1. MEETING OF THE UEMS ADVISORY COUNCIL ON CME Brussels. 24 November 2007 CONFLICT OF INTERESTS IN CME HOW IS IT REGULATED ? Helios Pardell. MD Director of the Spanish Accreditation Council for CME (SACCME) seaformec@cgcom.es

2. WHAT IS CONFLICT OF INTERESTS (COI) A situation in which there are two jobs, aims, roles, etc. and it is not possible for both of them to be treated equally and fairly at the same time Oxford Advanced Learners Dictionary. 7th edition. 2005

3. WHAT IS COI IN HEALTH A set of conditions in which professional judgement concerning a primary interest (such as a patients welfare or the validity of research) tends to be unduly influenced by a secondary interest (such as financial gain) Thompson DF.NEJM. 1993; 329:573-6

4. AGENTS INVOLVED IN POTENTIAL COI Physicians Physicians Institutions Institutions Industry Industry Lay Press Lay Press Scientific Press Scientific Press Regulatory Bodies Regulatory Bodies

5. ATTITUDES TO PROPERLY COPE WITH THE COI To avoid it (escape) To avoid it (escape) To disclose it To disclose it To manage it To manage it Davis M, Stark A, eds.Conflict of interest in the professions. Oxford: OUP; 2001

6. THE UNIVERSE OF CME/CPD Physicians Medical Associations Organizers/Providers MECCs/Facilitators Employers Accrediting Bodies/Regulators Commercial Sponsors Health Administration

7. RATIONALE Cooperation between the medical profession and the pharmaceutical industry is important and necessary at all stages of the development and use of medicines to secure safety of patients and efficacy of therapy Commercial sponsorship (CS) accounts for more than 60% of CME/CPD offer in Europe and the USA. CS is essential to assure the access of physicians to qualified CME/CPD, complementing the resources allocated by employers and the health administration (in many European countries)

8. WHAT IS COMMERCIAL SUPPORT Financial or other kind of contributions given by a commercial organization wich is used to pay all or part of the costs of a CME/CPD activity

9. THE MAIN OBJECTIVE OF COMMERCIAL SUPPORT REGULATION To ensure the independence of CME/CPD activities by preventing the commercial bias COI is not bias but a tendency toward bias (M. Davis)

10. DIFFERENTIATION BETWEEN CME/CPD AND MARKETING PROGRAMMING CME/CPD ACTTIVITIES CME/CPD ACTTIVITIES Evidence-based unbiased educational programmes aimed to teach physicians about safe and effective patient care strategies MARKETING EDUCATIONAL ACTIVITIES MARKETING EDUCATIONAL ACTIVITIES Strategies used by drug companies, pharmaceuticals and device manufacturers to educate physicians about use and outcome of new-to-market products and cutting-edge medicine central to the changing healthcare environment Capizzi SA. ACME. 2007

11. ACCME STANDARDS FOR COMMERCIAL SUPPORT-2004 (I) STANDARD 1. Independence STANDARD 1. Independence STANDARD 2. Resolution of personal conflicts of STANDARD 2. Resolution of personal conflicts of interest interest STANDARD 3. Appropriate use of commercial support STANDARD 3. Appropriate use of commercial support Written agreement documenting terms Written agreement documenting terms of support of support Expenditures for an individual Expenditures for an individual providing CME providing CME Expenditures for learners Expenditures for learners Accountability Accountability

12. ACCME STANDARDS FOR COMMERCIAL SUPPORT-2004 (II) STANDARD 4. Appropriate management of associated commercialpromotion STANDARD 4. Appropriate management of associated commercialpromotion STANDARD 5. Content and format without commercial bias STANDARD 5. Content and format without commercial bias STANDARD 6. Disclosures relevant to potential commercial STANDARD 6. Disclosures relevant to potential commercial bias bias Relevant financial relationships of those with Relevant financial relationships of those with control over CME content control over CME content Commercial support for the CME activity Commercial support for the CME activity Timing to disclosure Timing to disclosure See: ACCME Policy Updates. August 2007. www.accme.org

13. CANADIAN MEDICAL ASSOCIATION POLICY ON PHYSICIANS AND THE PHARMACEUTICAL INDUSTRY (2001) General Principles General Principles Industry-Sponsored Research Industry-Sponsored Research Industry-Sponsored Surveillance Studies Industry-Sponsored Surveillance Studies CME/CPD CME/CPD Clinical Evaluation Packages (Samples) Clinical Evaluation Packages (Samples) Other Considerations Other Considerations Medical Students and Residents Medical Students and Residents

14. EACCME STANDARDS FOR COMMERCIAL SUPPORT (I) A. CRITERIA FOR INTERNATIONAL ACCREDITATION OF CME (D 9908. 1999) OF CME (D 9908. 1999) The provider must assure the independence (non-biased education) The provider must assure the independence (non-biased education) Industry-presented education must be clearly distinguished from CME Industry-presented education must be clearly distinguished from CME Educational grants should always be made with no strings attached and be acknowledged in the program Educational grants should always be made with no strings attached and be acknowledged in the program

15. EACCME STANDARDS FOR COMMERCIAL SUPPORT (II) B. DISCLOSURE OF COMMERCIAL SUPPORT (2007) Speakers have to disclose existing financial arrangements with any commercial company contributing to the CME event Speakers have to disclose existing financial arrangements with any commercial company contributing to the CME event The disclosure form has to be singed by speakers and organizing/scientific committee members The disclosure form has to be singed by speakers and organizing/scientific committee members Ther is an obligation on both the organizers (faculty) and speakers to openly declare any conflict of interest or support to participants Ther is an obligation on both the organizers (faculty) and speakers to openly declare any conflict of interest or support to participants

16. EACCME STANDARDS FOR COMMERCIAL SUPPORT (III) C. DIRECTORS DECLARATION (2007) The scientific programme was developed under my supervision and The scientific programme was developed under my supervision and responsibility, that it is scientifically balanced and without bias responsibility, that it is scientifically balanced and without bias All faculty and other speakers are aware of, and have agreed, to All faculty and other speakers are aware of, and have agreed, to sign the UEMS/EACCME disclosure form, and have disclosed any sign the UEMS/EACCME disclosure form, and have disclosed any potential conflict of interest that they may have. This must be potential conflict of interest that they may have. This must be stated at the begining of the presentation and in all printed stated at the begining of the presentation and in all printed material material I am aware of the source and form of any commercial funding I am aware of the source and form of any commercial funding received to develop this programme received to develop this programme

17. EACCME STANDARDS FOR COMMERCIAL SUPPORT (IV) D. DECLARATION ON DISCLOSURE (2007) In compliance with UEMS/EACCME guidelines, the Organizing Committee confirms that all speakers/chairpersons participating in this programme have disclosed any potential conflicts of interest or support that might cause bias in their presentation In compliance with UEMS/EACCME guidelines, the Organizing Committee confirms that all speakers/chairpersons participating in this programme have disclosed any potential conflicts of interest or support that might cause bias in their presentation The Organizing Committee accepts that it is responsible for ensuring that all potential conflicts of interest relevant to the presentation/event are declared to the audience prior to the CME activities The Organizing Committee accepts that it is responsible for ensuring that all potential conflicts of interest relevant to the presentation/event are declared to the audience prior to the CME activities

18. JOINT DECLARATION OF CPME* AND EFPIA** ON THE COOPERATION BETWEEN THE MEDICAL PROFESSION AND THE PHARMACEUTICAL INDUSTRY (2005) Product Information and Promotion of Approved Medicines Meetings Organized or Sponsored by Industry Clinical Research Consultancy and Affiliations *Comité Permanent des Médecins Européens (Standing Committee of European Doctors) ** European Federation of Pharmaceutical Industries and Associations

19. FEDERATION OF THE ROYAL COLLEGES OF PHYSICIANS STANDARDS FOR COMMERCIAL SUPPORT GUIDELINES FOR APPROVAL APPLICATION OF CPD (2006) Declaration of Conflict of Interest Declaration of Conflict of Interest If the organiser or any of the speakers have any conflict of interest (vested interest) these must be declared and submitted with the application

20. SPANISH COMMISSION STANDARDS FOR COMMERCIAL SUPPORT (2004) Independence of the Scientific Programme Independence of the Scientific Programme Independence of the Faculty/Speackers (Disclosure) Independence of the Faculty/Speackers (Disclosure) Control of Logos Control of Logos

21. SACCME STANDARDS FOR COMMERCIAL SUPPORT (2004) Independence of the Scientific Programme Independence of the Scientific Programme Independence of the Faculty/Speakers (Disclosure) Independence of the Faculty/Speakers (Disclosure) Control of the Promotional and Educational Materials Control of the Promotional and Educational Materials Control of Logos Control of Logos Differentiation of Areas during the CME Event Differentiation of Areas during the CME Event

22. COMMERCIAL SUPPORT IN THE ROME DOCUMENT CONSENSUS ON BASIC VALUES AND RESPONSIBILITIES UNDERLYING THE SUBSTANTIAL EQUIVALENCY OF CME AND CPD SYSTEMS (2005) RESPONSIBILITIES OF THE PROVIDER/ORGANIZER OF CME/CPD ACTIVITIES TO BE FULFILLED IN ORDER TO GRANT CREDITS 2.11. Any commercial sponsorship or interests of the activity planner, presenters, or facilitators must be disclosed to the provider/organizer and the accrediting bodies 2.12. Any support, sponsorship of funding by commercial heatlh care organizations must not influence the structure or content of the educational activity and should be made clear to the participants and the accrediting bodies

23. THE US SENATE FINANCE COMMITTEE REPORT ON PHARMA COMPANIES AND CME (April 2007) (I) Analysis of the answers from the 23 largest US manufacturers and the ACCME as well as other sources Analysis of the answers from the 23 largest US manufacturers and the ACCME as well as other sources www.acme-assn.org/home/prb042507a.pdf www.acme-assn.org/home/prb042507a.pdf

24. THE US SENATE FINANCE COMMITTEE REPORT ON PHARMA COMPANIES AND CME(April 2007) (II) The Committee staffs review has led to the conclusion that the major drug companies have adopted corporate policies that, on their face, do not allow educational grants to be awarded for unlawful purposes The Committee staffs review has led to the conclusion that the major drug companies have adopted corporate policies that, on their face, do not allow educational grants to be awarded for unlawful purposes To prevent the abuse, the Committee reccomends to focus the attention on the following four areas: To prevent the abuse, the Committee reccomends to focus the attention on the following four areas: - Kickbacks - Veiled advertising - Bias in clinical protocols - Off-label promotion