Today the BIA and the ABPI have published a write-up of our one stop shop event on the European Medicines Agency’s (EMA) Adaptive Licensing pilot project. We also co-hosted the event with the Centre for the Advancement of Sustainable Medical Innovation (CASMI), which was created to develop new models for medical innovation. Thanks once again to Taylor Wessing for hosting us.
The adaptive licensing event follows hot on the heels of our previous ‘one stop shop’ on the MHRA’s Early Access to Medicines Scheme (EAMS). The day was designed to provide attendees with a clearer understanding of which medicines would be appropriate for the pilot project and to explain in detail how the pilot would work in practice.
One of the speakers, Dr Hans-Georg Eichler, Senior Medical Officer at the EMA, said there have been a positive reception for the pilot project across Europe, which is now progressing with a ‘coalition of the willing’, referencing the MHRA’s significant support and involvement in the design of the pilot. To date, 20 applications have been received, two of which have been accepted onto the pilot project from an initial batch of nine reviewed so far.
Since 2011 the UK government has been in support of introducing some form of adaptive licensing as another step towards providing timely access to innovative medicines in order to address unmet medical needs. Also known as ‘staggered approval’ or ‘progressive licensing’, the adaptive licensing approach allows experimental medicines in the early stages of development to be authorised for use within a restricted patient population. Evidence collected during its use in this ‘real world’ setting will then be used to adapt the marketing authorisation and gradually expand access to broader patient populations. This moves away from the current ‘magic moment’ scenario in licensing, whereby once a drug is licensed it is immediately available to a large number of patients. In these cases, where use of the drug increases exponentially, it can be difficult to monitor adverse reactions and determine their significance. An adaptive pathway allows for greater control of the process and monitoring of side effects.
Thanks to highly informative presentations from the EMA, MHRA, NICE and the Department of Health, delegates were left with a clear understanding of both the rationale behind the project, and the mechanics of using this as a route to marketing authorisation, utilising existing regulatory pathways. Lord Howe’s introductory remarks, and attendance, further highlighted the high level government commitment to this project specifically and more broadly to innovation in biopharmaceutical regulation.
The candid comments from speakers and panellists prompted an open and honest interaction with delegates. This attitude will be central to the success of the pilot project. The first step is a discussion in a safe harbour environment, between patients, clinicians, industry, regulators and payers. The importance of trust between all parties was repeatedly emphasised and the dialogue during the day laid the groundwork for future discussions.
The workshop was an excellent opportunity to ensure concerns and challenges relating to the adaptive pilot project were heard directly by those responsible for running the scheme (see details in our press release here), and we hope they are taken into consideration as therapies begin to progress using this approach. We believe there is much to be gained through entering into a dialogue on the possibilities of adaptive licensing, and we encourage UK companies to consider submitting suitable live assets for consideration by the EMA. Full details of the criteria can be found here.
Without doubt the UK is moving to a new research paradigm where healthcare and research are becoming more closely intertwined, additionally the data used for analysis is changing. The speakers at our event were clearly championing adaptive licensing and embracing this new era, and the challenge is now for industry to do the same.
For those who were unable to attend this ‘one stop shop’ and would like more information, please read the full write-up available here and please do feedback your thoughts on the pilot directly to us at the BIA and ABPI.
Steve Bates, Chief Executive Officer of the BIA
Stephen Whitehead, Chief Executive of the ABPI