Market entry barriers for HIV self-testing in South Africa .

Majam, Mohammed
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South Africa faces the greatest burden of the HIV epidemic worldwide. Even though significant progress has been made in South Africa to improve HIV testing rates, there still remains a significant testing gap. HIV Self-Testing using Rapid Diagnostic Technology is a novel, innovative approach that can potentially be disruptive to the industry and can aid in closing this testing gap in order for South Africa to realise the targets set by UNAIDS. Currently, no legislation, regulation or statutes exist that govern the sale and use of HIV Self-Tests in South Africa. HIV Self-Tests are currently being sold in several countries worldwide, however, there are currently no major device manufacturers that are willing to transact in South Africa. This study examines the structural and strategic barriers to market entry that these device manufacturers believe exist, whilst also interrogating the role and extent to which statutory barriers inhibit market entry. Using qualitative research techniques, the study identifies the main barriers that constrain market entry. The study uses data collected through semi-structured interviews with representatives of 15 participants in the sector, including device manufacturers, Global and National HIV Policy makers, Key Opinion Leaders and technical experts. The participants were identified using purposive sampling, and the data was analysed using thematic content analysis. The study found that the greatest barrier to market entry is the uncertainty regarding the regulatory pathway that a device has to go through before it enters the market. Absence of clear policies from the South African Department of Health and normative guidance from the World Health Organisation has made it an investment risk to enter the South African market. Several structural and strategic market entry barriers were identified which included, but were not confined to, financial risk, capital and resource requirements, lack of access to distribution channels and an undefined market. Key opinion leaders believe that HIV Self-Testing has the potential to change the market, however, needs to be done correctly, taking into consideration several socio and economic considerations. The study concludes that, on balance, conditions for entering the South African market are cogent on the development of a clear regulatory pathway and explicit acceptance of the concept by government. This requires a considerable amount of evidence based research in both the South African and International context in order for the modality to gain explicit approval. Recommendations are made for a pathway towards a South African National policy on HIV Self-Testing. The pace at which it then grows and proves to be beneficial, and the ultimate impact that it achieves, will depend on the extent to which the identified barriers can be overcome, and the factors that favour its use are effectively exploited.
AIDS (Disease) -- Economic aspects,Patients -- Care ,HIV infections -- South Africa