Codes of Conduct The International Pharmaceutical Regulatory

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Codes of ConductThe International
Pharmaceutical Regulatory Compliance Congress
and Best Practice Forum6 June 2007

• Heather Simmonds
• Director
• Prescription Medicines Code of Practice Authority
• www.pmcpa.org.uk

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Prescription Medicines Code of Practice Authority
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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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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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IFPMA CODE

• Established 1980s
• Updated
• Current version 2007
• Implementation
• Complaints mechanism
• Code Compliance Network

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EFPIA CODE

• Established 1992 ahead of EU Directive
• Updated 1993, 2004, 2008?
• Code on the promotion of medicines to and
  interactions with healthcare professionals
• Implementation
• Complaints mechanism via national
  associations
• EFPIA Code Committee
• Annual meeting to share experiences

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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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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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Advertising and Promotion of Medicines in the UK
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What has changed?

• Apart from the updated ABPI Code and
  Constitution and Procedure?
• Increased engagement
• New IFPMA Code, EFPIA Code being revised
• Health Select Committee
• MHRA prevetting NCEs
• Continuing media interest

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Impact of 2006 ABPI Code

• 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

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Areas that have caused discussion

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

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Constitution and Procedure

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

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Complaint to Prescription Medicines Code of
Practice Authority
Code of Practice Panel
Can report companies to Appeal Board
Complainant Advised of Ruling
Respondent Advised of Ruling
Accepted
Accepted
Appealed
Appealed
Code of Practice Appeal Board
Can report companies to ABPI Board
ABPI Board of Management
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• Chairman, independent, legally qualified
• Three independent medical members one general
  practitioner one hospital consultant
• Five other independent members one pharmacist
  
  one nurse prescriber
  
  one representative of the interests of
  patients one from a body that provides
  information on medicines one lay member
  
  
• Industry members 4 medical directors or
  equivalent 8 directors or senior executives

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• Rapid cessation of promotion.
• Publication of case reports.
• Recovery of items.
• Audit of companys 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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• 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