codes of conduct the international pharmaceutical ... · current version 2007. implementation....
TRANSCRIPT
Codes of Conduct
The International Pharmaceutical Regulatory & Compliance Congress and Best Practice Forum
6 June 2007
Heather SimmondsDirector
Prescription Medicines Code of Practice Authoritywww.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 1958Regularly updatedApplies to member and non member companiesReflects 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 1980sUpdatedCurrent version 2007
ImplementationComplaints mechanismCode Compliance Network
IFPMA CODE
Established 1992 ahead of EU DirectiveUpdated 1993, 2004, 2008?Code on the promotion of medicines to and interactions with healthcare professionals
ImplementationComplaints mechanism – via national associationsEFPIA 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 → 100Council 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 PMCPACommitment to self regulation
Sets out the roles of the PMCPA and MHRASelf regulation should be the first means of dealing with complaintsMHRA 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 managermore training – companies, individuals, third party agenciesmore complaints – largest group health professionalsmore voluntary admissionsmore use of sanctionsmore transparencymore independent members of the Appeal Boardmore complaints from employees/exemployees
Impact of 2006 ABPI CodeImpact of 2006 ABPI Code
HospitalityProvisions of giftsProvision of medical and educational goods and servicesWorking 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 proceduresanctionspublicationcharges
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 patientsone from a body that provides information on medicinesone 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.
CommunicationIncrease awareness amongst health professionals – Code Awareness DayPR activityGuide for Health Professionals updatedGuide for patients/public to be producedTraining
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