Pharma group critiques patient rights in Euro Health Data Space

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The German Medical Association (Bundesärztekammer, BÄK) welcomes the compromise adopted by the EU Parliament for the future European Health Data Space (EHDS) in its current form. However, the German Pharmaceutical Industry Association (BPI) believes that the compromise deviates too much from the original Commission proposal. It is therefore calling for a review of the regulation.

"The European Health Data Space has the potential to simplify the exchange of patient data across Europe. It can make it easier for patients to access their health data and give them more autonomy in handling their data," says BÄK President Dr. Klaus Reinhardt.

The BÄK is also positive about the fact that "as a rule, only anonymized data will be passed on, and the passing on of pseudonymized data will only be possible with a special justification". It is also right that an independent body should check the transfer of data. So far, however, there are still no adequate protective measures in place, which is particularly important for especially sensitive data.

Objection possible

In Reinhardt's view, the EHDS has now been significantly improved: "Only the present compromise does justice to our idea of patient autonomy over their data". Appropriate options for objection, which are also provided for in the regulation, must be implemented in Germany soon.

According to Patrick Breyer from the Pirate Party, "at least it was possible to prevent a Europe-wide compulsion for electronic patient records", but according to his information, the EU Commission "confirmed shortly before the vote that the right to object to foreign access to health data promised by the German government is 'not provided for' in the final version of the regulation. Anyone who does not object to the electronic patient file or its evaluation in its entirety will thus inevitably allow cross-border access to it by foreign practitioners, researchers and governments. The right planned by the German government to object specifically to cross-border data access is not provided for in the regulation in a legally secure manner," explained Breyer.

Doctors do not want to have to provide secondary data

Member states should be allowed to decide whether medical practices also have to provide data for secondary use. "The EHDS will inevitably entail changes for medical practices when collecting and feeding in patient data from the affected categories," emphasized Reinhardt. "Medical practices, which already suffer from a high bureaucratic burden, will be additionally burdened by the changeover. The federal government should therefore make use of this exemption rule and prevent further overburdening. It is also clear that the costs incurred by practices as a result of the changeover must be compensated."

However, this has drawn criticism from the BPI, which sees "progress in the development of important medicines and therapies" at risk: This exemption rule could lead to an "incomplete data basis". "The decision of the Member States to allow patients to refuse access to their health data by healthcare professionals or for research purposes weakens the basic idea of a European Health Data Space," says BPI Managing Director Dr. Kai Joachimsen. He sees an "urgent need for consistent European harmonization in the area of research data".

Pharmaceutical industry sees potential of the EHDS at risk

In addition, the review of "requests for access to health data [...] leads to additional administrative work at European level and further complicates the exchange between member states", according to a statement. Joachimsen warns of a "dilution of the original intention of the European Health Data Space. Such a development jeopardizes the full potential of the EHDS and leads to a European patchwork that does not promote the research landscape," said Joachimsen.