New ABPI Code of Practice What are the key messages in the new Code? What difference will the new code make? PDIG 8 th

1. New ABPI Code of Practice What are the key messages in the new Code?What difference will the new code make?PDIG 8th June 2006 Martin Anderson ABPI Director of NHS Policy & Partnerships

2. ABPI Code of Practice for the Pharmaceutical Industry • Introduced in 1958, regularly updated • In consultation with BMA, RCN, RPSGB, MHRA • Members (and non members) ‘abide by the Code, in both the spirit and the letter’ • The Code is designed to prevent unethical and inappropriate practices

3. The Code Incorporates • IFPMA Code of Pharmaceutical Marketing Practices • EFPIA European Code of Practice for the Promotion of Medicines • European Directive on the Advertising of Medicinal Products for Human Use (Articles 86-100 of Directive 2001/83/EC • WHO Ethical Criteria for Medicinal Drug Promotion

4. The Code is administrated by the Prescription Medicines Code of Practice Authority (PMCPA) which is responsible for the provision of advice, guidance and training; as well as the complaints procedure. The Code reflects and extends well beyond the legal requirements controlling the advertising of medicines. ANYBODY can complain! ABPI Code of Practice for thePharmaceutical Industry

5. The Code covers: • Scope Clause 1 • Discrediting the industry Clause 2 • Marketing Authorisations Clause 3 • Prescribing information Clause 4 • Abbreviated advertisements Clause 5 • Information claims Clause 6

6. Disparaging references Clause 8 • High standards, suitability Clause 9 • Disguised promotion Clause 10 • Provision of reprints Clause 11 • Distribution of promotional material Clause 12

7. Scientific Service Clause 13 • Certification Clause 14 • Representatives Clause 15 • Training Clause 16 • Samples Clause 17

8. Gifts and Inducements Clause 18 • Hospitality and meetings Clause 19 • Relations with the Public Clause 20 • Internet Clause 21 • Compliance With Undertakings Clause 22

9. ABPI Code of Practice Review2004 /05Key objectives • Update Code in response to EU and UK reforms • Respond to public expectations of the industry • Demonstrate that self-regulation continues to work • Build public confidence in the safety of medicines

10. April 2004 – Review announced to ABPI members September 2004 Review Working Group established set up with 12 companies represented November 2004 Views of all member companies sought December 2004 Public consultation on Code of Practice opens January 2005 Market research with key stakeholders including patient advocacy April 2005 Feedback to ABPI Board of Management and ABPI May-July 2005 Proposals to companies and relevant ABPI committees Informal consultation with MHRA and others August-September 2005 Responses reviewed ABPI Board agrees proposals Formal consultation with ABPI member companies, non member companies, MHRA, BMA, RPSGB, RCN October 2005 Responses reviewed. ABPI Board agrees final proposals November 2005 Changes agreed by the ABPI January 2006 New Code and procedures come into operation Comprehensive Consultation Progress

11. Patient advocacy groups British Heart Foundation, Mind, CancerBACUP, Carers UK, Contact a Family, Diabetes UK, Hafal, Healthcare Coalition Initiative, Long-term Medical Conditions Alliance, Rethink, Asthma UK Scotland, Epilepsy Scotland, Diabetes UK Scotland Consumer groups Voluntary Health Scotland, Scottish Association for Mental Health, Citizens Advice, National Consumer Council , Which? Professional bodies Royal College of Physicians, National Pharmaceutical Association, NHS Alliance, Royal College of Physicians of Edinburgh, British Medical Association, British Medical Association Cymru Wales, British Dental Association, Royal College of Nursing, Royal College of Nursing (Scotland), NHS Confederation, NHS Confederation Wales,Royal College of General Practitioners, Royal College of General Practitioners Wales, Royal College of Surgeons of England, Royal College of Psychiatrists, Royal College of Psychiatrists (Scotland), Community Pharmacy Wales, Royal College of Physicians and Surgeons of Glasgow Miscellaneous Ask About Medicines Executive, Developing Patient Partnerships, Elsevier Ltd, The Kings Fund, Congrex Holding bv, The Lancet, Medicines Partnership, British Medical Journal Public sector Department of Trade and Industry, Department of Health, National Public Health Service for Wales, Health Protection Unit, Welsh Assembly Government, Scottish Executive, Scottish Executive Health Department, NHS Quality Improvement Scotland, Scottish Health Council, Tayside Health Board, Scottish Intercollegiate Guidelines Network, Scottish Medicines Consortium Regulators Nursing and Midwifery Council, Advertising Standards Authority, Medicines and Healthcare products Regulatory Agency, Health Professions Council, General Medical Council, General Osteopathic Council, General Chiropractic Council, Proprietary Association of Great Britain, National Patient Safety Agency, General Dental Council, Council for Healthcare Regulatory Excellence, Royal Pharmaceutical Society of Great Britain, Royal Pharmaceutical Society of Great Britain (Welsh Executive), Royal Pharmaceutical Society of Great Britain (Scottish Executive) Trade bodies National Union of Journalists, Institute of Public Relations, Healthcare Communications Association, Chartered Institute of Marketing Organisations approached by ABPI about consultation

12. Emerging themes from stakeholder research • Code needs to cover • All audiences with which the industry communicate • Including patients, patient advocacy groups, media, communication agencies, elected officials, government, think tanks, professional bodies, new prescribers • Issues around hospitality and gifts need to be reviewed • New Code should be widely communicated to all stakeholders • Sanctions should be strengthened to underpin Code and be seen to work

13. Emerging themes from industry responses • Organisational • Sanctions should increase • Code needs to be well publicised • Scope / content • Emphasis on behaviour as well as materials • New clauses to cover clinical trial databases; activities that result in therapeutic substitution or payments; partnering with NHS • Procedure • Faster, more transparent complaints and appeals process • Inter-company dialogue; also, mediation to be facilitated • Review of relationships between PMCPA/MHRA

14. Main Changes:Patient safety is being further promoted - all printed, promotional material to include prominent information about reporting ADRsFurther restrictions on what can be provided to health professionals in the way of promotional aids, hospitality, subsistence, travel, and accommodationRelationships with patient groups and the provision of information to the public are covered in greater depthStronger sanctions New Code Of Practice For Pharmaceutical Industry Agreed In November 2005

15. Main changes to Code • Additional requirements re safety • Reduction in journal advertising for one product • Limits on the number of mailings

16. Main changes to Code • Certain non promotional material to be certified • Pharmacists to certify certain promotional material in place of medical signatory • Promotional competitions no longer allowed

17. Main changes to Code • More requirements regarding medical & educational goods and services, acceptable promotional aids • More requirements about hospitality/subsistence. Delegates sponsored to attend meetings limited to economy air travel

18. Main changes to Code • Increased transparency regarding interactions with patient groups • More detail about information to the public

19. Main changes - Clause 19 Hospitality limited to subsistence (meals and drinks), accommodation, registration fees and reasonable travel costs Economy air travel only for delegates sponsored to attend meetings Lavish or deluxe venues not to be used. Companies should avoid using venues renowned for their entertainment facilities Additional guidance on holding meetings outside the UK

20. Memorandum of Understanding Agreed by the MHRA, ABPI and PMCPA Sets out the roles of the PMCPA and the 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

21. Sanctions • detailed case reports published for all cases • recovery of items • audit of company procedures, and pre-vetting • publishing corrective statements • public reprimand • suspension / expulsion from ABPI

22. Communications Plan • Increase awareness amongst health professionals • PR activity – launch and beyond • Communication manager to be appointed • Guide for health professionals to be updated • Guide for patients/public to be produced • Training

23. What difference will it make? • Time will tell………. • But ALL need to play their part in making it work