THE COOPERATION BETWEEN PHYSICIANS AND THE PHARMACEUTICAL INDUSTRY INFORMATION FROM THE AUSTRIAN MEDICAL CHAMBER AND PHARMIG

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1 THE COOPERATION BETWEEN PHYSICIANS AND THE PHARMACEUTICAL INDUSTRY INFORMATION FROM THE AUSTRIAN MEDICAL CHAMBER AND PHARMIG

2 PREFACE Transparency and clear rules for the cooperation of the medical profession and the pharmaceutical industry Physicians are members of a liberal profession who, due to their specialist qualification, render their services personally, at their own authority and professionally independent. It is their duty to represent their patients interests without being influenced by a third party and are therefore exclusively bound to medical necessity and the patients consent when prescribing medication. Information of the pharmaceutical industry concerning medicinal products and research data is especially important for exercising the medical profession, further medical education, as well as to ensure the highest standard of quality in healthcare. In 2014, both the Austrian Medical Chamber and Pharmig have decided on amendments concerning the cooperation between physicians and the pharmaceutical industry in their respective Codes of Conduct. The aim is to ensure the free choice of therapy for physicians, as well as to promote research in medicinal products. 2

3 PREFACE Both sets of rules are based upon high ethical standards and transparency. In addition to other applying laws, in particular the Act on the Medical Profession and the Medicinal Products Act, they form the basis for the successful sharing of expertise in order to gain or recover patient health and to enhance the patients quality of life. This jointly developed booklet shall guide physicians and staff of the pharmaceutical industry in their daily cooperation. ÖÄK/Mathis Dr. Artur Wechselberger President of the Austrian Medical Chamber Prof. Dr. Robin Rumler President of Pharmig Association of the Austrian Pharmaceutical Industry 3

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5 CONTENT Cooperation and information on medicinal products... 6 and events... 7 and hospitality... 8 and non-interventional studies... 9 and the offering/accepting of medical samples and exchange of services and benefits and transparency

6 INFORMATION ON MEDICINAL PRODUCTS Cooperation and information on medicinal products Providing information on medicinal products is an important duty of the pharmaceutical industry. In cooperation with physicians this information shall support them in the appropriate choice and administration of medicinal products. Information can be provided in various ways (e.g. conversation with sales representatives, or conferences). Specialist information on medicinal products must be based on state-of-the-art scientific data. The information must be accurate, balanced, fair, objective, verifiable and complete in order to ensure the free choice of therapy for physicians. All statements concerning the information on medicinal products must comply with the respective summary of the products characteristics (SmPC) and be limited to the medical indications of the medicinal products for which they have been authorised. If patients or their representatives turn to pharmaceutical companies with individual questions on medicinal products, the pharmaceutical company shall recommend the consultation of a physician. Stauke Fotolia 6

7 EVENTS Cooperation and events Events, such as symposia, scientific congresses, workshops, or lectures, are recognised means for the sharing of knowledge and experience with medicinal products and medicinal therapy. Events must exclusively serve to provide scientific information and/or further specialisation. The assumption of costs for these events by the pharmaceutical industry shall be restricted to travel costs, room and board, as well as the original admission fee. Entertainment may not be financed or organised. Neither the organisation, nor the assumption of costs for an accompanying person is permitted. The venue must be appropriate for the purposes of the event and located in the home country. Events promoting further education are only permitted to be held abroad if they are international medical-scientific events for which the majority of participants come from abroad or if there are logistical reasons for choosing this particular venue (e.g. visits to scientific/production facilities). The invitation for participating or speaking at an event must not be made dependent on the recommendation, prescription or dispensing of a particular medicinal product. Potential conflicts of interests must be disclosed to the organiser and participants of the event. 7

8 HOSPITALITY Cooperation and hospitality Hospitality to physicians is only admissible in the framework of events and business dinners for the purpose of exchanging information. The occasion is to be documented appropriately by the pharmaceutical company. Hospitality shall be offered to an appropriate extent and shall not be lavish. Hospitality for accompanying persons is not permitted. vege Fotolia 8

9 NON-INTERVENTIONAL STUDIES mike6050 Fotolia Cooperation and non-interventional studies Non-interventional studies (NIS) are studies which, in accordance with the Medicinal Products Act, serve to obtain knowledge of the application of medicinal products, and their efficacy and tolerance in practice. NIS are supervised by the medical department of the pharmaceutical company. NIS must not be carried out in order to influence the choice of therapy and procurement decisions. Remuneration of the administrative and specialist services must be proportionate, may only consist of money and must not be profit-related. 9

10 OFFERING/ACCEPTING OF MEDICAL SAMPLES Cooperation and the offering/accepting of medical samples Medical samples may only be supplied at a written request and free of charge. They must be labelled with the clearly legible and irremovable notice Unverkäufliches Ärztemuster (free medical sample not for sale). Medical samples may only be supplied in a package that is no larger than the smallest presentation on the market and may only be supplied according to the amounts provided for in the Medicinal Products Act. Pharmaceutical companies must have an adequate system for the control and documentation of the samples supplied. Fabian Schmidt Fotolia 10

11 EXCHANGE OF SERVICES Julien Eichinger Fotolia Cooperation and exchange of services Successful research on medicinal products requires the cooperation of physicians and pharmaceutical companies. The exchange of specialist knowledge and mutual support are important in order to ensure treatments of high quality. Services provided by physicians for pharmaceutical companies may only serve the purpose of training/further education, research, support of the healthcare system or be provided within the framework of scientific or specialist activities. For the provision of services a written contract must always be concluded. The remuneration must be proportionate and must not be linked with conditions relating to the recommendation, prescription, dispensing of a medicinal product. Donations or subsidies to physicians are not permitted. Within the framework of cooperation with physicians acting as public officials, additionally any other applying law, as well as professional and organisational regulations must be observed. 11

12 BENEFITS Cooperation and benefits Pharmaceutical companies and their employees must not offer, promise or grant any premiums, financial, or material benefits to physicians, unless they are permitted in accordance with the provisions of the Pharmig Code of Conduct or the law. Physicians may not accept even small gifts if the acceptance is directly or indirectly linked with conditions relating to the recommendation, prescription, dispensing of a medicinal product and/or a medical device. scusi Fotolia 12

13 TRANSPARENCY Cooperation and transparency In order to ensure the best possible supply of medicinal products, the cooperation of physicians and the pharmaceutical industry is essential. The disclosure of transfers of value at the individual level increases trust in this cooperation. The duty to disclose, as decided upon in the Pharmig Code of Conduct is only applicable to transfers of value concerning: research and development donations and subsidies events services and consultation provided including expenses Disclosure is aimed at the documentation of transfers of value in connection with medicinal products which are subject to prescription. The purchase and sale of medicinal products are exempt therefrom. Disclosure shall be presented in a structured and standardised form and shall be made available on the Internet for a period of, at least, three years. The disclosure of transfers of value, including donations and subsidies, is to be made publicly accessible on the homepage of the pharmaceutical company. 13

14 TRANSPARENCY ra2studio Fotolia In principle, the disclosure of transfers of value is to be made at the individual level. Consent of the physician shall be obtained prior to disclosure at the individual level. Applicable data protection regulations shall be observed. In case that there is no consent of the physician, disclosure has to be made in aggregated form. Content of disclosure are individual information on the recipient of the transfer of value and the details of the cooperation (e.g. name, service, remuneration). If the disclosure is made in aggregated form, the total number of recipients, the fees and the relation to all recipients of services of the same kind are to be disclosed. 14

15 EPILOGUE Gender equality In as much as personalised terms are used in this booklet, they apply to both women and men. Disclaimer This booklet constitutes a summary in note form of the provisions of the Code of Conduct of Pharmig, Association of the Austrian Pharmaceutical Industry, and the ordinance of the Austrian Medical Chamber on the Code of Conduct for the Medical Profession with additional information to serve as an overview. Exclusively the wording of the Pharmig Code of Conduct and the Code of Conduct for the Medical Profession in their up-to-date versions are legally binding, as well as the provisions of the Medicinal Products Act (MPA), the Act on the Medical Profession, the law against unfair competition, the penal code and other laws, in their up-to-date versions. The publisher is exempt from any liability for the contents of this booklet. 15

16 IMPRINT: Österreichische Ärztekammer, Weihburggasse 10 12, 1010 Wien, Tel.: +43/1/ , Pharmig, Verband der pharmazeutischen Industrie Österreichs, Garnisongasse 4/1/6, 1090 Wien, Tel.: +43/1/ , Ärztlicher Verhaltenskodex: > Arztinfo > Rechtsgrundlagen Pharmig Verhaltenscodex: > Publikationen > Verhaltenscodex