Enforcement of the rules on advertising and promotion of medicinal products
Enforcement of the rules on advertising and promotion of medicinal products

The following Life Sciences guidance note provides comprehensive and up to date legal information covering:

  • Enforcement of the rules on advertising and promotion of medicinal products
  • Introduction to the medicines advertising enforcement landscape
  • The Medicines and Healthcare products Regulatory Agency (MHRA)
  • Advertising Standards Authority (ASA) investigations
  • The Prescription Medicines Code of Practice Authority (PMCPA)
  • Proprietary Association of Great Britain (PAGB)
  • Anti-bribery

Introduction to the medicines advertising enforcement landscape

Directive 2001/83/EC on the Community code relating to medicinal products for human use (Pharmaceutical Code) establishes the rules on the advertising and promotion of medicinal products in the EU. It requires Member States to ensure that there are adequate and effective methods to monitor the advertising of medicinal products. Such methods must include legal provisions which allow persons or organisations regarded as having a legitimate interest in prohibiting any advertisement inconsistent with the Pharmaceutical Code to:Article 97 of Directive 2001/83/EC (consolidated version 28.01.2019), the Pharmaceutical Code

  1. take legal action against such advertisement, or

  2. bring such advertisement before an administrative authority competent either to decide on complaints or to initiate appropriate legal proceedings

In the UK, Part 14 of the Human Medicines Regulations 2012, SI 2012/1916 (HMRs) implement the Pharmaceutical Code’s rules on advertising of medicinal products. In particular, Chapter 3 of Part 14 of the HMRs contains the provisions for enforcing the requirements on the advertising of medicinal products contained within the HMRs. The statutory framework is supplemented by industry self-regulatory codes of conduct such as the Association of the British Pharmaceutical Industry (ABPI) Code of Practice for the Pharmaceutical Industry (ABPI Code), and associated enforcement by industry trade associations. See Practice Note: Advertising and promotion of medicinal products.Human Medicines Regulations 2012, SI 2012/1916, Pt 14ABPI Code of Practice for the Pharmaceutical Industry

Despite the availability of the statutory enforcement framework, the greatest enforcement action is seen at the self-regulatory level. This is in part due to numerous complaints brought by companies bringing the potential non-compliance of competitors to the attention of