Medicines regulators in Germany and Finland have refused to let independent researchers access documents detailing the outcomes of clinical trials, raising concerns about patient safety, an open letter published today warns.
At the centre of the dispute are Clinical Study Reports (CSRs), lengthy documents that pharma companies submit to regulators when they seek permission to sell a new drug. A recent study found that CSRs contain important information on harms of cancer drugs detected during clinical trials that cannot be found elsewhere.
ACCESS TO CLINICAL STUDY REPORTS VARIES ACROSS EUROPEAN COUNTRIES
Usually, pharma companies seek to gain access to the entire European market by submitting CSRs to the European Medicines Agency for review. Thanks to European transparency rules, those CSRs can later be reviewed by independent scientists, allowing them to gain a detailed picture of new drugs’ benefits and harms.
However, pharma companies can choose to bypass the European Medicines Agency and seek marketing approval for a single country only. In that case, they submit CSRs to the national medicines regulator for review – and some of those regulators keep those documents firmly locked away.
In the past, national regulators in Denmark, the Netherlands, Sweden, and the United Kingdom have released CSRs in response to freedom of information requests filed by scientists. However, the German regulator BfArM and the Finnish regulator FIMEA have refused to do so, as the table below shows.
Source: Letter to HMA, 2021
LOOPHOLE ALLOWS MEDICAL EVIDENCE TO REMAIN HIDDEN
Today’s letter notes that this “creates a loophole since drugs approved through decentralised and national approval routes are not applicable to the same degree of transparency as centrally approved drugs”.
This prevents researchers from accessing important data and provides pharma companies with a way to circumvent European transparency standards.
The letter calls on the Heads of Medicines Agencies (an umbrella organisation that brings together all national regulators in Europe) to compile an overview of which European Union countries currently provide access to CSRs, and to issue a statement setting out its position on the issue.
The full letter, which was signed by five scientists and TranspariMED, can be downloaded here:
CSRs FOR SOME COVID VACCINES REMAIN INACCESSIBLE
Transparency International recently raised concerns that CSRs for some Covid vaccines distributed outside Europe remain inaccessible because only two regulators worldwide, the European Medicines Agency and Health Canada, proactively make CSRs available to independent researchers. Regulators in the United States, India, China, Russia and Japan do not provide access to CSRs.
Note: CSRs are currently available in the UK only through FOI requests.
Image source: Transparency International report, 2021
TranspariMED will continue tracking this issue and will report on the Heads of Medicines Agencies’ response to today’s letter. Follow @TranspariMED on Twitter and stay tuned to this blog.