The benefits of access to clinical trial data are related to their inestimable value from the perspective of clinical trial participants, society as a whole, public health systems and scientific ...progress. In light of the development of innovative data analysis technologies, access to raw clinical trial data opens up an ever-widening array of possibilities: it can profoundly facilitate machine data analysis for,
inter alia
, hypothesis generation, risk modelling, counterfactual simulation and – finally – drug repurposing and development. The enactment of the new Clinical Trials Regulation (EU) No. 536/2014 (CTR) and introduction of the Clinical Trials Information System (CTIS) were heralded as ensuring a level of transparency in clinical trials that is sufficient to contribute to protecting public health and fostering the innovation capacity of European medical research, while recognizing the legitimate economic interests of sponsors. This paper presents the hitherto binding rules for the disclosure of clinical trial data and, against this background, their new framework, introduced by the CTR. In addition to assessing whether the CTR’s objectives are fulfilled, this paper examines whether the latest changes impact the hitherto existing rules on protection of regulatory data via regulatory exclusivities. Finally, it points out concerns regarding whether data gathered in the CTIS can be efficiently used by innovative data analysis technologies for further processing for both commercial and non-commercial purposes.
Abstract
Regulatory data protection is mandated in the Agreement on the Trade Related Aspects of Intellectual Property Rights (TRIPS Agreement) for two kinds of goods: medicinal products and plant ...protection products (PPP). In the European Union (EU), the level of their protection has been set far beyond the minimum TRIPS standards and the adopted model of protection has been, for the most part, based on temporary exclusivity. Innovative plant protection products benefit from data exclusivity combined with a compulsory data sharing regime. Data exclusivity refers to products being authorised for the first time for the market of the EU on the grounds of a complete authorisation procedure, based on submission of a full data dossier. Within the period of exclusivity, these data may not be referred to in the authorisation procedure of a generic product—an equivalent to the reference one. In this way, data exclusivity creates a period of factual monopoly for the innovative products and constitutes a sui generis intellectual property right. This paper presents the regime of regulatory data protection in the European Union law as an instrument of legal protection for innovative products in the agrochemical industry. It first analyzes the purpose and functions of regulatory data protection in EU law and in the TRIPS Agreement. Then, the rules of protection by means of data exclusivity and compulsory data sharing are examined. This allows for further considerations on the role of regulatory data protection and compulsory sharing of data in the overall legal protection for innovative products in the agrochemical industry. In view of the above, this chapter discusses both the instruments of protection for PPP regulatory data and poses several questions concerning their rules, practical meaning and possible future modifications. In particular, it is considered whether data exclusivity is the optimal regime of protection for registration data and recommend that a data sharing approach could be used instead of the data exclusivity rule, as is the case with compulsory vertebrate data sharing, to the benefit of the industry and public interest. This chapter allows for evaluation and assessment of the economic and social value of data exclusivity in said areas for fostering primary and secondary innovation, while acknowledging other vital interests such as protection of public interest and safeguarding competition in the relevant markets. Finally, this chapter maps challenges of the current model of protection and indicates areas for further consideration in both creating a coherent and balanced framework of PPP data protection and the possible extrapolation of the data sharing rules to systems of data protection for other life science products.
