Three initiatives affecting medicines, medical devices and clinical trials have been welcomed by the life sciences industry.
The UK Life Sciences Vision sought to address the some of the UK’s most significant healthcare challenges by strengthening the life sciences sector. The Medicines and Healthcare products Regulatory Agency ("MHRA") plays a vital role in fulfilling this vision as transforming regulatory processes helps provide an attractive environment in which the life sciences industry can thrive and, in turn, patients can benefit. The sector has faced many challenges over recent years with companies looking at where they can maximise market access most easily and cost effectively. Barriers to new technologies must be overcome and the duplication of regulatory requirements avoided.
Building on the response to the COVID-19 pandemic and the transition from being a member of the European regulatory network to becoming a standalone sovereign regulator, the MHRA is now seizing opportunities for change.
The following initiatives see the MHRA working in partnership with other regulators, both nationally and internationally, and establishing a platform from which the UK can develop innovative regulatory approaches to embrace emerging medical technologies while maintaining patient safety.
International Recognition Procedure for Medicines
The MHRA has announced a new licensing route for medicines which will operate alongside the UK's current national procedures. The International Recognition Procedure ("IRP") will begin operation on 1 January 2024.
Companies that have already received a marketing authorisation for the same medicinal product can apply under the new IRP for expedited access to the Great Britain market based upon the regulatory decisions of one of the MHRA's specified Reference Regulators. These trusted competent authorities will be the Australian Therapeutic Goods Administration, Health Canada, SwissMedic, Health Sciences Authority Singapore, the Pharmaceutical and Medical Devices Agency of Japan, the United States' Food and Drug Administration ("FDA"), the European Medicines Agency ("EMA") and EU member state competent authorities.
There are two recognition timetables for initial marketing authorisations, with a 60-day and 110-day timetable operating, with details of eligibility for each timetable set out in the MHRA guidance. The IRP may also be used at other stages of the product's lifecycle including for applications for extensions, variations and renewals.
The MHRA retains the power to conduct a full assessment where considered necessary and can reject applications if they are insufficiently robust. Medicines that are within the scope of the EU Centralised Procedure can only be authorised in Great Britain until the relevant provisions of the Windsor Framework come into force in January 2025.
With companies needing to make decisions on which markets to prioritise in terms of the time and cost required to achieve access, this is a welcome move. It also demonstrates the regulatory flexibility which the MHRA can now use for the benefit of patients, recognising the global nature of the industry but still ensuring the highest of safety standards.
Innovative Access Pathway for Medical Devices
The Department of Health and Social Care ("DHSC") and the MHRA have also launched a pilot for a new Innovative Devices Access Pathway ("IDAP"), which aims to support manufacturers with the rapid development of innovative medical technologies in order that they can be provided to UK patients and healthcare professionals at the earliest safest opportunity.
The IDAP is a key element of DHSC's Medtech Strategy, published in February 2023, and comes at a time of wider medical device regulatory reform in the UK.
Successful applicants will receive tailored non-financial support and scientific advice from a team of experts through the product design and development process. The multi-partner pathway (comprising DHSC, MHRA, the National Institute for Health and Care Excellence, Office of Life Sciences, Health Technology Wales and Scottish Health Technologies Group) will help developers generate evidence that meets the needs of the regulator and health technology assessment bodies as well as offering post market access support.
Specifically, participants in the IDAP will develop a product specific Target Development Profile roadmap, which will define regulatory and access touchpoints across the product's development. This might include quality management system support, safe-harbour meetings to discuss NHS adoption and notably, developers will have the opportunity to be granted exceptional use authorisation by the MHRA provided necessary standards are met.
The eligibility criteria for the pilot include that the condition that the product aims to address is life-threatening or seriously debilitating and there is a significant patient need; the product is innovative and transformative; will provide system wide benefit; and addresses one of the Life Sciences Vision’s Healthcare Missions, such as enabling early diagnosis or treatment and prevention of cardiovascular diseases and its major risk factors.
The idea for IDAP follows on from the Innovative Licensing and Access Pathway ("ILAP"), which supports the fast-tracking of approvals for innovative medicines. The pilot phase for IDAP is restricted to eight innovative technologies with applications closing on 29 October 2023. The purpose of the pilot is to test, define and scope how IDAP will best operate for the future and it is to be hoped that current numbers and timescales can be quickly accelerated.
Streamlined scheme for low-risk clinical trials
Clinical trials are a key element of healthcare innovation and regulation ensures patients benefit safely from pioneering new treatments as quickly as possible. It is a globally competitive field and the UK has experienced a slowdown in clinical trial uptake in recent years. Giving UK patients quicker access to potentially life-saving medicines and enhancing the UK’s attractiveness as one of the best countries in the world in which to conduct clinical research are goals set out in the MHRA’s Clinical Trial consultation which published its outcome in March 2023.
Recognising that clinical trials regulation should be flexible and proportionate to the risks, the MHRA has announced a new streamlined notification scheme for the lowest-risk clinical trials.
The scheme will see initial applications for the lowest-risk Phase 3 and 4 trials processed by the MHRA within 14 days instead of the statutory 30 days. About 20% of UK initial clinical trial applications are expected to be eligible for the scheme so although it is only open for late stage trials for the time being, it will still cover a significant number of trials. There is also the potential for the scheme to be expanded to some medium-risk trials in the future, with the criteria for notification of clinical trials being kept under review.
The trial sponsor will need to demonstrate that trial meets certain criteria set by the MHRA, including that there are no known safety issues with the medicine being investigated. An opinion from a research ethics committee will remain as a requirement for eligible trials. Applications for clinical trial amendments will not be eligible.
The scheme is based on that outlined in the MHRA’s Clinical Trial consultation and is just part of the reform process to be introduced by the MHRA, with support from partners including the Health Research Authority, in what will be the biggest overhaul in UK clinical trials regulation in over 20 years. The changes will reflect the review of clinical trials led by Lord O’Shaughnessy and which reported in May 2023.
Conclusion
The UK wants to be a global centre for innovative medical research, design and delivery to benefit patients, support the NHS and boost the UK economy. Both regulatory frameworks and their regulators need to keep pace with novel technologies. With such initiatives as the IRP, IDAP and streamlining low-risk clinical trials, innovators are more likely to choose the UK regulatory process as a supportive base for their products.
The task now is to build on these reforms and ensure they are just the beginning of the UK’s journey to becoming a global regulatory leader for innovative solutions to crucial health needs.
