Putting Patients First…..the new mission statement from the MHRA

The sharp eyed among you will have seen the MHRA’s 4 July publication of its 2021-23 Delivery Plan, which announces a series of initiatives to keep the UK in the vanguard of worldwide regulatory authorities, enabling patients early access to safe and effective innovation.  The agency has responded to the changes of Brexit and the Independent Medicines and Devices Review Report (IMDRR) to consider a number of wide-ranging reforms, with patient safety and involvement at the centre of its operations.

The delivery plan has six goals: Scientific innovation, Healthcare access, Patient safety, Dynamic organisation, Collaborative partnerships and Financial sustainability, each supported by key deliverables to enable the agency to sustain and support patient access to safe and effective innovation as early as possible (Figure 1).

Figure 1. Source: Medicines and Healthcare products Regulatory Agency Delivery Plan 2021-2023

Among the deliverables included to enhance scientific innovation, the MHRA has committed to developing various items to support the Innovative Licensing and Access Pathway toolbox, not least a novel trial design tool, with the aim of bringing this into use in 2022. In addition, further work on the CPRD and an increase in GP practice involvement, will allow construct of synthetic control populations, as well as tools to enable faster patient recruitment into commercially sponsored clinical trials with the aim of the first contracts for these services being in place later this year. The approach to clinical trial review and approval commits to enhancing speed of review via application of the streamlined combined MHRA and HRA approval procedures adopted during the COVID pandemic.

While helpful in shortening approval timelines, this trial-by-trial approach to development does not make the most efficient use of the ILAP process, which could be greatly facilitated by an ‘IND’ approach. This places greater emphasis on the overarching clinical development strategy with individual trial approvals resting predominantly on ethical committee rather than regulatory authority approval, once the regulator has assessed and agreed the suitability of a medicine for investigational use. Ongoing assessment of the benefit risk balance of the product is then managed via the development safety update reporting process. This approach works very satisfactorily in the US, is resource sparing, particularly for smaller companies, and facilitates streamlined development which is the intent of the ILAP process. Food for thought perhaps.

The Patient Safety deliverables, which will be primarily the responsibility of the newly appointed Chief Safety Officer, include development of new, more responsive, safety systems for devices and medicines, as well as exploration of the role of genetics in the development of adverse drug and vaccine reactions. This was discussed at the FPM Education week particularly from the perspective of potential for drug interactions. Given the IMDRR comments, greater focus on approaches to enhance successful pregnancy prevention programs among women taking teratogenic agents is included, as well as commitment to exploring greater patient and other stakeholder involvement in program development and design. A UK-specific falsified medicines scheme will be introduced to replace the EU system.

These activities will be further enhanced via greater collaboration with other agencies via the Access consortium and joining the International Pharmaceutical Regulators Programme.  This will also allow for dynamic collaboration across the regulatory spectrum to bring forward the potential for joint working and mutual recognition systems, again enhancing the global reach of the agency and ensuring ongoing relevance of the UK in international development, increasing potential for earlier access to medical innovations in the UK.

MHRA is to be congratulated on its ambitious and forward-thinking approach and the many advantages this is likely to provide in enhancing the understanding of the benefit risk balance of medicines and devices for the benefit of patients. However, it is likely that this plan may only be achieved if the MHRA retains and further develops its capacity and capability to build on its world renowned expertise.