National Medicines Policies learning from the South African experience 1994-2009

Andy Gray, Julia Botha

Abstract


Although South Africa, in common with many other developing and some developed countries, developed a National Drug Policy (NDP) in 1996, the implementation of this policy has met with mixed results (Minister of Health, 1996). Investigation of the process of developing and implementing the policy can reveal the extent to which local decisions were informed by available evidence. However, the available evidence may not be as instructive as expected. The first part of this thesis will therefore be a systematic overview of the existing evidence base for medicines policies as presented in published systematic reviews, and an assessment of the extent to which this evidence is applicable to low- and middle-income countries. Previous work in this field has identified weaknesses in relation to the process followed (Gray et al, 2002). The second part of this thesis will therefore extend and update this analysis, covering the entire post-apartheid period from 1994 to 2009. This will be a qualitative policy analysis of the development and implementation of the South African National Drug Policy, using the method of Walt and Gilson (1994). A key element identified in the previous analysis was the vulnerability of the NDP to legal challenge. Since 1999, two important court challenges to elements of the NDP have reached the Constitutional Court. The third component of this thesis will therefore be a qualitative, descriptive analysis of the process by which legislative interventions aimed at medicines pricing and the licensing of dispensing practitioners have been developed and implemented, including assessment of the relevant jurisprudence, to identify facilitating and constraining factors. Overall, the NDP aimed to ensure equitable access to essential medicines of good quality and to promote their rational use. Two key elements are effective control over pharmaceutical marketing activities and promotion of generic medicines. While the former objective has not been met, the latter is considered to be one of the relative successes of the NDP. However, given the delay in implementing the enabling legal provisions, and the extent to which reimbursement policies in the private sector anticipated the introduction of mandatory offer of generic substitution, the most important policy interventions may have been taken outside of the NDP process and in ways not anticipated in the policy document. In order to investigate this possibility, the fourth part of the thesis will be a quantitative, interrupted times series analysis of private sector sales of selected pharmacological groups, to determine the impact of the South African National Drug Policy on generic medicines utilisation in the private sector, using the methods described by Wagner et al (2002).

One of the key elements in relation to promoting rational use is effective control over pharmaceutical marketing. This thesis will therefore also draw on two completed and published studies. The first of these highlighted shortcomings in the regulation of pharmaceutical marketing (Shaw and Gray, 2009). The second identified the potential savings from generic substitution in the management of chronic conditions, and the ways in which medicines selection processes in the private sector may be improved (Nicolosi and Gray, 2009).

Finally, lessons from each of the studies described will be combined in order to suggest strategies to facilitate future medicines policy processes in South Africa.