How to make the European Health Data Space a reality? (Guest blog)
Spurred by the changes in digitalising healthcare during the Covid-19 pandemic, the Commission presented its recent plan for a European Health Data Space (EHDS) as a "game-changer" that will "will help the EU to achieve a quantum leap forward in the way healthcare is provided to people across Europe".
And, indeed, the EHDS proposal has won considerable plaudits, not least for its ambitious scope. It aims to enable patients to access their health data, for example via their smartphones, and share it freely with healthcare providers across Europe; accelerate research into new therapies; free up billions within healthcare systems that can be more efficiently spent on improving patients' lives.
It promises even more: to grow the European economy and, crucially, help Europe close the growing innovation gap, in science and business, with the USA and, increasingly, China by reviving its position as a powerhouse or, as Stella Kyriakides, EU Commissioner for Health calls it, "a treasure trove for scientists, researchers, innovators and policymakers working on the next life-saving treatment."
At a recent conference, Maria Buckland Hassel of the Swedish eHealth Agency declared that although the EHDS can be better called “a distant reality”, “it gives us all a goal to work towards”. The event which I attended with enthusiasm, was called “European Health Data Space – Opportunity for Innovation and Economic Growth – Vision or Reality?” and organised by the Czech Chamber of Commerce in collaboration with the Association of the Innovative Pharmaceutical Industry of the Czech Republic (AIFP). It was held in Prague under the auspices of the Czech Presidency of the Council of the European Union, and we at MSD were pleased to sponsor.
The EHDS proposal could well be a major milestone in empowering citizens to gain free and direct access at any time to their electronic personal health data. That has long been a demand from patients and patients advocacy groups (PAGs) which see the EHDS as offering the sharing of this data both in one's home country and in other EU Member States. Its cross-border nature will make medical records more readily available when overseas while enabling the individual to control who sees it.
The EHDS could have a huge impact on the way national health services are organised. In due course, the strict adoption of a common standard in data-handling and data-sharing – using constantly updated and reliable information – will boost research, innovation, policymaking efforts, not forgetting patient safety. Beyond that it could save considerable financial resources in an era of ever-growing demands on the public purse.
The European Commission estimates that, via the EHDS, hospitals could save 15% of their costs, with - to take just one example - shared data between hospitals and general practitioners cutting the spend on diagnostic imaging on an EU-wide basis by up to 10% or €1.4bn. Overall, the scheme could save the EU an estimated €11bn over ten years.
A critical benefit of the EHDS is that the proposed gathering and sharing of (anonymised or pseudonymised) health data on what amounts to a continental basis will aid the formulation and execution of vital projects such as Europe’s Beating Cancer Plan and the Roadmap against Non-communicable Diseases by making comparable information available. It's even possible to envision a day when patients will have access to treatment at the highest possible level as of right across Europe. And diagnosis and treatment will be better and faster. Indeed, added value will come to all – patients, health providers, national health services, policymakers, industry, society...a virtuous circle! And in practice?
...and the flipside
Obviously, as with all far-reaching projects, we should remain cautious but hopeful about success, that was a key lesson from the conference I mentioned above. The complex scale of the task ahead is daunting. Just take the promised benefits in terms of enhanced competitiveness and innovation.
Europe has fallen far behind the USA in this field in the past two decades. Only four of the top 100 AI start-ups globally are European; we're home to just 5% of global 'unicorns' ($1bn start-ups). America now attracts infinitely more pharmaceutical investment and is home to a lot more new companies. In the words of Lisbeth Nielsen, head of the Danish Digital Health Authority, Europe is over-estimating how fast this can all be achieved (while under-estimating its long-run significance).
What's more, I would argue that a major pitfall is the lack of standardisation and 'parameterisation' of primary health data. Incomplete, unrepresentative data or records kept without a clear definition of parameters cannot be used for automatic sharing. And this is compounded by the very different scales of HEALTH digitalisation (and other variables) within EU Member States, some of which are seriously lagging behind.
At the same time, for industry there is even talk of the EHDS as "a Trojan horse for pharma and medtech" because of organisations, including companies, potentially being forced to hand over valuable datasets to rivals or threats to Intellectual Property Rights (IPR) and trade secrets. Any threat to IPR could fatally undermine the very investment in research and innovation the EU wishes to promote with this legislation. It's all a question of balance and the legislation so far has yet to achieve this.
Vision and reality
If the EU's vision is to be more than a dream, there must be action in the form of an agreement between the EU 27 Member States and the European Parliament, the co-legislators. Now under way, the legislative process will not be a long, quiet river: despite the institutions’ wish to close the file by the European Elections of May 2024, we're in for the long haul here.
The pharmaceutical industry is ready, willing and able to play its part in making sure this ambitious vision becomes a reality that's fit for purpose. As Managing Director of MSD Czech Republic, the Member State holding the Council of the EU Presidency until the end of 2022, I trust that this is possible. As the baton will soon be handled over to Sweden, I hope that the progresses I’ve seen in multi-stakeholder collaboration in the Czech Republic will continue beyond 2022.