ec.europa.eu (Evropská komise)
World  |  May 03, 2022 17:13:37, updated

Remarks by Commissioner Stella Kyriakides at the press conference on the European Health Data Space


Ladies and gentlemen,

Today we present another pillar of the European Health Union – I dare say its backbone. A European Health Union that since 2020 now includes a wealth of initiatives that always place patients at the centre, from strengthening the mandates of ECDC and EMA, the creation of HERA, the launch of Europe's Beating Cancer Plan, the reform of the EU's pharmaceutical legislation to come at the end of the year, and now the European Health Data Space.

What was then seen as a vision is slowly but surely becoming a reality.

A Union rendered more resilient and able to adapt to crises, address longstanding challenges, and which will offer citizens what they expect in the area of health.

The COVID-19 pandemic has shown us the importance of digital tools and how much they improved patient care.

The EU Digital COVID Certificate is a prime example of this, setting a global standard for safe travel.

Today, we propose a European Health Data Space. An initiative that brings us closer to making health data work for patients, people and innovation.

Our target is for the Health Data Space to start functioning by 2025.

For the first time, we will have a common EU data space connecting all Member States, for the benefit of all EU citizens.

The European Health Data Space has two basic aims.

The first is to enable citizens to share health data, for example their medical history, test results or prescriptions with hospitals and medical practitioners in and across Member States.

Let's see what this means practically.

For example, if a person living in Portugal falls ill in Paris, a local doctor will be able to access her or his medical history in French and prescribe the right medicine. There is no need to repeat unnecessary medical exams, they can be shared digitally across the EU.

Likewise, if a cancer patient has to stay longer than expected away from their country of residence, but is running out of the medicine prescribed by their oncologist, he or she will be able to take the prescription to a pharmacy in the country they find themselves in and get the vital medication needed.

Or it will allow those for example with rare diseases to access doctors in other Member States. We have seen the value the European Reference Networks have brought to the treatment and care of patients with rare diseases. The European Health Data Space will help to further pool data, always in a safe way.

Sharing up-to-date, reliable health data is not only key to countering health threats like COVID-19, and developing effective treatments and vaccines, but it is also cost effective.

So, by sharing health data across hospitals and between medical practitioners across Member States, which will save further resources.

The European Health Data Space's second aim is to revolutionise how we use health data for research, innovation and policy-making.

It will create a strong legal framework to allow public researchers, institutions, and industry to access, combine and re-use health data.

This data can lead, for example, to the development of new, revolutionary life-saving treatments, medicines, medical devices or next-generation antibiotics; and to make progress on personalised medicine.

Our researchers will have access to large amounts of health data – real-world, concrete data, with the higher quality that medical breakthroughs require.

Meanwhile, easier access to health data for regulators and policy-makers will benefit public health and healthcare systems.

For our European industry this means an EU-wide market for electronic health records will be available, with the same standards and specifications, and the use of data for the development of innovative medicines and devices.

Here I would like to use two key words, the first is trust and the other is respect.

The framework we have put in place for the European Health Data Space respects citizens' and patients' rights.

For all the above to work, trust is vital. Strong privacy and security protections is how we will build this trust.

When it comes to our citizens, they can be confident that their personal health data will be handled with the greatest care, underpinned by strong data protection rules and data security.

The European Health Data Space will give citizens complete control over their data.

They will be able to add information, rectify errors, restrict access and find out which health professionals have accessed their data.

When it comes to industry or researchers, they will require a permit from their national health data access bodies.

And even then, only the data needed for a specific project will be provided in a secure and controlled environment, and will not allow people to be identified. Complete anonymity is secured.

Ladies and gentlemen,

Bringing together the health data of almost 450 million citizens will be a fundamental game changer, making the EU a global leader in this area.

Ultimately, the European Health Data Space can only be a success if we move forward together. I am convinced that through the pandemic, where we have seen how much we can do when we work together, this proposal will be supported.

It shows the power of cooperation, and that there is nothing more valuable for citizens than their health. It is therefore crucial that they are able to access and share their health data, and to make the best use of it in a very safe way, while at the same time encouraging research and innovation in a safe space.

Thank you.

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