#Health: ‘Unthinkable now irreversible' as UK votes to leave the EU

So, the dust is beginning to settle after the UK voted 52-48% to leave the European Union, writes European Alliance for Personalised Medicine (EAPM) Executive Director Denis Horgan. Britain’s Prime Minister David Cameron has been hoist with his own petard and will step down in October, while it remains to be seen what 'Boris and his Boys' will do with UKIP’s leader Nigel Farage.

Notably, Article 50 of the Lisbon Treaty - a prerequisite of departure - has yet to be invoked, and that can occur via a minuted speech by Cameron to his fellow European leaders or by formal letter.

There seems to be no rush from the Tory government, yet many of the other member states see no point in heel-dragging and want them to simply get on with it.In the meantime, the pound has plummeted.

On top of this, Scotland’s First Minister Nicola Sturgeon has suggested that her country - which voted largely for ‘Remain’ - may veto the ‘Leave’ decision. That seems unlikely, although a second Scottish referendum on independence is less so.

No matter, at some stage Britain will have to face the fact that last Thursday’s ‘leave’ vote could prove to be an unmitigated disaster for the health of almost 65 million citizens, despite empty promises of lots of cash being pumped into the NHS.

And it possibly goes further than that because the ‘supply lines’ of research and cross-border co-operation will surely suffer on a pan-European scale after Brexit starts to kick in.

Britain joined what was 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).

The potential for influence at European level has therefore been substantial, 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 Cameron’s hand and the arguments then raged in an often grubby campaign about the effects of staying in or leaving. Neither side emerged with much credit and even the opposition Labour party has suddenly been thrown into disarray after what a host of now-resigned shadow cabinet ministers strongly felt was a particularly lukewarm and limp ‘remain’ campaign from leader Jeremy Corbyn. His future as leader now looks grim.

Elsewhere, French President Francois Hollande has said that there is no going back on the UK's decision. He added: "What was once unthinkable has become irreversible.”

And, at the time of writing, German Chancellor Angela Merkel was preparing to host President Hollande, as well as Italian Prime Minister Matteo Renzi and President of the European Council Donald Tusk, in a meeting to prioritise getting Britain out of the EU as smoothly as possible and to safeguard the Union’s future.

In the area of health, NHS England chief executive Simon Stevens went on record during the campaigning to say that he took warnings of a possible post-Brexit recession "very seriously”. Stevens even 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 could leave 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 will the now-confirmed Brexit affect the UK and its supra-national dealings with other health care bodies across Europe?

It is clear that there is already a huge need for better collaboration across medical disciplines and borders, therefore this decision will not help anyone in that regard.

On a legislative note, 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 authorization is arguably more complex. Currently, one route to receiving authorization 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 decentralized procedure (a submission to several member states at once) and the mutual recognition route, which sees a company apply for a product authorized in one member state to be given the thumbs-up in others.

Put simply, once Britain has properly departed, a company would need a separate national authorization and the centralized and/or mutual recognition routes will 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 co-ordinates EU-wide pharmacovigilance).

Post-Brexit, the UK will have access to smaller data sets than those in the Union. Not only that, but the EU may lose data from the UK. This effectively means less collaboration and sharing of information. Tis scenario promises to affect patients, be less efficient and more expensive.

There are many unknowables at this stage. The jury is still 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 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 Brussels-based European Alliance for Personalised Medicine (EAPM) believes that the population of the UK would have been much-better served by the standardised and robust health regulations, best practices, collaboration and cooperation that occur in a united Europe, and that a British departure is therefore to the detriment of all.

It remains to be seen what, if anything, can be salvaged from the wreckage, although EAPM will continue to engage with personalised medicine stakeholders in the UK.

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