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)

seaformec@cgcom.esseaformec@cgcom.es

WHAT IS CONFLICT OF WHAT IS CONFLICT OF INTERESTS (COI)INTERESTS (COI)

A situation in which there are twoA situation in which there are two

jobs, aims, roles, etc. and it is notjobs, aims, roles, etc. and it is not

possible for both of them to be treatedpossible for both of them to be treated

equally and fairly at the same timeequally and fairly at the same time

Oxford Advanced Learner’s Dictionary. 7th edition. 2005Oxford Advanced Learner’s Dictionary. 7th edition. 2005

WHAT IS COI IN HEALTHWHAT IS COI IN HEALTH

A set of conditions in whichA set of conditions in which

professional judgement concerning aprofessional judgement concerning a

primary interest (such as a patient’sprimary interest (such as a patient’s

welfare or the validity of research)welfare or the validity of research)

tends to be unduly influenced by atends to be unduly influenced by a

secondary interest (such as financial gain)secondary interest (such as financial gain)

Thompson DF.NEJM. 1993; 329:573-6Thompson DF.NEJM. 1993; 329:573-6

AGENTS INVOLVED IN AGENTS INVOLVED IN POTENTIAL COIPOTENTIAL COI

PhysiciansPhysicians InstitutionsInstitutions IndustryIndustry Lay PressLay Press Scientific PressScientific Press Regulatory BodiesRegulatory Bodies

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

Industry-Sponsored Surveillance StudiesIndustry-Sponsored Surveillance Studies

CME/CPDCME/CPD

Clinical Evaluation Packages (Samples)Clinical Evaluation Packages (Samples)

Other ConsiderationsOther Considerations

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

www.acme-assn.org/home/prb042507a.pdfwww.acme-assn.org/home/prb042507a.pdf

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

- Off-label promotion- Off-label promotion