The Trade-Related Aspects of Intellectual Property Rights (TRIPS) is a comprehensive multilateral agreement setting minimum uniform standards of IP protection and enforcement in all WTO Member States.[1] Its provisions require a substantive degree of IP protection for all members, including a twenty year term of protection[2] that confers the exclusive right to prevent third parties from capitalizing in any way on a product that is the subject of the patent.[3]
While TRIPS is a benefit to Member States with the manufacturing capacity to sustain drug production, it represents a substantial barrier for developing and least developed countries ((L)DCs) in the context of access to medicines. By insisting that Member States implement strict patent protection, TRIPS ensures that patentees (largely situated in developed countries) can charge monopoly prices in markets of their choosing, and exclude generic manufacturers from producing cheaper versions for use in markets patentees have conscientiously preferred to avoid. This places a deadlock restriction on access to medicines in poor countries whose consumers substantially cannot pay monopoly prices. Additionally, these countries largely lack the manufacturing infrastructure to support domestic drug production. It is no surprise that patentees argue the impact of TRIPS will be minimal in this regard; many others insist on the contrary.[4] Clearly, strategies need to be implemented to prevent the TRIPS status of (L)DCs from castrating humanitarian drug access regimes.
Article 31 of TRIPS does permit compulsory licensing on domestic soil. Compulsory licensing occurs when government overrides a patent and allows a generic manufacturer (GM) to produce and sell that drug without patentee approval; it is only sanctioned for acute reasons such as emergencies or crises,[5] is limited to the purpose for which it is authorized and is to be terminated when the motivating circumstances cease.[6] Article 31 only permits manufacturing and distribution domestically however, and so is of no use to (L)DCs, which lack the capacity to produce their own generics. It also fails to address chronic global disease issues faced by these nations.
Patents arguably have little to no value in poor nations. Since patentees have deliberately avoided these markets, they derive comparatively miniscule revenue from them, if any at all. Flexible patents legislation in these regions would afford little to no economic loss for them.[7] However, Western governments and patentees continue to push for full TRIPS compliance in (L)DCs by 2016 at the latest. This lobby effort is ominous for countries and NGOs working to solve the disease crises in these nations; already anorexic humanitarian efforts will be further impeded, and the aggressive tone of patentees does not suggest that there will be any flexibility or creativity on their part in helping to support a continued global effort.
Certainly, the Doha Declaration (November 2001) and subsequent WTO August 2003 Decision have paved the way for Member States to issue compulsory licences for generic manufacturers to make drugs for export to (L)DCs. But these “relief valve” provisions, and any Western legislation that has implemented them to date,[8] are onerous, prohibitive and functionally impotent. In fact, no (L)DC has requested the use of these provisions to date, even though the need is glaringly apparent, signaling the failure of these provisions to even closely represent an efficacious solution to the access to medicines problem. On the contrary, the alleged solutions are designed for the full TRIPS intent to remain in force, while providing placating paper promises to “persistent” humanitarian parties. The horizon is bleak for many (L)DCs. Canada must make a concerted effort to fulfill its international humanitarian obligations by amending its “access to medicines” legislation to be more accessible, inviting to (L)DCs and GMs, and able to achieve its objective; it must also press the international community to guard against the impending consequences TRIPS will pose to disadvantaged nations and the collective humanitarian access to medicines effort.
[1] Maxwell R. Morgan, “Medicines for the Developing World: Promoting Access and Innovation in the Post-TRIPS Environment” (2006), 64 U.T. Fac. L. Rev. 45 at para. 19 [Morgan].
[2] Michael J. Trebilcock & Robert Howse, The Regulation of International Trade, 3d ed. (
London: Routledge, 2005) at 413 [Trebilcock].
[3] Morgan, supra note 1 at para. 20.
[4] Ibid., at para. 46.
[5] Trebilcock, supra note 2 at 413.
[6] Morgan, supra note 1 at para. 22.
[7] Ibid., at para. 17.
[8] For example, Canada’s Access to Medicines Regime (CAMR), now implemented as ss. 21.01-21.2 of the Patent Act, R.S.C. 1985, c. P-4.