ABSTRACT
This chapter addresses the regulatory requirements applicable to marketing approval of pharmaceutical products. It examines the Bolar exception in the light of the Agreement on Trade-Related Aspects of Intellectual Property Rights, particularly on the basis of the findings of a World Trade Organization panel that examined the consistency of such exception with Article 30 of the said agreement. The chapter analyses how the Bolar exception has been introduced in different countries without any intention, however, of presenting the full panorama. Finally, the chapter discusses several aspects that need to be considered in drafting and interpreting a Bolar-type provision. The US Food and Drug Administration, as well as other regulatory authorities, do not require the repetition of pre-clinical and clinical studies to establish safety and effectiveness. The Bolar exception serves the interest of the public as well as governments and social security systems that bear the cost of medicines.
