How to strike a balance between transparency and confidentiality in the conduct of clinical trials?

Speakers: Heynisch Thomas, O’Regan Fergal, Powrie-Smith Andrew
Moderator: De Nys Katelijne

On Wednesday, 21st of April, at the premises of Science14 Atrium in Brussels, PubAffairs Bruxelles hosted a debate on the theme of the balance between transparency and confidentiality in the conduct of clinical trials. The debate was moderated by Katelijne De Nys, Head of the Clinical Trial Center of the University Hospitals of Leuven, while the discussants were Mr Thomas Heynisch, deputy Head of Unit, European Commission, DG Grow, Mr Fergal O’Regan, Head Of Unit, European Ombudsman and Mr Andrew Powrie-Smith, Communications Director at EFPIA.

In the first part of the debate, Mrs De Nys introduced the speakers and the main topics which the debate would touch upon. She then asked a yes/no question to the public, which was to be put again to the audience at the end of the debate namely: “Do you think we should privilege transparency or confidentiality in clinical data trials?”. She then gave the floor to the discussants who could proceed to give their preliminary statements and to  informally discuss  the issues at stake.

Mr O’Regan replied to the preliminary question by pointing out that, although the issue should be further discussed in detail, as long as clinical trials and pharmaceuticals are related to the safety and efficacy of products which affect human beings’ health, the balance should lean towards transparency. Mr Powrie-Smith began his intervention by pointing out that the question of responsible transparency is of utmost importance for the industry and that transparency should be considered as a guiding principle. He continued by emphasising the fact that transparency is a dynamic process which has to be continuously reviewed, while remarking that patients anonymity and protection of commercial confidentiality, where appropriate, are also features of the process of developing an effective and innovative medicine. Mr Heynisch replied to the same question by agreeing with what the other speakers affirmed, while stating that, given the complexity of the matter, there is a need to adopt  a balanced approach. In his opinion, the utilisation of data for markets and the protection of patients’ personal information are features upon which the discussion should be focused.

A first point of discussion consisted of an exchange of views on which features of the clinical data trial information access will change with the introduction of the new reform package. Mr O’ Regan started by explaining that public access to information exists under the current laws regulating the functioning of the European Medicines Agency (Regulation 726/2004), as well as in the Agency’s own internal procedures. Several cases relating to such rules have already been brought both before the ECJ and to the EU Ombudsman office’s attention. Mr O’ Regan explained that this legislative setting already regulates public access to commercially confidential information and personal data  protection in documents held by EMA, such as clinical study reports which are documents containing detailed information about the methods and the results of a clinical trial. He continued by stating that there will be two major changes resulting from the entry into force of the Clinical Trials Regulation. First, the scope of documents will be expanded. The access to documents rules only apply to the documents in the possession of EMA. Currently,  EMA only holds documents that have been submitted to it as part of its regulatory work, such as clinical study reports submitted for the purpose of obtaining a marketing authorisation. Under the Clinical Trials Regulation, however, the scope of documents held by EMA will be expanded to cover all trials conducted in the EU. As a consequence, the access to documents rules will apply to a much wider range of documents. Second, certain exceptions to public access, such as those relating to commercially confidential information  and data protection, are more explicitly set out in the new laws. For example, as regards commercially confidential information, the Clinical Trials Regulation makes explicit reference to the status of a marketing authorisation as a relevant factor when determining if a document is commercially confidential. This could mean that there is now a more explicit legal presumption that after a marketing authorisation is granted a document will not be deemed to contain commercially confidential information, although this could be rebutted, exceptionally, by pointing out specific information that relates, for example, to novel testing methods. Mr O’ Regan also remarked that the questions related to personal data have been simplified. Mr Powrie-Smith began by agreeing with Mr O’ Regan that there will be an extension of the scope and that companies are already working on their internal procedures in order to adapt to the requirements of the new regulations. He added there are still some aspects on which a greater degree of clarity of law implementation would be needed as, for example, in the case of the timing for marketing authorisations to be operational. He continued by stating that in his experience of dialogue among institutions, patients’ organisations and industry representatives, there is a risk that the debate could become swiftly polarised. As a result, starting from the premise that the pharmaceutical sector shares the intents behind the new clinical trial regime, as well as from the consideration that the very implementation of the regulations is of vital importance in order to grant the most effective and transparent medicine to citizens, it will be important that all stakeholders and institutions continue their dialogue in order to ensure the right balance. Mr Heynisch started by premising that from a legal point of view, the fact that a regulation instead of a directive has been chosen as a legislative means is important as for a Regulation the implementation will be facilitated. He added that in his opinion the new legislation is going to increase the predictability of the environment and the level of transparency of data. However, as we are still three years away from the entry into force of the legislation, there is still some degree of uncertainty on some practical aspects of the implementation.

A second point of the discussion was the issue of potential clinical data trials disclosures and, more in general, how to enhance the sharing of information among experts and researchers. Mr O’Regan stated that, to date, from a legal point of view, public access to data can only be granted for information  held by public authorities. Nevertheless, if in the future the legislator is willing to enlarge the access to information in order to further improve the safety and efficacy of trials, this process will likely open a series of complex questions not only on reporting but also on personal data protection. Subsequently, he explained that the current legislative evolutions are, in his opinion, a step forward towards a greater reliability of trials and the improvement of data sharing practices among researchers. Mr Powrie-Smith added that the new regulations should be considered as a part of the wider transparency processes which are already underway especially within the relation between the industry and the academic sectors. He underlined that there are existing programmes which are leading to new formulas of cooperation for the benefit of both patients and healthcare systems. Mr Heynisch added that the international context is also relevant for  information sharing. However, he agreed on the fact that the new wave of legislation is a step forward while concluding that the legislation will be probably reviewed  in the longer term due to further developments in research and information sharing.

The final part of the debate and the Q&A session also covered the following issues: the nature of data which will be disclosed with the new regulation, the structure of the clinical study reports, the future of data sharing in Europe, the consequences of commercially confidential information disclosure, the question of consistency in EMA policies, the issue of clinical trials data in the international context, the differences between medical devices and drugs, the interrelations between the protection of personal data for clinical trials and the issue of personal data in the EU as a whole, the evolution of the life science industry in Europe, the level of protection of both patients’ and researchers’ personal data, the potential impact on TTIP of the clinical data trials regulation.     

Do you want to go further into the issues discussed in our debate? Check our list of selected sources which we have provided for you

European Medical Agency

Transparency, European Medical Agency

OECD Recommendation on the Governance of Clinical Trials

Clinical Trials, EFPIA, European Federation of Pharmaceutical Industry and Associations

European Ombudsman website

Ombudsman concerned about change of policy at Medicines Agency as regards clinical trial data transparency, European Ombudsman press release

EMA says complying with its scientific advice raises likelihood of approval, fewer objections, Regulatory Affairs Professional Society

University Hospitals of Leuven