Europe's Drug Regulator Makes a U-turn on Data Transparency

The BMJ’s Head of Research, Trish Groves and European Research Editor, Wim Weber question why the European Medicines Agency (EMA) has recently decided to backtrack on their decision for public access to clinical trial data, in an editorial published on bmj.com today.

In April, drug company AbbVie dropped its lawsuit against the EMA which delayed the agency’s plans to release previously hidden clinical trial data about drugs. This posed such a threat to public health that BMJ and the BMA were granted permission to intervene and AbbVie ended up withdrawing its case.

However, the EMA now say that clinical study reports will be available only to registered users through “controlled access” in a “view on screen only” mode. Furthermore, information could be redacted if study sponsors deem it confidential.

EMA’s management board meet on 12 June to finalise the policy and authors of the first ever Cochrane reviews “are aghast” saying they “could not have properly reviewed and cross checked the thousands of pages from Roche and GlaxoSmithKline if those companies had imposed conditions like those EMA is now proposing”.

Plus, in a rapid response posted on bmj.com, the German Institute for Quality and Efficiency in Health Care (IQWIG) warn that “data we cannot work with are still hidden – even if we see them on a screen”.

The European Ombudsman questioned the legal basis of the EMA’s decision, but in response, executive director Guido Rasi said the “revised access policy was deemed a reasonable compromise […] in line with ‘the commission’s clear message that we would also have to assure compliance with national and international obligations”.

Drs Groves and Weber do say that “despite setbacks, great strides have been made in the past three years towards clinical trial transparency” and even with this “watered down policy, EMA will be making visible vast quantities of new regulatory information […] about randomised controlled trials of drugs” and “other types of interventional or observational clinical research methodologies”.

They say however that a “great deal” still remains hidden from policymakers, clinicians, and patients and if EMA also stops releasing data on old trials (currently possible on request) we will all be even more in the dark.

They conclude that this is why AllTrials continues to campaign and the “research, advocacy, haggling, and politics must go on”.