Clashes between clinical trials data transparency, IPRs, trade secrets & the protection of personal data: What does it mean for precision medicine?

TY - ABST

T1 - Clashes between clinical trials data transparency, IPRs, trade secrets & the protection of personal data: What does it mean for precision medicine?

AU - Minssen, Timo

PY - 2017/6/12

Y1 - 2017/6/12

N2 - Recent initiatives and new legislation will considerably increase public access to clinical trials data (CTD) in both Europe and in the U.S. Greater CTD transparency entails enormous benefits, inter alia for the enhancement of precision medicine. Yet, the costs and concerns associated with increased transparency are also substantial. They include worries over patient privacy and misuses of clinical trial data in poor-quality analyses. Moreover, the drug industry has expressed concerns over fewer incentives to invest in innovative R&D and increased exposure to litigation owing to trolling of these data by class-action tort lawyers. Focusing on recent EU legislation and experiences, this presentation will describe the genesis of the regulatory transparency requirements, as well as the incidents, developments and policy concerns that have shaped them. Special emphasis will be laid on the model for increased transparency recently adopted in the EU with Regulation 536/2014 and the alleged conflicts between actual practices, policy goals and the EU’s new legislation on personal data protection and trade secrets. This presentation will argue that these clashes are real and must be swiftly addressed to reap the full benefits of CTD transparency.

AB - Recent initiatives and new legislation will considerably increase public access to clinical trials data (CTD) in both Europe and in the U.S. Greater CTD transparency entails enormous benefits, inter alia for the enhancement of precision medicine. Yet, the costs and concerns associated with increased transparency are also substantial. They include worries over patient privacy and misuses of clinical trial data in poor-quality analyses. Moreover, the drug industry has expressed concerns over fewer incentives to invest in innovative R&D and increased exposure to litigation owing to trolling of these data by class-action tort lawyers. Focusing on recent EU legislation and experiences, this presentation will describe the genesis of the regulatory transparency requirements, as well as the incidents, developments and policy concerns that have shaped them. Special emphasis will be laid on the model for increased transparency recently adopted in the EU with Regulation 536/2014 and the alleged conflicts between actual practices, policy goals and the EU’s new legislation on personal data protection and trade secrets. This presentation will argue that these clashes are real and must be swiftly addressed to reap the full benefits of CTD transparency.

M3 - Conference abstract for conference

T2 - Intellectual property, Ethics and the Market in the Era of Personalized Medicine, University of Oxford

Y2 - 12 June 2017 through 13 June 2017

ER -