APPENDIX 6
Memorandum by the Prescription Medicines
Code of Practice Authority (PI 14)
SUMMARY
1. The importance the pharmaceutical industry
places on its relationships with health professionals and others
with regard to promotion and other activities is demonstrated
by The Association of the British Pharmaceutical Industry (ABPI)
Code of Practice for the Pharmaceutical Industry (current edition
2003) and the transparency of the complaints procedure. The ABPI
Code has the support of the Medicines and Healthcare products
Regulatory Agency (MHRA) and health professional organisations.
Many countries have used it as a model for their own codes. Companies
not in membership of the ABPI can agree to comply with it and
most do so. Health professionals are aware of the Code and submit
complaints as do pharmaceutical companies and others. The complaints
system gives equal status to the complainant and the respondent.
Both parties have the right to appeal and to attend appeal hearings.
Publication of virtually a complete record of the submissions
and rulings contributes significantly to effective self regulation
and is a powerful sanction.
INTRODUCTION
2. The PMCPA was established by the ABPI
to administer the ABPI Code of Practice for the Pharmaceutical
Industry[11]
independently of the ABPI itself. The PMCPA is also responsible
for providing advice, guidance and training on the Code. The PMCPA
is not part of the day to day management structure of the ABPI
and this is explained in Paragraph 26 below. The relationship
between the ABPI and the PMCPA is set out in a Protocol of Agreement.[12]
Neither the staff of the ABPI nor the ABPI Board of Management
play any role in relation to the consideration of complaints.
The ABPI Board has a role in relation to sanctions in serious
cases once the adjudications have been made and this is explained
in Paragraph 30 below. Unless additional sanctions are necessary
the first notification from the PMCPA of the outcome of complaints
is when consideration of the case is completed and the PMCPA circulates
to the ABPI Board draft case reports prior to their publication.
The PMCPA is regarded as a body that carries out a public law
function and is thus subject to judicial review.
3. The ABPI Code covers the promotion of
medicines for prescribing to health professionals and appropriate
administrative staff and also covers information about such medicines
made available to the general public. It also applies to a number
of non-promotional areas. The ABPI Code does not cover the promotion
of medicines for purchase by the general public; this is covered
by codes established by the Proprietary Association of Great Britain.[13]
4. The ABPI Code aims to ensure that the
promotion of medicines is carried out in a responsible, ethical
and professional manner. It seeks to achieve a balance between
the needs of patients, industry, health professionals and the
general public. The ABPI Code is drawn up in consultation with
the British Medical Association (BMA), the Royal Pharmaceutical
Society of Great Britain (RPSGB) and the MHRA. The ABPI Code has
been regularly revised since its inception in 1958, currently
a new edition is agreed approximately every two years. The ongoing
review of the Code and its operation will take into account a
current European wide review of codes of practice and the conclusions
of the Health Select Committee Inquiry.
5. Compliance with the ABPI Code is a condition
of membership of the ABPI. About 60 companies which are not members
of the ABPI have also agreed to comply with it. The ABPI Code
thus covers most of the relevant companies in the UK.
6. The ABPI Code reflects, extends and provides
detailed guidance above and beyond the UK legal requirements,
which were first introduced in the Medicines Act 1968. The UK
legal requirements are now based primarily on a European Directive.[14]
The European Directive and UK law allow for voluntary control
by self regulatory bodies and recourse to such bodies in addition
to statutory control. The MHRA's stated view is that the control
of medicines advertising is based on the long established system
of self regulation which it sees as working successfully in the
UK and that the statutory powers are to underpin and support self
regulation, providing a means of enforcement should self regulation
fail.[15]
The role of the MHRA is restricted to the administration of UK
law which covers the promotion of medicines for prescribing and
the promotion of medicines for purchase by the general public.
The MHRA occasionally forwards complaints to the PMCPA for consideration
under the ABPI Code.
THE PROVISION
OF DRUG
INFORMATION AND
PROMOTION
7. The ABPI Code applies to the activities
of pharmaceutical companies and covers promotion in whatever form,
whether it be printed, verbal or electronic as set out in Clause
1.2 which defines promotion as any activity undertaken by a pharmaceutical
company or with its authority which promotes the prescription,
supply, sale or administration of its medicines. Exemptions are
also set out in Clause 1.2 and include those in the European Directive.
The Code of Practice booklet includes supplementary information
giving guidance on interpretation of the Code, guidelines on company
procedures which represent good practice, and the Constitution
and Procedure for the PMCPA, which sets out how the Code is operated
together with the sanctions.
8. Pharmaceutical companies are required
by Clause 7.1 of the Code to promptly provide health professionals
and appropriate administrative staff upon reasonable request with
accurate and relevant information about the products they market.
9. Clause 3 states that medicines cannot
be promoted before they have been granted a marketing authorisation
which permits their sale or supply and that promotion must not
be inconsistent with the summary of product characteristics (SPC).
Clause 7.2 requires information, claims and comparisons to be
accurate, balanced, fair, objective and unambiguous and based
on an up-to-date evaluation of the evidence and reflect that evidence
clearly. Material must not mislead either directly or by implication.
Material must be capable of substantiation and substantiation
must be provided on request from a health professional or appropriate
administrative staff unless the request relates to the validity
of the indications approved in the marketing authorisation (Clauses
7.4 and 7.5). When material refers to published studies references
have to be cited (Clause 7.6). Data on file when used as a reference
has to be supplied on request (Clause 7.7). Artwork including
graphs and tables must comply with the Code (Clause 7.8). It must
not be stated that a product has no side effects, toxic hazards
or risks of addiction. The word safe cannot be used without qualification
(Clause 7.9). There are restrictions on the use of the words "the",
"unique" and "new" (Clauses 7.10 and 7.11).
10. Prescribing information (a succinct
summary of relevant information in the SPC together with the cost
and legal classification) in accordance with Clause 4.2 must be
provided in all promotional material unless the material is an
abbreviated advertisement (Clause 5) which is an advertisement
limited in size, content and use, or the item is a promotional
aid as described in Clause 18. The non-proprietary name has to
appear immediately adjacent to the most prominent display of the
brand name in a specified size (Clause 4.3). The Code limits journal
advertising such that no journal advertisement can be more than
three pages long and no issue of a journal may bear advertising
for any one product on more than three pages, including inserts
(Clause 6).
11. Extremes of format, size or cost must
be avoided (Clause 9.7) and promotional material should only be
distributed to those persons whose interest in the material can
reasonably be assumed (Clause 12.1).
12. Clause 15 sets out the requirements
for representatives, including that they must maintain a high
standard of ethical conduct. The Code applies to what representatives
say and do as well the materials they use. The Code prohibits
the use of any inducement or subterfuge to gain an interview.
No fee should be paid or offered for the grant of an interview.
There are limits on the frequency of visits by one representative
to an individual doctor. Representatives have to inform their
companies about any information received which relates to the
use of the medicines they promote and must carry or have available
the relevant SPCs. Companies must prepare detailed briefing material
for representatives on the technical aspects of their medicines
and how they are to be promoted. This material is requested by
the PMCPA when a complaint is made about what a representative
has said.
13. Clause 16 sets out the training requirements.
All relevant personnel must be fully conversant with the requirements
of the Code and representatives must pass an examination within
two years of commencing such employment.
14. A sample is defined in Clause 17 as
a small supply of a medicine for the purpose of familiarisation
and acquiring experience. The provision of samples is limited
to no more than 10 samples per year per product per health professional
qualified to prescribe the product. Samples can only be supplied
in response to a signed and dated written request. Companies have
to comply with individual hospital arrangements and have systems
of control and accountability.
15. Clause 18 prohibits the provision or
offer of any gift, benefit in kind or pecuniary advantage as an
inducement to prescribe, supply, administer, recommend or buy
any medicine apart from promotional aids and competition prizes.
Promotional aids must be inexpensive, cost the company no more
than £6 plus VAT, and be relevant to the recipient's profession
or employment. Competitions must be a genuine test of skill and
prizes must be few in number, relevant to the recipient's profession
and each cost no more than £100 plus VAT. The ABPI Code permits
the provision of medical and educational goods and services to
enhance patient care or benefit the NHS but these must not be
an inducement to prescribe, supply, administer, recommend or buy
any medicine. Detailed guidance is given in the supplementary
information to Clause 18.1.
16. Clause 19 covers meetings and hospitality.
All meetings, including sponsorship of scientific meetings and
payment of travelling and accommodation expenses in connection
with such meetings, are covered. Hospitality must only be provided
in association with scientific meetings, promotional meetings,
scientific congresses and other such meetings. It must be secondary
to the purpose of the meeting and the level must be appropriate,
with the cost not exceeding that which the recipients would normally
adopt when paying for themselves. Hospitality can only be provided
for persons who qualify as proper delegates in their own right.
17. When meetings are sponsored by pharmaceutical
companies this must be disclosed in all the papers relating to
the meeting (Clause 19.3). Material relating to medicines and
their uses, whether promotional or not, which is sponsored by
a pharmaceutical company must clearly indicate that it has been
sponsored by that company. There is an exemption for market research
which needs to state that it is sponsored by a pharmaceutical
company (Clause 9.10).
18. Companies are required to formally certify
promotional material in its final form before it is issued, as
set out in Clause 14. Companies are also required to certify all
meetings which involve travel outside the UK. Certification is
undertaken by two nominated signatories, one of whom must be a
registered medical practitioner and the other must be some other
appropriately qualified person, often a pharmacist. The names
of the signatories have to be provided in advance to the PMCPA
and the MHRA. The certificate for promotional material must certify
that the signatories have examined the material in its final form
and that in their belief it is in accordance with the Code and
the relevant advertising regulations and it is not inconsistent
with the marketing authorisation and the SPC. Companies are advised
to examine non-promotional material, such as press releases, market
research, financial information for share holders, the stock exchange
and the like to ensure that it is non-promotional. The use to
which an item will be put is also an important consideration.
Certificates and other details have to be preserved for not less
than three years after final use of the material and be produced
on request from the PMCPA and/or MHRA.
19. In addition to the clauses mentioned
above, there are requirements that high standards must be maintained
at all times and that material and activities must recognise the
special nature of medicines, the professional nature of the audience
and must not be likely to cause offence (Clauses 9.1 and 9.2).
Clause 2 of the Code is used as a sign of particular censure.
It states that activities or materials associated with promotion
must never be such as to bring discredit upon or reduce confidence
in the pharmaceutical industry. Any breach of the Code is seen
as a serious matter, but a breach of Clause 2 is seen as a particularly
serious matter.
PROFESSIONAL AND
PATIENT EDUCATION
20. If education for health professionals
is promotional in nature then it is clearly covered by the Code.
The legitimate exchange of medical and scientific information
during the development of a medicine is not prohibited, provided
such activity is not promotional (Clause 3).
21. Patient education is covered by Clause
20 which deals with relations with the general public.
22. Medicines must not be advertised to
the general public if they are prescription only medicines or
may not legally be advertised to the public. There is an exemption
for vaccination campaigns approved by the Health Ministers. Companies
can provide information both to patients and to the public provided
it meets the requirements of Clause 20.2. Information must be
factual, presented in a balanced way and must not raise unfounded
hopes of successful treatment or be misleading with respect to
safety of a medicine. Statements must not be made for the purpose
of encouraging members of the public to ask their doctors to prescribe
a specific medicine. European public assessment reports, SPCs,
and package leaflets may be provided to members of the public
on request and may be made available on websites. Companies can
also provide materials about a medicine to patients who have already
been prescribed that medicine, provided that such material is
factual and non-promotional. Companies may conduct disease awareness
or public health campaigns provided the purpose is to encourage
members of the public to seek treatment for their symptoms while
in no way promoting the use of a specific medicine. Particular
care needs to be taken where a company's product, even though
not named, is the only medicine relevant to the disease or symptom.
23. The Code also covers the Internet. Sites
that are open access, ie available to all, must comply with Clause
20 of the Code ie no promotion of prescription only medicines
to the general public. Websites with access restricted to health
professionals may include advertising that complies with the Code.
THE CONDUCT
OF MEDICAL
RESEARCH
24. Clinical research is comprehensively
covered by law. The only relevant requirement in the Code is Clause
10 that clinical research and the like must not be disguised promotion.
ADDITIONAL POINTS
Source and outcome of complaints
25. Complaints submitted under the ABPI
Code come from three main sources: health professionals (40 (30%)
of the 131 complaints received in 2003); companies (46% of complaints
received in 2003) and those nominally made by the Director of
the PMCPA (17% of complaints received in 2003). The Director takes
up public criticisms of the industry such as published articles
and the like. Companies occasionally make voluntary admissions
to the PMCPA and anonymous complaints are considered. The 131
complaints received in 2003 led to 122 cases for consideration,
some complaints related to matters not subject to the Code (no
prima facie case) and others were withdrawn. Of the 122 cases
considered in 2003, 97 (80%) were found in breach of the Code
and 20% were found not to be in breach. Cases often consist of
more than one allegation. In 2003, 366 allegations were considered
with 208 (57%) ruled in breach and 43% ruled not in breach. In
2003, of the 65 rulings appealed 45 (69%) were unsuccessfully
appealed and 20 (31%) were successfully appealed. Comprehensive
information is published in the PMCPA Annual Report.[16]
The PMCPA also carries out a regular scrutiny of advertisements
and raises matters with companies which are usually settled without
recourse to a formal complaint.
CONSTITUTION AND
PROCEDURE
26. Complaints are first considered by the
Code of Practice Panel, which consists of the Director of the
Authority, Heather Simmonds (pharmacologist), the Secretary, Etta
Logan (solicitor) and the Deputy Secretary, Jane Landles (pharmacist).
The PMCPA is appointed by and reports to the ABPI Board of Management
but it is not part of the day to day management structure of the
ABPI. The Director of the PMCPA reports to the Code of Practice
Appeal Board for guidance on the interpretation of the Code and
the operation of the complaints procedure and to the President
of the ABPI for administrative purposes.
27. The Panel considers each case on written
evidence only and has access to expert assistance such as a medical
opinion. The parties are provided with full details including
the outcome. Both the complainant and the respondent can appeal
the Panel's rulings to the Code of Practice Appeal Board; both
see all relevant submissions and are entitled to attend or be
represented at an appeal. Appeals can however be on the basis
of written documents only. The Appeal Board has two roles, to
hear appeals and to supervise the activities of the Panel. The
Appeal Board is made up of 19 members including an independent
legally qualified Chairman, Mr Nicholas Browne QC. In addition
there are six other independent members: three medically qualified;
one a pharmacist; one representative of the interest of patients
and one from an independent body involved in providing information
on medicines. All independent members are appointed in consultation
with the MHRA and, in addition, the BMA for the medical members
and the RPSGB for the pharmacist member. The remaining 12 members
are from pharmaceutical companies, four medical directors or equivalent
and eight senior executives. All members of the Appeal Board are
appointed by the ABPI Board of Management. The Appeal Board also
receives details of all cases completed at the Panel level.
SANCTIONS
28. In each case where a breach is ruled,
the chief executive of the company concerned must give an undertaking
that the practice in question will cease forthwith, if it has
not already ceased, and that all possible steps have been taken
to avoid a similar breach in the future. This means that materials
have to be recalled immediately and destroyed. Companies cannot
wait until replacement material is available. Companies are required
to comply with undertakings given (Clause 22). The major sanction
is the publication of comprehensive reports on all completed cases
in the Code of Practice Review[17]
which is published quarterly, widely circulated and freely available
to all. The medical and pharmaceutical press frequently publish
details of cases and occasionally details appear in the national
press. Additional sanctions are imposed in serious cases.
29. The additional sanctions available to
the Appeal Board include a requirement to recover items given
in connection with the promotion of a medicine and a requirement
for a company to undergo an audit of its procedures in relation
to the Code, together with the ability to impose requirements
on the company concerned to improve its procedures. The Appeal
Board rarely requires recovery of items ruled in breach, although
this sanction has recently been used in relation to a complaint
made in 2003. Two of the complaints received in 2003 were the
subject of an audit. This involves the Director of the PMCPA and
either the Secretary or Deputy Secretary conducting an in depth
analysis of the company's procedures for complying with all aspects
of the Code including interviews with the chief executive, medical
director, registered signatories and other employees, including
a representative. A detailed report with recommendations is considered
by the Appeal Board which can require a reaudit to check that
the recommendations are implemented.
30. The additional sanctions available to
the ABPI Board of Management include a public reprimand, audit
(as for the Appeal Board), publication of a corrective statement
and suspension or expulsion from the ABPI, or, for a company not
a member of the ABPI, to advise the MHRA that responsibility for
that company under the Code can no longer continue to be accepted.
A public reprimand takes the form of an article on the front page
of the Code of Practice Review and is often reported by the medical
and pharmaceutical press. Arising from the complaints considered
in 2003 one company was publicly reprimanded. It is more usual
for audits to be required by the Appeal Board, although in 2003
the ABPI Board of Management required a company to undergo a reaudit
in relation to a complaint considered in 2002, the initial audit
having taken place in 2002. The ABPI Board has never required
a company to publish a corrective statement nor has a company
been expelled from membership of the ABPI. Companies have been
suspended from membership of the ABPI, but this sanction has not
been used since 1993. Two companies have been removed over time
from the list of non-member companies complying with the Code.
FINANCES OF
THE AUTHORITY
31. Administrative charges are paid by pharmaceutical
companies ruled in breach of the Code and companies which make
unsuccessful complaints. The charges are £1,250 per matter
if a case is settled at the Panel level and £5,000 per matter
if an appeal is unsuccessful. No charges are paid by complainants
outside the pharmaceutical industry. Administrative charges are
not regarded as being fines.
32. The PMCPA is self financing with its
income coming from an annual Code of Practice Levy paid directly
to the PMCPA by members of the ABPI, administrative charges and
charges for attending seminars on the Code. Further details appear
in the Annual Report and the Protocol of Agreement.
11 ABPI Code of Practice for the Pharmaceutical Industry
2003 Edition. Available from the PMCPA, 12 Whitehall, London,
SW1A 2DY (www.pmcpa.org.uk). Back
12
Protocol of Agreement between the Prescription Medicines Code
of Practice Authority and The Association of the British Pharmaceutical
Industry. Available from the PMCPA. Back
13
Proprietary Association of Great Britain. Vernon House, Sicilian
Avenue, London, WC1A 2QS (www.pagb.co.uk). Back
14
European Directive 2001/83/EC on the Community Code relating
to medicinal products for human use, as amended. Back
15
MAIL 130 March/April 2002. Available from the MHRA (www.mhra.gov.uk). Back
16
Prescription Medicines Code of Practice Authority Annual Report
2003. Available from the PMCPA. Back
17
Code of Practice Review. Published quarterly and available from
the PMCPA. Back
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