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European regulator is urged to release data on drugs approved in past 10 years

BMJ 2013; 347 doi: https://doi.org/10.1136/bmj.f5905 (Published 30 September 2013) Cite this as: BMJ 2013;347:f5905
  1. Zosia Kmietowicz
  1. 1BMJ

The European drug regulator should be more radical in demanding full disclosure of clinical trial data from drug companies, four groups representing the interest of patients have said.

The European Medicines Agency (EMA) should make available all data on the drugs it has approved in the last 10 years and not just from March 2014 as the agency has proposed, the campaigners say.

Since June this year the agency has been consulting on who should have access to what data when it begins publishing in January 2014 all trial data on drugs submitted to it for approval.1

The EMA has proposed different levels of access to the data from all types of trials conducted by drug companies on drugs that it reviews on or after 1 March 2014. But in response to a consultation on the proposals, which ends on 30 September, the four groups say that the policy should be applied retrospectively to all clinical trial data on drugs approved by the agency or national authorities in Europe in the last 10 years.

They say that proactively granting public access to the information could prevent drug induced harm and help save patients’ lives.

The groups calling for a more radical approach to clinical trial transparency are: the Association Internationale de la Mutualité, a group of not-for-profit health insurance and social protection bodies; Health Action International Europe, a non-profit, European network of consumers, public interest organisations, healthcare providers, academics, and others interested in improving the rational use of medicines; the International Society of Drug Bulletins, a network of bulletins and journals on drugs and therapeutics; and the Medicines in Europe Forum, created in 2002 to ensure that European pharmaceutical policy serves the public interest.2

The groups also want the EMA to introduce a stricter definition of “commercially confidential information” to ensure that transparency remains the rule rather than the exception. Any exception to disclosure should only involve the removal of specific elements within a document and should never be applied to entire sections or certain types of documents, they say.

In April this year US drug company AbbVie won an interim judgment preventing the agency from releasing documents about its rheumatoid arthritis drug adalimumab (Humira) to a rival company after a freedom of information request.3 It had argued in a European court that its actions were necessary “to protect AbbVie’s confidential and commercially sensitive information.”4

The campaigning groups also say that some companies may use patient confidentiality as a reason to restrict access to some trial data and that this needed to be avoided wherever possible.

Notes

Cite this as: BMJ 2013;347:f5905

References

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