The marketing practices used by pharmaceutical companies have been a longstanding concern,12 with controversial techniques including the use of medical opinion leaders and third parties such as patient advocacy groups. In many jurisdictions, including Europe,3 Japan,4 Canada,5 and Australia,6 marketing by pharmaceutical companies is largely regulated by the industry itself, based on codes of practice drawn up by national industry trade groups. The UK has one of the most advanced and extensively studied self-regulatory systems in Europe78910 and globally (box 1).34
UK’s pharmaceutical industry self-regulation
Oversight of prescription drug marketing in the UK is delegated by the medicines and medical device regulator, the Medicines and Healthcare Products Regulatory Agency (MHRA), to the industry trade group, the Association of the British Pharmaceutical Industry (ABPI), and its self-regulatory body, the Prescription Medicines Code of Practice Authority (PMCPA).7 The PMCPA’s jurisdiction is accepted by virtually all drug companies operating in the UK, including about 70 ABPI members and over 60 non-members that follow the ABPI code voluntarily.11
PMCPA sanctions
Companies found to be in breach of the ABPI code are required to pay “administrative charges” to contribute to the costs of processing complaints.11 These charges, which are explicitly defined as not being fines, are typically £3500 but increase to £12 000 if an appeal against a ruling is unsuccessful.
In cases of more serious wrongdoing, the PMCPA can publicly reprimand a company or require it to issue a corrective statement. For both sanctions the company pays the cost of advertising these in medical (The BMJ), pharmaceutical (Pharmaceutical Journal), and nursing (Nursing Standard) publications.
The PMCPA can also request compulsory audit of a …
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