Before work, here`s some background. The World Trade Organization (WTO) is the multilateral organization that has established the basic rules of trade among its 164 member states, including the United States. Within the WTO, there are two non-tariff agreements that directly affect FDA regulators: the Agreement on the Application of Health and Plant Health Measures (SPS), which includes food and animal safety measures essential to the protection of human and animal health, and the agreement on technical barriers to trade or the CTA, which covers the technical rules necessary to ensure compliance with FDA requirements (and packaging). transparency, normative measures and compliance assessment. The United States, Mexico and Canada have reached agreement on a modernized, quality chapter of intellectual property (IP) that provides effective protection and protection and intellectual property rights essential to promoting innovation, economic growth and supporting American jobs. For the first time, the new agreement also stipulates that 40-45% of parts of a non-tariff vehicle must come from a so-called high-wage plant. These plants must pay at least $16 per hour in average wages for production workers. That`s about three times the average wage at a Mexican plant right now, and government officials hope that this provision will force automakers to buy more supplies from Canada or the United States, or raise wages in Mexico. The agreement is designated differently by each signatory – in the United States, it is called the U.S.-Mexico-Canada Agreement (USMCA);   in Canada, it is officially known as the Canada-U.S.-Mexico Agreement (CUSMA) in English and the Canada-U.S.-Mexico Agreement (ACEUM) in French;  and in Mexico, tratado is called tratado between México, Estados Unidos y Canadé (T-MEC).   The agreement is sometimes referred to as “New NAFTA” with respect to the previous trilateral agreement for the successor, the North American Free Trade Agreement (NAFTA). In addition to its work with the WTO, the United States has concluded trade agreements with 20 countries that cover a number of issues, ranging from tariffs on goods and access to the agricultural market to intellectual property and the environment. For the FDA, the specific themes are chapters of agreements on regulatory issues such as SPS measures, OBTs and good regulatory practices – as well as sector chapters on cosmetics, medical devices and drugs, if any. The FDA helps develop negotiation proposals in the United States and the FDA is actively involved in trade negotiations with U.S.
trading partners. Sectoral chapters, including Chapter 12, on FDA-regulated products have not been considered in most previous trade agreements, including NAFTA. Therefore, the inclusion of these annexes by the USMCA is an innovation not only in U.S. trade policy, but also for international public health. In a major concession to Democrats, the Trump administration has agreed to support some protective measures for a class of drugs called advanced and very expensive drug biologists. The final agreement nullifies a provision that, for ten years, provided protection for drugs from cheaper alternatives in both Canada and Mexico.