EU’s own laws damaging bloc: Brussels at risk of losing health research leadership status

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A new study from three academy networks, the European Federation of Academies of Sciences and Humanities, the European Academies’ Science Advisory Council and the Federation of European Academies of Medicine (FEAM) found that the EU’s status as a health research leader is “at risk” thanks to the bloc’s own data protection laws.

The report found: “It has become apparent that implementation of the EU’s General Data Protection Regulation has contributed to barriers in sharing health data with researchers outside the EU/EEA [European Economic Area].”

It estimated that more than 5,000 international health projects were affected by GDPR requirements in 2019 alone.

GDPR was implemented in May 2018 to protect Europeans from data and privacy breaches.

The legislation was not intended to target biomedical research, but the rule has thrown up data-sharing restrictions for foreign institutions.

George Griffin, professor of medicine and infectious diseases at St. George’s, the University of London, and president of FEAM said: “The transfer of data is really quite difficult with the US in particular.”

GDPR rules have also stalled or delayed at least 40 cancer research studies funded by the US National Institutes of Health (NIH).

The issue is “escalating”, claimed Mr Griffin.

He added: “There is pressing need to find a simple solution, a common-sense solution.”

The biggest problem arises when EU researchers try to collaborate with those based in countries that have no equivalent to the bloc’s GDPR rules.

Rosa Castro, senior scientific policy officer at FEAM explained: “Researchers are faced with a lot of complexity and uncertainty here.

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“The big universities can find lawyers – the little ones may not have the resources to navigate all this.”

The European scientific community lobbied to ensure the bloc’s rules included multiple exemptions for research.

But the legislation is too confusing for labs and with costs of non-compliance too high to run the risk.

In some cases, while the researchers could conduct their study and comply with the law, the modifications “may increase costs, affect statistical analysis and sample size, and increase the possibility of inaccuracy”, the report added.

Researchers involved in the EU-based International Genomics of Alzheimer’s Consortium and the US-based Alzheimer’s Disease Sequencing Project have not been able to pool and process data sets with personal data.

The report said: “Processing these data sets together would have allowed a more streamlined research process for novel drug targets for Alzheimer’s disease.”

The report is calling on Brussels officials to come up with new model contract clauses for NIH researchers that do not conflict with US law for federal agencies, and updated “operational guidance” for researchers more generally.

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