The purpose of this report is twofold.
First, provide an exhaustive analysis of the clinical data transparency aspects of EU Parliament Regulation 536/2014 on clinical trials and EMA’s finalized policies on Publication and Access to Clinical Trials Data.
Second, review the wider policy implications and interface of these central EU-level policies with current data disclosure policies at the EU member state level, looking at five EU countries: Germany, Italy, Spain, Sweden, and the U.K.
Clinical trials represent one of the most important activities carried out by biopharmaceutical companies, scientists, and researchers today. They are fundamental components of the biopharmaceutical research and development process of new medicines and medical technologies. For individual countries and national economies, clinical trials provide direct social and economic benefits. Most obviously, clinical research enables the development of cutting-edge treatments, making novel and innovative medical technologies and products available to patients.
The EU has for a number of years seen a gradual decrease in clinical trial activity. Indeed, across the EU great disparity exists between top and bottom performers. Significantly, both EMA’s transparency policy and Regulation 536/2014 seek to stimulate and reverse this trend. It is within this wider context of the state of clinical research in the EU that this report seeks to examine the implications of the new EU regulation on clinical trials and EMA’s policy on data disclosure.
Based on this analysis the report highlights three key dimensions of the transparency and data disclosure debate:
- Transparency vs. Confidentiality: Increased transparency of clinical data and research is a laudable goal for all related stakeholders—government, researchers industry, NGOs, and patients. EMA’s goals of transparency and public access are both merited and valuable. At the same time, it is also important to balance greater clinical trial transparency with the need to protect proprietary and confidential information. The safeguards built into the EMA policy include a number of important features for market authorization holders, such as recognition by EMA of potential industry CCI, a redaction mechanism, a process of EMA-innovator dialogue prior to publication, and the availability of injunction relief. These are fundamental components of the finalized EMA policy and they need to be implemented and applied in full as the policy moves forward.
- Member State Differences: National transparency and disclosure policies vary greatly between EU member states, with some considerable “gray areas.” For instance, legal and regulatory frameworks in place at the member state level can, in some jurisdictions, provides quite broad protection for clinical trial data both in law and in practice. And while it appears that all drug regulatory authorities at the member state level in the five countries sampled are committed to the cause of increased transparency, none of them have a policy of proactively publishing submitted clinical research.
- Intragovernmental Differences: Significant differences exist in disclosure policies between different agencies and governmental bodies within member states. For example, while broadly speaking most institutions and policy bodies (such as drug regulatory authorities, clinical trial ethics committees, and health technology assessment bodies) examined at the member state level support increased disclosure policies, the extent to which they support (through specific policies or in practice) the proactive and specific policies adopted by EMA varies from body to body and country to country.