Open Access. Powered by Scholars. Published by Universities.®
Articles 1 - 2 of 2
Full-Text Articles in Law
The Drug Shortage Crisis: What Happens When Generic Manufacturers "Just Say No", Stacey B. Lee
The Drug Shortage Crisis: What Happens When Generic Manufacturers "Just Say No", Stacey B. Lee
Stacey B. Lee
In the past five years, the number of drug shortages in the United States has nearly quintupled. The majority of shortages involve generic sterile injectables used to fight infectious diseases and treat cancer. These complex drugs are produced in a concentrated market consisting of only a few generic manufacturers. Any disruption in their supply can result in shortages that leave patients without access to life-saving drugs which in some cases are the only treatment for their condition. These chronic shortages have been linked to many possible factors including product quality concerns, discontinuation of product lines, changes in supply and demand, …
Can Incentives To Generic Manufacturers Save The Doha Declaration's Paragraph 6?, Stacey B. Lee
Can Incentives To Generic Manufacturers Save The Doha Declaration's Paragraph 6?, Stacey B. Lee
Stacey B. Lee
A primary objective of the DOHA Declaration was to create a process for member countries with insufficient manufacturing capabilities to access generic versions of patented drugs without violating TRIPS intellectual property standards. This year marks the 10th anniversary of the process. Referred to as the “Paragraph 6 compulsory licenses provisions,” this first and only amendment to TRIPS was intended to ensure developing countries access to affordable medicines. Over the past decade, these provisions have failed to provide the gains initially anticipated. This article explores the reasons for this failure and suggests that an under-examined approach to reaching the DOHA …