Après l’EMA

Any forced separation is an emotional event and I must admit to feeling a sense of loss on Monday as the 'decree nisi' on the UK’s relationship with the EMA was made real with the announcement of it’s relocation to Amsterdam.

This is one of the first tangible (however unforeseen) consequences of the decision to leave the EU. I am pretty sure that the EMA was far down the list of reasons to vote leave. Few would have considered the oversight of medicines provision as a meddling regulatory annoyance. For 22 years we were part of shared programme that encouraged research, safety and a world class process of evaluating medicines.

Like many hidden benefits of EU membership that can’t be characterised by a financial contribution, the collaboration of the partners in the European medicines community is a case of the whole being greater than the sum of the parts. Being one of 28 countries contributing to this syncytium is inevitably more productive than going it alone. One hopes that somewhere the issue of the UK partnering EU colleagues again in many important initiatives (IMI and Erasmus come to mind) is being pragmatically considered. The contribution of and benefit to the UK must not be disposed of for the sake of winning a political argument.

In the run up to the decision my annoyance was heightened by the casual errors of the media; getting the EMA acronym wrong (European Medical Agency & European Medicines Authority were two I picked up from the British Broadcasting Company) and the ill-informed panic about how we would get medicines to market in the absence of the EMA. Poor political and journalistic research had erased the MHRA entirely from the collective 7 grams of knowledge many commentators had about the subject. [I can’t wait to see what they will make of that acronym].

So, while we watch the eversion of the EMA from our corpus we are left with the MHRA. I meant that more politely than it sounded. In fact, we know that the EMA was heavily dependent on the MHRA which managed up to 40% of the EMA workload. In this sense the UK won’t be set adrift, but we should consider what opportunities this situation affords us.

Notwithstanding any mutual recognition limitations, if we go down that path, what are the opportunities we could countenance. I have a couple of suggestions.

First let us consider our assets. A world class medicines regulator, a thriving research capability (academic and industry), the NHS, a mature pharmaceutical industry and a political inclination towards investment in science education and innovation.

Idea #1 is a national Medicines Information Strategy. In developing our new medicines information service, Keep Me Informed | Medicines (plug), I was impressed by the volume of information available through the EMA. A veritable cornucopia of information provides the basis for much of our content. It demonstrates clearly the incredible science employed in our industry, is accessible and comprehensive. It is also largely designed for a professional community. The MHRA, however, have yet to achieve this level of sophistication as anyone trying to find an SPC or PIL for a medicine can testify.

A rethink of the information the MHRA provides and its presentation, particularly for patients is a relatively low-cost solution to a burgeoning problem. Taking a leaf out of the FDA’s book we should set about organising this information better. The FDA Information Repository and DailyMed both contribute to the ability to produce good information about medicines easily. This also demonstrates that if regulators provide the core content, third parties can set about producing appealing and up-to-date applications for professionals and the public. This will require a realignment of the legislation regarding information to the public and funding either from the government or industry or both.

Idea #2 can contribute to ameliorating the worrying prospect that pharmaceutical companies will not consider the UK as an attractive R&D location. We know that investment in RCTs has been declining in the UK for some time. A decade ago we posited the value of health records in real world analysis. The heady days when we thought we could offer the research community 60 million plus anonymised health records via the NHS was crashed by the unmitigated disaster that was care.data. The poor selling of the benefits of medical record utility resulted in a lack of public confidence and yet another Caldicott report.

The ability to analyse such large data sets, to track the performance and safety of all medicines and to monitor patients on newer therapies, in actual or near real time, opens up any number of clinical and economic benefits.

This issue should be revisited, and the National Information Board charged with delivering a service that can be widely accessed by the research community. If we need patients’ permission, then let’s get on with it. It may take time but it means we can address the concerns of the public, whilst demonstrating the benefits.

Taking medicines is a lifetime commitment for many of us and the knowledge we are generating is being wasted. We can build a world class, lifetime clinical research programme that can reduce drug development costs and provide the pharmacovigilance safety net that could bring medicines to market earlier. An expanded CPRD. But we must include the public as an interested party.

To all our EMA colleagues who now face relocating, I wish you well and I am sure that the wonderful people of Holland will welcome you with open arms.

For those of us in the UK I urge you to speak up, friends and let this parting not be sweet sorrow but the dawn of a bright future.