FACTOR TECNOLÓGICO

It is now beyond question that international law exists to the clear effect that the right to health is a human right: According to the United Nations Committee on Economic, Social and Cultural Rights of 2000 (CESCR), the right to health includes a right to adequate and affordable health care, and imposes minimum core duties on governments. Lisa Foreman

400 _{World Bank, ‘Public and Private Sector Approaches to Improving Pharmaceutical Quality in}

Bangladesh’, Bangladesh Development Series Paper No. 23, March 2008, pp. 5, 15.

points out that ‘two-thirds of all countries ((153 of 192) have ratified the CESCR.402 Nevertheless, this Convention does not constitute binding law. That it has no more than a normative influence is evident in the fact that:

… despite AIDS being the worst infectious pandemic in modern history, the majority of infected people lack access to lifesaving, antiretroviral therapies. In sub-Saharan Africa, where over two-thirds of all people with HIV are located, only 28 percent have access to antiretroviral treatments.403

On Foreman’s view, what is lacking is an ‘established legal relationship between human rights and TRIPs obligations at both a practical and theoretical level’.404 This thesis writer is inclined to agree with Foreman, despite the well-worked case of Holger Hestermeyer, who argues that this legal relationship is in fact established by the TRIPs provisions themselves.405 Hestermeyer rightly points out that pharmaceutical patent rights are modified by specific provisions that take note of the human right to health of poor nations. The following are those statutory modifications:

(i) Article Art. 27(1) provides that WTO Members must grant patents ‘for any inventions ... in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application’.

(ii) Article 29 provides that if the invention is patentable, the inventor obtains a patent with a term of at least twenty years from the date of filing.

(iii) Article 33 provides that a patent on a product enables the patent-holder to prevent third parties from ‘making, using, offering for sale, selling or importing’ the product without that patent holder’s consent.

402 _{Foreman, Lisa, ‘Trade Rules, Intellectual Property, and the Right to Health’, vol. 21, no. 3, Ethics &} International Affairs, 2007, p.345.

403 _{Ibid. p.337.} 404 _{Ibid. p.346.}

405 _{Hestermeyer, Holger P. Human Rights and the WTO: the Case of Patents and Access to Medicines,}

However, as the 2001 Doha Declaration406 pointed out, these provisions allow for certain substantial ‘flexibilities’ that give access to patent medicines to poor countries. The ‘flexibilities’ are the following:

Article 31 enables the granting by Members of compulsory licences, so long as those members are able to put a convincing case for their need for such a licence, they pay within a reasonable time a remuneration for it that the patent holder considers reasonable. In the event of a national emergency, the ‘reasonable time’ requirement may be waived. Article 31(f) provides that patent medicines manufactured under compulsory licence are done so only for the supply of the local market that has obtained the licence. That is, ‘compulsory licence’ products are not exportable.

The export ban, of course, put at great disadvantage on countries without adequate manufacturing facilities. The Doha Declaration claimed to be aware of this situation, and to have moved to correct it with its Paragraph 6.407 That, Hestermeyer claims, constituted a waiver under Article IX of the WTO Agreement that effectively amounted to a revision of the TRIPs.408 That waiver, basically, lifted the Article 31 export ban on medicines produced under compulsory licence. But the waiver is subject to strenuous conditions: the intending importer must (i) notify the Council for TRIPs of the name and expected

quantity of the medication; (ii) prove that it is without the means of manufacturing the medication it intents to import; (iii) confirm that it has or will grant a compulsory licence if that medication is to be patented in its territory. With that process complete, the

406 _{Declaration on the TRIPs Agreement and Public Health, Doc. WT/MIN(01)/DEC/2, 20 November 2001.} 407 _{Doha Declaration on the TRIPs Agreement and Public Health, Doc. WT/L/540, 2 September 2003.} 408 _{Hestermayer, note 405, p. 109.}

exporting Member can issue a compulsory licence limited to the declared needs of the importing Member, and require that importing Member to colour-code (and otherwise identifying) the imported medications to prevent their re-export. Members can form pools as importers. This mechanism is subject to the annual review of the Council for TRIPs. For it to work, exporting members must amend their local patent laws to accommodate it. Doc. WT/L/641 (8 December 2005) amended the TRIPs with Article 31 bis409 to make this mechanism permanent.

Hestermeyer acknowledges that when Médecins Sans Frontières tested this new TRIPs provision in an effort to import the HIV drug TriAvir from the Canadian company Apotex, the mechanism proved too cumbersome, and in fact considerably more

expensive than its importation from India would have been. He nevertheless sees this as a procedural problem, and not as a problem intrinsic in the TRIPs.410 Médecins Sans Frontières, however, point out that ‘not a tablet of medicine has reached a single patient to any LDC under this WTO mechanism’.411

Even if one were to grant optimistically that the Médecins Sans Frontières’s Rwanda experience is attributable to something as eminently correctable as procedure, it would remain true that neither Article 31 bis nor the Doha Declaration took note of the ‘TRIPs- plus’ circumstances that work to restrict compulsory licensing rather than enable it. The

409 _{WTO General Council, ‘Amendment of the TRIPs Agreement’,}

http://www.wto.org/english/tratop_e/trips_e/wtl641_e.htm.

410 _{Hetermeyer, note 405, p. 189.}

411 _{Médecins Sans Frontières, ‘Neither expeditious, nor a solution: The WTO August 30th decision is}

unworkable’ Canada, MSF, 2006,

http://www.msf.ch/fileadmin/user_upload/uploads/communiques/images_2006/pdf/came_Neither_expediti ous_nor_a_solution_-_August_30_and_the_JCPA_single_page.pdf.

progenitors of TRIPs-plus conditions regarding patent medicines are the regional trade agreements, like the Free Trade Area of the Americas (FTAA) and the US-Central American Free Trade Agreement (CAFTA), that often make a point of committing partner states to foregoing the compulsory-licensing waivers of the TRIPs.412 Clearly, there is no possibility that the human right to health will attain the status of binding international law while bi-lateral trade agreements remain free to cripple even the gestures in the direction of recognizing such a law that the Doha Declaration and Article 31 bis of the TRIPs have made.

4.8 Conclusion

This Chapter attempted to make out an argument to the effect that the TRIPs should implement as binding law specific demands upon the form and content of domestic legislatures to be capable of response to requests from least-developed and developing countries acting on the compulsory licensing facility. If the TRIPs can make such demands for the protection of GIs, then nothing prevents it from doing so to make its compulsory licensing facility workable. This argument was derived from a context that (i) estimated the Paris Convention provisions regarding compulsory licensing above the TRIPs provions; (ii) gainsaid Chien’s view that compulsory licensing somehow harms the pharmaceutical industry; (iii) outlines the TRIPs GI regime to serve as a comparison with its compulsory licensing regimes; (iv) celebrated India’s clever handling of the interim between the Paris Convention and the TRIPs that earned her a sound

pharmaceutical industry; and (v) noted the exposure by Médecins Sans Frontières that

412_{Médecins Sans Frontières ‘Top ten list of the year's most underreported humanitarian stories’, Media}

the compulsory licensing facility was unworkable by the least-developed countries, and, according to another source, is inert in China for fear of trade reprisals; and (vi)

condemned the bullying tactics of the US ‘Special 301’.

The argument itself relied upon a distinction (of considerable pedigree) between ‘the rule of law’ and ‘rule by law’, making use of Intan Ramli’s method. The crux of the

argument was there while WTO member states are free to implement domestic legislation (or not implement it) with regard to their response-styles to requests for production and importation of medicines under the compulsory licensing facility, that facility is not grounded in law. Law and only law confers rights, and only law enables the redress of the denial of rights. The TRIPs compulsory licensing facility is therefore not law. Notably, the TRIPs regime regarding GIs in the wine and spirits industry is law. It was urged that if TRIPs can construct real law to protect wines and spirits, it can construct real law to protect the right to essential medicines of the people’s of least-developed countries.

A final look at the TRIPs from the point of view of the human right to health concluded that this agreement, the Doha Declaration notwithstanding, remains far away from acknowledging this human right.

In the next Chapter, the allegations levelled against the TRIMs by WTO member states will be discussed, including the predicament posed by trade from multi-national

companies resorting to transfer pricing, restrictive business methods, and other unfair practices. It will also discuss why TRIMs requires all WTO members to eliminate

domestic content requirements and why import/export balancing requirements are placed upon foreign affiliates.

The goal will be to demonstrate how the scope of the TRIMs is very narrow, and how the WTO is yet to make its ruling on the admission of foreign investment, or on such

concerns as financial incentives, tax reductions and the grading of land and various services in a privileged manner, nor does it dwell at all significantly on exclusions or the easing of restrictions existing at the national level.

Chapter 5