European pharmaceutical law is being reformed. On April 26, 2023, the EU Commission adopted a proposal for a new directive to replace the Community code on medicinal products for human use and a new regulation amending the existing regulations in the field of pharmaceutical law. The draft directive 2023/ 0132 (COD) does not reinvent the wheel, but does contain some deviations from the previous legal situation - including in advertising law.
Background to the planned new regulation of advertising law
With regard to advertising law, the Commission is responding to two rulings of the European Court of Justice. Firstly, the concept of pharmaceutical advertising has been expanded. Secondly, the draft directive now expressly permits the distribution of free samples of OTC medicines to pharmacists. In addition, the regulations for comparative advertising are tightened, probably in order to put a stop to the advertising of originators as "not interchangeable" with biosimilars. In addition, the European definition of healthcare professionals has been expanded.
The draft stipulates that its advertising regulations are to take precedence over the Directive 2005/29/EC as lex specialis (134th recital).
Definition of medicinal product advertising
Article 175(1)(h) of the draft directive stipulates that the term "advertising of medicinal products" also includes advertising relating to medicinal products that does not refer to specific medicinal products. This expands the concept of advertising of medicinal products and now also covers product range advertising. This is the Commission's response to the judgment of the European Court of Justice of July 15, 2021, DocMorris, Case C-190/20. The ECJ ruled that advertising that is not aimed at a specific medicinal product but at the entire range of prescription medicinal products offered by a pharmacy does not fall within the scope of the provisions of Title VIII of Directive 2001/83/EC.
This was preceded by a submission by the German Federal Court of Justice on the interpretation of Section 7 para. 1 German Drug Advertising Act (“HWG”) (decision of February 20, 2020, ref.: I ZR 214/18, available in German only). Following the European Court of Justice, the German Federal Court of Justice ruled in the decision Gewinnspielwerbung II (decision of November 18, 2021, ref.: I ZR 214/18, available in German only) that the term "advertising for medicinal products" within the meaning of Section 1 para. 1 no. 1 HWG does not correspond to the term "advertising for medicinal products" within the meaning of Art. 86 para. 1 of Directive 2001/83/EC, but goes beyond this and also covers advertising for the entire product range of the pharmacy - there would be no full harmonization in the case of product range advertising. With the new regulation, the stricter national understanding of the German Federal Court of Justice would now be codified at the Union level and harmonization would be achieved in this respect.
Distribution of free samples of OTC drugs to pharmacists
Article 185 para. 2 of the draft directive provides that free samples of non-prescription medicinal products may, under certain conditions, exceptionally also be supplied to persons authorized to supply them. This would clarify that free samples of OTC medicines may also be dispensed to pharmacists. This is justified by the fact that this group of people should also be given the opportunity to familiarize themselves with new products at an early stage.
The new regulation would now explicitly codify the judgment of the European Court of Justice of June 11, 2020, ratiopharm, Case C-786/ 18 on free samples. In the opinion of the European Court of Justice, Article 96 (1) of Directive 2001/83/EC is to be interpreted as meaning that the provision does not permit pharmaceutical entrepreneurs to supply free samples of prescription-only medicinal products to pharmacists. On the other hand, this provision does not prevent the supply of free samples of non-prescription medicinal products to pharmacists. The ruling of the European Court of Justice was preceded by a referral from the German Federal Court of Justice (Decision dated October 31, 2018, Ref.: I ZR 235/16 – Apothekenmuster, available in German only). In the Apothekenmuster II decision, the German Federal Court of Justice then ruled - following the European Court of Justice - that Section 47 para. 3 AMG must be interpreted in conformity with EU law to the effect that (only) the provision of free samples of prescription medicines to pharmacists is impermissible (Federal Court of Justice, ruling of December 17, 2020, Ref.: I ZR 235/16, available in German only). The distribution of free samples of OTC medicines to pharmacists, on the other hand, is not precluded by Section 47 para. 3 of the German Medicines Act (“AMG”) (but may be impermissible under Section 7 para. 1 sentences 1 and 2 HWG).
Extension of the term
Furthermore, in Art. 175, 180 and 181 of the draft directive, the description of healthcare professionals is expanded to include persons qualified to administer medicinal products. This means that nursing staff would now also be included in the definition of healthcare professionals under European law. The extension is justified by the fact that persons who administer medicinal products - as well as persons authorized to prescribe and dispense medicinal products - are also in a position to correctly assess the information contained in advertising on the basis of their knowledge, training and experience.
Comparative advertising
Furthermore, the draft directive tightens the requirements for comparative advertising. Art. 176 of the draft directive provides that negative emphasis on another medicinal product is to be prohibited. Advertising which suggests that a medicinal product is safer or more effective than another medicinal product is also prohibited under Art. 176 of the draft directive - unless this is proven and substantiated in the summary of the medicinal product's characteristics (SmPC).
The 136th recital elucidates the purpose pursued with the tightening of comparative advertising. According to this, the prohibition of comparative advertising that cannot be substantiated on the basis of the summary of the product characteristics of the advertised medicinal product also explicitly applies to biosimilars. It is misleading to state in advertising for the originator that the biosimilar is not interchangeable with the originator or another biosimilar.
Conclusion
With the planned new regulations on the concept of pharmaceutical advertising and the distribution of free samples, the Commission is following two fundamental rulings of the European Court of Justice. The inclusion of nursing staff in the definition of healthcare professionals is to be welcomed. As a result, the narrow definition of healthcare professionals in Section 10 para. 1 HWG will probably have to be adapted. It will be exciting to see - provided that the draft is adopted as planned - how the courts interpret the stricter requirements in the area of comparative advertising in practice and how far the wording of the SmPC can still be deviated from in the case of comparative advertising.
