Personalised medicines: new initiative to pool genomic data in EU

Out-Law News | 17 Apr 2018 | 2:43 pm | 2 min. read

Plans to create a new European database of more than one million sequenced human genomes have been outlined by 13 EU countries.

Cyprus, Czech Republic, Estonia, Finland, Italy, Lithuania, Luxembourg, Malta, Portugal, Slovenia, Spain, Sweden, and the UK intend to link "ongoing genomic medicine initiatives" as part of a drive to "provide cross-border, data-driven health and care solutions to benefit citizens" across the EU.

The collaboration promises to help deliver more targeted prevention, earlier diagnosis, and treatment of diseases, according to the declaration signed by the countries.

"Coordinating secure access to data from [more than one million] genomes that are linked to health data, as well as pooling analytical capabilities, in compliance with the General Data Protection Regulation, is crucial to advance the understanding of genetic associations that cause or predispose diseases," they said.

Expert in life sciences Helen Cline of Pinsent Masons, the law firm behind, described the initiative as "very positive news for the development of health care treatments tailored to individual patients, and potentially more affordable treatments for rare diseases".

Cline said, however, that it is a shame that countries such as Ireland with its own very unique genomic pool has not yet embarked on a national genome project and consequently is not a participant.

Under the plans, the 13 European countries will "ensure distributed, authorised and secure access to national and regional banks of genetic and other relevant data for the advancement of science and innovation, while taking appropriate measures to protect the privacy of individual data donors".

A governance model for cooperation will be set up to, among other things, allow for cross border access and use of the genomic data, the declaration said. Secure infrastructure and tools will be developed to support the data sharing and analysis, it said.

"The digital transformation of health and care and, in particular, the use of genomic medicine, will help health systems to meet the challenges they face and become more sustainable, thereby improving the provision of high quality health services for citizens and the effectiveness of treatments for patients," the 13 countries said in their declaration. "There is a need to ensure that the Union remains competitive in the global race to advance personalised medicine, and that its citizens benefit from the latest innovation in this field."

"Secure and authorised cross-border access to genomic and other health data in the Union will enable targeted research and innovation as well as efficient translation of that research into clinical settings and public health work, which can lead to more effective therapies for individual patients and improved preventive measures. It will enable researchers to define subsets of patients who are not benefiting from standard treatments," it said.

Cline said there would be challenges in respect of data privacy for the European initiative to overcome.

"Any consensus across Europe on the technical issues and safeguards needed to facilitate data sharing while at the same time minimising the risks to individuals of identification is to be welcomed," Cline said. "The initiative has the potential to build the trust and confidence needed to get the support and collaboration of medical professionals and patients.  However, work is also needed to ensure there is greater public understanding of why data sharing matters."

Uncertainty over future data flows between the UK and EU countries post-Brexit is a further issue that will need to be addressed, she said.

The European initiative was announced shortly after it was announced that the Wellcome Sanger Institute in Cambridge will sequence the full genomes of all 500,000 of the UK Biobank participants as part of a new project funded by the Medical Research Council. Those plans accord with the UK's life sciences strategy.

"Sequencing the whole genome is more complex than exome sequencing or genotyping, as well as being more expensive," the UK Biobank said in a statement. "It is, however, key to understanding how protein production is regulated and likely, to provide important information about ways in which to prevent and treat disease."

Professor Sir Rory Collins, UK Biobank principal investigator, said: "This development is transforming in many ways. It massively extends the sorts of questions that scientists can ask and the speed at which they will get results."