Politico | 18 August 2017
NAFTA could replay TPP biologics debate
By MEGAN CASSELLA
A battle over the length of data protection for biologic medicine appears to be shaping up in the NAFTA negotiations in a replay of an issue that helped block the Trans-Pacific Partnership from becoming law. The United States has 12 years of data protection for biologics under the Affordable Care Act, in contrast to eight years in Canada and five in Mexico.
Senate Finance Chairman Orrin Hatch pressed the Obama administration to get countries to agree to 12 years in the TPP deal. Instead, negotiators settled on two separate formulas, which former U.S. Trade Representative Michael Froman said guaranteed eight years of protection. However, Hatch and other Republicans were skeptical of that claim and pressed Froman for stronger guarantees.
“A modernized NAFTA needs to build on America’s competitive advantage in innovation, and that means doing better than TPP,” Hatch said in a statement to Morning Trade. “Twelve years of data protection for biologics and copyright standards at least equal to the highest found in earlier U.S. trade agreements would be a very strong start.” Twelve years is the U.S. position, a U.S. official confirmed.
But one veteran of the TPP biologics battle doubts that Canada, in particular, would agree to Hatch’s demand. “I cannot see Canada doing that,” said Burcu Kilic, an intellectual property expert and legal counsel for Public Citizen’s Global Access to Medicine Program. “Canada has a really good team, they will be tough.”
Canada resisted Europe’s proposal in talks on the Canada-EU Comprehensive Economic and Trade Agreement to move toward 11 years of protection, Kilic said. “Canada has a well-established and mature system, they won’t change it. That’s why we proposed in our submission that they should leave IP out if they want to conclude negotiations. Any proposal on 12 years will uber-complicate the negotiations,” she said.
But pharmaceutical manufacturers stressed the importance of getting 12 years of data protection in comments filed with USTR for the NAFTA negotiations. “This was not an arbitrary number, but rather the result of careful consideration and considerable research on the incentives necessary to ensure biopharmaceutical innovators and the associated global scientific ecosystem are able to sustainably pursue groundbreaking biomedical research,” the Pharmaceutical Research and Manufacturers of America said.