Bumps on the Road Towards Clinical Trials Data Transparency- A recent U-Turn by the EMA?

By Timo Minssen

In a recent blog I discussed the benefits and potential draw-backs of a new “EU Regulation on clinical trials on medicinal products for human use,” which had been adopted by the European Parliament and Council in April 2014. Parallel to these legislative developments, the drug industry has responded with its own initiatives providing for varying degrees of transparency. But also medical authorities have been very active in developing their transparency policies.

In the US, the FDA proposed new rules which would require disclosure of masked and de-identified patient-level data. In the EU, the EMA organized during 2013 a series of meetings with its five advisory committees to devise a draft policy for proactive publication of and access to clinical-trial data. In June 2013 this process resulted in the publication, of a draft policy document titled “Publication and access to clinical-trial data” (EMA/240810/2013).

Following an invitation for public comments on this document, the EMA received more than 1,000 submissions from stakeholders. Based on these comments the EMA recently proposed “Terms of Use” (TOU) and “Redaction Principles” for clinical trial data disclosure.

In a letter to the EMA’s executive director Dr. Guido Rasi, dated 13 May 2014, the European Ombudsman, Emily O’Reilly, has now expressed concern about what seems to be a substantial shift of policy regarding clinical trial data transparency. According to the proposed “Terms of Use” (TOU) and “Redaction Principles” (RPs) it seems that EMA plans to make available clinical trial data, with the exception of what it considers to constitute ‘Commercial confidential Information.’ This data is only disclosed to natural or legal persons or organisations that have registered with EMA and that agree to the conditions for such access that are set down in the ‘Terms of use.’ The TOU and RPs impose wide restrictions on the use of such data, which are only displayed on a screen using an interface provided by EMA.

In light of these developments, the Ombudsman had asked EMA’s Executive Director, Guido Rasi, to explain how the EMA plans to address requests for public access to existing clinical trial data. She also requested an explanation of the motives and the legal basis for what seems to be a significant change of policy.

In his response-letter dated May 22, Dr. Rasi rejected O’Reilly’s concerns and replied that EMA’s new policy is a ‘reasonable compromise’ that does not prevent researchers from asking for access to specific data sets on the basis of the existing access to information policy.

This response has been heavily criticized on a recent PLoS Blog by Trudo Lemmens of the University of Toronto, who also had sent a letter to EMA’s executive director outlining several legal concerns. Professor Lemmens writes i.a. that:

In short, EMA’s approach is strengthening industry’s legal control over data, making it more difficult and legally risky for independent scientists to use them. These are in essence regulatory data, created for public interest use. For the EMA, a key public institution, to now support the privatizing of pharmaceutical knowledge through contractual affirmations of companies’ rights over these data is truly astounding.

These critical remarks also find support in a rapid response by German experts in the British Medical Journal, who warn that  the proposed EMA policy presents an obstacle to meaningful scientific use and contradicts in many respects both the Ombudsman draft recommendations on clinical trials transparency and the transparency related provisions in the new EU Clinical Trials Regulation.

These reactions indeed raise serious issues in light of the recent shift towards more transparency. Yet, the evolving resistance against full data disclosure does not come as a complete surprise. The industry, authorities, and policy makers might have acknowledged that the enormous benefits of more clinical trial data transparency outweighs potential downsides. However, and as discussed in my previous blog, the potential costs and concerns are also significant, in particular with regard to worries about patient privacy and insufficient intellectual property protection. While increased transparency will i.a. provide a better environment for identifying new avenues of promising research, too much transparency might actually decrease incentives for drug companies to invest in R&D and clinical trials. Since an effective development of cutting edge drugs and innovative medical uses requires both private and public involvement, these issues should be considered very carefully.

The discussions are complicated by the risk that the industry might very well turn to alternative strategies in order to limit transparency and to protect their “know how” related to clinical trials. New battlefields might open up in the course of secret Free Trade Agreements (FTAs) on regulatory data exclusivities, and in the context of the ongoing EU efforts to harmonize and strengthen the protection of trade secrets.

All of this indicates that the debates on clinical trials transparency are far from over. Much needs to be done to achieve a reasonable and utilitarian comprise promoting both medical innovation and access to medicine. As mentioned before, we are engaged in further research on these issues and we will keep you updated.

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About Timo Minssen

Timo Minssen is Professor of Biotechnology Law specializing in legal aspects of biomedical innovation at the University of Copenhagen (UCPH), Centre for Information & Innovation Law (CIIR), Denmark. Before joining UCPH, Timo graduated from law school in Göttingen (Germany) in 2001 and was trained in the German court system from 2002-2003. He also passed the Swedish “juris licentiate” (LL.Lic.) and “juris doctor” exams (LL.D.) and holds two IP- and Biotech- related masters degrees from the Universities of Uppsala and Lund (Sweden). In addition he worked for a Life Science company and for various law firms in Sweden and Germany. From 2007-2009 Timo was a stipendiary at the Max Planck Institute for Intellectual Property and Competition Law in Munich. He was also responsible for a course in comparative patent law at the Chicago-Kent College of Law (USA) and worked for the European Patent Office. At Lund University he is engaged as a teacher at the Faculty of Law and in interdisciplinary epigenetics research at the Pufendorf Institute for Advanced Studies. At UCPH he is co-leading CIIR’s Copenhagen Biotech & Pharma Forum and teaches international classes for both students and pharma professionals in EU-, Competition-, and Pharmaceutical Law and IPR. Timo is a frequent speaker on a variety of topics and has published extensively in comparative US and European patent law, EU- and Competition Law. In 2013-14, he was a Visiting Scholar at Harvard Law School's Petrie-Flom Center and at the University of Oxford. In 2016 he will be Visiting Research Fellow at the University of Cambridge.