Forecast for 2025: on possible changes in health care law

And while it is impossible to predict all the surprises that the legislature may be preparing for us, it is already possible to list several important changes in the law, the likelihood of which seems to be particularly high in the coming months.

Pharmaceutical prescriptions and free drugs for seniors and children

The first major legislative process for the medical and pharmaceutical market this year is almost complete: the Act of December 5, 2024, amending the Act on health care services financed from public funds and certain other acts is now only awaiting the President's signature and publication. If the law is signed and published in the Journal of Laws, then it will enter into force within 14 days from the date of promulgation; this could happen as early as in the coming weeks.

This law is very important, first and foremost, for patients, as it introduces regulatory changes that should translate into increased access to medicines. These include changes to the prescribing rules for reimbursed drugs entitled free of charge to seniors and children, as well as to pharmaceutical prescriptions for vaccines. According to the amendment, patients over 65 or under 18 years of age will be entitled to free supply of selected reimbursed drugs on the basis of a prescription issued by an "authorized person" within the meaning of the Reimbursement Law; and not, as before, by a doctor or a nurse at the POZ. "Eligible person," as referred to in the provision amended by the amendment, is a person with the right to practice a medical profession who, under the regulations governing the practice of the medical profession in question, is authorized to issue prescriptions.

The second major change introduced by the December 5, 2024 law is an amendment to Article 96, paragraph 41 of the Pharmaceutical Law. It moves to allow pharmaceutical prescriptions to be issued for all immunological drugs used in recommended immunizations, not just for influenza vaccines; and it provides that such pharmaceutical prescriptions can be filled at a discount based on reimbursement, rather than exclusively at 100%.

Incidentally, it should be noted that there is currently no definition of a vaccine in Polish law; and the definition of an immunological product from the Pharmaceutical Law is quite vague. Therefore, on the occasion of the next amendment of this law, it is worth considering a clear and transparent definition of a vaccine; especially since we now have available drugs whose mechanism of action differs from traditional vaccines, but which are also used to induce immunity in patients. We can use here the proposed definition that is contained in the draft of the new pharmaceutical directive that would replace Directive 2001/83 (and which is part of the so-called pharmaceutical package). It is a definition broad enough to include various types of medicinal products intended for use to induce immunity against infectious diseases.

SNUR

The pharmaceutical market is eagerly awaiting another major law announced for adoption this year, namely another amendment to the Law on Reimbursement of Medicines, Foodstuffs for Special Dietary Purposes and Medical Devices. The amendment, commonly referred to as SNUR (as it was supposed to be a quick amendment), would primarily be aimed at reversing the negative effects of the previous major amendment (i.e. DNUR) on the reimbursement system.

Work on the SNUR appears to be well advanced at the Ministry of Health, as the Ministry presented very detailed assumptions of the law under preparation as early as six months ago at meetings with representatives of the pharmaceutical industry. According to the announcements, the finished draft was to be submitted for public consultation in the first quarter of this year, and thus would enter into force later this year. Will this be the case? We'll see, but undoubtedly a new law, removing errors and inaccuracies in the Reimbursement Act, is urgently needed.

Big revision of PF

We know from media reports that the Main Pharmaceutical Inspectorate is currently working on another major amendment to the Pharmaceutical Law. This is a law that is constantly changing, which is also due to the dynamic changes in the drug turnover market; and the amendment currently being prepared, according to media reports, is expected to focus on the issues of drug turnover and drug product safety in the broadest sense.

The amendment will certainly also include changes aimed at resolving the peculiar legislative stalemate associated with AdA 2.0, the 2023 amendment to the Pharmaceutical Law. That law was intended to seal the provisions of the Pharmaceutical Law introduced by a law called AdA ("Pharmacy for the Pharmacist"), preventing them from being circumvented by unauthorized entities acquiring control of pharmacies. However, due to the incompatible procedure of the amendment, which was not in accordance with the principles of correct legislation, the law called AdA 2.0 was declared unconstitutional and therefore invalid by the Constitutional Court; however, the verdict was issued by the Constitutional Court, which was composed by a judge appointed during the period of constitutional crisis. For this reason, the CT judgment was not published. As a result, it is unclear whether AdA 2.0 is valid if it was declared unconstitutional in a judgment that was not published and whose validity is debatable, since it was issued by a Court acting in a defective composition? But is AdA 2.0 not in force, due to irregularities in the enactment of the law? Undoubtedly, there is a big mess here that needs to be cleaned up urgently, which another amendment to the Pharmaceutical Law could help with.

Central electronic registration

In the List of Legislative and Programming Works of the Council of Ministers, we find mention of an interesting bill that would be adopted by the Council of Ministers later in the first quarter of 2025. It is about an amendment to the Law on Publicly Financed Health Care Services, which is to introduce a new centralized system of registration for health care services and ordering of their provision.

This is another project that is part of the process of progressive informatization in health care, which is already very advanced in Poland compared even to many European countries. As we read in the project description, it would be implemented in stages, gradually covering an increasingly broader catalog of health care services. In the first instance, central electronic registration would apply only to selected outpatient healthcare services; in 2025, these would include healthcare services provided under: cardiology, oncology and CT scanning, as well as healthcare services provided under the cervical cancer prevention program and the breast cancer prevention program.

Artificial intelligence law

It is worth mentioning that in the coming months we can also expect changes in regulations not strictly relevant to the healthcare industry, but nevertheless relevant to this market. For example, a draft law on artificial intelligence systems was released in October, which will be relevant to all entities using such systems in their professional activities.

The use of AI raises a number of legal problems, which are only partially solved by the EU Regulation (EU) 2024/1689 of the European Parliament and of the Council of June 13, 2024 on the establishment of harmonized rules on artificial intelligence - the so-called AI Act, which has been in force since last year. We expect further EU acts dealing with AI (for example, a directive on liability for the use of artificial intelligence systems). And a number of important issues related to the use of these technologies must be resolved at the local level, in individual EU member states. Hence, work is already underway in Poland on the adoption of a relevant law.

The October 15, 2024 draft is currently in the public consultation and approval stage.

PWP amendment

The List of Legislative and Programming Works of the Council of Ministers also announced a draft of a new Industrial Property Law, which would replace the current law, which has been amended several times. As the project description reads: "The purpose of the draft law is to regulate in a single legal act, in a transparent manner, institutions and procedures relating to industrial property protection, to propose new solutions enabling the protection of exclusive rights, to simplify and shorten proceedings, including shortening the time for granting protection. The draft is a response to numerous demands made by users of the industrial property protection system, i.e. entrepreneurs, representatives of business environment institutions and the scientific community."

The new law would respond to the economic challenges currently facing businesses, including the changes brought about by the Covid-19 virus outbreak. The bill is expected to place greater emphasis on technology and an efficient and rapid process for protecting it.

In conclusion, 2025 promises to be a time of intense and interesting changes in the laws governing health care and pharmacy in Poland. May they be, without exception, changes for the better, and changes that will not be the enemy of the good.

Author: attorney Katarzyna Czyzewska

Czyzewski law firm