European Medicines Agency backtracks on clinical trials data
29 May 2014
An editorial in The British Medical Journal (BMJ) has questioned
why the European Medicines Agency (EMA) has recently decided to
backtrack on their decision for public access to clinical trial
In April, drug company AbbVie dropped its lawsuit against the EMA
which delayed the agency’s plans to release previously hidden
clinical trial data about drugs. This posed such a threat to public
health that BMJ and the BMA were granted permission to intervene and
AbbVie ended up withdrawing its case.
However, the EMA now say that clinical study reports will be
available only to registered users through “controlled access” in a
“view on screen only” mode. Furthermore, information could be
redacted if study sponsors deem it confidential.
EMA’s management board meet on 12 June 2014 to finalise the
policy and authors of the first ever Cochrane reviews “are aghast”
saying they “could not have properly reviewed and cross checked the
thousands of pages from Roche and GlaxoSmithKline if those companies
had imposed conditions like those EMA is now proposing” .
Plus, in a rapid response posted on bmj.com, the German Institute
for Quality and Efficiency in Health Care (IQWIG) warn that “data we
cannot work with are still hidden — even if we see them on a screen”
The European Ombudsman questioned the legal basis of the EMA’s
decision, but in response, executive director Guido Rasi said the
“revised access policy was deemed a reasonable compromise […] in
line with ‘the commission’s clear message that we would also have to
assure compliance with national and international obligations”.
The MBJ's Head of Research, Trish Groves and European Research
Editor, Wim Weber say in the BMJ editorial that “despite setbacks,
great strides have been made in the past three years towards
clinical trial transparency” and even with this “watered down
policy, EMA will be making visible vast quantities of new regulatory
information […] about randomised controlled trials of drugs” and
“other types of interventional or observational clinical research
They say however that a “great deal” still remains hidden from
policymakers, clinicians, and patients and if EMA also stops
releasing data on old trials (currently possible on request) we will
all be even more in the dark.
They conclude that this is why AllTrials continues to campaign
and the “research, advocacy, haggling, and politics must go on”.
1. BMJ Editorial (subscription):
2. Link to blog from Cochrane reviewers:
3. Link to IQWIG Rapid Response: