Draft regulations passed by the European Parliament on April 2 are bringing some resolution to the contentious issue for the region. Legislation mandating the publication of data from all trials is expected to be finalised this June and come into effect in 2016.
Running in parallel with the European laws, the EMA’s trial data policy – which is pro-“full transparency” – will be subject to consultations next month with patients, academics and the pharmaceutical industry.
The talks will fine-tune the Agency’s principles, concentrating on what information may be redacted when companies submit their trial reports. The EMA has said that if redactions are allowed, these will be “for those parts of clinical trial data that exceptionally contain commercially confidential information.” Discussions will also cover how sponsors will be consulted before publication of their clinical study reports, and user-friendly technical measures to make data easy to access.
Meanwhile, the European Parliament’s statute will require companies to publish detailed reports of all clinical trials within the European Union from 2016.
The data must be submitted to a publicly-accessible database via an online portal. This includes details of trial sponsors, the end point being measured, information about patients and their recruitment, and adverse effects. All information not explicitly deemed commercially confidential will be made available to the public. Full reports will be required within 30 days of a drug receiving a marketing authorisation or rejection, and fines will be imposed for sponsors who flout deadlines.
Member of European Parliament (MEP) Glenis Wilmott, who negotiated for the new legislation, said at the start of talks:
“For too long, unflattering studies on new medicines have gone undisclosed. Around half of all trials are never published, usually those with negative or disappointing results.
“It is vital we know about negative outcomes, otherwise trials can be conducted repeatedly before it becomes public knowledge they are ineffective, or even dangerous.”
Plans for transparency were welcomed by organisations including the British Medical Journal (BMJ) and the Cochrane Collaboration, but originally attracted complaints from parts of the pharmaceutical industry about patient and commercial confidentiality.
The European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Pharmaceutical Researchers and Manufacturers of America (PhRMA) were accused in July 2013 of trying to mobilise patients groups against transparency plans, after the publication of a leaked email. However the groups have since expressed support of the new rules.
Transparency in action
Earlier this month, analysts reviewing data on neuraminidase inhibitors provided by flu vaccine makers Roche and GSK claimed there was a lack of evidence for the efficacy of Roche’s Tamiflu. Cochrane Collaboration researchers writing in the British Medical Journal (BMJ) said the vaccine reduced symptoms in flu patients by only 0.7 days, a finding Roche disputed in emails to our reporters.