The pandemic has propelled issues for the pharmaceutical industry to the top of the political and public agenda, from clinical trial recruitment to the journey required for medicines or vaccines to reach patients.
The public knows now more than ever that the Medicines and Healthcare products Regulatory Agency (MHRA) ensures the safety and quality of vaccines and medicines, and that evidence from clinical trials is required for any treatment to be approved.
MSD recognises the excellence of the MHRA, and feel proud to have collaborated with them. Now, we must take the ways of working developed during the pandemic and embed these in the healthcare system.
Getting the UK’s COVID vaccine and treatments programme ahead of schedule
Without the MHRA’s progressive mindset, the UK would not have been as successful in launching the vaccination programme, or in making treatments for COVID-19 available. Initiatives such as the RAPID-C19 pathway for investigational COVID-19 medicines are positive examples of how collaboration has resulted in benefits for patients and healthcare professionals, by accelerating access where research has demonstrated clinical benefit and a positive safety profile.
The UK’s response to COVID-19 showcases what is possible with flexibility; the same approach should be taken for other challenges, such as cancer, antimicrobial resistance, and cardiovascular disease.
To meet these challenges, the MHRA has a critical role to play in the collaboration with health authorities, public health bodies, healthcare providers, treatment developers, and the public. It needs to balance flexibility, with its sustained commitment to decision-making rigour, safety and efficacy. It’s global reputation and expertise ensures the MHRA has the qualities required to enable initiatives like this to flourish, but more can be done.
Creating the conditions for the MHRA to thrive
The Government has committed to relooking at regulation as it determines its own independent trading policy. For any reform to be a success, the MHRA must remain independent, well-resourced and internationally connected. The new Life Sciences Vision details priority areas for enhancing regulation.
MSD welcomed the Vision’s focus on using regulatory models to deliver fast assessments – building on the Innovative Licensing and Access Pathway (ILAP) – and ensuring accelerated approvals drive high quality real-world evidence generation. Such measures are essential to allow quicker access to safe and effective treatments.
Implementing the proposals on regulation within the Vision document will require collaboration. This includes between the Government, industry, the MHRA, NICE and the NHS, something identified by the MHRA as essential to integrate and improve outcomes.
Our industry operates globally, therefore regulatory frameworks which enable research, development, production and supply of medicines at an international level are vital. MSD believes that international collaboration, work-sharing and targeted assessment should be the primary focus for the MHRA, and that it should be able to take account of regulatory developments in other markets and their impact on innovation, access and competitiveness of the sector.
I was pleased to see this context recognised within the Vision, and by the MHRA’s plan for 2021-2023, which prioritises meaningful outcomes for patients. We must work with the EU through the establishment of the Medicinal Products Working Group, and pursue new collaborations with other regulators, to ensure patients have faster access to treatments. There is also a case for actively engaging in ongoing trade negotiations to align the regulatory agenda for the future.
Above all, it’s critical that the approach to regulation of medicines and vaccines in the UK remains based on science and evidence.
Why is this important for the UK?
Central to the strength of UK life sciences is a credible regulator, ensuring medicines and vaccines are safe and effective. Building Back Better from the pandemic, the UK must remain a leader in global life sciences, recognising the value of the industry to job creation, economic growth and improved patient outcomes.
Reform of the regulatory system must be supported by aligned policymaking in health technology appraisal and the medicines access and uptake environment (for which there are proposals in the Vision) to improve the innovation pathway as a whole, which is what ultimately matters.
The MHRA’s success – especially during the pandemic – has highlighted why the regulator is vital to the success of the UK’s life sciences sector. With its significant expertise, the MHRA is a global asset to the UK and it is critical that this is maintained. A properly resourced MHRA will help achieve the ambition in the Vision, and ensure positive experiences for those bringing new innovations to market. Ultimately, this will bring benefits for patients and public health
About the author
David Peacock is the managing director for MSD in the United Kingdom and Ireland having taken up his position in 2019. In this role, he is an active member of the ABPI Board.
Prior to his current appointment David served as the chief of staff for the Office of the chairman, president and CEO of Merck & Co. Inc. In this role, David worked closely with the CEO and members of the Executive Committee to coordinate and oversee enterprise-wide initiatives and ensured continued focus and progress on the company’s key strategic priorities.
Over the course of his career with MSD David has gained a broad set of leadership experiences including serving as the chief financial officer for MSD K.K. in Japan, leading the company’s business in Hong Kong & Macau, and successfully delivering in a variety of other commercial roles based in Japan, Vietnam, Singapore, and the United States.
MSD is a leading investor in the UK and our presence here goes back over 80 years. With a significant footprint across the UK, including the largest animal health business in the UK and the recently announced research discovery centre to be established in London, MSD is committed to the UK and ensuring it maintains its position as a life sciences leader.
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