Update to the European rules on advertising medicinal products

November 2025  |  SPECIAL REPORT: HEALTHCARE & LIFE SCIENCES

Financier Worldwide Magazine

November 2025 Issue

Advertising medicinal products is an important part of pharmaceutical companies’ activities. In the European Union (EU), this activity is strictly regulated by European and national law. The ongoing revision of the European general pharmaceutical legislation will soon modify those rules. This article explains the upcoming modifications.

European versus national

In the EU, advertising of medicinal products is regulated by articles 86 to 100 of Directive 2001/83/EC on medicinal products. Those articles, which set out the framework for advertising activities by pharmaceutical companies, have been transposed by all EU member states into their national law. This also applied to the UK as it had transposed the directive into national law and did not amend those rules following Brexit.

Many EU rules being general and vague, their national transposition was accompanied by a national implementation (more specific rules) and thus interpretation, which resulted in national divergences. The national divergences further increased through the application and enforcement of the national rules.

The Court of Justice of the European Union (CJEU) was asked to interpret European advertising rules in several cases, but those rulings were not sufficient to harmonise the divergent national rules. However, in the Gintec case, the court specified that national advertising rules may not be more restrictive than the EU rules unless the directive expressly gave that power to EU countries.

Overall, the general principles set out by the directive are the same throughout the EU. More specific and detailed rules, however, are not; hence, some issues remain governed by divergent national laws and communications designed for the EU market must be reviewed under the national law of each EU country where they will be used. In practice, companies tend to review EU communications under the national laws (and codes of practice) of the four biggest markets of the EU and the UK.

Besides the directive, advertising of medicinal products is regulated by the general rules on advertising such as Directive 2006/114/EC concerning misleading and comparative advertising and Directive 2005/29/EC concerning unfair business-to-consumer commercial practices. If advertising is made through digital platforms, Directive 2000/31/EC on electronic commerce also applies.

Advertising versus information

The EU and national advertising rules regulate the advertising of medicinal products but not information about medicinal products. While advertising is prohibited before approval of the medicinal product and then strictly regulated, information is neither prohibited nor regulated. It is thus essential for pharmaceutical companies to determine whether a communication is informational or promotional, especially prior to product authorisation.

Directive 2001/83 broadly defines ‘advertising’ as “any form of door-to-door information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products” and specifies activities that are considered as advertising, such as advertising of medicinal products to the general public as well as to the persons qualified to prescribe (doctors) or supply (pharmacists) them, provision of inducements to prescribe or supply medicinal products, and payment of transportation, accommodation and meals expenses (so-called ‘hospitality’) in connection with scientific meetings.

Certain communications are expressly considered as informational by the directive, such as labelling and accompanying package leaflets, answers to unsolicited questions and information relating to human health or diseases (provided that there is no direct or indirect reference to medicinal products). Other communications also qualify as information under national law, such as corporate communications (for example, communicating as milestones to investors).

For the other communications, the CJEU ruled that the distinction between promotional communication and informational communication lies with the intent of the author. This intent must be found in all relevant elements, such as the wording and layout of the communication, its purpose, the audience and the general context. The lawfulness of a communication thus must be assessed on a case by case basis.

Revision of the EU advertising rules

In 2023, the European Commission (EC) released two legislative proposals to revise the general pharmaceutical legislation, of which Directive 2001/83 is part. The proposals have already been reviewed and amended by the European Parliament and the Council of the European Union, so the legislative process is reaching its end.

A vote on the future EU general legislation is expected by the end of 2025 or beginning of 2026. The current proposals include a transitional period of three years so that the new rules will enter into force by the end of 2028 or beginning of 2029.

While the objectives of the revision do not relate to advertising, the proposal for a new directive (i.e., a directive to modify and replace Directive 2001/83) includes several modifications to the current advertising rules.

Under the new legal definition, advertising of medicinal products would include “any form of information, activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products”.

This would include in particular: (i) the advertising of medicinal products to the general public; (ii) advertising of medicinal products to persons qualified to prescribe, administer while providing healthcare or supply them (referred to as healthcare professionals); (iii) visits by medical sales representatives to healthcare professionals; (iv) the supply of samples of medicinal products free of charge; (v) the provision of inducements to prescribe or supply medicinal products by the gift, offer or promise of any benefit or bonus, whether in money or in kind, except when their intrinsic value is minimal; (vi) sponsorship of promotional meetings attended by healthcare professionals; (vii) sponsorship or any other form of financial contribution for scientific events, attended by healthcare professionals and in particular payment to the organising entity, of participants’ travelling, accommodation and catering expenses in connection therewith; and (viii) advertising related to medicinal products, that does not refer to specific medicinal products.

This new definition would broaden the concept of advertising. First, it would remove the terms ‘door to door’ and ‘canvassing’, thereby expanding the concept to any activity. Secondly, it would introduce the term ‘healthcare professionals’ that it would define as the “persons qualified to prescribe, administer while providing healthcare or supply [medicinal products]”. Persons other than healthcare professionals are considered the public. This would expand the scope to all professionals who, under national law, are authorised to administer medicinal products, such as nurses. Thirdly, advertising would no longer need to refer to a specific medicinal product – advertising for several medicinal products would also be covered. This new rule codifies the latest decision of the CJEU in the Euroaptieka case.

The definition would include the non-exhaustive list of advertising means, which are in essence the same as under the current definition, subject, however, to some adjustments or clarifications.

Denigrating advertising. Any form of advertising that aims to highlight negatively another medicinal product would be prohibited. This obligation is already imposed for all sectors by national rules on unfair trade practices. It also ties with the current trend in competition law to consider that a pharmaceutical company which conducts a large disparaging campaign of one or more competitive products, infringes competition law.

Along the same lines, a new recital would clarify that it is misleading to claim that a biosimilar medicinal product should not be interchangeable with the original biological medicinal product or another biosimilar from the same original biological medicinal product.

Comparative advertising. The future directive would include rules on comparative advertising that would play as lex specialis since comparative advertising is generally regulated by Directive 2006/114/EC.

Advertising which suggests that a medicinal product is safer or more effective than another medicinal product would be prohibited, unless a comparison of quality, safety and efficacy is supported objectively by a complete summary of product characteristics (SmPC).

This rule seems more stringent than for other types of advertising since the general rule is that advertisements must be consistent with the SmPC – they may include statements which are not expressis verbis in the SmPC, provided that those statements do not contradict or misrepresent the information in the SmPC.

Shortages. Prevention and mitigation of shortages are one of the big themes of the legislative revision. In that context, EU countries would be authorised to suspend the advertising of a medicinal product in case of shortages or risk of shortage of this medicinal product, provided that the suspension is withdrawn as soon as the shortage or risk of shortage ceases.

Powers of EU countries. Like Directive 2001/83, the future Directive 2006/114/EC would expressly authorise EU countries to sometimes adopt more restrictive rules. For example, EU countries would be able to ban advertising for ranges of medicinal products.

Are more changes coming? During the legislative process, the European Parliament proposed some rules that were not maintained by the Council. However, the three institutions are currently negotiating the latest amendments and, in that context, they may agree to reintroduce those changes.

The EU Parliament proposed that EU countries maintain a register for transfers of value made to healthcare professionals. Currently, such transfers of value (payment of fees for service, hospitality, etc.) must only be publicly reported in a few EU countries. While more and more EU countries legally mandate transparency (recently, in Italy), the revision could impose such transparency in all EU countries.

The EU Parliament also wanted to enable the EC to adopt specific requirements regarding advertising through social media and other media platforms and product placements by celebrities and influencers.

Conclusion

The upcoming changes to the current advertising rules focus on refining the existing framework and codifying CJEU case law. None is revolutionary, but EU countries will have to adapt their national legislation, and pharmaceutical companies will have to update their materials, training and practices.

 

Geneviève Michaux is a partner and Georgios Symeonidis is an associate at King & Spalding. Ms Michaux can be contacted on +32 2 898 0202 or by email: gmichaux@kslaw.com. Mr Symeonidis can be contacted on +32 2 898 0215 or by email: gsymeonidis@kslaw.com.

© Financier Worldwide

BY

Geneviève Michaux and Georgios Symeonidis

King & Spalding

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