Medical societies, health insurance companies, and patient organizations all have reservations about the amendment to the Medicines Act. Together, they have submitted more than a thousand comments. The Ministry of Health has proposed several changes in the amendment.
These include improving access to modern medicines for pediatric patients and for serious illnesses, ensuring continuity of treatment and the availability of medicines for patients in Slovakia, as well as simplifying and clarifying the conditions for exceptional medicines to enter the market. The proposed amendment also introduces measures aimed at reducing the illegal re-export of medicines.
The ministry wants to reach a consensus in the coming months. The organization Belasý motýľ (Blue Butterfly), which helps people with muscular dystrophy, has also expressed objections to the amendment. It fears that after the proposed changes, patients with rare diseases could face more complicated access to treatment.
“As soon as the European Medicines Agency approves a treatment, it is crucial that patients gain access to it as quickly as possible, because they have no alternative. Even now, they wait much longer compared to other countries,” said Andrea Madunová, chairwoman of the Belasý motýľ organization. The League Against Cancer, together with other patient organizations, has submitted a joint comment on the amendment. According to them, the proposed changes could mean that some patients may not gain access to medicines, or that treatments which currently work could be interrupted.
“We talked about increased administrative and bureaucratic burdens on doctors, who themselves are expected, based on clinical practice, to assess which medicine should or should not be used. As a result, they may have less willingness, or simply not have the time, to fill out applications for exceptional medicines,” said Eva Kováčová, director of the League Against Cancer. “For example, the amendment does not reflect at all the legal guarantees for patients in proceedings before health insurance companies when approving reimbursement for an exceptional medicine. In other words, it does not reflect what the Public Defender of Rights criticized in a submission to the Constitutional Court of the Slovak Republic in May 2025,” explained Branislav Gigac, spokesperson for the Public Defender of Rights.
The Association for the Protection of Patients’ Rights also sees several risks. “Across-the-board reductions in reimbursements could lead to specialized dietary foods being withdrawn from the market—especially products that are essential for saving the lives of patients with malnutrition and patients dependent on dietary nutrition,” said Mária Lévyová, president of the Association for the Protection of Patients’ Rights. The Ministry of Health responded that it is currently reviewing the comments and claims it is preparing for negotiations with all stakeholders in order to find a common agreement.
“I have created a timeframe of more than three months for us to address this, because together with the efficiency of state hospitals and medicines policy, these are two areas which, if resolved effectively, will move Slovak healthcare one step forward,” said Health Minister Kamil Šaško (Hlas-SD).
Parliament is expected to debate the amendment in the spring. If approved by lawmakers, it should come into force in the autumn.
Source: STVR
