Democrats push back at North American trade deal over biologic drug exclusivity

A new North American trade would give biologic drug brands a 10-year monopoly in Mexico and Canada, but critics don't like that idea one bit—and they're working to derail the rule before it can take effect.

President Donald Trump has already signed the agreement, known as the USMCA, and the Republican-controlled Senate is likely to ratify it, the New York Times reports. House Democrats, however, have a shot at blocking the deal.

The new agreement wouldn’t affect biologics exclusivity in the U.S., where current rules guarantee 12 years of protection, but Canada has set its own biologics exclusivity at eight years, and Mexico doesn't yet have specific rules. Democrats say setting biologic exclusivity in the trade agreement could impede future efforts to rein in drug costs, the NYT reports. Other portions of the deal have caught attention for their potential to hurt the generics and biosim markets. 

Last year, Rep. Jan Schakowski led a group of Democrats who urged Trump not to “give pharmaceutical corporations and their monopolies a handout” in the negotiations. In a letter sent to the president, Rep. Schakowski of Illinois wrote that she and others “believe that the balance between pharmaceutical monopoly profits and public health needs in current trade policies is already tipped toward industry.” 

“Inclusion of additional provisions in NAFTA to block access to generic drugs or provide new tools for pharmaceutical corporations to extort high prices would result in an even greater imbalance,” she wrote. 

Rep. Ro Khanna of California amplified the message this month by tweeting that any Democrat who "doesn’t sign this letter is selling out to Big Pharma.” 

Drugmakers see it differently. After Trump and leaders in Mexico and Canada signed the deal, PhRMA CEO Stephen Ubl said in a statement that when “countries protect and value innovation, America’s biopharmaceutical companies can continue bringing new medicines to patients around the world.” 

He said the negotiated IP protections “will help to usher in the next generation of medical treatments and cures.” They “far exceed those in any other international trade agreement,” Ubl added. 

While Trump has already signed the deal, it still needs to pass legislatures in all three countries, including the U.S. Senate and House. The Senate is more likely to pass it as the chamber is still controlled by Republicans, the Times reports. The “real battle” over the trade deal will be in the Democrat-led House of Representatives, Lori Wallach, Public Citizen’s director of Global Trade Watch, told the newspaper. 

The new trade deal isn’t the first to generate criticism for being too pharma-friendly. The Trans-Pacific Partnership would have set drug exclusivity protections in 12 countries, and critics said it would have exported U.S. drug policy to other nations. Trump ended the trade talks during his first week in office.