A plea for creative solutions in access to affordable medicines


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Intellectual property rights were in part designed to promote innovation by incentivizing research and development with the grant of rights to exclude others from creating, using or selling the patented technology.  However, particularly since the adoption of the agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), which promoted patent protections for a term of 20 years, people in developing nations have had difficulty gaining access to affordable medications.[1] Intellectual property rights allow for proprietary pricing, which can become a barrier to access to affordable medicines.[2] Moreover, strong patent protections for medications make it difficult for generics manufacturers to develop more affordable alternatives. The price difference between a patented drug and its generic counterpart can be quite large. For example, AZT, a drug that was originally used to treat cancer at a price of around $7,000 per person, only cost approximately $70 per person as a generic drug later used for HIV treatment.[3]  While people in wealthier nations may be able to afford health insurance plans that help them pay for more expensive medications, people in developing nations may not have the means of gaining access to these life-saving products.

The impact of patents on access to medicines has become a global issue and is at the center of debates regarding intellectual property policies and treaties. For example, many are outraged over the recently released Trans-Pacific Partnership Agreement (TPP) because they believe the agreement will promote patent policies that make it more difficult for people in developing nations to gain access to affordable medications.[4]  One of the more controversial provisions of the TPP involves patent linkage, a system under which a prior pioneer drug patent can prevent the grant of marketing approval of a generic version of the pioneer drug, until that original pioneer drug patent has expired or is found to be invalid.[5]  As Michael Grunwald explained in his article on the TPP Agreement, “[g]enerics are thriving in the U.S. despite linkage, saving Americans an estimated $239 billion on drugs in 2013.  But the U.S. is the world’s largest market, and advocates fear that generic manufacturers may not take on the risk and expense of litigation in smaller markets if the TPP tilts the playing field against them. One generics manufacturer, Hospira, reportedly testified at a TPP forum in Melbourne, Australia, that it would not launch generics outside the U.S. in markets with linkage.”[6]  Strong patent provisions in developing nations could entirely prevent generics manufacturers from entering these smaller markets.

In light of this pressing dilemma, in November, 2015[7], the United Nations Secretary General Ban Ki Moon formed the High Level Panel on Access to Medicines “’[t]o review and assess proposals and recommend solutions for remedying the policy incoherence between the justifiable rights of inventors, international human rights law, trade rules and public health in the context of health technologies.’”[8] This panel is designed to promote innovation and increase access to medicines, vaccines, and diagnostics. On December 21, 2015, the panel called “for contributions by interested stakeholders that address the misalignment between the rights of inventors, international human rights law, trade rules and public health where it impedes the innovation of and access to health technologies.”[9] The UN is now making efforts to find creative ways to balance the promotion of innovation with the promotion of access to the important, life-saving technologies we create.

Universities Allied for Essential Medicines (UAEM), an international student group, recently suggested a creative solution to this healthcare dilemma. The group voiced support for a global R&D agreement that would de-link the cost of R&D from the price of medicines.[10] UAEM explained, “On the whole, patent monopolies have proven to be the wrong incentive for research and development of medical products to meet global health needs. . . . This is the reason why UAEM has been calling for a new R&D model to meet global health needs that puts patients over profits. De-linking the price of drugs from their R&D costs in order to de-link the main incentive for their production from a market base and bring it back to the public interest.”[11]  This type of agreement would be a more collaborative approach to medical product development, and would incentivize innovation through mechanisms like prize funds and patent pools.[12] UAEM recently released a letter calling upon member states of the World Health Organization, which is scheduled to discuss a global biomedical R&D agreement in 2016, to consider the adoption of this alternative means of promoting innovation and access to medicines.[13]

While the creation and consideration of new and innovative solutions is certainly a positive step toward resolving this global dilemma, extreme dilution of the patent system is perhaps not ideal. Without evidence that incentive mechanisms like prize funds and patent pools are feasible and provide sufficient incentive to promote constant innovation and development, systems like a global R&D agreement may be risky. [14] Before enacting extreme reform, we should explore more moderate paths and other provisions including “compulsory licensing, the standards for patentability, parallel importing, differential pricing between and within countries, and other exceptions to exclusive rights, with the aim of a better balance between commercial interests and public health objectives.”[15] While we are headed in the right direction, it is impo

rtant not to forget that our new and creative solutions still need to adequately protect and incentivize innovation and development.

[1] Ellen F.M. ‘t Hoen, TRIPS, Pharmaceutical Patents and Access to Essential Medicines: Seattle, Doha and Beyond, World Health Organization (Jun. 25, 2003), http://www.who.int/intellectualproperty/topics/ip/tHoen.pdf.

[2] Joo-Young Lee, A Human Rights Framework for Intellectual Property, Innovation and Access to Medicines 233 (2015).

[3] Rupali Francesca Samuel, Drawn Up in Secret, the TPP’s Text Helps Big Pharma Put Patents Over Patients, The Wire (Nov. 16, 2015), http://thewire.in/2015/11/16/drawn-up-in-secret-the-tpps-text-helps-big-pharma-put-patents-over-patients-15571/.

[4] Id.

[5] Gladys Mirandah, Patent Linkage in Asian Countries Compared to the US, Lexology (Apr. 30, 2012), http://www.lexology.com/library/detail.aspx?g=73ee9ee5-1873-457e-b24f-8af6e96721ff.

[6] Michael Grunwald, Leaked: What’s In Obama’s Trade Deal?, The Agenda (Jul. 1, 2015), http://www.politico.com/agenda/story/2015/06/tpp-deal-leaked-pharma-000126.

[7] High-Level Panel Timeline, United Nations Secretary-General’s High-Level Panel On Access to Medicines, http://www.unsgaccessmeds.org/timeline/ (last visited Jan. 12, 2016).

[8] The Process, United Nations Secretary-General’s High-Level Panel On Access to Medicines, http://www.unsgaccessmeds.org/the-process/ (last visited Jan. 12, 2016).

[9] Call For Contributions, United Nations Secretary-General’s High-Level Panel On Access to Medicines http://www.unsgaccessmeds.org/call-for-contributions/ (last visited Jan. 12, 2016).

[10] William New, University Students Energise Global Campaign for Medical R&D Agreement, Intellectual Property Watch (Jan. 5, 2016), http://www.ip-watch.org/2016/01/05/university-students-energise-global-campaign-for-medical-rd-agreement/.

[11] Id.

[12] Make Medicines For People Not For Profit, Universities Allied for Essential Medicines, https://uaem.wufoo.com/forms/zmewncm1cznjbi/ (last visited Jan. 12, 2016).

[13] Id.

[14] See Matthew S. Clancy & GianCarlo Moschini, Incentives for Innovation: Patents, Prizes and Research Contracts, 35 Applied Econ. Perspectives and Policy, 206, 230 (Mar. 25, 2013) noting that “prizes may in principle be superior to patents, but only if it is easy to estimate the true value of an innovation with a relatively high degree of certainty, and if market information is costly to manipulate. However, relevant tradeoffs between a patent system and a prize system are difficult to gauge because a large prize system on a scale with a national patent system has never been tried.” See also Justus Baron & Tim Pohlman, The Effect of Patent Pools on Patenting Innovation- Evidence from Contemporary Technology Standards, Northwestern University Searle Center on Law (Feb. 2, 2015), http://www.law.northwestern.edu/research-faculty/searlecenter/innovationeconomics/documents/Baron_Pohlmann_effect_of_patents.pdf (“The effect of patent pools on the incentives to innovate is however subject to debate. The theoretical literature (Lerner and Tirole, 2004; Dequiedt and Versaevel, 2013; Schmidt, 2014) mostly predicts a positive effect of pools on innovation incentives. Recent empirical research (Lampe and Moser, 2012; Joshi and Nerkar, 2011; Flamm, 2013) in contrast shows that the creation of several pools was followed by a decline in related innovation activities. These findings however only describe a decline in follow-on innovation once existing patents were bundled into a pool.”).

[15] Lee, supra note 2, at 234.