Out-Law News | 09 Sep 2014 | 10:11 am | 1 min. read
George Freeman, who was appointed as the UK’s first life sciences minister last July, said in an interview with The Daily Telegraph that medical advancements such as ‘The 100,000 Genome Project’, which aims to sequence tens of thousands of genomes to map the genetic profile of rare diseases and cancers, are being put at risk by “hostile” European regulation.
Freeman said: “There are a number of areas where the UK and the National Health Service (NHS) is pioneering but EU regulation is in danger of holding back biomedical advances, in regenerative medicine, stem cells, genetics and data.”
The European Commission is considering a range of directives “which would basically risk making Europe, and therefore Britain in Europe, an increasingly unattractive place to do modern medicine and science and that would be a disaster for Britain and NHS patients”, Freeman said.
Freeman said: “We need the EU to put in a place a supportive regulatory framework to maximise benefits for patients and taxpayers. This is an area the UK leads and I will be reaching out to the European governments and to the Commission to highlight the work Britain is doing to shape this new landscape.”
Areas that risk being “harmed” by regulation include the UK’s new ‘Care.Data’ scheme, Freeman said. The scheme will see the medical records of all NHS patients transferred to a single central database so they can be accessed by research institutions.
The UK’s Care Act entered into force in May 2014 and, for the first time, “made clear a statutory basis for sharing information that will enable the tracking of patient outcomes across health and care services” the NHS said. Under the Act, a person’s data can only be shared and analysed “when there is a benefit to healthcare, never for other purposes”. In addition, the NHS said “all uses will be scrutinised with full transparency by an independent statutory body”. The Act also provides for “a legal basis for people to stop their data being shared if they wish to”, the NHS said.
The European Society of Medical Oncologists (ESMO) said this year that new EU data protection laws should not force medical researchers to seek consent from patients each time they wish to use their data or tissue samples in a new research project.
ESMO warned that "the survival of retrospective clinical research, biobanking, and population-based cancer registries in the EU" would be put at risk if current proposals backed by members of the European Parliament are introduced into law.