The European Medicines Agency has been progressively curtailing access to key documents that are required to fully evaluate the safety and efficacy of drugs, nonprofit health group Prescrire has warned.
UPDATE 31 May: EMA has strongly pushed back against Prescrire's criticisms. See further below.
In an editorial, the group’s publishing director Séverine Carré-Pétraud noted that:
“[W]hen requesting access to documents held by the EMA, Prescrire has come up against new procedures in recent years that have the effect of withholding information, with response times of several months. And important information, in particular on clinical data, is redacted on the grounds that pharmaceutical companies feel that its disclosure could jeopardise their commercial interests.”
New barriers to transparency
The group in parallel published a detailed report that chronicles a progressive decline over recent years in access to information held by EMA on clinical trial results.
UPDATE 09 May: The report's paywall has now been removed, you can access the report here.
Issues of concern flagged by the report include:
“The EMA has put in place a number of processes that have considerably increased response times: a queuing system; staggering the provision of documents over a period of several months; and a delay to allow drug companies to institute legal proceedings in the event of a disagreement over the disclosure of documents.”
“As of early 2022, these procedures mean that Prescrire can hope to receive, in a year, just one response from the EMA to an application it considers large (about 200 pages) and six scans of packaging items (about 10 pages each). Prescrire’s list of unanswered requests grew longer… [S]eeing no prospect of obtaining a timely response from the EMA, we retracted several requests.”
“In 2018, we searched the EMA website for the main reports on the clinical evaluation data submitted to obtain marketing authorisation for migalastat (Galafold). No documents were available on the website, and a message had been posted explaining that this was because the drug’s marketing authorisation holder, Amicus Therapeutics, had filed an action with the European General Court to prevent the disclosure of a Clinical Study Report.”
Call for official inquiry
The report concludes that:
“The obvious failings of the EMA’s access-to-documents service justify an official inquiry so that Members of the European Parliament can take appropriate steps: the EMA’s interpretation of exceptions to disclosure should be subjected to legal analysis; more resources must be allocated to implementing the right of access to documents; the specific needs of applicants with no profit motive (such as Prescrire) must be taken into account; and the EMA must be inspected and called to order if it censors clinical data.”
The report concludes that industry resistance to disclosure – coupled with the ever-present threat of litigation – is a key factor behind EMA’s shift towards opacity.
'No valid reason' to hide trial data
Prescrire regularly publishes independent analyses and assessments of new medicines, which are often based on clinical trial results and regulatory documents that the group obtains from EMA through Freedom of Information requests and other channels.
Séverine Carré-Pétraud, Prescrire’s publishing director, said:
“Transparency is not a fad or an end in itself. In the pharmaceutical field, it is a prerequisite for better and safer patient care.”
“There is no valid reason to hide information about clinical trials, their methodology or their results, or evaluation data obtained on drugs after their market introduction, particularly data on adverse effects.”
Other researchers have also complained about difficulties in accessing Clinical Study Reports held by EMA in particular.
EMA froze its proactive disclosure of Clinical Study Reports in 2018 and has yet to set a date for resuming the programme, despite repeated calls by TranspariMED and numerous other patient and health groups to do so.
Meanwhile, Health Canada’s Clinical Study Report disclosure initiative has reportedly been progressing smoothly since 2019, releasing clinical data from more than 160 submissions for drugs, biologics, vaccines and medical devices with only minimal redactions.
EMA pushes back against criticism
UPDATE 31 May: EMA has strongly pushed back against Prescrire's criticisms
According to reporting by APM Health Europe, an EMA spokesperson said:
"The article by Prescrire raises a number of concerns which we believe misrepresent the spirit and the true impact of an initiative which has ushered in such unprecedented levels of transparency both in Europe and globally."
"We have replied to Prescrire to clarify some of the specific issues that they raise.”
Note: Prescrire's full report was originally paywalled but is now publicly available. This blog has been updated accordingly.