UAEM Calls on AUTM to retract opposition to Panel Recommendations to improve access and innovation in field of genetic testing

March 17, 2010                                                                                   

For Immediate Release

UAEM Calls on autm to retract opposition to Panel Recommendations to improve access and innovation in field of genetic testing

Also Issues Call Encouraging HHS to Implement Recommendations

OAKLAND – Today, Universities Allied for Essential Medicines (UAEM) publicly called on the Association of University Technology Managers (AUTM) to withdraw its opposition to recent recommendations on patenting of gene diagnostics endorsed by a federal panel. The recommendations would help to remove roadblocks to affordable genetic testing and encourage innovation for genetic diagnostics. UAEM also sent a letter of support to department of Health and Human Services (HHS) Secretary Kathleen Sebelius encouraging her to implement the recommendations of the federal panel, the Secretary’s Advisory Committee on Genetics, Health, and Society (SACGHS).

According to the panel’s report, gene patents have prevented laboratories from providing genetic tests, such as those used to detect genes associated with hereditary breast cancer and Alzheimer’s disease.  One study in the report found that more than half (68%) of patents used to prevent genetic testing were owned by universities or research institutes – institutions where research is primarily paid for by taxpayer funded grants. The report also found that patenting of genes can create difficulty for researchers, discouraging them from using the patented genes to better understand human illness.  Multiple patents on different genes may force researchers to negotiate through dense tangles of legal liability, commonly referred to as “patent thickets,” or give up on research paths altogether.

The SACGHS panel offered six recommendations which include creating liability exemptions for developers of genetic tests and scientists who do research on genes, promoting norms to ensure access, enhancing transparency in licensing deals, and improving federal oversight in the area of gene tests.

AUTM, a professional association composed of university technology transfer managers, argues that gene patenting is needed to encourage private investors to license gene patents from universities and develop them for commercial use.

The problem with this argument is that genetic tests are often ready for use straight out of the lab, meaning they do not require the patent “carrot” to attract investment. “The recommendations would only exempt academic research and diagnostic tests, areas where gene patenting has led to needless drag on innovation,” said Sarah Sorscher, Harvard University JD/MPH candidate.  “What’s worse,” said David Watkins, a final year medical student at Duke University, “is that AUTM representatives publicly denounced the recommendations side-by-side with industry leaders.  They repeatedly misquoted and misrepresented the report to imply that it was trying to make dramatic changes to the entire U.S. patent system.  Nothing could be further from the truth: the recommendations only apply to gene tests, not drugs or anything else.”

UAEM expressed concern that AUTM has sided with industry to take a position that will harm the interests of university researchers, not to mention the patients who need these genetic tests.  Though AUTM does not represent universities directly, its constituents are university administrators expected to work in support the not-for-profit mission of their institutions.

Ethan Guillen, UAEM Executive Director stated, “Universities too often find themselves on the wrong side of the debate, fighting for the interests of industry as opposed to defending the public interest.  These are non-profits, they should be working for the good of society, not industry profits.”

As the federal report found, many companies use gene patents to clear their competitors out of the market, establishing a virtual monopoly on the test they offer.  In the case of breast cancer testing, monopoly power allowed Myriad Genetics to charge a high price and keep other tests off the market, despite complaints from the medical community that it was of poor quality.[1] In cases like these, business practices are in direct conflict with patient access, quality of testing, and future scientific innovation.

It is UAEM’s hope that these reforms will preserve the system of knowledge-sharing that has allowed America to be a leader in biotechnology innovation and, more importantly, that such reforms will lead to increased innovation and better access to affordable gene diagnostics for patients.   

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Contact: David Watkins

Phone: (901) 827-8153

Email: david.watkins@duke.edu

Contact: Ethan Guillen

Phone: (775) 287-2553

Email: ethan.guillen@essentialmedicine.org

About UAEM

Universities Allied for Essential Medicines (UAEM) is a coalition of students at over 60 top research institutions across the United States, Canada, the United Kingdom, and Germany.  UAEM’s mission is to ensure that people in developing countries have access to medicines developed in universities and that university medical research addresses the needs of the majority of the world’s population.  As an organization which values innovation, we work to empower students to find new ways to improve access to health throughout the world. www.essentialmedicine.org

[1] Walsh T, Casadei S, Coats KH et al. Spectrum of BRCA1, BRCA2, CHEK2, and TP53 in families at high risk of breast cancer.  Journal of the American Medical Association.  2006:295:1379-88.