Introduction Following our post here on the EMA’s consultation on the use of Artificial Intelligence (AI) in the medicinal product lifecycle, which is open for public consultation until 31 December 2023, it is the turn of the World Health Organization (WHO) to release a publication outlining key considerations for regulation of artificial intelligence for health. In the same line as the EMA’s reflection paper that aims to initiate dialogue with all groups of stakeholders in…
The European Medicines Agency (EMA) has published a draft reflection paper which considers the application of artificial intelligence (AI) and machine learning (ML) to the development, regulation and use of medicines. This paper, which is now open for public consultation, evaluates the risks, benefits and opportunities that AI and ML present to the entire lifecycle for medicines. Underlying the paper is EMA’s concern around the challenges of integrating AI and ML into the medicines lifecycle,…
We’ve set out our top ten tips on ensuring GDPR compliance if your organisation is procuring AI solutions from third parties, whether this is to train an AI imaging system, integrate AI solutions into a patient-facing app or to allow your staff to make use of generative AI. These tips are based on the issues which we see are attracting regulatory scrutiny in practice, the potential stumbling blocks we’re coming across in supplier terms, as…
At the end of last week, two European Parliament Committees published the latest version of the EU AI Act. The new draft reflects months of political wrangling, but it also demonstrates that EU legislators have listened to the (many) criticisms levied at the EU AI Act until now. So what’s new? We’ve set our top ten changes: Higher penalties: If you thought the previous proposal was eye-watering, it’s about to get steeper. The most serious breaches will…
In its white paper published last month, the UK Government set out its principles-based, adaptive approach to regulating AI. The UK approach stands in stark contrast to the more static and prescriptive approach of the EU AI Act. Instead of assigning responsibility for AI governance to a new single regulator, the UK Government is empowering existing regulators to come up with tailored approaches for specific sectors. The aim is to ensure that the UK remains a flexible…
The European Union’s draft AI Act is an ‘early-mover’ in the arms race towards a global blueprint for AI regulation. In December 2022, the European Council approved a compromise version of the AI Act, and next month, the European Parliament is scheduled to vote on the draft text. But despite its initial promise, the AI Act increasingly resembles the circumstances of its conception – a complex, one-time political compromise between thousands of MEPs with wildly differing views.…
Baker McKenzie partner Aarthi Belani, AbbVie head of immunology business development and acquisitions Rachel Strick, Flare Capital Partners co-founder Michael Greeley and Patient Square Capital founding partner Neel Varshney share their insights on M&A trends in the healthtech and biotech sectors for the third episode of the Talking M&A podcast. 🔊 Talking M&A Episode 3 – Spotlight on healthtech and biotech in partnership with #BakerMcKenzie, is available to listen to here: http://spr.ly/60473clHl 16 minute listen…
In brief Starting from 31 January 2023, the Clinical Trial Information System (CTIS), 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 (EEA) countries. Key takeaways 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…
In brief Pharma companies often employ Medical Science Liaisons (MSLs) in order to provide healthcare professionals (HCPs) with high-quality professional and scientific information that lacks promotional content thereby distinguishing it from the information provided by medical sales representatives. In a recently published decision, the National Institute of Pharmacy and Nutrition (NIPN) stated that it does not support distinction between professional and promotional communication. This position leaves pharma companies with two options: either to register MSLs…
In brief A new EU-level recommendation paper (“Paper”) sets out wide-ranging recommendations for sponsors of decentralized clinical trials (DCTs). The Paper is great news for sponsors facing an array of grey areas and gaps in regulatory guidance around DCTs. It provides guidance on common issues in designing and implementing DCTs: from documenting the delegation of tasks to digital service providers, to obtaining e-consents and how investigators should manage new streams of incoming data. The recommendations…