GIF on legal chaos, lack of data and the 2025 action strategy: "We issue a plan, but we are not the ones who make the law"

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Although the Chief Pharmaceutical Inspectorate declares full implementation of its plan for 2025 and improvement of supervision over the quality of medicines, it does not hide its limitations. - We issue a plan, but we are not the ones who create the law - GIF claims in an interview with politykazdrowotna.com. And this is the institution's position on legislative delays, including in the matter of AdA 2.0 and fragmentation of decisions of provincial pharmaceutical inspectorates.

The conversation between politykazdrowotna.com and GIF concerned, among other things , the Pharmacy for Pharmacists 2.0 (AdA 2.0) regulations. Let us recall that the introduction of the Pharmacy for Pharmacists (AdA ) Act in 2017 and its subsequent amendment – ​​referred to as AdA 2.0 – radically changed the landscape of the Polish pharmacy market. According to the new regulations, a pharmacy can only be opened by a pharmacist or a company in which pharmacists hold the majority of shares. In practice, this meant cutting off the path to development for pharmacy chains and investors from outside the profession, which was met with sharp criticism from many industry organizations, pharmacy employers, and even some patients.

The AdA was supposed to protect independent pharmacies and strengthen the role of pharmacists in the healthcare system. However, its opponents claim that it introduced unnecessary formalism, deepened demographic problems (e.g. inheritance of pharmacies) and limited competition. The effects? A decrease in the number of branches, a lack of pharmacies in hundreds of municipalities, problems with succession and life dramas for pharmacists who – in the event of death, divorce or a fire in the premises – lose the opportunity to transfer the pharmacy to someone outside the profession.

At the last meetings of the Parliamentary Team for Pharmacy Market Regulation, the topic of AdA 2.0 once again sparked heated discussions. Opponents demanded the complete repeal of the regulations, while supporters demanded their maintenance as a guarantee of pharmacists' independence and market fragmentation. At the same time, everyone agreed on one thing: the current system requires urgent changes. The regulations do not fit the realities of life and business, and too often they hit patients and those who want to run a pharmacy honestly.

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Meanwhile, the Chief Pharmaceutical Inspectorate – the institution responsible for supervising compliance with pharmaceutical law – has no way to counteract the chaos on its own. It is the legislator who must propose solutions. The pharmaceutical market supervision authority only enforces the law. In such a situation, its action plan for 2025 gains additional context: on the one hand, it assumes greater efficiency, quality control and increased transparency, on the other – its effectiveness in key areas depends on legislative changes, which the GIF… is still waiting for.

The Inspectorate confirms that work on amending the Pharmaceutical Law , including the provisions known as Pharmacy for Pharmacists 2.0 , is still ongoing. To quote the office:

Contrary to earlier announcements (autumn 2024), the project has not yet been submitted for consultation. The Inspectorate has not provided a date when its final version can be expected.

You can read more about the AdA 2.0 and AdA regulations here:

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When asked by politykazdrowia.com, the pharmaceutical supervision also refers to the problem of inconsistent interpretations of the law in different provinces. As it explains:

The Central Inspectorate acts solely as an appeal body and has limited ability to interfere in the decisions of the WIF :

However, the limitations are significant – the central inspectorate cannot issue general instructions or guidelines in individual cases:

This could mean that the current fragmentation of supervision could deepen – unless the regulations change.

When asked about the number of pending proceedings concerning permits to run pharmacies and the average time of their consideration, the state pharmaceutical supervision authority gives a clear answer:

As the inspectorate explains:

He adds that each case is analyzed individually:

The GIF activity plan for 2025 assumes full implementation of tasks in key areas: supervision of the quality of medicines, inspections in wholesalers, control of psychotropic substances and reporting of medicine shortages. As the office emphasizes:

The Inspectorate is recruiting for the Legal Department. When asked about the purpose of this recruitment, he replies:

The employment is expected to translate into more efficient operation of the office:

The 2025 activity plan also includes soft elements – building the authority of GIF and increasing its visibility. It assumes, among others: 15 meetings within international working groups, organization of 1 HMA WGEO event, 36 media appearances, 300 posts in social media, publication of 50 infographics, animations and video materials.

The pharmaceutical supervision authority is consistently implementing its operational plan, but the limitations resulting from the lack of amendments to the law and limited competences in relation to WIFs result in a lack of consistency and predictability of administrative decisions in the pharmacy sector . As the Inspectorate's response suggests - a reform of the law is needed, not only of the institution.