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ensure long-term access to treatments by the poorest popula-tions [2, 5]. The resolutions of 61
World Health Organization(WHO)’s World Health Assembly included patent pools as partof the whole Global Strategy on Public Health, Innovation andIntellectual Property aimed to increase access to medicines,stimulate R&D related to diseases that disproportionately af-fect the developing world, and delink R&D costs from the endproduct prices .A patent pool is created when a number of patents by dier-ent owners are pooled and made available on a non-exclusivebasis to third parties (for instance, the generic drug manufac-turers).Major commitment to putting the patent pool idea into ef-fect, by initially focusing on ARVs, is shown by UNITAID in itsreference eld as an international facility to provide long-termfunding to increase access to drugs and diagnostics for HIV,malaria and tuberculosis (TB) . As of November 1, 2010, the“Medicines Patent Pool” has transitioned out of UNITAID, and isfunctioning as a separate legal entity, though UNITAID contin-ues to support it and is funding its operations under a ve-yearMemorandum of Understanding .From public health and political economy perspectives, a keyissue is how to design a suitable trade context for making thepatent pool for ARVs both politically feasible and eective inachieving its goals. This paper contributes to debate and dis-cussion of these issues.
A Troublesome Matter for MultinationalManufacturers
The patent pool plan invites patent holders to oer the intel-lectual property (IP) related to their inventions to the Medi-cines Patent Pool [7, 8]. Any company that wants to use the IPto produce or develop ARVs can seek a license from the poolagainst the payment of royalties, and may then produce themedicines for use in developing countries (conditional uponmeeting agreed quality standards). The plan relies on a volun-tary mechanism, meaning its success will depend on the will-ingness of originator pharmaceutical companies to participateand commit their IP to the pool. Quantied benets are ex-pected to encompass, through greatly increased competition,substantially lower prices for second and third-line patent poolgenerated xed-dose combination (FDC) ARVs
.So compounded, the pool could help overcome inadequacieslimiting the roles currently played by the brand and generic
FDC ARVs are multiple antiretroviral drugs combined into a single pill. They may combine dierent classes of ARVs or contain only a single class. These combinations allow people living with HIV to reduce the risk of developing virus resistance to treatments, while making life easier andincreasing adherence by reducing the number of pills to be taken eachday.
World Health Organization’s TRIPS (Trade-Related Aspects of IntellectualProperty Rights) exibilities: http://www.wto.org/English/tratop_e/trips_e/intel2_e.htm
- Agreement with the patent’s owner formanufacturing and marketing. Notwithstanding royalty ratesimposition on generic rms, these licenses only imply straightforwardagreements between companies; they do not require changes innational legislation, while including non-exclusivity, openings towardstechnology transfer, access to owner’s data for branded drugs as well aspermission for export.
- When a poor country government allows tomanufacture domestically or to import copies of patented drugs atprices much cheaper than those imposed by the patent holder andwithout his consent. Both importing and exporting countries need tohave enabling legislation in place (a corresponding CL for export has tobe issued by the exporting country). Prior negotiation with the patentowner for VL rst is required except for situations including extremehealth crisis and not-for-prot government use. Royalties to the patentowner are encompassed by CL rules.
manufacturers in availability and supply of ARVs in resource-limited countries . Generic, mainly Indian, companies aresupplying Sub-Saharan Africa with most of these drugs atprices below those charged by brand enterprises, and untilnow almost exclusively provided FDCs. Brand companies havesupplied almost all newer second/third-line ARVs, stipulatedvoluntary licenses-VLs
with generic rms, and pursued dier-ential pricing.Note that the ability of Indian rms to provide these ARVs isdue to the fact that India delayed introduction of pharmaceuti-cal patents until 2005 . This means that most of the rst-linedrugs demanded throughout the developing world (and rec-ommended by the WHO) are not patented in India. Indeed, thefact that the drugs principally in demand were unencumberedby patents in India was a crucial factor in facilitating the mas-sive scaling up of ARV treatment since the early 2000s. The coincidental connection between the drugs demandedand the drugs that Indian rms could supply is changing how-ever [11, 13]. Newer drugs are subject to patent protection inIndia and other supplier countries, which will make the supplyheavily dependent on brand-name rms’ willingness to supplydrugs at low cost or via VLs. There is good reason to believethat, in the absence of generic competition, the sources of sup-ply are unstable. After all, VLs only account for a small fractionof current procurement, while non-enforcement policies haveonly been implemented selectively and at full discretion of thebrand enterprises. Eventually, dierential prices of brand prod-ucts remain (with isolated exceptions) higher than the onesof corresponding generics: frequently, such prices have onlybeen achieved after the threat of compulsory licenses-CLs
, orhave sometimes failed to meet the promised country coveragedue to delayed drug registration in entitled countries. Takingthese realities into account, suited cutting edge ARVs for ne-ARVs for ne-gotiations with the brand-name pharmaceutical sector wereselected and put in the November 2009 UNITAID Patent PoolImplementation Plan .