A new EU regulation, which entered into force in March, will give pharmaceutical companies across the European Union easier access to health data from member states. The rules are part of the creation of the European Health Data Space (EHDS), aiming to promote large-scale use of health data for research, innovation, and policymaking.
Easier access for private companies
Until now, in Denmark, pharmaceutical firms needed to collaborate with publicly employed researchers and maintain a local address to access national health data. Under the new EU framework, this requirement will be lifted. In the future, private companies across the EU will have the same level of access as public research institutions in Denmark.
This means that patient records, test results, medication histories, and data from health registries may increasingly be used in cross-border research and development. Industry representatives argue that this could speed up the development of treatments, particularly for rare diseases where data is scarce.
Public concern over privacy and commercial use
A recent survey by Epinion for Denmark’s DR shows that 54% of Danes oppose granting private companies the same access to health data as public researchers, while only one in four support the idea. The director of Danske Patienter (an umbrella group for patient organisations), Morten Freil, said this is “not surprising,” given that people are often uneasy about commercial actors accessing personal data.
Freil acknowledged the importance of allowing companies to use anonymised data to help develop new treatments, but warned that public fear might lead citizens to opt out of data sharing altogether, which could harm future research.
Opt-out rights under the new EU rules
The new regulation grants EU citizens the right to opt out of their health data being used for secondary purposes, such as research. However, there are exceptions for certain uses deemed to be in the public interest. The details of how this opt-out will be implemented in Denmark are still being decided.
Today, Danes can already refuse to allow their biological material or genetic information to be used in research by registering in the national tissue application register. The new EU rules extend opt-out rights to broader patient information.
Safeguards and national conditions
Denmark’s Ministry of Health has outlined some key principles for how it will apply the EU regulation. Access to Danish health data must still serve a significant societal purpose, research involving patients or biological material will continue to require approval by national ethics committees, and data will generally not be exported. Instead, foreign researchers will access Danish data through secure local environments.
The ministry emphasised that maintaining public trust is crucial, promising high data security and increased transparency about how data is used. It also suggested that people might eventually be able to specify which uses of their data they wish to opt out from.
Industry perspective: more efficient research
The Danish pharmaceutical industry association (LIF) welcomed the changes, arguing that concerns are likely to diminish once people understand that companies will only receive aggregated or pseudonymised data, not information directly linked to individuals.
Thomas Klit Christensen, head of trade policy at LIF, noted that this could especially benefit research into rare conditions. “The better our understanding of diseases, the more we can drive research and development of new drugs to the benefit of patients,” he said.