1 General – Medicinal Products
1.1 What laws and codes of practice govern the advertising of medicinal products in your jurisdiction?
On 31 January 2020, the UK left the EU although this was followed by a transition period, during which EU law continued to be applicable in the UK, unless otherwise provided by the European Union (Withdrawal Agreement) Act 2020. The transition period expired on 31 December 2020. EU legislation, as it applied to the UK on 31 December 2020 (either because it was derived from EU law or because before the end of the transition period it was directly applicable EU law), is now a part of UK domestic legislation. In addition, EU case law up until the end of the transition period is also retained EU law unless or until an appellate court in the UK departs from it.
The Medicines and Medical Devices Act, enacted on 11 February 2021, allows the Secretary of State to amend or supplement the existing UK regulatory framework for medicines, medical devices and veterinary medicines, with the result that deviation from EU law is now possible.
At present, the advertising of medicinal products in the UK continues to be controlled by a combination of legislation and codes of practice that derive from EU rules on pharmaceutical advertising and the European Federation of Pharmaceutical Industry Associations (EFPIA) Code of Practice.
The relevant regulatory provisions are mainly found in Part 14 of the Human Medicines Regulations 2012/1916 (the Regulations). The Medicines and Healthcare products Regulatory Agency (MHRA) supervises the advertising of medicinal products on behalf of the licensing authority. The Regulations are supplemented by guidelines published by the MHRA; principally, the Blue Guide – Advertising and Promotion of Medicines in the UK, updated in July 2019, and general guidance published on the MHRA website.
In addition to enforcement by the MHRA, most pharmaceutical companies operating in the UK agree to self-regulation in accordance with industry codes of practice, controlling the advertising of medicines and related activities. The Association of the British Pharmaceutical Industry Code of Practice (the ABPI Code), administered by the Prescription Medicines Code of Practice Authority (PMCPA), regulates the advertising of prescription-only medicines (POM); a revised version was agreed in January 2021 and is applicable from 1 July 2021. The ABPI Code is applicable to all companies who are members of the ABPI and all non-member companies who have agreed to be bound by its terms. The Proprietary Association of Great Britain (PAGB) Consumer Code regulates the advertising of over-the-counter medicines to the general public and the PAGB Professional Code regulates the advertising of over-the-counter medicines to persons qualified to prescribe or supply. The codes of practice repeat the law but, in several respects, go beyond the legal requirements. Companies who have not agreed to abide by the relevant codes of practice and the associated self-regulatory mechanisms are supervised directly by the MHRA.
Further to the controls which specifically relate to medicines, other general legislation, such as the Trade Descriptions Act 1968, may in principle be applicable. Commercial practices (including advertising) relating to consumer goods are subject to a series of laws on trading of consumer goods, including the Consumer Protection from Unfair Trading Regulations 2008 (business-to-consumer practices) and the Business Protection from Misleading Marketing Regulations 2008 (business-to-business practices). The MHRA works with the Advertising Standards Authority (ASA), the UK's independent regulator for general advertising across all media, and the Committee of Advertising Practice (CAP), the body responsible for writing and maintaining the UK Advertising Codes and providing authoritative advice on the rules, to maintain high and consistent standards.
1.2 How is "advertising" defined?
"Advertisement" is defined in regulation 7 of the Regulations, as "anything designed to promote the prescription, supply, sale or use" of a medicinal product. This is stated to include: doorto-door canvassing; visits by medical sales representatives to persons qualified to prescribe or supply medicinal products; the supply of samples; the provision of inducements to prescribe or supply medicinal products by the gift, offer or promise of any benefit or bonus, whether in money or in kind (except where the intrinsic value is minimal); the sponsorship of promotional meetings attended by persons qualified to prescribe or supply medicinal products; and the sponsorship of scientific congresses attended by persons qualified to prescribe or supply medicinal products, including payment of expenses.
The Regulations state that the definition of "advertisement" does not include: packaging; correspondence answering specific questions about a medicinal product (which may be accompanied by material of a non-promotional nature); and reference material and announcements of a factual and informative nature (including: (i) material relating to changes to a medicinal product's package or package leaflet; (ii) adverse reaction warnings; (iii) trade catalogues; and (iv) price lists), provided that no product claim is made.
The ABPI Code does not define "advertising", but uses the term "promotion". Promotion under the ABPI Code is stated to cover "any activity undertaken by a pharmaceutical company or with its authority which promotes the administration, consumption, prescription, purchase, recommendation, sale, supply or use of its medicines" (Clause 1.17 2021 ABPI Code). Certain activities are explicitly stated to fall within or to be excluded from the definition of promotion.
The Court of Justice of the European Union (CJEU) has clarified the definition of advertising and the persons subject to EU advertising rules. At present, these rulings still apply in the UK. In particular, Article 86(1) of Directive 2001/83/EC (the Directive), reflected in regulation 7(1) of the Regulations, provides a definition of advertising that focuses on the purpose of the message and the objective pursued, i.e. if the intention is to promote the prescription, supply, sale or consumption of medicinal products, it is advertising (C-316/09 MSD). It is not necessary for the message to be disseminated by a person linked to the manufacturer and/or seller of the medicinal product or to be disseminated in the context of commercial or industrial activity in order for it to be held to be advertising (C-421/07 Damgaard ). However, the prohibitions, for example, in relation to the provision of financial inducements, do not apply to national authorities pursuing public health policy, including any policy on the public expenditure on pharmaceuticals (C-62/09 ABPI).
The dissemination of information that is a faithful reproduction of the approved package leaflet or summary of product characteristics (SmPC) of a medicinal product is unlikely to be considered advertising, although the selection, manipulation or rewriting of any such information can likely be explained only by a promotional purpose (C-249/09 Novo Nordisk).
1.3 What arrangements are companies required to have in place to ensure compliance with the various laws and codes of practice on advertising, such as "sign off" of promotional copy requirements?
Companies who supply POMs and have agreed to abide by the ABPI Code should make sure that all relevant personnel involved in the promotion are appropriately trained on Code requirements. Although companies may have different internal procedures and guidelines for reviewing material, promotional material must not be issued unless its final form has been certified by a person on behalf of the company. This person must be different from the person responsible for developing the material.
Materials that will be printed can be certified in electronic form by a company signatory in the usual way; however, such material must not be used until the company signatory has checked and signed the item in its final printed form (in those circumstances, the material will have two certificates and both must be preserved). The signatory should be a registered medical practitioner or a pharmacist registered in the UK. UK-registered dentists may also certify promotional material if the product is for dental use only.
All promotional materials must be certified, regardless of format (e.g. printed, electronic, audio or audio-visual). The following materials must be certified in a similar manner (Clause 8.3 2021 ABPI Code): (i) educational material for the public or patients issued by companies that relates to disease or medicines, but is not intended as promotion for those medicines; (ii) material relating to working with patient organisations; (iii) material prepared in relation to Collaborative Working between the pharmaceutical industry; (iv) material relating to patient support programmes, healthcare organisations and others; (v) agreements for donations and grants; and (vi) protocols for non-interventional studies. Material that is still in use must be recertified at intervals of no more than two years. Certificates and accompanying material must be retained for at least three years after the final use of the material. There is no requirement to certify or examine meetings which involve travel outside the UK if the only involvement is sponsoring a speaker to present at a meeting and the pharmaceutical company has not participated in the arrangements for the meeting in any way.
Companies must have a scientific service to compile and collate all information (whether received from medical representatives or from any other source) about the medicines they market.
1.4 Are there any legal or code requirements for companies to have specific standard operating procedures (SOPs) governing advertising activities or to employ personnel with a specific role? If so, what aspects should those SOPs cover and what are the requirements regarding specific personnel?
There are no legal requirements for companies to have specific SOPs. The ABPI Code provides that each company should have a senior employee who is responsible for ensuring that the company meets the requirements of the Code. There is an assumption that this responsible person is the managing director or chief executive or equivalent unless other formal arrangements have been made within the company. In addition, the Regulations require marketing authorisation holders to establish a scientific service to compile and collate all information relating to the product. This legal requirement is mirrored by the ABPI Code.
1.5 Must advertising be approved in advance by a regulatory or industry authority before use? If so, what is the procedure for approval? Even if there is no requirement for prior approval in all cases, can the authorities require this in some circumstances?
The Regulations do not require the advance approval of advertising. However, the MHRA has the power under regulation 304 of the Regulations to issue a notice requiring any person concerned with the publication of advertisements relating to medicinal products to supply copies of advertisements prior to publication and not to use those advertisements until they have been approved. It is a criminal offence to fail to comply with such a notice. Circumstances in which pre-use vetting may be required include: (i) where a newly licensed product subject to intensive monitoring is placed on the market; (ii) where a product is a reclassified product; for example, from prescription-only to pharmacy; or (iii) where previous advertising for a product has breached the Regulations. Pre-use vetting may also be requested as a result of a major new indication for use or where there are safety concerns. In addition, the MHRA has committed to vet initial advertising for all new active substances.
The duration of the vetting is commonly two to three months, and does not normally extend for longer than six months. This period can be reduced or extended depending on the quality of the initial advertising material submitted and other relevant factors.
It is also open to companies to seek guidance from the MHRA on proposed advertisements or to request a meeting to discuss issues that arise during the vetting procedure.
The ABPI Code does not require any prior approval for the advertising of POMs, but again, guidance can be sought prior to publication. MHRA vetting does not guarantee compliance with the ABPI Code.
In the case of over-the-counter medicines, the PAGB Consumer Code requires prior approval. However, this requirement does not apply to advertisements aimed at persons qualified to prescribe or supply medicines, or their employers (caught by the PAGB Professional Code). The PAGB reviews all of their members' advertising to the public against their code of practice.
Originally Published by ICLG
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.