This study would use literature reviews and expert interviews to create a detailed account of the development and clinical adoption of HPV testing in three countries, in order to understand how it has been affected by the patenting (and exclusive licensing) of strains of HPV, and to assess stakeholder views on these issues. It would address the need for more empirical data to inform bioethical deliberation on gene patents by extending the evidence base beyond the realm of clinical genetics. It w ould provide a fuller context for the evaluation of the harms and benefits of DNA patents by weighing the importance of such IP against other factors (such as healthcare systems, regulatory regimes and industry structure) which affect the innovation process in molecular diagnostics and the adoption, quality and availability of new tests; and by assessing whether the interplay of these factors varies across countries. This broader evidence base and analytic framework will form a platform from which to reassess the bioethical implications of DNA patents and to revisit the existing policy consensus which favours non-exclusive licensing to consider whether a more nuanced approach is required which reflects the heterogeneities of national, clinical and commercial contexts across the diagnostics sector.