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#Brexit talks must not undercut health care, or all of Europe will suffer

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This week, enfin, the Brexit negotiations began at the European Commission in Brussels, between the EU’s Michel Barnier and the UK’s David Davis, alongside their back-up teams, writes European Alliance for Personalised Medicine (EAPM) Executive Director Denis Horgan.

The two held a joint press conference afterwards at which Barnier announced: “We agreed on dates, organization, and we agreed on priorities for the negotiations.”

What also emerged was Britain’s early concession to EU pressure to conduct the negotiations in two phases, rather than parallel talks about a trade deal, and it emerged that (as expected by most in Brussels) primary talks would cover the rights of EU citizens in the UK (and vice-versa), the border between Ireland and Northern Ireland post-Brexit, and the UK’s ‘divorce bill’.

After these key elements are agreed, talk will turn to trade deals. Basically, the UK has had to climb down as early as day one.

Barrier added: “The UK has decided to leave the EU - it's not the other way round. The consequences are substantial. I’m not in the frame of mind to make concessions or ask for them,” adding that the job ahead is to "unravel 43 years of patiently-built relations".

Both men appeared to be happy to be constructive and somehow reach a productive agreement in less-than-ideal conditions, with the clock ticking rapidly down to March 2019. The talks will take place for one full week per month, including through the summer.

There are many items to be covered, but one of the key areas is undoubtedly health. The impact of Brexit could result in an adverse effect on access to healthcare for citizens as well as on biomedical research across the EU as a whole, and Britain in particular.

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Basically, amid the uncertainty, the UK may find itself isolated in healthcare and research, at least temporarily.

Cross-border co-operation in such fields is sub-optimal, given member state competence for health,  yet a great deal of scientific co-operation between the UK and others does actually occur. At least for now.

And with the European Medicines Agency (EMA) on the move from London (destination as yet undecided) there are other issues that the UK must take into account - not least that the EMA and the European Commission have stated that all centrally approved medicines must be registered to an EU-based entity.

This affects global companies as well as pan-European ones. Many are now setting up what are known as ‘ghost offices’ in other member states to pre-empt the UK’s departure down the line.

Internally for the UK, many of the trained staff in Britain’s already beleaguered National Health Service are from the EU and it seems that potential new ones are currently reluctant to head there.

NHS England Chief Executive Simon Stevens went on record last year to say 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.

Meanwhile, the UK must, surely, agree to maintain already introduced EU-wide laws and recommendations on the likes of IVDs, clinical trials and data protection and sharing.

The aforementioned 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.

And insofar 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.

Meanwhile, as alluded to earlier, the ‘supply lines’ of research and cross-border cooperation will surely suffer on a pan-European scale after Brexit starts to kick in.

Post-Brexit, the UK may 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. This scenario promises to affect patients, be less efficient and more expensive.

Also, importantly, cross-border health care for those seeking treatment outside the UK (and vice-versa) may be affected without the right agreements in place.

None of this can be allowed to happen and negotiations here are key.

The EAPM believes that the population of the UK will be much-better served by the standardized and robust health regulations, best practices, collaboration and cooperation that already occur in a united Europe, so what is important is that any eventual deal takes all of the above into account.

It remains to be seen what any final deals will involve, although EAPM will continue to engage with personalised medicine stakeholders in the UK.

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