Health Policy and the WTO

Diamond Jared , Guns, Germs, and Steel: The Fates of Human Societies (New York: W.W. Norton & Company 1997).

For example, Hilary John , The Wrong Model: GATS, Trade Liberalization and Children's Right to Health , Save the Children, 46 (October 2001) (stating that WTO dispute settlement panels that consider cases involving member states' health regulations “rule … on the basis of trade considerations, not public health concerns”). Save the Children contends generally in this report that the WTO dispute resolution process pays little more than lip service to language in GATT '94 and other WTO-associated agreements permitting health-based exceptions to liberal trade rules.

de Wildt Gilles , “Which Comes First — Health or Wealth?,” Lancet 357, 9262 (April 7, 2001): 1123–4, at 1123. (discussing the UN Sub-Commission on human rights proclamation that the TRIPS agreement “does not adequately reflect the fundamental nature and indivisibility of all human rights,” including the right to health); Price David , “How the World Trade Organization is Shaping Domestic Policies in Health Care,” Lancet 354 No. 9193 (November 27, 1999): 1889–92 (arguing the WTO policies conflict with the basic priorities undergirding many national health systems).

See Pauwelyn Joost , “The Role of Public International Law in the WTO: How Far Can We Go?,” American Journal of International Law 95 (2001): 535–578, at 561 n. 175 (summarizing commentary taking the position that WTO law does not assimilate other international law, aside from rules of treaty interpretation).

A consensus of opinion holds that Art. 3.2 of the Understanding on Rules and Procedures Governing the Settlement of Disputes (DSU), I.L.M. 33 (1994): 112–135. (instructing dispute settlement panels and the DSU Appellate Body to “clarify” WTO treaty provisions “in accordance with customary rules of interpretation of public international law”) incorporates the customary international law rules of treaty interpretation codified in Articles 31–33 of the Vienna Convention on the Interpretation of Treaties. E.g. Jackson John. H. , The World Trading System: Law and Policy of International Economic Relations (Cambridge: MIT Press, 1997): 120–21. But scholars and member states have differed over whether and to what degree substantive customary and conventional international law outside the trade realm — e.g. environmental and human rights law — is thereby brought within the WTO sphere for purposes of treaty interpretation. Although the Appellate Body has from time to time referenced international agreements outside the trade realm, it has not spoken clearly and generally to this question.

The preambles to the agreement establishing the WTO, the General Agreement on Tariffs and Trade (GATT and GATT 1994), the General Agreement on Trade in Services (GATS), and the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) make reference to economic development and employment but not to public health. Only the Agreement on the Application of Sanitary & Phytosanitary Measures (SPS), devoted specifically to the application of GATT 1994 to member states' public health regulations, affirms human health as an objective in its preamble.

See Art. 25(1) (declaring that everyone has a right to a standard of living adequate for the health of himself and his family, including food, clothing, housing, and medical care…”).

See Art. 12(1) (declaring “the right of everyone to the enjoyment of the highest attainable standard of physical and mental health”). Other international law instruments that make reference to a right to health include the International Convention on the Elimination of All Forms of Racial Discrimination, Art. 5(e)(iv) open for signature, I.L.M. 3 (1966): 161–165, at 164; the Convention on the Elimination of All Forms of Discrimination Against Women, Art. II (1)(f) and Art. 12 open for signature March 1, 1980, 1249 UNTS 13; and the Convention on the Rights of the Child, Art. 24 adopted by General Assembly, I.L.M. 28 (1989): 1448.

See Kinney Eleanor D. , “The International Human Right to Health: What Does This Mean for Our Nation and World?,” Indiana Law Review 34 (2001): 1457–1475, at 1464 (discussing prospects for recognizing health as a right in customary international law).

Callahan Daniel , What Kind of Life?: The Limits of Medical Progress (New York: Simon & Schuster, 1990): 31–68.

Sunstein Cass , “Against Positive Rights,” Eastern European Journal of Constitutional Review 2 (1993): 35–38.

See generally De Villiers Bertus , “The Socio-Economic Consequences of Directive Principles of State Policy: Limitations on Fundamental Rights,” South African Journal on Human Rights 8 (1992): 188–199.

Auerbach James A. Krimgold Barbara K. , “Improving Health: It Doesn't Take a Revolution,” in Auerbach James A. Krimgold Barbara K. eds., Income, Socioeconomic Status, and Health: Exploring the Relationship (Washington: National Policy Institute, 2001): 1.

Leonard Syme S. , “Understanding the Relationship Between Socioeconomic Status and Health: New Research Initiatives,” in Auerbach James A. Krimgold Barbara K , eds., Income, Socioeconomic Status, and Health: Exploring the Relationship (Washington: National Policy Institute, 2001): 12. Syme observes:

There is no more important environmental issue than socioeconomic status. The relationship between SES and health is well-known. It produces disease in all bodily systems — digestive genitourinary, respiratory, circulatory, nervous, blood, and endocrine. It also results in higher rates of mortality for most malignancies, congenital abnormalities, infections, parasitic diseases, accidents, poisoning, violence, perinatal mortality, diabetes, and musculoskeletal impairments. Id. at 14.

For example, Kawachi Ichiro Blakely Tony A. , “When Economists and Epidemiologists Disagree,” Journal of Health Politics, Policy, & Law 26, no. 3 (2001): 533–541; Wilkinson Richard D. , Unhealthy Societies: The Affliction of Inequality (London: Routledge, 1996). See Mellor Jennifer M. Milyo Jeffrey , “Reexamining the Evidence of an Ecological Association between Income Inequality and Health,” Journal of Health Politics, Policy, & Law 26, no.2 (2001): 487–522 (disputing the validity of the statistical reasoning employed by those who contend that the steepness of wealth gradients in societies is a determinant of health, independent of levels of personal wealth).

House James S. , “Relating Social Inequalities in Health and Income,” Journal of Health Politics, Policy, & Law 26 (2001): 523; Wagstaff A. Doorslaer Evan , “Income Inequality and Health: What Does the Literature Tell Us,” Annual Review of Public Health 21 (2000): 543.

WHO Commission on Macroeconomics & Health, Macroeconomics & Health: Investing in Health for Economic Development (2001): 21–40; Smith J. P. , “Healthy Bodies and Thick Wallets: The Dual Relation between Health and Economic Status,” Journal of Economic Perspectives 13 (1999): 145–166.

Sen Amartya , Development as Freedom (Oxford: Oxford University Press, 1999): 43–49.

Anand Sudhir Ravallion Martin , “Human Development in Poor Countries: On the Role of Private Incomes and Public Services,” Journal of Economic Perspectives 7 (1993): 133–150.

Nussbaum Martha , Women and Human Development (Cambridge UK, Cambridge University Press, 2000): 294–95.

Anand Ravallion , supra note 19.

Sen, 45–47 at supra note 18.

Id; Dreze Jean Sen Amartya , Hunger and Public Action (Oxford Clarendon Press: 1989).

Sen, 195–98 at supra note 18.

Id. at 198–99.

Id. at 146–59.

See Id. at 178–88 (arguing that political and civil rights empower people threatened by potential famine to mobilize the state to provide income support, employment, or other aid necessary to enable those in need to purchase food when they cannot grow or afford it themselves).

See generally Stiglitz Joseph E. , Globalization and its Discontents (New York: W. W. Norton & Co.: 2002).

At the Cancun Ministerial Conference in September 2003, for example, a group of developing countries that became known as the “Group of 21” or “G-21” acted in concert to oppose the positions of the United States, Europe and Japan in agriculture negotiations. See Thompson Ginger , “Protesters Swarm the Streets at WTO Forum in Cancun,” New York Times, September 14, 2003, at A14.

The dispute settlement process is established by the Dispute Settlement Understanding, which was one of the Uruguay Round agreements that established the WTO. See Agreement Establishing the World Trade Organization, 1994, Annex 2: Dispute Settlement Understanding, available at <http://www.wto.org/english/docs_e/legal_e/28-dsu.pdf> (last visited Oct. 19, 2003). For the WTO's official description of the dispute settlement process, see World Trade Organization, A Unique Contribution, at <http://www.wto.org/english/thewto_e/whatis_e/tif_e/disp1_e.htm> (last visited Oct. 19, 2003).

The GATT was completed in 1947 and went into effect in 1948. It has since evolved through a series of multilateral negotiating “rounds,” and in 1994 it was incorporated into the newly-created WTO.

General Agreement on Tariffs and Trade 1994, Art. XX(b). This authorization is subject to the chapeau (introductory clause) to Art. XX, which requires that such measures not be applied in a manner which would constitute a means of arbitrary or unjustifiable discrimination between countries where the same conditions prevail or a disguised restriction on international trade.

Understanding on Rules and Procedures Governing the Settlement of Disputes, Art. 11.

Dumping has been variously defined as the sale of goods abroad for a price below the price charged in the ‘home’ (or exporting) market and as the sale of goods abroad for a price below their cost of production. Definition of dumping and consideration of policy responses to it is complicated by possibilities for expanding production at low marginal cost and for increasing profitable sales through price discrimination. Jackson , supra, note 5, at 251–61.

Countervailing duties are assessed and collected by importing countries for the asserted purpose of neutralizing the market impact of exporting nations' subsidies. Id. at 281–83.

‘Safeguards’ are restrictive trade measures (typically temporary) in response to imports that purportedly pose a serious threat to a competing domestic industry, or to a country's economy in general, absent any recognized unfair trade practice. Id. at 175–81.

See Agreement on Implementation of Article VI of the General Agreement on Tariffs and Trade 1994, Art.17.6 (stating (i) that if national authorities' “establishment of the facts was proper and the evaluation was unbiased and objective, even though the [WTO dispute resolution] panel might have reached a different conclusion, the evaluation shall not be overturned”, and (ii) that “[w]here the panel finds that a relevant provision of the [antidumping] Agreement admits of more than one permissible interpretation, the panel shall find the authorities' measure to be in conformity with the Agreement even if it rests upon one of those permissible interpretations”). To the extent that panels and the Appellate Body are willing to concede the possibility of multiple, permissible inferences from facts and treaty text, instead of imposing their preferred interpretations in formalistic fashion, Art. 17.6 gives member states discretion to take antidumping measures. Daniel Tarullo points to the parallel between Art. 17.6 and U.S. administrative agencies' discretion, under Chevron, USA v. National Resources Defense Council, 467 U.S. 837, 842–43 (1984), to adopt any “permissible construction” of an ambiguous statute. Tarullo Daniel K. , The Hidden Costs of International Dispute Settlement: WTO Review of Domestic Anti-Dumping Decisions 5–6 (2002) (unpublished manuscript, on file with the author, DKT).

It has done so largely by purporting to ascertain single, correct interpretations of facts and law, thereby eliding treaty language, see Tarullo , supra note 38, that allows member states to choose from among multiple permissible interpretations. Id. at 8–24.

For example, United States' Imposition of Countervailing Duties on Certain Hot-Rolled Lead and Bismuth Carbon Steel Products Originating in the United Kingdom , WT/DS138/AB/R (May 10, 2000); United States — Definitive Safeguard Measures on Imports of Circular Welded Carbon Quality Line Pipe From Korea , WT/DS202/AB/R (February 15, 2002); United States — Safeguard Measures on Imports of Fresh, Chilled or Frozen Lamb Meat from New Zealand and Australia , WT/DS177/AB/R (May 1, 2001).

See Agreement on Safeguards, Art. 4.2(a) (instructing national authorities to “evaluate all relevant factors of an objective and quantifiable nature having a bearing on the situation of that industry, in particular, the rate and amount of the increase in imports of the product concerned in absolute and relative terms, the share of the domestic market taken by increased imports, changes in the level of sales, production, productivity, capacity utilization, profits and losses, and employment”).

U.S. — Lamb Meat Safeguard, para. 106 (“Panels must, therefore, review whether the competent authorities' explanation fully addresses the nature, and especially, the complexities, of the data, and responds to other plausible interpretations of that data. A panel must find, in particular, that an explanation is not reasoned, or is not adequate, if some alternative explanation of the facts is plausible, and if the competent authorities' explanation does not seem adequate in the light of that alternative explanation.”).

European Communities — Measures Affecting Asbestos and Asbestos-Containing Products , WT/DS135/AB/R, para. 155 (April 5, 2001).

Id. at para. 178.

See Ruessman Laurent , “Putting the Precautionary Principle in its Place: Paramaters for the Proper Application of a Precautionary Approach and the Implications for Developing Countries in Light of the Doha WTO Ministerial,” American University International Law Review 17 (2002): 905–949, at 926 (suggesting that EC-Asbestos and an earlier decision, U.S. — Shrimp, 'arguably afforded deference to a precautionary approach); Boutillon Sonia , “The Precautionary Principle: Development of an International Standard,” Michigan Journal of International Law 23 (2002): 429–469 at 457 (contending that “in Asbestos, the Appellate Body relied upon the precautionary principle as a standard in its analysis”). The “precautionary principle” holds, in general terms, that where scientific proof of a practice's adverse health and environmental impact is uncertain, policymakers should err on the safe side by curtailing the practice sufficiently to ensure that its health and environmental risks do not exceed accepted levels.

EC-Asbestos, supra, note 43, at para. 168.

Thailand Restrictions on Importation of and Internal Taxes on Cigarettes Nov. 7, 1990, GATT B.I.S.D. (37th supp.) at 200 (1991).

Id. at para. 75.

Id. at 81.

It is defensible, in our view, without undercutting the importance of national public health aims. High-enough nondiscriminatory taxes would surely undermine cigarette-marketing efforts as effectively as would discriminatory taxes on imports. To be sure, nondiscriminatory taxes would be more politically difficult to enact because of opposition from domestic producers. But it is hardly clear that the power of domestic interest groups to push national policy in protectionist directions should count in favor of a finding that discriminatory treatment of foreign products” is necessary to achieve national health goals.

EC-Asbestos, supra, note 43, at paras. 173–74.

Institutional competence here might incorporate a variety of factors, including scientific and technical know-how, closeness to popular sentiments concerning health risks, respect for national sovereignty in health and safety matters, and the democratic legitimacy of national versus transnational balancing among risks and benefits.

Id. at para. 172. The Appellate Body's treatment of health as a “vital and important” value is also evident in its decision to overturn the EG Asbestos panel's ruling that similarly employed construction materials with and without asbestos are “like products” under GATT Art. 111(4), for purposes of GATT's “national treatment” requirements. In reversing the panel, which emphasized the shared end-uses of these materials, the Appellate Body put primary emphasis on the different health risk profiles of materials that do and do not contain asbestos. Id. at paras. 125–41.

European Communities — Measures Concerning Meat and Meat Products (Hormones), AB Report, WT/DS26/AB/R, WT/DS48/AB/R (February 13, 1998).

Charnovitz Steve , “The Supervision of Health and Biosafety Regulation by World Trade Rules,” Tulane Environmental Law Journal 13 (2000): 271–302, at 301.

Agreement on the Application of Sanitary and Phytosanitary Measures, decision date April 14, 1995 1867 U.N.T.S: 493.

Id. Art. 5.1

EC — Hormones, supra, note 55, at paras. 207–08.

See id. at paras. 205–06 (rejecting, as “fundamental legal error”, the dispute resolution panel's view that risk resulting from poor administrative control cannot be counted in an SPS risk assessment).

See supra, text accompanying note 47.

EC — Hormones, supra, note 55, at para. 186.

Id. at para. 187.

Id. at para. 124 (construing SPS Agreement Art. 5.7).

Id. at para. 188–89. The Appellate Body treated the SPS Agreement Art. 5.1 requirement that regulation be “based on” a risk assessment as a requirement that there be a logical (“objective”) relationship between the risk assessment and the regulation at issue, not as a requirement that the risk assessment play a role in the regulatory decision-making process as a matter of historical fact. Id.

Id. at para. 193.

Id. at para. 194.

Id. at para. 198. Citing several scientific reports concluding that use of hormones to promote growth in cattle is safe, the Appellate Body declined to recognize, as a divergent scientific opinion, a single scientist's expressed view (not based on his own studies) that use of some of the hormones at issue posed a tiny but non-zero risk. Id. at paras. 196–98.

The content of such a threshold test is beyond our scope here, but one might imagine something similar to the approach taken to admissibility of scientific testimony in Daubert v. Merrill Dow Pharmaceuticals, 509 U.S. 579 (1993), relying on both empirical grounding and peer support for the scientific viewpoint at issue.

“U.S. to Push WTO Case Unless EU Biotech Moratorium Lifted,” Inside U.S. Trade, May 16, 2003, at 5–6. The U.S. complaint also alleged violations of the Agreement on Technical Barriers to Trade, another component of the WTO scheme. Because it preceded the adoption of the EU's final GMF regulations, the WTO complaint cites only the moratorium as its basis for action, not the new regulations. Id.

Washington Post, August 8, 2003, at E2.

Almost 40 percent of American grown corn is genetically modified. Leonhardt David , “Talks Collapse on U.S. Efforts to Open Europe to Biotech Food,” New York Times, June 20, 2003, at A1. Because almost one-third of American crops are exported, the American Farm Bureau describes the EU moratorium on GMFs as a “nightmare.” Becker Elizabeth Barboza David , “Battle Over Biotechnology Intensifies Trade War,” New York Times, May 28, 2003, at C1.

Leonhardt , supra note 72.

From 1998 until 2003, the EC maintained an informal moratorium on GMF imports. Becker Elizabeth , “U.S. Contests Europe's Ban on Some Food,” New York Times, May 14, 2003, at C1. In response to American objections, the EC implemented a new regulatory scheme in 2003 that in principal permits introduction of GMF products. “New EU Law on Biotech Food,” Washington Post, July 3, 2003, at E2. But the Bush Administration says this scheme is unsatisfactory, since it mandates that GMFs be labeled and traceable, a requirement U.S. agricultural firms claim would be prohibitively expensive and virtually impossible to meet. See “U.S. Agriculture Groups Weigh WTO Case Against New EU GMO Rules,” Inside U.S. Trade, July 11, 2003, 4–5 (describing the details of the traceability and labeling rules and the U.S. position that the regulations are a “pyrrhic victory” because they are as restrictive as the moratorium).

Some EC member states have refused to allow even GMFs that comply with these regulations, and the EC has initiated enforcement action against these states. See Washington Post, July 16, 2003, at E2 (reporting a suit filed in the European Court of Justice); European Union, Press Release, Genetically Modified Organisms: Commission takes Court action against eleven Member States, July 15, 2003 (on file with author). In a 2003 case the European Court of Justice considered whether member nations could take protective measures against foods containing transgenic proteins. Case C-236/01 Monsanto Agricoltura Italia SpA and Others v. Presidenza del Consiglio dei Ministri and Others, Sept. 9, 2003. The Court held that protective measures were only justified if the “Member State has first carried out a risk assessment which is as complete as possible given the particular circumstances of the individual case, from which it is apparent that, in the light of the precautionary principle, the implementation of such measures is necessary in order to ensure that novel foods do not present danger for the consumer.” Id. at paras. 84, 114. The court stated that the risk targeted by a nation's ban must not be based on a purely hypothetical approach to risk, founded on mere suppositions which are not yet scientifically verified. Id. at para. 106. To be valid, a ban on novel foods must be based on “detailed grounds” to suspect health risks, the court said. Id. at para. 108; Meller Paul , “Italy Loses Ruling on Modified Food,” Washington Post, Sept. 10, 2003, at W1.

Gillis Justin , “U.S. Attacks European Biotech Ban,” Washington Post, May 14, 2003, at E1.

WHO Commission on Macroeconomics & Health, supra, note 17, at 47.

Id. at 51.

Many of these can afford anti-retroviral agents only sporadically and therefore receive ineffective treatment. Id.

Patent-protected prices are hardly the whole story behind large-scale failure to make treatment for AIDS and other life-threatening infectious diseases available to the third world poor. As pharmaceutical industry representatives often point out, inadequate medical clinics and other public health infrastructure constitute enormous barriers to drug access in poor countries.

Balf Harvey E. Jr. , “Patent Protection and Pharmaceutical Innovation,” New York University Journal International Law & Politics 29 (1997): 95–107. Weissman Robert , “A Long, Strange TRIPS: The Pharmaceutical Industry Drive to Harmonize Global intellectual Property Rules, and the Remaining WTO Legal Alternatives Available to Third World Countries,” University of Pennsylvania Journal of International Economic Law 17 (1996): 1069.

See Pruzin Daniel , “Intellectual Property: Call for Affordable Medicines to Be Put on Doha Ministerial Agenda,” BNA International Trade Report 18 (2001): 737–738; (reporting on concerns expressed by African and South American trade officials).

For example, Wojahn Patrick L. , “A Conflict of Rights: Intellectual Property under TRIPS, the Right to Health, and AIDS Drugs,” UCLA Journal of International Law & Foreign Affairs 6 (2001): 463–497, at 476–480. Weissman , supra, note 81, at 1100.

Grabowski Henry , “Patents, Innovation and Access to New Pharmaceuticals,” Journal of International Economic Law 5 (2002): 849–860.

Consideration of these competing claims from the pharmaceutical industry and its critics is beyond our scope here. We shall confine ourselves here to the proposition that in the TRIPS context, as in the GATT and SPS settings, the WTO has come to treat health as a value with privileged status when interpretive questions arise.

Pruzin Daniel , “Intellectual Property: Rewriting TRIPS Could Hurt Research, Pharmaceutical Industry Strongly Warns WTO,” BNA International Trade Report 18, September 27, 2000: 1507–1508. International pharmaceutical industry leaders warned that any perceived weakening of TRIPS patent protection would be “disastrous” for research investment. The United States, Switzerland, Canada, Japan, and Australia proposed that the November 2001 WTO Ministerial Conference issue a declaration stating, inter alia, that “strong, effective, and balanced protection for intellectual property is a necessary incentive for research and development of lifesaving drugs …” Id. The declaration on TRIPS and public health eventually issued by the Ministerial Conference included no such statement.

Declaration on the TRIPS Agreement and Public Health, Ministerial Conference, 4th Session, Doha November 9–14, 2001, WT/MIN(01)/DEC/2, para. 4 (November 20, 2001) [hereinafter Doha Declaration].

Arbitrage opportunities result from the different prices that pharmaceutical firms charge for the same patent-protected drugs in different countries. Such price discrimination enables firms to increase revenues and to expand access to drugs (through prices as low as marginal cost), but it creates opportunities for movement of drugs (parallel importing) from higher price to lower price countries.

See id. at para. 5(d) (stating that TRIPS provisions relevant to exhaustion of intellectual property rights “leave each Member free to establish its own regime for exhaustion …, subject to the most favored nation and national treatment provisions”). “Exhaustion” frees buyers of patent-protected intellectual property (from a patent holder or licensee) to resell this property to others. Once the patent holder (or licensee) has sold the property, it cannot claim intellectual property rights against subsequent buyers and sellers; hence the rights are said to be exhausted. So-called “national” exhaustion regimes, preferred by the pharmaceutical industry, treat intellectual property rights as exhausted only within the country of initial sale: Subsequent sellers, and users must comply with the rights in every other country. Thus national exhaustion, with robust enforcement, precludes parallel importing. “International” exhaustion schemes, by contrast, treat intellectual property rights as exhausted throughout the world after the initial sale. They thus permit parallel importing and are disfavored by drug patent holders. So-called “regional” exhaustion regimes represent a compromise, barring patent holders from claiming the rights against subsequent sellers and users within a group of nations but requiring subsequent sellers and users to comply with the rights in countries outside this group. The TRIPS agreement itself explicitly declines to speak to the question of exhaustion: Art. 6 states that “subject to the provisions of Articles 3 and 4 [TRIPS' “National Treatment” and “Most-Favored Nation Treatment” clauses] nothing in this Agreement shall be used to address the issue of the exhaustion of intellectual property rights.” Thus the Doha Declaration went well beyond the TRIPS text in construing the agreement to leave member states free to choose their exhaustion regimes.

TRIPS, Art. 3 1.

Doha Declaration, supra note 87, para. 5(c).

TRIPS, Art. 31 (b). Absent (i), “national emergency or other circumstances of extreme urgency,” or (ii), “public non-commercial use,” Art. 31 (b) permits compulsory licensing only after “the proposed user has made efforts to obtain authorization from the right holder on reasonable commercial terms and conditions and such efforts have not been successful within a reasonable period of time.”

Doha Declaration, supra, note 87, para. 5(b).

Id. at para. 5(c).

TRIPS, Art. 31 opens as follows: “Where the law of a Member allows for other use of the subject matter of a patent without the authorization of the right holder. … the following provisions shall be respected:”.

This issue is frequently referred to as the “Paragraph 6” issue because it was raised and left unresolved by paragraph 6 of the Doha Declaration. See Doha Declaration, supra, note 87, para. 6.

Brazil and India are the principal examples, and they are rare exceptions. No sub-Saharan African nation (except, to some degree, South Africa) has significant pharmaceutical manufacturing capacity.

Doha Declaration, supra, note 87, para. 6. The Declaration directed the TRIPS Council to report back to the WTO General Council with a solution. Id.

Becker Elizabeth , “Trade Talks Fail to Agree on Drugs for Poor Nations,” New York Times, December 21, 2002, at C3.

Blustein Paul , “Talks on Low-Cost Drugs for Poor Nations Stall,” Washington Post, Dec. 21, 2002, at E1.

Becker Elizabeth , “U.S. Unilateralism Worries Trade Officials,” New York Times, March 17, 2003, at A8.

WTO General Council, Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, WT/L/540 (Aug. 30, 2003), available at <http://www.wto.org/english/news_e/news03_e/trips_stat_28aug03_e.htm> [“Implementation Decision”] (last visited December 9, 2003). When, in 2003, U.S. pharmaceutical firms backed away from their previous insistence on limiting compulsory licensing for export to HIV/AIDS and other life-threatening infections, U.S. negotiators followed suit. They pressed instead for assurances that only countries that truly lack domestic capacity could exercise this option, as well as safeguards against illicit export of drugs produced under compulsory licenses. The industry and the Bush Administration sought to include these assurances and safeguards in the implementation agreement so they would have more legal force, but they eventually agreed to accept a General Council chairman's statement outlining these conditions. “Zoellick Vows to Work for TRIPS Deal, Lays Out U.S. Conditions,” Inside U.S. Trade (Aug. 1, 2003): 7–8; see also General Council Chairperson Carlos PÈrez del Castillo, The General Council Chairperson's Statement (Aug. 30, 2003), available at <http://www.wto.org/english/news_e/news03_e/trips_stat_28aug03_e.htm> [“Chairperson's Statement”] (last visited November 12, 2003).

See, e.g., Flawed WTO Drugs Deal Will Do Little to Secure Future Access to Medicines in Developing Countries, Doctors Without Borders (Aug. 20, 2003), at <http://www.msf.org/content/page.cfm?articleid=C1540425–7F56–4D60-A6CB9D7ABA6D627F> (last visited December 9, 2003); Smith Tony , “Mixed View of Pact for Generic Drugs,” New York Times, August 29, 2003, at C3.

See Agreement Establishing the World Trade Organization, Art. X (setting out procedures for amendment of WTO multilateral agreements, including TRIPS).

Charnovitz Steve , “The Legal Status of the Doha Declaration,” Journal of International Economic Law 5 (2002): 207–211; see also Agreement Establishing the World Trade Organization, Art. IX(2) (setting out procedure, not followed at Doha, for adoption of formal interpretations of a WTO multilateral agreement by a three-fourths vote, on the basis of a recommendation by the Council overseeing the agreement).

Charnovitz , supra, note 106. Art. IV(l) of the Marrakesh Agreement states as follows: “The Ministerial Conference shall have the authority to take decisions on all matters under any of the Multilateral Trade Agreements, … in accordance with the specific requirements for decision-making in this Agreement and in the relevant Multilateral Trade Agreement.” Art. 111(2) states that the WTO provides “a framework for the implementation of the results” of multilateral trade negotiations “as may be decided by the Ministerial Conference.” These ambiguous references to Ministerial Conference decisions leave open the question of whether the Conference's decision-making authority concerning the meaning of TRIPS and other multilateral trade agreements extends beyond its power, under Art. X, to amend these agreements and its authority, under Art. IX(2), to formally interpret them.

The Vienna Convention on the Law of Treaties , with annex, done at Vienna, UNGA UN Doc. A/Conf, 39/27, May 23, 1969.

Id. Art. 31(3)(a).

Id. Art. 31(3)(b).

Id. Art. 31(3).

Id. Art. 3 1 (1).

See generally Charnovitz , supra, note 107.

This power, of course, is subject to the unlikely possibility of the Appellate Body's being overruled (or “not adopted”) by consensus in the Dispute Settlement Body within 30 days of circulation of the Appellate Body report. Understanding on Rules and Procedures Governing the Settlement of Disputes, Art. 17(14).

Jackson , supra, note 5, at 124–27.

Understanding on Rules and Procedures Governing the Settlement of Disputes, Art. 8.

A classic example is the National Labor Relations Board. This awkward mingling of rule orientation and responsiveness to political currents raises nettlesome legitimacy questions, beyond our scope here. These questions are even more difficult for the WTO than for domestic administrative agencies, owing to (i) the contractual nature of member states' commitments to the WTO and its associated treaties, and (ii) the absence of any international institutional or constitutional system, analogous to legislative oversight and presidential supervision of administrative agencies, by which WTO decision makers can be held to account for the balances they strike between trade concerns and other public values. For a discussion of these problems and some ideas about how to ameliorate them, see Howse Robert L. Nicolaidis Kalypso , “Legitimacy and Global Governance: Why Constitutionalizing the WTO is a Step Too Far,” in Porter R. B. eds., Efficiency, Equity, and Legitimacy: The Multilateral Trading System at the Millennium, (Washington: Brooking Institution Press, 2001): 227–252.

The Declaration on the TRIPS Agreement and Public Health is illustrative. The Ministerial Conference reached agreement only after the U.S. dropped its efforts to obtain language portraying pharmaceutical firms' intellectual property rights more expansively. Yerkev Gary G. Pruzin Daniel , “Agreement on TRIPS/Public Health Reached at WTO Ministerial in Doha,” BNA International Trade Report 18 (November 15, 2001): 1817–1819. Some developing nations had threatened to hold up the issuance of another ministerial statement, launching a new Doha round of trade talks (a high priority for the U.S. and other industrialized countries), unless the U.S. compromised on TRIPS. Pruzin Daniel , “Global Drug Industry Association Blasts ‘Nutty’ WTO Text on TRIPS, Public Health,”' BNA International Trade Report 18 (November 8, 2001): 1782–1783; EC — Hormones, supra, note 55, is also illustrative. Although the U.S. prevailed, it did so on narrow grounds, with the Appellate Body endorsing a more deferential approach to member states' health risk assessment under e SPS agreement than the U.S. had urged. See supra, text accompanying notes 57–69.

See National Foreign Intelligence Board, Global Trends 2015: A Dialogue about the Future with Nongovernment Experts , (Washington: National Intelligence Council, 2000) (warning that AIDS and other health crises undermine development of effective economic and political institutions and aggravate domestic and international conflicts); Kassalow Jordan S. , Why Health is Important to U.S. Foreign Policy (Washington: Council on Foreign Relations & Milbank Memorial Fund, 2001) (urging that U.S. foreign policy work toward improving international health through a variety of economic and political means).

See Loewenstein George F. , “Risk as Feelings,” Psychology Bulletin 127 (2001): 267–286 (arguing, based on review of empirical literature, that people's beliefs and decisions concerning risk often vary from those predicted by expected utility and rational choice theory); see also Gregg Bloche M. , “The Invention of Health Law,” California Law Review 91 (2003) 247–322 (weighing legal and policy implications of subjectivity and variation in perceptions of health and medical risk).

See Bloche, supra, note 120 (discussing obstacles to pursuit of systematic rationality in health policy).

See Breyer Stephen , Breaking the Vicious Circle: Toward Effective Risk Regulation (Cambridge: Harvard University Press, 1993) (offering proposals for more expeditious pursuit of systemic rationality in U.S. risk regulation and arguing that visible striving toward this goal, by highly competent federal authorities, would enhance the actual and perceived legitimacy of regulatory governance).

There is an analogy here to the contention that international criminal tribunals for human rights abusers are problematic because their interpretations of law are not nested in a single, national legal and political culture, as are rulings by domestic criminal courts.

Indian Constitution of 1950, Art. 37.

Olga Tellis v. Bombay Municipal Corp. , A.I.R. (Bom.) 1996.

Id. at paras. 32–33. The Court opined that “[the State may not, by affirmative action, be compellable to provide adequate means of livelihood or work to the citizens,” but “any person, who is deprived of his right to livelihood except according to just and fair procedure established by law, can challenge the deprivation as offending the right to life …” Id. at para. 33.

Art. XIX of the General Agreement on Trade in Services (GATS) calls for progressive rounds of negotiation over liberalization of trade in services. The Ministerial Conference in Doha set out a “Work Programme” calling for a round of such talks, leading to an exchange of trade liberalization commitments. Ministerial Declaration, Ministerial Conference, 4th Session, Doha November 9, 2001, WT/MIN(01)/DEC/1 para. 15 (November 20, 2001). Hospital management services, competition between the private and public sectors in health care, managed health care, and other medical insurance products are among the activities and ventures that fall within the GATS. See Lipson Debra J. , “The World Trade Organization's Health Agenda,” British Medical Journal 323 (2001) 1139–1140; warning that liberalized trade in health services, pursuant to GATS, could reduce poor people's access to care.

Indeed, at Doha, the Ministerial Conference explicitly declined to recognize such a right. A draft ministerial declaration proposed by a group of developing countries called for the Conference to present its TRIPS pronouncements as, in part, a “discharging” of “the obligation to protect and promote the fundamental human rights to life and the enjoyment of the highest attainable standard of physical and mental health, including the prevention, treatment and control of epidemic, endemic, occupational and other diseases and the creation of conditions which would assure to all medical service and medical attention in the event of sickness, as affirmed in the International Covenant on Economic, Social and Cultural Rights.” TRIPS: Proposal: Draft Ministerial Declaration: Proposal from a Group of Developing Countries, IP/C/W/312, WT/GC/W/450, October 4, 2001 (01–4803), http://www.wto.org/english/tratop_e/trips∼_e/mindecdraft_w312_e.htm (visited Feb. 11, 2002). The Ministerial Conference did not include such a statement in its Declaration on TRIPS.

For some, this idea is an oxymoron: Many hold that there is no such thing as a right without a legal remedy. We are of the view that the idea of a non-justiciable right can make pragmatic sense, but consideration of this complex jurisprudential question is beyond our scope here.