Good afternoon, health colleagues, and welcome to the European Alliance for Personalised Medicine (EAPM) update, which today focuses on the crucial issue of health data co-operation, writes EAPM Executive Director Dr. Denis Horgan.

Co-operating on data

In operational terms, data sharing is technical. At a deeper level, data sharing is political, in that it depends on a commitment from governments and official bodies to reach out beyond their own national or regional borders.  

But at the most fundamental level, sharing of health data is more than technical, more than political. It transcends the customary forms of thinking in national governments and authorities about “what the patients in our country need”. This is because patients are not, and should not be seen as, a national issue. 

Center stage: Data Empowerment for the patients at the EU Level

Being a patient is a personal issue, for an individual, for his or her family and entourage, and for any health professionals involved in diagnosis or treatment. The nationality of the patient or anyone else involved is secondary. What is central to the experience of ill-health – and to any response to it – is intensely personal and individual. And that applies at a level so fundamental that nationality is utterly irrelevant. What unites everyone everywhere is their common humanity, the fate that we all, as individuals, inescapably share with everyone else: life, good health, ill-health, mortality. 

To the extent that there are significant common factors between patients, it is not that patient A and patient B are both French, or both Spanish. It is rather that they both suffer from the same condition, or have the same age, or profile. At that point, there is merit in taking a view wider than the individual, because as science and technology open more doors to understanding, the experience with one other case – or a hundred similar cases – may shed light on the nature, cause, prognosis, and even treatment options. 

At that point the sharing of data becomes not just useful; sharing is so valuable that it would be negligent not to share at an EU level. The sharing should be open, neither defined nor limited by irrelevant considerations of nationality, and subject only to the norms of protecting personal privacy. 

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This is why systems should give way to a spirit of cooperation – and to the extent that it is within the remit of a system to do so, each system should seek to maximise the sharing of data, adapting as appropriate its administrative, organisational, technical and, yes, political arrangements accordingly.

Stage Left: GDPR

The list of what still has to happen to win success in this area, drawn up by the Commission in its 2013 (nearly 10 years ago) –omics paper, takes on the character of a prophecy largely unfulfilled.   The paper noted, obviously but presciently, “the amount of medically relevant data available electronically is increasing dramatically. The challenge is to organise electronic data and to make them usable for research.

 The essence of this dilemma is that normalising the widespread use of digital solutions for health and care can increase the well-being of millions of citizens and radically change the way health and care services are delivered to patients – but it isn’t happening anything like as much or as fast as it should.

In EAPM’s  multi-stakeholder engagement with patient groups, scientific societies and professional and academic organisations unite around an agenda that included some strong messages of support for progress in tackling the deficiencies in this domain. It explicitly backed setting up a European Health Data Space to produce a range of health data to inform the work of policymakers, researchers, industry and healthcare providers. 

As our stakeholders have stated, data privacy clearly remains a major issue for healthcare professionals and for researchers, and when they were asked to what extent the EU’s general data protection regulation had affected their work, more than half of them said the impact had been negative and less than a third thought it had been positive. 

Areas of concern included the need for new solutions for big data projects and for secondary use of data, the brake effect the regulation’s bureaucracy had on speed of work, accompanied by uncertainties over how it is implemented in different countries. Industry respondents were even more critical, and in much larger numbers, highlighting divergent interpretation and increased compliance requirements complicating international collaboration on the use of big data.

Health-care professionals also felt that current regulations can constitute barriers for the best possible use of the data. They too cited data protection rules, lack of uniformity of European legislation and interpretation, and a focus on privacy at the expense of advancing science and healthcare. 

For healthcare professionals, the main barriers to the use of personalised medicine are lack of data, economic issues, lack of training and education, the disparity between diagnostics and related therapeutics, drug shortages, national guidelines, access to diagnostic testing, and clinical trial design. Oncologists and pathologists found reimbursement to be the principal limiting factor for cancer patients to access medication and drug pricing came close as another major barrier.

Stage Right: EU Deputy Ambassadors

EU deputy ambassadors tomorrow (13 May) will sign off on the Data Governance Act, the bill that aims to regulate neutral data intermediaries to foster data-sharing. Work has already started though, as the Commission confirmed it started setting up the new European Data Innovation Board (EDIB).

And what is the EDIB you may ask:  The Data Innovation Board is a new entity, bringing together both national and EU representatives, advising the Commission on practices for data-sharing and drawing up guidelines for the adjacent data spaces.

A view from the wings in the last days: European Data Protection Supervisor

European Data Protection Supervisor Wojciech Wiewiórowski says access to data should ‘always be properly defined and limited to what is strictly necessary and proportionate’!

In a joint opinion, the European Data Protection Supervisor and the European Data Protection Board drew attention to a “number of overarching concerns,” urging both Parliament and Council to address them in relation to the EU Health Data Space.

Both bodies acknowledged that efforts have been made to make sure that the Data Act doesn’t interfere with current data protection rules, but “additional safeguards” are deemed necessary in order to not lower the data protection bar. The opinion is a blow for the Commission — a top official claimed earlier that the Data Act is not a data protection instrument and that none of the measures wants to “change or interfere” the General Data Protection Regulation.

The Data Act — presented in February as part of the EU’s 2020 Data Strategy — is off to a bad start.   In any case, EAPM will be there to support the Data governance framework. 

Several committees in Parliament are jostling for a role in deciding the bill, sparking a turf war. One of the panels vying to have a say is the civil liberties committee, which is in the lead on the EU’s data protection rules. The draft opinion of the privacy bodies might boost the committee’s campaign.

View from Brexit: GP data sharing ‘a mistake’

More than 1 million people have withdrawn consent for the UK’s National Health Service’s GP data sharing scheme, eventually resulting in the plan being shelved following public outcry. That happened in 2021 and now the country faces a very different future for its health data, one that Ben Goldacre — who led the review into how the country can harness its health data —  is significantly more positive about. 

Speaking before MPs on Wednesday (11 May), Goldacre said that it was a mistake to launch the GP data sharing scheme without having the risks appropriately addressed. 

Central to Goldacre’s recommendations is the creation of Trusted Research Environments (TREs), which the government has actually already started to roll out. What’s so different about these TREs is that they allow approved researched access to de-identified data in secure environments, where the use of this data can be tracked and the data itself can be developed so it’s more useful for future researchers wanting to use it. 

On to good news….

€100 million for health research in Italy

€100 million worth of government funding is now available for researchers in the health field. The project is divided into two parts: the creation of research-focused life science hubs to drive innovation, and the opening of a pandemic hub to deal with future health emergencies. 

And that is everything from EAPM for now. Stay safe and well, and enjoy your weekend.

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