The National Health Fund demanded that the pharmacy return over one million zlotys in reimbursement and contractual penalties for alleged irregularities in the dispensing of compounded medications.
The Regional Court in Katowice entirely dismissed the claims of the National Health Fund, pointing out that the refund repayment cannot be an automatic penalty for minor technical or recording errors.
The National Health Fund cannot automatically demand the reimbursement refund from a pharmacy in every situation. Important judgment of the Regional Court in Katowice
Over a million zlotys in refunded reimbursements to be returned and contractual penalties? These are the claims the National Health Fund pursued against one of the pharmacies we represent following an audit. However, the Regional Court in Katowice did not share the Fund's position. It is clear from the oral grounds for the judgment that the obligation to return the reimbursement does not arise automatically, but requires proof that public funds were actually misspent. This is a position that could be of significant importance for all pharmacies dispensing reimbursed prescriptions.
What was the case about? The National Health Fund (NFZ) wrongfully demanded the return of a refund following an inspection
The National Health Fund demanded that the community pharmacy run by our Client return reimbursement in a total amount exceeding 1 million PLN, along with statutory interest for delay, and pay a contractual penalty. The basis for the claims was findings made in the course of an inspection conducted by one of the regional branches of the National Health Fund, concerning the correctness of dispensing prescriptions for reimbursed extemporaneous medicinal products.
In the Fund's assessment, the irregularities identified during the audit justified the application of Article 43(1)(6) of the Act of 12 May 2011 on the reimbursement of medicines, foodstuffs intended for particular nutritional uses and medical devices (hereinafter: the "Reimbursement Act"), and consequently claiming back the disbursed reimbursement from the pharmacy. At the same time, the NFZ considered that the pharmacy's conduct constituted grounds for imposing a contractual penalty resulting from the agreement on the fulfilment of reimbursed prescriptions.
However, from the very beginning, this position raised fundamental objections on our part. The essence of the dispute did not boil down solely to the assessment of individual audit findings nor to deciding whether certain irregularities occurred during the dispensing of prescriptions. Much more important was the systemic question: does every irregularity identified during a pharmacy audit automatically entitle the NFZ to demand the refund of the reimbursement paid?
It was precisely the answer to this question that was crucial to the resolution of the whole case.
The Regional Court in Katowice confirmed: the NFZ had no right to demand the return of reimbursement
By a judgment dated 15 July 2026, the Regional Court in Katowice fully accepted our arguments and established that in this case the National Health Fund was not entitled either to demand the reimbursement of the refund or to impose a contractual penalty.
What particularly pleases us is that, from the oral grounds for the decision, it is evident that the Court did not limit itself to assessing the individual charges raised in the course of the audit. Above all, the Court confirmed a crucially important issue regarding the interpretation of Article 43(1)(6) of the Reimbursement Act, setting the limits on the admissibility of the National Health Fund applying the most severe sanction provided for in that provision.
A refund clawback cannot be a punishment for absolutely every pharmacy mistake.
As the Regional Court in Katowice stated, the mere finding of certain irregularities by the National Health Fund during an inspection of a pharmacy does not yet mean that the Fund acquires the right to demand the return of the refund paid.
The court entirely agreed with our position, according to which Article 43(1)(6) of the Reimbursement Act cannot be interpreted as a provision establishing a mechanism of automatic pharmacy liability for every identified violation. For us – practitioners in disputes with the National Health Fund (NFZ) – this is a fundamental issue. The refund of reimbursement is the most far-reaching consequence that a pharmacy can face in connection with an NFZ audit. In practice, it means the obligation to return public funds that were previously paid to the pharmacy in connection with the fulfilment of reimbursed prescriptions. Such a far-reaching interference in the financial situation of an entrepreneur cannot occur solely because formal, technical or organisational irregularities were detected during the audit.
The Regional Court emphasised that for the National Health Fund (NFZ) to demand the return of a refund, it is necessary in each case to establish that the irregularities found during the audit actually led to the faulty dispensing of the prescription, and consequently resulted in the unauthorised expenditure of public funds. Only such a situation can justify the application of the sanction provided for in Article 43(1)(6) of the Reimbursement Act. In our view, this direction of interpretation is justified not only by the provisions of the Reimbursement Act, but perhaps above all by the relevant regulations concerning entrepreneurs, and ultimately even stems from the Constitution of the Republic of Poland.
In accordance with Article 68(2) of the Constitution: 'Citizens, irrespective of their material situation, shall have equal access to healthcare services financed from public funds. The conditions and scope of the provision of services shall be specified by statute.' It follows from the above that it is the authorities of the Republic of Poland that bear the obligation to subsidise medicines for persons entitled to receive them, and it is precisely for the purpose of fulfilling this obligation that the National Health Fund has been endowed with inspection powers. In our view, this means that the Fund's role is to ensure that public funds within the healthcare system are spent in accordance with their intended purpose, rather than to penalise pharmacies for every irregularity, even a minor one.
In other words, not every irregularity identified during an inspection will justify a demand for the repayment of a refund. Before applying this sanction, it is necessary to determine that the breach was of a sufficiently significant nature to undermine the correct execution of the prescription and the purpose served by the reimbursement system.
Such an understanding of the provision is of great practical significance. In many cases, after all, the principal subject of dispute is not the establishment of specific irregularities as such, but rather the answer to the question of whether their nature truly justifies the application of the most far-reaching sanction provided for in the Act on Reimbursement. The judgment in question shows that an equals sign cannot be placed between these issues.
Why did the Court rule that the reimbursement was spent correctly and the return of the reimbursement is not due?
Next, the Regional Court assessed whether, in light of the aforementioned interpretation of Article 43(1)(6) of the Reimbursement Act, the circumstances of the case justified the application of the sanction of reimbursement of the refund. The answer was unequivocally negative.
Firstly, the Court pointed out that the evidence which we submitted
in question, led to the conclusion that the prescriptions were dispensed correctly. Crucially,
In the oral motives for the decision, the Court emphasised that the compounded drugs were dispensed to entitled persons on the basis of valid prescriptions and in accordance with their therapeutic purpose. At the same time, the National Health Fund failed to demonstrate that any of the patients received a product that failed to meet quality requirements or posed a threat to their health.
In the Court's assessment, this was of fundamental importance for the resolution of the case. Since the primary objectives of the reimbursement system were achieved – patients received properly compounded medicines, in accordance with the medical prescription and without prejudice to the safety of therapy – the mere finding of certain irregularities could not automatically lead to an obligation to repay the reimbursement in the amount of over one million zlotys.
Technical errors do not justify a request for a refund
One of the most significant elements of the oral grounds for the judgment was the Court's clear distinction between technical errors and the defective execution of reimbursed prescriptions. The Court did not challenge the findings of the National Health Fund (NFZ) that certain irregularities had been revealed during the audit. At the same time, however, it pointed out that the mere occurrence of technical errors does not yet determine a breach of regulations that would justify the recovery of reimbursement. In the Court's opinion, the ascertained shortcomings did not affect the process of compounding the prescription medicine itself, its quality, safety of use, or the effectiveness of the therapy.
This distinction is extremely important. After all, an NHF audit cannot ignore the actual nature of the identified irregularities. A situation in which a patient receives a defectively prepared medicinal product must be assessed differently from cases involving record-keeping, accounting or organisational errors that have no impact whatsoever on the execution or dispensing of a prescription.
Extemporaneous medicines were not prepared quickly enough for reimbursement to be due
One of the more characteristic allegations made by the NHF was the claim that compounded medications were prepared by our Client in an unrealistically short time. The Fund derived this conclusion solely from the data recorded in the pharmacy's IT system. In the NHF's opinion, such a short time between successive entries was meant to indicate that the correct preparation of the compounded medications was objectively impossible, and thus the prescriptions were improperly fulfilled.
However, the Regional Court did not share this reasoning. Based on the gathered evidence, it held that the inspection incorrectly equated the moment when the preparation of the medicinal product was recorded in the system with the entire process of its compounding. The compounding of a prescription medicine is a process comprising a series of successive technological and organisational activities. The entry in the system itself or the affixing of a label merely constitutes the final stage of this process, when the medicine is already ready to be dispensed to the patient. In pharmacy practice, many activities are performed almost in a serial manner, or in other words – in a well-organised way, which makes it possible to streamline work without any detriment to the quality of the compounded medicines.
In the Court's view, such work organisation not only does not indicate the defective dispensing of prescriptions, but constitutes evidence of the rational and efficient functioning of the pharmacy. For it is not possible to draw a conclusion that a medicinal product has been improperly prepared solely on the basis of the time at which the final operation is recorded in the IT system, completely disregarding the actual course of the technological process.
Permissible minimum deviations in the composition of a magistral preparation
An essential element of the Court's reasoning was also the addressing of the allegations concerning the amounts of active substances used in the preparation of compounding medicines. The National Health Fund assumed that the discrepancies identified between the values resulting from the prescriptions and the amounts shown in the pharmacy documentation indicated that the prescriptions had been executed incorrectly. However, the Regional Court did not share such a categorical assessment. It pointed out that when preparing compounding medicines, certain technological deviations are permissible, resulting from the Polish Pharmacopoeia and the principles of pharmaceutical knowledge. Therefore, the mere occurrence of a minimal difference in the amount of the active substance used does not yet mean that the medicine was prepared incorrectly.
Errors in messages sent to the NFZ
Similarly, the Court assessed the remaining allegations concerning the functioning of the pharmacy system. This applied both to the erroneous designation of symbols used in communications transmitted to the NFZ and to irregularities related to the prescription pricing stage in the IT system. The Court held that these shortcomings had no impact on the actual process of preparing the medicinal product or on the product dispensed to the patient. They constituted technical errors associated with the operation of the IT system, rather than proof of the defective execution of reimbursed prescriptions.
Active defence at the audit stage already matters
It is also noteworthy that the Court recognised the pharmacy's attitude during the audit itself. The plaintiff attempted to explain and rectify the identified irregularities, but – as follows from the oral grounds – this argumentation was not accepted by the NFZ. This element was also assessed by the Court in favour of the pharmacy involved in the dispute with the NFZ.
In our view, this is a significant judgement for the entire pharmacy market
The discussed ruling has significance extending far beyond the circumstances of the specific case. It touches upon the fundamental question regarding the limits of the National Health Fund's inspection powers, in particular what actions the National Health Fund should take in the course of pharmacy inspections, and the manner of applying Article 43(1)(6) of the Reimbursement Act.
The direction of interpretation presented by the Regional Court in Katowice deserves recognition. The reimbursement system was created in order to ensure patients' access to reimbursed medicinal products and to guarantee the proper expenditure of public funds. However, it should not lead to the imposition of an obligation on pharmacies to refund very large amounts solely due to irregularities of a technical, organisational or record-keeping nature, which had no impact whatsoever on patient safety or the correct implementation of pharmacotherapy.
At the same time, this case demonstrates the crucial importance of involving professional legal support at a sufficiently early stage of handling a matter concerning an inspection by the National Health Fund (NFZ). The outcome of a court dispute regarding the refund of reimbursement to the NFZ can often be positively or negatively determined by the explanations submitted during the inspection, the manner in which objections to the post-inspection report are formulated, and the proper preparation of evidence even before the case is referred to court. When defending your rights, it is worth availing yourselves as early as possible of the support of a lawyer with experience in disputes with the NFZ – and this is not just about us, as there are several professional law firms operating on the market. It is important that you give yourselves the chance to be assisted at the earliest possible stage.
If your pharmacy is in a dispute with the National Health Fund or has been subjected to an audit regarding the fulfilment of reimbursed prescriptions, both the identified problems and the audit findings, as well as possible legal measures, should be analysed with an experienced lawyer as early as possible. If necessary, our entire Team I remain at your disposal for the analysis of the case, as well as for representation at the audit, appeal and court stages.
We also invite you to read our guide on NFZ audits and demands for reimbursement refunds.