The promotion of medicines and medical devices in the UK is regulated by several self-regulatory bodies and the MHRA. In this article, we aim to explain who these bodies are and how they fit together to ensure consumers are protected and standards are kept high.
The advertising of medicines is regulated through dedicated provisions of the Human Medicines Regulations 2012 and supplemented by helpful guidance published by the MHRA, most notably the Blue Guide, and industry codes of practice. The Blue Guide explains the requirements for promoting medicines and provides useful information on the regulatory landscape in the UK.
The advertising of medical devices is conversely not currently regulated through specific UK legislation and is only subject to the general laws relating to consumer advertising. However, we note that adverts in Northern Ireland are subject to the provisions of the EU MDR regarding misleading claims, by virtue of the terms of the Northern Ireland Protocol. Furthermore, the UK government is currently consulting on the future regulation of medical devices in the UK. The consultation proposals indicate that an equivalent prohibition on making misleading claims relating to medical devices may be introduced in the UK.
Medicine and medical device advertising in the UK is primarily controlled through a system of self-regulation by industry bodies. The statutory powers of the MHRA support these industry bodies and underpin the system.
Proprietary Association of Great Britain (PAGB)
The PAGB is the industry self-regulatory body for the advertising of branded over-the-counter (OTC) medicines, self-care medical devices, traditional herbal remedies and food supplements in the UK. The PAGB publishes a variety of codes of practice and guidelines which set out the requirements for adverts involving these products aimed at consumers and professionals.
These resources are the primary means of self-regulation. In addition, the PAGB offers a pre-publication copy clearance service to member companies. It is a condition of membership with PAGB that all OTC medicines adverts aimed at consumers are submitted to PAGB for screening and approval must be given prior to publication. The PAGB also offer advice on adverts aimed at professionals and regulatory consultancy services. Summary reports of formal advertising complaints decided by the PAGB are published online.
The Association of the British Pharmaceutical Industry (ABPI)
The ABPI Code of Practice for the Pharmaceutical Industry (ABPI Code) sets out the requirements for promotions of prescription medicines to healthcare professionals (HCPs) and other relevant decision makers in the UK. It also sets out in detail the standards for the provision of non-promotional information about prescription only medicines to the public and patients.
All ABPI members agree to abide by the Code as a condition of membership and non-members typically also volunteer to abide by the Code. Virtually all pharmaceutical companies operating in the UK are bound.
The Code is administered by the Prescription Medicines Code of Practice Authority (PMCPA), which operates independently from the ABPI. The PMCPA considers complaints under the Code and has the power to impose automatic fines (and other sanctions, including ordering audits to be conducted) for breaches. Reports on completed cases are published online alongside a list of ongoing cases.
Association of British HealthTech Industries (ABHI)
The equivalent of the ABPI Code but for the health technology community, the ABHI Code of Ethical Business Practice sets out minimum standards appropriate to various activities including advertising and promotions of medical devices aimed at HCPs. The ABHI Code is directly administered by the ABHI itself. The ABHI publish anonymised reports on decisions of the complaints committee. These are available on request.
Advertising Standards Authority (ASA)
The ASA is responsible for administering the UK non-broadcast advertising code (the CAP Code) and the UK broadcast advertising code (the BCAP Code). These codes apply to advertising across all forms of media and aim to ensure adverts are legal, decent, honest and truthful. The codes provide guidance and advice to industry and act as the key pillar of the self-regulatory system. The codes contain dedicated sections on medicines, medical devices and other related products.
The ASA investigate complaints about marketing communications to ensure compliance with the CAP and BCAP Codes. The ASA publishes its rulings online, acting as an effective deterrent due to the potential reputational damage of being publically named and shamed. In the case of serious breaches, the ASA can refer matters to Trading Standards. Trading Standards are able to commence court proceedings against advertisers to enforce consumer protection law and can ultimately impose fines for breaches. We note that advertising directed at HCPs is exempt from the CAP and BCAP Codes.
Statutory regulation – the MHRA
The MHRA conducts a range of different activities to control medicines advertising. These include vetting advertising prior to publication in certain circumstances, monitoring published advertising of medicines, handling complaints relating to advertising, and taking enforcement action.
Where the MHRA receive a complaint relating to medicines advertising directly, depending on the nature of the complaint, the MHRA may consider it appropriate to pass the complaint to the relevant self-regulatory body for investigation (such as the PMCPA or PAGB). The Blue Guide sets out in detail how the MHRA process complaints.
The MHRA publish reports of investigations into complaints monthly and in some circumstances issue statements regarding specific cases to highlight concerns and clarify industry good practice. While it has very broad powers to impose sanctions, the MHRA prefers to resolve complaints informally, usually requiring companies to issue corrective statements or amend advertising.
The MHRA is less involved in the regulation of advertising of medical devices; its principal role here is enforcement under the powers consolidated earlier this year by the Medicines and Medical Devices Act 2021.
Overall, the twin frameworks, self-regulatory and statutory, are viewed as complementary and there is a significant degree of cooperation between the MHRA and the different bodies to ensure high standards, transparency and consumer protection.