Members of the European Parliament (MEPs) have voted overwhelmingly in favour of the pharmaceutical reform package following a debate on 10 April.

The vote is a key step in the passage of the new Directive and Regulation, which together form the EU’s revisions to the General Pharmaceutical Legislation (GPL). These revisions are part of the overall EU pharmaceutical strategy that was announced by the European Commission in November 2020, with the core GPL amendments proposals published in April 2023.

With the vote, the European Parliament has now endorsed the position adopted by the Environment, Public Health and Food Safety Committee on 19 March 2024. The Committee had amended the Commission’s proposal in several respects. Overall, the Parliament’s amendments are aimed at encouraging and fostering more innovation in the EU, and industry will be pleased that some of its core concerns have been addressed, although significant areas of uncertainty remain.

The adoption of the package is likely to be delayed by the European Parliament elections in June this year. The reforms will be taken up by the new Parliament after the elections, and so it is difficult to see any agreement being reached before 2026.

Below is a summary of the Parliament’s position in some of the key area. This summary is, however, not exhaustive but rather highlights topics that have been subject to increased interest for industry and extensive discussions in the European Parliament.Continue Reading European Parliament backs reforms to the EU Regulatory Framework for Medicinal Products

On 19 July 2023, the European Medicines Agency (EMA) published a draft Reflection paper on the use of artificial intelligence (AI) in the lifecycle of medicines (the Paper). The Paper recognises the value of this technology as part of the digital transformation within healthcare, and acknowledges its increasing use and potential to “support the acquisition, transformation, analysis, and interpretation of data within the medicinal product lifecycle”, provided of course it is “used correctly”.

The Paper reflects EMA’s early experience with and considerations on the use of AI, and gives a sense of how EMA expects applicants and holders of marketing authorisations to use AI and machine learning (ML) tools. The EMA has made clear that the use of AI should comply with existing rules on data requirements as applicable to the particular function that the AI is undertaking. It is clear that any data generated by AI/ML will be closely scrutinised by the EMA, and a risk-based approach should be taken depending on the AI functionality and the use for which the data is generated.

The Paper is open for consultation until 31 December 2023. EMA also plans to hold a workshop on 20-21 November 2023 to further discuss the draft Paper. EMA’s plan is to use the feedback from the public consultation to finalise the Paper and produce future detailed guidance. Our summary below sets out the key takeaways and the key issues that arise in the Paper.Continue Reading EMA publishes first draft of reflection paper on the use of AI in the medicinal product lifecycle

On June 14, 2023, an overwhelming majority of the European Parliament (Parliament) recently voted to pass the Artificial Intelligence Act (AI Act), marking another major step toward the legislation becoming law. As we previously reported, the AI Act regulates artificial intelligence (AI) systems according to risk level and imposes highly prescriptive requirements on systems considered to be high-risk. The AI Act has a broad extraterritorial scope, sweeping into its purview providers and deployers of AI systems regardless of whether they are established in the EU. Businesses serving the EU market and selling AI-derived products or deploying AI systems in their operations should continue preparing for compliance.

Now, the Parliament, Council, and Commission have embarked on the trilogue, a negotiation among the three bodies to arrive at a final version for ratification by the Parliament and Council. They aim for ratification before the end of 2023 with the AI Act to come into force two (or possibly three) years later.

In our recent advisory, we summarize the major changes introduced by the Parliament and guide businesses on preparing for compliance with the substantial new mandates the legislation will impose.Continue Reading European Parliament Adopts Its Version of AI Act