The coalition – which counts the International Society of Drug Bulletins, NoGracias and the Nordic Cochrane Centre as members – issued a response to the revised policy this week, raising concerns about proposals that would require parties seeking access to documents to file a written request.
“While we commend the EMA for clarifying its approach to document disclosure, we regret that the revised access to documents policy falls short on proactive disclosure,” HAI senior policy advisor Ancel.la Santos Quinano told in-PharmaTechnologist.com.
“Public access to the EMA’s clinical data, decision-making and corporate documents is critical for strengthening accountability and trust in its regulatory processes,” she said.
The coalition argued that research and civil society organisations have experienced long delays and cumbersome administrative processes when accessing documents via written request.
“Regulators should not wait for requests to access documents, but actively disclose every piece of information that is relevant from a public interest perspective. Reactive disclosure results in a more controlled and cumbersome access, whilst proactive disclosure enhances transparency,” Santos Quinano told us.
Furthermore, the coalition says these documents would likely be redacted for commercial confidentiality.
It recommends the EMA organise a public register of all its documents, in order to prioritise health over commercial interests at all times.
“Arguments on commercial confidentiality are recurring amongst the pharmaceutical industry,” said Santos Quinano.
“We’d like to see the definition of commercial confidentiality being narrowed down and the question of the overriding public interest in disclosure to be taken in due consideration at all times.”
Santos Quinano suggested industry pressure may in part be responsible for EMA’s reactive disclosure-based amendments.
“The EMA is again being challenged in court by some pharmaceutical companies over the issue of data disclosure.”
“We call for the EMA to continue expanding and deepening its access to documents policies amidst pressure from the industry. Public health always trumps commercial confidentiality,” she said.
Campaign for transparency
Trial data publication has regularly been debated since 2013, when the British Medical Journal and Cochrane Collaboration-backed AllTrials group began campaigning for all past and present studies to be registered, and their methods and summary results disclosed.
“Trials with negative results are twice as likely to remain unreported as those with positive results. This means that people who make decisions about medicines don’t have full information about the benefits and risks for treatments we use every day,” said AllTrials.
In 2015, the World Health Organisation (WHO) similarly called for summary results from all trials to be published.
The EMA is reviewing submitted comments regarding its proposed amendments before a final version is submitted to the EMA’s management board for approval.