Top-notch treatment can save a person's life. If available, the doctor will decide at the right time. The patient is a priority for the Ministry of Health, so drug policy experts have prepared an amendment to the law, thanks to which today unavailable expensive medicines should no longer be a taboo topic for Slovak patients. The amendment to Law 363/2011 has now entered into inter-ministerial commentary proceedings. The amendment aims to promote the entry of innovative medicines, as well as the transfer from the exemption regime approved by the health insurance undertaking to the regime categorised, that is to say, standard reimbursements from public health insurance. We aim to ensure that innovative medicines, with proven clinical effect, are normally paid without any differences by all health insurance companies. We are therefore putting into practice negotiations with producers and we want the regulations to be clear and clear what will ever apply. At the same time, we want patients to have a better overview of the processes and their impacts. Vladimír Lengvarský, Minister of Health of the Slovak Republic, will therefore be directly involved in the processes.
This brings greater transparency and predictability to the whole system, with the involvement of patient representatives, and the State Secretary Róbert Babeľa MZ SR explained. In the context of the government's programme statement, the resort is also working on further steps to obtain treatment for severely ill patients. The Slovak Republic is the only country across the EU where the threshold of cost efficiency based on QALY is linked to the average monthly wage. The Ministry of Health therefore wishes to amend the mechanism for calculating the threshold for assessing the cost-effectiveness of medicinal products by amendment.Slovakia will follow the same principle as other EU countries and the QALY economic parameter will be linked to GDP. When considering medicines in addition to QALY, we will mainly look at the medical need, but we will also create room for assessing others, e.g. social impacts. This measure will also ensure faster entry of new effective medicines into the system of public payments and their availability to Slovak patients, describes Peter Polák, general director of the Department of Pharmacy and Drug Policy of MZ SR.
The resort also aims at a more efficient process of concluding contracts on the conditions for reimbursement of medicines.

Agreements between producers and health insurance companies are standard in all European countries. Although they were introduced in Slovakia a few years ago, they do not work and very few were closed. This caused new drugs not to enter the system and patients to have them available through approved exceptions or at all.
The agreements will therefore be concluded with producers by the state responsible for the therapeutic opportunities it intends to offer to citizens. This will significantly strengthen the state's bargaining power. In practice, if medicines do not comply with the economic conditions for their inclusion in the system of public reimbursement, they will be able to enter the market when pharmaceutical companies offer discounted prices for medicines and agree conditions of entry with the State, Minister Lengvarsky explained.
At the same time, the Ministry of Health plans to extend the possibility of concluding a contract on the terms and conditions for reimbursement of a medicinal product to cover all the approved indications, that is, if one medicinal product is also intended for several diagnoses, the resort will look at it as a whole and thus deal with manufacturers.
Thus, new medicines can enter the system cheaper, simpler and faster and, above all, will be available to patients throughout the wide range and not only limited, as has been the case so far. added Róbert Babeľa State Secretary.
Patients with rare disease should no longer be discriminated against thanks to the novelty. Unique diseases have so far been defined in Slovakia according to the Ministry defined ratio of occurrence in populations. Unfortunately, it was not in any way aligned with the rest of Europe. This is changing with the amendment and people with rare diseases will be treated in the same way as elsewhere in Europe.
We also want to introduce new categories of drugs into the law, namely drugs for very serious diseases and new innovative medicines, under which the drugs of the future will fall, such as the latest cell or gene therapies,
On the other hand, we want all these medicines to be paid only in proportion to the clinical benefit that the medicine brings to the patient. Unique medicinal products as well as medicinal products for major diseases and innovative medicinal products will therefore be required to submit a pharmaco-economic analysis. This means that the medical need of the medicine for Slovak patients will be assessed, but also financial efficiency and budgetary impact. We will ensure sufficient, reliable and verifiable information on the basis of which we will be able to make a responsible decision on the clinical benefit and economic impact of these medicines, Róbert Babeľa, State Secretary of the MZ SR, explains in detail which field of pharmaceutical and pharmaceutical policy falls under.
In the long term, it was also in our system for medicinal products that are categorised but not fully covered, determined so-called fixed surcharge. This was particularly a disproportionate burden on the patient and the system for expensive, oncology or biological treatments. – We are therefore introducing a so-called exemption from the fixed surcharge and, for those medicines where there is no generic or biosimilar medicine, or where there is a contract with the manufacturer, we will ensure that the difference between the full price and the fixed price can be compensated for by the patient. We will also review the existing reimbursement groups and in those where there will be a supplement of more than 3% and there will be no medicine with a lower supplement, we will ensure that the patient gets compensation, says Minister of Health of the SR Lengvarský.
For patients in the case of treatment e.g. oncology or isolated diseases, this will mean the possibility of reducing or abolishing the surcharge completely.
Effective spending of funds will also be ensured by the resort by promoting the market entry of generic and biosimilar medicines. The Ministry also plans to introduce an automatic review of credit transfers and to change the three-threshold entry of generic and biosimilary medicinal products into single-threshold. This will ensure that these medicines enter the system faster and easier and are realistically available to patients.
Public resource savings will also ensure more effective reviews of reimbursement or referencing of medicines so that they continue to be among the three cheapest in Europe when they enter. For this purpose, we will also introduce new tools, such as the introduction of a new process for determining credit transfers or the possibility of determining that a medicinal product is subject to specific price regulation, Minister Lengvarsky explained.
The resort also plans to dig through the system of medical devices to make them more accessible to patients. For some medical devices, patients wait too long for bureaucracy. For selected medical devices, we will therefore introduce exemptions from the obligation to submit medical-economic analysis and automate their entry into the system, as is the case in the Czech Republic, for example, and the State Secretary of the Ministry Róbert Babeľa says.
In order for medical devices to have equivalent opportunities to medicinal products, the resort wants to introduce the possibility of concluding a contract on medical device reimbursement conditions, special medical material or dietetic food between the Ministry or health insurance company and the manufacturer/large distributor. Conclusion: what we want to bring to patients by amending legislation:- access to modern, advanced medicines, which are also available elsewhere in Europe and the world: enabling and promoting the entry of new medicines;