Tuesday 27 September 2016

EU watchdog O'Reilly demands data over AbbVie's top drug

Ben Hirschler

Published 11/06/2016 | 02:30

Ombudsman Emily O'Reilly
Ombudsman Emily O'Reilly

Details of clinical trials involving AbbVie's rheumatoid arthritis drug Humira, the world's top-selling prescription medicine, are still being withheld without justification, according to the EU ombudsman.

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Humira has been at the centre of a protracted row, with AbbVie battling to keep some data secret in the face of plans by the European Medicines Agency (EMA) to make the information routinely available.

Many doctors and campaigners argue that free access to data is essential to inform medical decision-making and allow independent experts to test claims made about drugs.

Two years ago, AbbVie dropped a lawsuit against the EMA after the agency agreed to certain data redactions, resulting in the disclosure of some but not all of the information held by the EMA about Humira. European Ombudsman Emily O'Reilly said yesterday that this was not good enough and the EMA was still withholding details from clinical trial reports on the grounds of commercial interest.

O'Reilly said public health was more important than commercial interest and she considered four specific redactions to be unjustified. "I am asking EMA to reconsider the need for these redactions should it receive new requests for access to these reports," she said.

The EMA said it was pleased O'Reilly had found no maladministration in its handling of the matter, adding there was no agreed definition of commercially confidential data.

An AbbVie spokeswoman said the US drugmaker was committed to "responsible" transparency but there was a need to protect commercially confidential information. (Reuters)

Irish Independent

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