The UK’s Medicines and Healthcare products Regulatory Agency (‘MHRA’) is undergoing a fundamental change of its structure, culture and working practises in order to ensure the UK can continue to access innovative medicines, medical devices and other products during the COVID-19 pandemic and in the post-Brexit world. Its future strategy is outlined in its 2020-21 business plan which is designed to counteract what it has identified as the biggest potential challenges for industry in the near future: the UK’s exit from the EU; technological and scientific advances and new regulatory challenges (e.g. digitally based products/AI and product development, production processes and novel supply chains). Its overall aim is to implement new overarching long-term ideals: focus on UK patients’ access to highly innovative products whilst still prioritising patient safety; transform post-market surveillance into a systematic data driven analysis of real-world data (or ‘RWD’) and use Artificial Intelligence (‘AI’) and measure impact according to patient engagement, influence and ability to make informed choices.
To achieve its ends, the MHRA has established five key specific, strategic goals for 2020-21.
- Ensure patients, public and the health service can access effectively and acceptably safe medical products by enhancing its public messaging (including online), implement a ‘patient first’ culture and improve the exchange of information between the MHRA and public.
- Embed innovation and develop regulatory science to ensure patients access the most advanced healthcare products by improving regulatory science (launch the Clinical Practice Research Datalink (CPRD) to hold de-identified patient data from GP practices across the EU, enhance its scientific regulatory with a new science strategy (by Q3 of 2020-21) and innovative biological standard (by Q4 of 2020-21) and improve market entry mechanisms (including in biosimilar products).This theme is the same as that emphasised in respect of chemical regulation in the EU, as part of ECHA in its strategic plan, as we have previously outlined),
- Orient lifecycle and safety management based on data and information to improve proportionate decision-making in the interests of patients and published guidance by developing a risk-based approach to manage product safety, form strategic partnerships with healthcare professionals and determine success of MHRA’s operations by implementation of the Yellow Card (the voluntary reporting of suspected adverse side effects) biobank (By end of Q4 of 2020-21)
- Have data and evidence based analytics underpin the regulatory and science processes in order improve patient safety and health outcomes by improving analytics and automation of regulatory decision-making.
- Establish strong leadership, improve governance and operate strategically with across the health and care sector by enhancing management structure and assessment of deliverables .
Whilst many of the above goals are echoed across the UK life science regulators more broadly, there is a notable lack of emphasis on a multi-disciplinary approach with other UK authorities or external bodies, which is interesting in the context of its greater separation from European regulators more generally post-Brexit.
Based on the above, and the self-identified threats it faces in terms of imminent political and societal shifts that are concentrated across the next short period, the MHRA is at a crucial stage of culture and organisational change. The success or otherwise of the organisation over the business plan period is therefore pivotal in establishing the reputation of the regulator post-Brexit and post-COVID-19 pandemic.