Exorcising the Ghosts of Dr. No's War on Science: Exploring What the Constitution Means for the Institutions that Regulate Medicines

Abstract

Since the Constitution of the Republic of South Africa, 1996 came into effect, legal action on a range of socio-economic rights - in particular the right to have access to health care services - has demonstrated the significant value of express constitutional recognition. Collectively, the cases highlight the link that often exists between successful rights-based legal action and civil society organisation, mobilisation and advocacy. Importantly, they show that the law - particularly insofar as it relates to positive claims on the state - is ordinarily a weak tool when used on its own, but often significantly more powerful when combined with activism.

But these cases also raise deeper systemic questions about the health system. Collectively, they show that effective regulation and reasonable implementation of policies and programmes - as well as the ability of the state to meet its constitutional mandate - relies on the proper functioning of a number of independent regulatory and oversight institutions. Until recently, however, health rights litigation had largely overlooked these important concerns. To date, South African jurisprudence has yet to consider the nature and extent to which the Constitution imposes obligations on the state in respect of such institutions.

With a singular focus on the regulation of medicines, this paper seeks to start to address this deficit. Cognisant of the broader legal and political context within which medicines have been regulated in South Africa over the past decade, it begins by exploring recent legislative moves to replace the Medicines Control Council (MCC). By considering proposals for the MCC's successor - the South African Health Products Regulatory Authority ("the Authority") - as set out in the recently adopted Medicines and Related Substances Amendment Bill [B 44D-2008] ("the Bill"), this paper seeks to contextualise concerns regarding the Authority's structure and mandate.

Thereafter, this paper considers the state's positive obligations in respect of regulatory institutions in general and drug regulatory authorities (DRAs) in particular. In so doing, it focuses on a wide range of legal developments in South Africa, including jurisprudence on socio-economic rights and other superior court decisions that consider constraints on the exercise of public power - openness, accountability, transparency, the delegation of subordinate legislative authority and the grant of discretionary powers. In particular, this paper considers the impact of the Constitution on certain aspects of the structure, mandate and operations of a DRA such as the Authority.

This paper concludes by identifying ways in which new regulations to the Medicines Act - as amended by the Bill - could address outstanding concerns relating to the Authority's ability to discharge its functions effectively, efficiently and in accordance with the Constitution. Simply put, this paper ends by considering how best to address many - if not most - of the deficiencies in the Bill by way of the regulation drafting process. In so doing, it implicitly recognises that further opportunities for amending the Medicines Act - whether by way of law reform or litigation - are unlikely to arise in the short to medium term.

JEL Classification: K29