The Impact of Intellectual Property and Regulatory Law on the Propagation of Medical Products to Various Countries

Abstract

Has anyone ever wondered how people abroad have access to medical products developed in the United States? What processes did the medical products have to go through in order to be distributed in a foreign country and what affected the distribution? These are all questions that served as the basis for the Science, Technology and Society project of how regulatory and IP laws affect the propagation of medical products to various countries. This question was tackled through a comparative analysis of regulatory and IP laws in the US and South Africa, and an analysis of how their systems would impact the transfer of HIV/AIDS treatments and diagnostic tools from the US to South Africa. The STS framework of civic epistemology was selected to perform the comparative analysis. The approach of the paper was to: 1) define civic epistemology and the context in which it was being used for this project, 2) discuss IP law for the US and South Africa, 3) compare US and South Africa IP law through civic epistemology, 4) discuss regulatory law for the US and South Africa, 5) compare US and South Africa regulatory law through civic epistemology and, 6) use each country's law to understand what affects the transfer of HIV/AIDS diagnostic tools and treatments from the US to South Africa. In the end it was discovered, that regulatory and IP systems can impact the availability of medical products distributed and marketed within a foreign country.