American Journal of Law & Medicine

Foreword: globe-hopping pharmaceuticals.

Each spring the incoming editorial staff at the American Journal of Law and Medicine chooses the focus for the following year's Symposium Issue, and well-known scholars in the field are asked to contribute to its publication. Since these authors are already experts in the area, we give them free rein to explore whatever aspect of the overall topic interests them most. We thought that this year's subject, GLOBALIZATION OF PHARMACEUTICALS: INTERNATIONAL REGULATORY ISSUES, might produce papers exploring high-profile international controversies related to direct-to-patient advertising, (1) pharmacovigilance (2) or the regulation of dietary supplements increasingly consumed all over the globe. (3) We also expected articles dealing with regional and international efforts to achieve greater regulatory harmonization, such as those involving the European Medicines Agency, (4) the nascent Trans-Tasman Pharmaceutical Products Regulatory Authority, (5) or the International Committee on Harmonisation. (6) Two of our authors chose to examine one of those latter predicted subjects tangentially, but only one focused squarely on achieving more regulatory congruence on an international scale.

This symposium topic drew forth a series of nine articles from our twelve experts that fell--somewhat surprisingly--into four seemingly disparate categories; intellectual property dilemmas affecting global pharmaceuticals, parallel trade of licit drugs between the US and Canada, the increasing threat presented by counterfeit pharmaceuticals, and the inadequate regulation of manufacturer conflicts of interest likely to compromise human subject and patient safety.

These categories encompass a wide range of subjects, but on close examination the articles share a common subtext. The increasing globalization of pharmaceutical markets--trade in pharmaceuticals now constitutes approximately 3% of total world commerce (7)--means that no single nation can hope to resolve the countless dilemmas related to drug development, safety, efficacy, access, and pricing alone. Moreover, no one-size-fits-all regulatory or market solution to these global problems exists. Instead, the articles that follow attempt to grapple with second-best remedies from distinctive points of view, offering a mix of regulatory and market solutions to these complex issues.

INTELLECTUAL PROPERTY DILEMMAS

The first article in this collection offers Kevin Outterson's innovative approach for delivering essential medicines at low cost to the developing world--where most of the global disease burden lies--without depriving manufacturers of their expected return on investment in patented pharmaceuticals. …

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