50of health years law
50 years of health law This year, Boston University School of Law celebrates the 50th anniversary of our interdisciplinary collaboration in health law. From its beginnings as the Law-Medicine Research Institute in 1958, one of the first medical-legal institutional collaborations in the United States, the BU Health Law Program has grown in stature and complexity, mirroring the development of health care itself. Health law has evolved well beyond its original roots in forensic medicine and the doctor-patient relationship. Today, health law scholars cover very disparate domains including: embryonic stem cell research, food and drug law, genetic testing, antitrust, insurance, emergency preparedness, environmental health, product safety, privacy, torts and intellectual property. Health law is a dynamic field, with high demand for graduates who understand the nuances of the complex interface between health care and law. Boston University offers an integrated array of academic and practical resources in health law and policy. Law students can take advantage of courses and internships at the School of Public Health, School of Management and at BU’s own Boston Medical Center. Clinical externships also exist at Boston’s health care institutions to test cutting-edge legal theory in the real world of patient care and biomedical research. BU Law students may choose our health law concentration or enroll in dual-degree programs: Law and Health Care Management (JD-MBA), with the BU School of Management, and Law and Public Health (JDMPH), with the BU School of Public Health, both of which offer a wide range of cross-disciplinary courses.
Health Law: A Rich History Fifty years ago, Boston University School of Law recognized the importance of the emerging field of health law and built the foundation for a growing and responsive Health Law Program. Today, it is an innovative collaboration among lawyers, physicians, academics and public health leaders.
The Law-Medicine Research Institute Boston University established the Law-Medicine Research Institute in 1958, when it first recognized the widening scope of what was then called the medico-legal field. The director was William J. Curran, Professor of Legal Medicine, who published numerous journal articles about the need for cooperation between doctors and lawyers and the “increasing role of law in the regulation of medical practice, public health and medical care programs.” Trained in law and in public health, Professor Curran held dual appointments from the BU Schools of Law and Medicine. In 1960 he compiled the first comprehensive health law casebook, Law and Medicine: Text and Source Materials on Medico-Legal Problems.
William J. Curran, first director of the Institute, pictured above left.
The Law-Medicine Institute’s three major functions were:
Boston on Beacon Hill, near the State House.
• interdisciplinary training for students from BU Law and medical schools
At BU Law, the first course in health law began as a seminar, Medico-Legal Trial Practice, taught by professors from the Institute. Other courses introduced interdisciplinary teaching: Domestic Relations, taught by a lawyer and psychiatrist; and Law and Behavioral Science, taught by two lawyers, a psychiatrist and a psychologist. Institute professors also lectured at the Medical School.
• research on the current status of medico-legal education in U.S. law and medical schools, and • service with government and private agencies drafting medical and health legislation. Funded by the Schools of Law and Medicine, the Institute also held a grant from the National Institutes of Health to develop medico-legal courses and seminars in BU’s professional schools, one of the many federal and state grants received throughout its history. At this time, the institute was housed in downtown
One of the Institute’s first research projects, supported by the National Institutes of Health, involved the legal, ethical and moral problems with medical experimentation on human subjects and patients. The principal investigator on the project, Irving Ladimer, a BU professor from 1958–66, co-edited the country’s first major collection of documents assembled on
3 50 years of health law
The beginnings of the Boston University Law-Medicine Research Institute (William J. Curran pictured on right)
“When I attend the American Health Lawyers Association meeting, I’m always amazed at the remarkable number of senior lawyers who graduated from the BU Health Law program. It’s a real testament to Professor Miller who thought about the field in ways that people hadn’t and helped to shape the industry.” Linda V. Tiano ‘81 Senior Vice President, General Counsel, Health Net, Inc. Woodland Hills, California BS in Psychology, University of Cincinnati
human experimentation and the law, Clinical Investigations in Medicine: Legal, Ethical, and Moral Aspects in 1963. In 1962, Boston psychiatrist Leo Alexander, a consultant to the U.S. Secretary of War during the 1947 international trial of Nazi doctors, donated his papers to the Law-Medicine Research Institute for inclusion in a new medico-legal library. An Allied war crimes investigator, Alexander helped to convict 16 of the 23 defendants, most of whom were doctors, for the murderous medical experiments. He also assisted the court in formulating the Nuremberg Code, which became part of its judgment on the legal principles governing permissible experiments on humans, as well as the basis of all subsequent codes of medical ethics in the United States and abroad. His papers are currently housed at BU Law’s Mugar Library. Other Institute projects included drafting the Massachusetts Sanitary and Public Health Code; drawing up legislation that reorganized the Massachusetts tuberculosis hospital system and led to consolidating 18 institutions into five regional hospitals; and drafting a statute for the first state drug-addiction rehabilitation program. Members of a legal psychiatry clinical program worked with Bridgewater State Hospital for the Criminally Insane and established the first professional training program in the institution’s history.
In 1970, the Institute was renamed the Center for Law and Health Sciences to convey the expanding range of subjects in the field. Judge David Bazelon chaired the Center’s new board of directors, and Professor Baram and Law School Associate Dean John P. Wilson co-directed the Center’s pilot projects.
Frances Miller Reshapes the Study of Health Law at BU Professor Frances Miller, also a member of the Center’s Faculty Committee, began teaching a course on health care organization, finance and delivery in 1971, moving the curriculum away from a primary focus on forensics. Medicaid and Medicare, enacted in 1965 to provide health insurance for the poor and elderly, respectively, were already straining federal and state budgets with increasing demand for governmentsubsidized benefits, ranging from hospitalization to nursing home care. By the late 1960s, the vast majority of Americans were covered by public or private health insurance, which was a new phenomenon. All of these programs not only stimulated difficult contractual issues but also new health care legislation and regulation to contain costs. These in turn raised new administrative and adjudicative questions for lawyers. “I knew back then health law was a much broader subject than doctors in the courtroom”, said Professor Miller. “So I broke with
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“BU has the edge because we’ve been teaching legislative drafting for 30 years. We’re way ahead of the curve.” —Professor Robert Seidman Students in the Legislative Policy and Drafting Clinic work on both local and global health-related legislation under the direction of Law Professor Robert B. Seidman, who co-teaches the clinic with Professor Ann Seidman. One project drafted legislation to improve the importation and effective distribution of essential medicines throughout the East African Community, comprised of five member states: Uganda, Kenya, Tanzania, Rwanda and Burundi. At the local level, another bill would require improved access to second opinions on breast cancer diagnoses for Massachusetts residents. In the Legislative Drafting Clinic, health law students learn the guiding legislative theory, methodology and techniques they need to draft proposed laws for real-life clients. Their clients include state legislators, state government agencies, representatives of nongovernmental advocacy organizations and, through the International Consortium for Law and Development (ICLAD), lawmakers in approximately 30 developing and transitional countries. Each student drafts a bill, accompanied by a substantial research report that provides the facts, logically organized, to demonstrate that the bill’s detailed provisions will likely prove effective in helping to resolve the targeted social problem. In addition, Professor Kevin Outterson and his students work with a network of state legislatures on consumer issues relating to drug safety and marketing. Using skills learned in BU’s Legislative Drafting Clinic, ICLAD interns have begun to work in the five East African countries to assist their lawmakers in drafting a legislative program to establish a Health Research Commission and to introduce bills to improve health care for all East Africans. “Engaging students in drafting real-world legislation equips them to think about law as society’s instrument to transform inherited institutions and foster development in the health care field,” Professor Robert Seidman explained. “Very few law schools concentrate on the lawmaking process. BU has the edge because we’ve been teaching legislative drafting for 30 years. We’re way ahead of the curve.”
the past, developed my own course materials and taught students how the law interacted with the economics of health care delivery. The rest of the world caught up with the concept later.” This was the beginning of a seismic shift away from the way health law had been taught in the past. Congress and the states were beginning to focus on health care cost containment, initiating increasing legal complexity, but achieving only modest financial success. Professor Miller taught about health law antitrust, reimbursement for Medicare and Medicaid providers, food and drug law, rate structures and health care resource allocation. She also served as a commissioner on the Massachusetts Rate Setting Commission, which set Medicaid and Worker’s Compensation rates of reimbursement, and approved Blue Cross Blue Shield reimbursement, thus making her a leading go-to scholar in the field.
George Annas Leads the Center for Law and Health Sciences In 1973, Professor George Annas started his career at BU as the new director of the Center for Law and Health Sciences. Professors Miller and Baram were among the Center’s Faculty Committee and Leonard Glantz, Barbara Katz and Harry Beyer joined as staff attorneys. Under Professor Annas’ leadership, the teaching, research and public-service organization was dedicated to defining health law and its role in public policy decisions, and developing effective teaching modalities in health law at the graduate level. Multidisciplinary courses were offered in patient rights, human experimentation, mental health law, health care regulation and genetics and the law.
From 1973–1977, the Center staff published four books, Psychosurgery; The Rights of Hospital Patients; Genetics and the Law; and Informed Consent to Human Experimentation: The Subject’s Dilemma, as well as numerous articles in law and legal-medicine journals. Professors Annas, Glantz and Katz’s research on informed consent became the basis for their recommendations to the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Commission recommended federal regulations for research with human subjects, culminating in the Federal Policy for the Protection of Human Subjects, informally known as the Common Rule. As part of its dedication to civic engagement, the Center sponsored public symposia on such topics as recombinant DNA research, psychosurgery, model malpractice trials, fetal research and mental health law. Center staff also served on the Health Facilities Appeals Board, which hears appeals from Certificate of Need decisions for the Commonwealth of Massachusetts (with Professor Miller chairing the board for the better part of two decades.) In addition, Professor Annas chaired the state’s Board of Registration and Discipline in Medicine. The Center’s survey research on Boston’s largest
hospitals resulted in front-page Boston Globe coverage, which prompted the hospitals to change their policy and allow patients access to their medical records. Beginning in 1976, Professors Annas and Glantz taught six courses through the M.P.H. program, including Public Health Law and Health Care Regulation. They also offered Regulating Science Through Law jointly with the law school. Another seminar, Law and Medicine: The Rights of Patients and Their Providers, became a required course for the first-year medical school class and remains part of BU’s required medical school curriculum today.
The American Journal of Law and Medicine The American Journal of Law and Medicine (AJLM), a collaboration between the law school and the American Society of Law, Medicine and Ethics (ASLME), was first published in 1975. BU has a long association with ASLME, founded by Professor Annas and Elliot Sagall, MD, of Harvard Medical School. Dr. Sagall served as a member of the Faculty Committee at BU’s Center for Law and Health Sciences. Professor Annas also created the journal, Medicolegal
“Being editor-in-chief of the American Journal of Law and Medicine gave me a fantastic opportunity to hone my writing skills and to learn about the practice and issues people face as members of the health care bar.” David T. Morris ‘95 Associate General Counsel, Provider Relationships Group, Blue Shield of California, San Francisco, California BA in Rhetoric/Political Science, UC Berkeley
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“ The faculty at BU Law School is excellent. The training was both practical and policy based. My job is incredibly challenging and diverse. In the course of a week, I can be negotiating with the Chinese government; talking with the press, consumer groups, and FDA scientists; and testifying before Congress. Deborah Autor ’92 Director, Office of Compliance, Center for Drug Evaluation and Research U.S. Food and Drug Administration, Bethesda, Maryland BA in Psychology, Barnard College
News, now named the Journal of Law, Medicine and Ethics. By the late 1970s, the University had given ASLME a home at the law school and shortly thereafter BU Law students began editing AJLM as a student-run law review. The law school and ASLME co-sponsor annual working conferences for AJLM’s symposium issue. Past topics have included “Genetic Disability: DNA Profiling of Embryos and Fetuses;” “Globalization of Pharmaceuticals: International Regulatory Issues;” “Brain Imaging and the Law;” and in 2008, “Tackling Global Health Issues through Law and Policy.” The topic for the 2009 AJLM symposium is “Access to HPV Vaccines: Women’s Rights and Global Health.”
George Annas organizes the first Health Law Professors Conference In 1978, Professor Annas organized the country’s first workshop on teaching health law in medical schools, law schools and schools of public health at BU Law. It was “designed to categorize the differences, similarities and parameters among health law courses; to exchange ideas on curricula content; and to disseminate information on teaching materials.” The program’s topics included: “Is Health Law a Discipline?”; “Bioethics; Content of a Health Law Course”; and “Materials in Teaching Health Law”. A second workshop was again held at Boston University in 1980, and subsequent meetings of what is now known as the annual Health Law
Professors Conference have rotated among law schools around the country, co-sponsored by ASLME.
The Rise of Bioethics and Human Rights By the late 1970s and early 1980s technological advances in biology, chemistry, medical devices and pharmaceuticals had dramatically changed the face—and the cost—of health care. Procedures that had been unthinkable a few years earlier became commonplace, including in vitro fertilization, surrogate motherhood and increasingly complex organ transplantation. Issues swirled around patient-provider relationships, informed consent to treatment, access to health records, biomedical and behavioral research involving human subjects, refusal of treatment, the rights of hospital patients, wrongful birth and life and euthanasia. Stephen M. Weiner became the Center’s new director in 1978, when Professors Annas and Glantz joined the faculty of the new BU School of Public Health to create its Health Law Section (now the Department of Health Law, Bioethics and Human Rights). This move strengthened the ties between the BU Schools of Law and Public Health. A prolific advocate for bioethics and patient rights, Professor Annas addressed cutting-edge issues in his writings, which include 17 books, regular articles in the Hastings Center Report (“At Law,” 1976–1991), the American Journal of Public Health (“Public Health and Law,” 1983–1992), the New England
Journal of Medicine (“Health Law, Ethics & Human Rights,” 1991–present) and in various law journals. In 1995, Professors Annas, Glantz and Patricia A. Roche drafted the Genetic Privacy Act and Commentary, which is the final report for the Guidelines for Protecting Privacy of Information in Genetic Data Banks project, funded by the Ethical, Legal and Social Implications (ELSI) on Human Genome Research project. The report was unanimously endorsed by the ELSI Working Group and has served as the basis for several state laws, most notably in Oregon and New Jersey. In addition, together with Professor Mariner, they have submitted amicus curiae briefs to the U.S. Supreme Court in cases on abortion and physicianassisted suicide.
Global Lawyers and Physicians Professor Annas and Dr. Michael Grodin founded Global Lawyers and Physicians (GLP), an NGO, in 1996 “to reinvigorate the collaboration of the legal and medical/public health professions to promote and protect the human rights and dignity of all persons.” Today, one of GLP’s initiatives, the Boston Center for Refugee Health and Human Rights at Boston Medical Center, provides services for refugees and asylum seekers from more than 60 countries and gives law students hands-on experience in helping clients. Here, BU students can gain experience in international health work without leaving the country. Other projects have concentrated on children held at Guantanamo, military medical ethics and international research rules. According to Professor Annas, most of the scholarly and activist health law work at BU is grounded in two great codes: the Universal Declaration of Human Rights and the human genome. “Both address universals—humanity’s shared values and humanity’s shared genetic structure,” he said. “The challenge, of course, is to use these great codes to promote equality, justice and human rights.”
“ After working on asylum and human rights cases in the Civil Litigation Clinic, students can go out and practice in the immigration area of the law.” —Clinical Professor Susan Akram
In 1993, Professor Akram joined the BU Civil Litigation Program faculty and brought her particular expertise in asylum and human rights law to the School’s clinical offerings. “In any legal case pertaining to asylum, getting medical treatment and medical evaluations for our clients is the key to success,” said Professor Akram, who specializes in immigration and in human rights law, and is a co-founder of the Boston Center for Refugee Health and Human Rights with five Boston Medical Center physicians. The center is a major U.S. resource for survivors of torture, traumatized refugees, and those seeking asylum. In the clinic, students learn pretrial and courtroom skills and collaborate with medical caregivers to represent torture survivors in their asylum and refugee-related cases. The attorney-physician collaboration is essential in both the legal representation and the provision of medical treatment for trauma, post-traumatic stress disorder, depression, and the physical effects of torture and persecution. Students also learn to advocate for human rights in the international arena by working on “shadow reports,” submitted to the UN bodies that monitor states’ compliance with international human rights treaties. They have also advocated on behalf of Guantanamo detainees who have been found eligible for release but have valid refugee claims and worked on amicus briefs on national or international asylum and refugee issues. “Students interested in immigration law can’t learn only through theory,” Professor Akram said. “After working on asylum and human rights cases, students can go out and practice in the immigration area of the law.”
9 50 years of health law
The N. Neal Pike Institute for Law and Disability
“BU has unparalleled expertise in all aspects of health care.”
— Professor Ashley J. Stevens, BU School of Management
Two BU professors are championing the cause for less expensive drugs for low-income people around the globe: Law Professor Kevin Outterson has proposed a market-based Generic Open (GO) License and School of Management Professor Ashley J. Stevens has zeroed in on universities, the initial source for most drug research. “Universities are very prolific in the discovery of drugs, biologics and vaccines,” said Professor Stevens, who also serves as Executive Director of the Office of Technology Development. “They have to amend their licensing practices and take into account the needs of the developing world.” “We need to make powerful new drugs available around the world on an equitable basis, without harming R&D incentives,” said Professor Outterson. “Universities have a significant role to play, as the source of many pharmaceutical innovations.” In a forthcoming paper, Professor Stevens and his co-author, April E. Effort, cite a Boston University study that identified 131 vaccines, small molecule drugs, biologic drugs and in vivo diagnostics that were discovered in whole or in part at academic institutions since 1980, all of which were patented and licensed. They commend Universities Allied for Essential Medicines (UAEM), a student-led organization dedicated to ensuring that health-related university innovations are made available in the developing world at low costs. Professor Stevens teaches “From Bench to Bedside” at the BU School of Management, a course co-listed at BU Law. The course focuses on translating biomedical innovation from the laboratory to the marketplace. “Between the Health Law Program at the law school, the Health Sector MBA in the School of Management, and the Health Law, Bioethics and Human Rights Program at the School of Public Health, BU has unparalleled expertise in all aspects of health care,” Stevens said. “Most importantly, we work together. Students learn more with the cross-disciplinary approach.”
By 1986, Henry Beyer became the director of the Center for Law and Health Sciences. The Center focused principally on two areas: rights of individuals with mental and physical disabilities and the relationship between law and maltreatment. The N. Neal Pike Institute for the Handicapped, later the Institute for Law and Disability, was established within the Center in 1983 with a generous endowment from the Pike family. Director Beyer’s long-term commitment to education and advancing the rights of individuals with disabilities has been internationally recognized and applauded. He helped to organize and train human rights committees for people with mental illnesses and disabilities in 1984. Until his retirement in 1997, he directed research and advocacy projects for the President’s Committee on Mental Retardation, the National Institute of Mental Health, the Administration on Development Disabilities, the U.S. Department of Education and many New England state agencies.
At the Forefront of Health Law In the 21st century, the Health Law Program remains at the forefront of the ever-widening field of health law, continuing the interdisciplinary collaboration that began with the LawMedicine Research Institute 50 years ago. Professor Annas, Dr. Grodin and co-authors introduced global human rights issues in health law with Health and Human Rights (1999), which was dedicated to Jonathan Mann and his work in health and human rights. In the field of public health, Professors Mariner and Annas, together with Ken Wing and Dan Strouse, co-authored the first casebook, Public Health Law (2007). The faculty in the Schools of Law and Public Health collaborate and sponsor seminars and conferences, such as the annual American Journal of Law and Medicine and Pike Health Law Conferences. In recent years, public conferences have addressed the broader topics of health and human rights. One conference focused on the impact
Health Law at Boston University: Upcoming Lectures and Symposiums of interrogation and confinement on the mental health of Guantanamo prisoners, particularly children. Another timely health law conference was the symposium, “Beyond Cloning: Protecting Humanity from Species-Altering Procedures.”
From Forensic Medicine to Global Human Rights Human Rights and Health September 24, 2008 Health Law: Past and Future
In 2006, the Pike Health Law conference considered the legal, medical, ethical and political lessons of Terri Schiavo’s tragic situation. U.S. Rep. Barney Frank provided the keynote address and other speakers included the trial court judge, George Greer, who was awarded the law school’s Pike Prize, and Dr. Ronald Cranford, the prinicipal expert witness in the case.
September 25, 2008 Election 2008: A Health Reform Agenda September 26, 2008 Voices of Experience September 27, 2008
In 2007, the annual Pike Conference revisited the event that marked the beginning of the health law, bioethics and human rights movement. “The Nuremberg Doctors’ Trial: 60 Years Later” examined the role of military physicians in World War II and the relevance of the Nuremberg Code to the war on terror today. In 2008, fittingly, the topic was “The Future of Health Law,” and former BU Professor Irving Ladimer joined the list of illustrious recipients of the Pike Award.
AJLM Symposium: HPV Vaccines Human Rights and Global Health February 7, 2009 Pike Conference March 20, 2009
This year, Boston University will celebrate a half-century of health law. Held on September 24-27, 2008, the 50th Anniversary Celebration, “From Forensic Medicine to Global Human Rights,” will span four days of symposia at the Schools of Law, Public Health and Medicine.
“The Health Law Program at BU Law taught me how to sift through complex fact patterns to identify and analyze the underlying legal issues. As a general counsel, I use that skill to help Harvard Pilgrim manage its legal and business risks.” Laura S. Peabody ’83 Senior Vice President, General Counsel, Harvard Pilgrim Health Care, Inc., Wellesley, Massachusetts BS in Genetics, State University of New York at Binghamton
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Prof. George J. Annas with Judge George Greer and Ronald Cranford
A Tradition of Faculty Collaboration
BU School of Public Health
Frances Miller, J.D. ’65, the law school’s N. Neal Pike Scholar, is an expert in American health care law and policy and a specialist on comparative health systems. Wendy
Mariner is a member of the Massachusetts Health Care Quality and Cost Council Advisory Committee, which helps
Collegial collaboration is a hallmark—and a tradition—at
implement the state’s landmark 2006 health care reform
BU Law, which has one of the best law faculties in the nation.
legislation, and has served on committees for the World
The Leiter Law School Rankings and the Princeton Review have
Health Organization and National Institutes of Health.
rated BU Law # 1 for Teaching quality. Our health law faculty
Michael S. Baram, an advisor to Congress, the United
are scholars who love to teach, and their expertise is sought
Nations and the European community, is a specialist in
by government agencies, industry and nongovernmental
biotechnology law and ethics and in environmental law. A
organizations as well as by the legal profession.
gifted teacher, Leonard
H. Glantz concentrates in public
health interventions, including privacy, the rights of children The law school’s six health law professors are internationally
and mental health law. Kevin
recognized authorities in their fields and productive scholars,
his innovative work regarding global pharmaceutical markets
often co-writing articles and books with each other. Professor
and health disparities before the U.S. Senate Committee on
Annas, often called the “father of patient rights” after writing
Health Education, Labor and Pensions, as well as many state
the first book on the subject, The Rights of Hospital Patients
legislative and regulatory bodies.
(1975), is renowned for his scholarship and advocacy in the field of health law, bioethics and human rights.
BU School of Law
Outterson has testified about
George J. Annas Professor of Law, Boston University School of Law; Edward R. Utley Professor and Chair, Department of Health, Bioethics and Human Rights, Boston University School of Public Health; Professor of Socio-Medical Sciences and Community Medicine, Boston University School of Medicine Professor Annas is internationally renowned for his scholarship and advocacy in the fields of health law, bioethics and human rights. He is a member of the Institute of Medicine, a fellow of the American Association for the Advancement of Science (AAAS) and a member of the National Academies’ Human Rights Committee. He is the author or editor of 16 books on health law and bioethics including: The Rights of Patients (3rd ed., 2004), American Bioethics: Crossing Human Rights and Health Law Boundaries (2005), and Public Health Law (2007). He also writes a regular feature on “Health Law, Ethics, and Human Rights” for the New England Journal of Medicine, the world’s most respected medical journal. His current teaching focuses on health care regulation and bioethics. As co-founder of Global Lawyers and Physicians, a nongovernmental organization of lawyers and physicians working collaboratively to promote human rights and health, Professor Annas is at the forefront of the human rights and health movement.
13 50 years of health law
Michael S. Baram Professor of Law, Boston University School of Law; Professor of Health Law, Boston University School of Public Health; Professor, Boston University Bioinformatics Department Professor Baram has advised national, state, international and private sector organizations including the United States Congress, the Environmental Protection Agency, the United Nations, the World Health Organization, the Commonwealth of Massachusetts, the Conservation Law Foundation and several industrial associations. He has served on committees of the National Academy of Sciences, the Department of Energy, the American Bar Association and other organizations. His seven books discuss alternatives to regulation, safety management, risk communication and right-to-know law. In more than 110 published papers, he has dealt with issues related to social control of science and technology, and the regulation and management of technological risks to health, safety and the environment. His recently published papers deal with gene therapy, biotech foods and agriculture, products liability, corporate safety culture, and the governance of workplace safety.
LEONARD H. GLANTZ Professor of Law, Boston University School of Law; Associate Dean and Professor of Health Law, Boston University School of Public Health; Professor of Socio-Medical Sciences and Community Medicine, Boston University School of Medicine Professor Glantz is the author of numerous articles on a wide array of health law issues. He has served on several national task forces, including the Task Force on Public Health Ethics of the Association of Schools of Public Health, and has been a member of the Institutional Review Board of Boston University School of Medicine for more than 20 years. Professor Glantz’s current research and teaching focuses on the regulation of human subjects of research, constitutional aspects of public health interventions, tobacco control policies, reproductive rights, the rights of children, the rights of people with mental illnesses and the rights of people with disabilities. He and Professors Annas and Mariner have submitted amicus briefs on behalf of bioethics professors in several U.S. Supreme Court cases.
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WENDY K. MARINER Professor of Law, Boston University School of Law; Professor of Health Law, Bioethics and Human Rights, Boston University School of Public Health; Professor of Socio-Medical Sciences and Community Medicine, Boston University School of Medicine; Chair, Boston University Faculty Council Professor Mariner is an internationally recognized authority in health law, teaching and publishing in the specialties of health insurance, ERISA, patient rights, public health and biomedical research. She is a member of the Massachusetts Health Care Quality and Cost Council Advisory Committee, which helps implement the state’s 2006 health reform legislation. She has served on numerous national and international committees, including the WHO/ CIOMS Committee on International Ethical Guidelines for Research Involving Human Subjects, the National Institutes of Health’s AIDS Program Advisory Committee, and several Institute of Medicine Study Committees. As legal director of the Boston University School of Public Health Project on Reform Legislation in the Russian Federation, Professor Mariner traveled to Russia to provide technical assistance in developing health care legislation. Professor Mariner is also faculty coordinator for the J.D./M.P.H. dual degree program at the School of Public Health.
FRANCES H. MILLER Professor of Law, N. Neal Pike Scholar, Health Law Faculty Advisor, Boston University School of Law; Professor of Public Health, Boston University School of Public Health; Professor of Health Care Management, Boston University School of Management Frances H. Miller, a BU Law graduate, is a national authority on health law. Appointed a Fulbright Scholar for the UK in 1991 and again in 1998, and a Kellogg Foundation Fellow from 1983-1986, Professor Miller has written widely for law review publications and medical journals on health care policy, antitrust in the health sector and food and drug law. Her current research interest focuses on pharmaceutical regulation in the global context. She is also a specialist on comparative health systems and publishes extensively comparing competition initiatives in the British National Health Service with competition in the U.S. health care sector. Professor Miller is currently a member of the Institutional Review Board of Partners Healthcare, the parent corporation for Massachusetts General, Dana Farber and Brigham & Women’s Hospitals. Professor Miller also serves on the boards of the Joslin Diabetes Center, Adolescent Consultant Services, Inc., and is a trustee of Mount Holyoke College.
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KEVIN OUTTERSON Associate Professor of Law, Boston University School of Law Kevin Outterson’s research work focuses on two primary areas: global pharmaceutical markets and health disparities. Before joining BU Law in 2007, Professor Outterson taught at West Virginia University where he received the WVU College of Law Outstanding Research award for his article “Pharmaceutical Arbitrage” in the Yale Journal of Health Policy, Law & Ethics. In 2007, he received the Professor of the Year award at the College of Law at WVU. Prior to teaching at WVU, he was an income partner in the Tax and International groups at McDermott Will & Emery and a capital partner in the Health Law group at Baker Donelson. In 2004, he was appointed by Governor Wise to the West Virginia Pharmaceutical Cost Management Council, where he worked to reduce the cost of prescription drugs. He serves on the board of Prescription Policy Choices and consults with governments and NGOs concerning pharmaceutical pricing and access to medicines. He is a graduate of the University of Cambridge (LL.M.) and Northwestern University (B.S. & J.D.). Professor Outterson teaches courses in health care, business law and globalization. For several years, Professor Outterson has led annual foreign study trips to Brazil in which participating students have the opportunity to study international and comparative law.
The Health Law Program at BU Law Today BU’s Health Law Program is consistently ranked among the top ten in the nation by U.S. News & World Report, ranking #7 in the most recent edition. Its health law curriculum is unparalleled in breadth and depth. BU’s health law journal, the American Journal of Law and Medicine is the #1 cited health law journal in the United States as ranked by impact factor. According to a study by John Doyle, law librarian at Washington & Lee University, it is cited more often than the principal law review of many other schools. The journal has been published at BU Law in conjunction with the American Society of Law, Medicine and Ethics for more than 20 years. It publishes professional articles, student notes, case comments, summaries of recent legislative and judicial developments and book reviews on the subject of health law and policy. The journal has an international circulation and specializes in both traditional health law issues and less conventional subjects such as dietary supplement regulation, brain imaging and the globalization of pharmaceuticals.
The J.D. concentration in health law is comprised of seven health law classes plus a major research paper on a related topic. A wide range of cross-disciplinary courses are available through the Schools of Law, Public Health and Management, which are taught by some of the professions’s leading scholars. Health law concentration courses can also count toward an accelerated dual degree program.
Dual Degrees J.D./M.B.A. in Law and Health Care Management The J.D./M.B.A. dual degree program in Law and Health Care Management, offered jointly by the Schools of Law and Management, provides a comprehensive understanding of the interaction between legal and management principles in the field of health service delivery. The program is limited to a select group each year, with students earning both the J.D. and M.B.A. degrees in an accelerated program of four years rather than the usual five.
J.D./M.P.H. in Law and Public Health The J.D./M.P.H. dual degree program in Law and Public Health is an accelerated four-year course of study leading to the award of both the J.D. and M.P.H. degrees. Offered by the Schools of Law and Public Health, the program trains students for leadership roles in both the public and private sectors. Public health courses in epidemiology, biostatistics, environmental health, social sciences, health policy and management are combined with the health law courses to provide a systematic understanding of the health field.
“BU Law was a wonderful yet challenging experience. My professors were talented and highly regarded in their fields. Most importantly, in teaching us how to think as lawyers, they were genuinely interested in what we as students had to say.” Stephanie Switzer ’94 Associate Counsel, Health Care and Tax Cleveland Clinic Foundation, Cleveland, Ohio BS in Chemistry, Oberlin College
19 50 years of health law
Real-World Health Law Experience in Boston Boston University is located in one of the world’s foremost cities for health care delivery and medical and biotechnology research. Boston’s Massachusetts General and Brigham & Women’s hospitals were recognized as two of the top 11 hospitals in the nation by U.S. News and World Report. In addition, Boston is a major center for national and global health policy, and home to the Massachusetts Legislature, a frequent innovator in health care legislation. Boston offers ample opportunity for pursuing any health law interest, whether it be protection of participants in clinical trials, pharmaceutical regulation or cutting-edge legislation designed to cover the uninsured. Boston’s biotechnology industry leads the world; Genzyme and Biogen are located here, along with the 550 other members of the Massachusetts Biotechnology Council. BU Law has one of the finest health law curricula in the country, one that melds academic theory with handson experience. Opportunities extend far beyond formal course work and include health law externships, clinics and interdisciplinary research activities.
Program Opportunities at BU Law The Legal Externship Program in Health Law allows students to work in a health law field placement in one of Boston’s world-class nonprofit health institutions including hospitals, health insurers and government agencies. Recent placements have included Boston Medical Center, Beth
Israel, Deaconess, Massachusetts General and Brigham & Women’s Hospitals, the Joslin Diabetes Center, the Center for Integration of Medicine and Innovative Technology at Massachusetts General Hospital and the New England Organ Bank. Other externs serve the legal needs of children in poverty with BU Medical School Professor Barry Zuckerman’s innovative program in childhood and adolescent health, the Medical Legal Partnership for Children at Boston Medical Center.
The Legislative Counsel Clinic gives students the opportunity to work on bills that will be considered by the Massachusetts Legislature, a consistent leader in health law issues in the U.S. Under the guidance of a director with extensive experience as a legal advisor and counsel to committees of the Massachusetts legislature, students assist senators and representatives on a variety of health care bills. Students recently worked on the innovative Massachusetts bill designed to cover the uninsured. In addition, the Legislative
Internship Program offers students the chance to work in the office of a Massachusetts legislator, gaining an internal perspective on the process. One student in the Internship program recently produced a proposed statute banning gifts from pharmaceutical and medical device companies to doctors.
The Legislative Drafting and Policy Clinic offers students the opportunity to draft health related global, national and state statutes. Students learn client interviewing, fact investigation, legal research, drafting and revision, while producing a draft bill with extensive accompanying documentation. A board of student editors and faculty advisors assists through all stages of drafting the bill and writing the supporting memorandum. Clients include state legislators and agencies, nongovernmental advocacy organizations
and lawmakers in developing countries, especially the East African Community.
The Boston Center for Refugee Health & Human Rights is a multidisciplinary project of Boston University School of Medicine, School of Public Health, School of Law and the Boston Medical Center. The Center provides comprehensive care for refugees and asylum applicants, including survivors of torture and related trauma. Students can participate and assist in the preparation of asylum cases
“We work with real bills that are under consideration, some of which become law. It’s a great day to see the governor sign your bill.” —Clinical Associate Professor Sean Kealy A BU Law student is researching an amendment to the Massachusetts stem-cell law. The issue: developing ethical alternatives to paying women for donating their eggs for medical research. Another student is working in the Senate offices on Beacon Hill, crafting the $1 billion bill to expand life sciences research, industrial development and workforce training.
and work on refugee policy. The Center has provided legal assistance, court testimony, medical evaluations, medical and psychiatric care and social assistance to more than 750 patients from more than 67 countries.
The Civil Litigation Clinic allows students to collaborate with the Boston Center for Refugee Health and Human Rights, where they work with health care professionals, led by Dr. Michael Grodin of the BU Schools of Medicine and Public Health, and Professor Susan Akram, to represent clients in refugee and asylum cases.
Research & Fellowship Opportunities Numerous opportunities exist at BU Law to give students practical, research-based experience. Students may find employment as research assistants for projects like the current work of Professor Mariner, director of the J.D.-M.P.H. program, on the national Institute of Medicine’s Committee on Smoking Cessation in Military and Veteran Populations, or Professor Miller’s work on injuries related to clinical trials.
“The Massachusetts Legislature is involved in high-profile health issues, so we don’t have to work on hypothetical cases,” said Sean Kealy, Clinical Associate Professor and Director of the Legislative Counsel Clinic and the Legislative Internship programs. “We work with real bills that are under consideration, some of which become law. It’s a great day to see the governor sign your bill.” Massachusetts is a national model for health law reform. In 2006, the state continued that tradition with the Act Providing Access to Affordable, Quality, Accountable Health Care. Recognizing the significance of this legislation, Professor Kealy has spearheaded a project to archive the full legislative history of the Act. A team of Counsel Clinic students is contacting House and Senate offices, collecting summaries, expert testimonies, floor speeches and legislative sources. “It’s exciting,” he said. “It’s a big complicated bill that took a lot of negotiating to pass. At some point there will be litigation, and the question will be asked, ‘How did the Legislature intend the law be read?’ The answer will be found in the documents we gather.”
Both law students and public health students helped Professor Mariner develop health reform
21 50 years of health law
legislation for the Russian Federation in a project funded by the United States Agency for International Development (USAID) and saw several proposed laws enacted. An interdisciplinary project was completed by Carolina Rossini, a student in BU Law’s LL.M. in Intellectual Property law program, who, through her coursework, researched socially responsible and open licensing arrangements to facilitate access to medicines. Her thesis focused on the role of universities in the research process, with an emphasis on access to patented inventions and medicines.
The Patients' Rights Program (PRP) at Boston University's School of Public Health initiated the International Committee on the Universal Rights of Patients, composed of health law and human rights scholars from diverse countries, to encourage effective implementation of patient rights around the world. PRP conducts research on legislation, court decisions and other events affecting patient rights. The program offers semester and summer internships for law students who want to participate in PRP projects.
Global Lawyers and Physicians (GLP) is a nonprofit
For law students in the J.D.-M.P.H. dual-degree program who are interested in teaching, the School of Public Health offers
organization of lawyers and physicians from all over the
two competitive fellowships: the Health Law and Bioethics
GLP offers a rare opportunity for lawyers and physicians
Fellowship and the Human Rights and Health Fellowship. Fellows learn teaching skills, assist faculty in the Department of Health Law, Bioethics and Human Rights and conduct their own research for a publishable article. The fellowship covers tuition to complete the M.P.H. program at the School of Public Health. The 2006–2007 fellow helped Professors Annas and Mariner prepare the Public Health Law casebook, in addition to acquiring invaluable experience as a teaching assistant.
who are committed to justice and health to work together to
world who collaborate to promote human rights and health.
advance knowledge about the inextricable link between health and human rights. Students can conduct research for GLP projects, prepare amicus briefs in court cases raising human rights and health issues, identify ways to implement the health-related provisions of international covenants on human rights and participate in educational conferences.
“My classes proved essential in discussing what has been negotiated in international treaties and arenas and in understanding the global politics surrounding medicines.” Carolina Rossini ’08 Former professor and researcher at Fundação Getulio Vargas Law School, Rio de Janeiro, Brazil LL. B. University of Sao Paulo, Brazil MBA Instituto de Empresa, Spain
A Sampling of Course Offerings Administrative Law Antitrust Issues in Health Care (S) Biotechnology Law & Ethics (S) Biotechnology Law & Policy Corporations The Dynamics of Health Care Reform (S) Ethical Dimensions of Public Health Policy Ethical Issues in Medicine and Public Health Food and Drug Law Forensic Mental Health Issues for Lawyers Genetics, Law and Public Health Health Care Markets: Law & Policy (S) Health Insurance, Managed Care and the Law (S) Health Law Health Law, Bioethics and Human Rights Human Rights and Health (S) Independent Study (with faculty) Insurance Law Legal Rights of Individuals with Disabilities (S) Legal Strategies to Reduce Health Risks Medical Research and the Law (S) Mental Health Law and Ethics Nonprofit Organizations Regulation of Research with Human Beings War on Drugs: 25 Years of U.S. Drug Policy (S)
Adjunct Faculty Adjunct or part-time faculty play a key role in educating BU Law students. The Law School welcomes the following faculty who work in such practice areas as forensics, child custody and domestic violence and health care law and business.
Jeffrey Donohue ’97 Corporate Counsel, Novartis Institutes for BioMedical Research, Inc.
Alexandra Glazier General Counsel, New England Organ Bank
Dr. Robert Kinscherff Director of Forensic Training for the Law and Psychiatry Service, Massachusetts General Hospital; Senior Forensic Psychologist, Boston Juvenile Court Clinic
(S) Seminar
23 50 years of health law
www.bu.edu/law On the cover: Professor Fran Miller