Heather Simmonds Director Prescription Medicines Code of Practice Authority pmcpa.uk
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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
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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.
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ABPI Code
Established in 1958
Regularly updated
Applies to member and non member companies
Reflects and extends beyond UK law
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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
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Established 1980s
Updated
Current version 2007
ImplementationComplaints mechanism
Code Compliance Network
IFPMA CODE
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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
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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
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LEGISLATION
The Medicine (Advertising) Regulations 1994, as amended (1994 No. 1932)
The Medicines (Monitoring of Advertising) Regulations 1994, as amended (1994 No. 1993)
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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.
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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
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MHRA - The Blue Guide
Advertising and Promotion of Medicines in the UK
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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?
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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
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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
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Sets out how the Authority operates including: the complaints procedure sanctions publication charges
Constitution and ProcedureConstitution and Procedure
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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
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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
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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.
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Communication
Increase awareness amongst health professionals – Code Awareness Day
PR activity Guide for Health Professionals updated Guide for patients/public to be produced Training
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Publications
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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
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Conclusion and Questions