* EMA says more transparency will increase R&D efficiency
* Says drugmakers will benefit from plan to release data
* EU agency being sued by two drugmakers over data release
By Ben Hirschler
LONDON, Oct 21 Europe's medicines regulator has
come out fighting for greater transparency for clinical trials,
arguing that its controversial policy to end data secrecy will
be "a boon to drug developers".
The strong defence of greater openness by the boss of the
European Medicines Agency (EMA) and colleagues comes as the
agency battles a lawsuit from two U.S. drugmakers over its plans
to release data on their medicines.
The London-based watchdog has been on a collision course
with much of the drugs industry since deciding to lift the lid
on previously secret trial data submitted by companies as part
of the application process for new medicines.
Researchers and patient groups want access to this raw data
to improve third-party scrutiny and stress-test claims about
drugs. But many companies fear that this will damage their
businesses and undermine the ability to defend patents.
EMA Executive Director Guido Rasi, who has championed data
transparency since taking over at the agency two years ago, and
his colleagues say that industry concerns are misplaced.
Rather than reducing the incentive to invest in drug
research, releasing data from clinical trials would help drug
company scientists hunting for new medicines, they said in a
paper published in the New England Journal of Medicine on
The paper, entitled "Access to patient-level trial data - a
boon to drug developers", says that the sharing of detailed
trial results would increase efficiency in drug development and
improve cost-effectiveness by reducing duplication of effort.
"Contrary to industry fears, we argue that access to full -
though appropriately de-identified - data sets from clinical
trials will benefit the research-based biopharmaceutical
industry," they wrote.
"It is ironic that the organisations that most resist wider
access to data are the ones that stand to benefit so much from
A central concern among companies is that releasing raw data
showing the effects of medicines on individual patients - whose
identity is to remain hidden - would lead to "free riding" by
rivals, who could avoid the cost of doing their own research.
It is an objection at the heart of the legal challenge to
the EMA's policy by drugmakers AbbVie and InterMune
, which in April won an interim ruling preventing the
agency from releasing documents, pending a final court decision.
The EMA has since applied to have the injunction lifted and
its appeal was heard in Luxembourg this month, but an EMA
spokesman said it is unclear when the court will deliver its
In the meantime, demands for more transparency are growing,
particularly in Europe, where Germany's Institute for Quality
and Efficiency in Health Care recently complained that the EMA
measures do not go far enough.
The debate has also crossed the Atlantic. The U.S. Food and
Drug Administration is considering new ways to increases data
disclosure, while the U.S. Institute of Medicine will discuss
sharing of clinical trial data at a two-day meeting in
Washington this week.