On 20 February 2025, our law firm scored a double victory before the District Court of Krakow, successfully defending the interests of our clients against (as confirmed by the Court) unjustified claims by the National Health Fund. Both cases concerned the obligation of the National Health Fund to reimburse pharmacies for the sale of medicinal products. These medicines contained highly potent substances in their composition and were dispensed to patients by pharmacy technicians. The NFZ claimed that these technicians were not authorised to sell such products. Our clients did not agree with this position and the Court shared our argumentation and awarded the NFZ the funds that were unjustifiably not paid to pharmacies.
The facts of the cases - why did the NHF impose penalties on pharmacies?
The facts of both cases were similar, medicines containing very potent substances were dispensed by pharmacy technicians employed in pharmacies. The National Health Fund, after conducting inspections in pharmacies, tried to prove that they were not authorised to do so. The dispute concerned the legal interpretation of Article 91 of the Act Pharmaceutical law, according to which:
Article 91. 1. A pharmacy technician with two years of full-time practice in a pharmacy may perform professional activities in a pharmacy involving the preparation, manufacture, dispensing of medicinal products and medical devices, with the exception of medicinal products having in their composition:
(1) Very potent substances as defined in the Official List of Medicinal Products Authorised in the Republic of Poland,
2) intoxicating substances,
(3) psychotropic substances of groups I-P and II-P
- specified in separate regulations.
Key reasons for the court's favourable decision for pharmacies
The provision of Article 91(1) Pharmaceutical Law does not refer to the 'A' list of the Polish Pharmacopoeia contained therein
The Court shared our view that Article 91(1) refers, inter alia, to the Official List of Medicinal Products Authorised for Marketing in the Republic of Poland (UWPL), which does not contain a list of very potent substances.
The court pointed out that although this provision of the pharmaceutical law also refers to "separate regulations", the The Polish Pharmacopoeia is not a source of law within the meaning of Article 87 of the Constitution of the Republic of Poland.but is merely an official publication containing technical and quality standards. Thus, it cannot be argued that the Pharmacopoeia is a "separate regulation" within the meaning of the above-mentioned regulation and, consequently, the rights of pharmaceutical technicians cannot be restricted on the basis of it.
Neither the NFZ nor the Court can replace the legislator
The court also emphasised that the legislator had long been aware of the imprecise regulations of the pharmaceutical law and the need to amend them, but had not taken the necessary legislative steps in this direction until the date of the NFZ inspection of pharmacies.
The adjudicating panel noted that the defect in Article 91(1)(1) of the Pharmaceutical Law is a failure of the legislator, which the Court cannot rectify by way of a ruling, as it is not allowed to substitute the legislator in this respect. The amendment of the law belongs to the powers of the legislature, and neither the NFZ nor the judicial authority has the right to step into such a role by making an expansive interpretation of the aforementioned provision. Until the law is amended, pharmacies should not be penalised.
Article 91(1)(1) of the Pharmaceutical Law must be interpreted restrictively
In the oral recitals of the decision, the Court noted that Article 91 of the Pharmaceutical Law limits the competence of a pharmacy technician. However, its nature in accordance with the principles of correct legislation means that the interpretation of this provision should be restrictive. Thus, there is no basis for "supplementing" the aforementioned provision by referring to the Polish Pharmacopoeia. Where the legislator wished to refer to the above-mentioned official publication, it did so explicitly. Such an explicit reference, in turn, is lacking in the above-cited Article 91 of the Pharmaceutical Law.
Thus, the court acknowledged our arguments and awarded our clients payment of outstanding funds that had previously been unjustifiably deducted by the National Health Fund. They will therefore recover their money.
What do today's rulings mean for pharmacies, their owners, pharmacists and pharmacy technicians?
The judgments described above confirm the line of rulings by the Supreme Court, from which it follows that the role of the NFZ in the course of its control activities is to take care of the spending of public funds and the tightness of the reimbursement system. However, it is not its role to play the role of an 'evil policeman' who punishes pharmacists regardless of the seriousness of the infringement and regardless of whether the medicinal product reached the authorised person in accordance with the medical prescription.
Today's win is another step in our mission to effectively protect the rights of pharmacy workers. We believe that today's judgments will influence future interpretations of drug reimbursement regulations, thereby creating a friendlier environment for pharmacy business.
We would like to thank our customers for their trust and perseverance in allowing us to fight this battle, in what is after all a just cause. After all, it is the NFZ that is obliged to pay for medicines for patients, not pharmacy owners.
The team of our Pharmaceutical Law Office will invariably remain at your disposal.