Codes of Conduct

The International Pharmaceutical Regulatory & Compliance Congress and Best Practice Forum

6 June 2007

Heather Simmonds

Director

Prescription Medicines Code of Practice Authority

www.pmcpa.org.uk

Prescription Medicines

Code of Practice AuthorityPrescription MedicinesCode of Practice Authority

Heather Simmonds, DirectorEtta Logan, SecretaryJane Landles, Deputy Secretary

Appointed by and reports to ABPI Board of Management.

ROLE:

Responsible for administration of the Code and complaints procedure including provision of advice, guidance and training.

Scrutiny of advertising and meetings.

Arranging conciliation.

ABPI Code

Established in 1958

Regularly updated

Applies to member and non member companies

Reflects and extends beyond UK law

OTHER CODES - INTERNATIONAL

IFPMA Code of Pharmaceutical Marketing Practices

EFPIA Code of Practice on the Promotion of Medicines

Guidelines

WHO Ethical criteria for Medicinal Drug Promotion

Established 1980s

Updated

Current version 2007

ImplementationComplaints mechanism

Code Compliance Network

IFPMA CODE

Established 1992 ahead of EU Directive

Updated 1993, 2004, 2008?

Code on the promotion of medicines to and interactions with healthcare professionals

ImplementationComplaints mechanism – via national associations

EFPIA Code CommitteeAnnual meeting to share experiences

EFPIA CODE

EU LEGISLATION

Council Directive 2001/83/EC of 26 November 2001 on the Community Code relating to medicinal products for

human use

(original Directive dated 1993)

Articles 86 → 100

Council Directive 2004/27/EC of 31 March 2004

LEGISLATION

The Medicine (Advertising) Regulations 1994, as amended (1994 No. 1932)

The Medicines (Monitoring of Advertising) Regulations 1994, as amended (1994 No. 1993)

RELATIONSHIP WITH MHRA

Control of advertising is based on self regulation. MHRA acts on behalf of health ministers when self regulation fails or there is a clear case for protection.

Memorandum of understanding.

MEMORANDUM OF UNDERSTANDING

Agreed by the MHRA, ABPI and PMCPA

Commitment to self regulation

Sets out the roles of the PMCPA and MHRA

Self regulation should be the first means of dealing with complaints

MHRA to act ‘when there is a clear case for protection’ or if self regulation fails

MHRA - The Blue Guide

Advertising and Promotion of Medicines in the UK

Apart from the updated ABPI Code and Constitution and Procedure?

Increased engagementNew IFPMA Code, EFPIA Code being revisedHealth Select CommitteeMHRA prevetting NCEsContinuing media interest

What has changed?What has changed?

More press coverage

new communications manager more training – companies, individuals, third party agencies more complaints – largest group health professionals more voluntary admissions more use of sanctions more transparency more independent members of the Appeal Board more complaints from employees/exemployees

Impact of 2006 ABPI CodeImpact of 2006 ABPI Code

Hospitality Provisions of gifts Provision of medical and educational goods and services Working with patient groups, information to the public

Areas that have caused discussion

Areas that have caused discussion

Sets out how the Authority operates including: the complaints procedure sanctions publication charges

Constitution and ProcedureConstitution and Procedure

COMPLAINTS PROCEDURE

Complaint to Prescription Medicines Code of Practice Authority

Code of Practice Panel

Complainant Advised of Ruling Respondent Advised of Ruling

Accepted AcceptedAppealedAppealed

Code of Practice Appeal Board

ABPI Board of Management

Can report companies to ABPI Board

Can report companies to Appeal Board

CODE OF PRACTICE APPEAL BOARD

Chairman, independent, legally qualified

Three independent medical membersone general practitionerone hospital consultant

Five other independent membersone pharmacist

one nurse prescriber one representative of the interests of patients

one from a body that provides information on medicines one lay member

Industry members4 medical directors or equivalent8 directors or senior executives

SANCTIONS

Rapid cessation of promotion.

Publication of case reports.

Recovery of items.

Audit of company’s procedures can be followed by pre-vetting.

Public reprimand.

Corrective statements.

Advertising of certain cases in medical/pharmaceutical press.

Suspension/expulsion by ABPI Board of Management.

Communication

Increase awareness amongst health professionals – Code Awareness Day

PR activity Guide for Health Professionals updated Guide for patients/public to be produced Training

                                                                                                                   

Publications

FINANCES

Annual Levy paid by members of ABPI.

Administrative charges paid by:

Complainant companies when no breach ruled

Respondent companies ruled in breach

Amount depends on: number of matters, outcome of any appeal and whether an ABPI member or not.

Audits

Seminars

Conclusion and Questions