The categorisation of medicines within the public health insurance system involves two key commitments: human rights obligations and the patient’s entitlement to treatment in line with the latest medical knowledge, provided eligibility criteria are met. On the other hand, the state is responsible for professionally assessing treatments and their benefits and financing them from public resources.

A decision to include a medicine in reimbursement therefore represents not only improved patient access but also a long-term financial commitment. This depends primarily on the price of the medicine and the number of patients who will use it.

“In practice, every reimbursement decision also represents a decision on how to allocate limited public health insurance resources. Funding a specific therapy means those same resources cannot be used for other healthcare interventions, other patients, or other types of care. This creates significant demands for professional judgement and difficult decision-making dilemmas,” said Deputy Chair of the Office, Jaroslav Ivančo.

Spending on medicines and dietary foods has consistently exceeded planned budgets, surpassing them by a total of €793 million between 2021 and 2024. After 2022, the number of newly included medicines rose significantly, threatening the sustainability of public health insurance resources. Although the law ties approvals to the system’s financial capacity, new medicines continued to be added in 2023 and 2024, creating pressure on the budget and requiring additional state funding.

If expenditure on medicines grows faster than revenues, resources must be reallocated from other parts of the system. This may gradually reduce—and eventually crowd out—funding for other healthcare services.

The most significant shortcomings identified by the audit are concentrated in the area of managed entry agreements (MEAs). Here, procedural flexibility, extensive amendments, and weak oversight of compliance allow financial commitments to be modified without adequate analytical counterbalance.

These agreements between the Ministry of Health and marketing authorisation holders (pharmaceutical companies) are largely confidential and not accessible to the public, contributing significantly to the system’s lack of transparency and limited oversight. Although MEAs are intended to reduce financial risk when introducing new medicines, in practice the state often pays for medicines upfront and only later receives partial reimbursements—if at all, or often with delays.

In 2023 and 2024, pharmaceutical companies were expected to return approximately €72.6 million to health insurers, but €43.5 million has not yet been repaid and remains in company accounts. The maximum penalty for non-compliance is only €20,000, which is clearly disproportionate given repayments reaching tens of millions of euros and fails to incentivise timely fulfilment of obligations.

At the same time, rules and internal documents often do not reflect the current system setup, whose stability increasingly depends on negotiation quality and the state’s ability to control the financial impacts of these agreements.

Auditors found that the categorisation process in the audited years was driven more by practice than by formal rules. Some procedures relied on established habits rather than clearly defined regulations. Consultations with marketing authorisation holders lacked transparency, were not properly documented as required by law, and were often recorded by the applicant rather than the Ministry.

The Ministry’s representation was not formally defined, and the process could not be properly assessed in terms of consultation scope as required by legislation. The voting system of the categorisation committee is also unbalanced.

Analysis of recordings shows that MEA negotiations extended beyond economic conditions and included discussions outside official records, including silent or unclear sections. This raises concerns about whether the process sufficiently protects the public interest and prioritises the protection of public resources.

The audit also identified conflicts of interest at multiple points in the process, particularly through links between individuals from the pharmaceutical sector and state institutions, as well as the appointment of certain managerial positions without transparent selection procedures.

Conflicts also appeared within expert committees, where some individuals participated in preparing analytical materials, then evaluated them, and also formulated recommendations for final decisions.

Financial relationships between experts and pharmaceutical companies—although formally permitted and capped—may accumulate and are primarily monitored through self-declaration. This weakens independent oversight, reduces transparency, and increases the risk that decisions on public resources are not sufficiently objective.

Unlike stricter European rules requiring active assessment and exclusion of experts in cases of conflict of interest, the Slovak model places much of the responsibility on members of advisory bodies themselves.

“If there is no fundamental systemic reform of medicine categorisation processes—strengthening the role of expert assessment and introducing periodic evaluation of benefits and financing—we can expect a continuation of negative trends, including rising expenditure pressures, increasing budget uncertainty, and the accumulation of commitments whose economic impacts are not fully predictable,” added Jaroslav Ivančo.

This will gradually weaken the system’s ability to respond to new technologies and manage cost efficiency. The current setup cannot therefore be considered sustainable from a long-term public finance perspective.

Without stronger analytical integration, control mechanisms, and contractual discipline, there is a risk of further weakening efficiency and increasing the misuse of public resources. Legislative changes have concentrated decision-making powers within the Ministry of Health, which sets rules, manages the categorisation process, negotiates prices, and makes final reimbursement decisions.

The Supreme Audit Office therefore recommends strengthening control mechanisms, making analytical thresholds binding, and formally embedding contractual tools to restore balance between treatment accessibility and protection of public resources, while ensuring long-term sustainability and accountability.

To assess the entry of medicines, the QALY (Quality-Adjusted Life Year) indicator was introduced, representing the health system’s willingness to pay for a unit of health benefit. It is a measure of cost-effectiveness.

In Slovakia, the threshold at which medicines are considered economically efficient increased significantly after 2022 following an amendment to Act No. 363/2011 Coll. Before August 2022, the threshold was linked to average wages and ranged between €30,000 and €46,000 per QALY. The amendment introduced a new approach based on multiples of GDP per capita.

As GDP increased, the threshold rose to €72,000–€240,000 in 2026 (GDP per capita, 2024) for innovative medicines and treatments for rare diseases.

“Despite its relatively weak economic position, Slovakia now has one of the highest cost-effectiveness thresholds for medicines in Europe. Reimbursement is assessed between three and ten times GDP per capita depending on medical benefit expressed in QALY. By comparison, Hungary sets the lower threshold at 1.5 times GDP per capita, while Estonia, Greece and Czechia use one times GDP per capita,” explained Jaroslav Ivančo.

In 2021, the state established the National Institute for Value and Technologies in Healthcare (NIHO) to provide objective, evidence-based assessments of whether new technologies are cost-effective.

Auditors found that in approximately 51% of cases assessed by NIHO, medicines were included in the reimbursement system at higher prices than those deemed economically appropriate by the state’s own analyses. As NIHO recommendations are not binding, the protection of public resources is weakened.

The Office warns that the Ministry is not acting in accordance with the law in the categorisation process, resulting in breaches of financial discipline. The estimated financial impact of such decisions is €244–356 million over five years.

The Supreme Audit Office emphasises that the Ministry must ensure these resources are returned to the system to fund healthcare. Overall, while the categorisation system functions procedurally, it does not currently provide an effective mechanism for protecting public resources and interests.

“We are paying more from healthcare funds than we potentially should, and that is a problem,” concluded Jaroslav Ivančo.