The Changing Regulatory Environment for Industry

SupportThe accreditation bodies’ point of view.

Ian Starke (UK)

Competing Interests

• Vice-chair Academy of Medical Royal Colleges Directors of CPD committee

• No commercial affiliations

Learning objectives

• To know about the proposals for medical revalidation in the UK

• To understand the effect that these proposals may have on the accreditation of CME/CPD activities

• To appreciate the importance of industry’s commitment to quality CME/CPD

Overview

• Medical revalidation in the UK• The medical regulator’s review of CPD• The industry regulator’s guidelines for

commercial support• The view of the accrediting bodies• An example for discussion.

Regulatory Structures in the UK

Department of Health

UK Government

General Medical Council (GMC)

Revalidation Support Team (RST)

Responsible Officer

Appraiser

Doctor

Royal Colleges (the N.A.A.)

Medical Revalidation in the UK

• Revalidation is the means by which, every five years, licensed doctors will demonstrate that they remain up to date and fit to practice (GMC 2011).

• “The more that [CPD] credits can encompass the value of the learning and not simply the time spent engaged in CPD, the more it will be valued by doctors and the better a measure it will be of their CPD activities” (CMO 2008).

The Revalidation Process

Annual appraisalSupporting

information

ResponsibleOfficer

X 5

PersonalDevelopment

PlanCPD

Recommendationto GMC

ClinicalGovernanceinformation

Professional excellence.

Lord Patel and the GMC (2010)

• The regulator should, therefore, be extremely cautious before seeking to intervene directly in CPD through application of prescriptive requirements which may add little or no value and put effective practice at risk.

• The GMC should re-examine how the regulatory role in CPD should be exercised so as to support doctors in meeting the requirements of revalidation and providing high quality care for their patients.

http://www.gmc-uk.org/Patel_review.pdf_39254211.pdf

Review of the GMC’s Role in Doctors’ CPD: final report (2011)

• A continuing learning process, outside formal undergraduate and postgraduate training, which enables doctors to maintain and improve their performance across all areas of their medical practice through the development of knowledge, skills, attitudes and behaviours.

http://www.gmc-uk.org/Final_Report_on_review_of_CPD_14_Oct_2011_web_version.pdf_448

Review of the GMC’s Role in Doctors’ CPD: final report (2011)

• GMC: – Will not dictate content of individual CPD– Will not dictate a minimum number of hours– Quality assurance of activities may be carried out

by Colleges / Faculties

• The individual is responsible for ensuring quality and value for money

• The effectiveness of the CPD activity should be discussed at appraisal.

ACADEMY STANDARDS AND CRITERIA

Draft Standards and Criteria

• Clearly defined target audience• Clearly defined learning aims / objectives• Programme has scientific or educational

content only• Delivery methods appropriate to the learning

aims• Supporting information clear and relevant

Draft Standards and Criteria

• Expertise of Faculty appropriate for the programme

• No influence or bias by commercial interests• The feedback process must include:– Whether the learning objectives were met– Presence or absence of bias

• Compliance with legislative and ethical requirements

OTHER REGULATORY ISSUES

Association of the British Pharmaceutical Industry

CODE OF PRACTICEfor the

PHARMACEUTICAL INDUSTRY2011

in association with THE PRESCRIPTION MEDICINESCODE OF PRACTICE AUTHORITY

Meetings, Hospitality and Sponsorship

• Clear educational content• Appropriate venue• Subsistence secondary to the meeting• Sponsorship clear and open• Costs similar to those the attendee would pay• Complaints may be made to the Prescription

Medicines Code of Practice Authority.• http://www.pmcpa.org.uk/files/sitecontent/

ABPI_Code_2011.pdf

Not that far apart?

• “The fact that a meeting or course has CPD approval does not mean that the arrangements are automatically acceptable under the Code” (ABPI).

• “You must not ask for or accept any inducement, gift or hospitality which may affect, or be seen to affect, the way you prescribe for, treat or refer patients” (GMC).

Summary

• Medical regulation must not mean that the regulator determines the content of CME/CPD

• The primary responsibility for keeping up to date through CME/CPD rests with the learner

• The effectiveness of CME/CPD activity should be evaluated regularly

• Industry regulators are increasingly aware of the need to avoid competing interests and bias

Thank you!