Post-#Brexit Europe must turn health-care ‘negatives’ into ‘positives’

On 28 March, around about the same time as the European Alliance for Personalised Medicine (EAPM) conference was wrapping up, UK Prime Minister Theresa May signed the historic letter announcing Britain’s intention to leave the EU.  By having this communication delivered to European Council President Donald Tusk on Wednesday (29 March), May formally triggered Article 50 of the Treaty of Lisbon, which paves the way for Britain to leave the EU in two years’ time, writes EAPM Executive Director Denis Horgan.

The clock is now ticking in a very real sense.  It will surely be a difficult process, with the EU’s chief negotiator Michel Barnier looking to wrap up talks within 18 months. Given that the rules of engagement won’t actually be settled until a special summit at the end of April, and real negotiations are not expected to start until the end of May, this is a tight timetable.  To date, the two sides have not even agreed the common language for the talks, which will be held in Brussels.  Frenchman Barnier seems to be determined to have three things agreed before even thinking about formal talks on trade relationships.

These are: the rights of EU citizens living in the UK (and Britons living in the EU); the question of the border between EU member Ireland and non-EU member Northern Ireland, and; the final settlement of the UK’s ongoing financial commitments to the Union.

These three ‘red lines’ are likely to be supported by the European Parliament next week.  (As an aside, Manfred Weber, the leader of the EPP, which is the largest political group in Parliament, has described Brexit as an "historic mistake”, has warned that it "will be costly” for the UK, and insisted that campaign promises that it would be positive for the British budget were "not correct”.)  All in all, the Brexit negotiations promise to be chaotic, although how much of that we will actually witness as citizens remains to be seen. However, if the tough talk from both sides in the nine months since the referendum is anything to go by, it could get messy sooner rather than later.  Add to this the fact that, at the end of the process, the divorce settlement has to be adopted by the 27 remaining Member States as well as the European Parliament. (This is the main reason behind Barnier's desire to finish talks in 18 months - to allow time for the necessary ratifications.)

If there is no agreement by the end of the two-year period (beginning Wednesday 29 March, 2017), the UK will have to leave without a deal, unless the EU-27 unanimously agree to extend the process.  Barnier has warned that a ‘no deal’ scenario would be bad news for the UK, on the basis that it could very well have a huge impact on trade, air traffic and more. Meanwhile, Theresa May’s "hard Brexit" will see the UK leaving the single market, the customs union and the jurisdiction of the European Court of Justice.

Upsetting the apple cart on both sides, to put it mildly.  Many sectors look set to be affected by Brexit, not least the massive area of healthcare and, underlying that, the sharing of vital research and health data.  Indeed, at EAPM’s conference, several delegates expressed a fear that the impact on healthcare options, especially in personalised medicine, would have huge implications for the bloc.  Uncertainty is unhelpful in any arena, and fears that cooperation between the UK and mainland Europe could start to stutter, and that standards across the English Channel could even drop once the UK is free of EU jurisdiction, are very real.  As we know, 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 current 28 member states.  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.  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).

Obviously, while a ‘hard Brexit’ could certainly hurt Britain (even in the short term through a lack of good will, although many are working hard to avoid that), there is no denying that the European Union will also feel the loss of the UK down the line.  It is already hard enough to co-ordinate and cooperate across medical disciplines and across borders, avoiding unnecessary and costly duplication in research, breaking down silo thinking, while collecting, storing and (vitally) sharing health data. The chance of any of the above actually improving post-Brexit seems unlikely.

Stakeholders concerned with the healthcare of an ageing population, 500 million potential patients and a huge rise in co-morbidities across the EU were already facing a huge challenge. It is fair to say that the eventual departure of the UK, while lowering the EU’s burden of overall healthcare by some 65 million citizens, is on balance a negative development.  Europe cannot afford to be negative, however. Therefore, it is up to stakeholders such as EAPM, as well as decision-makers and political leaders across the remaining 27 EU countries, to ‘make-do-and-mend’, seize what could be an opportunity for ‘smarter’ use of healthcare budgets, and head into the future with a positive outlook.

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