Facilitating Medical Product Development Through Voluntary Data Sharing: A Look at the Legal Issues
Posted by Social Science Research Network
Facilitating Medical Product Development Through Voluntary Data Sharing: A Look at the Legal Issues – Aliza Y. Glasner (Georgetown University – The O’Neill Institute for National and Global Health Law), Erin E. Wilhelm (Georgetown University Medical Center), Lawrence O. Gostin (Georgetown University – Law Center – O’Neill Institute for National and Global Health Law) and Ira Shoulson (Georgetown University)
ABSTRACT: The generation, dissemination, and sharing of research data are key ingredients in contributing to scientific progress and the public good. Data sharing has been encouraged to facilitate open science within the clinical research enterprise, improve the development of drugs and devices, and benefit public health. To date, the subject has received considerable attention in the media and scientific literature, however focused mainly on philosophical arguments. Of the empirical research that exists, much of it has focused on data sharing among academic investigators in the field of life science, including biomedical research, medicine, and genetics. A number of commentaries and editorials have dealt with the ethical repercussions when researchers choose not to share data; others have discussed real or perceived legal barriers to data sharing. These barriers include (1) compromised intellectual property rights and unfair advantages to competitors, (2) risk of increased product liability, (3) issues of collusion under antitrust laws, and (4) risks to research participant privacy.
This report examines the legal issues that may pose barriers to data sharing. The report provides a helpful guide to those in the biomedical community who wish to engage in data sharing. In each section, the authors provide an overview of the legal issue, including the statutes and other background, and suggest approaches for surmounting legal issues.
Note: The report was researched and written by collaborators from the O’Neill Institute for National and Global Health Law at Georgetown University Law Center, and the Georgetown University Medical Center. The effort was supported by the Georgetown University Center of Excellence in Regulatory Science and Innovation (CERSI), a cooperative agreement (FD U01004319) funded by the U.S. Food and Drug Administration.
Featured News
ConocoPhillips Acquires Marathon Oil for $22.5 Billion in Major Energy Sector Consolidation
May 29, 2024 by
CPI
Judge Denies Amazon’s Bid to Dismiss FTC Lawsuit Over Prime Membership Practices
May 29, 2024 by
CPI
Germany and France Advocate for Major EU Competition Reform
May 29, 2024 by
CPI
Equifax Accused of Monopolizing Employment Verification Market in New Suit
May 29, 2024 by
CPI
Car Battery Makers to Challenge EU Cartel Charges in Brussels
May 29, 2024 by
CPI
Antitrust Mix by CPI
Antitrust Chronicle® – Merger Guidelines Retrospective
May 21, 2024 by
CPI
Mergers of Complements
May 21, 2024 by
CPI
Personality Traits, Private Equity, and Merger Analysis
May 21, 2024 by
CPI
The 2023 Merger Guidelines: Lessons in the Importance of Incipiency, Modern Economics, and Monopsony
May 21, 2024 by
CPI
The 2023 Merger Guidelines: Sharpening Merger Analysis
May 21, 2024 by
CPI