Life Sciences 1Q/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.
Critical Medicines Act
In March 2025, the European Commission proposed the Critical Medicines Act (CMA) to improve the availability, supply and production of critical medicinal products within the EU.
The key features of CMA are:
- strategic projects for critical medicinal products or their ingredients can be designated, so that they benefit from easier access to funding and fast-trackes procedures,
- public procurement to incentivise the resilience of supply chains of critical medicines or to improve access to orher medicines of common interest;
- collaborative procurement among different member states will be supported by the Commission at the request of member states, to address availability and access disparities of crucial medicines and other medicines of common interest;
- international partnership with likeminded countries / regions will be explored, to broaden the supply chain and reduce dependencies on single suppliers;
- state aid guidelines to assist member states in financially supporting such strategic projects.
The CMA has been proposed in the context of the European Health Union, which seeks to ensure that all EU citizens have access to necessary medicines.
For more information:
Veterinary medicines – rules on Good Manufacturing Practices (GMP)
The European Commission has launched a public consultation as part of its “Have Your Say” initiative. This consultation seeks feedback on proposed implementing rules under Regulation (EU) 2019/6, which governs veterinary medicinal products in the EU.
The draft introduces comprehensive rules covering all aspects of manufacturing, including quality management systems, personnel, premises, equipment, documentation, and laboratory controls. Special provisions are included for sterile, biological, and herbal substances, as well as certain exceptions like substances used in parasiticidal products for bees.
The regulation emphasizes risk-based approaches, consistent quality assurance, and clear responsibilities for manufacturers to ensure product safety and efficacy.
Stakeholders are encouraged to provide feedback on the proposed rules to help shape the final implementing regulation. The consultation period ended on 19 February 2025.
For more information:
Decree on the distribution of public health insurance expenditure by type of health care for 2025
On 7 March 2025 a decree on the distribution of public health insurance expenditure by type of health care for the year 2025 was published. However, according to Act No. 581/2004 Coll. on Health Insurance Companies, Health Care Supervision, the amount of public funds for the reimbursement of medicines for the relevant calendar year is to be published annually by 1 February at the latest.
The total amount of expenditure allocated for health care has been set at EUR 8,303,829,873.00.
The decree entered into force on 1 April 2025.
For more information:
Decree on the distribution of public health insurance expenditure
Transaction tax
The financial transaction tax or transaction tax is effective from 1 April 2025. This tax was introduced by Act No. 279/2024 Coll. on Financial Transaction Tax and the subject of the tax is:
- a financial transaction in which an amount of funds is debited from the taxpayer’s payment account,
- the use of a payment card issued to a transaction account for the purpose of carrying out a financial transaction, and
- a recharged expense relating to the execution of a financial transaction which relates to the taxpayer’s domestic activity.
However, the transaction tax will only affect natural persons who are entrepreneurs, legal persons and branches of foreign persons.
The amount of the transaction tax is 0.4% of the amount of the transaction, up to a maximum of EUR 40.00 per transaction, and 0.8% of the amount of the withdrawal.
For more information:
Regulation on the European Health Data Space
The Regulation on the European Health Data Space (EHDS) has been published in the Official Journal of the EU. The EHDS Regulation will become applicable in different phases according to data types and use cases, however one part of EHDS Regulation has already entered into force on 26 March 2025.
The Regulation is an important milestone in the EU’s efforts to build a secure and efficient digital health ecosystem as part of the European data strategy.
The benefits of EHDS are:
- empowering citizens, giving them better control over their personal health data and enabling seamless access to their medical records across the EU, whenever and wherever they need healthcare, and
- strengthening the re-use of health data in anonymised or pseudo-nymised form, for research, innovation, public health, and policymaking.
For more information:
EU Action Plan to strengthen the cybersecurity of hospitals and healthcare providers
The Commission has presented an EU Action Plan to strengthen the cybersecurity of hospitals and healthcare providers. In 2023 alone, EU countries reported 309 significant cybersecurity incidents targeting the healthcare sector – more than any other critical sector. As healthcare providers increasingly use digital health records, the risk of data-related threats continues to rise.
The new Action Plan builds on existing legislation, such as the EU-wide legislation on cybersecurity, and extends its scope to include general practices. The Plan also aims to establish a pan-European Cybersecurity Support Centre to provide more tailored guidance to hospitals and healthcare providers.
It is based on 4 priorities:
- enhanced prevention;
- better detection and identification of threats;
- response to cyberattacks to minimise impact;
- deterrence.
The action plan is the first among the initiatives the Commission will present during the first 100 days of the new mandate, as announced by President von der Leyen in her political guidelines.
For more information:
EU Action Plan to strengthen the cybersecurity of hospitals and healthcare providers
New Clinical trials map
A new map of clinical trials for medicinal products is now available on the Clinical Trials Information System – CTIS website.
This map provides patients and healthcare professionals with easy access to detailed and up-to-date information on clinical trials of medicinal products conducted in the region or within the EU.
For more information:
New version of ICH GCP Guideline E6(R3) on Good Clinical Practice
The International Council for Harmonisation (ICH) adopted the revised Good Clinical Practice (GCP) Guideline E6(R3) on January 6, 2025, updating the previous E6(R2) from 2016.
This revision aims to standardize clinical trial practices across ICH member regions, enhancing data acceptance by regulatory authorities. Key updates include a clearer structure, emphasis on a proportionate risk-based approach, and detailed guidance on informed consent and data governance.
A new section on data governance provides guidance on managing data integrity throughout the trial process. Annex 2, addressing pragmatic and decentralized trials using real-world data, is under public consultation and expected to be finalized by middle of 2025.
For more information:
New version of ICH GCP Guideline E6(R3) on Good Clinical Practice
(Non)categorisation of medicinal products
Although the categorisation of medicinal products formally resumed in January 2025, only few medicinal products were approved for inclusionin the list of categorised medicinal products within the first three months. The same applies for extensions of indication restrictions.
The overall pace of decision-making remains strikingly slow, with the vast majority of submissions left without a positive outcome.
For more information:
(Non)categorisation of medicinal products
New CJEU clarification of advertising of medicinal products
The Court of Justice of the European Union (CJEU) has provided important guidance on what does and does not constitute “advertising of medicinal products” under Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use.
The CJEU reaffirmed that the decisive factor in determining whether a communication qualifies as advertising for medicinal products is its purpose. A campaign falls within the scope of the general prohibition on advertising if its primary aim is to promote the prescription, supply, sale, or consumption of medicinal products. Conversely, if the campaign merely aims to influence the customer’s choice of pharmacy in which to purchase products, it does not fall within the concept of “advertising of medicinal products”.
For more information:
New CJEU clarification of advertising of medicinal products