The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics
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This manuscript addresses how developing countries can maximize access to essential medicines and minimize unwanted side-effects within the legal environment of a compulsory license regime. While compulsory licensing can play a role in improving public health, external social and political conditions must be considered in order to make licensing an effective practice.
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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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Comparative Study
Compulsory licensing in Canada and Thailand: comparing regimes to ensure legitimate use of the WTO rules.
This paper examines two recent examples of compulsory licensing legislation: one globally embraced regime and one internationally controversial regime operating under the same WTO rules. In particular, we consider Canadian legislation and the use of compulsory licensing for HIV/AIDS drugs destined for a developing country. ⋯ This is used to analyze the Canadian and Thai regimes and frame the expected implications of each national policy. It is hoped that the assessment will guide changes to compulsory licensing design to ensure that legitimate regimes are embraced while illegitimate ones are disallowed.