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

New ABPI Code of Practice New ABPI Code of Practice What are the key messages in the What are the key messages in the

new Code?new Code?What difference will the new code What difference will the new code

make?make?

PDIG 8PDIG 8thth June 2006 June 2006

Martin Anderson

ABPI Director of NHS Policy & Partnerships

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

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

ABPI Code of Practice for thePharmaceutical Industry

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!

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

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

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

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

ABPI Code of Practice Review2004 /05

Key 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

Comprehensive Consultation Progress

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

Organisations approached by ABPI about consultation

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

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

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

Main Changes:Patient safety is being further promoted - all printed, promotional material to include prominent information about reporting ADRs

Further restrictions on what can be provided to health professionals in the way of promotional aids, hospitality, subsistence, travel, and accommodation

Relationships with patient groups and the provision of information to the public are covered in greater depth

Stronger sanctions

New Code Of Practice For Pharmaceutical New Code Of Practice For Pharmaceutical Industry Agreed In November 2005Industry Agreed In November 2005

Main changes to Code

Additional requirements re safety

Reduction in journal advertising for one product

Limits on the number of mailings

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

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

Main changes to Code

Increased transparency regarding interactions with

patient groups

More detail about information to the public

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

Main changes - Clause 19

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 selfregulation fails

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

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

What difference will it make?

Time will tell……….

But ALL need to play their part in making it work