Patient access to treatment and the availability of medicines in Slovakia are set to improve under an amendment to the law governing the scope and conditions for reimbursement of medicines, which Parliament approved on Tuesday (October 6). The new legislation introduces several changes, including a legal entitlement for patients to so-called exceptional medicines, clearer and more transparent rules for the categorization process, faster market access for new medicines, and measures to reduce the illegal re-export of medicines. Health Minister Kamil Šaško (Hlas-SD) announced the changes at a press conference on Wednesday.
The amendment introduces a patient entitlement to exceptional medicines, meaning medicines that are not covered by public health insurance. It also sets clear rules governing access to such medicines, including obligations for health insurance companies. “Until now, entitlement to such medicines was decided by the three insurance companies we have in Slovakia. Each had its own internal methodologies and processes, and patients were, so to speak, left to fend for themselves and did not know where to turn if such an exception was rejected,” Šaško explained. Under the new system, uniform criteria will be set directly in law and will apply equally to all three insurers. Patients who meet the criteria will be entitled to reimbursement. If an insurer rejects a patient’s request, the legality of its decision will be reviewed by the Health Care Surveillance Authority.
The amendment also abolishes the financial limit on health insurers for reimbursing exceptional medicines. “There is still a budgetary limitation within the overall ceiling for public expenditure, meaning the total allocation earmarked for medicines. So there is still a ceiling, but within those resources, insurers can manage their patients and will no longer be restricted by nonsensical caps,” Šaško said.
New medicines should enter the system more quickly and based on patients’ specific needs, particularly medicines for conditions where there is no alternative available on the market. “Such medicines will not have to go through the lengthy so-called categorization process,” the health minister said, adding that an expert committee will decide which medicines should be prioritized. The reform also establishes clearer and more transparent rules for approving medicines through the categorization process and includes measures aimed at ensuring that generic and biosimilar medicines remain available on the Slovak market over the long term.
The legislation also introduces measures against the illegal re-export of medicines. “Medicines intended for Slovak patients must, first and foremost, remain in Slovakia. Nobody can make a business out of this, and only once Slovak patients have been served, then by all means,” Šaško said. He also pointed to a proposal under which falsifying a medical prescription would become a criminal offense. The proposal was prepared jointly by the Health Ministry and the Justice Ministry and was approved by the government in August.
Speaker of Parliament Richard Raši (Hlas-SD) welcomed the amendment, describing it as a major step in improving patients’ access to medicines. “This is a law that literally and precisely improves access to medicines for our patients across the entire range of diseases, including cancer and rare diseases,” he said, adding that it would improve access for patients who had previously struggled to obtain their medicines. Šaško thanked lawmakers and everyone involved in preparing the amendment, while stressing that further work remains, including the adoption of implementing regulations and guidelines in cooperation with the healthcare sector. The law takes effect on November 1, with all key changes expected to apply from January 2027 after the necessary technical details are finalized.
Source: TASR
