The amendment to Acts 362/2011 and 363/2011 aims to bring clear rules for the entry and reimbursement of medicines, faster decision-making, and fewer inequalities among patients. The ministry is inspired by the Czech approach and promises predictability for doctors and insurers while maintaining budget sustainability. A key theme is an overhaul of the exceptional reimbursement regime under §88 and measures against re-export.
Clearer rules and faster entry of medicines
The Ministry of Health wants to set uniform, predictable procedures for everyone in the sector: how medicines enter categorization, how doctors will plan treatment, and what patients can expect. Alongside standard cost-effectiveness assessment, the entry of certain innovative medicines, including those with conditional registration, is to be eased and accelerated. The inspiration is the Czech model, where similar "fast track" rules already operate.
An important change is discounts granted already at entry, so that funds return to the system immediately and are used for treatment. The ministry states that since autumn dozens of new medicines and indications have been added with a managed budget impact, with the aim of bringing therapy availability closer to the level in the Czech Republic. Elements of risk management and expert assessment are to remain, but with greater emphasis on predictability for practice.
Exceptions revamped: uniform rules and shorter deadlines
The biggest intervention concerns §88 on exceptional reimbursement, which, according to critics, restricted patient access through a fixed percentage of the budget and uneven rules among insurers. Exceptions, however, will not disappear entirely, as they are needed for off‑label use, after transplants, or for innovative medicines with incomplete data. The goal is for patients to have the same conditions in these situations regardless of insurer.
The new process envisages two branches of exceptions with a defined entitlement and an insurer's decision within 15 days. Repeated internal appeals will be shortened: after a rejection, the patient may turn directly to the courts and at the same time to the Office for Supervision, which is to gain the power to review the case within two months and impose a fine if the rules were not followed. It also includes systematic collection of data on rejected applications, to make clear where the system is failing, and education of doctors and patients will be important as well.
Re-export and the availability of "old" medicines
Parallel export is primarily a consequence of price differences in the EU, so it is not only a moral issue. The amendment seeks to significantly curb re-export by tightening rules, joint inspections by the Slovak and Czech regulators, and also criminalizing prescription forgery in cooperation with the Ministry of Justice. The aim is for pharmacies to be first and foremost places for the safe and reliable dispensing of medicines, not channels for export.
It also addresses the withdrawal of proven, low-cost medicines from the market and their subsequent price increases outside categorization. Generic medicines will be able, via a simple application, to return to the average of the three lowest prices, and for critical molecules even to the third-lowest price, so that they remain available. The measures are intended to stabilize supply and reduce pressure on exceptions, although the complete disappearance of re-export or exceptions cannot be expected; success will be their reduction in frequency and greater predictability for the patient.
