DNA patents beyond clinical genetics: HPV testing and cervical cancer screening in India, the UK and the USA. A comparative investigation of the bioethics of biomarker IP and its implications for public policy.
Research Fellowship project led by Dr Stuart Hogarth and funded by the Wellcome Trust under its Bioethics and Society programme from 2012-2015.
The commercialisation of genetic testing has been accompanied by ethical controversy about the patenting of genes and the consequent creation of diagnostic monopolies. Critics suggest that gene patenting exemplifies the corporatisation and commodification of biomedicine in which publicly-funded research is used for private gain. There are fears that such patents will stifle innovation, harm the quality of tests and limit patient access to testing. However, many in the diagnostics industry argue that such patents are vital to the commercial innovation process. The debate about whether gene patents are a spur to innovation or a block on scientific and clinical research is thus of considerable relevance to broader policy concerns about the effectiveness of the translational pathway for moving new biomarker discoveries into use as clinical diagnostics.
There has been much discussion of policy options such as compulsory licensing and patent pools but, aside from a few high-profile cases (in particular Myriad Genetics patents on the BRCA1/2 genes), there is little empirical evidence to demonstrate whether the harms of gene patents outweigh their benefits. Furthermore current evidence is largely derived from the field of clinical genetics, yet the most commonly used molecular diagnostics are in the field of infectious disease testing where there has been much (viral) DNA patenting in HIV, HCV and HPV. Advocates believe that Human Papilloma Virus (HPV) testing could greatly improve cervical cancer screening and it is seen as having great potential in developing countries which cannot afford traditional cytology-based screening. The existence of a HPV patent thicket could thus have major public health implications if it has had a negative (or positive) impact on the quality or cost of tests.
This study analysed the impact of DNA patents on the development and use of HPV tests for cervical cancer screening (where they are used either alongside, or instead of, the traditional Pap smear) in three countries, in order to 1) understand how it has been affected by the patenting (and exclusive licensing) of strains of HPV, and 2) to assess stakeholder views on these issues. It addressed the need for more empirical data to inform bioethical deliberation on gene patents by 1) extending the evidence base beyond the realm of clinical genetics and 2) examining the impact of DNA patents in low- and middle-income countries (India). The latter is a topic which is relatively neglected in the existing literature, but which interconnects with the broader debate about whether the patent regime which underpins the global bioeconomy has been designed to protect the interests of the developed world at the expense of poorer nations.
In forthcoming publications, the findings of the project will 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 offers 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.