The UK Regulatory Landscape for Drugs Three Years into Brexit
SummaryBrexit reached a significant milestone at the end of January 2023 - three years since the United Kingdom left the European Union. Whilst we’ll be debating its relative merits and pitfalls for decades to come, here in the pharmaceutical industry we can perhaps offer our own litmus test.
- Author Company: Certara
- Author Name: Claire Dyer, Director Global Submissions; Justin Hay, Senior Director; Daniel Smith, Director Regulatory Strategy
- Author Website: https://www.certara.com/
Brexit reached a significant milestone at the end of January 2023 - three years since the United Kingdom left the European Union. Whilst we’ll be debating its relative merits and pitfalls for decades to come, here in the pharmaceutical industry we can perhaps offer our own litmus test.
Since 1 January 2021, MHRA has gained independence from the EU regulatory system, allowing it to make decisions about the approval of medicines in the UK without being influenced by the EU, except for in Northern Ireland, which is covered by the Protocol on Ireland/Northern Ireland. Throughout the transition period, the Medicines and Healthcare products Regulatory Agency (MHRA) and the UK Government made efforts to minimise this impact, by amending the Human Medicines Regulations 2012 (HMRs) by the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 and 2020 legislations and passing the Medicines and Medical Devices Act 2021 allow the MHRA to be a standalone regulator.
Research from Imperial College London in July 2022 suggested that the UK had fallen behind the EU in its first post-Brexit year when approving novel medicines, with 35 approved in 2021, compared with 40 in the EU and 52 in the US. This was attributed to a combination of Brexit bureaucracy, the smaller size of the UK market, and the complexity of dealing with the National Health Service (NHS).
Further research from the Nuffield Trust in December 2022 showed that more than 100 products have been approved for use in Great Britain but not in Northern Ireland, with 52 approved for use in Northern Ireland and not in Great Britain. Regulatory review of medicines is complex, but what is being done by the government to help the pharmaceutical industry in the UK?
According to the MHRA Corporate Plan 2018 to 2023, a post-Brexit priority is to remain a globally recognised regulatory agency and continue to support innovation that accelerates routes to market. The MHRA wishes to be seen as a “globally unique concentration of expertise in data, standards and regulation,” and its plan over the next few years is ambitious. This aspiration was reiterated in the MHRA Delivery Plan 2021 to 2023 with a focus on ‘becoming a truly world-leading, enabling regulator’.
The UK has a 150-day assessment for ‘high quality’ national applications aimed at accelerating assessments. Rolling Review is a new route in the UK for MAAs intended to enhance development of novel medicines by offering ongoing regulatory interaction and advice. The process uses a phased, modular, approach with the applicant submitting modules of the eCTD dossier incrementally for pre-assessment, permitting early identification of issues. This was extensively used for COVID-19 therapies and vaccines.
Since the transition period, the MHRA has launched reliance procedures. For example, the European Commission Decision Reliance Procedure (ECDRP) and Decentralised and mutual recognition reliance procedure (MRDCRP) offer an abbreviated assessment of 67 days for products that have already gone through the EU centralised, decentralised, and mutual recognition procedures, respectively. However, the ECDRP is likely to be replaced with a new international reliance framework from 2024 while the MRDCRP will remain in place.
The MHRA has also joined Project Orbis (a programme to review and approve promising new oncology products initially reviewed by the FDA) and the Access Consortium (a coalition of regulatory authorities together with Australia, Canada, Singapore, and Switzerland), two initiatives in which international regulators share knowledge to help review and approve new medicines. The aim is to improve the efficiency of regulatory submissions and assessment systems for key products, such as cancer therapies.
Advanced Therapy Medicinal Products (ATMPs) and biosimilar products will be regulated in Great Britain by the MHRA according to the same principles that previously applied; however, the MHRA issued biosimilar guidance in early 2021 which places greater emphasis on quality and the confirmatory clinical PK study. Northern Ireland will continue to follow the EU regulatory framework.
Early Access to Medicines Scheme (EAMS) is a scheme designed to give patients early access to promising new medicines that are still in the development process and have not yet received full approval. Medicines approved under EAMS are subject to ongoing monitoring and review.
The MHRA has also developed innovative and expedited licensing routes, such as the Innovative Licensing and Access Pathway (ILAP) for new chemical entities, biological medicines, new indications, and repurposed medicines.
The ILAP is positioned as a model to consider for accelerated market access. Organisations can apparently gain advantage in securing regulatory, reimbursement, and scientific advice from early in the clinical development path; time and resources could be saved that may otherwise have been expended in achieving market access. The ILAP could be especially important for smaller companies with less strategic support in the future.
The ILAP allows applicants access to enhanced regulatory and other stakeholders’ input through collaboration between the MHRA, health technology assessment bodies, such as the National Institute for Health and Care Excellence (NICE) and the Scottish Medicines Consortium (SMC), the National Health Service England and NHS Improvement (NHSE&I), the Health Research Authority and the National Institute for Health Research.
Before the UK’s exit from the EU, the MHRA was part of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) under the EU system. Since Brexit, the UK became a standalone regulator and an observer nation in the ICH. Since 2022, it has become a full sovereign member.
Brexit now means that MHRA now has increased responsibilities in terms of the assessment and approval of medicines in the UK, which has put pressure on the agency to build up its capabilities and expertise. The MHRA has been working on restructuring its staffing and resources to meet these new demands.
Time will tell as to whether the UK can use Brexit to its advantage in the pharmaceutical industry. One thing is for certain, we’re experiencing a period of intense change within our profession; the regulatory landscape will continue to shapeshift.
We have put together a detailed guide on the post Brexit regulatory landscape which you can download here. If there is any other matter in relation to development and registration strategy, you can reach our experts here: Regulatory Consulting and Regulatory Affairs.