with the 1998 Act. It should be noted that breach of
the Act could result in criminal penalties.
In the United States, federal legislation called the
Health Insurance Portability and Accountability
Act of 1996 (HIPAA) to make patient information
more strictly protected than before. Although most
pharmaceutical companies have limited access to
patient names and other health information, any
patient information must be carefully guarded to
avoid violation of HIPAA statutes, which address
the use anddisclosureofindividuals’ medical infor-
mation by ‘covered entities’, and set standards for
individuals’ rights to control the use of their med-
ical information. Violations can result in fines and/
or, in some instances, imprisonment.
46.8 Pharmaceutical industry
voluntary codesIn addition to the provisions of the UK Medicines
Act (1968), European Directives and other similar
mandates, the pharmaceutical industry also carries
out a measure of self-regulation through its indus-
try bodies. In the United Kingdom, for example,
the Association of the British Pharmaceutical
Industry (ABPI) is the trade association for around
100 companies in the United Kingdom producing
prescription medicines. The Association’s Code of
Practice for the Pharmaceutical Industry (‘the
Code’) is operated by the Prescription Medicines
Code of Practice Authority (PMCPA), which was
established by the ABPI as an independent author-
ity. The Code applies to the promotionto UK health
professionals and National Health Service man-
agers of medicines for prescribing, and to informa-
tion made available to the general public about
such medicines. It does not cover the promotion
of OTC medicines when the object is to encourage
purchase by the public.
Voluntary codes are not legally enforceable in
the sameway as a statute. However, it is a condition
of membership of the ABPI that the pharmaceuti-
cal companies abide by the Code. In addition, the
Code contains a number of sanctions that may be
imposed against member companies. Complaints
are made to the PMCPA, and if it is decided that
there has been a breach of the Code, the company
concerned has 10 working days to provide awritten
undertaking to discontinue the promotional activ-
ity in question, with an ‘administrative charge’
levied. The amount depends on the breach. There
are also other sanctions available to the PMCPA,
such as auditing the company in breach of its
procedures to comply with the Code or reporting
it to the Board of the ABPI, which has the authority
to publicly reprimand the company or revoke its
membership to the ABPI. All complaints and their
outcomes are reported in a quarterly review.
Some provisions of the Code are of particular
importance to pharmaceutical physicians. Clause
14, for example, requires that promotional material
be certified by two senior officials in the company,
one of whom must be a registered medical practi-
tioner. The other is usually a pharmacist. The pro-
motion must be certified to be in accordance with
the Code; it must confirm that the material is accu-
rate, balanced, fair, objective and unambiguous
and based on an up-to-date evaluation of all the
evidence and be in no way misleading. Certificate
renewal is required every two years.
The US equivalent is the Pharmaceutical
Research and Manufacturers of America
(PhRMA), a trade association founded in 1958.
PhRMA is a nonprofit scientific and professional
organization of more than 100 pharmaceutical man-
ufacturers. The Association promulgates voluntary
standards (‘Guiding Principles’) for producers,
encourages product research and prepares and dis-
seminatesinformation on behalfofthe industry. The
Association also publishes consumer-orientated
informational materials on drug utilisation. Volun-
tary standards proposed in 2005 include initiatives
regarding direct-to-consumer advertising of pre-
scription medicines, use of an electronic system to
track pharmaceuticals from the place of manufac-
ture to the place where dispensed, and broader dis-
semination of clinical study data.46.9 Conclusion
Caution and compliance are the bywords for
pharmaceutical physicians. He or she must be46.9 CONCLUSION 601