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‘Hostile’ Europe risks derailing medical innovation, warns minister

“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.”

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