Monthly Archives: June 2015

The scare of the Trans-Pacific Partnership Agreement

The Trans-Pacific Partnership (TPP) agreement is the current US administration’s signature multinational trade policy initiative in the last several years. The policy  is seen as a means to facilitate trade around 12 pacific rim countries currently sans, importantly China.  Some see this as President Obama’s attempt to give some economic muscle to his Asia pivot policy. However from a public health point of view, the TPP is turning out to be a potentially scary monster  –  what some people are calling the restrictive WTO IP regime on steroids.

Terms of negotiations for the TPP are highly secretive, as negotiators feel open negotiations could undermine their bargaining chips. However, some drafts of the negotiations have been leaked by Wikileaks. If the provisions outlined on the leaked documents were to pass, the TPP could seriously jeopardize public health, especially access to medicines, here in the US, but also across the rest of the world.

The TPP attempts to further tighten current intellectual property laws, heavily in favor of the originator companies. First, it has proposed additional impositions on data exclusivity, making them unavailable for generics manufacturers to use these data before launching their own generic drugs. Second, it makes it easier for holders of originator molecule patents to file for process patents and renew their patents, in a process that is often derisively called evergreening. Third and more dangerously, it extensively expands the the purview of what’s called the Investor State Dispute Settlement (ISDS) tribunals, an extra-judicial mechanism mostly comprised of corporate lawyers that will enable corporations to bring on cases against states for curtailing or perceived curtailing of their profits.

This could seriously impede the government’s ability to advance a public health agenda and secure means to make drugs and health services more affordable. Under this provision, even arrangements like drug formularies, preferred drug lists or generic substitution may be considered anti-trade and be subjected to the ISDS tribunal, thereby forcing governments to pay hundreds of millions to corporations while attempting to safeguard public health. Drug companies like Eli Lily, and tobacco manufacturer Philip Morris have used this mechanism under provisions of various trade agreements to bring on cases worth hundreds of millions of dollars when governments tried to impose policies to ensure public health.

The greatest adverse impact however, could be on medicine access in some of the low and middle income countries like Vietnam, that are directly affected by the TPP. The TPP attempts to impose US standards of IP regulation on  signatories. This will have a direct effect of raising drug prices across much of the world, but more so in less developed countries. Furthermore because how sweeping the TPP proposes to be, its impact will be far reaching in that it will be a template for future such regulation.

In New England Journal this week, Amy Kapczynski in a commentary outlines the possible effects of the TPP on access to medicines all over the world. Several other organizations like Public Citizen and MSF have outlined the dangers imposed by the current draft of the TPP on medicine access. A few months ago, organizations including the MSF, AFL-CIO, AARP, Oxfam-America and Generics Pharmaceutical Association wrote to President Obama outlining their fears of the dangers posed by the TPP on public health, and especially access to medicines across the US and the world. Whether these fears are assuaged, or the TPP does indeed turn out to the scary monster that several public health advocates have been predicting, only time will tell.