Life Sciences 3Q/2025
Lukáš Michálik, LL.M.
Klaudia Popélyová
Natália Polomská
Dear Reader,
we are pleased to present to you a quarterly overview of news in the field of Life Sciences in Slovakia and the European Union. In this issue, we will briefly introduce you to the changes or legislative amendments that have entered into force or are still in the process of approval and relate to drug policy, health care or regulation of related areas that affect the Life Sciences field.
EU cardiovascular health plan
The EU plan for cardiovascular health will prioritize measures that deliver concrete benefits to individuals, governments, and stakeholders across the EU.
The plan seeks to strengthen the EU’s economic resilience by:
- improving the health of millions of citizens through prevention, early detection and treatment,
- fostering innovation,
- strengthening the market capacity and competitiveness of the EU health sector.
The Commission is expected to adopt the plan in the fourth quarter of 2025.
For more information:
Crucial amendment to Act No. 363/2011 Coll.
Members of the National Council of the Slovak Republic have submitted a draft amendment to Act No. 363/2011 Coll. on the scope and conditions of reimbursement of medicinal products, medical devices and dietary foods based on public health insurance and to Act No. 581/2004 Coll. on health insurance companies, supervision of healthcare and on amendments to certain laws. The parliamentary draft focuses on expanding access to reimbursed medicinal products, revising reimbursement lists, and adjusting conditions for co-payments and administrative procedures to increase transparency and reduce burdens on patients and providers. A key element of the proposal is also the establishment of the Fund for the Reimbursement of Selected Medicinal Products, which will be created by transforming the existing Health Quality Fund. The Fund is to provide targeted and predictable financing of innovative and high-cost therapies, with contributions not only from public health insurance but also from market authorization holders.
In parallel, the Ministry of Health has presented its own proposal for amending the same Act, discussed within a roundtable with stakeholders. This initiative emphasizes the creation of clear legal conditions for reimbursement of exceptional medicinal products, medical devices and dietary foods, including the establishment of a dedicated Fund by transforming the existing Health Quality Fund. The Ministry of Health aims to ensure long-term sustainability of the reimbursement system while strengthening patient access to modern and effective treatment.
For more information:
Crucial amendment to Act No. 363/2011 Coll.
Europe as a world leader in the life sciences
The European Commission has launched a new strategy, as part of the Competitiveness Compass, aimed at making Europe the most attractive place in the world for life sciences by 2030. The strategy builds on a public consultation and a wide body of evidence, including two studies prepared by the Commission’s Joint Research Centre.
The strategy proposes to:
- optimize the research and innovation ecosystem through an EU investment plan to facilitate the financing of clinical trials conducted in multiple countries,
- enable rapid market access for innovations in the life sciences by proposing a European Biotechnology Act,
- boost confidence in innovation, as well as its uptake and deployment, by raising EUR 300 million to stimulate public procurement of innovation in the life sciences, focusing on areas such as climate change adaptation, next-generation vaccines, and affordable cancer treatments.
For more information:
Europe as a world leader in the life sciences
Draft decree of the Ministry of Health on the details of contracts for the provision of healthcare and on model contracts for the provision of healthcare
The aim is to fulfill the commitment from the Memorandum of 2022 on improving the Healthcare system.
The following shall be established:
- the method and form of stating the amount of reimbursement in the contract for the provision of healthcare so that it is possible to compare these reimbursements between individual healthcare providers and social assistance facilities,
- model contracts for the provision of healthcare,
- the minimum payment for healthcare provided in the amount of economically justified costs and the definition of economically justified costs.
For more information:
Draft decree of the Ministry of Health on the distribution of public health insurance expenditures by type of healthcare for 2026
The aim of the draft decree for 2026 is to establish the distribution of public health insurance expenditure by type of healthcare and to enable public health insurance resources to be directed to areas that are priorities of Slovak health policy.
A preliminary information notice on the preparation of the decree has already been published. The Ministry of Health is required to establish, by means of a generally binding legal regulation, the distribution of public health insurance expenditures according to individual types of healthcare by 1 February of each year.
For more information:
Amendment to the law on the public health insurance system
A draft amendment is being submitted to amend and supplement Act No. 580/2004 Coll. on insurance and related legislation.
The amendment primarily addresses:
- the entry of self-employed individuals from third countries,
- procedures related to viewings of the deceased,
- protection of families and children.
It introduces specific conditions for the entry of self-employed individuals from third countries and establishes rules for children born outside the Slovak Republic, who would now be insured from birth.
The amendment also proposes to shorten the period for withdrawing health insurance applications to 30 days from the date of submission, replacing the current deadline of 31 October, which is considered disproportionately long and in practice allows for an informal second phase of switching insurers after the official deadline.
For more information:
Amendment to the law on the public health insurance system
Revoked measures on refusal to grant approval for reimbursement of medicinal products
At hearing on 22 August 2025, the Administrative Court in Košice upheld two lawsuits filed by the General Prosecutor’s Office of the Slovak Republic against health insurance companies’ refusal to approve reimbursement for the exceptional medicinal products VOXZOGO, which is indicated for the treatment of achondroplasia.
In both cases, the Administrative Court agreed with the legal conclusions of the General Prosecutor’s Office of the Slovak Republic and revoked the measures taken by the health insurance companies as unlawful.
For more information:
Revoked measures on refusal to grant approval for reimbursement of medicinal products
New decree of the Ministry of Health for outpatient clinics
The Ministry of Health has adopted a new decree regulating the minimum requirements for staffing and material and technical equipment in outpatient healthcare facilities.
The decree is intended to simplify the operation of outpatient clinics, improve the use of staff and equipment, and maintain the safety and professional standards of care provided, including:
- the employment of a practical nurse – assistant in a specialized outpatient clinic,
- the sharing of nurses or equipment between two to four outpatient clinics in the same location.
The decree came into force on 22 September 2025.
For more information:
New decree of the Ministry of Health for outpatient clinics
Discussion on the draft amendment to Act on the conditions of reimbursement of medicinal products
17 leading experts have discussed the draft amendment to Act No. 363/2011 Coll. As part of the preparation process, the Ministry of Health plans to hold consultations with the general public, representatives of health insurance companies, and pharmaceutical companies before launching the formal legislative procedure.
For more information:
Discussion on the draft amendment to Act on the conditions of reimbursement of medicinal products
New project of the Ministry of Health
The Ministry of Health has officially launched a new national project for the systematic creation of standard clinical procedures.
It should provide the base for improving the quality, efficiency, and consistency of healthcare in Slovakia and it follows up on national projects from years 2017-2023.
The aim is to strengthen the outpatient sector, which is a key part in the provision of primary and specialized healthcare.
The use of standard clinical practices will contribute to:
- definition of responsibilities between pharmacies and other healthcare staff,
- improving the quality of healthcare,
- unification of procedures in the field of medicinal products,
- elimination of the wrong procedures,
- raising prevention awareness,
- increasing the detection rate of preventable diseases through screening.
For more information:
New project of the Ministry of Health
Better cancer prevention
Patients in Slovakia can expect significant changes in cancer screening programs. The Ministry of Health has prepared a proposal to strengthen prevention by revising existing screening rules. However, the Association of Private Doctors has called on the Ministry of Health to withdraw the material, arguing that the changes were not properly communicated with medical professionals and were not discussed in expert working groups. According to the association, the draft also contains a number of errors.
Several changes are expected, such as:
- updated criteria for patient selection,
- changes to screening rules for colorectal cancer, cervical cancer, lung cancer, and breast cancer,
- how patients are invited.
For more information:
Provision of one-day healthcare – analysis by the Health Care Supervision Authority
On 21 August 2025, the Health Care Supervision Authority published a comprehensive analysis of the activities of health insurance companies in the field of one-day healthcare for 2024.
Although the number of patients declined, the overall costs of one-day healthcare also decreased compared to 2023.
In 2024, Všeobecná zdravotná poisťovňa concluded 184 contracts for the provision of one-day healthcare with healthcare providers, Dôvera zdravotná poisťovňa concluded 203 contracts, and Union zdravotná poisťovňa concluded 244 contracts.
For more information:
Provision of one-day healthcare – analysis by the Health Care Supervision Authority
More expensive treatment for cancer patients
The Ministry of Health has removed 5% glucose as an essential medicinal product for cancer patients from the list of categorized medicinal products.
After the removal, the price of glucose is not regulated, so pharmacies sell it at their own discretion. Glucose is a fundamental component of treatment, and therefore its removal directly endangers patients.
For more information:
More expensive treatment for cancer patients
Vaccination will be among the certified activities of pharmacists from October
Vaccination of adults will be included among the certified work activities of pharmacists. This results from a government regulation on professional competence for the practice of healthcare professions. After completing certification training, pharmacists will be authorized to administer flu vaccinations in pharmacies. This represents the final step towards the effective implementation of the new competence of pharmacy care providers, which has been provided for in law since the beginning of 2025.
For more information:
Vaccination will be among the certified activities of pharmacists from October
SALUS Haus vs. Astrid
Judgment of the Court of Justice of the European Union (CJEU) of 26 June 2025 in case C-186/23 concerned the classification of certain products, such as medicinal teas, under the terms “medicinal products” or “foodstuffs.”
The CJEU ruled that in order to qualify as a traditional herbal medicinal product, a product must meet all the requirements set out in Directive 2001/83/EC. Such products cannot simultaneously fall within the scope of other legislation not specific to medicinal products.
Specifically, the CJEU held that Article 1(29) and Article 16a of Directive 2001/83/EC must be interpreted as meaning that products classified as “traditional herbal medicinal products” within the meaning of those provisions, and thus falling within the scope of Directive 2001/83, cannot at the same time be considered “traditional herbal preparations” within the meaning of Annex I to Regulation (EU) 2018/848, which fall within the scope of that Regulation pursuant to Article 2(1).
For more information:
Novartis to acquire Tourmaline Bio
Novartis has announced the acquisition of Tourmaline Bio, a clinical-stage biotechnology company, in a transaction valued at around USD 1.4 billion. Tourmaline’s lead product, pacibekitug, is an anti-IL-6 monoclonal antibody developed to address residual inflammatory risk in atherosclerotic cardiovascular disease.
In a Phase 2 trial, pacibekitug reduced high-sensitivity C-reactive protein levels by about 85–86% compared to placebo, with a safety profile comparable to control. The medicinal product is now ready for Phase 3 clinical development and has the potential to complement existing cardiovascular therapies by targeting systemic inflammation, a driver of cardiovascular risk not fully addressed today.
Under the terms of the agreement, Novartis will launch a tender offer at USD 48 per share in cash. The transaction is expected to close in the fourth quarter of 2025, subject to customary regulatory approvals.
For more information: