ABSTRACT
The chapter presents a general overview of the compulsory licensing regime under the TRIPS Agreement and the circumstances that may justify the use of the system. It discusses how the system affects least developed countries that are not yet required to enforce the substantive provisions of the TRIPS Agreement but may still need to use the system should they require a foreign country to issue a compulsory license to manufacture pharmaceutical products for their domestic use. The Chapter traces the history of compulsory licensing of patents and how it became part of the TRIPS Agreement after a series of intensely negotiated deliberations. The circumstances that culminated in the emergence of the Doha Declaration, the Implementation Decision and Protocol Amending TRIPS are then discussed to provide an insight into the legal framework for the use of compulsory licensing by countries without local manufacturing capacity in the pharmaceutical sector.
