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From the 2016 News Archive
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Essential Medicines Symposium Brings Together Medical and Legal Academics

The Law & Health Care Program (L&HCP) organized a unique symposium that brought together legal academics, bioethicists, lawyers, and medical researchers from North America and southern Africa for an international roundtable. The symposium, "Clinical Trials and Access to Essential Medicines in African Countries,” was held at the law school on October 30.   

The event was held to examine ethical and legal challenges to developing and distributing essential medicines in African countries and included four panels:

  • Panel One: Access to Essential Medicines as a Human Right
  • Panel Two: The Law and Ethics of Clinical Trials: What Rules Should Govern Clinical Research in Africa?
  • Panel Three: What do Clinical Researchers and Sponsors Owe to Host Communities?
  • Panel Four: Legal Regimes and Obstacles: Free Trade, Intellectual Property, and Access to Medicine

Each panel was composed of an interprofessional and international group of speakers who shared their academic and professional perspectives on conducting research in southern Africa where such research brings both enormous promise and the potential for grave ethical conflicts. 

Panelists included:

  • Chikosa Banda, professor, University of Malawi Chancellor College Faculty of Law
  • Mark Barnes, partner, Ropes & Gray, LLP
  • Danwood Chirwa, professor, University of Cape Town Law Faculty
  • Sean Flynn, associate director, Program on Information Justice and Intellectual property, Amercian University Washington College of Law
  • Lisa Forman, assistant professor, University of Toronto
  • Heinz Klug, professor and director, Global Legal Studies Center, University of Wisconsin
  • Miriam Laufer, associate professor, University of Maryland School of Medicine
  • Joseph Mfutso-Bengo, professor of Bioethics and director of the Centre for Bioethics, University of Malawi College of Medicine
  • Victor Mwapasa, associate professor, University of Malawi College of Medicine
  • Seema Shah, faculty bioethicist, NIH
  • Hilda Kaluwa Soko, law lecturer, University of Malawi Chancellor College of Law
  • David Wendler, senior investigator and head of the Section on Research Ethics, NIH
  • Lucie White, professor, Harvard Law School

Conducting research abroad is attractive because of lower site costs, fewer competitive trials, and treatment-naïve subjects, among other reasons.  According to Mark Barnes, a partner at Ropes & Gray, LLP and international expert in legal issues surrounding clinical research, “[g]lobal forces are creating an environment of change in health research, services and education.” For humanitarian and political reasons he explained, “. . . developed countries have long been involved in addressing emerging and chronic public health problems in low-resourced countries but in recent times, there is increased interdependence of the global academic community and a great deal of government and industry funding of research and global health that raise new and complex ethical questions.”

In addition to the traditional public health model of research abroad, new models for global health engagement are emerging, including programs that deliver on-site training/education for health professions students and providers. 

While there are benefits to this new level of global engagement, there are risks involved that need to studied and avoided. These risks include potential exploitation of local populations, overcommitted institutions and principal investigators who are not able to conduct logistically complicated and culturally appropriate projects, and potential legal liability for such things as research violations, misuse of grant funds, and injuries to project staff. 

Human rights law is widely seen as a legal and policy framework to ensure ethical conduct of research, particularly in low-resourced countries.  As the medical research world becomes increasing globalized, human rights law presents a vehicle to inform ethical conduct of research, protect vulnerable populations, and, when necessary, seek justice in courts. 

Danwood Chirwa, professor at the University of Cape Town Law Faculty, and others on the first panel spoke about human rights law as a vehicle to ensure that everyone has the right to the highest attainable standard of physical and mental health, a concept which includes protection from unethical research trials. 

In addition to the academics in medicine and law who served as panelists at the roundtable, the U.S. Ambassador to Malawi, Necton Mhura, was an active participant in the event. Mhura holds a Bachelor of Laws degree from the University of Malawi and a Master of Laws degree from University of London, University College. He lectured in law at the University of Malawi for thirty years. During part of this period, he held the position of Head of Department in the Faculty of Law and Dean of the Faculty.

Many of the panel participants’ talks will be published as articles in upcoming symposium issues of the L&HCP’s Journal of Health Care Law & Policy and the Maryland Journal of International Law.

The roundtable was organized by Professors Diane Hoffmann and Leslie Meltzer Henry of the Law & Health Care Program and Professor Peter Danchin, director of the Law School’s International and Comparative Law Program. The three professors also collaborated with Chikosa Banda, a professor at the Faculty of Law at Chancellor College in Malawi. 

The symposium was the latest in a long collaboration between Maryland Carey Law and the Faculty of Law at Chancellor College in Malawi which began in 2010 when University of Maryland, Baltimore’s (UMB) Center for Global Education Initiatives sent an interprofessional team of faculty and students to Malawi to study the health and legal needs of orphans and vulnerable children. During the course of that project, UMB researchers began collaborating with Banda.  In the summer of 2013, Hoffmann and Danchin worked with Banda to organize a workshop for students and faculty from both universities on the subject of HIV/AIDS. Since that time, faculty from both schools have conducted visits and workshops in both Baltimore and Malawi, including the Essential Medicines symposium.

The symposium was generously supported by the UMB Center for Global Education Initiatives, Alan & Nancy Eason , the Stuart Rome Lecture Fund, the Reuben Shiling Mental Health Law Fund, the Leonard C. Homer/Ober|Kaler Law and Health Care Fund, and the Dr. Richard H. Heller Fund.

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Admissions: PHONE: (410) 706-3492 FAX: (410) 706-1793

Copyright © 2018, University of Maryland Francis King Carey School of Law. All Rights Reserved