How does the EU AI Act impact upon medicines R&D? The answer is not much at all. This position stems from an exemption for scientific R&D in the AI Act, as explained by a recent statement from the European Federation of Pharmaceutical Industries and Associations (EFPIA). This will be welcome news for the pharmaceutical industry, but questions remain for the medical device industry, where the position is far murkier at the research and development stages.…
Baker McKenzie has recently conducted a survey across over 100 jurisdictions, asking our Healthcare & Life Sciences global network of specialists to compare the degree of flexibility clinical trial sponsors have to negotiate with sites in clinical trial agreements. We have received input from our healthcare regulatory experts in 105 jurisdictions and are therefore able to build a global picture of how the flexibility afforded to sponsors varies from market to market. The results are…
The World Health Organisation (WHO) has issued new guidance on the ethics and governance of large multi-modal models (LMMs). The guidance details over 40 recommendations for governments and companies involved in healthcare and technology, and covers both the design and deployment of LMMs. So what are LMMs? LMMs, also known as “general-purpose foundation models”, are a type of generative AI. LMMs can accept one or more type of data input and generate diverse outputs that…
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has published a new roadmap setting out its timeline for an overhaul of the UK medical device regulations. The MHRA is taking a phased approach, with new legislation pencilled in for 2024 on Post Market Surveillance (PMS) and in 2025 for a wider core framework. Current plans indicate certain areas of alignment with the requirements of the EU Medical Devices Regulation (EU MDR). The MHRA further…
Manufacturers of Machine Learning-Enabled Medical Devices (MLMDs) face a key challenge: existing requirements and processes on the notification and management of ‘substantial’ and ‘significant’ changes to medical devices need adapting for MLMDs. The MHRA, together with the U.S. Food and Drug Administration (FDA) and Health Canada, has published five guiding principles on predetermined change control plans (PCCPs) to help resolve this tension. What is the tension between AI and change management for medical devices? Some…
The UK’s Information Commissioner’s Office (ICO) has launched a public consultation on its draft guidance on transparency in the health and social care sector. The proposed guidance emphasises the importance of going beyond the legal requirements of the GDPR in order to build trust with patients, and builds on themes of openness, honesty and patient engagement. The consultation is open until 7 January 2024. We’ve set out our top six takeaways on the proposed guidance…
The EU has published its draft Standard Contractual Clauses for the procurement of AI (AI SCCs). These are drafted for public organisations (such as public hospitals) wishing to procure AI systems developed by an external supplier, and are based on the requirements for high-risk AI systems in the EU AI Act. The AI SCCs might be a good starting point, but dig a little deeper, and you’ll find that the clauses are based on some…
The UK government has issued proposals for a new licensing regime for currently unregulated cosmetic procedures whilst also intending to classify and regulate certain cosmetic products such as dermal fillers as medical devices. The government has brought forward an amendment to the Health and Care Act 2022 that gives the Secretary of State for Health and Social Care the power to bring into force a licensing scheme in England for non-surgical cosmetic procedures. The purpose…
The European Parliament (EP) has published two draft reports on the Commission’s proposals for a new Pharmaceutical Regulation and Directive. The reports have been drafted by the MEPs assigned as rapporteurs for the Directive (Pernille Weiss, EPP) and for the Regulation (Tiemo Wölken, S&D) and will be debated at the Committee for the Environment, Public Health and Food Safety (ENVI) later this month or beginning of November. The report on the Directive is favourable to…
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,…