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

1. 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

2. Prescription Medicines Code of Practice Authority Heather Simmonds, Director Etta Logan, Secretary Jane 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. Prescription Medicines Code of Practice Authority

4. ABPI Code Established in 1958 Regularly updated Applies to member and non member companies Reflects and extends beyond UK law

5. 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

6. IFPMA CODE Established 1980s Updated Current version 2007 Implementation Complaints mechanism Code Compliance Network

7. 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

8. 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

9. LEGISLATION The Medicine (Advertising) Regulations 1994, as amended (1994 No. 1932) The Medicines (Monitoring of Advertising) Regulations 1994, as amended (1994 No. 1993)

10. 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.

11. 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

12. MHRA - The Blue Guide Advertising and Promotion of Medicines in the UK

13. 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

15. 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

17. 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

18. Constitution and Procedure Sets out how the Authority operates including: the complaints procedure sanctions publication charges

19. COMPLAINTS PROCEDURE 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 Appealed Appealed Accepted Code of Practice Appeal Board Canreport companies to ABPI Board ABPI Board of Management

20. CODE OF PRACTICE APPEAL BOARD • 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

21. 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.

24. Communication • Increase awareness amongst health professionals – Code Awareness Day • PR activity • Guide for Health Professionals updated • Guide for patients/public to be produced • Training

26. Publications

27. 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

28. Conclusion and Questions