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* EU court stops EMA releasing AbbVie, InterMune drug data
* Medicines agency says will appeal interim ruling
* EMA head says public distrust makes transparency vital
By Ben Hirschler
LONDON, April 30 (Reuters) - The head of Europe's medicinesregulator is digging in for a fight over data transparency afterbeing stopped from releasing information on drugs from two U.S.companies by a court ruling.
Defeat for the European Medicines Agency (EMA) at the handsof AbbVie and InterMune highlights a growingbattle between campaigners for more openness and companies whichfear it will harm their business.
The influential Pharmaceutical Research and Manufacturers ofAmerica lobby group said in a statement after Tuesday's rulingthat industry supported responsible data sharing but "the EMA'scurrent and proposed policies fail to respect these principles".
EMA Executive Director Guido Rasi believes thepharmaceutical industry will be the loser in the long run if itdoes not accept the need for greater transparency in the face ofmounting public distrust.
"If the court decides we have to stop the release of data, Ithink that would be the worst possible boomerang for theindustry," he said in an interview.
"The most powerful weapon we have to tackle distrust istransparency."
The EMA said it intended to appeal the interim ruling by theEuropean Union's general court preventing it from releasingdocuments until a final decision is given.
The London-based watchdog has been on a collision coursewith some drugmakers since deciding to lift the lid onpreviously secret clinical trial data that is submitted bycompanies as part of the application process for new medicines.
Since November 2010, the EMA has released nearly 2 millionpages of detailed clinical trial information - an approach itsays reflects growing public demands for more openness to ensurethat drugmakers cannot conceal adverse drug effects.
Its policy was challenged, however, by both AbbVie andInterMune, which sought an injunction in cases relating torequests for the release of data about their drugs.
In the case of AbbVie, information had been sought about itsrheumatoid arthritis drug Humira, the world's top-sellingmedicine. One of those seeking the data was UCB, arival Belgian drug company.
The InterMune case also related to information sought by apotential competitor.
An AbbVie spokeswoman said the U.S. company supportedtransparency of clinical research for the benefit of patients,but was concerned that commercially confidential informationcontained in EMA filings could help competitors.
Ben Goldacre, co-founder of the AllTrials campaign for datadisclosure and author of "Bad Pharma", a book criticising theindustry, said the interim ruling was a "disgrace".
"Forcing them (the EMA) to hide this information is nothingshort of absurd," he said.
SYSTEMATIC RELEASE
The EMA plans to step up transparency further byestablishing a process for the release of full clinical trialdata, which will come into force on Jan. 1, 2014.
The agency is currently consulting on how exactly to publishthe data proactively - an initiative that Rasi said would takeaccount of the views of all concerned parties, includingpharmaceutical companies.
Some industry executives fear full transparency willundermine incentives for future investment by releasing datathat has been generated in trials paid for by companies andeffectively helping rivals.
But Rasi said such issues could be addressed by appropriate"rules of engagement", including measures to prevent thosegroups who receive data from unfairly exploiting the informationto undermine commercial data exclusivity rights.
Similar rules would also ensure that patient confidentialitywas not compromised, he added.
Public distrust of drug companies and the regulatoryauthorities that police them has grown in recent years,following a series of scandals over the safety of drugs such asMerck & Co's now withdrawn painkiller Vioxx andGlaxoSmithKline's (GSK) diabetes pill Avandia.
The decision by the EMA to opt for greater openness comes ata time of rising demands for transparency, with the BritishMedical Journal and others raising concerns that too many drugsare approved on the basis of selective evidence.
The EMA's stance has triggered varied responses fromdrugmakers.
While AbbVie and InterMune opted for court proceedings, GSKsaid last year it would routinely release patient-level datafrom its trials.
Roche this month agreed to hand over data from allclinical trials of its best-selling flu drug Tamiflu to a groupof outside researchers after a four-year fight.
