21 February 2022

UK Government launches public consultation on proposed revisions to UK clinical trial legislation

The UK Government, via the Medicines and Healthcare products Regulatory Agency (MHRA), recently announced a call for views on new proposals to improve and strengthen UK clinical trial legislation.

In brief, the consultation is designed to seek opinions on proposals to update clinical trial legislation  with a view to increasing patient and public involvement, improving diversity of trial participants, streamlining approvals and enhancing transparency.

The responses will help the UK Government assess whether changes to the legislation can help make the UK a hotspot for the research and development of new healthcare products, with the aim of promoting innovation whilst protecting patients and trial participants.

Why is this consultation happening?

The Medicines and Medical Devices Act 2021 provides the powers to update the legislation for clinical trials. Since the UK left the European Union in 2020, the Government is seeking to position the UK as a go-to sovereign regulatory environment for clinical trials. The Government also intends to support the development of innovative medicines and ensure that the UK retains and grows its reputation as world leading life sciences base, generating opportunities for skilled jobs. 

This consultation supports a wider programme of work in relation to developing and optimising the UK’s clinical research environment as part of the UK Government’s Saving and Improving Lives: The Future of UK Clinical Research Delivery and its implementation initiative, as well as its Life Sciences Vision

What will the consultation focus on?

The call for views focuses on a number of specific areas:

  1. Patient and public involvement – in particular, how to focus trials on patients to achieve the best outcomes, and to address barriers to participation to make trials as inclusive as possible.
  2. Research transparency – to make sure that trial findings benefit the research community, participants, health professionals and other stakeholders.
  3. Clinical trial approval process – streamlining processes to support quicker timelines for approval and provide a competitive advantage when running trials in the UK.
  4. Research ethics – to safeguard the rights, safety, dignity and well-being of people taking part in clinical trials.
  5. Simplifying obtaining informed consent in cluster trials to encourage update in lower risk trials.
  6. Safety reporting – balancing high standards of participant safety whilst removing reporting requirements that burden investigators without improving safety.
  7. Good clinical practice – updating principles to ensure flexibility and applicability across a range of trial types.
  8. Appropriate sanctions – to ensure proportionate and strong regulatory oversight.
  9. Manufacturing and assembly – in particular, labelling requirements for auxiliary medicinal products and for authorised products to allow for risk-adapted labelling.

Responding to the consultation

The call for views will run until 11pm on 14 March 2022 – respondents must submit a completed response form (available online). The form sets out a number of questions further breaking down the key areas described above.

What happens after 14 March 2022?

After the deadline, the UK Government will consider the responses and we can expect the publication of a formal report summary in due course. The call for views states that the information obtained will inform the Government’s decision on any potential changes to the clinical trials legislation and to support the clinical research ecosystem.

We are pleased to see the attention the UK Government is dedicating to promoting innovation and creativity within the UK using IP frameworks. If any clients or contacts have views on any of the questions the consultation seeks answers on, we would be happy to hear their thoughts.