A new and ambitious Delivery Plan centred on putting patients first, has been published by the UK Medicines and Healthcare products Regulatory Agency (UK MHRA).
“Putting patients first: A new era for our agency”, ensures the agency keeps a constant focus on delivering meaningful outcomes for patients, protecting public health through excellence in regulation and science and becoming a truly world-leading, enabling regulator.
At the core of the plan is how the MHRA will draw together its scientific and regulatory expertise to help facilitate the UK life sciences sector and health service; develop new regulatory frameworks; quickly realise the benefits of new therapies and innovative technologies such as artificial intelligence (AI), to improve outcomes for patients; and ensure the continued safety, quality and efficacy of medicines and medical devices.
The plan recognises the significant challenges the agency will have to overcome to deliver against its ambition. Priorities include delivering the recommendations set out in the Independent Medicines and Medical Devices Safety Review by ensuring patients are listened to and engaged with more systematically.
Another key challenge will be the strengthening of international regulatory relationships and enhancing partnerships with the wider health system now that the UK has left the EU; the agency will need to work quickly to evolve regulatory frameworks, so they remain fit for purpose in an era of fast-paced, cutting edge scientific developments.
Underpinning this delivery is the creation of a new business model that provides a financially sustainable future that will meet the increasing expectations of patients, healthcare professionals, partners, the pharmaceutical industry, government and wider industry and non-profit stakeholders alike.
Delivery of the plan will build on the MHRA’s outstanding service to the UK public during the Covid-19 pandemic and the challenges it continues to pose to global science and healthcare.
The plan sets out 14 objectives grouped into 6 central themes: Scientific innovation; Healthcare access; Patient safety; Dynamic organization; Collaborative partnerships; Financial sustainability.
Overarching all of these, for every member of staff, is the priority to deliver better patient and public involvement and putting patients first.
Dr June Raine CBE, chief executive, Medicines and Healthcare products Regulatory Agency, said: “Our response to the Covid-19 pandemic is proof positive that we can rise to challenges with fresh thinking and innovative approaches – fulfilling our responsibilities to patients first and foremost, as outlined in the Independent Medicines and Medical Devices Safety Review, and opening up the many opportunities now that the UK has left the EU, with real benefit to the brilliant UK Life Sciences industry and to healthcare.”
“This plan is our response to these challenges and more. We have shown that we can not only excel under pressure and in exceptional circumstances, but also where we can take direct action to support and protect patients and improve health outcomes.”
“It marks a step-change in our efforts to build a world-leading organisation, bringing together excellence in science and regulation to serve patients and public health to the best of our ability.”
Stephen Lightfoot, Chair, Medicines and Healthcare products Regulatory Agency, said: “We are acutely aware of the many opportunities and challenges we face, but we are confident in the course we have set, our scientific expertise and our vision for progressive regulation to support the global life science industry.”
“Our Delivery Plan sets out our ambition plainly and prioritises the steps we are taking to achieve it: integrating our undeniable assets in science and regulation; building the UK and international partnerships we need to support our delivery; and taking the necessary decisions to improve our organisational resilience. These actions will enable us to dramatically improve patient involvement and outcomes from the faster introduction of safe and effective medical products to patients around the world.”
Innovation Minister Lord Bethell said: “During the many challenges posed by Covid-19, the UK’s brilliant life sciences and healthcare sectors have led the way for scientific innovation, rapidly developing life-saving vaccines and treatments which have helped turn the tide on the pandemic.”
“The MHRA has played an absolutely crucial role in the success of our vaccination programme by thoroughly assessing and batch testing all vaccines, allowing the UK to be the first country in the world to roll out an approved jab – which has prevented more than seven million infections and 27,000 deaths in England alone.”
“MHRA’s new delivery plan sets out how the UK will apply the lessons learned from the pandemic and grasp the opportunity of innovation now we have left the EU to make sure NHS patients are able to benefit first from all medical innovations.”
The Medicines and Healthcare products Regulatory Agency is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.