OUR DEMAND

Make medicine more affordable by eliminating NAFTA rules that increase costs.


How does NAFTA 2.0 measure up?

Demand: Add no new terms that go beyond the existing World Trade Organization patent rules.

The text includes intellectual property and other provisions that extend beyond WTO terms and beyond the original NAFTA terms to lock in bad U.S. policies that keep prescription drug prices high and export those policies to Mexico and Canada.

The text would require at least 10 years of government-granted marketing exclusivity – that is, longer monopoly protections – for cutting-edge biologic medicines, such as many new cancer treatments. The 10-year exclusivity period would lock the United States into its current bad system that keeps cancer medicine prices sky-high and would export it to Mexico, which now does not provide any additional exclusivity period for biologic medicines, and to Canada, which now has an eight-year period. A five-year biologics exclusivity term that was included in the TPP was considered so controversial that the remaining countries – including Mexico and Canada – suspended the provision after the United States withdrew from the TPP. Patients’ lives will be placed newly at risk by this provision, as it would delay access to more affordable cancer and other biosimilar treatments becoming available.

There are an array of giveaways to brand name drug firms in the new text, which will grant pharmaceutical firms new monopoly rights that extend beyond NAFTA or the WTO’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). These terms also violate the so-called “May 10” standard set in 2007 that set a floor for the access to medicines standards, which many U.S. Free Trade Agreements (FTAs) followed until the TPP. The revised rules are worse than the original NAFTA in that they require the following, among other harmful measures. Countries must establish special marketing exclusivity periods and, separately, patent “evergreening” policies, each intended to provide additional monopoly protections to new uses, forms and combinations of older medicines. (“Evergreening” means making monopoly rights last longer with lax patentability standards that help keep older medicines under monopoly control and thus let corporations charge higher prices.) And countries must offer multi-year extensions on patent terms when reviews at the regulatory or patent office take longer than terms deemed “unreasonable,” while the public gets no reduction in patent terms when these processes move quickly.

Demand: Add no new terms that limit countries’ abilities to negotiate lower prices for government health programs like Medicare or Medicaid.

The original NAFTA text did not include terms on this issue. But the U.S.-Korea FTA included outrageous terms that require government health care programs pay “market-derived” prices to pharmaceutical firms, rather than being able to negotiate for a discount for their bulk purchases. The pharmaceutical industry pushed for these terms, which increase the costs to taxpayers of government health programs, to be included in NAFTA. The revised NAFTA text has a new annex on “Transparency and Procedural Fairness for Pharmaceutical Products and Medical Devices.” However, while its terms reflect the current U.S. practice of giving drugmakers opportunities to intervene in and challenge certain public program reimbursement decisions, unlike similar provisions in the TPP, these obligations are entirely unenforceable. These terms are not subject to state-state dispute settlement, nor were they in the TPP context. But, with the elastic “Minimum Standard of Treatment” investor right and ISDS phased out of this agreement, pharmaceutical firms would have no means to enforce these terms, which otherwise could have be used to claim a “reasonable expectation” of certain forms of treatment by a government. Thus, in contrast to the TPP, this annex is entirely unenforceable.