Ethical Medicines Industry Group (EMIG)
Quarterly Meeting Review

Attending the Ethical Medicines Industry Group (EMIG) quarterly meeting on 19 Feb 2024, always allows me the opportunity to develop my understanding in areas I have less experience in.  As usual pricing and reimbursement remain a central tenant of these meetings as change is coming, as the Chair Lesley Galloway outlined in his introductory remarks. The 2023 Voluntary Scheme for Branded Medicines Pricing and Access (VPAG) is a non-contractual agreement, negotiated between DHSC, NHS England and the ABPI, as the representative body of the pharmaceutical industry in the UK.

This Scheme is available for companies to join from January 2024 until the end of 2028 and agrees that NHS expenditure on branded medicines will stay within an agreed limit. Voluntary Schemes are designed to strike a balance between supporting innovation in the pharmaceutical industry and ensuring medicine spending in the UK remains under control.

The theme of the afternoon was understanding and investing in data to improve patient outcomes, listening to NHS clinician Phil Woodland give an insight on Real World Evidence (RWE) and biologics, the NHS investment in secure data enterprises and how access to NHS data can give a new insight to RWE.

However for me as a regulatory professional through and through, the highlight of the day, and a reason to endure truly dreadful train travel – I am not alone: thank you Martin Lewis for calling this out – was to hear directly from Julian Beach, the Interim Executive Director for Healthcare Quality and Access from the MHRA.

The MHRA are an agency in transition. Accepting that there is still a backlog of applications and needing to be decisive and fair going forward. They provide access to 17, 000 medicines and more than 2 million medical devices across the UK. Their mission is to protect and improve patient health, following their vision to be one agency delivering for patients, “to be a truly world-leading, enabling regulator, protecting public health through excellence in regulation, science and delivering the right outcomes for patients”. 

Its fair that the agency is slowly making headway in its performance measures.  You can access the latest rolling statistics here. In the rolling year to Jan 2024, 100% of Type IA variations were within target, and >85% Type IB applications have been assessed. However, the backlog remains, as of 05 Feb 2024, there are now 1136 national abridged MAAs that have exceeded this target  of 210 days assessment (the post Brexit euphoria of a 150 day national assessment timetable for MAAs, for pendants with good memory recall is never cited). It is these applications that the agency states would have needed its staff performance to exceed 200% in 2023 to have processed these applications. The agency is looking to provide more guidance on its process and gave an insight to the prioritisation of the work queue:

  • Public health priority (shortages both short term and long term) to ensure robust supply.
  • First generics out of data market exclusivity to ensure robust supply.
  • First in first out.

In addition, the agency aims to adopt a streamlined assessment report process:

  • Conversion of available MAAs to IRP or reliance where applicable.
  • Checklist to improve quality of submissions.
  • Checklist for bioequivalence applications.
  • Template for companies to prepopulate responses to questions.
  • Streamline process for applications under well established use (Reg 54/10a).

There will be more to follow on this, and I know my team will be issuing further advice and guidance. Please follow us to stay in touch with the ever-changing dynamics of the UK regulatory system.

In fairness its easy to throw stones at the MHRA glasshouse, Julian Beach does not shy away from the difficult conversation, he stood up in front of a busy industry meeting, nor is he a spin doctor telling us there is nothing to see here. The MHRA will get better, but it needs time and some of our patience to enable it to start to deliver against its mission and vision.

Janet Worrell