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Published 2 febrero 2022
Improving health outcomes
Clinical trials are a critical element of medical research. They are key for achieving advances in treatment by demonstrating if medicines are safe and effective as has been seen with the successful introduction of new vaccines and therapeutics over the course of the COVID-19 pandemic.
The Medicines and Healthcare products Regulatory Agency (‘MHRA’), the UK’s medicines and medical devices regulator, has launched a consultation to review and update the UK legislation for clinical trials. This has been hailed by the MHRA’s Chief Executive, June Raine, as an opportunity to “deliver a more streamlined, transparent and flexible regulatory regime whilst always protecting patients and trial participants”.
As clinical trials may be designed and conducted by commercial, academic, or NHS organisations, the consultation seeks the views of manufacturers, healthcare professionals, researchers, developers, sponsors, investigators as well as clinical trial participants and the wider public in order to help shape improvements for the future.
The purpose of the consultation
The consultation, which is open until 14 March 2022, is available here.
It aims to reframe the UK legislation for clinical trials by responding to the needs of the sector by delivering a more streamlined and flexible regulatory regime while protecting the interests of patients and trial participants.
This aligns with the objectives of the Life Sciences Vision to make the UK the leading global centre for innovative research, design and delivery across all types and phases of trials. The Life Sciences Vision is the government and life science industry’s plan for the next decade to create a thriving sector and tackle some of the UK’s most significant healthcare challenges including cancer, dementia, and obesity.
Enabling the consultation
Following the UK’s departure from the European Union, the Medicines and Medical Devices Act 2021 (‘MMDA’) provides the powers and the mechanism whereby legislation in respect of medicines, devices and clinical trials can be updated. Part 2 of the MMDA sets out the powers for making amendments with the requirement for a consultation at section 45(1) of the MMDA.
The EU backdrop
The current UK legislation, The Medicines for Human Use (Clinical Trials) Regulations 2004, as amended, implemented the EU Clinical Trials Directive 2001/20/EC into national law.
However, from 31 January 2022, the new Regulation (EU) 536/2014 (the ‘EU CTR’) applies in the EU. While there is a long and complex transition period, this new regulation significantly changes the process for applying for and conducting clinical trials in the EU, as well as updating the rules regarding the reporting of outcomes. The EU CTR harmonises the assessment and supervision processes and also sees the implementation of the long-awaited Clinical Trials Information System (CTIS). CTIS will contain the centralised EU portal and database for clinical trials, set up and maintained by the European Medicines Agency (‘EMA’) in collaboration with Member States and the European Commission.
On 13 January 2022, the EMA also announced the launch of the Accelerating Clinical Trials in the EU initiative (‘ACT EU’), intended to transform how clinical trials are initiated, designed and conducted within the EU, encouraging the conduct of multi-state trials in particular. ACT EU will operate in conjunction with the new EU CTR and CTIS.
Against this backdrop and having left the European Union, the MHRA consultation takes the opportunity “to design a world-class sovereign regulatory environment for clinical trials that will support the development of innovative medicines and ensure that the UK retains and grows its reputation as [a] world leading base for life sciences”.
Consultation objectives – safety and innovation
The consultation recognises that due to innovation in treatments and ever-advancing technology, the way in which clinical trials operate is evolving. There is a stated need to move away from a ‘one size fits all’ regulatory approach and instead to enable flexibility and proportionality in clinical trials legislation.
The regulation of clinical trials needs to provide for more innovative, high-quality and efficient clinical trials, streamlining clinical trial approvals, enabling innovation, enhancing transparency and bringing in greater risk proportionality. At the same time, the safety of all trial participants must be ensured with the promotion of patient and public involvement in clinical trials and improved diversity of participants.
Specific policy objectives include reducing unnecessary burden on those running trials; reducing the burden of disease on patients and society by facilitating the evaluation and development of new or better medicines; and building in international interoperability so that the UK remains a preferred site to conduct multi-national trials.
Key proposals in the consultation
Having set out the policy objectives, the consultation provides its proposals and the questions to which it seeks responses for the following key areas:
The way in which clinical trials operate is evolving and so is the legislation. This consultation was both necessary and inevitable in the light of innovation in treatments and technologies as well as the changes taking place for clinical trials conducted in the EU.
As with the MHRA consultation last year to update the UK’s medical device regulatory framework, the challenge will be to achieve a lasting balance between removing burdens and introducing improvements while always protecting those participating in trials.
Responses to the MHRA will be used to inform the drafting of the amending legislation.
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