Regulations on medicine advertising and promotion
The advertising and promotion of medicinal products in the UK is regulated by a combination of European and national legislation. The MHRA publishes a helpful "Blue Guide" on the advertising and promotion of medicines in the UK which explains the requirements of the relevant legislation, and provides additional clarification on the interpretation of the law and its application.
A system of self-regulation
The control of medicines advertising in the UK is primarily conducted on a self-regulatory basis by a range of industry bodies, supported by the statutory role of the MHRA.
The ABPI Code
The Association of the British Pharmaceutical Industry (ABPI) Code of Practice for the Pharmaceutical Industry (the “ABPI Code”) sets the standard for the promotion of prescription medicines to health professionals and appropriate administrative staff in the UK. The ABPI Code reflects the requirements of relevant UK and European laws, and in many cases goes beyond those requirements. All ABPI member companies are required to comply with the ABPI Code as a condition of membership. In addition, approximately 60 companies that are not members of the ABPI have agreed to abide by the ABPI Code in their promotional activities.
The ABPI Code is administered by the Prescription Medicines Code of Practice Authority (PMCPA), which operates independently of the ABPI. The PMCPA adjudicates on matters that are alleged to amount to a breach of the ABPI Code, and has the power to impose fines and a range of other sanctions in relation to breaches of the ABPI Code.
The PAGB Codes
The Proprietary Association of Great Britain (PAGB) is the self-regulatory body for the advertising and promotion of pharmacy medicines. The PAGB has a number of Medicines Advertising Codes including a code for advertising directed at persons qualified to prescribe or supply medicines and a code for advertising pharmacy medicines to the general public.
The ASA
The promotion and marketing of pharmaceuticals must also meet the standards set for all advertisements in the UK. The Advertising Standards Authority (ASA) is a self-regulatory body that administers the broadcast (BCAP) and non-broadcast (CAP) advertising codes.
What are the key rules?
There is a general prohibition on the advertising of prescription-only medicines to the public.
It is also prohibited to advertise unlicensed medicines. In limited circumstances some factual information can be disseminated before a licence is granted, such as the provision of pricing information to relevant administrative staff for the purposes of budget planning. In addition, the prohibition on advertising unlicensed medicines does not prevent the provision of a factual answer to an unsolicited question about an unlicensed medicine, provided the response is balanced and non-promotional in nature.
All advertisements for medicines must also comply with quality standards. For example, advertisements must:
- comply with the particulars listed in the summary of product characteristics;
- present the product objectively without exaggerating its properties and encourage the rational use of the product;
- not be misleading; and
- not state or imply that a product is "safe".
Advertisements for medicines directed to persons qualified to prescribe or supply must convey all the key information from the summary of product characteristics including the name and classification of the product, a list of the active ingredients, licensed indications, side-effects and contra-indications, and dosage and method of use.
If the advertisement is directed at treatment of a particular group of patients, for instance children, the advertisement should contain all the relevant information from the summary of product characteristics for that particular group.
Advertisements for medicines that are not prescription-only
The advertising to the public of pharmaceuticals classified as pharmacy or general sale medicines is permitted. Advertisements should not be directed exclusively or principally at children. Advertisements must:
- make it clear that it is an advertisement for a medicine and include the name of the product and, if there is only one, the name of the active ingredient;
- include the information necessary for the product’s correct use and a clear invitation to read the instructions on the packaging or in the packaging leaflet;
- not suggest that the effects of taking the product are guaranteed, are better than other identifiable treatments or that the product does not have any side-effects; and
- not refer to recommendations from scientists, healthcare professionals or celebrities who could encourage consumption of the medicine.
Claims that a product is "fast acting" or "provides 24 hour relief" must be substantiated with clinical data. Samples of products or vouchers which enable consumers to obtain the product for free or at an unreasonably low price are not permitted.
If you have any questions on this article or would like to propose a subject to be addressed by Synapse please contact us.
Paul England
Paul is a senior associate and professional support lawyer in the Patents group based in our London office.
"If the advertisement is directed at treatment of a particular group of patients, for instance children, the advertisement should contain all the relevant information from the summary of product characteristics for that particular group."