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 - PowerPoint PPT Presentation

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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

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Title: 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


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
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!

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
Comprehensive Consultation Progress
  • 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
  • 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


                                                                                                                   
11
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

                                                                                                                   
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 ChangesPatient 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
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