Forecast for 2024: what changes in the law may await the pharmaceutical industry?

On the other hand, it is much more difficult to guess what new legislation governing health care in Poland awaits us in 2024; primarily because it is not uncommon for drafts of important laws to appear quite unexpectedly on the pages of the Government Legislation Center. Nevertheless, it is already possible to point to several areas that will be subject to legislative changes in the coming months.

Legislative changes - pending project

First of all, it is worth mentioning a bill on which work is already underway. This is the Law on the Protection of Whistleblowers, a new draft of which was released on the website of the Government Legislation Center on January 12 this year. Although this bill does not strictly concern the pharmaceutical industry, it is so important that it is worth mentioning here.

Work on the implementation of Directive 2019/1937 of the European Parliament and of the Council (EU) of October 23, 2019 on the protection of whistleblowers (i.e., concerning the protection of so-called whistleblowers) has been going on for a long time; the first draft of a law on this issue was published in October 2021. Now, however, work on the law can be expected to accelerate, due to the fact that Poland, as a member state of the European Union, is obliged to implement the directive, and we are already past the deadline for enacting the national legislation that would be necessary to implement the directive (the deadline expired in December 2021). As the law will introduce specific obligations regarding the handling of infringement notifications, which will be incumbent not only on state bodies, but also on entrepreneurs, it is worth following the fate of this law. In particular, it is important to note the short deadline for legal entities to comply with the obligation to establish a procedure for internal notifications; unlike what was stipulated in the original draft of the law, the new draft indicates that compliance with this obligation will have to take place within a month of the law's entry into force, which in turn will take place one month after the law's promulgation. As a result, legal entities (including entrepreneurs) will have only two months to implement procedures in their organizations for dealing with internal notifications.

Planned legislative changes

It is worth knowing that the website of the Prime Minister's Office publishes a list of legislative and programmatic work of the Council of Ministers, which provides insight into the range of issues that the government is currently working on regulating or amending. Currently, the list includes work scheduled for the last quarter of 2023 (some of which is not yet completed) and the first quarter of 2024.

Among the planned legislative changes listed in the list of legislative and programmatic work of the Council of Ministers, one can find mention of several projects that will directly affect the health care market. For example, in light of the information revealed in the list, in the near future we should expect a draft resolution of the Council of Ministers, amending the resolution on the adoption of the document - the Plan for Rare Diseases. The new resolution is primarily aimed at extending the planned period for its implementation, as work on the Plan is dragging on. Therefore, it is necessary to extend the deadline for implementation of the Plan until the end of 2024, as well as to make corresponding changes in the schedule for carrying out the various tasks covered by the Plan. In addition, some organizational and substantive changes are also to be included in the new resolution.

Also included in the list of the government's legislative and programmatic work is the development of a draft resolution of the Council of Ministers amending the resolution on the adoption of the multi-year program "National Oncology Strategy" for 2020-2030. As indicated next to this item on the list, the need to develop the resolution is due to the fact that the first years of implementation of the National Oncology Strategy coincided with the period of the Covid-19 pandemic, which was also compounded by the challenges of the outbreak of war in Ukraine. As a result, there have been delays in the implementation of some of the tasks envisaged in the NSO, which means that the dates covered by the timetable for the implementation of the National Cancer Strategy have had to be changed or the scope of some of the tasks changed. The government is working in parallel on a draft resolution of the Council of Ministers on the adoption of the schedule for the implementation of the National Cancer Strategy for 2024 and on a draft resolution of the Council of Ministers amending the resolution on the adoption of the schedule for the implementation of the National Cancer Strategy for 2023.

Anticipated (by the pharmaceutical industry) legislative changes

Finally, it is impossible not to mention a change in the law, which is not yet in sight, but which is highly anticipated, especially by pharmaceutical entrepreneurs. We are, of course, talking about another amendment to the Law on Reimbursement of Medicines, Foodstuffs for Special Nutritional Purposes and Medical Devices. Last year's major amendment (DNUR) introduced a number of new difficulties and obstacles on the path of applying for product coverage, making it now even more difficult to obtain reimbursement, and the potential legal and financial risks for applicants even greater. The reimbursement process was already not business-friendly before the amendment, and it has become even more difficult after the regulatory change.

Therefore, there is much talk in the market about the need for a quick amendment of the law, in order to reverse at least the most unfavorable changes for the market. Will such a change occur in the coming months? We shall see.