Intellectual Property and Access to Essential Medicines: Options for Developing Countries

Abstract

This paper, which is an excerpt from the report on ‘Affordable ARV Drugs for People Living with HIV/AIDS in Vietnam: Legal and Trade Issues’ commissioned by the Ford Foundation, reviews some major issues relating to intellectual property and pharmaceuticals in order to find ways to increase or improve access to essential medicines for developing countries. It is suggested that developing countries should take positive steps to review and amend the existing law and policy relating to patents and pharmaceuticals. The following proposals may be adopted: prohibit patenting of the use, composition and combination of known medicines; encourage local production and import of generic drugs; encourage parallel import of patented medicines; review existing law to facilitate easy use of compulsory licensing; undertake price negotiation with the companies that hold patents; provide waiving of drug registration or provide a fast-track registration for generic medicines; and prohibit exclusive protection of test and other relevant data.

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References

WTO, WT/MIN(01)/DEC/2, available at http://www.wto.org.

See WTO, IP/C/W/405, available at http://www.wto.org.

Correa

C. M.

(2003) ‘TRIPS and access to drugs: Toward a solution for developing countries without manufacturing capacity?’, Emory International Law Review, Vol. 17, p. 390.

See, for example, Vietnam's Civil Code, Art. 787 and Decree 63-CP, Art. 4 (4); Thailand's Patent Act B.E. 2522, Section 9(4).

Interview with officials of the Intellectual Property Department, Ministry of Science and Technology, Hanoi, Vietnam, 10th March, 2004, and with officials of the Department of Intellectual Property, Ministry of Commerce, Bangkok, Thailand, 17th January, 2004.

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C. M.

(2000) ‘Integrating Public Health Concerns into Patent Legislation in Developing Countries’, South Centre, Geneva, Switzerland, p. 55.

Scherer

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Watal

(2002) ‘Post-Trips options for access to patented medicines in developing nations’, Journal of International Economic Law, Vol. 5, pp. 913–939.

This provision is in compliance with Art. 5 of the Paris Convention and Art. 8 of the TRIPS Agreement. A number of countries (eg the UK, Thailand, India etc) have adopted the policy of requiring the patented invention to be commercially exploited within the national boundary.

When governments issue a compulsory licence, the result is often a sharp decrease in prices, similar to the introduction of other competitive forces like generic drugs. The cases of the USA, Canada and Brazil provide good examples of the successful application of this safeguard. See: Chien

(2003) ‘Cheap drugs at what price to innovations: Does the compulsory licensing of pharmaceuticals hurt innovation?’, Berkeley Technology Law Journal, Vol. 18, pp. 853–907; Bass

N. A.

(2002) ‘Implications of the TRIPS Agreement for developing countries: Pharmaceutical patent laws in Brazil and South Africa in the 21st Century’, George Washington International Law Review, Vol. 34, pp. 191–222.

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For economic aspects of parallel importing see Maskus

K. E.

(2000) Intellectual Property Rights in the Global Economy, Institute for International Economics, Washington, D.C.

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For the arguments for and against parallel importing, see: Abbott

(1998) ‘First report (final) to the Committee on International Trade Law of the International Law Association on the subject of parallel importation’, Journal of International Economic Law, Vol. 1, pp. 607–636; Beal, H. E. (1998) ‘The conflicts between parallel trade and product access and innovation: The case of pharmaceuticals’, Journal of International Economic Law, Vol. 1, pp. 637–653.

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Chiappetta

(2000) ‘The desirability of agreeing to disagree: The WTO, TRIPS, international IPR exhaustion and a few other things’, Michigan Journal of International Law, Vol. 21, pp. 333–392.

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