2. European Legislation – Directive 2001/83

1. European Legislation – Directive 2001/83

The overarching legislation regulating promotion of medicinal products in Europe is Directive 2001/83/EC, and therein in Articles 86 to 100 under ‘Title VIII, Advertising’ and Title VIIIa ‘Information and Advertising’. Due to the fact that the EU legislation is a directive and member states must incorporate its provisions into their national law, but are free in the legal formulation, there are significant differences between national jurisdictions (However, national authorities must ensure provisions are correctly applied and inform the Commission accordingly by a deadline) [1] . In some cases, regulatory authorities offer detailed guidance at a national level. [2]

For example, in France, advertisement for medicinal products to both, the general public or health professionals must be pre-approved by the ANSM (The National Agency for the Safety of Medicines and Health Products (L'Agence nationale de sécurité du médicament et des produits de santé)) (Public Health Code (PHC) Articles L.5122-8, 9, R.5122-5 to 7, 12 to 16). The approval document by the ANSM is called an advertisement “visa”. In contrast, advertising for medicinal products in Germany needs no approval in general or specifically. There is also no obligation in Germany to provide competent authorities with advertising material.

The advertising and promotion field of medicines is fragmented and open to interpretation in various aspects. A number of law firms offer insights and comparisons between different countries’ rules and their application. For the interested who wants to take a deep dive into this rather convoluted area, here are three possible entry points from the web (selected examples of comparisons are provided in Annex 1 for illustration):

CMS Expert Guide to advertising of medicines and medical devices
‘Provides high level information on life sciences and healthcare advertising in 27 jurisdictions and offers a quick and simple understanding of the applicable laws. The Expert Guide covers, amongst others, different types of advertising, regulatory aspects as well as legal consequences of non-compliance.’

https://cms.law/en/int/expert-guides/cms-expert-guide-to-advertising-of-medicines-and-medical-devices

The Legal500
‘The aim of this guide is to provide its readers with a pragmatic overview of the law and practice of pharmaceutical advertising law across a variety of jurisdictions.

Each chapter of this guide provides information about the current issues affecting pharmaceutical advertising in a particular country and addresses topics such as self-regulation, press releases, gifts, samples, grants or donations, anti-bribery rules, regulatory authorities and courts, as well as insight and opinion on the most common issues in their respective country.

The Q&A template for each chapter has been provided by Sally Shorthose of Bird & Bird.

2nd Edition | Published: December 2020. https://www.legal500.com/guides/guide/pharmaceutical-advertising/

Chambers Pharmaceutical Advertising 2021 

‘The new Pharmaceutical Advertising 2021 features 17 jurisdictions. The guide covers regulatory frameworks, advertising to the general public and healthcare professionals, transparency, inducement/anti-bribery and enforcement.’ Last Updated: March 04, 2021

https://practiceguides.chambers.com/practice-guides/pharmaceutical-advertising-2021

The following sections provide a closer view on the main content of the respective articles of the directive.



[1] Sources and scope of European Union law; →B. Secondary legislation of the European Union →; 3. The various types of EU secondary legislation; →b. Directives
https://www.europarl.europa.eu/factsheets/en/sheet/6/sources-and-scope-of-european-union-law