European Medicines Agency

Martyn Day Excerpts

Wednesday 12th October 2016 Westminster Hall

[Martyn Day (Linlithgow and East Falkirk) (SNP)]

It is a pleasure to serve under your chairmanship, Mr McCabe. I thank the hon. Member for Cambridge (Daniel Zeichner) for initiating this very important debate.

As we know, the European Medicines Agency is a decentralised agency of the European Union, employing about 890 people and located at Canary Wharf in London, which makes it the biggest EU operation in the UK. As we have heard, its staff is multinational; only 7% are from the UK, but all now face the prospect of a painful and uncertain period that almost inevitably will lead to relocation. It is inconceivable to me that an EU institution would not be located within the EU, although that will be decided by the member states at some point after the UK has left. Given that it took seven years to establish the organisation and given the possible further complication of its recent 25-year lease for its headquarters, who knows how long it may take to disentangle?

Of course, it is not just the staff who face the prospect of an expensive move. There are likely to be repercussions for the public purse and implications for medicine regulation. We know that currently more than one third —almost 40%, in fact—of EU drug approvals are outsourced to the Medicines and Healthcare Products Regulatory Agency, which clearly places significant reliance on that business for its income. Consequently, there will be a financial gap for the UK. I would be interested to hear from the Minister how the Government plan to plug that gap.

The complications are not just financial; there may well be implications for how medicines are regulated. We seem to be looking at a hard Brexit. If the UK does not become a member of the European economic area, marketing authorisations will be required from the MHRA for the UK. I am in no doubt that the implications of that will be less efficiency and possibly longer processes for obtaining authorisations in the EU and the UK, resulting—I fear—in innovative drugs taking longer to reach patients. Some industry leaders predict delays in the region of 150 days, based on the examples of Switzerland and Canada.

According to a piece that appeared in the Financial Times, when Sir Michael Rawlins, chair of the MHRA, was asked whether it would be able to take on all the extra work registering new drugs and medical devices that is currently carried out by the EMA, he said: “Certainly not.” Considerable investment and recruitment would be required to re-establish it as a stand-alone national regulator.

The EMA is central to the harmonised approach to medicines regulation. Losing this mechanism would have huge implications for the way in which drugs and medicines are tested and marketed, with concerns already expressed by many in the pharmaceutical industry that leaving the EU will result in the UK losing out on some trials that might otherwise benefit patients, as we will no longer be part of that harmonised procedure. The pharma industry argues that the UK is involved in about 40% of all adult rare disease trials in the EU at present, but that would be undermined by a change of status. Some in the pharma industry argue that that would in itself reduce the importance of this country in the eyes of the global drug companies. Being outside the EU would mean that the UK was not part of the harmonised procedure and so might lose out on some trials that might otherwise benefit patients. Officials at the National Eczema Society say that they have been informed by two US companies that trials of new treatments will not take place in the UK in the event of Brexit.

Across the UK, the pharmaceutical industry will be dealt a hammer blow through the loss of the European Medicines Agency, which is crucial for attracting foreign investment. It is clear that international pharma companies like to be close to their regulators. Until now, the EMA has been an attraction for companies to locate their European headquarters in the UK. The Japanese Government recently published a report detailing consequences if requirements from UK-EU negotiations are not delivered. Many Japanese pharmaceutical companies operate in London because of the EMA’s location in London. The Japanese Government have said that the appeal of London as an environment for the development of pharmaceuticals would be lost, which could lead to a shift in the flow of research and development funds and personnel elsewhere.

Thanks to a reckless gamble with our membership of the EU, the UK now faces the prospect of losing being part of the EMA, which not only will mean patients losing out on pioneering and beneficial medical trials, but will leave a disastrous trail when the inevitable happens and it seeks to have its headquarters in the EU.