Transparency data

Annual accountability review minutes 2017 to 2018: 18 October 2018

Updated 19 January 2024

Chair and attendees

Chair: Lord James O’Shaughnessy, Parliamentary Under Secretary of State for Health, Department of Health and Social Care (DHSC).

Attendees:

• Professor Sir Michael Rawlins, Chair, Medicines and Healthcare products Regulatory Agency (MHRA)
• Dr Ian Hudson, Chief Executive (MHRA)
• Jonathan Mogford, Director of Policy (MHRA)
• John Quinn, Director of Transformation (MHRA)
• Boryana Stambolova, Deputy Director of Finance (MHRA)
• Elizabeth Woodeson, Director of Medicines and Pharmacy (DHSC)
• Carly McGurry, Deputy Director of Medicines Regulation and Prescribing (DHSC)
• Rebecca Diment, Head of MHRA Sponsorship (DHSC)
• Victoria Crawford, Private Secretary to Lord O’Shaughnessy (DHSC)

Review of progress in 2017 to 2018

Dr Ian Hudson set out an overview of the key achievements by the MHRA over the past year.

At the European Union (EU) level, the MHRA acted as a rapporteur or co-rapporteur in the authorisation of several new medicines across Europe, whilst ensuring the preparatory work to plan for the UK’s exit from the EU was in place.

The MHRA continued to focus on growing the UK’s role in international forums and bilateral relationships, and securing global supply chains for medicines and medical devices through global strategic alliances. The MHRA expanded the Clinical Practice Research Dataline (CPRD) and renewed the National Institute for Biological Standards and Control (NIBSC) designation as a World Health Organization collaborating centre. Following receipt of a grant, the MHRA worked with the Bill and Melinda Gates Foundation to strengthen capacity in pharmacovigilance in low and middle-income countries.

The MHRA built further links across the health and social care system to facilitate better regulation, innovation, and development of strategic priorities. The MHRA supported the work on the Early Access to Medicines Scheme, as well as Life Sciences Industrial Strategy and the life sciences sector more generally.

The MHRA began to implement the recommendations in the Patient Safety and Vigilance Strategy for medicines and medical devices, a critical pillar of the MHRA’s work. The MHRA developed further work on the Scan for Safety Programme to help improve future traceability of medical devices and medicines, which was positively received.

Lord O’Shaughnessy thanked the MHRA for its hard work and achievements last year. He also recognised that this has been carried out in parallel to managing an increasing workload due to EU exit, and commended the MHRA for managing such a complex workload.

MHRA and EU exit

There was discussion of MHRA’s ongoing work to prepare for the UK’s exit from the EU. Lord O’Shaughnessy noted the extensive work that the MHRA has done to consider the impact of EU exit.

Supply chain

Dr Hudson recognised the importance of the MHRA working closely with DHSC on supply chain preparations. The MHRA will continue to work collaboratively with DHSC as further work takes place.

Operational transformation

There was a brief update on the Operational Transformation Programme. Dr Hudson described the progress that has been made to replace the end-of-life IT systems. Lord O’Shaughnessy recognised the progress made to date and asked the MHRA to set realistic goals for the programme, recognising the pressures of EU exit.

The Independent Medicines and Medical Devices Safety Review

Dr Hudson reflected on the role of the MHRA and the importance of the Review with regards to how the whole system responds to, and engages with, patients. Lord O’Shaughnessy highlighted the importance of patient safety and being patient-facing and focused. Dr Hudson provided some examples of how the MHRA is enhancing how it listens to and engages with patients proactively, which included Yellow Card Scheme reporting, meetings with patients, patient groups and charities, and lay representation on their committees.

Any other business

There was a brief discussion on how the MHRA is using its resources. Lord O’Shaughnessy encouraged the MHRA to carefully consider how resources can be reutilised in new areas of work, such as the innovative regulation opportunities being developed under the second element of the life sciences industrial strategy.

Lord O’Shaughnessy concluded the meeting by reiterating his thanks for the MHRA’s hard work over 2017 to 2018 and his enthusiasm for continuing to work closely with them.