Inside EU Health: UK Biobank suspended; France chooses ‘sovereign’ cloud for health data; latest EMA medicines approvals

UK Biobank suspends access following Alibaba revelations; France chooses ‘sovereign’ cloud for health data; EMA recommends five new medicines, including a first-in-class small interfering RNA treatment

Inside EU Health: UK Biobank suspended; France chooses ‘sovereign’ cloud for health data; latest EMA medicines approvals

UK Biobank suspends access following Alibaba revelations

Access to UK Biobank has been suspended after data was found listed for sale on a Chinese website Alibaba. The charity is introducing stricter controls, including limits on file exports and daily monitoring.

“This is a clear breach of the contract signed by these academic institutions and they, along with the individuals involved, have had their access suspended,” said CEO and Principal Investigator of UK Biobank, Professor Sir Rory Collins.

As a result of the data breach the UK Biobank has temporarily suspended all access and “a comprehensive and forensic Board-led investigation” is promised.

The breach raises concerns as Europe develops the European Health Data Space, highlighting the challenge of protecting sensitive information while enabling research.

UK Biobank suspends access following Alibaba revelations
UK Biobank promises to carry out comprehensive and forensic board-led investigation

France chooses ‘sovereign’ cloud for health data

French Health Data Platform (PDS - Plateforme des données de santé) has announced that it has chosen Scaleway as the future host for its technology platform.

“The migration to a sovereign cloud marks an important step in the evolution of its service offering, designed to accelerate the provision of health data to stakeholders in research and innovation,” reads the press release.

PDS considers that, given the sensitivity of the data hosted, the system must be resilient, scalable and have a very high level of security.

“This migration is part of a long-standing commitment to maintaining a high level of security and trust for all users of the platform. It marks an important step towards accelerating the use of [health] data and, more broadly, of all research and innovation projects that rely on health data, in France and across Europe,” said Director of the PDS, Hela Ghariani.

EMA recommends five new medicines, including a first-in-class small interfering RNA treatment

The European Medicines Agency (EMA) has recommended five new medicines for approval following its April meeting of the Committee for Medicinal Products for Human Use (CHMP), alongside nine existing medicines for expanded therapeutic use.

Among the highlights is Redemplo, a first-in-class RNA interference (RNAi) therapy developed by Arrowhead Pharmaceuticals. It targets a harmful liver protein and is designed to treat familial chylomicronaemia syndrome (FCS), a rare inherited disorder.

“This milestone reflects the strength of the clinical data and the ability of our Targeted RNAi Molecule platform (TRiM™) [...] we are working with regulators and the healthcare community to bring this therapy to more patients as quickly as possible,” said President and CEO at Arrowhead Pharmaceuticals, Christopher Anzalone.

EMA recommends five new medicines, including a first-in-class small interfering RNA treatment
Five new medicines are recommended for approval; a further nine medicines are recommended for extension of their therapeutic indications