* U.S. firms seeking to block release of drug data by EMA
* AbbVie, InterMune say they defending business secrets
* EU's top court refers case back to lower court
By Ben Hirschler
LONDON, Dec 5 A legal case over access to
details of clinical trials held by Europe's drugs regulator -
sparked by two U.S. firms wanting to keep their data secret -
has been hit by delay after the EU's top court sent it back to
be re-examined by a lower body.
The decision leaves in limbo a high-profile fight that has
pitched the European Medicines Agency (EMA), Europe's equivalent
of the U.S. Food and Drug Administration, against AbbVie
Officials said on Thursday that the vice president of the
European Court of Justice had annulled earlier interim orders
preventing the release of data and had referred the matter back
to the European Union's General Court for further consideration.
With the legal situation still uncertain, sensitive data
from trials involving AbbVie's rheumatoid arthritis treatment
Humira - the world's top-selling prescription medicine - and
another drug from InterMune will remain under wraps for now.
"Until a new decision is taken by the courts, we will not
release the documents relating to the AbbVie and InterMune
products," EMA spokesman Martin Harvey said.
Still, the London-based watchdog does not intend to let
uncertainty in this case prevent it from continuing its policy
of responding to outside requests for documents about clinical
trials on other medicines.
The EMA has already released millions of pages of detailed
clinical trial information about different drugs - an approach
it says reflects growing public demands for more openness to
ensure that drugmakers cannot conceal adverse side effects.
The vast majority of all documents released by the EMA -
some 76 percent in the past 12 months, according to Harvey -
have been handed over to academic groups and researchers.
AbbVie and InterMune argue in a case brought earlier this
year that they have a right to the protection of their business
secrets, since this information could be used by competitors.
In the case of the AbbVie drug, those seeking data include
rival Belgian drugmaker UCB.
Spokeswoman Fiona Olivier said AbbVie remained confident the
General Court would rule in favour of upholding the provisional
injunction, since the clinical study reports held by the EMA
contained commercially confidential information.
AbbVie backed sharing of data with qualified researchers
when this did not undermine its ability to innovate, she added.
Europe's medicines body has been on a collision course with
parts of the pharmaceuticals industry since deciding to lift the
lid on previously secret clinical trial data.
This data is routinely submitted by manufacturers as part of
the application process for new medicines and, until recently,
it had been view as confidential.
But in 2010 the European Ombudsman, which investigates
complaints about EU institutions, ruled that the EMA should
provide access to it - and the EMA plans to proactively release
detailed data, rather than just waiting for requests, from 2014.
A number of drug companies have recently shifted their
position towards more transparency in the face of this pressure
from the agency and some stern critics in academia.
Pfizer, the largest U.S. pharmaceutical company,
became the latest to take a step down this path on Wednesday by
broadening access to information from its clinical trials to
independent researchers and to patients.
Britain's GlaxoSmithKline, meanwhile, has already
set up an online system to provide researchers with access to
anonymous patient-level data about its medicines.