Publication date: October 05, 2026
Poland’s Ministry of Health wants to place medicines with different active substances in a single reimbursement limit group where they work in a similar way, and to reward hospitals for choosing the cheapest therapy available. The change is meant to bring prices down and free up funds for innovative treatment, but clinicians warn that cost equivalence is not the same as clinical equivalence. We examine how the proposed baskets of equivalent therapeutic technologies could affect physicians’ autonomy, patients’ rights and competition in the pharmaceutical market, and what safeguards the legislation should contain.
KG LEGAL KIELTYKA GLADKOWSKI supports international pharmaceutical, biotechnology and healthcare businesses operating in Poland. For legal assistance with pharmaceutical regulation, reimbursement and market access, contact our team at office@kg-legal.pl.
Introduction
The aims of the reform
Optimising the spending of the National Health Fund (NFZ), keeping the total reimbursement budget stable and stimulating price competition: according to its official explanatory memorandum, these are the aims of the draft amendment to the Polish Reimbursement Act, adopted by the Council of Ministers in October 2026. The draft reforms the rules on public funding of pharmacotherapy and medical devices, introducing new instruments such as baskets of equivalent therapeutic technologies and price corridors. Although it is intended to protect the economic interests of the system and improve healthcare in Poland, its content has provoked lively debate from the outset. To assess the real value of the planned changes, it is worth starting with the legal framework they are meant to replace.
The previous model: individual decisions and unanimity of manufacturers
Until recently, the description of a drug programme was an annex to the individual administrative decision issued to a specific manufacturer. As a result, any change to the programme – adding a new medicine, modifying patient eligibility criteria or updating the required diagnostics – required the unanimous consent of all manufacturers holding reimbursement decisions within that programme. Limit groups also played an important role; in practice they generally comprised medicines containing the same active substance, although the Act already allows, to a limited extent, medicines with different international non-proprietary names to be grouped together. In the Ministry of Health’s view, this model fostered blocked competition and monopolisation, since the objection of a single manufacturer could halt the introduction of a new therapy and thus hinder the timely adjustment of drug programmes to current clinical guidelines and patient needs.
What has already changed and what is still to come
The first step was an amendment that entered into force on 1 July 2026. Its priority was to move away from the former annexes to decisions and to introduce Article 16a, which removes drug programme descriptions from the decisions issued to individual companies. This was, however, only one of the changes announced in the draft. Its central proposal remains a new way of grouping medicines, namely baskets of equivalent therapeutic technologies: placing medicines with different active substances in a common limit group where they show a similar therapeutic effect and a similar mechanism of action. In addition to organisational benefits for healthcare providers, the change is meant to generate savings, on the assumption that putting alternative medicines in a single basket and financially rewarding hospitals for choosing the cheapest of them will drive prices down and reduce public expenditure.
I. How are the baskets of equivalent therapeutic technologies meant to work?
Criteria for inclusion in a basket
To assess whether this solution will actually achieve its stated aims, we first need to look at its mechanisms and assumptions. Under Article 15a(2) of the draft, the basic criteria for placing medicines in a common limit group are the same or similar indications or intended uses for which they are reimbursed, and similar efficacy. A basket may include a medicine with the same international non-proprietary name (i.e. meeting the criterion of an identical active substance, which is the primary criterion under the current Reimbursement Act) or a medicine with a similar therapeutic effect and a similar mechanism of action. The baskets are to apply primarily to medicinal products and foods for special medical purposes used in drug programmes. They cover advanced innovative medicines, biologics and biosimilars used in specialised hospital therapies, including oncology (including chemotherapy), haematology, rheumatology and dermatology.
The procedure for setting a drug programme description
The description of the drug programme within which a basket operates goes through several stages set out in Article 16a, in force since 1 July 2026:
1. the Minister of Health prepares a draft description after consulting the relevant national or regional consultant and, where justified, the relevant medical society;
2. the draft is sent to the President of the Agency for Health Technology Assessment and Tariff System (AOTMiT) for an opinion and, once the opinion is received, forwarded to the applicant;
3. the applicant is required to submit its opinion within no more than 7 days; that opinion is, however, not binding on the Minister.
These rules, already in force, show how the role of expert opinions in shaping drug programmes has changed: they are now the substantive basis for creating and updating programmes. The requirement of unanimity among pharmaceutical companies has been replaced by a mandatory consultation of the national or regional consultant in the relevant field of medicine and a mandatory opinion from the President of AOTMiT. This obligation applies, however, to the creation of a description; when it is later amended, the Minister may, but need not, seek these opinions. In addition, where a change to the programme description alters the target population, the President of AOTMiT calls on the applicant to supplement its health technology assessment (HTA), i.e. the analysis comparing the technology with the existing standard of care (Article 35(2a)). Consulting a medical society, by contrast, remains optional. The programme description prepared in this way is annexed to the Minister of Health’s notice on the list of reimbursed medicines, foods for special medical purposes and medical devices, published in the Minister’s official journal.
The doubts: what exactly does “equivalence” mean?
Although the direction of the draft seems positive at first glance, several issues may prove problematic in implementation. The first point of contention is the scope of the baskets, i.e. the criteria for their “equivalence”. The draft uses only general phrases such as “similar therapeutic effect” and “similar mechanism of action”, without any verifiable quantitative criteria. This has raised concerns among clinicians, who point out that the absence of an exhaustive list of clinical indicators may give the regulator broad discretion. This creates a real risk of equating economic equivalence with clinical equivalence. In the view of experts in the specialties covered by the programmes, grouping therapies deemed equivalent in a single basket will significantly complicate physicians’ everyday practice. In the current wording of the proposed provisions, the healthcare sector therefore sees above all an economic motive.
II. Financial incentives for hospitals to use the cheapest therapies
These concerns appear justified, especially as the proposed basket model is closely linked to the way the NFZ settles payments for healthcare services. The system is to rely on an existing instrument, correction coefficients, which are currently used to adjust the valuation of services, for example for holding quality accreditation, meeting certain staffing standards or delivering comprehensive care programmes. The drafters give this tool a new purpose: rewarding hospitals for choosing the medicine that sets the limit base within a given basket. A hospital that, within a basket, treats a patient with the drug technology with the lowest average cost per day of therapy, or with the product selected in a tender as the most price-competitive, is to receive a more favourable correction coefficient. In practice, the mechanism therefore encourages hospitals to be guided by the lowest unit price.
Formally, all products included in a given basket remain on the reimbursement list, as follows from Article 37 of the Reimbursement Act. The problem is therefore not a narrower range of available medicines, but a possible restriction of physicians’ freedom of decision and autonomy. This risk is particularly real given the chronic underfunding of hospitals, where management decisions may be driven by the need to stabilise finances and tilt towards the cheapest medicine in the hospital’s public tender.
III. Cost equivalence versus clinical equivalence
Same line of treatment does not mean interchangeable
The key question in assessing equivalence baskets is whether the same line of treatment and the same indication are enough to consider medicines equivalent. Medical experts and national consultants answer this firmly in the negative: belonging to the same line of therapy does not mean that medicines are clinically interchangeable. They may have different chemical structures and differ in, among other things, toxicity profile, metabolism or route of administration. The basket mechanism therefore cannot be equated with safe generic or biosimilar substitution. Whereas generics and biosimilars involve demonstrated bioequivalence (or, for biosimilars, demonstrated biosimilarity) of the same active substance, distinct therapeutic technologies show only comparable efficacy in averaged populations. What does this mean in practice?
The different characteristics of products are particularly significant in fields where treatment efficacy relies on molecularly targeted therapies, such as oncology and haematology. The cheapest medicine in a basket may be less precisely targeted at a specific genetic mutation than a more expensive one that does not set the limit base. More generally, adverse reactions must also be considered, as their frequency and severity may differ between medicines in the same basket. The negative consequences of selecting a product in this way may be especially severe for frail patients.
A patient is not a population average
The burden of choosing a one-size-fits-all, economically advantageous solution therefore grows with the degree to which a patient’s needs are individual. Previous therapies often affect the immune system and the body’s response to subsequent treatment, so the sequence of therapies is crucial. Widespread use of a single medicine also carries a risk of interactions in patients with comorbidities, which may sometimes absolutely rule out the use of a given product. Moreover, choosing a suboptimal medicine at an early stage may make it impossible to use the most effective therapy in a later line. All of this shows the possible consequences of a simplified assessment of equivalence and underlines the importance of personalised medicine, which should not give way to a hospital’s economic pressures.
The methodology of the studies on which medicines are authorised, and subsequently reimbursed, is based on population statistics. Similar average efficacy across a study sample cannot be equated with efficacy in an individual patient. Analysis of a patient’s individual biological profile cannot be reduced to simplifications introduced to make product selection easier; it should take individual predispositions into account so as to minimise the risk of ineffective treatment or, worse, serious complications.
IV. Physician autonomy and responsibility for the choice of therapy
Due diligence versus economic pressure
Taking the patient’s individual situation into account, as part of acting in accordance with current medical knowledge, is a statutory duty of physicians under the Act on the Professions of Physician and Dentist and, at the same time, a deontological duty under the Code of Medical Ethics (KEL). Since physicians must practise in accordance with current medical knowledge, using the methods and means available and with due diligence, they should not use the cheapest medicine in a basket if it does not comply with current clinical guidelines for the particular disease subtype. Imposing such a product for cost-saving reasons would be contrary to the standards set by Article 4 of the Act on the Professions of Physician and Dentist, the Code of Medical Ethics and Article 6 of the Act on Patient Rights and the Patient Ombudsman. These provisions guarantee physicians freedom to choose the methods they consider most effective. Rewarding hospitals for using the tender-winning medicine may, however, lead to a situation in which physicians’ formal autonomy is in practice curtailed by market mechanisms and economic considerations.
Who bears the consequences?
An independent public healthcare institution (SPZOZ) covers its operating costs from its own revenue and must cover any net loss itself. If debt ratios are at risk of being exceeded, hospital management may be forced to issue internal instructions and design tender procedures so that only the cheapest medicines in a given basket are used, placing administrative pressure on physicians. If, as a result, a patient suffers serious adverse reactions where current medical knowledge called for a different product, the physician may face professional liability before a medical court and criminal liability and, depending on the legal basis on which they provide services, civil liability. The healthcare provider is also liable for damage resulting from the provision of services or the unlawful failure to provide them: for physicians employed under an employment contract, it is generally the provider that is liable to the patient (Article 430 of the Civil Code in conjunction with Article 120 of the Labour Code), while for physicians engaged under civil-law contracts it is jointly and severally liable with the physician (Article 27(7) of the Act on Medical Activity). Such an event may also constitute a culpable infringement of the patient’s right to services consistent with current medical knowledge, giving rise to a claim for compensation for non-pecuniary harm under Article 4 of the Act on Patient Rights.
How can physicians protect themselves?
To avoid breaching the law, a physician may, and sometimes should, depart from the economically preferred technology. In doing so, the physician must give the patient accessible information about the proposed treatment methods, their risks and expected benefits, which includes the reasons for choosing a specific therapy. Choosing a personalised therapy that departs from the hospital’s economic standard should be documented in detail in the medical record, together with the substantive medical justification.
V. Patients’ rights and the principle of individualised treatment
Informed consent requires full information
Polish law thus imposes specific duties on physicians towards patients. Besides treatment consistent with current medical knowledge and tailored to the specific condition, i.e. personalised treatment, patients have the right to information about their health, diagnosis and possible treatment options, including the alternatives available within the basket. From this perspective, patients should also know whether the choice of a particular medicine results from its clinical profile or from the facility’s organisational and financial constraints. This information is not an empty formality but a condition of informed consent. A patient may consent to, or refuse, specific healthcare services only after receiving the full information specified in Article 9 of the Act on Patient Rights. If a patient consents without having received this information in an accessible and comprehensible form, the consent is defective and the medical intervention is, as a rule, unlawful.
The risk of unequal access to therapy
The legal position of patients in Poland is grounded both in statute and in Article 68 of the Constitution, which guarantees the right to health protection and equal access to publicly funded healthcare services. In practice, however, these principles face obstacles. Besides the risk of a hidden barrier to access resulting from the drive to balance the budget, there is a risk that the level of care will vary between patients. Equivalence baskets, combined with rewarding hospitals for choosing the medicine that won a local tender, may lead to fragmentation of treatment. Imagine that hospital A in one region selects medicine X in its tender, while hospital B in a neighbouring region selects medicine Y. Two patients with identical biological and clinical profiles may then receive different medicines simply because one was admitted to hospital A and the other to hospital B. Making geography and the outcome of a tender the deciding factor in treatment could raise serious doubts as to compliance with the constitutional principle of equal access to healthcare services (Article 68(2) of the Constitution).
VI. Could the mechanism restrict competition in the pharmaceutical market?
Market concentration around the tender winner
From the Ministry of Health’s perspective, creating common limit groups for medicines with similar therapeutic effects is meant to break down artificial monopolies and introduce price competition between manufacturers. Introducing baskets may, however, also have a less desirable effect: strong pressure to choose the most economically advantageous product. Medicines will formally remain on the reimbursement list, but a large share of orders will go to the winner of the hospital tender. This would mean market concentration around the medicine setting the limit base, even though the basket also includes other, more expensive options.
Unit price is not the whole cost of therapy
It is also worth looking more closely at the economics of the solution. The most financially advantageous options in tender procedures and in setting the limit base are determined using a fairly narrow criterion: the official selling price or the price per dose unit. Relying solely on this indicator can be misleading, as it ignores additional costs related, for example, to the pharmaceutical form and route of administration and, in some cases, to medicines that mitigate adverse reactions or the need to switch therapy when the first product does not deliver the expected results.
Risk-sharing discounts as the benchmark for further cuts
Existing risk-sharing schemes (RSS) also take on a new significance. The draft provides that the mandatory 25% price reduction after protection expires is to be calculated from the effective price, i.e. the price net of the confidential RSS discount. Whereas the idea behind these instruments was to separate the official selling price from the actual cost to the budget, once the proposed changes take effect the discount would become a fixed benchmark for further cuts. Paradoxically, those who stand to lose most are the companies that have so far been the most flexible in price negotiations.
Across the system as a whole, the cumulative price pressure – mandatory 25% reductions after protection expires and price corridor requirements – may lead some manufacturers to withdraw from the reimbursement list because it is no longer profitable. The draft’s option of extending the settlement period for outcome-based RSS to as long as 10 years does not solve the problem. Given the costs of manufacturing, transport and certification, selling a medicine in Poland may become loss-making for a manufacturer, and to limit losses manufacturers may stop offering large RSS discounts when launching new therapies, knowing that a discount granted today will be used in a few years as the basis for a forced, drastic price cut. A solution meant to increase price competition may thus restrict competition in another area and even jeopardise the continuity of supply of medicines to patients.
VII. Potential benefits – the drafters’ arguments
Price pressure and cost-effectiveness
How do the drafters justify the proposed changes in the face of clinicians’ objections? The Ministry of Health’s arguments include several important elements: aligning the legal framework with market realities, creating mechanisms for flexible management of the total reimbursement budget (CBR) and improving cost-effectiveness. Flexible design of limit groups is meant to exert price pressure, bring prices closer to market levels and strengthen hospitals’ negotiating position when purchasing medicines at prices close to the limit base. Inclusion in a common limit group, and indirectly the level of funding, would no longer be determined by the active substance alone but by a broader clinical profile, so that large price disparities would gradually even out. The amendment therefore aims to reduce the costs of inpatient care on many levels.
Where are the savings meant to go?
According to the Ministry of Health, the savings are to fund new, innovative therapies: technologically advanced medicines whose use places a significant burden on the budget over the longer term. These include in particular targeted therapies in oncology and haematology, advanced therapy medicinal products (ATMPs) and highly innovative drug technologies (TLWI). Clinical experts and representatives of the pharmaceutical industry stress, however, that translating these savings into genuinely better access to treatment will require additional safeguards, so that legitimate aims are not reduced to a mere battle over price.
VIII. What safeguards should the legislation contain?
Precise equivalence criteria
A safe implementation of the new rules therefore requires solutions that reconcile rationalised spending with a guarantee of personalised medical care. First and foremost, precise criteria for creating baskets should be considered, so that baskets are not based on a general similarity of indications and on regulatory discretion. Membership of a common limit group should be determined by demonstrated clinical equivalence, not merely by belonging to the same line of treatment. A comprehensive health technology assessment (HTA) covering the molecular profile of the disease, mechanism of action, metabolism, route of administration, toxicity profile and sequencing of therapies would be an effective preventive measure.
Expert involvement and ongoing monitoring
Since such an assessment requires specialist medical knowledge, it seems natural that specialists from the relevant fields of medicine must take part in it. The rules in force since 1 July 2026 require the national or regional consultant to be consulted when a drug programme description is created, but not when it is amended. Given the risks arising from an improperly conducted procedure, it would be justified to extend this obligation to amendments and to make consultation with medical societies and patient organisations mandatory as well. Beyond precise rules on determining the composition of baskets, there must also be oversight of how they operate and monitoring of the efficacy and safety of therapies, with the possibility of modifying a basket. The legislation should require AOTMiT to carry out periodic reviews of existing limit groups for hidden costs of hospitalisation, treatment of complications and rates of treatment discontinuation, based on reliable NFZ registry data. It should also provide for an appeal procedure against drug programme descriptions published in the Minister of Health’s notice, together with a list of entities entitled to lodge formal objections. The lack of an appeal route has also been raised by INFARMA, which, after the public consultation closed, called for the baskets to be removed from the draft.
Protecting the individual patient
The most important matter to be regulated remains the protection of health as the paramount value that the amendment is ultimately meant to serve. To this end, the drafters could add a transparent and fast procedure for exempting a patient from the basket mechanism where justified by the patient’s individual clinical profile, as well as a guarantee of continuity of treatment: the right to continue therapy with a given drug technology until the end of the treatment cycle if it has already been started. Physicians’ decisions on how to conduct treatment should be driven above all by the patient’s interest and should not have adverse financial consequences for the hospital if the chosen medicine is not the cheapest. If a hospital in which a physician individualised the therapy and gave substantive reasons for it in the medical record retained the right to full payment for the service without a reduced correction coefficient, the influence of economic considerations on treatment decisions would be significantly weakened.
Conclusion
The Ministry of Health’s aim of optimising the budget and freeing up funds for breakthrough innovations, including ATMPs and TLWI technologies, is justified from the perspective of public finance management. The analysis shows, however, that the drafters should do more to strike a balance between optimising public spending, physicians’ autonomy and patients’ right to personalised therapy. The mechanisms proposed in the current wording of the draft may bring hospitals’ financial constraints into conflict with physicians’ statutory and ethical duty to provide medical services with due diligence. Care must be taken to ensure that economic pressure on inpatient care does not result in merely formal improvements in access to advanced therapies. This can be achieved by supplementing the draft with the safeguards discussed above. Equivalence baskets could then benefit the public healthcare system on several levels without restricting the rights of patients, whom the Reimbursement Act is, after all, meant to protect.