Optimal governance of and stakeholder involvement in a medicines regulatory authority to enable pharmaceutical innovation

Abstract

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.