The European Medicines Agency (EMA) published its response to the Court of Justice of the European Union finding that the public had a right to access documents submitted for the purpose of receiving a marketing authorization application.
PTC Therapeutics had argued in the court that the decision should be annulled based on the protection of the company’s commercial interests, under the application of the general presumption of confidentiality.
However, the court found in favor of the EMA, which, as an agency of the European Union (EU), has a core objective to “work as openly as possible.”
The court documents stipulate that “recourse to a general presumption of confidentiality is merely an option for the EU institution, body, office or agency concerned.”
Later concluding, “In so far as, by its arguments, the appellant claims that the EMA relied on considerations that may not lawfully be covered by the concept of overriding public interest, it does not criticize any aspect of the reasoning of the judgment under appeal, but merely challenges the content of the decision at issue. Therefore, these claims must be rejected as inadmissible.”
Guido Rasi, EMA’s executive director, welcomed the decision and called transparency “an important feature of the Agency’s operations.”
This time last year, a report highlighted the lack of trials publishing their data to the clinical trial registry, with over 50% of trial data missing.
This was followed up by an investigation into European universities and their tendency to make trial results public – during which 83% of all trials were unreported.
In light of the most recent court decision, the EMA stated that it supported the ‘widest possible’ public access to documents held by EU agencies.
Not an exclusively European problem
Though the case was Europe-specific, the issue of ensuring greater transparency in regard to clinical trial data is a global one.
A study published last week found that compliance with the US Food and Drug Administration (FDA)’s transparency regulation was also being challenged by sponsors.
In total, 59% of clinical trials had not submitted their trial data by the deadline and, should the FDA follow its fining structure, the agency could reap over $7bn (€6.3bn) in fees.