'Hostile' Europe risks derailing medical innovation, warns minister
Europe's 'hostile' attitude to scientific advancement risks leaving Britain in
the 'slow lane' of medical development, the new life science minister George
Freeman has warned
Worrying devlopments in Europe could
hinder the progress Britain in medical innovation, the new life sciences
minister George Freeman has warned
7:00AM BST 07 Sep 2014
Original link: http://www.telegraph.co.uk/science/science-news/11077912/Hostile-Europe-risks-derailing-medical-innovation-warns-minister.html
Medical advancements like ‘The 100,000 Genome Project’ risk being derailed by
‘hostile’ European regulation, the new life sciences minister has warned.
Britain is leading the world in genetic research and personalised medicine, but is being hindered by increasing interference from the European Commisson, George Freeman told The Daily Telegraph.
Mr Freeman, who was appointed as the UK’s first life sciences minister in the
recent cabinet reshuffle, said it would be a ‘disaster’ for NHS patients if
Europe continued to condemn Britain to the ‘global slow lane’ of medical
innovation.
He warned that 'increasingly unhelpful' red tape was holding up vital clinical trials while new data protection laws risk preventing medical records being gathered for research.
"There are a number of areas where the UK and NHS is pioneering but EU regulation is in danger of holding back biomedical advances: in regenerative medicine, stem cells, genetics and data," said Mr Freeman.
“There are a whole serious of directives which they are looking at 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.
"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 the European governments and to the commission to highlight the work Britain is doing to shape this new landscape.”
Last year the European Commission announced a reform of the existing data protection legislation which would give people the right to know every time their records are accessed from medical databases.
Mr Freeman warned the new regulations could damage the government’s ‘100,000 Genome Project’, which is aiming to sequence tens of thousands of genomes to map the genetic profile of thousands of rare diseases and cancers.
It could also harm the new Care:Data scheme which will see all NHS patients’ medical records moved to one central database so they can be accessed by research institutions.
“The new EU rules could pose a serious threat to these ambitions,” he said.
Researchers would have to apply for “specific, informed and explicit consent” every time they wanted to look at individual records, a measure that could tie-up scientists in so much red tape as to render the projects useless.
The European Commission's 2001 Clinical Trials Directive has already contributed to a 25 per cent decline in the number of new trials undertaken in the EU between 2007 and 2011.
During the same period administrative costs have risen by 98 per cent and insurance costs by 800 per cent. The average delay for launching a clinical trial has increased 90 per cent to 152 days.
Mr Freeman said it was vital that trials on technologies like mitochondrial DNA transfer – in which donor DNA from a 'second mother' to be implanted into a defective egg – are allowed to go ahead.
“There is very strong consensus from all parties that we should get on this because children our dying unnecessarily of rare diseases,” he said.
But 34 members of the Council of Europe have warned that Britain may be breaching The United Nations Education, Scientific and Cultural Organisation's (UNESCO) Universal Declaration on the Human Genome and Human Rights because the genetic alteration would be passed down through generations.
Mr Freeman is calling for greater freedom for Britain to be able to determine its own medical and science policies.
However he believes that healthcare in the UK is undergoing a ‘quiet revolution’ which will see it become the most advanced in the world.
“My mission is to make Britain in the 21st century the best place in the world to discover design and develop modern medicines and healthcare technology; to harness the extraordinary power of biomedical science and research, to accelerate the development of the new generation of diagnostics, drugs and preventative therapies,” he said.
“We’re the first country in the world to pioneer a genomic medicine service based on sequencing the entire genome. People have done big studies of little snips. We’re building the platform here to make Britain the pioneer.
“21st century medicine and healthcare will not just come from the drug but from the smart delivery of the drug, site-specific deliver. There’s an extraordinary revolution of remote sensing, remote diagnostics.
“Today’s 20 and 30 years olds will expect their healthcare to be digital. There is a noble collective health mission here which goes right to the heart of the DNA of the NHS.”
"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 the European governments and to the commission to highlight the work Britain is doing to shape this new landscape.”
Last year the European Commission announced a reform of the existing data protection legislation which would give people the right to know every time their records are accessed from medical databases.
Mr Freeman warned the new regulations could damage the government’s ‘100,000 Genome Project’, which is aiming to sequence tens of thousands of genomes to map the genetic profile of thousands of rare diseases and cancers.
It could also harm the new Care:Data scheme which will see all NHS patients’ medical records moved to one central database so they can be accessed by research institutions.
“The new EU rules could pose a serious threat to these ambitions,” he said.
Researchers would have to apply for “specific, informed and explicit consent” every time they wanted to look at individual records, a measure that could tie-up scientists in so much red tape as to render the projects useless.
The European Commission's 2001 Clinical Trials Directive has already contributed to a 25 per cent decline in the number of new trials undertaken in the EU between 2007 and 2011.
During the same period administrative costs have risen by 98 per cent and insurance costs by 800 per cent. The average delay for launching a clinical trial has increased 90 per cent to 152 days.
Mr Freeman said it was vital that trials on technologies like mitochondrial DNA transfer – in which donor DNA from a 'second mother' to be implanted into a defective egg – are allowed to go ahead.
“There is very strong consensus from all parties that we should get on this because children our dying unnecessarily of rare diseases,” he said.
But 34 members of the Council of Europe have warned that Britain may be breaching The United Nations Education, Scientific and Cultural Organisation's (UNESCO) Universal Declaration on the Human Genome and Human Rights because the genetic alteration would be passed down through generations.
Mr Freeman is calling for greater freedom for Britain to be able to determine its own medical and science policies.
However he believes that healthcare in the UK is undergoing a ‘quiet revolution’ which will see it become the most advanced in the world.
“My mission is to make Britain in the 21st century the best place in the world to discover design and develop modern medicines and healthcare technology; to harness the extraordinary power of biomedical science and research, to accelerate the development of the new generation of diagnostics, drugs and preventative therapies,” he said.
“We’re the first country in the world to pioneer a genomic medicine service based on sequencing the entire genome. People have done big studies of little snips. We’re building the platform here to make Britain the pioneer.
“21st century medicine and healthcare will not just come from the drug but from the smart delivery of the drug, site-specific deliver. There’s an extraordinary revolution of remote sensing, remote diagnostics.
“Today’s 20 and 30 years olds will expect their healthcare to be digital. There is a noble collective health mission here which goes right to the heart of the DNA of the NHS.”
