Robinson, M., The Impact of the Agreement on Trade-Related Aspects of Intellectual Property Rights on Human Rights, Report of the United Nations High Commissioner for Human Rights, E/CN.4/Sub.2/2001/13 (June 27, 2001): Para. 42, available at <http://www.unhchr.ch/huridocda/huridoca.nsf/AllSymbols/590516104E92E87BC1256AA8004A8191/$File/G0114345.doc?OpenElement>..>Google Scholar

Attaran, A. and Gillespie-White, L., “Do Patents for Antiretroviral Drugs Constrain Access to AIDS Treatments in Africa?,” JAMA, 286, no. 15 (2001): 1886–992. For replies, see Boelaert, M. et al., LettersJAMA, 287 (2002): 7; Goemaere, E., Letters JAMA, 287 (2002): 7; Selgelid, M.J. et al., Letters JAMA, 287 (2002): 7.CrossRefGoogle Scholar

The term “essential medicines” is used here to connote the necessity of particular medicines to the survival of a large proportion of people in the developing world. It is not intended in the specialized way that “essential drugs and medicines” are defined for purposes of the list generated by the World Health Organization (WHO). A broader definition, with the Essential Drugs List criteria based on health need rather than current prices, is advocated. This is in keeping with the recommendation of the WHO Expert Committee on Essential Drugs in November 1999, which stated, “Essential drugs are those drugs that satisfy the health care needs of the majority of the population; they should therefore be available at all times in adequate amounts and in the appropriate dosage forms, and at a price that individuals and the community can afford.”Google Scholar

Expert Committee on the Selection and Use of Essential Medicines, Summary of Recommendations, 12th Expert Committee on the Selection and Use of Essential Medicines Meeting, Geneva, April 15–19, 2002, available at <http://www.who.int/medicines/organization/par/edl/expertrecommend.shtml>..>Google Scholar

Commisskmer of Patents v. The Wellcome Foundation [1983] N.Z.L.R. 385, at 398.Google Scholar

Committee on Economic, Social and Cultural Rights, United Nations Economic and Social Council, Human Rights and Intellectual Property, Statement by the Committee on Economic, Social and Cultural Rights, E/C.12/2001/15 (December 14, 2001): Paras. 4 and 6.Google Scholar

Bristol-Myers Squibb Co. v. FH Faulding & Co. Ltd [2000] FCA 316, available at <http://www.ipcr.gov.au/SUBMIS/docs2/Sub11AttA.pdf>..>Google Scholar

In an affidavit filed in support of the Treatment Action Campaign in Pharmaceutical Manufacturers Association of South Africa v. President of the Republic of South Africa, No. 4183/98 (High Court of South Africa, Transvaal Provincial Division February 18, 1998), Professor Colleen Flood of the University of Toronto mapped how patent law in Canada evolved since 1923 with the “expressly stated goal of making food and medicine affordable to the public” (at para. 4). To facilitate this, various legal devices, including compulsory licensing and administrative mechanisms (a Patented Medicines Prices Review Board), were established. However, in common with developing countries, Canada has been pressured to strengthen intellectual property protection. In Australia, the government negotiates with industry as a monopsonist purchaser and is thus able to provide drugs to the community at greatly reduced prices under a Pharmaceutical Benefits Scheme.Google Scholar

Bermudez, J. et al., Access to Drugs, the WTO TRIPS Agreement, and Patent Protection in Brazil: Trends, Perspectives, and Recommendations to Help Find Our Way, paper prepared for the Médicins Sans Frontières Drugs for Neglected Diseases Working Group (February 20, 2002): at 2 (citation omitted).Google Scholar

Lanjouw, J.O., “The Introduction of Pharmaceutical Product Patents in India: ‘Heartless Exploitation of the Poor and Suffering’?,” Oxford Intellectual Property Research Centre, Electronic Journal of Intellectual Property Rights, WP 07/99 (originally published August 10, 1999), available at <http://www.oiprc.ox.ac.uk/EJWP0799.html>..>Google Scholar

See, for example, Article 28 of the Paris Convention for the Protection of Industrial Property (March 20, 1883, as amended on September 28, 1979), available at <http://www.wipo.int/clea/docs/en/wo/wo020en.htm>..>Google Scholar

According to Audrey Chapman, Brazil, Ecuador, India, Pakistan, South Africa, and Thailand were among the countries subject to trade threats. Chapman, A.R., Approaching Intellectual Property as a Human Right: Obligations Related to Article 15(1)(c), E/C. 12/2000/12 (November 27, 2000): at para. 33, cited in Robinson, , supra note 1.Google Scholar

Markandya, S., Timeline of Trade Disputes Involving Thailand and Access to Medicines, Version 1.0, Consumer Project on Technology (July 23, 2001), at <http://www.cptech.org/ip/health/c/thailand/thailand.ntml>.Google Scholar

Ryan, M., Knowledge Diplomacy, Global Competition and the Politics of Intellectual Property (Washington D.C.: Brookings Institution Press, 1998): at 12.Google Scholar

Braithwaite, J. and Drahos, P., Global Business Regulation (Cambridge, England: Cambridge University Press, 2000): at 83.CrossRefGoogle Scholar

Final Act Embodying the Results of the Uruguay Round of the Multilateral Trade Negotiations, April 15, 1994, available at <http://www.wto.org/english/docs_e/legal_e/03-fa.pdf>..>Google Scholar

Agreement on Trade-Related Aspects of Intellectual Property (April 15, 1994), available at <http://www.wto.org/english/tratop_e/trips_e/t_agm0_e.htm>..>Google Scholar

Id. at Article 7.Google Scholar

One such measure might be the use of parallel importation, a legal mechanism on which TRIPS allows countries to determine their own law. Parallel importation means that once the patent holder has sold its product, it has exhausted its rights over the product and the new owner may sell it to others. As pharmaceuticals vary dramatically in price internationally, this is a useful provision that is widely used in the European Union. It has also been exploited successfully by the Philippines government to buy patented medicines from India at prices lower than they were being sold in the Philippines. However, in 2016, when all countries are to become members of the WTO, there will be limited benefit to parallel importation as there will be less variation in the price of patented medicines between countries as a result of the elimination of generic competition.Google Scholar

Compulsory licensing involves the licensing of companies that are not the inventors (patent holders) of a medicine to produce and sell that medicine. It means a deprivation of certain rights ordinarily granted to patent holders. Its benefit in the context of medicine is drastically lower prices. Compulsory licensing is of no effect when there is no domestic industry, as TRIPS does not allow the export of medicines produced under compulsory license. This leaves poor countries without their own industry at the mercy of donor agencies and multilateral organizations. Contractual agreements sometimes suggested as an alternative legal route for obtaining pharmaceuticals would be subject to the contingences created by unequal bargaining power.Google Scholar

Robinson, , supra note 1, at para. 22.Google Scholar

Bhagwati, Jagdesh, interview by Geraldine Doogue, Life Matters, Australian Broadcasting Corporation (March 12, 2002).Google Scholar

Weisbrot, M., Center for Economic and Policy Research, Rich Country Protectionism Puts WTO on the Slow Track (November 16, 2001), at <http://www.cepr.net/columns/weisbrot/rich_country_protectionism.htm>. Love, James, director of the Consumer Project on Technology, states simply, “market incentives for health care R&D are not efficient.” See Love, J., Paying for Health Care R&D: Carrot and Sticks, paper prepared for the Médicins Sans Frontières Drugs for Neglected Diseases Working Group (January 2001): at 1..+Love,+James,+director+of+the+Consumer+Project+on+Technology,+states+simply,+“market+incentives+for+health+care+R&D+are+not+efficient.”+See+Love,+J.,+Paying+for+Health+Care+R&D:+Carrot+and+Sticks,+paper+prepared+for+the+Médicins+Sans+Frontières+Drugs+for+Neglected+Diseases+Working+Group+(January+2001):+at+1.>Google Scholar

World Health Organization, Removing Obstacles to Healthy Development, Report on Infectious Diseases, WHO/CDS/99.1 (Geneva: World Health Organization, 1999): at § 1.1, available at <http://www.who.int/infectious-disease-report/pages/textonly.html>..>Google Scholar

Pharmaceutical Manufacturers Association of South Africa v. President of the Republic of South Africa, No. 4183/98 (High Court of South Africa, Transvaal Provincial Division February 18, 1998).Google Scholar

Stern, R., AIDS Treatment Access in Latin America: The Year in Review, Consumer Project on Technology (January 7, 2002), at <http://www.cptech.org/ip/health/aids/stern01072002.html>.Google Scholar

Laverack, S., presentation on the Aid for AIDS program, Cape Town, June 2001. “Significant sustained cost savings have been achieved primarily by reduced expenditure on hospitalisation.” Id.Google Scholar

See Attaran, and Gillespie-White, , supra note 2, at 1892, who make the strange assertion that “the data suggest that patents in Africa have generally not been a factor in either pharmaceutical economics and anti-retroviral drug treatment access (South Africa, with its larger affluent market, is an exception.).” In addition to its “affluent market,” where 22 million people live below the poverty line (?), South Africa has one tenth of the global total of people living with HIVGoogle Scholar

United Nations Development Programme, “Human Development Indicators,” Human Development Report 2001 (New York: Oxford University Press, 2001): at 159.Google Scholar

National AIDS Drug Policy, Ministry of Health, Secretariat of Health Policies (2001). Also according to the National AIDS Drug Policy of the Brazilian Ministry of Health, “Congressional Bill 9113, of 13 November 1996, guarantees every patient access, free of direct costs, to all the medication required for his/her treatment, including protease inhibitors.”Google Scholar

UNAIDS, Report of the Global HIV/AIDS Epidemic, UNAIDS/00.13E (June 2000): at 102, available at <http://www.unaids.org/epidemic_update/report/Epi_report.htm>..>Google Scholar

Robinson, , supra note 1, at para. 52.Google Scholar

See ’t Hoen, E. and Moon, S., Médicins Sans Frontières, Pills and Pocketbooks (July 18, 2001), at <http://www.msf.org/content/page.cfm?articleid=1A25BDD8–64D1–4B40-BA2C06C23BEAFFCE>. ’t Hoen and Moon write, “Lessons can be learned from Brazil where the price of AIDS drugs fell by 82% over five years as a result of generic competition. The prices of drugs that had no generic competitor remained stable, falling only 9% over the same period.” See also World Health Organization, World Trade Organization, Norwegian Foreign Affairs Ministry, and Global Health Council, Report of the Workshop on Differential Pricing and Financing of Essential Drugs (April 2001): at 7, available at <http://www.who.int/medicines/library/edm_general/who-wto-hosbjor/wholereporthosbjorworkshopfin-eng.doc>: “It was noted that within the year prior to the workshop, a combination of corporate responsiveness, domestic production, and competition have led to substantial reductions in the price of HIV/AIDS drugs.”.+’t+Hoen+and+Moon+write,+“Lessons+can+be+learned+from+Brazil+where+the+price+of+AIDS+drugs+fell+by+82%+over+five+years+as+a+result+of+generic+competition.+The+prices+of+drugs+that+had+no+generic+competitor+remained+stable,+falling+only+9%+over+the+same+period.”+See+also+World+Health+Organization,+World+Trade+Organization,+Norwegian+Foreign+Affairs+Ministry,+and+Global+Health+Council,+Report+of+the+Workshop+on+Differential+Pricing+and+Financing+of+Essential+Drugs+(April+2001):+at+7,+available+at+:+“It+was+noted+that+within+the+year+prior+to+the+workshop,+a+combination+of+corporate+responsiveness,+domestic+production,+and+competition+have+led+to+substantial+reductions+in+the+price+of+HIV/AIDS+drugs.”>Google Scholar

Law No. 9.279 of May 14, 1996, to Regulate Rights and Obligations Relating to Industrial Property, Article 71 states: “In cases of national emergency or of public interest, declared in a decision of the Federal Executive Power, and where the patent owner or his licensee do not satisfy such need, a temporary nonexclusive compulsory license to exploit the patent may be granted ex officio, without prejudice to the rights of the owner of the patent.”Google Scholar

On August 22, 2001, the Brazilian Ministry of Health announced its intention to “break the patent of the drug Nelfinavir”; it was pointed out that a Brazilian government laboratory “has succeeded in producing the drug at a saving of 40% over that charged by Roche. This will mean a saving of 88 million reais per year.” Brazilian Ministry of Health, Official Note (August 22, 2001), available at <http://lists.essential.org/pipermail/pharm-policy/2001-August/001410.html>..>Google Scholar

Robinson, , supra note 1, at para. 58.Google Scholar

See United Nations Development Programme, supra note 31, at 159. It is also significant that Thailand occupies a relatively high position (99 out of 191) in terms of general health system attainment and performance. See World Health Organization, World Health Report 2000 (Geneva: World Health Organization, 2000): at Annex Table 1, “Health System Attainment and Performance in all Member States,” at 152–55.Google Scholar

Oxfam, , The Impact of Patent Rules on the Treatment of HIV/AIDS in Thailand, Thailand Country Profile (March 2001): at 1.Google Scholar

Id. at 2.Google Scholar

Id. at 5.Google Scholar

Id. at 3.Google Scholar

See Attaran, and Gillespie-White, , supra note 2.Google Scholar

Robinson, , supra note 1, at para. 25, citing World Bank, World Development Indicators 2000 (Washington, D.C.: World Bank, 2000): at Table 5.12.Google Scholar

Gamier, J.P., presentation at the Lehman Brothers 5th Annual Global Healthcare Conference, Orlando, Florida, February 26, 2002, available at <http://corp.gsk.com/financial/lehbrothers_26feb2002.htm>.Google Scholar

World Health Assembly, Revised Drug Strategy, WHA52.19 (May 24, 1999), available at <http://www.who.int/gb/EB_WHA/PDF/WHA52/ResWHA52/e19.pdf>..>Google Scholar

The Ministerial Conference is the highest decision-making body of the WTO and it can make decisions on all matters under any of the WTO agreements, including the TRIPS agreement.Google Scholar

World Trade Organization, Declaration on the TRIPS Agreement and Public Health, WT/MIN(01)/DEC/2 (adopted November 14, 2001): at para. 5, available at <http://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.htm>..>Google Scholar

Inside U.S. Trade, “EU and U.S. Split over Scope of TRIPS Exceptions for Public Health” (March 8 2002), available at <http://lists.essential.org/pipermail/ip-health/2002-March/002756.html>..>Google Scholar

World Health Organization, supra note 39, at 4.Google Scholar

Id. at 4.Google Scholar

Reference has already been made to the Medicines and Related Substances Control Amendment Act, 1997, in South Africa. In 2001, the government of Kenya passed a new Industrial Property Bill which, according to Médicins Sans Frontières, represented a landmark victory, includes rights concerning parallel importation, compulsory licensing, and a Bolar provision. Médicins Sans Frontières, Press Release (May 10, 2001), at <http://www.msf.org/content/page.cfm?articleid=D2BCAC7D-8881-4391-83ACD5D23BDBED2A>..>Google Scholar

General Assembly, United Nations, International Covenant on Economic, Social and Cultural Rights (adopted December 16, 1966): at Article 15.Google Scholar

See Robinson, , supra note 1.Google Scholar

Chapman, Audrey, American Association for the Advancement of Science, “New Projects Focus on Intellectual Property and Human Rights,” Report on Science & Human Rights, XXII, no. 1 (Winter 2002), available at <http://shr.aaas.org/report/xxii/ip.htm>.Google Scholar

Washington File USIS, “United States Abstains from Vote on AIDS Drugs Resolution: Measure to Increase Access Is ‘Flawed,’ Ambassador Says,” April 23, 2001, available at <http://www.aegis.com/default.asp?req=http://www.aegis.com/news/usis/2001/US010405.html>..>Google Scholar

Committee on Economic, Social and Cultural Rights, supra note 6, at para. 12.Google Scholar

Robinson, , supra note 1, at para. 22.Google Scholar