The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics
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This paper offers an economic rationale for compulsory licensing of needed medicines in developing countries. The patent system is based on a trade-off between the "deadweight losses" caused by market power and the incentive to innovate created by increased profits from monopoly pricing during the period of the patent. ⋯ As a result, these markets are systematically ill-suited to exclusive marketing rights, a problem which can be corrected through compulsory licensing. Open licenses that permit any qualified firm to supply the market on the same terms, such as may be available under licenses of right or essential facility legal standards, can be used to mitigate the negative effects of government-granted patents, thereby increasing overall social welfare.
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Presently, the pharmaceutical industry funds about half of the costs of continuing medical education (CME) programs in the U. S. This contributes to the ethical problems that pervade the relationship between medicine and the pharmaceutical industry: trustworthiness and conflicts of interest. ⋯ The industry believes that it will recoup $3.56 in increased sales for every dollar that it invests in CME. New guidelines instituted by the Accreditation Council for Continuing Medical Education (ACCME) in 2004 may succeed in reducing excessive commercial influence, especially since the Department of Health and Human Services has also warned the industry of possible anti-kickback violations if firewalls are not erected between CME funding and marketing of drugs. Critics counter that early indicators of improvement are lacking.
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Comment
Commentary: Public outreach by the FDA: evaluating oversight of human drugs and medical devices.
As nanotechnology emerges as an important public policy issue, the FDA's relationship with society is about to be tested. Most would agree that fostering public input will be critical to developing effective public policy for nanotechnology. ⋯ Low public confidence in the FDA, the general lack of knowledge about nanotechnology among ordinary Americans, and the way in which the "average" citizen obtains and evaluates knowledge about a public policy issue all pose serious challenges to any public outreach by the FDA. It will be necessary for the FDA to be attentive to not only its own public messages, but also to who is listening and how those messages are being perceived.
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Historical Article
Gene therapy oversight: lessons for nanobiotechnology.
Oversight of human gene transfer research ("gene therapy") presents an important model with potential application to oversight of nanobiology research on human participants. Gene therapy oversight adds centralized federal review at the National Institutes of Health's Office of Biotechnology Activities and its Recombinant DNA Advisory Committee to standard oversight of human subjects research at the researcher's institution (by the Institutional Review Board and, for some research, the Institutional Biosafety Committee) and at the federal level by the Office for Human Research Protections. The Food and Drug Administration's Center for Biologics Evaluation and Research oversees human gene transfer research in parallel, including approval of protocols and regulation of products. This article traces the evolution of this dual oversight system; describes how the system is already addressing nanobiotechnology in gene transfer: evaluates gene therapy oversight based on public opinion, the literature, and preliminary expert elicitation; and offers lessons of the gene therapy oversight experience for oversight of nanobiotechnology.