Posts Tagged: "regulatory data protection"

Earlier this week, Speaker of the House of Representatives Nancy Pelosi (D-CA) reached an agreement with President Donald Trump on passage of the United States-Mexico-Canada Agreement (USMCA), which if passed into law would replace the defunct and much maligned North American Free Trade Agreement (NAFTA). Not everyone is happy about the latest version of the USMCA agreed upon by the White House and House Democrats, including the U.S. Chamber of Commerce, which continues to support the overall agreement but has great concerns about the new provisions in the latest negotiated agreement between President Trump and Speaker Pelosi, which strikes expanded protection for biologic drugs from the agreement completely. Over the summer, House Democrats vocally opposed granting 10 years of regulatory data protection (RDP) for biologics inventions—an increase from 8 years in Canada and from 5 years in Mexico—arguing it would result in higher drug prices and delayed entry for biosimilars.

President Donald Trump and House Speaker Nancy Pelosi have reportedly reached an agreement on the much debated United States-Mexico-Canada Agreement (USMCA), which would, if ratified, replace the defunct and maligned North American Free Trade Agreement (NAFTA). The agreement, announced by Speaker Pelosi on Tuesday morning, comes as the House prepares to impeach President Trump, which makes it somewhat surreal, given that House Democrats seem poised to deliver President Trump a victory. During his presidential campaign, then-candidate Trump promised at nearly every campaign stop to renegotiate NAFTA. “It is infinitely better than what was initially proposed by the administration,” Ms. Pelosi said. “It’s a victory for America’s workers.” In remarks posted on Twitter, President Trump said: “America’s great USMCA Trade Bill is looking good. It will be the best and most important trade deal ever made by the USA. Good for everybody – Farmers, Manufacturers, Energy, Unions – tremendous support. Importantly, we will finally end our Country’s worst Trade Deal, NAFTA!”

In the face of pressure to pull provisions in the United States-Mexico-Canada Agreement (USMCA) that would grant 10 years of regulatory data protection (RDP) for biologics inventions, a recent report claims that the requirement would not result in higher drug prices for U.S. patients. The USMCA is currently being negotiated, but the chances of a vote this summer are quickly dwindling. In addition to other objections, many Democrats have opposed granting 10 years of RDP—an increase from 8 years in Canada and from 0 in Mexico (the U.S. period of exclusivity is longer, at 12)—arguing it would result in higher drug prices and delayed entry for biosimilars. Patrick Kilbride, Vice President of International Intellectual Property for the Global Intellectual Property Center (GIPC) at the U.S. Chamber of Commerce, has argued here before that the data does not support those claims.

Promoting public health has always been a bipartisan priority in Washington, D.C. Under the previous administration, lawmakers passed the 21st Century Cures Act and launched the cancer moonshot, two initiatives that aimed to transform health outcomes through greater investment in the next generation of medical treatments. In his State of the Union address last month, President Trump announced an ambitious plan to end HIV/AIDS by 2030 and increase funding for often-neglected childhood cancers. For each of these initiatives to be successful, lawmakers must recognize that investing in the cures of tomorrow requires continued bipartisan cooperation. This rings true for passing the U.S.-Mexico-Canada Agreement (USMCA), as well. The next generation of medical innovation depends on significant private sector investments. The intellectual property (IP) provisions of USMCA help to lay the foundation for continued investment into the research and development (R&D) of innovative cures across North America. In particular, the 10-year term of regulatory data protection for biologics will help ensure that North America continues to lead the world in developing life-saving technologies.