scp_15_3-annex5.pdf - SCP/15/3 ANNEX V 5 Patent...

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SCP/15/3 ANNEX V 5. Patent Exceptions and Limitations in the Health Context by Coenraad Visser Table of Contents 1 Human Rights Framework ................................................................................................. 1 2 Patent Exceptions and Limitations ..................................................................................... 3 2.1 Compulsory licences ............................................................................................... 3 2.2 Individual Prescriptions ........................................................................................ 24 2.3 Parallel imports ..................................................................................................... 24 2.4 Regulatory Exception ............................................................................................ 26
SCP/15/3 Annex V, page 1 Patent Exceptions and Limitations in the Health Context 1 Human Rights Framework A fundamental distinction in human rights law is between the so-called civil and political rights (“first generation” rights), on the one hand, and socio-economic rights (“second generation” rights), on the other. The former are “negative” rights that curb state power by imposing a duty on it not to act in certain ways; the latter are “positive rights” that impose obligations on the state to secure for its citizens a basic set of social goods - education, health care, food, water, shelter, and access to land and housing. The most important international instrument on socio-economic rights is the International Covenant on Economic, Social and Cultural Rights (ICESCR) 1 of 1966, which has been ratified by some 130 states. One of the substantive rights recognized by the Covenant is “the right of everyone to the enjoyment of the highest attainable standard of physical and mental health”. 2 In particular, parties are obliged to take steps necessary for “the prevention, treatment and control of epidemic, endemic, occupational and other diseases”, 3 and “the creation of conditions which would assure to all medical service and medical attention in the event of sickness”. 4 The overarching obligation imposed by the Covenant is “to take steps, individually and through international assistance and co-operation, especially economic and technical, to the maximum of its available resources, with a view to achieving progressively the full realization of the rights recognized in the present Covenant by all appropriate means, including particularly the adoption of legislative measures”. 5 It is important to note that the obligation is not absolute 6 - states have to move “progressively” towards the full realization of the right, and they have to do so within their available resources. Many constitutional democracies incorporate socio-economic rights along the lines of the Covenant. Some do so in the form of directly enforceable rights, 7 while the majority 1 GA res. 2200A (XXI), 21 UN GAOR Supp. (No. 16) at 49, UN Doc. A/6316 (1966); 993 U.N.T.S. 3; 6 I.L.M. 368 (1967) [hereinafter “ICESCR”]. It entered into force on 3 January 1976, in accordance with Article 27. 2 ICESCR, Art. 12(1). 3 ICESCR, Art. 12(2)(c). 4 ICESCR, Art. 12(2)(d). 5 ICESCR, Art. 2(1). 6 Compare Art. 2(1) of the International Covenant on Civil and Political Rights, GA res. 2200A (XXI), 21 UN GAOR Supp. (No. 16) at 52, UN Doc. A/6316 (1966); 999 U.N.T.S. 171; 6 .IL.M. 368 (1967): : “Each State Party ... undertakes to respect and ensure to all individuals within its territory and subject to its jurisdiction the rights recognized in the present Covenant.” 7 For example, Hungary (Constitution of the Republic of Hungary, 1949, as amended, Art. 70/D), Lithuania (Constitution of the Republic of Lithuania, 1992, Art. 53), Portugal (Constitution of the Portuguese Republic, 1976, Art.

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