17 March 2009
The US Secretary’s Advisory Committee on Genetics, Health and Society (SACGHS) has released a draft report on gene patents and their impact on patient access to genetic tests for public comment (see GenomeWeb report). The report was drafted together with Duke University’s Centre for Genome Ethics and contains findings on how gene patents affect clinical and patient access to genetic tests, as well as suggested policy options for consideration by the public. In conducting this inquiry, the Committee has narrowed its scope to “genetic tests that rely on analysis of nucleic acid molecules to determine human genotype, whether used for diagnostic, predictive or other clinical purposes” (see press release). This means that patent claims in relation to genetic tests that infer genotype based on analysis of other biomarkers (e.g. biochemical assays for proteins) were not included.
Information on the impact of gene patents on patient and clinical access to genetic tests was gathered through conducting literature reviews, expert consultations, exploring international perspectives and gathering public views. They examined eight-comment-gene case studies of ten diseases to see how gene patents influence pricing, access to and availability of genetic tests, new innovations and research related to genes, and other areas. They also considered the effects of gene patents on translational research, as patient access could also be influenced by how new tests are developed and integrated into clinical practice. The findings indicated that although there was little consistent evidence to indicate either positive or negative influence of gene patents on patient access to genetic tests, there were several issues of concern which could create barriers in the future, as the number and complexity of genetic tests increase. One of these concerns is that multiplex testing and whole genome sequencing may be hindered by patenting of genes.
As a result, the Committee has suggested a number of policy options such as developing a set of principles and guidance documents to engage stakeholders in a discussion of issues related to patenting and licensing strategies, and adoption of practices by Federal regulators that would allow increased transparency of intellectual property rights in order to allow uniform assessment and monitoring of the landscape. In addition, they also propose policy developments to allow more data on gene patenting and licensing to be gathered, and studies of the implementation of Federal intellectual property laws, as information in respect to these (especially in relation to DNA-based interventions) was found to be lacking.
SACGHS is hoping to receive input on its preliminary findings contained in the report and the policy options from the public prior to developing specific recommendations for the Secretary of Health and Human Services (HHS).