“For God’s sake, Tommy, whatever you do, find a cure.” That was my brother Eddie’s final request before he died of pancreatic cancer. The disease has also taken my brother Artie and my best friend Ervin. It kills roughly 45,000 Americans annually.
There is still no cure. But the United States-Mexico-Canada Agreement (USMCA) could create a pathway to discover one.
The trade deal would help American innovators develop the next generation of breakthrough treatments by forcing Canada and Mexico to strengthen their intellectual property protections for an innovative class of medicines known as biologics, which are made from living organisms. Doctors already use these drugs to treat cancer, blindness, and rare immune disorders.
It can take billions of dollars to bring a single drug to market – and the odds are stacked against drug innovators.
The FDA ultimately approves only 12 percent of experimental medicines that enter clinical trials. It took 242 unsuccessful attempts between 1998 and 2014 to create just 13 drugs to treat brain cancer and lung cancer.
But stronger intellectual property protections, like those in the USMCA, would encourage future investment in biologics, spurring new research, clinical trials and even first-in-class cures. These safeguards give them a chance to earn back their upfront costs and earn a return should their biologic product make it to market.
Specifically, the USMCA expands regulatory data protection. Right now, the U.S. offers 12 years of regulatory data protection for biologic drugs. During this time, competitors can’t access innovators’ lab or clinical trial data. This means rival firms can’t get a head start on manufacturing knockoffs, which gives innovators a better chance of recouping their upfront research costs.
Canada offers innovators just eight years of regulatory data protection. Mexico, meanwhile, has no data protection laws for biologics on the books. Therefore, the USMCA would raise Canada’s and Mexico’s protections closer to U.S. standards by requiring both nations offer drug makers a full decade of regulatory data protection for biologics. But the current 12-year standard would remain the same for the United States.
Once ratified, the USMCA would also prevent generic firms in Mexico and Canada from prematurely copying U.S. medical innovations furthering the potential for even more breakthrough biologic research and cures, which is good news for patients suffering from deadly and currently incurable diseases.
Yet, some lawmakers aren’t sold on the USMCA. They fear patients will end up paying more out-of-pocket if Congress ratifies the deal.
These lawmakers needn’t worry. The USMCA doesn’t change any intellectual property standards in the U.S.; it merely forces Canada and Mexico to strengthen their own protections. So, the U.S. drug market – and how U.S. health care programs, both private and public, cover medicines – will be unaffected. Put simply: The new trade deal won’t impact U.S. drug prices at all. The USMCA could ultimately spur medical breakthroughs, and in doing so, spare thousands of families from the pain of watching loved ones suffer from an incurable disease.
Tommy Thompson is a former governor and secretary of the U.S. Department of Health and Human Services.