Life Sciences 2Q/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.
Changes in legislation
The Ministry of Health of the Slovak Republic has submitted two drafts and so began the process of statements on preliminary information.
The first is a draft of act on fund to cover the cost of selected medicinal products. The aim of this draft is to allow the reimbursement of selected medicinal products through the newly established Fund.
The second is draft of the act amending Act no. 363/2011 Coll. On the extent and conditions of reimbursement of medicinal products, medical devices and dietic foods based on public health insurance and amendments to certain acts, as amended. The aim is to adjust the conditions for the entry of medicinal products to isolated diseases and medicinal products for serious illnesses for categorization.
For more information:
Data Reform and Digitalisation of Healthcare
The Ministry of Health of the Slovak Republic has submitted a draft amendment to Act No. 153/2013 Coll. on the National Health Information System.
The primary objective of this amendment is to reduce the administrative burden on healthcare professionals, improve the availability and quality of healthcare data, and support the effective use of digital tools in the health sector.
Additional legislation will also be amended. For example, Act No. 576/2004 Coll. will be amended to include updated definitions of live birth, stillbirth, and abortion.
The draft further proposes the digitalisation of the process of voluntary termination of pregnancy upon a woman’s request, with the aim of making the process more flexible and accessible in line with the system’s technological capabilities.
The law is proposed enter in force on 1 January 2026.
For more information:
Data Reform and Digitalisation of Healthcare
EU Pharma Package updates
The Council has adopted its position on new legislation intended to ensure a fairer and more competitive pharmaceutical sector in the EU.
The proposed regulation and directive, which together form the so-called pharma package, aim primarily to:
- ensure fair access to effective, safe, and affordable medicinal products for all EU patients,
- increase the competitiveness of the EU pharmaceutical industry,
- address supply security through measures focused on monitoring and preventing shortages,
- reduce the environmental impact of medicinal products through more effective enforcement of environmental rules.
The Council’s mandate for negotiations with the European Parliament sets out several key amendments to the proposed legislation, including regulatory data protection, regulatory market protection, obligation to supply, transferrable exclusivity voucher, and intellectual property exemption for generic medicinal products.
The Council is now ready to enter into negotiations with the European Parliament with the aim of reaching an agreement on the legislative package. The new rules will be adopted following legal-linguistic revision.
For more information:
EFPIA statement on the Pharma Package
On 4 June, the EU Council announced its position on the revision of the General Pharmaceutical Legislation, prompting concern from the life sciences sector. Critics, including European Federation of Pharmaceutical Industries and Associations (EFPIA), argue that the reforms fail to provide the clarity and stability needed to support pharmaceutical innovation in a volatile global environment.
The decision to reduce intellectual property protections is seen as a deterrent to investment and a threat to Europe’s competitiveness in drug development. While some member states recognize the need to boost Europe’s edge, the final text lacks bold action. EFPIA calls on EU legislators to prioritise long-term competitiveness as the legislative process moves forward.
For more information:
EFPIA statement on the Pharma Package
Amendment to Decree No. 129/2012 Coll. on the Requirements for Pharmacy Practice
A draft decree of the Ministry of Health of the Slovak Republic, which amends and supplements Decree No. 129/2012 Coll. on the requirements for pharmacy practice, is currently undergoing the legislative process.
One of the key changes is the expansion of the scope of pharmaceutical care to include new activities. Certain examinations and vaccinations will be allowed to be carried out directly in the pharmacy.
The decree also introduces new types of specialized departments, establishes the obligation to continuously monitor and record temperature and humidity in medicine storage areas and eliminates several outdated requirements, such as the obligation to have a bell-equipped service window in the dispensary or certain separate rooms that are no longer operationally necessary.
For more information:
Amendment to Decree No. 129/2012 Coll. on the Requirements for Pharmacy Practice
The Constitutional Court of the Slovak Republic will review the procedure of insurance companies regarding exceptional medicines
The Constitutional Court of the Slovak Republic has admitted for further review a petition by Public Defender of Rights Róbert Dobrovodský challenging the constitutionality of the law governing exceptional reimbursement of medicinal products. He argues that the current framework allows health insurers to apply inconsistent internal rules, resulting in unequal access for patients with the same diagnosis. The legislation is alleged to breach the Slovak Constitution, international human rights treaties, and UN conventions.
The Constitutional Court also merged Dobrovodský’s proposal with a previous petition from the Administrative Court in Bratislava concerning the same law. The case will now proceed as a joint case.
For more information:
Food Safety
The European Commission has published the 2024 annual report on the Alert and Cooperation Network (ACN), which supports the exchange of information between Member States on controls within the agri-food chain.
The report recorded an 8% increase in notifications compared to the previous year – with a total of 9,460 alerts. Food and feed safety warnings rose by 12%, reaching 5,250. Most cases (16%) concerned fruit and vegetables, mainly due to pesticide residues. Incorrect labelling of food supplements, such as unauthorized health claims, was also frequently reported.
For the first time, the report also includes notifications related to pet animals and animal welfare. The Pet Animals Network facilitates the rapid exchange of information between authorities to prevent fraudulent practices and protect the safety of animals and their owners.
For more information:
New Act on Foodstuffs
A completely new legal regulation on food is currently being prepared to replace the existing Act No. 152/1995 Coll. on Food. The main objectives of the new legislation include:
- the unification of terminology,
- adjustment of the competences of food control authorities,
- implementation of the EU Regulation on official controls, and
- clarification of the rules related to food donation.
The draft law is being prepared by the Ministry of Agriculture and Rural Development of the Slovak Republic, with the start of the interministerial commenting procedure expected in August 2025.
For more information:
Law on conditions for selling energy drinks
Members of the National Council of the Slovak Republic have submitted a draft law on the conditions for the sale of energy drinks.
The proposed legislation prohibits:
- the sale and serving of energy drinks to persons under the age of 16,
- their sale through vending machines without the possibility of verifying the buyer’s age,
- the sale of energy drinks in playgrounds, schools, shops primarily selling goods for children, and at events primarily intended for persons under the age of 16.
The aim of this measure is to strengthen the protection of minors’ health and to reduce their exposure to risky substances, as energy drinks contain excessive amounts of caffeine, which may negatively affect their development and health.
For more information:
Law on conditions for selling energy drinks
Strengthening the regulation of nicotine-containing products
The Ministry of Health of the Slovak Republic has submitted a draft amendment to Act No. 89/2016 Coll. on the Manufacture, Labelling and Sale of Tobacco Products and Related Products, as well as an amendment to Act No. 377/2004 Coll. on the Protection of Non-Smokers.
The proposed amendment introduces several key changes aimed at strengthening the regulation of nicotine-containing products and enhancing public health protection, particularly for minors.
The main measures include:
- prohibition of flavoured nicotine products such as fruit, cola, candy, and similar varieties,
- ban on disposable electronic cigarettes,
- restrictions on marketing and product design,
- prohibition of economic incentives in sales,
- tightening of
The act is proposed to take effect on 1 January 2026.
For more information:
Strengthening the regulation of nicotine-containing products
The draft decree on the calculation of the cost-effectiveness threshold has entered the reconciliation procedure
The Ministry of Health of the Slovak Republic has submitted a draft of a new decree aimed at fundamentally revising the method for calculating the cost-effectiveness threshold for the categorization of medicinal products.
The primary objective of the draft decree is to establish a cost-effectiveness threshold for the inclusion of new medicinal products in the reimbursement system, at a level that reflects the clinical benefit of the therapy for the patient, while also ensuring access to healthcare for all insured persons under the public health insurance system. The decree aims to specify the method for calculating this threshold.
The draft decree has attracted significant public attention and, during the comment procedure, received a large number of comments from the public, patient organizations, health insurance companies, and various institutions. The public attention seems to be the reason for the decree to be on hold and sparked discussions with key institutions within the sector.
For more information:
New Accessibility Law Takes Effect in Slovakia
On 28 June 2025, Slovakia’s new Accessibility Act, based on EU Directive 2019/882, comes into force to ensure equal access to digital products and services for people with disabilities.
The law applies to a broad range of entities providing digital offerings to the public, including private companies (e.g. e-shops, mobile apps), financial and telecom service providers (e.g. banks, insurers), and operators of self-service devices like ATMs, ticket machines, and info kiosks. These businesses must adapt their interfaces and products to be usable by individuals with visual, motor, or other impairments.
The legislation mandates compliance with standards such as WCAG 2.1 and requires accessibility for documents, multimedia, and online forms. Certain exceptions exist for microenterprises and outdated platforms, but most providers face strict obligations. Non-compliance may lead to penalties of up to EUR 30,000, withdrawal of products, or bans on service provision.
For more information:
New Accessibility Law Takes Effect in Slovakia
New AI Test Could Personalize Prostate Cancer Treatment
Researchers in the UK have developed a new AI-based test that may identify which prostate cancer patients will benefit from a promising drug called olaparib. The test analyses genetic mutations and cancer cell profiles to predict whether the treatment will be effective, potentially sparing patients from unnecessary side effects.
In clinical trials, it showed benefits for only a subset of prostate cancer patients. The AI tool aims to improve treatment precision and efficiency by helping doctors tailor therapies to individual patients. Scientists hope this breakthrough will mark a shift toward more personalized cancer care.
For more information:
New AI Test Could Personalize Prostate Cancer Treatment
EU Simplifies Medical Device Instructions to Advance Digital Healthcare
On 25 June 2025, the European Commission introduced a regulation allowing healthcare professionals across the EU to receive instructions for medical devices in electronic format, rather than solely on paper. This change aims to modernise healthcare systems, reduce environmental impact, and alleviate administrative burdens on device manufacturers. While electronic instructions become the default, professionals can still request paper versions if preferred. The measure received broad support from healthcare professionals and industry representatives during consultations.
An evaluation of the current regulatory framework is also underway, with potential revisions to be presented at a conference in Brussels this December.
For more information:
EU Simplifies Medical Device Instructions to Advance Digital Healthcare