The year has passed in the blink of an eye. We’ll skip the recap and instead start looking forward to 2025 already. Next year will bring us many interesting but also challenging legal developments in the life sciences and healthcare sector. We will hereby give you a short overview of the upcoming changes.
The Health Technology Assessment Regulation (HTAR) will apply from January 2025
The new EU Health Technology Assessment Regulation (HTAR) aims to streamline access to innovative health technologies for patients across the EU. To do so, the HTAR foresees that certain health technologies will be subject to joint clinical assessment at the EU level, rather than assessment at the level of member states. Hence, the regulation seeks to reduce duplication of effort by national HTA bodies and foster wider access to new health technologies in the EU.
Under the HTAR, the Coordination Group on Health Technology Assessment (“the HTACG”) composed of member states’ representatives, mainly from HTA authorities and bodies, will carry out joint clinical assessments for:
- certain medicinal products, including medicinal products containing a new active substance and medicinal products which are regulated as advanced therapy medicinal products, and
- certain medical devices, i.e. medical devices classified as class IIb or III and in vitro diagnostic medical devices classified as class D.
The focus of the HTACG will be on comparing the benefits of the new health technology to existing treatments. Once the joint clinical assessment is done, the member states should not request at the national level information, data, analyses or other evidence that has been already submitted during the joint clinical assessment procedure. However, the HTAR does not affect member states’ competence to draw conclusions on the relative effectiveness of health technologies or to take decisions on the use of health technology in their specific national health context. It means that member states will remain in charge for non-clinical assessment (i.e. economic, social, and ethical factors).
The full implementation of the HTAR will be achieved by 2030 (if everything goes as planned). Please contact our Life Sciences and Healthcare team should you have any additional questions.
The Data Act will become applicable in September 2025
The Data Act entered into force on 1 November 2024, and will be applicable from 12 September 2025 (with some exceptions). The Data Act is a cross-sectoral (horizontal) regulation that largely affects the life sciences sector, among others. Particularly impacted are healthcare providers and manufacturers of medical devices or other health devices.
Namely, as the goal of the act is to create a common market for data, the Data Act establishes obligation for data holders (including hospitals, manufacturers of medical devices or other health devices, etc.) to share the data generated through the use of a connected device or data that indirectly results from the use of the device with the user or data recipient, e.g. data collected by the glucose monitor. In emergency situations, the data holders will have an obligation to also share the data with the public sector.
For this reason, as soon as possible, companies should get acquainted with the new act in order to define the impact of the Data Act on their products, services and business model in general. If the impact has been identified, the necessary changes to the user terms should be considered and a contractual framework for sharing data with data recipients should be built up. Please contact our data protection team for any assistance needed.
Biotech Act expected in 2025
In “Political guidelines for the next European Commission 2024−2029”, Ursula von der Leyen emphasised that increasing Europe’s competitiveness requires putting research and innovation, and science and technology at the centre of the EU’s economy. From this perspective, one clear legal activity in the plan is to propose a new European Biotech Act in 2025.
This would be part of a broader Strategy for European Life Sciences to look at how the EU can support green and digital transitions and develop high-value technologies. The Biotech Act seeks to “bring biotech from the laboratory to the factory and then onto the market.” The stakeholders in the field have already expressed their hopes and expectations regarding the act (e.g. see EuropaBio’s article “A Biotech Act for Europe: INVENT – MAKE – APPROVE – USE”).
As things stand, we do not yet know what the act will look like, which means now is the perfect time to act and propose our own ideas, highlight legal issues and work together to get a successful result. Please contact our government relations team for any assistance needed in that regard.
What is especially important to take away?
- Medicinal products containing a new active substance and medicinal products which are regulated as advanced therapy medicinal products will be subject to joint clinical assessment from 12 January 2025.
- The Data Act’s impact on the life sciences industry is substantial; in order to stay on top of the regulatory requirements, companies should already start defining the impact of the Data Act on their products, services and business model in general.
- If the Biotech Act is something that might be relevant for your business activities, then gathering relevant ideas and working out a strategy for policy communications in this field should start as soon as possible.
Our international Life Sciences & Healthcare team is at your disposal, should you need advice on any legal issues you are facing.
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Contact our experts:
Regional co-head of Life Sciences & Healthcare sector group, Estonia
Regional co-head of Life Sciences & Healthcare sector group, Latvia
