Legislative developments to watch in the Life Sciences sector

In this article we zoom in on EU legislative developments that are relevant to the Life Sciences sector.

The EU institutions are close to adopting 51 legislative proposals. With the European Parliament (EP) elections coming up in June 2024, the pressure to complete the adoption of various EU legislative proposals, is mounting rapidly. This is because the elections may have an unpredictable impact on the position of the EP regarding either of the proposals.

Belgium has the Presidency of the Council of the EU (CoEU) until the end of June 2024. The Presidency is in charge of setting priorities and responsible for facilitating the adoption process. The Belgian Presidency of the CoEU has highlighted the proposals regarding an AI Act, the European Health Data Space and the Cyber Resilience Act, as  main priorities.

Selected legislative proposals

The adoption of the below proposals is, in principal, imminent:

• Proposal for an EHDS Regulation: In December, the European Parliament (EP) adopted its position on a Regulation on the European Health Data Space. Negotiations regarding the final text are ongoing. This Proposal could provide a framework to access patient files or records for research purposes. Medtech Europe published a plea for refinement of the Proposal.

• Proposal for an AI Regulation: The presumably final text was made available on 22 January 2024. If the EP and the CoEU votes are positive, then, the AI Regulation will be adopted. This Proposal will have an impact on AI used in the lifecycle of medicinal products, as well as, on manufacturers of medical devices incorporating an AI as a safety component. Manufacturers of such medical devices would have about 5 years to comply with the Regulation followings its adoption. However, this may not be ample time to implement the new conformity assessment procedure considering the bottlenecks witnessed with the MDR and the IVDR.

• Proposal for a new Product Liability Directive: The EP and the CoEU have reached a provisional agreement regarding the Proposal mid-December. If the EP and the CoEU adopt the Proposal then the Proposal will be published in the OJ and enter into force. The adoption of the related Proposal for a Directive to adopt non-contractual civil liability rules governing AI, will be accelerated, once that the Proposal for an AI Regulation is adopted.

• Proposal for a Regulation on Critical Raw Materials: This Proposal is intended to ensure that the EU has access to a secure and sustainable supply of critical raw materials which are deemed crucial for a transition to clean energy. The Proposal provides for a list of critical raw materials. If adopted, the proposal may have an impact on the supply chains of Life Sciences companies in the future.

• Proposal for a Cyber Resilience Regulation: On 30 November 2023, the CoEU and the EP's negotiators reached a provisional agreement on the Cyber Resilience Act. The Proposal covers a broad range of devices, namely, all products that are connected either directly or indirectly to another device or network, including hardware, software and ancillary services. Medical devices would, however, be excluded from the scope of the Regulation.

• Proposal for a CLP-Regulation: The EP and the CoEU reached a provisional agreement on the revision of the regulation on the classification, labelling and packaging of chemicals (CLP) in December. If the EP and the CoEU endorse the agreement, then, the Proposal will be adopted. This Proposal puts an emphasis on the implementation of new hazard classes and may have an impact on cosmetics, food contact material and medicinal product manufacturers.

NEW: Proposal to amend the In Vitro Diagnostics Regulation and the Medical Devices Regulation

Further, on 23 January 2024 the European Commission published a proposal for a Regulation to amend the In Vitro Diagnostics Regulation and the Medical Devices Regulation. The Proposal would provide for a gradual roll-out of EUDAMED, an information obligation in case of interruption of supply and an extension of the transitional period for certain in vitro diagnostic medical devices. The additional time granted to companies depends on the type of device:

• high individual and public health risk devices such as HIV or hepatitis tests (class D) would have a transition period until December 2027;

• high individual and/or moderate public health risk devices such as cancer tests (class C), would have a transition period until December 2028;

• lower risk devices (class B such as pregnancy tests and class A sterile devices such as blood collection tubes), have a transition period until December 2029.

Navigating the plethora of proposals

In light of the above, Life Sciences companies may be facing a plethora of new rules and obligations in the future. To maintain an overview, it may be helpful to systematically assess the (final) scope and applicability of these proposals to your operations, as soon as they are adopted.

If you have any questions on how to navigate the above please reach out to Alexander Wenzel and Annabelle Bruyndonckx.