Click here to view the write-up.
Whenever we embark on an event like this, there needs to be a clear aim and a clear appetite for information. We certainly knew this was the case when we decided to host this joint event, bringing in the expertise of both the Association of the British Pharmaceutical Industry (ABPI) and the BioIndustry Association (BIA). We hosted the event to increase understanding about the scheme to help companies to make an informed decision about their participation.
The scheme will benefit patients, the NHS and the UK clinical research community, of which our industry is a part. The regulation and development time for any new medicine is long and complex and the scheme should ultimately help patients with life-threatening or seriously debilitating conditions, without adequate treatment options, get faster access to innovative medicines. The concept of getting medicines to patients faster, without compromising safety, was first highlighted by Sir David Cooksey in his Review of UK Health Research Funding and was also considered at a Ministerial Industry Strategy Group (MISG) event in September 2007. The ABPI and the BIA responded to the MHRA consultation in 2012, highlighting the importance of continuous feedback and addressing concerns throughout the implementation process. Both organisations were also part of the Expert group on Innovation in the Regulation of Healthcare, which was set up following publication of the 2011 Life Sciences Strategy. Despite all this engagement, things have moved slowly and the first application deadline for EAMS was only earlier this month and it remains unchartered territory for the companies which are being encouraged to utilise it. The Government’s commitment to launch the EAMS was a major milestone, having taken many years to reach this point, but it soon became apparent that we were far from having the full picture about the scheme, and our member companies fed back to us that much more detail would be needed to allow them to fully evaluate the utility of EAMS.
We needed to get these unanswered questions answered if the scheme was going to get off the ground and benefit patients. To this end, we gathered all the key stakeholders, MHRA, NHS England, Government, patient groups and NICE and also members of the industry who could talk about their own experiences and impressions of the scheme so far.
The day was hugely productive, as the write-up highlights. There’s no doubt that everyone went away from the event with a clear understanding of the three-step process, expertly navigated by MHRA’s Daniel O’Connor. Also evident was the interest in the scheme - the room was full to capacity, and the MHRA alluded to several conversations which have already taken place with companies, although of course it remains to be seen how much of this interest will result in actual applications.
The other positive clearly evident at the event was the eagerness from all stakeholders to work collaboratively, flexibly and, in partnership with, industry. In practice, this will require timely feedback from industry to the MHRA on their experiences of using the scheme - which they encouraged multiple times throughout the event - and early, confidential dialogue with NICE to signal the direction of travel with PIM designations.
The potential of the scheme certainly came across for both industry and patients; however, this potential can only be realised once there is greater certainty.
The event went some way to addressing some of the key questions surrounding the scheme, such as making clear that the EAMS will sit alongside the EMA’s adaptive licensing scheme - for those who want to hear more about the adaptive licensing pilot, the ABPI, the BIA and the Centre for the Advancement of Sustainable Medical Innovation (CASMI) are holding another joint “one-stop shop” on 2 June, to register click here.
However, other areas still require greater clarification, such as:
The timeline and framework for commissioning within the NHS
How many centres will take part in EAMS
How the pathway for gaining commissioning approval will work
The process for NICE evaluation and at what stage they will be involved in the commissioning
Of the concerns raised, of most significance was the lack of funding for the scheme, which was a much discussed topic and is a key feature which the ABPI and the BIA will continue to push for, particularly at a one-year review.
It was extremely positive to get these questions and concerns out on the table, and heard first hand by the organisations and individuals who will be taking this scheme forward. We hope these points will now be taken back to organisations and addressed as a matter of urgency so that the scheme can quickly begin to benefit patients. There was without doubt a very encouraging level of interest and debate at the event, and we encourage those of you who would like to know more to read the write-up available here, and to feed back your comments directly to us at the ABPI and the BIA.
Stephen Whitehead Chief Executive of the ABPI
Steve Bates Chief Executive Officer of the BIA