The industry's codes of practice
126. The industry has its own arrangements for regulating
the sales and marketing activities of its companies. This is largely
achieved through the Code of Practice of the ABPI.
The Medicines Act and related EU legislation requires Ministers
to exercise oversight of these activities. All aspects of the
promotion of medicines, including advertisements, representatives'
activities, meetings, the provision of education and hospitality
and the provision of medical information by the industry are subject
to self-regulation through the Code. The ABPI states that the
industry "works well within self-regulation".
127. The Code, first established in 1958 and since
revised several times, was drawn up in consultation with the BMA,
the Royal Pharmaceutical Society of Great Britain (RPSGB) and
the medicines regulator. Compliance with the Code is a requirement
for membership of the ABPI. A review of the Code, which began
public consultation on December 17th 2004, is currently underway
and is expected to conclude in November 2005.
128. The Proprietary Association of Great Britain
(PAGB, the trade association representing the manufacturers of
OTC medicines) covers promotion of OTC medicines. A condition
of membership of the PAGB is the pre-vetting of all material directed
129. The Prescription Medicines Code of Practice
Authority (PMCPA) was established by the ABPI to administer the
Code for the pharmaceutical industry at arm's length from the
ABPI itself. The Code covers the promotion of prescription-only
medicines to health professionals and other staff, and communication
with the general public.
There is no requirement for pre-vetting promotional material under
the ABPI Code. The PMCPA is responsible for providing advice,
guidance and training on the Code of Practice and it also handles
complaints regarding advertising materials.
130. Complaints submitted under the ABPI Code come
from three main sources: health professionals (30% in 2003); companies
(46%) and those nominally made by the Director of the PMCPA (17%).
In total, 131 complaints were received in 2003. Of the 122 cases
actually considered (some related to matters not subject to the
Code with no prima facie case and others were withdrawn),
97 (80%) were found in breach of the Code and 20% were not. Allegations
may be appealed; 31% of appeals succeeded in 2003.
Details are published in the PMCPA's quarterly reviews and are
expected to be made available on the Internet.
131. In each case in which a breach is ruled to have
occurred, the chief executive of the company concerned must give
an undertaking that the practice in question will cease forthwith,
and ensure "all possible steps have been taken to avoid a
similar breach in the future". This means materials have
to be recalled immediately and destroyed. The major sanction is
"the publication of comprehensive reports on all completed
cases in the Code of Practice Review", which may be picked
up by the medical and pharmaceutical press and occasionally the
132. Additional sanctions of the Appeal Board include
a requirement to recover items distributed in connection with
the promotion of a medicine and for the company to undergo an
audit of its procedures in relation to the Code of Practice (two
such audits occurred in 2003). In addition, the ABPI Board of
Management may make a public reprimand, demand an audit, publish
a corrective statement or suspend or expel the offender from the
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.
133. Gifts and hospitality are also covered by the
ABPI Code of Practice:
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
Hospitality can only be provided for persons
who qualify as proper delegates in their own right.
134. Promotional reminder gifts (pens, pads etc)
carrying a product name are permitted, up to the value of £6
and providing they are relevant to professional practice. The
ABPI's Code of Practice states that hospitality may be offered
only at a level that the recipient would be expected to pay him