The EMA has decided to change its data sharing policy in line with the letters we’ve all been sending.
The Agency has announced that at its board meeting yesterday Executive Director Professor Guido Rasi tabled amendments to remove the on-screen-only access clause to allow researchers to download, save and print clinical study reports. This is great. The policy will now be closer to the original draft the EMA published in June 2013 and that hundreds of us supported.
Yesterday’s improvement to the policy only happened because hundreds of you called for it. We’ve heard that a number of the attendees at the meeting did not know there had been any criticisms of the policy. If our correspondence hadn’t been tabled the changes probably wouldn’t have been voted through. Huge well done to everyone who wrote a letter or email, this is down to you.
Síle Lane, Sense About Science, said
This is a good move. It will mean researchers will be able to scrutinise, compare and share clinical trial information. Allowing researchers access to clinical trial information on-screen-only would have made their job impossible. This change to the policy moves it closer to the EMA’s original draft and to the new clinical trial law which the European Parliament agreed in April. The move only happened because hundreds of researchers, patients and citizens urged the EMA not to put commercial interests before the public interest.
Ben Goldacre, doctor and co-founder of AllTrials, said:
We remain deeply concerned at the EMA redactions policy, especially in light of the excessive and inappropriate redactions the Agency seems to have agreed with AbbVie, manufacturers of Humira. Doctors cannot make informed decisions about whether to use medicines such as Humira when important information about the clinical trials on that treatment are still being withheld from doctors, researchers and patients.
The EU Ombudsman Emily O’Reilly said today that she “remains puzzled as to why EMA abandoned its original draft disclosure policy from 2012 and substituted it with a different draft policy, more in line with the pharmaceutical industry’s wishes.”
Glenis Willmott MEP who led the negotiations on the recently agreed EU Clinical Trials Regulation said “In April the European Parliament voted almost unanimously for strict new transparency requirements which will require clinical trial data from all trials to be uploaded to a publicly accessible database. Although the law does not come into force until 2016, until then EMA should be working in the spirit of the transparent and user-friendly system that we agreed.”
The EMA is finalising the text of the policy over the next few weeks and we understand it will be published in September.