CPME C omité P ermanent des M édecins E uropéens Standing Committee of European Doctors

1. Doctors and industry - European perspective International Conference “Transparency in medicine”, Bucharest, 17 October 2012 Konstanty Radziwill MD, PhD, CPME president CPME Comité Permanent des Médecins Européens Standing Committee of European Doctors

2. Cooperation between the medical profession and the medical industry is important and necessary at all stages of the development and use of medicines/devices to secure safety of patients and efficacy of therapy.

3. Facts • Medical industry supports doctors in their work and professional development for the benefit of the patients. • Industry employs physicians as their consultants and experts.

4. Parties of cooperation • CPME - Standing Committee of European Doctors (30 national medical associations and 8 cooperating international medical organizations from Europe) • EFPIA - European Federation of Pharmaceutical Industries and Associations (33 national associations and 35 leading pharmaceutical companies) • Eucomed - European Medical Technology Industry Association (30 national associations and 62 corporate members representing design firms, manufacturers and suppliers of medical technology industry)

5. Result • "Joint Declaration on Cooperation of Physicians and the pharmaceutical industry", Brussels, 8 June 2005 • "Joint Declaration on Cooperation of Physicians and Medical Technology Industry" - in development

6. Areas of the CPME/EFPIA declaration • Product information and promotion of approved medicines • Meetings (education) organized or sponsored by industry • Clinical research • Consultancy and affiliations

7. Product information and promotion of approved medicines Industry must: • provide honest and up-to-date information regarding their products, accurately describing their advantages and disadvantages based on current scientific evidence; • make sure that sales representatives and personnel providing information are adequately qualified and trained;

8. Product information and promotion of approved medicines Industry must: • disclose clinically relevant scientific data about their products at request of physicians; • follow reports concerning their products after the medicine is available on the market and disclose important observations to doctors without delay;

9. Product information and promotion of approved medicines Industry must: • not advertise medicines before they have been granted a marketing authorisation; • not offer unjustified hospitality - gifts/benefits should be inexpensive and must be relevant to the practice of medicine.

10. Product information and promotion of approved medicines Physicians must: • not ask for gifts/benefits from the industry; • not accept unjustified hospitality - gifts/benefits should be inexpensive and must be relevant to the practice of medicine; • report on adverse reactions of medicines.

11. Meetings (education) organized or sponsored by industry • Pharmaceutical companies may arrange or sponsor educational meetings for doctors. Such events must have a clear educational content. The information rendered at any meeting should be based on scientific and medically relevant data. • Activities, which form part of systematic CPD should be reviewed and certified by relevant bodies.

12. Meetings (education) organized or sponsored by industry • In an announcement the purpose of the event should be clearly stated. It should be indicated whether the event is reviewed and certified. • Venue of a meeting should be appropriate for the scientific purpose of the meeting, and should not involve travelling beyond what is needed. • Industry may pay for lecturers, study material and facilities that are needed for the meeting. It can also pay for travelling and lodging for participants but not for any accompanying persons.

13. Meetings (education) organized or sponsored by industry • Hospitalityshould be generally acceptable, reasonable and strictly limited to the purpose of the event. Sponsoring or organising of sporting or entertainment events is prohibited. • The same principles shall apply also for activities taking place outside Europe when European doctors are involved.

14. Clinical research Cooperation between the pharmaceutical industry and the medical profession in conducting studies and clinical trials is essential to the development of medicinal products, for an in-depth knowledge of them and for their optimal use in the patient’s interest.

15. Clinical research • All partners in a clinical trial must follow ethical and professional principles and guidelines, such as the WMA’s Declaration of Helsinki and ICH’s Good Clinical Practice guidelines; • Each trial must pursue a scientific and therapeutically relevant aim. No trial should be performed primarily for promotional purposes. The aim of the trial must always be improvement of therapy, diagnostic methods and/or medical knowledge for the best of patients;

16. Clinical research • The aim of the trial must be stated beforehand. Research protocols must be drafted in such a way as to ensure that this aim is achieved and that the conclusions of the study are valid; • The sponsor has to be disclosed to the patients recruited to the study; • A physician must not receive payment or other benefits for only referring patients to clinical trial;

17. Clinical research • A physician may receive compensation for his work in a trial. The compensation must be related to the work done, and must be disclosed to the ethical committee reviewing the study protocol. The compensation must not be linked to any expected result of the study; • All efficacy and safety results on marketed products should be honestly published irrespective of the outcome, at least in summary form on the Internet, within one year after the product received its marketing authorisation. Also other results of clinical importance should be published;

18. Clinical research • In publications, lectures and other presentations the sponsor has to be disclosed; • When giving presentations on trials a doctor has to disclose his connections with all companies in the therapeutic field covered.

19. Consultancy and affiliations • Industry may ask physicians to act as consultants. In this capacity they can give service or expert advice to industry. • Connections to the pharmaceutical industry of this kind must not compromise the clinical autonomy of the consulting or affiliated doctor, who always has to abide by the ethical duty to make medical decisions independently and practise medicine for the benefit of patients.

20. Consultancy and affiliations • Payment for a consultancy assignment should relate directly to the work performed. • When consulting physicians are presenting views or results to other parties, which concern the medico-pharmacological field of the consultancy assignment, a declaration of interest should be presented to ensure transparency.

21. Life • Better do not participate in meetings that are not accredited. • Pay attention to the meetings organized very far or in very attractive places. • Do not accept sponsoring in the events of recreational, cultural or sporting character and of travel/participation of the accompanying persons. • Do not expect gifts when dealing with representatives of the industry. • Do not accept valuable gifts (especially not related to medical practice) and excessive hospitality.

22. Life • Inform representatives of the industry about adverse reactions and in such situations expect explanation and assistance. • When conducting clinical trials stick to the generally applicable rules in this area (especially the Declaration of Helsinki and the Good Clinical Practice guidlines) and in particular the rule that every trial must be accepted by the relevant ethics committee.

23. Life • Clinical trial must have a clearly defined objective, the protocol must follow it. • Remuneration of a doctor performing any kind of work for industry must be proportionate to the work done and can not be related to the results of the study. • Research should be published regardless of their outcome.

24. Before accepting a gift, hospitality, service or support from a representative of medical industry... ...ask yourself three questions: after: American College of Physicians–American Society of Internal Medicine

25. What Would My Patients Think about This Arrangement?

26. What Is the Purpose of the Industry Offer?

27. What Would My Colleagues Think about This Arrangement?

28. Vă mulţumesc foarte mult pentru atenţie! Konstanty Radziwill, CPME