The year 2025 in legislation: a brief summary

However, 2025 was not one of the most tumultuous years in this regard; in fact, health care law did not undergo a revolution last year on a similar scale as, for example, in 2023 and 2024, when the successive amendments to the Drug Reimbursement Act, introduced by DNUR, the amendment of August 17, 2023, came into force. However, this does not mean that nothing interesting happened in health care law last year; on the contrary, several important things happened that have had or will have a significant impact on the overall regulation of health and pharmacy in Poland.

Pharmaceutical package

Noteworthy certainly are the upcoming changes in European Union law, which will directly translate into Polish regulations and procedures. We are, of course, talking about the so-called pharmaceutical package, i.e. the draft of a new EU directive that will replace the current Directive 2001/83/EC on the Community code relating to medicinal products for human use; as well as a new EU regulation that will replace Regulation 726/2004 establishing Community authorization procedures for medicinal products for human use.

Work on the new package of EU pharmaceutical regulations has been ongoing since at least 2023, and in the first half of 2025, representatives of the Polish Ministry of Health were particularly actively involved, due to the fact that Poland then assumed the presidency of the Council of the European Union. However, a significant step forward in the process of working out the new EU acts was when the Council and the European Commission reached an agreement on the content of the two drafts, which was publicly announced last December. The modified drafts of the new directive and regulation, which would take into account the recent changes introduced by the Council of the EU and the European Commission, have not yet been published, but the press announcement, published on the European Commission's website, shows, among other things, that the new directive will include a provision (Article 56a) granting EU member states the right to require manufacturers of medicines with regulatory protection (i.e., data or market exclusivity) to supply the market with medicines in sufficient quantities to meet patients' needs. Also to be amended is the Bolar exception, allowing manufacturers of replicable drugs to prepare for the entry of a generic into the market so that it is available to patients from the first day after the expiration of the original drug's patent protection; this preparation for market entry is to include, among other things, the right to bid in a public tender while the original drug's legal protection is still in force.

These and other changes in Community law, resulting in particular from the content of the new directive, will not immediately come into force in Poland, as EU directives must be implemented into national legal orders and do not apply directly. However, this does not apply to the new regulation, which, once it is finally enacted and enters into force, will also be directly applicable in Poland.

Deregulation in the area of health care

The year 2025 was to be the year of deregulation, including in health care. Two teams, a government team and a social team, the latter led by Rafał Brzoska, a well-known Polish entrepreneur, were working in parallel on simplifying procedures and eliminating administrative barriers to business. The work of this team also included the health care sector, so it seemed that among the several hundred changes submitted to the team there would be some that would significantly facilitate the activities of entrepreneurs operating in the medical and pharmaceutical markets.

Unfortunately, deregulation in health care turned out to be a big cloud from which a little rain fell, for the changes to the Pharmaceutical Law that did indeed come into effect were minor and spotty. For example, responsible entities were exempted from the obligation to report to the Integrated Monitoring System for the Circulation of Medicinal Products information about the planned place of delivery of medicines; and distribution of advertising samples of medicinal products became possible not only on the basis of written requests from persons authorized to prescribe, but also on the basis of requests made in documentary form (for example, sent by e-mail). These are, of course, important changes, but nevertheless their scale of impact on the conduct of business in the field of health care in Poland is very limited, and one could list a number of other issues that would require deep deregulation.

Pharmacy advertising

Last year, a topic that seemed to have been somewhat forgotten already, namely Poland's ban on pharmacy advertising, returned to public debate. Its introduction to the Pharmaceutical Law in its current form in 2012 caused great controversy due to the almost absolute nature of the ban; in fact, Article 94a of the Pharmaceutical Law is often interpreted very restrictively as meaning that any message about a pharmacy or pharmacy point, with the exception of information about the location and opening hours of the establishment in question, constitutes prohibited advertising.

In June of last year, there was a judgment of the Court of Justice of the European Union on this issue (Case C-200/24), in which Poland's ban on pharmacy advertising was found to be incompatible with EU law, primarily precisely because of its absolute nature. This means that Article 94a of the Pharmaceutical Law will have to be amended; and in fact, a draft amendment to the Pharmaceutical Law has already been drafted.

Announced on the website of the Government Legislation Center, the December 11, 2025 draft provides for replacing the current absolute ban on pharmacy advertising with a definition of such advertising and a catalog of prohibited forms of pharmacy advertising. According to the draft, the advertising of a pharmacy or pharmacy point is "the activity of: informing or encouraging the use of the offer of a pharmacy or pharmacy point, aimed at increasing sales of the assortment available in the pharmacy or pharmacy point, as well as the services provided therein and the benefits or programs provided therein"; while advertising of a pharmacy or pharmacy point will not be allowed:

1) consist in offering, directly or indirectly, any benefit in exchange for: the purchase of a medicinal product, medical device, foodstuff for special nutritional purposes or other assortment available at a pharmacy or pharmacy point, or in exchange for taking advantage of services, benefits or programs provided at a pharmacy or pharmacy point, or in exchange for providing evidence of taking advantage of this offer;

2) constitute comparative advertising within the meaning of Article 16(3) of the Anti-Unfair Competition Law of April 16, 1993;

3) bé directed to children and young people under 18 years of age, contain any element that is directed to them, or use their image or voice;

4) use the image or voice of publicly known persons, scientists, persons with medical training or suggesting that they have such training, or rely on referring to the recommendations of such persons;

5) contain content suggesting that there will be deterioration or lack of improvement in health if the offer is not taken;

6) be misleading, be worded in a way that may cause fear or pressure the patient to take advantage of the services, benefits offered at the pharmacy or pharmacy point or to purchase the product offered by it;

7) contain content that is inconsistent with the law or good morals;

8) violate professional secrecy or the rules of professional ethics and deontology binding on the pharmacist;

9) as part of the message contained therein, be combined with information that does not relate to the activities of the pharmacy or pharmacy point.

Undoubtedly, replacing the general ban on advertising pharmacies and pharmacy outlets with a catalog of specific forms of prohibited advertising is a step in the right direction, in line with the judgment of the EU Court of Justice. It is also right to introduce a definition of pharmacy advertising into the law, which will make it possible to distinguish ordinary information about a pharmacy from its advertising. However, it seems that the definition proposed in last December 11's draft is too general and may cause practical problems. Particularly problematic is the inclusion as advertising of a pharmacy ("Advertising of a pharmacy or pharmacy outlet is the activity of: informing or encouraging the use of the offer of a pharmacy or pharmacy outlet..."), because this does not solve the problem that has arisen under the current legislation, namely, what kind of information about a pharmacy constitutes its advertising. Is putting information on a pharmacy's website about the fact that it sells reimbursed medical devices its advertising? Or about the fact that one can be vaccinated at it?

The draft is still in the early stages of legislative work, so it may change significantly before the amendment to the Pharmaceutical Law enters into force; so perhaps the definition of advertising of pharmacies and pharmacy outlets will also change.

Pharmacy vaccinations

Last year can be considered a breakthrough year for pharmacists due to the dramatic increase in the scope of immunizations that can be performed in pharmacies. Our regulator has noticed and appreciated the role of pharmacies in the immunization system, as the first point of contact for many patients, especially in smaller towns. As a result of the regulatory changes adopted last year, getting vaccinated in pharmacies has become even easier and more accessible than before.

The changes primarily involved expanding the scope of pharmacists' authority to issue pharmaceutical prescriptions for vaccines (this is a change to Article 96 of the Pharmaceutical Law). The amendment to the law, which came into force on February 14 last year, stipulates that a pharmacist can issue a pharmaceutical prescription for any immunological product necessary for a recommended vaccination at the pharmacy, not just the one against influenza. What's more, after the amendment to the Pharmaceutical Law, this prescription can be issued with the patient's right to a price reduction based on reimbursement, and not, as before, only at 100%.

In addition, last year the Minister of Health issued two new announcements on the list of pharmacy immunizations that can be fully or partially publicly financed. An analogous announcement, effective from 2023, provided for the possibility of covering only vaccinations in selected age groups against Covid-19, influenza and pneumococcal disease with public funding. The latest list, from the Ministry of Health's December 23, 2025 announcement, already lists 18 recommended vaccinations carried out at the pharmacy, which can be fully or partially financed with public funds; and this applies to vaccinations in all adult patients (over 18 years of age).

The above changes mean that a patient will be able to obtain a pharmaceutical prescription for a vaccine in a single visit to a pharmacy, purchase it with the right to a reimbursement discount and obtain a vaccination, the cost of which can be covered in whole or in part by public funds.

In addition to the above and other legislative changes, there have been other events in 2025, undoubtedly important for the health care system in Poland; these include, in particular, personnel changes at the Ministry of Health (including the position of Minister of Health), or the hole in the budget of the National Health Fund, which has been the subject of much publicity in recent months.

And what awaits us in 2026? Legislatively, this year may again be interesting, if only because of the anticipated next major amendment to the Drug Reimbursement Act, or SNUR. On the other hand, based on the experience of recent years, it is safe to assume that 2026 will certainly still surprise us when it comes to pharmaceutical legislation; for health care law changes extremely frequently and dynamically. Let's hope these changes are only for the better.