Modern medical devices used in plastic surgery and aesthetic medicine now operate within an exceptionally complex regulatory environment. The issue no longer concerns only product safety itself, but above all the boundary between permissible information, advertising, and the legal architecture of digital communication platforms used by manufacturers in the life sciences sector.
Poland has for years represented one of the most restrictive approaches in Europe. That is precisely why the recent judgment of the Court of Justice of the European Union in Commission v Poland, delivered on 19 June 2025 in Case C-200/24, is so important. It does not only affect one domestic provisions. It forces us to revisit a broader question: where is the proper legal balance between public health protection, professional ethics, consumer information, and economic freedom in the pharmacy sector?
The Polish Ministry of Health has published an official announcement (January 30, 2026) in which it explains its interpretation regarding aesthetic and remedial medicine procedures (i.e. treatments such as Botox, hyaluronic acid, mesotherapy, lasers, etc.).
Since January 1, 2012, a complete ban on advertising pharmacies and pharmacy outlets has been in effect in Poland. Information limited to the location of a pharmacy or pharmacy outlet and its opening hours is not considered advertising. Consequently, this ban covers not only advertising the pharmacy itself but also advertising its activities. This regulation was introduced in Article 94a of the Pharmaceutical Law Act.
The justification for banning advertising of pharmacies and pharmacy outlets was the legislature’s assumption that pharmacies play a special role in the public health system, and therefore their operation should not be subject to mechanisms specific to the consumer goods market. It was argued that pharmacy advertising could lead to, among other things, excessive consumption of medicinal products, a weakening of the principles of rational pharmacotherapy, and an undesirable influence of economic factors on patient decisions.
Medicines resulting from research and development (R&D) activities include medicinal products developed through a multi-stage process of preclinical and clinical trials conducted to demonstrate their quality, safety, and efficacy. This process is lengthy, expensive, and fraught with a high risk of failure. It is financed by both private and public funds (according to research by Claudie Wild, Ozren Sehic, Louise Schmidt, and Daniel Fabian, “Public contributions to R&D of medical innovations: A framework for analysis,” 26 publications were identified, which found that half of all approved medicines and >90% of target medicines are linked to public sector institutions or their funding), including EU funds and national innovation support programs. From a pharmaceutical law perspective, R&D medicines are subject to specific regulatory requirements at all stages of the product lifecycle, from clinical trials to marketing authorization and pharmacovigilance. In this context, the proposed changes to EU pharmaceutical regulations, concerning data standardization and information transparency, constitute part of a broader regulatory framework for the functioning of the innovative medicines market. The research and development process is as follows:
