The MHRA held a six-week consultation on its proposals for EAMS in August/September 2021 and the proposed legislative changes were formulated following an analysis of the responses received. One key finding of the consultation showed that although stakeholders reported largely positive experiences of EAMS, they acknowledged that the EAMS process requires a significant amount of resource and that the level of evidence currently needed to apply for an EAMS outweighs the potential benefit provided. Another key finding was that EAMS is a crucial element in ensuring that the UK has a competitive and attractive market access environment for the launch of new products, and that more should be done to ensure that EAMS remains competitive. Overall, the MHRA found that the comments and views received from a variety of stakeholders from across the UK were broadly positive and there was support for amending the Human Medicines Regulations 2012 to introduce specific EAMS provisions.
Key takeaways
On the back of this consultation, the MHRA decided to lay a statutory instrument to introduce the policy considered during the consultation and to develop future guidance alongside the statutory instrument, expected soon in 2022.
The proposed legislative changes are designed to ensure that EAMS remains relevant and attractive following the UK's exit from the European Union and to ensure that UK patients are able to access cutting edge therapies in advance of licensing decisions, where they fulfil the EAMS criteria.
The proposals include five key areas:
- EAMS key principles of operation: to describe the objectives of EAMS and clearly detail its principles of operation
- Simplifying the supply of EAMS medicines: to simplify and harmonise expectations for the manufacturer, assembly and importation of EAMS medicines
- Create a supportive framework for the collection of real-world data (RWD): to allow for RWD collection without the need for a clinical trial approval, as long as the MHRA has no concerns about the collection of that data
- Clarifying the liability for prescribers and patients: to provide clarity around the use of EAMS medicines, in line with General Medical Council (GMC) recommendations
Pharmacovigilance (safety monitoring): In order to best support safe use and to reassure patients and healthcare professionals, introduce pharmacovigilance requirements in line with those currently expected through guidance
In more detail
The MHRA states that the changes will provide the UK with an opportunity to:
- maximise EAMS' impact by accelerating availability of medicines for patients
- reduce the regulatory burden on manufacturers supplying EAMS medicines by simplifying the supply of EAMS medicines
- facilitate the collection of real-world data that may potentially be used as evidence to support regulatory decision making for future authorisations
The MHRA hopes that this will support more patients to benefit from important EAMS medicines and ensure that the UK remains internationally competitive in the pre-market access landscape. Dr. June Raine, Chief Executive of the MHRA, said that the consultation gave a clear indication that patients, clinicians and industry are supportive of introducing a bespoke EAMS provision within the UK medicines legislation.
Kidney Care UK and the British Liver Trust, have both welcomed the news as likely to benefit patients with kidney and liver diseases by granting them access to medicines that are deemed safe much more quickly whilst further evidence is collected.
For further information please contact Julia Gillert of our London office.
