Better access to treatment for patients, or clear rules for the approval of new medicines brings about a new drug reform, which the members of the National Council of the Slovak Republic have moved to second reading. The amendment to the Act on the scope and conditions for reimbursement of medicinal products, medical devices and dietetic foods introduces patients' entitlement to medicinal products for derogation, increases the availability of innovative medical devices, tailor-made medical devices and dietetic foods while at the same time strengthening control over the trade in medicinal products and forgery of prescriptions.
Health Minister Kamil Šaško stressed that this draft law is behind the whole sector and is the result of countless discussions and compromises. The debate on the drug law, which I consider to be one of the key in the field of health, has shown that this Parliament is also able to conduct the correct and constructive debate that the whole sector has followed. I am pleased that no one voted against in the vote on the move to second reading. That's the first important signal. said the Minister for Health. He stressed that any possible changes would be discussed at the level of the Health Ministry round table with representatives of patients, doctors and the entire health sector.The new drug legislation brings the following seven key changes:
1.We are introducing clear rules for the approval of new medicines, setting clear procedural deadlines and conditions for the market entry of medicines, medical devices and dietetics, as well as transparent information on them.
2. More new medicines and easier access to medicines for children and patients with severe diseases.
- we are willing to pay more for modern treatment for those who need it most
- new ways of entering new medicines, following the Czech Republic model
- higher threshold values for paediatric indication medicinal products
- new parameters for the entry of medicinal products with significant clinical benefit and conditional registration accelerated and simplified for at least 3 years
3. We introduce a patient's entitlement to medicines for exemption and clear rules on how to get medicines, including health insurance obligations
- We have completely redesigned the exceptional payment mechanism, introducing the patient's entitlement
- Strengthening Our Competences Health Care Supervisory Authority as Audit Authority
- canceling the financial limit
4.We facilitate the entry of innovative medical devices and dietetic foods with balanced nutritional composition will also be covered.
- gluten-free and low protein pasta and bread will again be covered by public health insurance
5. We ensure the availability and retention of medicines on the Slovak market, on which patients are dependent.
- For the first time in the law, we simply make it possible to call for the prices of generics and biosimilators to be increased - so that these medicines do not leave our market
6. Fight against reexport - we strengthen control of drug trafficking and forgery of recipes so that medicines intended for Slovak patients remain in Slovakia.
- We strengthen control over the legal movement of medicines, we specify the rules of extraordinary ordering
- We impose an obligation on pharmacies to ensure that the non-issued medicinal product is sold back to the wholesaler and the marketing authorisation holder.
- Large distributors and registration holders will have clearer rules to reject suspicious orders
- introducing penalties for infringements so that the rules are clear and enforceable
- tougher penalties for counterfeiting recipes
7.We introduce the concept of treatment certainty - the patient must not remain without his treatment - the registration holder will have an obligation to treat patients.
- patients should never be treated again daily for commercial calculations
