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The Thai Journal of Pharmaceutical Sciences

Abstract

For pharmaceutical companies, obtaining patent protection for the pharmaceuticals they develop is essential. Patent protection assures that the pharmaceutical company will have a reasonable opportunity to recoup their most likely quite heavy investment in the new drug and allow the company to control the wholesale market price of the drugs. These key intellectual property rights are truly at the heart of the internationally recognized intellectual property regime. For patent right holders in general merchandise, say an innovative paperclip or mousetrap, the absolute right of the patent holder as to the distribution and price is perfectly acceptable. Pharmaceutical patents however, with the ability to control the price present unique societal issues. A patient dying of HIV-AIDS, cardiovascular disease, or cancer must pay the full market price for the drugs, or die. It is as simple as that. In countries where critical drugs are not available due to high prices or the refusal of the patent holder to market the drugs, the government may under a convergence of domestic and international agreements (TRIPS and Doha) issue çcompulsory licensesé that enable another drug manufacturer to produce the patented drug without the fear of a patent infringement action by the patent holder. The patentee not only loses its right to control the production of the patented product in that country, but also loses the right to set the wholesale price.1 But the citizens of that government get the needed medical treatment. Compulsory licensing of pharmaceuticals presents certain compelling social and political questions. In general, under what circumstances may a government consider that the epidemiological situation in regard to certain chronic diseases has become such a critical a public health crisis to justify the compulsory license? Do TRIPS and the Doha Agreement provide a legal basis to issue a compulsory license? 2 The compulsory licenses the Thai government is considering at present are for chronic diseases. All prior compulsory licenses were for an infectious disease, namely AIDS, as were all earlier compulsory licenses by other governments. The compulsory licenses under consideration are for drugs used to treat coronary heart disease and several cancers. Thus, how the Thai government deals with this within the proper boundaries of international law will be a case of first impression that cannot help but influence compulsory licensing by other governments. The issue of compulsory licenses is also allegorical. Are patent rights as the metaphorical heart of the patent system, open to change in order to help the literal heart of a living patient? Pharmaceutical companies are, after all, active participants in the worldwide healthcare system and are ethically obligated to the patients, much as much as practicing physicians are.3 These are very intriguing questions that in addition to going to the heart of patent law, also go to the heart of the pharmaceutical and health care industry.

DOI

10.56808/3027-7922.3321

First Page

61

Last Page

83

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