PhRMA 2024 Special 301 submission: USTR needs to support American innovation, global access to medicines

The Biden administration should support U.S. innovators abroad and policies that give patients timely access to the innovative medicines that help them live longer, healthier, more productive lives.

Ernest KawkaJanuary 31, 2024

PhRMA 2024 Special 301 submission: USTR needs to support American innovation, global access to medicines.

This week, PhRMA submitted comments to the Office of the U.S. Trade Representative (USTR) to inform USTR’s 2024 Special 301 Report. PhRMA’s comments show how strong intellectual property (IP) protections, open market access and enforcement of trade commitments help medicines reach patients around the world, support American jobs and foster innovation. Our comments highlight IP, market access and trade barriers in twenty markets that threaten American competitiveness.

Strong IP protections are a key component of America’s global competitiveness that incentivize the investment necessary to bring new medicines to market. Some foreign governments continue to undermine American biopharmaceutical innovation and put at risk nearly $90 billion of American biopharmaceutical exports and more than four million jobs across all 50 states. PhRMA urgently requests that USTR combats foreign trade barriers and unfair policies abroad:

  • Demonstrate leadership in international institutions: Foreign governments continue to advance proposals in multilateral organizations, including the World Trade Organization, World Health Organization and World Intellectual Property Organization to undermine fundamental IP rules underpinning American innovation and jobs.

  • Engage allied economies: Pending legislation in the European Union would weaken IP rights and increase uncertainty on the continent and beyond. Specifically, the changes would reduce and condition regulatory data protection on market access and facilitate the use of compulsory licensing across the EU. Government price controls in markets such as Canada and Japan are non-tariff barriers to trade that deny American inventors and workers the ability to compete on fair and equitable terms.

  • Enforce existing trade commitments: Despite clear commitments made in trade agreements, many U.S. trading partners have yet to implement needed reforms. Mexico has yet to implement key IP provisions of the United States-Mexico-Canada Agreement. Korea has not adopted market access policies that are transparent and appropriately value American-made innovative medicines as required by the U.S.-Korea Free Trade Agreement.

Policies that deny adequate and effective protection of IP rights, or deny fair and equitable market access, significantly threaten the ability of the American biopharmaceutical industry to develop and export life-saving treatments and cures. Previous Special 301 reports, from bipartisan administrations, made clear that the United States will not ignore policies that discriminate against U.S. companies or impede their ability to access foreign markets. The Biden administration should support U.S. innovators abroad and policies that give patients timely access to the innovative medicines that help them live longer, healthier, more productive lives. 

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