A new European Commission task force aimed at further developing the digital strategy in health will significantly help Europe’s healthcare systems and thus their patients, writes Denis Horgan.
Denis Horgan is the executive director of the European Alliance for Personalised Medicine.
Leaders of major European countries, France, Germany, Italy and Spain, this week came out in support of a multi-speed EU, in advance of a summit in Rome to mark 60 years since its founding treaty in the same city.
The European Commission also concurs that projects do not have to involve all member states, whose number will, of course, fall from 28 to 27 after Brexit.
Hosting the meeting of the leaders, (German Chancellor Angela Merkel, Spanish Premier Mariano Rajoy, and Italian PM Paolo Gentiloni) in the Versailles Palace, French President François Hollande stressed that “Unity does not mean uniformity.”
This comment perfectly ties in with a recent announcement by DG Connect Director-General Roberto Viola and DG Sante Director-General Xavier Prats Monné, who are behind the setting up of a new task force aimed at further developing the digital strategy in health, alongside other Commission DGs.
In their article on the Digital Single Market section of the Commission’s website, the two directors-general state that “the Task Force will work across portfolios on developing concrete proposals to harness the potential of data and technology in order to deliver better health and care conditions in Europe”.
The strategy will be to examine incentives and obstacles to achieve secure exchange of health data across the EU, as well as defining new actions to strengthen pan-EU cooperation networks that can contribute to the acceleration of genetic research.
Certainly, in genetics, “Unity does not mean uniformity.” All patients are different, as are all healthcare systems. But the new task force believes that “strengthening EU cooperation and avoiding fragmentation will serve patients, health professionals, national health systems and European industries”.
The European Alliance for Personalised Medicine (EAPM), is firmly supportive of this new initiative and has already done considerable work on its own Big Data Working Group.
This working group has the following Key Policy Ask among its goals:
“By 2020, the EU should endeavour to achieve widespread benefits for patients and citizens from personalised healthcare by defining and subsequently executing a Data Strategy for Personalised Medicine.”
The mix of EAPM members provides extensive scientific, clinical, caring and training expertise in personalised medicine and diagnostics, across patient groups, academia, health professionals and industry. Relevant departments of the European Commission have observer status, as does the European Medicines Agency.
It is clear that Europe faces a major challenge with the sustainability and quality of health and care provision, as a consequence of demographic change and improvements in medical treatment, among other matters.
The better use and re-use of healthcare data will improve patient outcomes, make our healthcare systems more sustainable, drive innovation in research and help Europe to remain a centre for investment in medical research.
Just to focus on the health system benefits, estimates have suggested that better use of data across the EU could save the equivalent of the health budget of a medium-sized EU member states.
Pan-EU cooperation in this field is now more important and urgent than ever. This has been difficult in the past as, of course, competence for healthcare systems lies within each individual member state (although recent legislation on IVDs, clinical trials and, of course, data protection have made their mark in the health arena).
Key among the Alliance aims is to substantially improve such cooperation and collaboration among all stakeholders as well as encouraging all players to communicate better across inter-connecting areas in healthcare (and even within their own fields).
The General Data Protection Regulation (GDPR) will play a key role in this since it will determine the conditions under which such data can be accessed by researchers. GDPR must be implemented by May 2018. It contains many flexibilities which can advance or hinder research. At present, we see very little evidence of discussion across member states on how to align in approaching research and this presents a real danger that we end up with 27 different systems. The sorts of problems now emerging are:
- Different approaches to how data should be de-identified
- Different definitions of key concepts such as research
- Lack of alignment around the breadth of consent (many secondary uses of data are unknown at the point at which data is collected, so flexibility is important on this point
Big Data is here and here to stay. The key question, clearly, is how to use these new data superhighways to put Europe’s 500 million potential patients across the current 28 EU member states at the heart of this incredible revolution.
As we know, it is now possible to network almost anything – ‘smart’ wearables that pass data back to hospitals while we are at home and pill-boxes that tell us that it’s time to take our medicines, are just a couple of examples in the field of health.
Gadgets that send back information are, of course, part of the gathering apparatus of big data – data that is stored, channelled and, theoretically at least, can be used for the greater good.
It is clear that patients, researchers, and industry all need information. And there’s no doubt that there are ever-more new ways of collecting it. But to put patients at the heart of the big data phenomenon, individuals, and especially those who share all that very private data about their health, should be in control of their own information, become empowered through it, and use it to help themselves and others when it comes to health.
It is important that experts in all areas be persuaded of the benefits of leaving their silos and work together on a wider platform and have trust in the system. The research enterprise depends on the confidence of the people who share their data. As we engage more in using health data more extensively, there will be a parallel need to build systems of governance and accountability at both a national and a European level. At present, these efforts seem fragmentary and uncoordinated.
Obvious ways spring to mind – the sharing of clinical trial data across borders due to many more rare diseases now being identified with, by definition, smaller patient groups, for example, and the usage of data that they have chosen for the benefit of research and development.
Things would be a great deal better for patients if data on rarer diseases was collected, shared and analysed. This allows more information-flow with the result that diseases are identified earlier and new drugs can also be developed. This is not only the case with rare diseases, of course.
There is a wealth of data out there now, more than ever before and growing by the day. We must remember that, in health, this information should revolve around, and give benefit to, the patient.
The better use of data will undoubtedly improve patient outcomes while making the EU’s healthcare systems more sustainable. It will also drive innovation in research and aid Europe in holding its place as a centre for investment in medical research.
There is no doubt that, with the work being done by DG Connect and DG Sante, alongside their Commission colleagues and stakeholder groups, Europe’s healthcare systems and thus their patients can benefit hugely down the line.