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Court blocks EMA release of pharma company data

AbbVie and InterMune successfully challenge request for trial data for Humira and Esbriet

Court blocks EMA release of pharma company dataAbbVie and InterMune have blocked a European Medicines Agency (EMA) bid to release clinical data about their drugs following a ruling by the General Court of the EU, although the regulator says it may appeal.

The two companies sought the injunction earlier this year after the EMA said it had received requests for data under its access-to-documents programme, part of a transparency drive initiated by the agency in 2010.

The case has focused attention on a row between the EMA, transparency advocates and the drug industry on what constitutes commercially confidential information.

To date, the regulator has granted access to 1.9 million pages of data filed by pharma companies as part of marketing authorisation applications (MAAs) in response to freedom of information requests, but AbbVie and InterMune are the first to legally challenge the new policy.

AbbVie's objection centres on requests for data on its rheumatoid arthritis drug Humira (adalimumab), while InterMune - whose only marketed product is idiopathic pulmonary fibrosis drug Esbriet (pirfenidone) - is trying to block access to information sought by academic researchers.

Their position is backed by industry groups, including the European Federation of Pharmaceutical Industries and Associations (EFPIA) which has warned that the interests of drug developers could be significantly harmed if data is released indiscriminately. In the opposing camp are those who claim the industry's aversion to transparency is damaging both to patient health and to pharma companies' reputations.

US trade group the Pharmaceutical Research and Manufacturers of America (PhRMA) said that while its members "support responsible data sharing that protects patient privacy, maintains the integrity of the regulatory review process, and preserves incentives for biomedical research", the EMA's policies "fail to respect these principles".

The EMA said in a defiant statement that it remains committed to "transparency and openness of information to meet the legitimate public interests to enable scrutiny of the agency's recommendations on medicines" and would continue to operate the access-to-documents programme on a case-by-case basis.

More contention to come?
The transparency debate looks set to become even more contentious in the coming months, given that the EMA pledged last year to proactively publish trial data - once a drug has completed the marketing-authorisation process - by the start of 2014.

At the same time as announcing the EU court decision, the EMA published final advice from advisory groups set up to help it draft the policy and would be pressing ahead with the plans, pledging to develop a system that "ensures transparency in the best interest of public health without impinging on the company's intellectual property rights".

A draft policy will be published in July and finalised in November, said the regulator.

1st May 2013

From: Research, Regulatory



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