Life Sciences 4Q/2024
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 to the DRG system
From 1 January 2025, several changes will be introduced to the SK-DRG system (Slovak Diagnosis-Related Groups) aimed at improving its accuracy and efficiency. One of the key updates involves revising the Definition Manual, where certain existing DRG groups will be discontinued and replaced by new ones.
Additionally, new rules for integrating non-categorized drugs into the SK-DRG system will be introduced. These rules will include assessments of cost-effectiveness and the financial impact on the public health insurance budget, specifically for drugs administered in inpatient care.
However, the financing of the DRG system remains a contentious issue. The Slovak Association of Hospitals has raised concerns about a potential reduction in the base rate, which could negatively affect hospital funding. This may lead some hospitals to implement additional fees for provided services.
For more information:
New VAT rates
From January 1, 2025, Slovakia will implement significant changes to value-added tax (VAT) regulations, impacting the prices of a wide range of goods and services. This measure is part of a broader consolidation package aimed at improving public finances.
The new VAT rates will be as follows:
- Standard rate of 23%;
- Reduced rate of 19%;
- Reduced rate of 5%.
The standard VAT rate will increase from 20% to 23%, while two reduced rates of 19% and 5% will be introduced. The VAT rate for medicines and selected medical supplies will be reduced from the current 10% to 5%. The reduction of VAT on medicines is expected to lead to lower prices for end consumers, which is positive news for patients and the healthcare sector.
For more information:
First instance decision on reducing the price of medicines was issued
The Ministry of Health of the Slovak Republic (the Ministry) initiated a proceeding in late 2024 to reduce the final price (Konečna c.) of medicines listed in the list of categorized medicines. This proceeding was prompted by the reduction of VAT from 10% to 5%, effective from January 1, 2025. On December 31, 2024, the Ministry issued a first-instance decision on the matter.
The issued decision reveals that the Ministry rejected most objections raised by MAHs, which primarily concerned the incorrect calculation of UZP2.
The price reduction was supposed to be implemented in accordance with the relevant provisions of Decree No. 280/2022 Coll., which governs the determination of standard medicinal doses, the determination, reduction, and increase of the maximum reimbursement by health insurance for a standard dose of a medicinal product, as well as the determination, modification, and cancellation of reimbursement groups (the Decree). The Decree stipulates that when the reference price of a medicinal product changes, the medicine’s price must be adjusted so that the ratio between the maximum co-payment by the insured for the reference medicinal product and the maximum price of the reference medicinal product in public pharmacies remains unchanged.
The Ministry itself emphasized the need to ensure that the ratio of health insurance reimbursement and patient co-payment for medicines remains unchanged from January 1, 2025 in the initiation of the proceeding.
By dismissing the objections, the Ministry’s decision ultimately means that for certain medicines, the ratio of health insurance coverage and patient co-payment will change, often leading to an increase (or the emergence) of patient co-payments.
For more information:
First instance decision on reducing the price of medicines was issued
Changes to the clinical trials regulation
The changes revolve around the transition from the Clinical Trials Directive (CTD) to the Clinical Trials Regulation (EU) 536/2014 (CTR). Even though the CTR was already adopted in 2014, due to delayed technical development of the portal called Clinical Trial Information System (CTIS), the CTR officially came into force on the 31 January 2022. The 31 January marks the end of the 3-year transition period from the CTD to CTR.
Only clinical trials approved under the CTD that have an (i) expected completion date after the 30 January 2025, (ii) have at least one active site within the EU/EEA after the 30 January 2025, and (iii) will be conducted in an additional Member State, for which no CTD application was submitted before the 31 January 2023, need to be transitioned to comply with the CTR.
CTD needed to be transposed into national legislation, while CTR is binding in its entirety and immediately applicable in all Member States without national modifications. However, the Medicinal Products Act will be amended with the effect from the January 31, 2025.
For more information:
Changes to the clinical trials regulation
Amendment of Act No. 89/2016 on the production, labelling and sale of tobacco and related products
The Slovak Republic, in connection with the transposition of Delegated Directive (EU) 2022/2100 amending Directive 2014/40/EU of the European Parliament and the Council regarding the removal of certain exemptions for heated tobacco products, was required to adopt the necessary laws and regulations to achieve compliance with this directive no later than 23 July 2023.
The Ministry of Health of the Slovak Republic submitted a draft law defining heated tobacco products as a new category of tobacco products that release nicotine emissions through heating, encompassing both smokeless tobacco products and tobacco products for smoking. It also clarifies technical standards for emission measurement and extends the ban on marketing tobacco products with a characteristic flavour to include heated tobacco products, thereby harmonizing rules across various categories of tobacco products.
The amendment is in force from January 1, 2025.
For more information:
Amendment of Act No. 89/2016 on the production, labelling and sale of tobacco and related products
CJEU Rules Hungarian VAT Law Incompatible with EU Directive
On 12 September 2024, the Court of Justice of the European Union (CJEU) issued a significant ruling in Case C-248/23, finding Hungary’s VAT legislation incompatible with EU law. Hungary’s exclusion of pharmaceutical companies’ mandatory contributions to the public health insurance agency from VAT reductions breaches EU law. The decision clarifies that Article 90(1) of Directive 2006/112/EC requires reductions in taxable amounts for such payments, emphasizing the principle of fair tax adjustments. The judgment reinforces the EU’s principles of fair tax adjustments and harmonization across member states.
For more information:
CJEU Rules Hungarian VAT Law Incompatible with EU Directive
SIDC Extends Medical Device Processing Time Beyond 90 Days
The Slovak State Institute for Drug Control (the SIDC) has announced that processing times for medical device applications have extended beyond 90 days due to a sharp increase in submissions related to the transitional period under EU Regulation 2023/607. The delay has been attributed to staffing and system constraints, as well as the submission of incomplete applications.
SIDC clarified that by submitting the application, applicants fulfil their legal obligation under Sec. 110b(2) of Act No. 362/2011 on Medicinal Products and Medical Devices. A SIDC code is not mandatory for the marketing of non-categorised devices or for participation in public tenders under Slovak law. However, for faster processing, SIDC urges applicants to submit complete documentation, including the necessary transitional period documents from both the manufacturer and the notified body.
Applications must also comply with legal requirements, such as correct forms, an EC Declaration of Conformity, a CE certificate from a European Notified Body, correct CE marking and instructions for use in Slovak. SIDC has also clarified that it is not necessary to submit notifications for pure extension of the transitional period under EU Regulation 2023/607 without other substantial changes, such as manufacturer details or changes to the classification of the equipment.
For more information:
SIDC Extends Medical Device Processing Time Beyond 90 Days
New regulation on HTA
The new Regulation (EU) 2021/2282 on Health Technology Assessment (HTA) entered into force on 11 January 2022 and it will become applicable from 12 January 2025.
The Regulation replaces (i) the current system based on the voluntary network of national authorities, and (ii) the EU-funded project-based cooperation.
Under the new regulation the European Medicines Agency (EMA) and HTA bodies will collaborate in the context of:
- Joint clinical assessments,
- Joint scientific consultations, and
- The identification of emerging health technologies.
The HTA Regulation emphasizes the clinical aspects of HTA. Member States’ HTA bodies will conduct Joint Clinical Assessments for new medicines and certain high-risk medical devices to evaluate their relative clinical effectiveness and safety compared to existing technologies.
They will also participate in Joint Scientific Consultations, offering guidance to technology developers on clinical study designs to support evidence-based decision-making. Additionally, “horizon scanning” exercises will identify promising health technologies early, enabling health systems to prepare for their adoption.
The main benefit of the HTA Regulation is the improvement of the availability of innovative medicines and certain medical devices for patient in the EU.
For more information:
New EU Plant Health Rules to Strengthen Protection
Following the adoption of Regulation (EU) 2024/3115 amending the Plant Health Regulation (EU) 2016/2031, the EU will implement new plant health rules from 5 January 2025.
The reforms aim to better protect plant health by introducing stronger safeguards, a transparent process for temporary import derogations and reduced administrative burdens, including a single annual report for passenger baggage and postal parcel checks.
A Union Plant Health Team of technical experts will provide rapid assistance to Member States facing new pest outbreaks and can assist third countries posing a risk to the EU.
While most rules will enter into force in January 2025, third countries will have to declare measures against non-quarantine pests on plant health certificates from 6 July 2026.
EU plant health rules protect crops, fruit, vegetables, flowers, ornamental plants and forests from harmful pests and diseases.
For more information:
New EU Plant Health Rules to Strengthen Protection
Partial Restriction of E-Prescriptions
As of January 2025, the ability to electronically prescribe medications was restricted to certain medicinal products. This occurred after the National Health Information System Act was amended in December. The amendment was related to the preparation of a data reform aimed primarily at reducing the administrative burden on healthcare professionals and improving data accessibility.
However, a phrasing error in the amendment inadvertently blocked the electronic prescription of medicinal products that are paid for directly by the patient. This amendment came into effect on 1 January 2025.
On 9 January, the Minister of Health informed the public that the issue had been resolved and electronic prescriptions were reinstated through a professional guideline on legal interpretation. However, the exact wording of the guideline has not yet been published. A definitive legislative change is expected to be approved in early February during a regular parliamentary session.
Despite the Ministry of Health’s guideline, a group of medicinal products will remain excluded from electronic prescription, specifically, medicinal products prescribed in clinics that do not have contracts with health insurance companies.
For more information:
Partial Restriction of E-Prescriptions
Non-categorization of medicinal products
Since October 2024, the Ministry of Health has not categorized any medicinal product that, based on its characteristics, does not belong to any reference group listed in the categorized medicinal products list (innovative medicinal product), nor has it expanded the treatment options (indication restrictions) of already categorized medicinal products.
For more information: