EMA management agreed a policy on trial transparency in a meeting on June 12 which reversed draft regulations opponents said would severely limit academic and public access to clinical study reports.
The previously proposed policy would have restricted researchers to viewing trial data on-screen via an EMA interface. Users would have been forbidden from copying, printing or making notes.
The campaign group Sense about Science told Outsourcing-Pharma.com earlier this week that if the policy were to come into force it would make academics’ jobs “almost impossible. They need to be able to compare studies and share information across teams.”
Now the EMA has approved “more user-friendly amendments” reversing this stipulation.
Sense about Science’s spokesman Ian Bushfield told us the group was “pleased” with the move to grant researchers easier access to information, attributing the change of heart to “the public pressure they’ve been under in the last few days from All Trials and MEPs [Members of the European Parliament].”
But Martin Harvey, EMA spokesman, told Outsourcing-Pharma.com the change was due to “a second round of consultations” involving academics and medical journals, industry representatives, and patient and doctor groups.
Other concerns
The policy wording is expected to be finalised in writing by mid-July and to be effective from October 1, 2014.
The latest version of the document has not been shared with the media so it is unclear how the policy addresses two of the other issues that have troubled transparency campaigners: redactions and the possibility of legal action against researchers.
In an open letter to the EMA last week, the All Trials campaign claimed the draft policy was likely to lead to “excessive redaction” because of ambiguous guidelines, and that “researchers will be asked to agree to a clause that allows trial sponsors to take direct legal action against the researcher for possible violation of the terms of use.” Due to the “poorly specified” rules, this was likely to lead to legal wrangling and a chilling effect on research, said the signatories.
Similarly the European Ombudsman Emily O’Reilly said she was “unaware whether the Management Board has suggested any changes”relating to concerns about redaction and legal conditions, and planned to examine the EMA’s Terms of Use when they are available, to see “how EMA intends to redact the documents.”
She also said she was carrying out an inquiry “to determine the legality” of “more extensive redactions” made by the EMA to clinical study reports for Humira (AbbVie) and Esbriet (InterMune) “as part of a compromise deal with a pharmaceutical company.”
She added “the Ombudsman 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.”
EMA: ‘the company can take us to court if they’re not happy’
By contrast, the EMA told us yesterday that claims any version of its policies would have allowed excessive redaction are “not true.”
The final draft of the policy will include Redaction Principles giving guidelines for when omissions are appropriate, said spokesman Martin Harvey giving. “The redaction principles say the overwhelming majority of content of a clinical study report is not commercially confidential.”
He added that levels of redaction may seem to vary widely between different study reports only because early stage studies which reveal their exploratory endpoints may give away a company’s intentions for a drug. For trials taking place later in the pipeline, endpoints will already be publicly known and redaction will not be required.
“What is and isn’t commercially confidential depends on the point in time,” said Harvey.
The EMA representative stressed that “Ultimately the decision of whether or not to accept redaction is a decision that we take. Industry does not control the process. The company can take us to court if they’re not happy – we have had challenges from AbbVie and from InterMune. Or similarly even an academic researcher can challenge us in court.”
Harvey equally denied that researchers could experience a legal chill as a result of the EMA’s policy. “Ultimately if you are doing legitimate academic non-commercial research activities [you will not be breaking the rules.] That is in there to prevent companies taking data from us and using it for their own commercial gain.”