INDUSTRY NEWS
In a meeting held last June, the Secretary's Advisory Committee on Genetics, Health, and Society (SACGHS) raised issues in two sessions that could affect IVD manufacturers. In one session, the committee discussed the ongoing development of its recommendations on pharmacogenomics. In another session, the committee heard presentations on gene patenting and licensing practices in the United States, and their subsequent effect on the provision of genetic tests and services to patients, and their economic impact on IVD development.
SACGHS' recommendations on pharmacogenomics will eventually be part of its report to the Secretary of Health and Human Services on issues affecting pharmacogenomics research and its integration into clinical and public health practice. At the June meeting, the committee reviewed and refined draft recommendations discussed at the previous meeting and other recommendations developed since then. The committee agreed that the draft recommendations would focus on issues of health outcomes research, education of health providers and the public, codevelopment of drugs and pharmacogenomics products, and drug dosing informed by pharmacogenetic test results.
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Emily S. Winn-Deen, PhD
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Emily S. Winn-Deen, PhD, vice president, strategic planning and business development, at Cepheid (Sunnyvale, CA) and the SACGHS pharmacogenomics task force chair, said that the task force would further develop the recommendations based on the committee's input.
"The plan is to take the draft recommendations and background report, continue to work at the task force level, and have the report and recommendations ready to present to the committee at the next SACGHS meeting in November," said Winn-Deen. "If it gets committee approval at that meeting, it would go out for public comment. At the March 2007 meeting, the committee would consider the public comments, work on how to make modifications to the report based on those comments, and then try to have a finalized report published in mid-2007."
Two years ago, SACGHS identified the impact of gene patents and licensing practices on access to genetic tests and services as a high-priority issue. At the previous meeting, the committee reviewed a report by the National Academy of Sciences (NAS) on this issue and concluded that NAS' recommendations sufficiently addressed intellectual property concerns in the research realm. However, there was still a need to examine the impact of patents and licensing practices on clinical practice. At the June meeting, the committee heard from three experts who gave presentations on the following topics: the nature of gene patents and licensing and their effects on the ability of clinical laboratories to provide genetic tests and services to patients; the effect of patents and licensing practices on access to genetic tests and services; and the role and economic impact of gene patents in IVD development.
After the presentations, the committee agreed that further study of the effects of gene patents and patent licensing practices on clinical practice was warranted. The committee expressed particular interest in examining three areas: patient access to and use of genetic/genomic services; healthcare delivery and financing; and quality of genetic/genomic services. In investigating these areas, the committee will consider the following: single and complex gene diseases; legal and legislative issues; industry, healthcare provider, and patient perspectives; economic considerations; and the processes of granting and licensing of medically relevant patents.
"This was the meeting where the committee decided there was something that hadn't been addressed by the NAS study, and that still needed to be addressed," said Winn-Deen. "There will be more discussions on this issue planned for the November meeting. There's a patents task force that will be working on specific agenda items. It will focus on the clinical medicine issues that primarily come down to this whole issue of access. While there are all kinds of things that could come out of that, better licensing practices would be a good thing to come out of it."
Additional information about SACGHS can be accessed via its Web site at www4.od.nih.gov/oba/sacghs.htm.
