The Slovak National Council approved the amendment of the Act No. 363/2011 Coll. on the scope and conditions of reimbursement of medicines, medical devices and dietetic foods. This is a significant milestone for the Kamil Šaška health sector, as the new legislation is the result of several months of negotiations of the MZ SR with representatives of the whole health sector.
Patients will no longer have to beg for treatment. Thanks to this reform, they will be entitled where the willingness of the insurance company has so far been determined. If they meet clear criteria, the exemption medicinal product must be paid by the insurance undertaking and this principle will be the same in all three insurance undertakings. We are abolishing the ceiling that limits spending on these medicines, introducing shorter deadlines and better surveillancesaid Minister of Health Kamil Šaško.
Drug policy reform will ensure:
- clear rules for the approval of new medicinal products in the categorisation,
- a patient's entitlement to a medicinal product for exemption and removal of the insurance premiums ceiling,
- facilitating the entry of innovative medical devices,
- more new medicines and easier access to medicines,
- the availability and continued availability of generic and biosimillary medicines on the market,
- combating reexport, strengthening control over drug trafficking and forgery of recipes,
- the introduction of the concept of treatment certainty must not leave the patient without treatment.
The biggest change is prioritisation, which will allow new medicines to enter the system according to patients' needs. The recommendation will be made by a panel composed of experts, doctors and patient organisationsadded the minister.
The amendment will increase the availability of innovative medical devices, tailor-made medical devices and dietetic foods, while also responding to the need to eliminate application uncertainties, align national legislation with European Union law and international standards, and to ensure a higher level of legal certainty for regulated entities in the field of human and veterinary pharmaceuticals, transfusion services and distribution chains of medicinal products. The new legislation will enter into force on 1 November 2026, with the exception of the provisions of the derogation medicines which will apply from January 2027.
