Optimal governance of and stakeholder involvement in a medicines regulatory authority to enable pharmaceutical innovation
Year: 2017
Type: dissertation
Abstract: The South African medicines regulatory authority will shortly be moving from under the \ncontrol of the National Department of Health to become a Section 3A public entity with \nits own governance structure. This presents the ideal opportunity to address the urgent \nneed for evaluation of stakeholder engagement and mechanisms to improve the \nefficiency of the regulatory authority. This research was designed in order to join and \ncontribute to the on-going conversation regarding the optimum functioning of the \nmedicines regulatory authority by evaluating stakeholder engagement and governance, \nthrough the perceptions of stakeholders involved in the regulation and approval of \nmedicines in South Africa. Governance, stakeholder and industry dynamics theory \nprovided the foundation on which the research was based, allowing the researcher to \ncreate a lens through which the results of the research were viewed. \nQualitative, deductive exploratory research was performed using perceptions of twelve \nrespondents. These included key stakeholders involved in the provision of \npharmaceuticals, as well as medicine regulatory decision-makers. Perceptions of \nprevious experiences with, and proposed future optimal frameworks for, stakeholder \ninteraction and governance of the medicines regulator to enable innovation in the \npharmaceutical industry were derived from in-depth interviews. \nThe research found many areas of improvement urgently needed in the current model \nof governance of the medicines regulatory authority. New academic insight was \ndeveloped into the efficiencies needed within a medicines regulatory authority, as well \nas the stakeholder interactions to improve efficiencies and operating conditions within \nthe pharmaceutical industry. It was found that internal efficiencies within the medicines \nregulatory authority as well as more effective stakeholder interaction framework would \nbetter enable innovation of products and processes within the pharmaceutical industry. \nAnalysis of themes derived from in-depth stakeholder interviews, along with the \nliterature review, was used to construct a framework of optimal governance and \nstakeholder interaction of the new medicines regulatory authority. This provides a \ncontribution to theoretical management literature and provides guidance for regulators \nand stakeholders to create an efficient regulatory system to allow for innovation and \nresult in better quality healthcare for the public.
Author: Amanda Calder
Language: English
Topic: Healthcare Regulation
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W2608046984