E-drug: New EU rules for clinical trials
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Dear friends,
If you agree to the contents of the petition mentioned in the
BMJ article below, please sign it and send it to as many people
as you can. If the EU parliament does not repeal this law (the
decisive session is going to take place on the first of May), it
will be curtains for publicly sponsored clinical research in
Europe. The costs of clinical trials will sky-rocket so that only
Big Pharma will be able to meet them. With all the obvious
consequences...
Valeria
Dr Valeria Frighi
Diabetes Trials Unit
Oxford Centre for Diabetes Endocrinology and Metabolism
Churchill Hospital, Old Road
Oxford OX3 7LJ
UK
tel: -44-1865-857248
fax: -44-1865-856286
e-mail: valeria.frighi@dtu.ox.ac.uk
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BMJ 328:187, 24 January 2004.
Scientists beg EU to repeal new rules for clinical trials
Brussels - Rory Watson
Thousands of academics and scientists across Europe are
appealing to the European Union to repeal new legislation that
they fear could seriously damage the prospects of
non-commercial, academically led, patient focused clinical
research.
Opponents of the new rules, which are due to come into effect
on 1 May, are mounting a last ditch campaign. In the space of
just two weeks they have collected signatures from over 2000
medical researchers, including some 150 professors of
medicine and science, across Europe and further afield.
Their criticism is directed at the description of "sponsor" in the
European Union's good clinical practice legislation. In future,
any individual or organisation in this position would have to take
full legal and financial responsibility for the clinical trial. This
would include covering the cost of all drugs and devices while
patients are being studied.
They point out that, although the pharmaceutical industry can
provide this level of funding to support commercially inspired
trials while developing potentially highly profitable new drugs,
charities and academic institutions cannot.
The campaign is being led by the Brussels based Breast
International Group and the Irish Clinical Oncology Research
Group.
Dr Brian Moulton, who is coordinating the campaign on behalf
of the Irish group, maintains that cancer research in particular
would be badly hit by the new definition. "Almost half of all
oncology research in Europe is academic led, and the major
advances that have been made in breast cancer treatment in
the past 18 months have been non-commercial," he explained.
In an ironic twist, the new rules could also mean the end of a
number of non-commercial trials that are currently being funded
by the European Union from its multibillion pound research
budget. They would also make the union a less attractive venue
for research investment, damaging EU leaders' medium term
objective of making Europe the world's most competitive,
knowledge based economy by 2010.
Critics acknowledge that the legislation was not intended to
place potentially insurmountable obstacles to non-commercial
clinical research. But they are angry that this could be the
unintended consequence as there was not wider consultation
with the academic and medical communities when civil servants
were drafting the legal text.
The campaigners are lobbying every single MEP and European
commissioner. However, it would be unprecedented if EU
governments and decision makers agreed to repeal the
legislation (which is designed to ensure high quality standards
in European research) before it even came into force.
But there is a glimmer of hope that the legislation might be
accompanied by a guidance document that could indicate that
some flexibility should be exercised when its provisions on
sponsors are being implemented.
A European Commission spokesman confirmed that it was
committed to the new requirement in the legislation that there
be a clear chain of responsibility.
"We want one identifiable person in charge of a project. But
within that it is possible for certain responsibilities to be
delegated. We will listen to problems and explore with member
states what can be done," he said.
See www.saveeuropeanresearch.org for details of the petition.
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