Belgium: Regulator to impose fines for unreported clinical trials
Belgium’s medicines regulator has announced that it will fine medical research institutions that violate transparency laws a minimum of 4,000 Euros.
The move suggests that authorities across Europe might finally be running out of patience with institutions that ignore their obligations to make clinical trial results public.
EUROPEAN REGULATORS GAIN NEW POWERS
From the end of this month, when the EU Clinical Trial Regulation becomes fully applicable across the continent, pharma companies, universities and hospitals across the European Union will be required by law to make the results of new drug trials public.
However, each country will decide individually how to apply the law.
Denmark announced long ago that it will take law-breaking sponsors to court, and may even seek prison sentences. However, it seems likely that this treatment will be reserved for the worst offenders because it will require the Danish Medicines Agency to spend a lot of time and effort pursuing each individual case through the legal system.
BELGIAN REGULATOR TAKES ACTION
The Belgian regulator FAMPH seems to have come up with a more elegant solution.
FAMPH plans to offer sponsors that failed to make results public on time an “amicable settlement” under which the sponsors pay a minimum of 4,000 Euros. If the sponsor refuses to settle out of court, the Public Prosecutor may then initiate further proceedings.
In July 2021, FAMPH contacted all sponsors that had failed to report trial results to remind them of their obligations and started monitoring compliance.
According to the regulator, this outreach was successful at boosting trial reporting in Belgium. FAMPH has also been actively supporting sponsors in the country by organising information sessions.
Till Bruckner, founder of TranspariMED, said:
“Last year, the European Medicines Agency sent reports to all national regulators. Those reports listed every single trial missing results. We applaud FAMPH for doing the right thing and following up on unreported trials in Belgium, and we welcome its plan to start imposing fines.”
“The positive example set by FAMPH raises the question of why not all national regulators are taking these simple, common-sensical steps to protect patients and save valuable medical evidence from being lost forever. For example, we are not aware of ANSM in France or AIFA in Italy doing anything to address this problem.”
“This year, patient and health groups across Europe will be keeping a close eye on what national regulators are doing to ensure that no clinical trial is left behind.”
BELGIAN INSTITUTIONS UPLOAD MISSING RESULTS
Some Belgian clinical trial sponsors have put significant effort into uploading missing clinical trial results onto the European database EudraCT.
The country’s largest institution, KU Leuven, has uploaded an impressive 76 trial results since June 2020. In contrast, Vrije Universiteit Brussel and Universite libre de Bruxelles have gotten off to a very slow start.
Out of the nine largest institutions in Belgium, four have already uploaded all of their missing clinical trial results, or are rapidly nearing the finishing line:
Cliniques Universitaires Saint-Luc
CHU Brugmann
EORTC
KU Leuven
Four additional institutions are also making progress. Only one sponsor, CHU de Liège, still appears to be ignoring the problem.
HOW DO BELGIAN SPONSORS COMPARE?
The largest non-commercial sponsors in Belgium have so far uploaded an estimated 43% of due drug trial results.
This puts them behind German universities, whose average reporting rate is already around 60%, but far ahead of Dutch universities whose reporting rate is a rock bottom 7%.
ACCESS THE FULL REPORT
For more details on FAMPH’s plans and Belgian sponsors’ performance, see the new report launched today by three Belgian groups – Cochrane Belgium, consumer group Test Ankoop, and patient group Kom op tegen Kanker – in collaboration with TranspariMED.
Click below to download the full report.