The Interpretation of the TRIPS According to the Doha Declaration

not legally binding, it still constitutes soft law with substantial hortatory authority that puts political pressure on governments and international institutions to comply.⁸⁹

2.2. The Interpretation of the TRIPS According to the Doha Declaration

If the in Doha Declaration has interpretive weight according to some scholars assert, its influence on TRIPS can be explained as follow: The Doha Declaration on the TRIPS Agreement, adopted on 14 November 2001, explicitly underscored that it is necessary for the TRIPS Agreement to address issues in respect of health problems which afflicted developing countries and least-developed countries. It calls upon attentions for placing the needs and interest in those countries at heart of application of TRIPS provisions. Declaring that members should make positive efforts designed to deal with the issues.

87 See IAN BROWNLIE, PRINCPLES OF PUBLIC INTERNATIONAL LAW 15 (4^th ed. 1990); Bruno Simma&

Philip Alston, The Sources of Human Rights Law: Custom, Jus Congens, and General Principles, 12 Austl. Y. B. Int’l L. 82 (1992); OSCARSCHACHTER, INTERNATIONAL LAW IN THEORY AND PRACTICE 85 (1991); ANTHONY AUST, MODERN TREATY LAW AND PRACTICE 26-46 (2000).

88 Abbott Frederick M., The TRIPS Agreement, Access to Medicine and the WTO Ministerial Declaration, 5 J. WORLD INTELL. PROP. 15, 612 (2002).

89 RESTATEMENT (THIRD) OF FOREIGN RELATIONS LAW OF THE UNITED STATES, § 103 cmt. c (1987);

see also James T. Gathii, Good government as a Counter Insurgency Agenda to Oppositional and Transformative Social Projects in International Law, 5 BUFF. HUM. RTS. L. REV. 65, 117-20 (1990).

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The declaration plays an important role in connecting the application of intellectual property rights stipulated by TRIPS and the crucial problems of public health facing less-developed countries. It officially recognize the gravity of health problems in these countries, especially those resulting from HIV/AIDS, tuberculosis, malaria and other epidemics, pointing out that TRIPS should be “interpreted an implemented in a manner supportive of WTO members’ right to protect public health and in particular, to promote medicine for all”⁹⁰ It acknowledged that ensuring respect of intellectual property rights protection is an essential way to incentivize the development and research of new drugs. At the same time, it also recognized the concerns expressed by developing countries about the effect of patent protection on the price of drugs. Thus, by giving weight of effectiveness to the declaration interpreting TRIPS, the facilitation of use of compulsory license was a main focus as a means dealing with the access to medicines.

By examining the context of the declaration, much effort was put in establishing a mechanism useful for issuance of compulsory license by which developing countries can make use of in order to provide access to drugs for the diseases-stricken portion of their populations. As elucidated in Paragraph 5, it states that “each [WTO] member has the right to determine what constitute a national emergency, it being understood that public health crises, including those relating to HIV/AIDS, tuberculosis, malaria and other epidemics, can represent a national emergency or other circumstances of extreme urgency.” In addition, Paragraph 5 further provides that

90 The Doha Declaration on the TRIPS Agreement and Public Health, WT/MIN (01)/Dec/2 (Nov. 14, 2001).

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compulsory licenses can be granted under domestic law without prior negotiation without patent owners.⁹¹

The Doha Declaration allows nations additional flexibility under TRIPS with regard to granting compulsory licenses, defining national emergencies. To the extent these options under the Declaration are utilized by WTO members, they help constitute subsequent practice that can be used in interpreting the TRIPS agreement.

Moreover, a mechanism was establish to permit countries with incapacity and insufficiency of manufacturing generic drugs to solicit importation of generic versions of patented drugs under compulsory licenses to third party countries. It is a notable design considering that, before Doha, only countries such as India and Brazil had considerably large pharmaceutical manufacturing capacities, making them able to take advantage of the compulsory licensing provision. The manufacturing capacity in generic versions of medicine was crucial under circumstances that multinational companies with forfeited patents refused to continue production or supplying the country with these medicines.

In conclusion, the Doha Declaration on TRIPS and Public Health

91 Paragraph 5 of the Doha Declaration on TRIPS and Public Health states: “Accordingly and in the light of paragraph 4 above, while maintaining our commitments in the TRIPS Agreement, we recognize that these flexibilities include:

a. In applying the customary rules of interpretation of public international law, each provision of the TRIPS Agreement shall be read in the light of the object and purpose of the Agreement as expressed, in particular, in its objectives and principles.

b. Each member has the right to grant compulsory licences and the freedom to determine the grounds upon which such licences are granted.

c. Each member has the right to determine what constitutes a national emergency or other circumstances of extreme urgency, it being understood that public health crises, including those relating to HIV/AIDS, tuberculosis, malaria and other epidemics, can represent a national emergency or other circumstances of extreme urgency.

d. The effect of the provisions in the TRIPS Agreement that are relevant to the exhaustion of intellectual property rights is to leave each member free to establish its own regime for such exhaustion without challenge, subject to the MFN and national treatment provisions of Articles 3 and 4.”

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clarifies the reference in TRIPS Article 31 to emergencies and remuneration that justify the issuance of compulsory licenses. However, one commentator has argued that this approach “leaves the door wide open for abuses by allowing WTO members absolute subjective power in determining whether to issue a compulsory license.”⁹²