On 12 June 2014 the European Medicines Agency (EMA) Management Board agreed a policy on publication of clinical trial data that will allow it to proactively publish clinical trial data that is submitted as part of a marketing authorisation application after grant of that authorisation. The draft policy1 arose from the EMA's commitment to increase access to clinical trial data and has been shaped by the many comments the EMA received during the consultation phase. In light of discussions at the Management Board, the wording of the policy, including practical arrangements for academic and non-commercial research users, will now be finalised with a view to its adoption by the Board in October 2014.2
The EMA states that it has aimed to achieve the broadest possible consensus among its stakeholders. Consequently, and due to the level of response during the first consultation, the EMA carried out a second round of targeted consultation in May 2014 that showed support for the policy, but also highlighted concerns. At the EU-level, contributions came from, amongst others, the European Ombudsman, Emily O'Reilly. She expressed concerns about what appears to be a significant change of policy concerning clinical trial data transparency.3 According to the Ombudsman, the EMA is planning to limit access to clinical trial data by imposing strict confidentiality requirements and by allowing data only to be seen on screen using an interface provided by the EMA, as well as imposing wide restrictions on the use of such data. On the other hand, some parties argued that the policy would infringe the rights on commercially confidential information, would encourage unfair commercial use of data outside of the EU, would provide a disincentive to innovation in Europe and risk companies moving their research and development activities outside of the EU. It has even been said that it could endanger international agreements on intellectual property protection.
Arguments in favour of a restricted publication of clinical trial data
The clinical trial advisory group on legal aspects also discussed whether or not clinical trial data containing commercially confidential information could undermine the legitimate commercial interests of the author if published.4 The advisory group has not managed to reach an agreement about commercially confidential information. However, the advisory group pointed out some important arguments objecting to proactive publication. Firstly, clinical trial data contains or amounts to commercially confidential because it contains information in the area of control proceedings and manufacturing. It is also not exceptional for clinical trial data to be commercially confidential because it contains information such as know-how and intellectual property regarding: the manufacturing, technological approaches and development of innovative medicines; efficacy and safety measurements and statistical analyses; and, the innovator's clinical-trial design and product development strategy as well as the market authorisation holder's confidential strategies for managing its clinical development programme. This and other information, which is not in the public domain and for which the author has taken active steps to maintain confidentiality, would damage the company's commercial interests if made public. In particular, the know-how, commercially confidential information and trade secrets in clinical-trial data would be disclosed. This is in a context where efforts incurred in developing novel medications by companies are high; the costs ever-increasing.
On the judicial side, the Court of Justice of the European Union has held in several cases that there exists a general presumption that documents submitted by a party pursuant to a specific administrative procedure, and their confidentiality under Article 4(2) of Regulation 1049/2001, should be favoured.5 Nevertheless, the decision of the European Union General Court in the case InterMune UK and Others v EMA6 on the subject needs to be awaited after the case was referred back by the Court of Justice of the European Union.
Furthermore, it is argued that a consistent approach with Regulation 1049/2001 should be adopted. There are suggestions that the EMA should install a procedural step to control the process of disclosure before any data is made publicly available and should not assume that data is not commercially confidential without considering the data on an individual basis. The EMA should judge whether or not there is an overriding public interest in disclosure, for which the purpose of the request and the ability to prevent subsequent improper use following disclosure is critical to determining the public interest in disclosure/publication. In light of the presumption that marketing authorisation dossiers may contain commercially confidential information, consultation with the market authorisation holder on a possible disclosure is needed, in line with Article 4(4) of Regulation (EC) 1049/2001, unless the market authorisation holder in advance indicates that there is no confidentiality concern.
There should be no assumption that publication of commercially confidential information contained in the marketing authorisation application is generally justified by an overriding public interest in disclosure, because the publication as such does not lead to an improvement of public health. Competitors would be favoured by this publication, as proven by the fact that the majority of current requests for access to documents are from industry. Finally, a proactive disclosure would require a clear legal basis and it is doubtful if Regulation 726/2004 or Regulation 1049/2001 provide such a basis at present.
For the pharmaceutical industry the topic "transparency" will remain controversial. With the approval of the EMA policy on publication of clinical trial data by the Management Board the EMA will in future be allowed to proactively publish clinical trial data that is submitted as part of marketing authorisation applications, after grant of the authorisation. Nevertheless, the concerns about the proactive publication in regard to the protection of commercially confidential information remain. However, the decision of the European Union General Court in the caseInterMune UK and Others v EMA may clarify the situation. A careful monitoring of these proceedings by industry seems to be advisable.