President Biden’s issuance of the Executive Order on Artificial Intelligence (AI) on 30 October 2023 marks a significant legislative stride in AI regulation. This directive, extending beyond the US, has profound implications for European businesses and the EU’s regulatory landscape on AI.
On 14 December 2023, the Council of the EU and the European Parliament reached a compromise on the Corporate Sustainability Due Diligence Directive (CSDDD), paving the way for its formal adoption by both institutions and thus the CSDDD’s entry into force before year end. The CSDDD is intended to significantly reshape corporate due diligence obligations regarding human rights and environmental standards in the EU and beyond. With its imminent enactment, the EU Member States will have two years to enact national laws providing for respective corporate due diligence obligations, similar to that already provided for by the German Supply Chain Act in its current form.
After three days of extensive final debate the EU Parliament, Council and Commission finally announced provisional agreement on the EU AI Act, the bloc’s landmark legislation regulating development and use of AI in the European Union. It is one of the world’s first comprehensive attempts to regulate the use of AI.
The EU AI Act awaits formal adoption by both Parliament and Council before it will become EU law.
The new EU Deforestation Regulation (2023/1115/EU) will impose due diligence obligations from 30 December 2024 aimed at tackling deforestation and forest degradation. The Regulation will require companies dealing in in-scope products to undertake due diligence into the source of a wide range of commodities, including cattle, cocoa, coffee, palm-oil, rubber, soya and wood, to ensure that they have not been obtained as a result of deforestation.
On 18 November 2023, Germany, France, and Italy reached a significant agreement on the future of AI regulation, marking a step forward in shaping the AI landscape within the European Union.
On 3 February, the European Medicines Agency, the Heads of Medicines Agencies and the European Commission launched a public consultation on the establishment of a multi-stakeholder platform to improve clinical trials in the European Union.
On 19 January 2023, the Court of Justice of the European Union specified that Art. 2(2) of Directive 2001/83/EC, pursuant to which, in case of doubt on the classification of a product as a medicine or a medical device, the provisions on medicinal products shall apply, covers both “medicinal products by function” (i.e., substances exerting pharmacological, immunological or metabolic action) and “medicinal products by presentation” (i.e., substances presented as having properties for treating or preventing disease).
2023 is gearing up to be an interesting year for those in the life sciences sector, with upcoming reforms to the established regulatory and IP landscapes that will impact innovator strategies in R&D, commercialization, and patent enforcement. While reforms are currently under draft by the European Commission, the key areas of anticipated change are highlighted in a newly published article in The Life Sciences Lawyer.
On 19 December 2022, the Recommendation Paper on Decentralized Elements in Clinical Trials was published on the website of the European Medicines Agency (EMA), with the aim to facilitate the conduct of decentralized clinical trials in the EU, while safeguarding the rights and well-being of participants and the robustness and reliability of the data collected.
Starting from 31 January 2023, the Clinical Trial Information System, provided for in Art. 80 of Regulation EU 536/2014, will become the single point of access for the submission, authorization and supervision of clinical trial applications in the EU and the European Economic Area countries. The single portal was launched on 31 January 2022, initiating the one-year transition period during which sponsors could choose whether to submit a clinical trial application according to the Clinical Trials Directive or through the single portal. As of 31 January 2023, submission of clinical trial applications through the single portal will become mandatory.