In this newsletter, we hope to draw your attention to legal news that, in one way or another, affects innovations in the life sciences and healthcare sector. Whether this relates to the early stages of product development (the Biotech and Biomanufacturing Hub) or questions related to the use of innovative products (the AI Act), innovation must still adhere to the legal frameworks that ensure safety. We, as lawyers, of course, do our best not to hinder innovation but to promote and incentivise it in a legal way.
Worth noting:
- As of 12 January 2025 Regulation (EU) 2021/2282 on health technology assessment became applicable, which aims to ensure a more efficient evaluation of new medicinal products and medical devices uniformly across all EU member states. Read more here.
- As of 31 January 2025, the Clinical Trials Regulation is fully applicable. This means that transition procedures are no longer available and sponsors of ongoing older (directive-based) trials are required to submit a new application via CTIS.
- Certain provisions of the AI Act apply from 2 February 2025. One of the obligations that now already applies to all AI deployers is an obligation to ensure a sufficient level of AI literacy within the organisation. Read more below.
- The EU Commission launched a new Biotech and Biomanufacturing Hub to support companies in bringing innovative products to the EU market and to increase their competitiveness. The hub will also help companies identify the support available to them at the EU level, as well as how to access this support to help them expand and grow.
- A new guide to assessing health technologies has been published in Estonia. The guide should provide clearer guidelines for all parties involved in developing health technologies and help ensure that effective, cost-effective, and innovative treatments reach Estonian residents faster. Read more below.
- Starting from 2 February 2025, marketing authorisation holders (MAHs) and national competent authorities of the European Union (EU) member states must use the new European Shortages Monitoring Platform (ESMP) to report on shortages of nationally and centrally authorised medicines. Read more here.
#sorainenlifesciences: our practice in action
- We advised Oxipit, an AI medical imaging application developer, on a major partnership deal with Unilabs. This partnership will see Oxipit’s AI solutions, ChestLink and ChestEye, integrated into Unilabs’ radiology workflows. The partnership between Oxipit and Unilabs will have an international impact, with the initial rollout starting in Portugal. Read more here.
- In January, the Sorainen Life Sciences team attended several high-profile events in the sector, including sTARTUp Day and Estonia-Finland Alliance: Leading AI-Driven HealthTech Regulatory Solutions in Estonia.
- In February, Sorainen hosted a business breakfast, “The Leader’s Challenge: How NIS2 Changes the Rules of the Game?”, in Lithuania. The event focused on how the NIS2 directive will impact company executives, the cybersecurity challenges businesses face, and why cybersecurity is not just an IT issue but a strategic business priority.
AI Literacy – what is it, and how can it be implemented?
On 2 February 2025, certain provisions of the AI Act started to apply. Among these is Article 4, which establishes the need for AI literacy. The article states: “Providers and deployers of AI systems shall take measures to ensure, to their best extent, a sufficient level of AI literacy of their staff and other persons dealing with the operation and use of AI systems on their behalf, taking into account their technical knowledge, experience, education and training and the context the AI systems are to be used in, and considering the persons or groups of persons on whom the AI systems are to be used.”
Article 4 is part of the General Provisions (Chapter I) of the AI Act. This means that this obligation applies to all providers and deployers of AI systems, not only to providers and deployers of high-risk AI systems. In essence, the provision is aimed at all entrepreneurs whose employees are exposed to AI systems in one way or another in their daily work, whether this is an AI system being used for text generation or AI as a medical device being used in the course of everyday work.
As a starting point, companies should first map out whether and which AI systems are already used in their everyday work. To enable this, the EU Commission has published the first set of guidelines on defining an AI system. These guidelines should assist providers and other relevant persons in determining whether a software system constitutes an AI system. The document is accessible here, but please note that these guidelines are not binding and may be subject to changes in the future.
Secondly, companies should as soon as possible include in their training plan training courses explaining and concerning the use of AI or creating a guide for employees to follow when using AI systems. Employees must be able to understand how and when to use AI system(s) in order to prevent the associated risks occurring. The greater the risk, the greater the due diligence measures required to ensure AI literacy. For example, hospitals using high-risk AI systems, including medical devices, should be particularly careful when complying with their obligations.
New guidelines for assessing health technologies in Estonia
The new guidelines aim to update the 2002 Baltic guidelines for the pharmacoeconomic evaluation of medicines. They are designed for institutions involved in evaluating health technologies and those using the results from these technologies, such as the Health Insurance Fund and various committees. The guide outlines the methodology for health technology assessment (HTA), including defining research tasks using the PICO format, conducting systematic literature reviews on effectiveness, safety and cost-effectiveness, and performing economic evaluations like cost-effectiveness analysis (CEA) and budget impact analysis (BIA).
The guide also details decision-making principles, emphasising criteria such as effectiveness, safety, cost-effectiveness and budget impact. Special considerations are given to technologies addressing high unmet needs, those with low budget impact, or those used for rare diseases, allowing for flexibility in evidence requirements.
For example, given the limited patient populations, the guidelines allow for flexibility in the evidence requirements, acknowledging that high-quality evidence such as randomised controlled trials may not always be feasible in case of rare diseases. In such cases, decisions can be based on other reliable sources of evidence. As a result, the guide should help to ensure that effective, cost-effective, and innovative treatments reach Estonian residents faster.
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
Senior Associate, Latvia
Senior Associate, Lithuania
