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The Prescription Medicines Code of Practice Authority (PMCPA) was
established by the Association of the British Pharmaceutical Industry
(ABPI) on 1 January, 1993 to operate the ABPI
Code of Practice for the Pharmaceutical Industry at arm's length
from the ABPI itself.
The Code of Practice for the Pharmaceutical Industry 2006
The Code of Practice has been regularly revised since its inception in 1958 and is drawn
up in consultation with the British Medical Association, the Royal Pharmaceutical
Society of Great Britain and the Medicines and Healthcare products Regulatory
Agency.
Compliance with the Code is obligatory for ABPI member companies
and, in addition, around sixty non-member companies have voluntarily
agreed to comply with the Code and to accept the jurisdiction of
the Authority.
The Code covers the promotion of medicines for prescribing to health
professionals and administrative staff and also covers information
made available to the general public about prescription only medicines.
The Code also applies to a number of areas which are non-promotional.
It does not apply to the promotion of over-the-counter medicines
to the general public. Nor does it cover the promotion of over-the-counter
medicines to health professionals when the object is to encourage
purchase by the general public.
The aim of the Code is to ensure that the promotion of medicines
to health professionals and to administrative staff is carried out
within a robust framework to support high quality patient care.
The Code also sets standards relating to the provision of information
about prescription only medicines to patients and the public as
well as relationships within patient groups.
The Code reflects and extends beyond the legal requirements controlling the
advertising of medicines.
Complaints
The Constitution and Procedure for the Prescription
Medicines Code of Practice Authority, which is included in the Code of Practice
booklet, provides details of the complaints procedure.
Complaints submitted under the Code are considered in the first instance by
the Code of Practice Panel which consists of the Director, Secretary and Deputy
Secretary of the Authority, acting with the assistance of independent expert
advisers where appropriate. Both the complainant and the respondent company
may appeal to the Code of Practice Appeal Board against rulings made by the
Panel. The Code of Practice Appeal Board is chaired by an independent legally
qualified chairman and includes independent members from outside the industry.
Details of its composition can be found in the Constitution and Procedure.
A
leaflet on the role of the PMCPA, the complaints procedure and
the charges associated with complaints has also been published.
Companies can be publicly
reprimanded and/or required to issue a Corrective
statement as sanctions under the Code.
Advertisements to communicate Clause 2 breaches
for activities or materials associated with promotion which have brought discredit
upon, or reduced confidence in, the pharmaceutical industry are
placed in the medical and pharmaceutical press.
Further Information
Information on the status of ongoing cases
is available, as are reports on completed
cases. Comments on matters of current concern are published
quarterly in the Code of Practice
Review.
The Prescription Medicines Code of Practice Authority publishes an annual
report which includes details of the work of the Authority,
the Code of Practice Panel and the Appeal Board.
Guidance
has been published to assist the complainant and the respondent
company when lodging an appeal or responding to one.
The Authority has issued Guidance
notes for health professionals and others to assist in understanding
the Code and its operation.
Seminars
designed to explain the requirements of the Code of Practice
are held by the Authority on a regular basis and are open to all.
A Memorandum
of Understanding setting out the arrangements for the regulation
of the promotion of medicines for prescribing has been agreed between
the Authority, the ABPI and the Medicines and Healthcare products
Regulatory Agency (MHRA). The MRHA administers UK law on behalf
of the Health Ministers.
The Authority and the ABPI has issued advice on written
agreements with patient groups.
The Authority also issues press
releases about ongoing news.
All publications are available from:
Prescription Medicines Code of Practice Authority
12 Whitehall
London SW1A 2DY
Tel: +44 (0)20 7930 9677
Fax: +44 (0)20 7930 4554 |