MEETING OF THE UEMS ADVISORY COUNCIL ON CME MEETING OF THE UEMS ADVISORY COUNCIL ON CME Brussels. 24 November 2007 Brussels. 24 November 2007 CONFLICT OF INTERESTS IN CME CONFLICT OF INTERESTS IN CME HOW IS IT REGULATED ? HOW IS IT REGULATED ? Helios Pardell. MD Helios Pardell. MD Director of the Spanish Accreditation Council for CME Director of the Spanish Accreditation Council for CME (SACCME) (SACCME) [email protected][email protected]
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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.
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MEETING OF THE UEMS ADVISORY COUNCIL ON CMEMEETING OF THE UEMS ADVISORY COUNCIL ON CMEBrussels. 24 November 2007Brussels. 24 November 2007
CONFLICT OF INTERESTS IN CMECONFLICT OF INTERESTS IN CME
HOW IS IT REGULATED ?HOW IS IT REGULATED ?
Helios Pardell. MDHelios Pardell. MDDirector of the Spanish Accreditation Council for CME (SACCME)Director of the Spanish Accreditation Council for CME (SACCME)
ATTITUDES TO PROPERLY ATTITUDES TO PROPERLY COPE WITH THE COICOPE WITH THE COI
To avoid it (“escape”)To avoid it (“escape”)
To disclose itTo disclose it
To manage itTo manage it
Davis M, Stark A, eds.Conflict of interest inDavis M, Stark A, eds.Conflict of interest inthe professions. Oxford: OUP; 2001the professions. Oxford: OUP; 2001
THE UNIVERSE OF CME/CPDTHE UNIVERSE OF CME/CPD
Physicians
Medical Associations
Organizers/Providers
MECCs/Facilitators
Employers
Accrediting Bodies/Regulators
Commercial Sponsors
Health Administration
RATIONALE RATIONALE
Cooperation between the medical profession and the Cooperation between the medical profession and the
pharmaceutical industry is important and necessary at all pharmaceutical industry is important and necessary at all
stages of the development and use of medicines to secure stages of the development and use of medicines to secure
safety of patients and efficacy of therapysafety of patients and efficacy of therapy
Commercial sponsorship (CS) accounts for more than 60% of Commercial sponsorship (CS) accounts for more than 60% of
CME/CPD offer in Europe and the USA.CME/CPD offer in Europe and the USA.
CS is essential to assure the access of physicians to qualified CS is essential to assure the access of physicians to qualified
CME/CPD, complementing the resources allocated by employers CME/CPD, complementing the resources allocated by employers
and the health administration (in many European countries)and the health administration (in many European countries)
WHAT IS COMMERCIAL WHAT IS COMMERCIAL SUPPORT SUPPORT
Financial or other kind of contributions Financial or other kind of contributions
given by a commercial organization given by a commercial organization
wich is used to pay all or part of the wich is used to pay all or part of the
costs of a CME/CPD activitycosts of a CME/CPD activity
THE MAIN OBJECTIVE OF THE MAIN OBJECTIVE OF COMMERCIAL SUPPORT COMMERCIAL SUPPORT
REGULATIONREGULATION
To ensure the independence of To ensure the independence of CME/CPD activities by preventing CME/CPD activities by preventing the commercial biasthe commercial bias
COI is not bias but a “tendency” toward bias COI is not bias but a “tendency” toward bias (M. (M. Davis)Davis)
DIFFERENTIATION BETWEEN DIFFERENTIATION BETWEEN CME/CPD AND MARKETING CME/CPD AND MARKETING
PROGRAMMINGPROGRAMMING
CME/CPD ACTTIVITIESCME/CPD ACTTIVITIES
Evidence-based unbiased educational programmes aimed to teach Evidence-based unbiased educational programmes aimed to teach
physicians about safe and effective patient care strategiesphysicians about safe and effective patient care strategies
MARKETING EDUCATIONAL ACTIVITIESMARKETING EDUCATIONAL ACTIVITIESStrategies used by drug companies, pharmaceuticals and device Strategies used by drug companies, pharmaceuticals and device manufacturers to educate physicians about use and outcome of manufacturers to educate physicians about use and outcome of new-to-market products and cutting-edge medicine central to the new-to-market products and cutting-edge medicine central to the changing healthcare environmentchanging healthcare environment
Capizzi SA. ACME. 2007Capizzi SA. ACME. 2007
ACCME STANDARDS FOR ACCME STANDARDS FOR COMMERCIAL SUPPORT-2004 COMMERCIAL SUPPORT-2004
(I)(I) STANDARD 1. IndependenceSTANDARD 1. Independence
STANDARD 2. Resolution of personal conflicts ofSTANDARD 2. Resolution of personal conflicts of interestinterest
STANDARD 3. Appropriate use of commercial supportSTANDARD 3. Appropriate use of commercial support
Written agreement documenting termsWritten agreement documenting terms of supportof support
Expenditures for an individualExpenditures for an individual providing CMEproviding CME
Expenditures for learnersExpenditures for learners
AccountabilityAccountability
ACCME STANDARDS FOR ACCME STANDARDS FOR COMMERCIAL SUPPORT-2004 COMMERCIAL SUPPORT-2004
(II)(II) STANDARD 4. Appropriate management of associated STANDARD 4. Appropriate management of associated
commercialpromotion commercialpromotion
STANDARD 5. Content and format without commercial biasSTANDARD 5. Content and format without commercial bias
STANDARD 6. Disclosures relevant to potential commercialSTANDARD 6. Disclosures relevant to potential commercial biasbias
Relevant financial relationships of those withRelevant financial relationships of those with control over CME contentcontrol over CME content
Commercial support for the CME activityCommercial support for the CME activity Timing to disclosureTiming to disclosure
See: “ACCME Policy Updates”. August 2007. www.accme.orgSee: “ACCME Policy Updates”. August 2007. www.accme.org
CANADIAN MEDICAL ASSOCIATION CANADIAN MEDICAL ASSOCIATION POLICY ON PHYSICIANS AND THE POLICY ON PHYSICIANS AND THE
PHARMACEUTICAL INDUSTRY (2001)PHARMACEUTICAL INDUSTRY (2001)
General PrinciplesGeneral Principles
Industry-Sponsored ResearchIndustry-Sponsored Research
Medical Students and ResidentsMedical Students and Residents
EACCME STANDARDS FOR EACCME STANDARDS FOR COMMERCIAL SUPPORT (I)COMMERCIAL SUPPORT (I)
A. CRITERIA FOR INTERNATIONAL ACCREDITATIONA. CRITERIA FOR INTERNATIONAL ACCREDITATION OF CME (D 9908. 1999)OF CME (D 9908. 1999)
The provider must assure the independence (non-The provider must assure the independence (non-biased education)biased education)
Industry-presented education must be clearly Industry-presented education must be clearly distinguished from CMEdistinguished from CME
Educational grants should always be made with Educational grants should always be made with “no strings attached” and be acknowledged in “no strings attached” and be acknowledged in the programthe program
EACCME STANDARDS FOR EACCME STANDARDS FOR COMMERCIAL SUPPORT (II)COMMERCIAL SUPPORT (II)
B. DISCLOSURE OF COMMERCIAL SUPPORT (2007)B. DISCLOSURE OF COMMERCIAL SUPPORT (2007)
Speakers have to disclose existing financial arrangements Speakers have to disclose existing financial arrangements with any commercial company contributing to the CME with any commercial company contributing to the CME eventevent
The disclosure form has to be singed by speakers and The disclosure form has to be singed by speakers and organizing/scientific committee membersorganizing/scientific committee members
Ther is an obligation on both the organizers (faculty) and Ther is an obligation on both the organizers (faculty) and speakers to openly declare any conflict of interest or speakers to openly declare any conflict of interest or support to participantssupport to participants
EACCME STANDARDS FOR EACCME STANDARDS FOR COMMERCIAL SUPPORT (III)COMMERCIAL SUPPORT (III)
C. DIRECTOR’S DECLARATION (2007)C. DIRECTOR’S DECLARATION (2007)
The scientific programme was developed under my supervision andThe scientific programme was developed under my supervision and responsibility, that it is scientifically balanced and without biasresponsibility, that it is scientifically balanced and without bias
All faculty and other speakers are aware of, and have agreed, toAll faculty and other speakers are aware of, and have agreed, to sign the UEMS/EACCME disclosure form, and have disclosed anysign the UEMS/EACCME disclosure form, and have disclosed any potential conflict of interest that they may have. This must bepotential conflict of interest that they may have. This must be stated at the begining of the presentation and in all printedstated at the begining of the presentation and in all printed materialmaterial
I am aware of the source and form of any commercial fundingI am aware of the source and form of any commercial funding received to develop this programmereceived to develop this programme
EACCME STANDARDS FOR EACCME STANDARDS FOR COMMERCIAL SUPPORT (IV)COMMERCIAL SUPPORT (IV)
D. DECLARATION ON DISCLOSURE (2007)D. DECLARATION ON DISCLOSURE (2007)
In compliance with UEMS/EACCME guidelines, the In compliance with UEMS/EACCME guidelines, the Organizing Committee confirms that all Organizing Committee confirms that all speakers/chairpersons participating in this programme have speakers/chairpersons participating in this programme have disclosed any potential conflicts of interest or support that disclosed any potential conflicts of interest or support that might cause bias in their presentationmight cause bias in their presentation
The Organizing Committee accepts that it is responsible for The Organizing Committee accepts that it is responsible for ensuring that all potential conflicts of interest relevant to ensuring that all potential conflicts of interest relevant to the presentation/event are declared to the audience prior to the presentation/event are declared to the audience prior to the CME activitiesthe CME activities
JOINT DECLARATION OF CPME* AND JOINT DECLARATION OF CPME* AND EFPIA** ON THE COOPERATION BETWEEN EFPIA** ON THE COOPERATION BETWEEN
THE MEDICAL PROFESSION AND THE THE MEDICAL PROFESSION AND THE PHARMACEUTICAL INDUSTRY (2005)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) Comité Permanent des Médecins Européens (Standing Committee of European Doctors) ** European Federation of Pharmaceutical Industries and Associations** European Federation of Pharmaceutical Industries and Associations
FEDERATION OF THE ROYAL COLLEGES OF FEDERATION OF THE ROYAL COLLEGES OF PHYSICIANS STANDARDS FOR COMMERCIAL PHYSICIANS STANDARDS FOR COMMERCIAL
SUPPORT SUPPORT
“GUIDELINES FOR APPROVAL APPLICATION OF CPD” (2006)“GUIDELINES FOR APPROVAL APPLICATION OF CPD” (2006)
Declaration of Conflict of InterestDeclaration of Conflict of Interest
If the organiser or any of the speakers have If the organiser or any of the speakers have any conflict of interest (vested interest) these any conflict of interest (vested interest) these must be declared and submitted with the must be declared and submitted with the applicationapplication
SPANISH COMMISSION SPANISH COMMISSION STANDARDS FOR COMMERCIAL STANDARDS FOR COMMERCIAL
SUPPORT (2004)SUPPORT (2004)
Independence of the Scientific ProgrammeIndependence of the Scientific Programme
Independence of the Faculty/Speackers Independence of the Faculty/Speackers (Disclosure)(Disclosure)
Control of LogosControl of Logos
SACCME STANDARDS FOR SACCME STANDARDS FOR COMMERCIAL SUPPORT (2004)COMMERCIAL SUPPORT (2004)
Independence of the Scientific ProgrammeIndependence of the Scientific Programme
Independence of the Faculty/Speakers Independence of the Faculty/Speakers (Disclosure)(Disclosure)
Control of the Promotional and Educational Control of the Promotional and Educational MaterialsMaterials
Control of LogosControl of Logos
Differentiation of Areas during the CME EventDifferentiation of Areas during the CME Event
COMMERCIAL SUPPORT IN THE ROME COMMERCIAL SUPPORT IN THE ROME DOCUMENT DOCUMENT “CONSENSUS ON BASIC VALUES “CONSENSUS ON BASIC VALUES
AND RESPONSIBILITIES UNDERLYING THE AND RESPONSIBILITIES UNDERLYING THE SUBSTANTIAL EQUIVALENCY OF CME AND CPD SUBSTANTIAL EQUIVALENCY OF CME AND CPD
SYSTEMS “ (2005)SYSTEMS “ (2005)
RESPONSIBILITIES OF THE PROVIDER/ORGANIZER OF RESPONSIBILITIES OF THE PROVIDER/ORGANIZER OF CME/CPD ACTIVITIES TO BE FULFILLED IN ORDER TO CME/CPD ACTIVITIES TO BE FULFILLED IN ORDER TO GRANT CREDITSGRANT CREDITS
2.11.2.11. Any commercial sponsorship or interests of the activity Any commercial sponsorship or interests of the activity planner, presenters, or facilitators must be disclosed to the planner, presenters, or facilitators must be disclosed to the provider/organizer and the accrediting bodiesprovider/organizer and the accrediting bodies
2.12.2.12. Any support, sponsorship of funding by commercial Any support, sponsorship of funding by commercial heatlh care organizations must not influence the structure or heatlh care organizations must not influence the structure or content of the educational activity and should be made clear to content of the educational activity and should be made clear to the participants and the accrediting bodiesthe participants and the accrediting bodies
THE US SENATE FINANCE THE US SENATE FINANCE COMMITTEE REPORT ON PHARMA COMMITTEE REPORT ON PHARMA
COMPANIES AND CME (April 2007) (I)COMPANIES AND CME (April 2007) (I)
Analysis of the answers from the 23 Analysis of the answers from the 23 largest US manufacturers and the largest US manufacturers and the ACCME as well as other sourcesACCME as well as other sources
THE US SENATE FINANCE THE US SENATE FINANCE COMMITTEE REPORT ON PHARMA COMMITTEE REPORT ON PHARMA
COMPANIES AND CME(April 2007) (II)COMPANIES AND CME(April 2007) (II)
The Committee staff’s review has led to the conclusion The Committee staff’s review has led to the conclusion that the major drug companies have adopted corporate that the major drug companies have adopted corporate policies that, on their face, do not allow educational policies that, on their face, do not allow educational grants to be awarded for unlawful purposesgrants to be awarded for unlawful purposes
To prevent the abuse, the Committee reccomends to To prevent the abuse, the Committee reccomends to focus the attention on the following four areas:focus the attention on the following four areas:
- - KickbacksKickbacks
- Veiled advertising- Veiled advertising
- Bias in clinical protocols- Bias in clinical protocols