequences for Public Health Economy Internal Market Concrete threats Loss of confidence Negative effects on Pharma Industry Health care systems Member States start taking action at national level

6 Strategies IPR Protection Customs Action Criminal Law International Pharma Legislation Awareness Cooperation Enforcement & Super vision i Raising

7 Legal Proposal: 3 Pillars` 1. Product characteristics and GMP 2. Actors in the supply chain and Good Distribution Practices (GDP) 3. Active Substances (API) (incl. Inspections) Directive amending Directive 2001/83/EC

8 1st t Pillar : Product characteristics and Good Manufacturing Practices (GMP)

9 Placing on the market/manufacturing (1) Obligatory safety features The issue: No legal basis for harmonisation of safety features Proposed change (Proposed new Article 54a): Legal basis for harmonised approach in Community Scope: prescription medicines & risk-based Characteristics ti set out in implementing measures

10 Placing on the market/manufacturing (3) Information obligation The issue: In case of detected counterfeit e t medicines es No information obligation to report this Proposed change in legislation: Information obligation when suspicion about counterfeit medicines (Proposed new Article 46 (g))

11 2nd d Pillar : Actors in the supply chain and Good Distribution Practices (GDP)

12 The issue: Actors in supply chain/gdp (1) Traders`` Wholesaler covered by pharmaceutical acquis Brokers, commercial agents not covered Proposed change: Positive definition of trader trader (proposed new Article 1(17a)) Certain wholesaler requirements apply (incl. record- keeping, audit) (proposed new Article 85b) Notification obligation (proposed new Article 85b) NB: No change of definition of wholesaler

13 Actors in supply chain/gdp (2) Introducing` medicines not inteded to be placed on the market The issue: Legal uncertainty whether rules on importation apply to products which are introduced Proposed change: Clarification, that regime for wholesalers apply (proposed new Article 85a, whereas 6 of the proposal) Rules for introduction (proposed new Article 52b)

14 Actors in supply chain/gdp (4) EudraGDP database The issue: No transparency about compliant wholesalers Proposed changes: Compliant wholesale distributors are registered in a EudraGDP database (proposed new Article 77(4)) Same rules as for EudraGMP database apply pp y (proposed new Article 111 (3), (5) - (7))

15 The issue: Actors in supply chain/gdp (5) Information obligation In case of detected counterfeit medicines No information obligation to report this Proposed change: Information obligation to NCA/MAH when suspicion about counterfeit medicines (Proposed new Article 80(i))

16 3rd pillar : Active pharmaceutical ingredients ( API ) There are recognised international standards These apply independently as to where the product is manufactured Shortcomings of enforcement mechanisms

17 The issue: API (1) - Enforcement abroad by competent authorities It is not possible to inspect all 3rd country API plants by EU national competent authorities Proposed changes: Confirmation on GMP compliance from exporting country (proposed new Article 46b (2b)) Confirmation not required if exporting country has an eqivalent control and enforcement mechanism (proposed new Article 46b (3), 111b)

18 Farmacovigilancia - Pharmacovigilance

19 The Commission proposal p Revision of the legal framework under co-decision i procedure include amendments to: Directive 2001/83/EC (nationally authorised products and common provisions) Regulation (EC) No 726/2004 (specific provisions on centrally authorised products and tasks of the European Medicines Agency)

20 Why modify existing EU legislation? Current pharmacovigilance rules are complex and unclear with overlapping responsibilities between the parties Lack of clear standards for the authorities and industry Lack of legal basis for certain requirements

21 Objectives 1. Clear tasks and responsibilities for all parties 2. Improved decision-making procedures and efficient use of resources 3. Proactive and proportionate risk management avoiding unnecessary administrative burden and providing for stronger link between safety assessments and regulatory action 4. Strengthened transparency, patient involvement and oversight of non-interventional studies

22 Clear tasks and responsibilities: the European Medicines Agency ( EMEA ) Coordinating role at the centre of Community Pharmacovigilance system reinforced New scientific committee at the EMEA: the Pharmacovigilance Risk Assessment Advisory Committee ( PhV committee ) responsible for providing advice on pharmacovigilance il Key role in signal detection and follow-up

23 The reporting of the Pharmacovigilance Committee Committee for Medicinal Products for Human Use ( CHMP ) Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human ( Coordination group ) Pharmacovigilance committee ( PhV Committee )

24 Clear tasks and responsibilities: Member States Key role in the conduct of pharmacovigilance for products placed on their markets, signal detection and follow up with marketing authorisation holder, healthcare professionals and patients Operation of a pharmacovigilance system Provisions for increased cooperation and work- sharing within the network of authorities (including possibility to delegate) Imposition of penalties for non-compliance

25 Clear tasks and responsibilities: Marketing authorisation holders Operation of a pharmacovigilance system (summary submitted to authorities; detailed updated Pharmacovigilance system master file kept on site for submission on request) Risk management system (proportionate to risks) in all Marketing authorisations Continuous monitoring of safety information (all information, incl. clinical trials or use outside summary of product characteristics) and up- dating of marketing authorisation

26 Objectives 1. Clear tasks and responsibilities for all parties 2. Improved decision-making procedures and efficient use of resources 3. Proactive and proportionate risk management avoiding unnecessary administrative burden and providing for stronger link between safety assessments and regulatory action 4. Strengthened transparency, patient involvement and oversight of non-interventional studies

27 Improved EU decision- making procedures Revision of current Article 107 Directive (urgent changes to the marketing authorisation on the basis of evaluation of pharmacovigilance data) with list of binding criteria initiating the procedures Scope of the procedures to cover all products concerned to ensure single assessment of the safety issue Rules to ensure the (harmonised) regulatory follow-up as regards the marketing authorisation

28 Community (urgency) procedure Member States shall initiate this procedure in specific circumstances, e.g. when they consider to prohibit the supply of a medicinal i product or to suspend or revoke a marketing authorisation ti May concern individual medicinal products or range of products or a therapeutic class

29 Objectives 1. Clear tasks and responsibilities for all parties 2. Improved decision-making procedures and efficient use of resources 3. Proactive and proportionate risk management avoiding unnecessary administrative burden and providing for stronger link between safety assessments and regulatory action 4. Strengthened transparency, patient involvement and oversight of non-interventional studies

30 Proactive and proportionate risk management Proactive monitoring and signal detection Risk management plan for all products, proportionate to risks and information available Marketing authorisation subject to conditions related to safety (key measures in the plan, post authorisation safety studies) List of intensively monitored products

31 Adverse drug reaction reporting Simplification by providing all reports directly to Eudravigilance Same reporting rules for nationally and centrally authorised products Reporting not limited to side effects in normal conditions of use but includes medication errors, overdose Patient reporting Literature monitoring by EMA

32 Periodic safety update reports Analysis of benefit-risk vs. line listings of adverse reactions Reporting requirements proportionate to risks; no routine periodic safety update reports for certain product groups EU reference dates for a harmonised frequency of reporting Rules to ensure the (harmonised) regulatory follow-up as regards the marketing authorisation

33 Assessment of periodic safety update reports involving several Member States t [1] A single assessment for medicinal products authorised in more than one Member State and for products containing the same active substance (with established Community reference date and frequency of reports) to be conducted either by:

34 Objectives 1. Clear tasks and responsibilities for all parties 2. Improved decision-making i procedures and efficient use of resources 3. Proactive and proportionate risk management avoiding unnecessary administrative burden and providing for stronger link between safety assessments and regulatory action 4. Strengthened transparency, patient involvement and oversight of non- interventional studies

35 Role of the administration Eudravigilance database: single point to receive and share reports Network of European and national safety web portals Publication of recommendations, opinions and decisions Coordination by the EMEA of communications on safety issues

36 Increased role of patients and health care professionals Patient report Adverse Drug Reactions Public hearing gpossible under Community procedure Better informed patients and health care professionals as a result of transparency

37 Non-interventional post-authorisation safety studies [1] Clear legal basis for requesting post- authorisation safety studies Oversight of such studies e.g. to ensure that they are non-promotional Draft protocol submitted prior to national authority or PhV committee for (i) letter of objection or (ii) recommendation

38 Muchas Gracias!

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