The TPP: Trading Patients for Patents
The Trans-Pacific Partnership (TPP) agreement is currently being negotiated between the US and eleven other Pacific Rim nations: Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore and Vietnam. The agreement may expand its membership to all 21 Asia Pacific APEC nations. The negotiations have been conducted in secret since 2010 however leaked drafts have revealed stringent TRIPS-plus provisions which elevate intellectual property protection at the expense of access to affordable medicines in developing countries.
For many years, the US has been conducting its foreign IP policy by negotiating IP provisions in bilateral and regional free trade agreements, securing ever-higher standards of IP protection than those mandated by TRIPS. The TPP represents the latest example of this. Through the TPP, the US is seeking provisions that will:
- Extend patent terms beyond 20 years;
- Extend patentability to cover new forms and uses of a known product without evidence of additional benefit;
- Require countries to permit patents for diagnostic, therapeutic and surgical methods;
- Adjust patent terms to compensate for delays in issuing patents or obtaining marketing approval;
- Eliminate the process for opposing patent claims before they are granted;
- Extend periods of data exclusivity for pharmaceutical products;
- Link generic marketing approval to patent status;
- Eliminate therapeutic reference pricing; and
- Introduce onerous disclosure and transparency provisions that permit industry intrusion into price-setting processes.
This agenda, if signed, would significantly delay the introduction of generic medicines, thereby reducing access to affordable treatment in developing countries such as Chile, Peru and Vietnam. This would exacerbate existing inequities and disproportionately affect disadvantaged groups. It would also remove developing countries’ sovereignty over IP policy by restricting their ability to use the public health flexibilities available under TRIPS and supported by the 2001 Doha Declaration. The adverse health consequences of the TPP have been the subject of numerous campaigns by groups such as Médecins Sans Frontières, Oxfam and Public Citizen. Their calls for change, however, have fallen on deaf ears, proving that the TPP forms part of a broader, seemingly unstoppable shift towards bilateralism at the expense of transparent multilateralism.
Since the introduction of TRIPS in 1996, the US, Japan and members of the European Free Trade Association (EFTA) have wielded their political power in backdoor negotiations to secure ever-higher levels of IP protection. These TRIPS-plus provisions have found their way into numerous preferential trade agreements such as the 2004 US-Chile FTA, the 2006 EFTA-Korea FTA and the 2004 US-Singapore FTA, to name only a few. In the eighteen years since the introduction of the most comprehensive multilateral IP agreement in history, political giants have worked to remove much of the flexibility permitted under TRIPS, replacing it with strict foreign IP standards imposed on countries with poor bargaining power. Almost two decades after TRIPS’ widely-hailed introduction, it is revealed as little more than a floor, with no ceiling in sight.
The ongoing trend of raising IP protection through trade negotiations is concerning for many reasons. Private, non-transparent trade negotiations are not an appropriate vehicle for domestic IP lawmaking, particularly as the people affected by these laws are not represented at the negotiation table. The asymmetry of power relations and the mismatch of trade priorities which often characterise such negotiations leads to the transplant of foreign IP law which is ill-suited to the diverse legal regimes and health systems of developing countries.
Susan Sell describes the vertical expansion of the international IP policymaking arena from the multilateral level down to the individual level as “top-down vertical forum-shifting”. Sell explains that stronger parties engage in vertical forum shifting when they are unable to achieve their goals in a multilateral setting. At the narrower bilateral level, stronger parties like the US can wield the carrot of increased market access to persuade developing countries to accept unsuitably high levels of IP protection. As the negotiating arena narrows, powerful players are increasingly able to exploit disparities in economic wealth to achieve outcomes they would not be able to obtain from stronger parties. Viewed through the lens of vertical top-down forum shifting, the TPP represents the latest example of a broader, more concerning shift towards private trade talks at the expense of multilateral forums.
How should we proceed through the complex, tangled web of international IP norm-setting? First, by lobbying TPP members to modify the TPP’s IP provisions to protect access to affordable medicines in the developing world. Secondly, by encouraging greater pushback against TRIPS-plus provisions from middle-income countries and rising powers such as India, China, Brazil and Thailand. Thirdly, by promoting the renewed use of transparent multilateral forums for international IP norm-setting and discouraging reliance on top-down vertical forum-shifting. Fourthly, by promoting greater scholarship on new models of innovation for pharmaceutical R&D to overcome the existing struggle between innovation and access. The positive correlation between high IP protection and greater R&D is not absolute; overprotective terms may actually limit innovation as researchers cannot share data. Knowledge is a cumulative enterprise; unless information is shared, it cannot be built upon. Accordingly, new models for pharmaceutical innovation such as prizes and grants may reduce reliance on high levels of IP protection and improve access to medicines in developing countries.
This article is written by Katrina Geddes, a right to health advocate from Boston.
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