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AbbVie drops legal action in EU drug secrecy case

Source: Reuters - Thu, 3 Apr 2014 18:58 GMT
Author: Reuters
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* AbbVie drops lawsuits against European Medicines Agency

* Decision follows EMA acceptance of redactions to documents

* AbbVie says move will preserve commercial confidentiality

* Legal fight between EMA and InterMune continues (Adds EMA and BEUC comment, background)

LONDON, April 3 (Reuters) - AbbVie, one of the two U.S. companies trying to stop Europe's drugs regulator from releasing previously secret clinical trials data, said on Thursday it had withdrawn lawsuits against the watchdog.

The decision follows a move by the London-based European Medicines Agency (EMA) to accept a new set of redacted documents submitted by AbbVie, along with the company's rationale for removing certain commercially confidential information.

"A significant portion of data will be disclosed while protecting the information that is commercially sensitive," AbbVie said in a statement. "As a result, AbbVie has withdrawn its lawsuits."

The EMA said the "very limited redactions" would have no significant impact on the readability of the clinical study reports that were at the centre of the litigation.

The legal row between the EMA, AbbVie and a second drugmaker, InterMune, has thrown a spotlight on attempts by parts of the pharmaceutical industry keep its data secret, even as many doctors and campaigners demand greater transparency.

For AbbVie, the case was significant because the clinical trial data at stake related to its blockbuster rheumatoid arthritis treatment Humira, which is the world's top-selling prescription medicine.

Medical researchers and patient groups want access to detailed clinical trial data to improve third-party scrutiny of the drugs industry and to allow independent scientists to stress-test claims about drugs.

But many companies fear that complete disclosure of all information will damage their businesses and undermine the ability to defend patents.

The London-based watchdog has been on a collision course with much of the industry since pledging in 2010 to lift the lid on previously secret trial data submitted by companies as part of the application process for new medicines.

The scale of the data releases was to have been increased significantly this year under the EMA plans. But the process was stalled by the legal battle with AbbVie and InterMune.

The European consumer organisation BEUC, which was involved in the case as an official participant in favour of the EMA, said AbbVie's decision was a significant first step forward.

"It is our strong hope that InterMune, the other complainant, will follow suit," said Ilaria Passarani, head of BEUC's food and health department.

The EMA said the other court case brought by InterMune against the agency, challenging a decision to grant access to clinical-study reports, was ongoing.

AbbVie's decision to drop its lawsuits comes just one day after the European Parliament voted in favour of new legislation governing clinical trials that will force drug companies to be more transparent in releasing study results. (Reporting by Ben Hirschler and Kate Holton; Editing by Jane Merriman and Anthony Barker)

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