New rules for access to clinical reports
The European Medicines Agency has adopted a policy of proactive publication of reports from clinical trials. The rule of transparency of clinical results is to be implemented starting 1 January 2015, and the first publications should coincide with entry into force of the EU’s new Clinical Trials Regulation, scheduled for 28 May 2016. What will the new rules mean in practice?
From 2015, after the European Commission issues marketing authorisation for a medicine through the centralised procedure, the EMA will publish excerpts from the clinical reports, with trade secrets redacted.
In order to obtain access to the data, an individual or firm will have to register on the EMA site. After logging on and accepting the terms of use for the EMA database, users will be able to review the data on their computer screen. Moreover, researchers and national medical technology agencies making reimbursement decisions will be able to save data on their own media, edit the data using the copy/paste functions, and print out the data. However, data obtained in this way may not be used for commercial purposes.
So far the EMA’s practice has been to provide access to portions of clinical reports upon request in accordance with the EU’s Access to Documents Regulation (1049/2001). A request may be submitted by anyone, including a competitor. The EMA has refused access to documentation if disclosure could infringe the protection of commercial interests or intellectual property, unless disclosure was in the public interest. In practice, the scope of publication of data from trials has generated disputes between the owners of the data and the EMA. (On our portal, we reported on such a dispute before the European Court of Justice in EMA v InterMune UK Ltd, Case C-390/13 P(R).) This procedure could still be applied from 2015 onward, but in practice will probably rarely be used.
It appears the sheer amount of data from clinical trials that will be released under the new policy will be vastly greater than under the existing system of providing access to data upon individual request. But this will also greatly increase the legal risks.
Risk of disputes over scope of published information
As defined in the publication European Medicines Agency policy on publication of clinical data for medicinal products for human use, the term “commercially confidential information” means any information contained in the clinical reports submitted to the EMA by an applicant or marketing authorisation holder that is not in the public domain or publicly available and where disclosure may undermine the legitimate economic interest of the applicant or marketing authorisation holder. This is a broad definition, but could generate disputes over what interests are regarded as legitimate and entitled to protection.
Relying on its past practice, EMA recognises that portions of clinical reports may contain commercially confidential information, e.g. detailed data concerning collection of samples, 3D presentation of molecules, or strategic plans for the research programme in which trials are conducted.
But these EMA guidelines do not release applicants or marketing authorisation holders from providing a detailed justification of why specific passages from a report must be treated as confidential and redacted from the publicly accessible version of the report.
If the EMA disputes the scope of information identified by the applicant as commercially confidential, the applicant has the right to seek a stay of publication from the court. When litigation is underway over the permissible scope of publication of the data, the EMA will release only the data for which publication is undisputed.
Risk of unlawful use of published data
Under the terms of use of the EMA database, the data may be used only for non-commercial purposes, i.e. not for obtaining marketing authorisation.
In practice, the situation could not be avoided in which the original purpose for accessing the data is non-commercial research, but during the research the information is processed or supplemented by the user’s own tests to create a commercial research project for a new medicine, followed by an application for registration of the medicine.
The boundary between commercial and non-commercial use cannot be precisely defined in advance. The manner of use of publicly available data could be the source of numerous disputes between pharmaceutical companies and the researchers they work with.
Seemingly anticipating this hotbed of future disputes, the EMA has declared that it will not be liable for users’ violation of the terms of use of the EMA database. Pharmaceutical firms injured by such use would thus have to pursue their rights under fair competition regulations directly against the persons who have violated their rights.
Joanna Krakowiak, Life Science and Regulatory Practice, Wardyński & Partners
