Open Access. Powered by Scholars. Published by Universities.®
- Keyword
-
- Access to information (1)
- Agencies (1)
- Authority (1)
- China (1)
- China Securities Regulatory Commission (1)
-
- Disclosure (1)
- Drug approvals (1)
- Drugs (1)
- Enforcement (1)
- Federal agencies (1)
- Food and Drug Administration (1)
- Information (1)
- Inside information (1)
- Insider trading (1)
- Law reform (1)
- Liability (1)
- Manufacturers (1)
- Misappropriation (1)
- Pharmaceuticals (1)
- Public policy (1)
- Regulation (1)
- Research (1)
- Rulemaking (1)
- Scientific progress (1)
- Secrecy (1)
- Sensitive information (1)
- Stock exchanges (1)
- Trade secrets (1)
- Publication Type
Articles 1 - 2 of 2
Full-Text Articles in Comparative and Foreign Law
A New Prescription To Balance Secrecy And Disclosure In Drug-Approval Processes, Gerrit M. Beckhaus
A New Prescription To Balance Secrecy And Disclosure In Drug-Approval Processes, Gerrit M. Beckhaus
University of Michigan Journal of Law Reform
To obtain approval to market a drug, a manufacturer must disclose significant amounts of research data to the government agency that oversees the approval process. The data often include information that could help advance scientific progress, and are therefore of great value. But current laws in both the United States and Europe give secrecy great weight. This Article proposes an obligatory sealed-bid auction of the sensitive information based on the experience with similar auctions in mergers and acquisitions, to balance manufacturers' interest in secrecy and the public interest in disclosure.
Enforcement Without Foundation? Insider Trading And China's Administrative Law Crisis, Nicholas C. Howson
Enforcement Without Foundation? Insider Trading And China's Administrative Law Crisis, Nicholas C. Howson
Articles
China's securities regulator enforces insider trading prohibitions pursuant to non-legal and non-regulatory internal "guidance." Reported agency decisions indicate that enforcement against insider trading is often possible only pursuant to this guidance, as the behavior identified is far outside of the scope of insider trading liability provided for in statute or regulation. I argue that the agency guidance is itself unlawful and unenforceable, because: (i) the guidance is not the regulatory norm required by the statutory delegation of power; and (ii) the guidance is ultra vires because (a) it addresses something substantively different from what is authorized under the statutory delegation, …