POLAND Trends and Developments Contributed by: Marta Sroka-Maleta, Andrzej Siwiec, Katarzyna Kroner and Maciej Adamczyk, DBS Law Firm
For orphan medicines, the Multi-Criteria Decision Analysis (MCDA) is to be implemented as a part of the economic analysis during reimbursement pro- ceedings. By introducing the MCDA, the Ministry of Health aims to consider the non-cost criteria of these specific medicines more broadly. According to the schedule adopted by the Ministry of Health, the act is expected to be passed in the middle of the year. CJEU Ruling on Pharmacy Advertising and its Consequences for the Domestic Pharmacy Market Since 1 January 2012, the advertising of pharma- cies has been prohibited in Poland. This ban covers direct advertising and advertising of pharmacy activi- ties. Based on regulations, only information about the location and opening hours of a pharmacy does not constitute advertising. The ratio legis for introducing the ban is that pharmacies perform a special function in the healthcare system and their activities should not be subject to the mechanisms typical of the consumer goods market. Enforcement of the ban is entrusted to provincial pharmaceutical inspectors. These authorities have developed a very broad interpretation of the term “advertising”, covering not only classic promotional activities, but also informational communication. Pro- hibited advertising includes, for example, information about price reductions, loyalty programmes, preven- tative campaigns, or the use of slogans evaluating the activities of a pharmacy. A violation of this ban may result in a financial fine or a decision to cease the advertising. The advertising ban raised doubts as to its compli- ance with the constitutionally protected freedom of economic activity and the principle of proportionality. In 2013, the ban on advertising pharmacies was chal- lenged before the European Commission, which then brought an action against Poland before the CJEU in March 2024. On 19 June 2025, the CJEU issued a judgment in case C-200/24, ruling that the ban on advertising pharmacies and their activities in force in Poland is incompatible with EU law because:
• it restricts the ability of pharmacists working in pharmacies to advertise, while EU regulations allow all pharmacists to advertise regardless of their business activities; • it prevents anyone who intends to operate a phar- macy in Poland from informing potential customers about this, which is particularly disadvantageous for entrepreneurs based in a member state other than Poland; and • a total ban on advertising limits the ability of per- sons engaged in a given activity to present them- selves to potential customers and promote the services they intend to offer. The CJEU judgment has influenced the ruling of Polish administrative authorities and courts despite the lack of changes in Polish law, based on the principle of direct effect and the primacy of EU law. In particular, the Chief Pharmaceutical Inspector began to discon- tinue proceedings concerning violations of the ban on advertising pharmacies, and also annulled decisions of provincial inspectors to impose financial penalties. Due to the CJEU ruling, a draft act was prepared to align the advertising ban with EU regulations. It aims to allow advertising of pharmacies while introducing restrictions to prevent advertising that goes beyond the standard of objectivity and neutrality of advertising messages. The draft includes: • a definition of pharmacy advertising as an activity consisting of informing or encouraging patients to take advantage of a pharmacy’s offer to increase sales; • a ban on comparative advertising, understood as advertising that directly or indirectly identifies a competing pharmacy or products offered; • a ban on using the image of public figures, scien- tists, persons with medical education in advertis- ing, as well as persons suggesting that they have such education, and also the use of recommenda- tions of these persons; • a ban on advertising aimed at persons under the age of 18, containing elements aimed at this group of people or using their image or voice; and • a ban on advertising suggesting that failure to take advantage of a pharmacy’s offer will result in a deterioration or lack of improvement in health, and
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