Not every medication that is legally available in the Slovak Republic is also covered by health insurance.
Uncategorized medicines (so-called off-label drugs) represent a group of registered medicines that, although duly registered and prescribable, are not included in the list of categorized medicines under the Act on Reimbursement. As such, they are not subject to the standard public health insurance reimbursement system.
The reimbursement of an uncategorized medicine is not based on a statutory obligation but solely on an individual assessment and subsequent approval by the health insurance company. Under § 88(6) of the Act on Reimbursement, the insurer may define its own criteria for deciding whether to grant coverage. The issue is not only the absence of a legal entitlement to reimbursement but also the lack of statutory standards for the decision-making process itself. The law sets no binding conditions or objective criteria that insurers must follow. Decisions are therefore made according to internal rules independently adopted by each insurer.
Although certain common decision-making elements have emerged in practice — such as medical necessity, uniqueness and justification of treatment, public interest, or compliance with legal and regulatory requirements — these remain internal and non-binding. The absence of a uniform and enforceable legal framework leads to unpredictable and inconsistent application, meaning that patients in comparable medical situations may find themselves in fundamentally different positions.
A request for reimbursement of an uncategorized medicine is submitted by a healthcare provider (e.g., the treating physician) in written form to the health insurance company, which must issue a decision within the statutory period of 15 or 10 working days. If reimbursement is approved, the maximum amount covered is 70% of the medicine’s price.
The Issue of Violation of the Right to Healthcare
The provisions governing reimbursement of uncategorized medicines raise serious constitutional questions, particularly in relation to the right to healthcare guaranteed by Article 40 of the Constitution of the Slovak Republic, Article 31 of the Charter of Fundamental Rights and Freedoms, and the Convention on Human Rights and Biomedicine.
Although these instruments stipulate that free healthcare shall be provided “under the conditions established by law,” in the case of uncategorized medicines, the decision-making process often takes place outside the statutory framework, since insurers determine the criteria themselves through internal regulations. This represents the first level of potential interference with the constitutionally guaranteed right to healthcare.
According to § 88(6) of the Act on Reimbursement, insurers may independently determine the conditions a reimbursement request must meet. However, the law contains no uniform or binding rules governing such decisions, resulting in legal uncertainty. Even when an applicant meets all of the insurer’s conditions, reimbursement is not guaranteed. In practice, insurers sometimes deny reimbursement even when the medicine is the only suitable and available treatment for a rare or atypical condition. The Slovak National Centre for Human Rights has also highlighted this disproportion, identifying it as a violation of the principles of equality, non-discrimination, and legal certainty. Patients dependent on exceptional (“out-of-list”) medicines are objectively disadvantaged compared to those whose treatments are reimbursed in the standard way.
The second level of interference concerns the position of the insured person in the reimbursement proceedings. The applicant is not the patient, but the healthcare provider — usually the attending physician. The patient is not a party to the proceedings and therefore cannot actively participate in the decision-making process or exercise their rights. Furthermore, any appeal against a denial can again be filed only by the healthcare provider. In practice, this means that the patient may have no influence over whether an appeal is filed at all or whether a decision directly affecting their health will be reviewed.
This procedural issue has been raised before the Constitutional Court in case PL. ÚS 1/2025, where the administrative court pointed to the constitutional problem of excluding the patient from the decision-making process. According to the court, the legal system does not allow a patient to directly defend their rights before the health insurer, which is incompatible with the principles of the rule of law and the protection of fundamental rights — especially when such shortcomings can have a direct impact on a patient’s health.
These two aspects — the absence of statutory, enforceable rules on the one hand and the exclusion of the insured person from the decision-making process on the other — open a broader legal debate about the scope of constitutional protection of the right to healthcare. Although the law formally grants patients a right to healthcare covered by public insurance, in the case of uncategorized medicines this right may in practice be significantly weakened.
When access to healthcare is determined by internal rules of insurance companies without the patient’s participation or any possibility to review the decision, serious doubts arise as to whether access to healthcare is truly equal and available as required by the Constitution. The right to healthcare should not remain merely a formal declaration in law, but should be effectively enforceable in practice — only then can it retain its real meaning and social function.
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