Sep 14, 2026
HFS supports both an innovative medicines fund and stronger patient rights under the reimbursement amendment, and expects a concrete plan: entry rules, quantified financing, clear responsibility and a timetable.
Healthy Future of Slovakia (HFS), an expert healthcare initiative of the Future Slovakia Forum think tank, supports the creation of an innovative medicines fund as part of a system of early access to selected therapies. At the same time, HFS considers it important to preserve and complete the legal safeguards for patients pursued by the amendment to Act No. 363/2011 on the scope and conditions of reimbursement of medicines.
In the view of HFS, the debate about the future of the medicines fund should not be reduced to a false choice between the amendment and the fund. Strengthening patients’ legal position and creating a functioning fund should complement each other, not block each other. Patients should know under which conditions treatment is reimbursed, receive a clear justification of each decision and have an effective way to have it reviewed. Supporting these principles does not mean blanket approval of every provision of the amendment, nor a claim that it will solve every access problem.
The amendment and the fund serve different purposes
The draft amendment already contains a special entry route for selected medicines, including conditionally authorised therapies, provisions on real-world data and a subsequent reassessment of reimbursement. Managed access therefore does not have to be created solely through a separate fund. HFS nevertheless distinguishes three functions. Categorisation sets the reimbursement conditions of a medicine for defined indications and patient groups. The exceptional reimbursement route addresses needs that standard reimbursement does not cover. The innovative fund should provide separately planned and monitored financing for managed access to selected high-cost therapies where the evidence still needs to be completed before a decision on their further reimbursement status.
The added value of the fund should not be yet another approval step, but the combination of timely access, predictable financing, risk sharing and mandatory evaluation of outcomes in a single, accountably managed programme. The fund must build on categorisation and existing reimbursement agreements, not duplicate or bypass them.
The HFS expert group stresses that the fund should be a stable part of the system, not a promise repeated by every new minister. Developing the fund must not weaken patient protection under the amendment, and the amendment must not become an excuse for postponing the fund.
What kind of fund HFS proposes
Within REFORMA 3.3, HFS understands the innovative fund as an earmarked, separately monitored and budget-capped early-access mechanism. Its legal form, funding sources and financial scope still need to be worked out. The fact that implementation remains open, however, does not mean that HFS is abandoning the objective.
• Priority should go to selected therapies with significant expected clinical benefit and unmet medical need, particularly in very rare diseases and advanced therapies, including gene and cell therapies.
• Inclusion should not be decided by price, an “innovative” label or the strength of a public campaign alone, but by expert assessment of benefit, uncertainty, disease severity and budget impact, with standardised patient involvement.
• Temporary reimbursement must have conditions agreed in advance: for whom it is intended, which outcomes will be monitored, who will supply and evaluate the data, and when a decision will be made to continue, adjust or end it.
• The rules must determine in advance who is responsible for completing treatment or ensuring a safe switch to a suitable alternative if the reimbursement regime changes, so that the burden does not fall on the patient once a contract expires.
• Real-world data should support both decision-making and oversight, with a legal basis, protection of patient data and a clear public overview.
Separate financing does not mean money outside the rules
The fund must be part of a common multi-year financial framework for healthcare, with a defined budget, rules for its use and a procedure for rising commitments. It cannot be created as an open-ended promise of reimbursement without funding, and its financing must not cause an unacknowledged shortfall in other necessary care. Multi-source financing must be quantified, not merely named: shifting money between existing budget lines does not create new money, and the same saving cannot be counted twice. HFS also does not present new medicines or data collection as an automatic promise of savings.
From promises to a concrete plan
HFS expects the Minister of Health to set out a long-term vision and a feasible strategy both before and after the 2027 elections – regardless of who leads the ministry. From the current ministry leadership, HFS expects concrete decisions and preparatory work that need not wait for the election result. From the leadership after the elections, it expects continuity with demonstrably effective steps, correction of those that do not work, and regular public evaluation.
For the medicines fund, this test is concrete. HFS expects a plan for establishing the fund that sets out entry rules, links to categorisation and exceptional reimbursement, quantified financing, clearly assigned responsibility and a timetable.
Open technical and financial questions are a reason to develop the fund responsibly, not to abandon it. The vision must reach beyond elections. Responsibility for delivering it, however, starts today.
The full HFS position (in Slovak) was published by ozdravme.sk on 14 September 2026.
Healthy Future of Slovakia is an expert healthcare initiative of Future Slovakia Forum. It is developing REFORMA 3.3, a system-wide expert framework for Slovak healthcare that is currently being reviewed by an international Advisory Board. REFORMA 3.3 is neither a government programme nor a party-political platform.