The South African medicines regulatory authority will shortly be moving from under the
control of the National Department of Health to become a Section 3A public entity with
its own governance structure. This presents the ideal opportunity to address the urgent
need for evaluation of stakeholder engagement and mechanisms to improve the
efficiency of the regulatory authority. This research was designed in order to join and
contribute to the on-going conversation regarding the optimum functioning of the
medicines regulatory authority by evaluating stakeholder engagement and governance,
through the perceptions of stakeholders involved in the regulation and approval of
medicines in South Africa. Governance, stakeholder and industry dynamics theory
provided the foundation on which the research was based, allowing the researcher to
create a lens through which the results of the research were viewed.
Qualitative, deductive exploratory research was performed using perceptions of twelve
respondents. These included key stakeholders involved in the provision of
pharmaceuticals, as well as medicine regulatory decision-makers. Perceptions of
previous experiences with, and proposed future optimal frameworks for, stakeholder
interaction and governance of the medicines regulator to enable innovation in the
pharmaceutical industry were derived from in-depth interviews.
The research found many areas of improvement urgently needed in the current model
of governance of the medicines regulatory authority. New academic insight was
developed into the efficiencies needed within a medicines regulatory authority, as well
as the stakeholder interactions to improve efficiencies and operating conditions within
the pharmaceutical industry. It was found that internal efficiencies within the medicines
regulatory authority as well as more effective stakeholder interaction framework would
better enable innovation of products and processes within the pharmaceutical industry.
Analysis of themes derived from in-depth stakeholder interviews, along with the
literature review, was used to construct a framework of optimal governance and
stakeholder interaction of the new medicines regulatory authority. This provides a
contribution to theoretical management literature and provides guidance for regulators
and stakeholders to create an efficient regulatory system to allow for innovation and
result in better quality healthcare for the public.
Mini Dissertation (MBA)--University of Pretoria, 2017.