Brexit Goes from Bad to Worse for Medicines

August 3, 2018
Peter O'Donnell
Applied Clinical Trials

With looming workforce loss-now much higher than first anticipated-prompting further cutback plans at EMA, the threat to drug developers, suppliers, and patients is intensifying.

I can offer no apologies for returning to the somber Brexit business, because it is now turning into a threat so serious to medicines-and the people who one way or another depend on them-that it would be a dereliction of duty not to flag up just how bad the prospects are looking.   The latest unintended consequence was revealed Wednesday by the European Medicines Agency (EMA): it now expects to lose a third of its highly skilled staff as a result of the enforced departure from its London base. This is bad news not just for the UK. This is going to hit EMA's ability to do its job-for drug developers and for patients right across Europe.   EMA had already anticipated that the move to Amsterdam would disrupt its activities, and had revised its business plan accordingly to focus on essential business. But now it has admitted it will have to further scale back and suspend activities that until two years ago were considered not just desirable but necessary.   In October, EMA will cut back on a swathe of its plans, projects, and programs "so as to safeguard its core activities related to the evaluation and supervision of medicines," the agency has announced. The cutbacks will severely hit collaboration at the international level, so that it will take "only a reactive role" in the harmonization of global medicine regulation, and its engagement on antimicrobial resistance and vaccines will be reduced to "a case-by-case basis".   Development and revision of guidelines will be another casualty, and meetings of many of the agency's working parties will cease. EMA will organize or attend only meetings related to Brexit. And publication of clinical data-until recently a proud boast of the agency -will be suspended as from now.    The decision springs from the agency's obligation to prepare for its physical move to Amsterdam in March 2019, and from the "significant" staff loss it now faces-much higher than it expected, at around 30%. There is, says EMA, "a high degree of uncertainty regarding mid-term staff retention." Staff who will not relocate to Amsterdam have already started to leave the agency, and EMA expects this trend to accelerate. To make things worse, employment rules in the Netherlands make it impossible for 135 short-term contract staff to move with the agency, so they will have to be let go. If EMA is going to be able to evaluate and supervise medicines to the level of quality and within the timelines expected, it has no remedy, it says, but to rein in other activities. That is the best it can do to protect its essential public health activities and to allow for training of EMA staff who will be reassigned to new duties ahead of the peak relocation time, which will start in early 2019.   Meanwhile, Sanofi and AstraZeneca have admitted they are stockpiling drugs to avert shortages after the March 2019 deadline, at which point UK borders are increasingly likely to be overwhelmed by delays and congestion as the UK's membership of the EU comes to an end. There had been hope on both sides of negotiating a compromise which would have allowed a transition period and even the continuation of frictionless trade, but the UK has been unable to meet the conditions for any such agreement, and as time runs out, the government appears less capable of reaching a position on anything at all within its own ranks, and much less able to present a convincing case to the EU. So belated and half-hearted government attempts are now being made to mitigate the downsides of an abrupt UK departure-a cliff-edge or hard Brexit-by turning motorways to Channel ports into lorry parks, or considering drafting in the army to ease supply routes and even to contain social unrest.   It is not just medicines, of course, for which supply is threatened. There is now a realistic prospect of empty shelves in UK supermarkets, or air travel between the EU and the UK grinding to a halt as the agreements underpinning it cease to be valid.  But the disruption to EMA will hit all medicine developers and suppliers everywhere in the EU.   Peter O'Donnell is a freelance journalist who specializes in European health affairs and is based in Brussels, Belgium