For Big Pharma, the setback marked a turning point. Four years ago, the drug industry helped end an Obama administration trade agreement with 11 Pacific countries and argued that a provision that would make it more vulnerable to protecting organic products for eight years was not enough. However, the recent U.S. trade agreement contains no biological protection. The excision of a key concept in the upcoming U.S.-Mexico-Canada trade agreement (USMCA), approved Thursday by the House of Representatives, that would have guaranteed minimum data exclusivity for newly licensed biologics, abandons U.S. trade policy that supports broad intellectual property protection for U.S. biotechnology and other technology-based companies. The industry - and the Trump administration - had argued that organic manufacturers needed several years of protection to take advantage of their drugs before reducing biosimilars in sales. Otherwise, branded drug companies and biotechnographic start-ups that rely on money from venture capital firms would have little incentive to invest in the development of new drugs.
According to CNN, "Democrats have opposed anchoring the agreement`s guarantees because they want Congress to be able to legislate on drug prices without being bound by the trade agreement." On December 10, 2019, an agreement was reached between the United States, Mexico and Canada to amend the U.S.-Mexico-Canada agreement ("USMCA"). The USMCA, if ratified by each country, would replace the North American Free Trade Agreement (NAFTA) that came into force on January 1, 1994. Ubl added: "Last year`s agreement with Canada and Mexico was an important step in establishing competitive conditions with our trading partners by providing strong ip protection to U.S. producers. As stated by the USTR [Office of the United States Trade Representative], nothing in the original agreement would have changed the U.S. biopharmaceutical law or the increase in drug prices for U.S. patients. However, part of the head-turning agreement is that it no longer contains an exclusivity provision for biologic drugs. Currently, U.S. law allows 12 years of exclusivity for organic products. However, this exclusivity does not automatically lead abroad, including Mexico and Canada.
The USMCA had a provision that allowed protection of the organic market for ten years, which would have allowed exclusivity in Canada and Mexico, although it was two years behind U.S. law. In a statement posted on Twitter, President Trump said, "The USMCA`s great U.S. trade law is good. It will be the best and most important trade agreement the United States has ever concluded. It is a good thing for everyone - farmers, producers, energy, unions - a huge support. The important thing is that we finally put an end to our country`s worst trade agreements, NAFTA! The industry also rejected the idea that biosmal product regulations would keep drug prices high and harm consumers.