U.S. ratification of trade agreements such as the USMCA is generally conducted in accordance with the procedure under the Bipartisan Congressional Trade Priorities and Accountability Act 2015. In accordance with TPA11, the President is responsible for submitting to Congress a draft implementation project. Senior Trump administration officials, including U.S. Trade Representative Robert Lighthizer and White House National Economic Council Director Larry Kudlow, said the White House would not introduce the bill to Congress until House of Representatives spokeswoman Nancy Pelosi, D-California, gave the go-ahead for the bill to be put to a vote. “This is one of the first times we`ve actually seen Pharma lose,” said Earl Blumenauer, a Democrat from Oregon who heads a trade subcommittee. “They have a remarkable track record because they are a great political force. They spend a lot of money on lobbying, advertising, campaigning. But we resisted, and we won in all areas. Drug manufacturers have begun to raise the prices of existing drugs several times a year, sometimes more than 20% per year. They also began introducing organic products with six-figure list prices in the 190s. In May, U.S. regulators approved a single gene therapy, Zolgensma, with a flashing price of $2.1 million per patient.
For years, U.S. government policy has sought to increase the legal and regulatory standards of our trading partners to those in the United States in terms of labour relations, the environment, investment protection and intellectual property. Ubl called on Congress and the government to “continue international trade agreements that hold foreign governments to account by ensuring that the ongoing discovery of drugs they sorely need to treat and cure the world`s most devastating diseases is protected and appreciated.” Last year`s government trade agreement with Mexico and Canada gave organics 10 years of protection against the near-cheaper copies known as biosimilars. Among the main drug biologists is the cancer treatment Rituxan and Humira and Enbrel, which fight against immune disorders. The revised USMCA also strengthens other intellectual property rights, of which no changes to U.S. law are required. These include the comprehensive national treatment of copyright and neighbouring rights, the establishment of a minimum term of life for the author plus 70 years or publication plus 75 years, as well as the establishment of safe ports to discourage online piracy and the implementation of enforcement mechanisms for digital products. In addition, it strengthens the civil and criminal protection of trade secrets and imposes patent extensions for inappropriate patent offices and regulatory delays. A more detailed summary of the intellectual property rules set by the USMCA of the Office of the United States Trade Representative can be provided here. Some are dissatisfied with the removal of this provision. Stephen J.
Ubl, President and CEO of Pharmaceutical Research and Manufacturers of America (PhRMA), said after the announcement: “Today`s announcement puts politics above patients. The abolition of biologist regulation at the USMCA removes vital safeguards for innovators, while American patients do nothing to afford their drugs or access to future treatments and remedies. The only winners today are foreign governments that want to steal American Intellectual Property (IP) and play a global leadership role in biopharmaceutical research and development. But the trade group, which represents the organic industry, said the changes would free the country from pharmaceutical innovations in the United States. 1. USMCA, Section 20.49.1.