Trudo Lemmens of the University of Toronto critiques the recently distributed draft EMA Clinical Trials Data Release Policy

(First published in the PLOS Blog. Click here for the original post.)

Things were looking good recently in Europe for data transparency, a necessary, albeit not sufficient, tool to promote integrity of pharmaceutical data. The European Court’s Vice-President overturned in November 2013 two lower court interim suspensions of EMA’s data access decision in relation to Abbvie’s drug Humira and Intermune’s Esbriet, which had stalled EMA’s data release approach. Shortly after, Abbvie withdrew the Humira lawsuit. Then in April 2014, the European Parliament approved the new Clinical Trials Regulation that introduced a requirement to register all clinical trials and make all clinical study reports in relation to EMA approved drugs publicly available. These developments put EMA again in the driver’s seat for the further implementation of its promised prospective data release policy.

Yet, when EMA recently distributed the draft policy to participants of its Clinical Trials Data Policy advisory groups, scientists and patient advocacy groups were dismayed, and the European Ombudsman sent a letter to inquire about EMA’s apparent shift: the proposed “Terms of Use” (TOU) and “Redaction Principles” impose various technical restrictions on data access, which would make it practically impossible to conduct decent research. If it were only technicalities, further discussions with the scientific community could fix the problems. But in the fracas around the technicalities, the legal booby-traps hidden in the (admittedly still draft) TOU received little attention. I therefore sent a letter to EMA’s executive director Guido Rasi outlining several legal concerns. [http://www.plos.org/wp-content/uploads/2013/05/EMA-Transparency.pdf]. Combining these with the technical restrictions suggests a problematic legal hijacking by industry of the transparency agenda.

What are the legal traps? First, by signing the TOU, data users would “acknowledge […] that the Information is protected by copyright and proprietary rights … and can be considered commercially valuable”. Brand name pharmaceutical companies increasingly insist that clinical trials data are protected by copyright and proprietary rights, and considered commercial confidential information. In the European Court cases, companies even made the spurious claim that companies have a fundamental human right to privacy over the data. But the idea that data are protected by copyright is highly doubtful, and it is little wonder that companies like to use the vague notion of ‘proprietary rights’ and refrain from using more concrete terms. Simply put, whether they have any such rights in data remains hotly contested, and is not firmly established in law. Many have convincingly argued the opposite, that these data are public goods, and that case law supports access to data on the basis of health related human rights. Remarkably, EMA is now asking scientists to recognize these rights while it is still involved in one case before the European General Court―the Intermune case―where a company is invoking such rights to block EMA’s decision to grant access to data. In light of this case and possible future court challenges, EMA has an interest in arguing for the most narrow interpretation of companies’ rights over data.

Second, the documents also strengthen industry’s attempt to qualify some data as commercial confidential information, which would offer industry the most far-reaching data protection. The TOU only mentions that data ‘can be considered commercially valuable’, which is indeed different than ‘confidential’. But the draft Redaction Principles, which set out how information will be made public, state that “novel statistical or other analytical methods and exploratory endpoint results about potential new uses of a medicine that are not the subject of the marketing authorization application” can qualify as “commercial confidential information.” Here again EMA embraces a questionable legal position that favours industry. Statistical methods are part of the scientific commons. It’s hard to see how they can be ‘unique’ enough to qualify as commercially confidential information while still providing reliable evidence according to widely accepted scientific methods. The ‘endpoint results of potential new uses’ appears to include clinical trials data related to off-label prescribed drugs. Some of the most troubling controversies that underlie the widely supported calls for data transparency involve pharmaceutical companies’ misrepresentation of data related to off-label prescribed drugs. These practices have impacted on the health, life and wellbeing of thousands of patients. Even if these ‘endpoint results of potential new uses’ are obtained at an exploratory stage with new statistical methods, accessing these data is of public health importance.

The “Redaction Principles” further grant industry much leeway in deciding what will be made public: companies would submit two different clinical study reports to EMA: a full report that EMA will keep hidden; and a redacted one that will be publicly available. What kind of information was hidden, and why, will likely be very difficult to know.

Third, EMA is also asking researchers to contractually agree that they can be sued under UK law “in accordance with the provisions of the Contracts (Rights of Third Parties) Act 1999.” As a result, pharmaceutical companies will be able to challenge researchers directly in court for violation of EMA’s TOU. This puts companies in a comfortable legal position, particularly when this is connected with the recognition of proprietary rights, copyrights, the commercial confidential nature of some information and the severe technical restrictions on data use, which make good faith violations of the TOU much more likely. This could have a significant chilling effect. The mere risk or threats of litigation could seriously hamper open scientific debate. Researchers may think twice about publicly challenging a company’s interpretation and representation of data or about correcting the published literature on the basis of EMA held data, as called for by the recent RIAT proposal.

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. Dr. Rasi’s recent response to the Ombudsman, that EMA’s new policy is a ‘reasonable compromise’, and does not prevent researchers from asking for access to specific data sets on the basis of the existing access to information policy, does not reassure. His response does not recognize the legal concerns raised by the draft TOU and Redaction Principles, let alone justify the approach taken. And Abbvie’s withdrawal of the legal challenge of the Humira data release notwithstanding, EMA appears back in the business of imposing more extensive limits on what it gives access to in response to specific access requests.

This troubling development is not entirely surprising. Even if the transparency movement had some major victories, including the adoption of transparency requirements in the recent European Clinical Trials Regulation, opposition has been mounting. Industry may now employ other regulatory initiatives to fight transparency. The European commission recently released a draft directive aimed at streamlining and strengthening Trade Secret protection in Europe. The European Federation of Pharmaceutical Industries and Associations (EFPIA) jumped already enthusiastically on the occasion, emphasizing the need to protect the “proprietary know-how” of drug development, including in the “clinical trials phase”. In the context of ongoing and largely secret transatlantic trade negotiations between Europe and the United States and Canada, the pharmaceutical industry has also been lobbying hard to strengthen data and IP protection and to include better data protection in the package. [http://www.plos.org/wp-content/uploads/2014/05/PhRMA_Comments_to_USTR_on_TTIP.pdf]. EMA now appears to be lending a helping hand.

Trudo Lemmens is Associate Professor and Scholl Chair in Health Law and Policy at the Faculties of Law and Medicine of the University of Toronto. His research focuses on legal and ethical issues of biomedical research and pharmaceutical product development. Other than receiving royalties for books published with University of Toronto Press and Themis (University of Montreal) and having a University salary, he has no relevant financial interests. He has written about data access issues in the past and participated in the consultation process on EMA’s prospective data release policy.

Acknowledgments: thanks to Ariel Katz (University of Toronto) for useful comments on an earlier version and to Peter Maybarduk (Public Citizen) for sharing documents related to the international trade negotiations.