Access to non-summary clinical trial data has been subject to a long-standing debate. Under the current EU legal framework, trial sponsors can exercise de facto exclusive control over patient-level data, while access to anonymised data for research purposes can be granted through negotiations with drug companies. The conventional policy approach is based on transparency-related considerations that emphasises access to data for confirmatory analysis. In the context of digital economy and data-driven innovation, access to data for exploratory research gains more on importance.
Benefits of secondary analysis of non-summary clinical trial data are broadly associated with improved research reproducibility, enhanced transparency, better informed clinical practice, elimination of duplicative research, and developing scientific knowledge beyond the risk-benefit assessment of the original investigational product. At the same time, the research-based pharmaceutical companies have claimed that mandatory disclosure of non-summary clinical trial data impedes their innovation incentives, and that such data constitutes their (intellectual) property.
The research project is structured around these two competing propositions and seeks to define: How can the rules of access to non-summary data be designed in order to maximise the research potential of data through secondary data analyses without negatively affecting innovation incentives of pharmaceutical companies?
Analysis de lege lata evaluates determinants of access and sources of control of drug sponsors over non-summary data under the current EU legal and regulatory framework. It also examines the potential impact of data disclosure on the policy instruments that are designed to promote innovation incentives.
Analysis de lege ferenda addresses the question of whether access for exploratory data analysis should be subject to the authorisation by the sponsors of the original investigational product. It draws broadly on the literature on law and economics of innovation, economics of knowledge, and, in particular, employs the concept of R&D externalities in order to define what regime of access to data as a knowledge resource for drug R&D would be normatively optimal. Further, several legislative options including the non-intervention scenario, the right of access for research purposes, and public disclosure of non-summary data are evaluated relative to the dual policy objective of protecting innovation incentives of the industry and maximising the research potential of data.
Overall, the study argues for the default rule of mandatory transfer of non-summary data to data repositories administered by an independent intermediate, whereby third-party access for research purposes is not subject to the authorisation of the initial trial sponsor. In order to protect competitive advantage of originator companies in drug R&D, reservations regarding the timing of data transfer and the scope of data are proposed.