Advertisement

A key medicine agency has left Britain. This is the start of a Brexodus | Mike Galsworthy

The European Medicines Agency in Canary Wharf, London.
The European Medicines Agency in Canary Wharf, London. Photograph: Amer Ghazzal/REX/Shutterstock

Amsterdam has won the right to become the new host for the European Medicines Agency (EMA). In a nail-biting final round last night, the 19 European cities that had put in bids had been whittled down to Milan and Amsterdam, sharing an equal number of votes. A draw from a hat sealed it for Amsterdam. Moments later, the same scenario played out for the European Banking Authority (EBA), with Paris and Dublin going into a hat and Paris being drawn.

And so it is settled. The EMA will move from London to Amsterdam after Brexit – taking with it nearly 900 jobs, a budget of €322m, and some 40,000 business visits every year, which support local hotels, restaurants, taxis and so on. Also likely to move with the EMA is the attendant industry that congregates around it for easy access to the regulator. It’s a substantial loss of finances, talent, infrastructure and influence.

As the EMA leaves the UK, the question now becomes: does the UK leave the EMA? The EMA is the regulatory body for the single market for medicines, and the two are entwined. Do we want to stay with that market of 510 million people and its regulator, or splinter off as a market of 65 million with our own framework that decides what medical drugs and devices can be developed and sold here?

The delusion of 'it’ll be alright on the night' should now be dispelled with the EMA and EBA relocations

During the referendum debate, the leave campaign claimed that the EU generated repressive “red tape” for clinical trials and life sciences, and that the UK should be free to be more innovative in this area. However, in the overwhelming judgment of our own life sciences industry, any potential gains would be small beans compared with the profound damage caused by splitting our huge collaborative market.

In September 2016, the Association of the British Pharmaceutical Industry (ABPI) and BioIndustries Association (BIA) jointly wrote: “Creating a standalone UK regulator would require significant resource, time and expertise, and … would likely still leave the UK behind the US and EU for new product launches, to the detriment of UK patients.” Switzerland and Canada have separate approval systems and are typically six months slower than the EU to bring new medicines to market – a critical consideration for new life-saving drugs. The government is caught between industry reality in one ear and continued Brexit fantasy in the other, hoping for a magical hybrid deal.

Meanwhile, the sands of time are running out. Companies fret over potential market fracture. On the EMA’s own website, a series of FAQs on legal concerns repeats that companies, processes and certain people must be established in the single market if they want the authorisations and support of the EMA after Brexit. The EMA guidance is unflinching advice to up sticks and move to elsewhere in Europe in order to preserve access to the single market for medicines and its regulator. Virginia Acha, executive director of research, medical and innovation at ABPI, estimated that the restructuring costs arising from UK pharma companies following the EMA’s guidance would run to “hundreds of millions of pounds”. Two pharmaceutical companies, AstraZeneca and Eisai, have already spent millions starting to duplicate their testing and approval procedures elsewhere in the EU in order to ensure market access after 2019.

The UK government knows it does not have enough time to arrange the Brexit it wants, and so is asking for a transition phase that respects single market rules, followed by some kind of deal that would ideally keep harmonisation with the EMA at least for a while. That means drugs developed or made here could be sold into the EU without separate authorisation and vice versa. Yet a timely deal is not a sure thing. After the precarious hurdle of the “divorce bill” lie multiple sectors all vying to get priority on deal-making and avoid falling off the over-stacked plate. Until any deal is finally signed, the colossal uncertainty continues to eat away at talent recruitment and inward investment.

These are real issues and consequences. The delusion of “it’ll be alright on the night” should now be dispelled with the EMA and EBA relocations. As recently as April, the Department for Exiting the European Union denied that they would have to move, with a spokesman brazenly and erroneously stating that their fate “will be subject to the exit negotiations”. It is time to stop the gaslighting. The EMA is gone. Without quick governmental moves to commit to preserving the EMA regulatory framework, the EU science programme, the European investment bank, Euratom and more, the high-value European medicines and research marketplace will continue to be lured from our shores.

• Mike Galsworthy is co-founder of the Scientists for EU (@scientists4EU) and Healthier In the EU (@healthierIN) campaigns