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Dissertation
Immaterialgüter- und Wettbewerbsrecht

Designing a Sui-generis Regime of Access to Clinical Trial Data in the Context of Competition in Innovation in the Pharmaceutical Industry

The project addresses the controversial question of access to individual patient-level data gathered in industry-sponsored clinical trials. While earlier research mainly justified access on the grounds of general public interest in transparency, this study undertakes an innovation-based perspective.

Letzte Änderung: 10.11.17

The central research question is:
How should legal rules of access to non-summary clinical trial data be designed in order to reconcile the policy objectives of maintaining innovation incentives of research-based companies through protection of competitive advantage in R&D, on the one hand, and maximising the research potential of clinical trial data through post-trial data analyses, on the other hand?


The controversy at heart of this question is captured by two competing claims. On the one hand, the research-based pharmaceutical industry has claimed that mandatory disclosure of non-summary clinical trial data impedes innovation incentives. On the other hand, broad access to individual patient data (IPD) has been argued to enhance the stock of biomedical knowledge and inform and facilitate new drug development. These opposing claims reflect the dual implications of erga omnes data disclosure for drug innovation. They also correspond to two potential legal regimes: one can support de facto exclusive control of drug sponsors over IPD (the scenario of non-interference into industry data-sharing practice); the other regime can implement measures that remove such control (a regulatory intervention scenario). What regime is more conducive for drug innovation given that the major share of clinical research and drug R&D in the EU is conducted by the industry?


The analytical framework of the study draws on the literature on law and economics of innovation, in particular, the theories of R&D externalities, economic incentives for innovation, competition in R&D, and the relation between academic research and industry R&D. The law-and-economics approach complements the public interest-based approach: after all, protection of innovation incentives is meant to fulfil public interest in the development of innovative medicine. As an empirical part of the study, I am conducting a survey aimed to gain the insights from the scientists and researchers, who use IPD analysis as a research method. The responses received so far contrast the opinions sometimes expressed in the policy and legal discourse that IPD is unlikely to generate new research lines potentially leading to the development of new medicines.


As a contribution to the scholarly debate, the study aims to show that access measures can be justified not only on the grounds of public interest in transparency, but from an innovation perspective as well. The overall argument is that a regulatory intervention by access measures can be justified on the grounds of promoting cumulativeness of biomedical research, knowledge and innovation. However, rather than erga omens disclosure of IPD (such as, for instance, the approach of the 2015 publication policy of the European Medicines Agency), a dedicated regime of access can provide for the balance of the interests at stake.


Personen

Doktorand

Daria Kim

Betreuer

Dr. Axel Walz

Doktorvater

Prof. Dr. Ulrich M. Gassner

Forschungsfelder

Immaterialgüter- und Wettbewerbsrecht zwischen Markt und Regulierung

Forschungsschwerpunkte

Rechtliche und ökonomische Rahmenbedingungen der Pharmaindustrie