The South African clinical trial industry: Implications of problems with the issuing of human tissue export permits

Abstract

The National Health Act requires a valid permit before human biological tissue samples are exported from South Africa. However, delays in issuing export permits make it difficult for many researchers and pharmaceutical companies to comply. There are misconceptions about who is responsible for obtaining such a permit. Delays have caused many new trials to start without a permit, and biological samples from ongoing trials have been exported using expired permits. This could have detrimental consequences for the South African trial industry, especially with the country’s history of vulnerable populations in developing areas. Medicine Control Council inspections have listed findings related to export permits for several trial sites. Researchers must be aware that it remains their responsibility to apply for such a permit. The most important steps to ensure a smoother approval process are for applicants to (i) familiarise themselves with the permit issue process and (ii) recognise the importance of correctly completing and signing application forms.