Transparency in medicines regulatory affairs – reclaiming missed opportunities

Abstract

Transparency is a salutary value in South Africa (SA)’s constitutional architecture. It has also been described as a necessary element in promoting accountability in the regulatory aspects of essential medicines. Nevertheless, despite its several incarnations since its promulgation, the Medicines and Related Substances Act No. 101 of 1965 retains a ‘preservation of secrecy’ provision (section 34). This contribution seeks to evaluate section 34 in the context of transparency; to ascertain whether it is in conflict with other legislation pertaining to the promotion of access to information; and, in particular, to establish whether it is consistent with the Constitution of the Republic of SA.