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#Health: Health-care training school ‘more important than ever’ after Brexit poll 

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DefiniensBigDataMedicine01The Brussels-based European Alliance for Personalised medicine (EAPM) has seen its first summer school for health-care professionals begin in Cascais, Portugal, today (Monday 4 July), writes EAPM Executive Director Denis Horgan.

Personalised medicine holds great potential for improving the health of many patients and ensuring better outcomes of health systems' efficiency and transparency. Yet, its integration into clinical practice and daily care is proving difficult given the many barriers and challenges to timely access to targeted health care that still exist.

One could argue that the recent UK referendum vote in favour of ‘Brexit’ will not help matters in this regard as, given that health care is a member state competence and health services across Europe are already disjointed, collaboration between UK and EU scientists, as well as those experts operating in the field of, for example, Big Data may well become harder.

And there are other implications. There is sure to be an impact in areas that EAPM has worked hard in over the years, and these include clinical trials, regulation, marketing authorizations, and pharmacovigilance.

For example, 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 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 a post-Brexit UK steps back from the legislation, it will face extra administration problems when holding trials in EU countries.

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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 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 decentralized 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 centralized 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 co-ordinates EU-wide pharmacovigilance).

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 they stay 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.

Despite the referendum result, the Alliance continue its work within all these sectors (and more) with its affiliates in the UK, and with those across the remaining Member States. Although Britain’s decision represents something of a set-back for patients in the EU, EAPM is still moving to the next stages of its development and various strategic actions that it has undertaken are now coming to fruition.

And, of course, science and knowledge never disappear into a black hole. It is difficult for things to be un-learned. You cannot un-invent the genetic technology that has put personalised medicine at the forefront of healthcare, despite cross-border difficulties, occasional silo mentalities and, crucially, a need to up-skill healthcare professionals (HCPs).

Past-president of the European Hematology Association (EHA) and a key player at the summer school Christine Chomienne said: “With Britain now not too far away from quitting Europe in a legal and practical sense, there are still current and future patients to think about. And their needs must still be met. Training for their doctors and nurses is vital. In fact, it is now more important than ever.”

So, as for the summer school itself, attendees from more than 20 countries (including the UK, as well as Germany, Netherlands, Italy, France, Bulgaria, Spain and more) have gathered in Cascais and will stay until Thursday this week (7 July). The faculty put in place by EAPM and its stakeholders and partners also has a similar EU-wide spread.

Topics and specialized areas being covered across the week include respiratory diseases, oncology, pathology, imaging, cardiology and hematology. The event’s sponsors are EFPIA (the European Federation of Pharmaceutical Industries and Associations), EHA, and genetic giants Illumina.

If personalised medicine is to be in line with the EU and member state=principle of universal and equal access to high quality health care, then clearly it must be made available to many more citizens than it is now. Part of what is required is a long-term approach to education to ensure the translation of new therapies from laboratories to patients.

This means that all HCPs in close contact with patients or their patients' families need to be up-to-date with the current aspects of personalised medicine and its latest breakthroughs in order to better understand their patients’ concerns.

This inaugural summer school recognises that the patient is at the centre of his or her own treatment and health-related decisions, the summer school will focus heavily on training in "how to communicate with patients" in several key areas.

EAPM is convinced that an improvement in such skills among HCPs is vital to giving the right treatment to the right patient at the right time.

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