ABSTRACT
This chapter discusses test data provisions under the TRIPS Agreement, its scope and the role it plays in the access to medicines challenge. It investigates the extent to which the TRIPS test data protection requirements impose fetters on compulsory licensing and the question of whether the right to keep undisclosed information confidential can be dispensed with through the compulsory licensing mechanism. The Chapter considers the connection between test data protection and the need to safeguard public health, with particular focus on the implication for access to medicines in Africa It considers TRIPS-plus test data protection in regional trade agreements and the potential impact on access to medicines in Africa and global public health. The chapter discusses the peculiar challenges raised by regulatory requirements for granting marketing approval for biologics. It takes the view that the promotion of free trade and development of pharmaceutical manufacturing capacity in Africa will go a long way in alleviating some of the challenges relating to access to medicines that may be caused by data exclusivity and intellectual property (IP) protection in the continent.
