What is self-regulation within the pharmaceutical industry?

Self-regulation is generally defined as an industry which regulates itself without intervention from an external body. It is a process whereby an industry-level organisation, such as a trade association, e.g. the Association of the British Pharmaceutical Industry (ABPI), as opposed to a government organisation, sets and enforces rules and standards, which compliment and often go beyond that of the law, to govern behaviours and uses 'self-policing' as the primary mechanism to ensure compliance and provide remediation.

The arrangements in the United Kingdom for the regulation of the promotion of medicines for prescribing and interactions with health professionals and other relevant decision makers are subject to two complementary systems of control: self-regulation by the pharmaceutical industry by means of the ABPI Code of Practice for the Pharmaceutical Industry which is administered by the PMCPA, and UK law. The Code also applies to a number of areas which are non-promotional including information made available to the public about prescription only medicines.

The advertising law is administered by the Medicines and Healthcare products Regulatory Agency (MHRA) on behalf of the UK Health Ministers. The control of medicines advertising in the UK is thus based on the long established system of self-regulation supported by the statutory role of the MHRA. The relationship between the MHRA, ABPI and PMCPA is set out in a memorandum of understanding which can be found on the PMCPA website.