#Brexit and #health: What departure may mean

The in-out referendum in the UK on EU membership is getting close, now, with just a few weeks for those undecided citizens to make up their minds.  Britain joined what as then the EEC in 1973 (voting to stay in two years later) and, today, has 73 European Parliament seats (one less than France and 23 less than Germany, both of whom have bigger populations) pus 29 Council votes (joint equal highest with France, Germany and Italy), writes European Alliance for Personalised Medicine (EAPM) Executive Director Denis Horgan. 

The potential for influence is therefore pretty substantial and has been down the decades, although many have noted the UK’s traditional wariness over a truly federal Europe (‘ever closer union’) and it is not, of course, part of the euro or the Schengen agreement. The rise of UKIP across Britain effectively forced the hand of Conservative Prime Minister David Cameron and the referendum will be held on Thursday, 23 June.

Arguments are raging about the effects of staying in or leaving with those on the remain side claiming that house prices will fall, the pound will falter and trade with Europe will have more restrictions and be less profitable. These views are all hotly disputed by those who wish to leave and top-level business men and high-office politicians can be found on both sides of the debate.

Bank of England Governor Mark Carney is on record as saying that leaving could damage the UK economy while adding that there was a risk of a “technical recession”.  And, in the area of health, NHS England Chief Executive Simon Stevens has stated that he takes warnings of a possible recession "very seriously”. Stevens added that a ‘leave’ vote would be a "terrible moment" at a time when the NHS needs extra investment.   Speaking to the UK’s national broadcaster the BBC in late May, Stevens said: "It's been true for 68 years of NHS history that when the British economy sneezes, the NHS catches a cold and this would be a terrible moment for that to happen at precisely the time the NHS is going to need extra investment.”

He also pointed out that the NHS had "benefited enormously" from employing doctors and nurses from the EU. He spoke of an impact in the event that 130,000 staff left due to uncertainty over work visas.  Across the EU, health is a national competence, although EU legislation on matters affecting health, such as rules on IVDs, data protection, clinical trials and cross-border health care have all been designed to apply across the 28 member states.

So how would a so-called Brexit affect the UK and its supranational dealings with other health care bodies across Europe?  Well, the new Clinical Trials Regulation seeks to turn current outmoded trial models into those fit-for-purpose in a health environment that has seen the rapid emergence of personalised medicine.  It will introduce an EU-wide data base and much greater collaboration and harmony - all for the benefit of research and, thus, eventually patients. It will also reduce red tape and simplify the ‘bench to bedside’ process in many cases of innovative drugs and treatments, usually when the medical product in question carries less risk.

If the UK steps back from the legislation, it will face extra administration problems when holding trials in EU countries. This is inevitable.

As far as good manufacturing practice is concerned, the UK adheres to EU directives and is of a standard that would allow it to export and import quality-assured medicinal products within the European Economic Area. This would only apply, though, so long as UK standards remain equivalent to those within the EU.

Marketing authorisation is arguably more complex. Currently, one route to receiving authorisation is through the European Medicines Agency, or EMA, which is ironically London based. This is called the centralised procedure which sees a single application submitted to the EMA.  Other routes are the decentralised procedure (a submission to several Member States at once) and the mutual recognition route, which sees a company apply for a product authorised in one member state to be given the thumbs-up in others.

Put simply, if Britain departs the centralised procedure, a company would need a separate national authorisation and the centralised and/or mutual recognition routes become difficult, especially administratively.

And in the case of pharmacovigilance, current legislation governing the procedures throughout the EU calls for speedy collection of data, reporting of adverse reactions, risk management, and transparency by health services and the EMA (which coordinates EU-wide pharmacovigilance).   If Brexit occurs, the UK would have access to smaller data sets than those in the Union. Not only that, but the EU would lose data from the UK. This effectively means less collaboration and sharing of information. Such a scenario would affect patients, be less efficient and more expensive.  The jury is out on cross-border health care and care for British expats living in EU countries. As it stands, the large UK community in Spain, for example (as well as others), has free access to doctors, paid for by the NHS. If the UK leaves but stays in the European Economic Area this arrangement could possibly continue. Equally, it may turn out that expats have to pay for their own health care. Cross-border health care for those seeking treatment outside the UK may also be affected.

The debate rages on, but the Brussels-based European Alliance for Personalised Medicine believes that the 65 million population of the UK, as well as the rest of the 500 million potential patients across Europe, would be better served by the standardized and robust health regulations, best practices, collaboration and cooperation that would occur in a united Europe, and that a UK departure would therefore be to the detriment of all.

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