(2002; 56 pages) [French] [Spanish]
Doha Declaration on TRIPS and Public Health: Sub-paragraph 5 (c)
5. Accordingly and in the light of paragraph 4 above, while maintaining our commitments in the TRIPS Agreement, we recognize that these flexibilities include: ...
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.
Paragraph 5 (c) of the Doha Declaration states what is an unquestionable right of Members States: the right to determine “what constitutes a national emergency or other circumstances of extreme urgency”. Such determination may be relevant for the granting of compulsory licences, the establishment of exceptions under Article 30, or the adoption of other measures permitted under Article 8.1 of the Agreement51.
Paragraph 5 (c) also includes a presumption:
“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”.
51 In May 2002, the Minister of Justice, Legal and Parliamentary Affairs of Zimbabwe issued a Declaration of Period of Emergency (HIV/AIDS) (Notice, 2002). In view of the rapid spread of HIV/AIDS among the population of Zimbabwe, the Minister declared “an emergency for a period of six months, with effect from the date of promulgation of this notice, for the purpose of enabling the State or a person authorised by the Minister under section 34 of the Act (a) to make or use any patented drug, including any anti-retroviral drug, used in the treatment of persons suffering from HIV/AIDS or HIV/AIDS related conditions; (b) to import any generic drug used in the treatment of persons suffering from HIV/AIDS or HIV/AIDS-related conditions”. A Declaration of Sanitary Emergency until 31 December 2002 was also issued by the Executive Power of Argentina (Decree 486, 12 March, 2002), but it does not make explicit reference to patent law provisions.
This provision is important for three reasons. First, it clarifies that “public health crises” can represent “a national emergency or other circumstances of extreme urgency”, thereby allowing for the granting of compulsory licences when provided for under national law52 and, pursuant to TRIPS Article 31 (b), without the obligation for prior negotiation with the patent owner.
52 A survey covering the patent laws of 70 developing countries indicates that only 13 have provided for national emergency or health emergency as specific grounds for the granting of compulsory licences. See Thorpe (forthcoming 2002).
Second, the reference to “HIV/AIDS, tuberculosis, malaria and other epidemics” indicates that an “emergency” may be not only a short-term problem, but a long-lasting situation, as is the case with the epidemics specifically mentioned for illustrative purposes. This recognition may be deemed an important achievement for developing countries in the Doha Declaration, since it implies that specific measures to deal with an emergency may be adopted and maintained as long as the underlying situation persists, without temporal constraints.
Third, if a Member complains about the qualification of a specific situation by another Member as a “national emergency or other circumstances of extreme urgency”, the language of paragraph 5 (c) places the burden on the complaining Member to prove that such emergency or urgency does not exist. This represents an important difference with respect to earlier GATT/WTO jurisprudence outside of the TRIPS context that, under the “necessity test”, put the burden of proof on the Member invoking an exception to its obligations53.
53 See, Correa, 2000b.