Implications of the Doha Declaration on the Trips Agreement and Public Health - Health Economics and Drugs Series No. 012
(2002; 56 pages) [French] [Spanish] View the PDF document
Table of Contents
View the documentForeword
View the documentAcknowledgements
View the documentAbbreviations and acronyms
View the documentExecutive summary
View the documentIntroduction
View the documentScope
View the documentThe role of TRIPS and IPRs
Open this folder and view contentsPublic health measures
Open this folder and view contentsFlexibility in TRIPS
Close this folderMembers with insufficient or no manufacturing capacities
View the documentAddressed problem
Close this folderPossible approaches
View the document(a) Article 31 (f)
View the document(b) Article 30
View the document(c) Moratorium
View the documentSafeguards
View the documentCompulsory licence in the importing country
View the documentEconomic feasibility
View the documentLegal implementation
View the documentTransfer of technology to LDCs
View the documentExtension of transitional period for LDCs
View the documentSpecial treatment under TRIPS
View the documentLegal status of the Doha Declaration
View the documentIssues not covered in the Declaration
View the documentConclusions
View the documentAnnex 1 - Doha Declaration on the TRIPS Agreement and Public Health
View the documentAnnex 2 - Levels of development of pharmaceutical industry, by country
View the documentReferences
 

(c) Moratorium

A moratorium93 does not imply any change of the substantive treaty obligations; it only temporarily suspends their operation94. The moratorium approach offers an “expeditious” response to the problem posed by paragraph 6, but not a “solution”, since it would not be straightforward enough either to induce potential exporting countries to change their legislation to permit production for export, or to induce generic manufacturers to invest in creating or increasing export capacity. In addition, it is unclear what procedures would be applied in order to adopt a moratorium, and whether formal changes to the TRIPS Agreement would be necessary95.

93 A “moratorium” is “a period during which an obligor has a legal right to delay meeting an obligation” (Blacks’ Law Dictionary, Abridged Sixth Edition, St. Paul, Minnesota, West Publishing, 1991, p. 698).

94 See Article 57 of the Vienna Convention of the Law of Treaties.

95 See, e.g. Article 64.2 of the TRIPS Agreement, which established a five years moratorium for “non-violation” complaints.

Though most waivers apply to just one named contracting party, in GATT history at least two waivers were framed in general terms to apply to any contracting party who fulfilled the criteria. At their eleventh session, the Contracting Parties formulated a series of guidelines for the issuance of waivers, partly as a response to the perception that a waiver could produce an effect substantially the same as an amendment (Jackson, 2000, p. 29).96 In exceptional circumstances, the Ministerial Conference can, by a three-fourth majority, waive an obligation imposed on a Member, for a determined period. A waiver is bureaucratic to administer, since it requires regular renewal by the Ministerial Conference if granted for a period of more than one year97.

96 Procedures adopted November 1, 1956, Basic Instruments and Selected Documents, 5th Supplement, 25.

97 See Article IX. 3 and 4 of the Agreement.

The main characteristics and some implications of the three above-examined proposed solutions are presented in Table 1.

Table 1

The main proposed solutions in comparison

Option

Steps to achieve

Conditions98

Considerations

Considerations

(a) To amend Article 31 (f) to carve out an exception for exports under CL, or to remove limitations on export entirely.

a. Agreement to reopen TRIPS and approval of amendment
b. Changes in national laws
c. Grant of CL

a. Criteria to ensure importing countries face serious public health problems
b. Safeguards against re-exportation of CL product
c. Reporting of action to trading partners

* Requires granting of two CLs
* Requires compensation in exporting and importing countries
* Changes in CL legislation in importing countries may be required

* Would require exporting country to asses “capacity” of importing country
* Subject to pressures both in importing and exporting
* Granting of licence case-by-case

(b) To interpret limited exceptions clause of Article 30 to allow production for export to countries with no or inefficient manufacturing capacity

a. Authoritative interpretation (¾ vote)
b. Change in national laws of exporting countries
c. Change in CL legislation in importing countries may be required

a. Entirety of the product must be exported to countries with the public health problem
b. Prohibition of re-export.

* Export country not required to do a case-by-case decision
* No amendment of TRIPS needed
* Compensation payable only in importing country

* Any party can invoke the exception, at any time, in exporting country

(c) Moratorium on WTO complaints/disputes

Ministerial Conference/Amendment

Criteria to be established

* Not a solution, as such, since it is only temporary
* The criteria could be disputable even if mechanism is not

 

CL = compulsory licence.

98 According to proposals by the USA and the EC and their Member States.

As indicated in the precedent Table, an Article 30-based solution would be more straightforward than one based on Article 31 (f). Some Members may fear that an authoritative interpretation of Article 30 might spill over into unforeseen categories of intellectual property, particularly copyright, because of the existence of a similar exceptions provision. However, appropriate wording may be adopted in order to avoid an unintended reading of such an interpretation.

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