Life Science Law Update – Key developments for pharma & device companies in EU November 2023

1. Life Sciences Regulatory

European Union

EU: General:

• The European Commission, European Investment Bank, and Bill & Melinda Gates Foundation have joined forces to provide €1.1 billion for global health initiatives, with a focus on polio eradication and improving health access.

Authors: Joerg Schickert, Sarah Zucht, Caroline Schmalenbach.

EU: Pharmaceuticals:

• In July 2023, the European Medicines Agency ("EMA") released a draft reflection paper discussing the application of artificial intelligence ("AI") in the development and regulation of human and veterinary medicines. The paper highlights the expanding role of AI and machine learning ("ML") throughout the entire medicinal product lifecycle, from drug discovery to post-authorization phases. It also underscores the importance of addressing challenges related to algorithm transparency, bias, technical issues, and ethical considerations while emphasizing a human-centric approach and adherence to legal requirements when using AI and ML in medicine.

• EMA has updated the transparency rules for clinical trials submitted through Clinical Trials Information System, simplifying the process and making data more accessible to stakeholders. Notably, the removal of data deferral benefits patients with early access and streamlines sponsor processes, while safeguarding commercial information.

Authors: Joerg Schickert, Sarah Zucht, Caroline Schmalenbach.

EU: Medical Devices

• A new Q&A on the transitional provisions for products without an intended medical purpose covered by Annex XVI of Regulation (EU) 2017/745 on medical devices ("MDR") was published by the European Commission. The Q&A document intends to facilitate the application of the transitional provisions set out in Commission Implementing Regulation on Common Specifications (EU) 2022/2346 as amended by Commission Implementing Regulation (EU) 2023/1194. In light of the fact that transitional provisions for products covered by a certificate issued by a notified body in accordance with Council Directive 93/42/EEC are provided in both the amended MDR and in the CS Regulation, Commission Implementing Regulation (EU) 2023/1194 was adopted to align the transitional provisions set out in the CS Regulation to those set out in the amended MDR. This Q&A document was drafted considering the requirements applicable from the amended MDR and the amended CS Regulation.

• European Commission updated the Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices ("Borderline Manual") on 27 September 2023. The third version of the Borderline Manual includes updates concerning qualification borderlines between medical devices and medicinal products (root canal irrigation solution), other medical device borderlines (temperature sensors embedded in orthopaedic devices for compliance tracking and system intended to produce sclerosing foam) as well as classification borderlines under Rule 8 of Annex VIII to the MDR (n-butyl-2-cyanoacrylate adhesives and custom-made cranial implant).

• On 14 September 2023, a number of medical technology industry associations across Europe, including MedTech Europe and the German MedTech Association BV Med, co-signed and issued an open letter to Commissioner Kyriakides urging for an intervention to address systemic issues to medical technology access for patients and health systems in Europe. One of the main issues raised in the letter is the need for the creation of a single, dedicated accountable structure to oversee and manage the regulatory system for medical devices and IVDs.

• European Commission published a survey to understand the communication needs related to the MDR and Regulation (EU) 2017/746 on in vitro diagnostic medical devices ("IVDR"). The European Commission seeks to understand how the amendments to the legislation governing medical devices and IVDs are affecting relevant stakeholders and identify the challenges that are faced by stakeholders in the transition to the new rules. The questions in the survey relate to a number of issues regarding the materials published by the European Commission and the channels of communication that stakeholders use to receive information on the implementation of the rules established in the MDR and the IVDR.

Authors: Fabien Roy, Anastasia Vernikou.

2. Corporate Governance & Corporate Social Responsibility

European Union

EU Commission adopted and published a delegated regulation which comprises an annex with an initial set of 12 European Sustainability Reporting Standards ("ESRSs") specifying content and structure of the reporting pursuant to the Corporate Sustainability Reporting Directive ("CSRD") on 31 July 2023, the (delegated regulation and ESRSs can be found here). If no objections are raised by the European Parliament and the European Council, the delegated regulation enters into force three days after its official publication in the Official Journal of the EU. This first set of ESRSs applies for entities which are already subject to the non-financial reporting for the first time for the financial year 2024 and from the financial year 2025 for all other large entities.

Authors: Lutz Angerer, Thomas Weber.

3. Anti-Bribery and Anti-Corruption

• European Union: Romania has joined the OECD Anti-Bribery Convention, demonstrating its commitment to fighting corruption.

• Members of the European Parliament refrained from making essential changes to the ethics system despite a recent corruption scandal, which means key reforms and addressing conflicts of interest remain unaddressed.

Authors: Joerg Schickert, Sarah Zucht, Caroline Schmalenbach

4. Competition and Antitrust

European Union:

On 19 September, the European Commission carried out unannounced inspections at the premises of an unnamed company active in the market for medical devices for cardiovascular applications. The company is suspected of violating the EU antitrust rules that prohibit abuses of a dominant market position.

Authors: Falk Schöning, May Lyn Yuen.

5. Data Privacy

European Union:

• European Commission’s adequacy decision for the EU-US Data Privacy Framework (“DPF”) came into force on 10 July 2023 and facilitates EU-US data flows (see our Engage article about this topic here). Any EU/EEA company may transfer personal data to a DPF certified company in the USA without the need for additional transfer mechanisms. A transfer impact assessment is only required when relying on other transfer mechanism, such as the EU standard contractual clauses. Given the invalidations of the predecessor frameworks, there remains some concerns about the continued existence of the DPF.

• European Data Protection Board (“EDPB”) published its final version of its Recommendations 01/2022 (“Recommendations”) on Binding Corporate Rules (“BCR”) for Controllers (“C-BCR”). BCR were able to defend their reputation as the most robust mechanism and “gold standard” for international transfers of personal data subject to the GDPR. Given concerns and potential actions against the DPF (as referenced above), BCR could once again serve as a transfer mechanism that ensures long-term legal certainty (see our Engage article about this topic here).

• The Data Governance Act (“DGA”) entered into force on 23 June 2022 and, following a 15-month grace period, is applicable since September 2023. The DGA aims to make more data available and facilitate data sharing across sectors and EU countries in order to leverage the potential of data for the benefit of European citizens and businesses. Both personal and non-personal data are in scope of the DGA, and wherever personal data is concerned, the GDPR applies.

Authors: Stefan Schuppert, Theresa Mengler.

Next steps

Our next update will provide an overview on the news on EU level and a deep dive on France, Germany, Italy, Spain and UK.

Subscribe to Engage for our quarterly updates on current and evolving European life sciences legal developments – and more.