1. Introduction

Introduction

Information on medicines is essential for patients and healthcare professionals. The public and the media are interested in information on new treatments and therapeutic innovations. Healthcare professionals need accurate, fair and objective information about medicinal products in a timely fashion, e.g., on the aims of the treatment, how it works, how to use it properly, the likelihood of benefit and harm, and how this medicine compares with other available treatment options or the option not to treat, as well as relative cost-effectiveness so that rational decisions can be made as to their use.

The main reason to have rules for advertising and promotion of medicinal products is to protect public health (this, of course, also applies to medical devices and will be covered in the new course on medical devices, which will be launched in 2022). Overconsumption and inappropriate use of medicines, e.g., beyond approved indications (off-label), choice of ineffective options, concomitant use of products that should not be combined, use by patients for whom there is no scientific evidence of benefit, excessive dosing, implies risks to patients. Risks may also arise through underuse, e.g., treatment failure or development of resistance caused by an inadequate dose or treatment duration, non-adherence to prescribed medication regimens. Many factors may contribute to inappropriate medicine use, including not only a lack of information but inaccurate and misleading promotional information. Promotion and advertising to patients and healthcare professionals should therefore be fair and correct (not misleading) in order to protect the public as well as professionals against these risks.  

In the interest of the concerned stakeholders, i.e., pharmaceutical companies, the public and healthcare professionals, advertising and promotion of medicinal products in the European Union (EU) is controlled by a combination of legislation and self-regulation through the relevant sections in industry codes of conduct:

  • The European Union (EU) via the European Commission (EC) and EU member states (MS) define legislations which regulate advertising and promotion regarding medicinal products.
  • The legal acts are complemented by said codes of conduct, mainly the European Federation of the Pharmaceutical Industry Association (EFPIA) Code of Practice (status 2021: the EFPIA Code 2019), which covers,among others, the promotion of medicines to healthcare professionals (HCPs) and patient organisations (POs). The EFPIA Code is designed to be implemented by its national member associations, and most national pharmaceutical industry associations have adopted their own codes of conduct based on the EFPIA code.
  • In addition, guidance is sometimes available at a national level from independent advertising bodies.[1]
  • In practice, the interpretation of the legislation and EFPIA guidance and other codes is determined at the national level. (see also lesson 3 on codes of conduct).
  • With the emergence of new forms of media (including social media), the legislators regularly need to revise existing provisions for advertising and to enact new laws. This also applies to respective codes of conduct by pharmaceutical industry associations. For example, online advertising is generally regulated under the same rules and controls as traditional advertising, although, in addition, various regulatory authorities’ legal or guidance provisions[2] and industry codes of practice[3] have been updated to add provisions specifically aimed at use of the internet by the industry, including the use of online platforms and social media.

This lesson provides details on the framework of the European legislation regarding the promotion and advertising of medicinal products. The legislation clearly differentiates between two audiences: the general public (including patients) and healthcare professionals.

Reflection question: Can you think of examples of indirect promotion/advertising of a medicinal product? 



[1] For example, the UK Advertising Codes by the Advertising Standards Authority (ASA)
https://www.asa.org.uk/codes-and-rulings/advertising-codes.html.

[2] Ethical Committee for the Pharmaceutical Industry in Denmark (ENLI), GUIDE regarding use of digital media in advertising activities
https://www.enli.dk/media/50000/uk-digital-medieguide-version-31-clean.pdf