Refocusing the TPP Debate – IP Rights are Critical to Improving Public Health

To listen to the critics, one would believe that the Trans-Pacific Partnership (TPP) Trade Agreement marks the end of the world for global health, especially for the poor. (Consider this, this, this, this, and this.) They are, in a word, wrong. Admittedly, the TPP Agreement is extremely contentious.   Moreover, the implications for global public health are significant, but for the better – if we do this right.

The TPP Agreement contains important provisions regarding intellectual property (IP) rights, especially the standards of protection for pharmaceuticals. Given that the TPP negotiations include a dozen nations[1] and these nations represents close to 40 percent of global GDP, the agreement presents a tremendous opportunity to improve global health. Moreover, through the TPP, the United States has a chance to both encourage trade, stimulate economic growth, and foster greater innovation. Medical progress is rooted in innovation, especially advances in pharmaceutical therapies and cures. History has taught us what works, and the TPP provisions will ensure that the standards that encourage innovation are protected.

Critics of the TPP Agreement claim that its IP standards will result in higher drug prices and create barriers to access for the world’s most vulnerable populations. The amfAR website claims that the TPP “threatens the future availability of affordable generic medicines and could undermine the global HIV response in developing countries”, while Doctors without Borders writes “the TPP agreement is on track to become the most harmful trade pact ever for access to medicines in developing countries”. IP Detractors are conflating two issues: intellectual property protection for pharmaceutical innovation and drug prices. They are separable.   Moreover, if the global community is to truly benefit from the promise of medical progress, we must stop the attack on the IP protections that incentivize innovation and turn our attention to the issues that genuinely inhibit access to medicines.

[Kristina]

For the most vulnerable among us, better health is inextricably linked to two things: poverty and incentivizing the development of treatments for diseases of the poor. Again, these issues are separable and must be addressed independently. Intellectual property protection addresses the second, and has done so to great success.   Moreover, creative applications of IP rights have resulted in the development of medicines for previously-ignored conditions. As reported by the New England Journal of Medicine, “In 2013, the Food and Drug Administration (FDA) approved 27 new drugs for marketing. Eight of these drugs are for orphan diseases, including six rare cancers. In fact, more than half of the 139 drugs approved by the FDA since 2009 are for orphan diseases and cancers.”[2]

Consider too the FDA’s Priority Review Voucher (PRV), which became law in 2007. In this case, upon the development of a treatment for a neglected or rare pediatric disease (one of 16 specified conditions), the innovator receives a voucher for priority review from the FDA to be used with a product of its choice, sold or transferred. The priority review reduces the amount of time needed to receive an FDA review decision, allowing blockbuster drugs to reach the market more quickly.[3]   As a result, innovation is rewarded and neglected diseases receive research attention.   To date, six vouchers have been awarded. (Details are available here.)

Pharmaceutical innovation and intellectual property rights are even more important as we consider the growing burden of non-communicable diseases (NCD’s), the most prominent drivers of healthcare costs. The costs in terms of both human health and economic prosperity are significant and Asia will be the hardest hit. A recent World Economic Forum report on NCDs reports the following:

Claiming 63% of all deaths, these diseases are currently the world’s main killer. Eighty percent of these deaths now occur in low- and middle-income countries. Half of those who die of chronic non-communicable diseases are in the prime of their productive years, and thus, the disability imposed and the lives lost are also endangering industry competitiveness across borders. . . Over the next 20 years, NCDs will cost more than US$ 30 trillion, representing 48% of global GDP in 2010, and pushing millions of people below the poverty line.[4]

To truly address global health issues and the future threats to our wellbeing, we should incentivize more – not less – pharmaceutical research and development. The IP standards contained within the TPP Agreement are a step in the right direction and should be embraced. Specifically, according to the Office of the U.S. Trade Representative, the TPP Agreement seeks “pharmaceutical IP provisions that promote innovation and the development of new, lifesaving medicines, create opportunities for robust generic drug competition, and ensure affordable access to medicines, taking into account levels of development among the TPP countries and their existing laws and international commitments”.[5]

Recalling Churchill’s famous words, “Democracy is the worst form of government, except for all those other forms that have been tried from time to time”.[6]   Intellectual property rights may be the worst form of incentivizing innovation, except for all those other forms that have been tried. Until a better system is devised, we should be extremely wary of those who suggest we abandon what works.

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[1] The United States and eleven other nations (Australia, Brunei Darussalam, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore, and Vietnam) are involved in the TPP negotiations.

[2] Kocher, Robert, and Bryan Roberts. “The Calculus of Cures,” The New England Journal of Medicine, online edition, 26 February 2014.

[3] Under a priority review, the FDA attempts to render a decision in 6 months. In contrast, a standard review is completed in about 10 month, and sometimes takes much longer. The median difference is approximately 7 months (Grabowski, Henry G., David B. Ridley, and Jeff Moe, “Priority Review Vouchers to Encourage Innovation for Neglected Diseases,” Prescribing Cultures and Pharmaceutical Policy in the Asia-Pacific, K. Eggleston Brookings Institution Press, 2009.)

[4] Bloom, D.E., Cafiero, E.T., Jané-Llopis, E., Abrahams-Gessel, S., Bloom, L.R., Fathima, S., Feigl, A.B., Gaziano, T., Mowafi, M., Pandya, A., Prettner, K., Rosenberg, L., Seligman, B., Stein, A.Z., & Weinstein, C. The Global Economic Burden of Noncommunicable Diseases. Geneva: World Economic Forum, 2011.

[5] United States Trade Representative. “Trans-Pacific Partnership: Summary of U.S. Objectives,” web posting.

[6] From a House of Commons speech on Nov. 11, 1947.