Category NAFTA

How Will Recent Trade Agreements that Extend Market Protections for Brand-Name Prescription Pharmaceuticals Impact Expenditures and Generic Access in Canada?

[R.F. Beall, L. Hardcastle, F. Clement and A. Hollis] Abstract: Canada recently entered into two multinational trade agreements (i.e., the Canada, United States, and Mexico Trade Agreement; and the Comprehensive Economic and Trade Agreement with the European Union). The resulting federal policy changes will prolong periods of market protection afforded to eligible brand-name prescription drugs by extending competition-blocking patent and data exclusivity terms. While previous studies have analysed these two policy changes in isolation, it remains unknown what the total combined impact will be in a typical year.

Former USTR Official: USMCA Can Be Amended If U.S. Wants To Pass A Law Violating Its Obligations

Former Deputy U.S. Trade Representative Mariam Sapiro has written a memo for the Pass USMCA Coalition arguing that the U.S.-Mexico-Canada Agreement (USMCA) would not prevent a future Congress from shortening the period of marketing exclusivity granted to new biologic medicines in the U.S. She argues that the countries could amend the agreement if the U.S. wanted to pass a law in violation of its current obligations.

Letter from 104 Members of Congress to USTR, re: Data Protection for Biologics in NAFTA 2.0

We write to express our strong opposition to provisions that limit access to medicines in the revised NAFTA agreement, also known as United States-Mexico Canada Agreement (USMCA).... The USMCA would keep drug prices out of reach for patients by increasing and locking in 10 years of marketing exclusivity for brand biologics, expanding the scope of brand biologics eligible for protection, and making it easier for brand-name drug companies to extend their monopolies through additional patents, patent extensions and other forms of patent "evergreening."

May 20: Webinar on the USMCA (NAFTA 2.0) and Access to Medicines

How will the recently-concluded United States-Mexico-Canada Agreement (USMCA) impact access to affordable medicines? The USMCA – the renegotiated North American Free Trade Agreement (also commonly referred to as NAFTA 2.0) – incorporates many of the harmful provisions from the Trans Pacific Partnership (TPP), including patent provisions that were suspended by the remaining Parties following the withdrawal of the US. It goes even further than the TPP in extending the exclusivities for biologics to ten years, an unprecedented TRIPS-plus measure. Beyond the intellectual property chapter, multiple other chapters and provisions of the USMCA also have implications for access to affordable, safe and effective medicines.

A Hard Pill to Swallow: A Critical Look at Eli Lilly & Co.’s NAFTA Challenge of the Canadian Patent Regime, and Its Potential Side Effects

[James Damian Hakert] Abstract: ... NAFTA allowing pharmaceutical companies to successfully dispute national patent laws could have significant future consequences. This note outlines the circumstances surrounding Lilly’s dispute, analyzes the dispute’s viability, and explores various potential implications of the dispute going forward.

NEW ANALYSIS: NAFTA 2.0 (U.S.-Mexico-Canada Agreement) Pharmaceutical Related Patent Provisions

The revised North American Free trade Agreement (NAFTA 2.0), rebranded by the Trump Administration as the U.S.-Mexico-Canada Agreement or USMCA, was signed last Friday during the G20 summit in Argentina. NAFTA 2.0 is an updated version of the nearly 25-year-old NAFTA, with significant and harmful changes to the intellectual property (IP) provisions, which build on the harmful TRIPS-plus standards in other U.S. free trade agreements since NAFTA 1.0.

U.S. Canada and Mexico Sign Re-Negotiated NAFTA, Critics Still Seek to Alter Problematic IP Provisions

...According to Inside U.S. Trade (paywalled) President Trump told reporters “I don't expect to have very much of a problem” with Congressional implementation of the deal. However, some Democrats in Congress and some civil society groups oppose key provisions and plan to block ratification unless certain provisions are changed.  Among the issues are intellectual property concerns.

Copyright Exceptions, Trade Agreements, and the Digital Economy

PIJIP has researched IP and trade for a while, but we’ve mostly focused on FTAs that included the US.  This year we’ve begun to broaden our view – to look more closely at agreements like RCEP and other Asia-Pacific agreements. This fall we began a detailed comparison of CPTPP, RCEP, CETA, RCEP, EU-Mercosur, EU-Japan, and the China-Korea FTA, with a focus on the copyright and enforcement provisions, and with an eye toward provisions that affect the digital economy. In the last few couple of weeks we’ve begun looking into the provisions in USMCA as well.  This post compares some of the existing text on two provisions: the ‘balance’ provision and protection of TPMs.

U.S., Canada and Mexico Agree Upon, and Release, Renegotiated Trade Agreement Text

Trade negotiators from the U.S., Canada and Mexico have agreed to a new NAFTA text. To take effect, the agreement will need to be approved by legislatures in all countries.... The Intellectual Property chapter lengthens copyright terms, and it does not include a version of the copyright balance language found in Art. 16.88 of the TPP. It requires 10 years of marketing exclusivity for biologic drugs and patents on second uses.