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At the beginning of July, the MHRA published its 2023 – 2026 Corporate Plan, which highlights, amongst many other topics, the importance of introducing new legislation and guidance on clinical trials in the UK to help provide the “stable and predictable regulatory environment that companies require”. The intention is that by 31 March 2026, the MHRA will implement a revised regulatory framework for clinical trials.

Work on a new clinical trial framework is already underway. On 21 March 2023, the MHRA published its response to the UK consultation (which ran from 17 January to 14 March 2022) on legislative proposals for changes to the law governing clinical trials, namely the Medicines for Human Use (Clinical Trials) Regulations 2004.

Responses demonstrated strong support to update and improve the legislation governing clinical trials, with most respondents agreeing that patient safety should remain the focus of the legislation, but with a more flexible and risk proportionate approach to decision-making. In line with responses to other recent consultations, the MHRA is looking to align with international standards rather than be limited by alignment with the EU. It is hoped that the implementation of the proposals will make it easier and more efficient to run trials in the UK, enabling greater patient access to new, safe and life-changing treatments, while retaining the UK as an attractive place for trials.

In terms of next steps, the drafting of the statutory instrument to update the clinical trials legislation is expected to be laid before parliament in the Autumn of 2023. Comprehensive guidance will also accompany the legislation.Continue Reading Legislative change is afoot for clinical trials conducted in the UK

On 4 January 2022, after approximately four years from the UK government’s first attempt to reform the UK national security screening regime, the National Security and Investment Act 2021 (NSIA) became operational. The NSIA represents a radical overhaul to investment screening in the UK as it introduces for the first time a mandatory and suspensory filing obligation for transactions in 17 sectors considered as particularly sensitive (among which are Synthetic Biology and Artificial Intelligence).

Alongside a mandatory and suspensory regime for certain transactions, parties are also encouraged to notify transactions voluntarily if—regardless of the sector concerned—the transaction might have national security implications based on (i) nature/identity of the acquirer, (ii) target’s activities, and/or (iii) nature and degree of control acquired. Unlike the mandatory filing obligation which only captures acquisition of entities, the voluntary regime also captures the acquisition of tangible and intangible assets—thereby including the acquisition, assignment and/or licensing of IP rights over e.g. molecules, compounds, methods or technologies.Continue Reading The UK National Security and Investment Act 2021 (NSIA) – Implications for Life Sciences