As highlighted in our recent series of blog posts (please see our Inside EU Life Sciences blog series here), the European Commission has at long last published its proposal to overhaul EU legislation for human medicinal products.
On 26 April 2023, the Commission published its proposal for a new human medicines directive (the “Proposed Directive”) to replace the current European Medicines Directive (Directive 2001/83/EC); as well as a regulation for centrally authorised medicines (the “Proposed Regulation”) to replace the current Regulation 726/2004.
Medicines advertising and promotion rules are of key interest to pharmaceutical companies operating in the EU. This blog looks into how the new legislative proposal might affect the advertising landscape, focusing on the Proposed Directive (whose advertising provisions also apply to products covered under the Proposed Regulation).
For those of you who are perhaps breathless from the suite of new proposals, advertising and promotion may appear to be one small area to exhale in relief. However, some of the proposed changes may have significant practical implications, particularly for comparative advertising.
The headline news is that – for advertising – the Proposed Directive largely maintains the status quo. It remains aligned almost entirely with the current framework, supplementing rather than revolutionizing current law.
The evolutionary approach is unsurprising. EU-level law is really only the “tip” of the proverbial “iceberg” when it comes to pharmaceutical advertising in Europe. Many operational rules are nationally diverse, and found in national laws, codes and rulings. Moreover, in practice, pharmaceuticals advertising is often largely governed and enforced through the self-regulatory system and self-regulatory codes, such as the Code of Practice of the European Federation of Pharmaceutical Industries and Associations (the “EFPIA Code”) and its various national incarnations. The Explanatory Memorandum to the Proposed Directive suggests legislators have tried to avoid overhauling the intricate framework regulating advertising. Nevertheless, the Proposed Directive does make some changes to advertising rules. Most are generally uncontroversial and/or “tidy ups”; but others may be more significant, particularly supplementing the definition of “advertising” and new provisions on comparative advertising.