2026-05-13
More rules, more access? Slovakia's draft amendment to § 88 of Act 363/2011
We have all experienced that the original § 88 was a pressure valve. In a system that has long restricted reimbursement of innovative drugs to manage the budget, it gave health insurers a discretionary tool to ease the impact of restrictive categorisation in individual cases, a narrow, simple mechanism that eventually evolved into a financially capped exception. That role gave it a clear systemic logic: categorisation was the main gate, exceptions were the edge case.
The proposed § 88a – § 88i fundamentally changes that. What the explanatory memorandum still calls a "statutory safeguard" becomes a fully proceduralised parallel approval mechanism: five separate legal titles, entitlement-based and discretionary tracks, two-stage decision-making, appeals, and a statistical layer. Conceptually, it is a partial fix that does not address the root problem, slow and insufficient access to modern therapies in standard categorisation.
The irony is that the explanatory memorandum itself warns against creating a "parallel categorisation", and the draft moves exactly in that direction. The hard 1.9% cap is removed and replaced with a "sufficiency of funds" test based on a methodology the Ministry has yet to issue. Entitlement titles (§ 88a, § 88b) leave insurers no room to refuse on budgetary grounds. For continuation of treatment, budget grounds are explicitly excluded. The result is an open-ended financial commitment without a firm ceiling. This is fiscally unsustainable by design.
The systemic answer is the opposite direction: narrow § 88 to genuinely exceptional individual cases, and open standard categorisation to more innovation through an improved HTA approach, broader use of managed entry agreements, and faster pathways for paediatric, oncology and orphan indications.
And here is the uncomfortable part we keep avoiding: we cannot build a system that delivers every treatment to everyone. We need the courage to say openly that, as a country, there are certain expensive technologies we cannot afford, and to say it to everyone, with no exception. That is the only honest form of equity left to us. Today's § 88 quietly produces the opposite: unequal access driven by who shouts loudest, who has the best provider, or which insurer they happen to be with. A clear, transparent "no" applied to all is more equitable than a discretionary "yes" applied to some. The draft amendment does not move us closer to that honesty, it institutionalises the ambiguity.
This is a textbook example of regulation that, instead of simplifying, adds another layer of rules on top of a dysfunctional base, at a time when Europe is being criticised for exactly this kind of overregulation. The full consequences will only become visible in time.
