Boston University School of Law

January 15, 2010

antibiotics

BU Law-UMass team awarded $150K for antibiotics regulation study

Access to effective antibiotics is critical to public health, but antibiotic resistance threatens to undermine many of the health gains from the past 60 years. Life in a post-antibiotic era would be rife with infectious diseases and many modern surgical procedures would be impossible. With that risk in mind, The Robert Wood Johnson Foundation (RWJF) awarded a grant to a multidisciplinary team led by Kevin Outterson, associate professor of law at Boston University School of Law, and Rosa Rodriguez-Monguio, associate professor at the School of Public Health & Health Sciences, University of Massachusetts Amherst.

Their project received an 18-month $150,000 RWJF grant to study the public health implications of antibiotic drug regulation, including a major empirical study on the relationship between changes in the legal environment and the introduction and conservation of antibiotics.

According to the researchers, who have experience in the legal, scientific and public health fields, patent law supports the introduction of new antibiotics, but the legal environment gives many mixed signals regarding antibiotic conservation and the appropriate use of existing antibiotics. Theoretical literature suggests that patent holders lack appropriate incentives to carefully protect antibiotics from resistance since their property right is time-limited. This study will empirically test this “patent holder waste” theory, as well as several others.

The grant is part of the RWJF’s Public Health Law Research Program (PHLR), which is based at Temple University’s Center for Health, Law, Policy and Practice. “The grant process was very competitive,” said Professor Outterson. “Only about 5 percent of the 240 applicants received funding.” The grants aim to help policymakers and researchers understand how laws can affect public health.

Professor Outterson, who is co-director of this project, has testified on intellectual property protection and pharmaceutical markets before legislative and regulatory bodies in several states, as well as the U.S. Senate Committee on Health, Education, Labor & Pensions. Professor Outterson’s previous work on antibiotic resistance can be found in such law reviews as Cardozo Law Review and University of Pittsburgh Law Review, and medical journals such as Lancet Infectious Diseases. His papers are available at www.ssrn.com. At BU Law, Professor Outterson co-directs the Health Law Program, where his primary research inquiry is the legal analysis of pharmaceutical markets, including intellectual property and reimbursement systems. He is considered one of the leading researchers in the intersection of antimicrobial resistance and intellectual property law.

Professor Rosa Rodriguez-Monguio is an assistant professor of public health, and associated researcher at the Institute for Global Health, at UMass Amherst. She is a health economist with extensive experience and expertise in analyzing intellectual property policies and the effects of these policies on access to pharmaceuticals.

Their team includes public health and pharmaceutical researchers from BU, Ohio State, Minnesota and Harvard, as well as infectious disease experts from BU, Harvard, and the National Institutes of Health.

Team members include:
• Enrique Seoane, Ph.D. of the College of Pharmacy and College of Public Health at Ohio State University (project co-director)
• Aaron S. Kesselheim, MD, JD, MPH, a physician and researcher at the Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital, Harvard Medical School;
• Marc Lipsitch, associate professor of epidemiology at Harvard School of Public Health;
• John Powers, senior medical scientist and infectious diseases attending at National Institutes of Health;
• John C. Rotschafer, professor at College of Pharmacy at University of Minnesota; and
• Susan Foster, professor of international health at BU School of Public Health, and director of public policy & education at the Alliance for the Prudent Use of Antibiotics.

Boston University School of Law, a top-tier law school ranked among the best in the nation for teaching quality, has been preparing leaders for 137 years. Since its founding in 1872, the School has welcomed qualified men and women from across the United States and abroad, without regard to background or belief. The BU Health Law program is consistently ranked in the top 10 by US News & World Report, which most recently ranked the program #4 in the country.

The University of Massachusetts Amherst School of Public Health and Health Sciences addresses complex health issues by integrating traditional core areas of public health with related health science disciplines. The School fosters a unique environment in which transdisciplinary research collaborations can flourish. It features award-winning faculty, numerous opportunities for community-based student internships, and outreach programs and partnerships that promote health and the quality of life in diverse populations.

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