The documents in question, Clinical Study Reports (CSRs), provide a highly detailed picture of the design, conduct, analysis and findings of clinical trials, including data on the positive and negative effects experienced by patients. CSRs thus allow far deeper insight into a trial’s methodology and findings than other information sources do.
Several large-scale incidents of harm to patients in the recent past could have been averted if data contained in Clinical Study Reports had been accessible at the time.
A pharmaceutical company had taken the European Medicines Agency to court to prevent its release of the documents, citing concerns about commercial confidentiality, even though commercially sensitive information is already being redacted before CSRs are released.
The court found that CSRs are not covered by a “general presumption of confidentiality,” and that redacted CSRs do not contain commercially confidential information.
Around the world, companies seeking to bring a new drug onto the market must submit CSRs to medicines regulators for review, but those regulators have traditionally kept CSRs under lock and key.
The European Medicines Agency gained acclaim from patient and transparency groups when it became the first regulator worldwide to grant access to CSRs. Recently, Canada has also started releasing CSRs. The U.S. Food and Drug Administration still refuses to provide access to CSRs.
Cochrane, Transparency International and TranspariMED in 2017 recommended that regulators worldwide should provide access to all Clinical Study Reports they hold. More recently, 43 patient and public health groups have called for access to CSRs in Europe to be maintained.
Till Bruckner, founder of TranspariMED, said:
“This is excellent news for patients in Europe and beyond. Scientists and public health agencies will continue to be able to access the complete evidence base on the benefits and harms of medicines that patients in Europe take. The court has sent a clear message: In a modern democracy, locking away data on drug safety and effectiveness is not acceptable. Hopefully, the U.S. Food and Drug Administration will take note and soon also begin releasing the Clinical Study Reports held in its archives.”
Guido Rasi, EMA’s Executive Director, said:
“Transparency is an important feature of the Agency’s operations. We welcome today’s judgments and will continue to work to secure transparency on medicinal products in the EU, in the interest of patients and public health. I would like to thank all EU institutions and external stakeholders who have publicly endorsed our policies, as well as our staff who have been defending our approach to transparency for the past eight years”.
Yannis Natsis, patient representative on the EMA Management Board, said:
“This is a clear victory for transparency against obscure and secretive pharmaceutical systems, and a clear victory for the European Medicines Agency, patients, scientific progress and society”.
Rachel Cooper of the Transparency International Health programme said:
“It is very reassuring that the Court has maintained the presumption of transparency. Timely, full release of clinical study reports is key to ensuring that research knowledge and findings are captured, reviewed and built upon rather than hidden and duplicated. This is clearly in the public interest.”
Pierre Chirac, publication manager of Prescrire, an independent drug bulletin, said:
“The idea that clinical data should be considered commercially confidential would have been shocking as it goes against many ethical principles in healthcare. The court ruling is very good news for patients, healthcare professionals and the global health community as the publication and dissemination of clinical trial information improves transparency and enables independent scrutiny. Access to clinical study reports provides the opportunity for independent research and assessment of reporting and evaluation of bias, detailed evaluations of harms and adverse events, trial re-analyses and their integration in systematic reviews and meta-analyses.”
Jörg Schaaber of the German BUKO Pharma-Kampagne said:
“Today is a good day for patients because good therapeutic decisions rely on complete knowledge of [drug] benefits and harms. The European Court of Justice has confirmed that health takes precedence over commercial interests.”
Jaume Vidal, Senior Policy Advisor of Health Action International, said:
“The CJEU ruling is a victory that resonates for all those who favour greater transparency and a powerful endorsement of the EMA’s landmark access to documents policy… the Croatian Presidency of the European Council must decisively push for the full implementation of the European Clinical Trial Regulation.”
Pharma lobby group EFPIA “noted” the decision in a statement, commenting that:
“Responsible data sharing means supporting enhanced data sharing, while safeguarding patient privacy, respecting the integrity of national regulatory systems, and maintaining incentives for investment in biomedical research. As an industry we are committed to continuing to work with partners across the research and regulatory community to develop a shared understanding and vision of where that balance lies.”