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12 December 2019Big PharmaSaman Javed

New USMCA agreement scraps ten-year marketing exclusivity provision

The US, Canada and Mexico have signed a new, finalised trade agreement to replace the old North American Free Trade Agreement.

In a press conference on Tuesday, December 10, Nancy Pelosi, the speaker of the US House of Representatives, said the agreement will not include an earlier proposition which would have given pharmaceutical companies ten-years of market exclusivity for biologics in both Canada and Mexico.

Pelosi said the new agreement is “infinitely better than what was initially proposed by the Trump administration”.

Also speaking at the conference, congresswoman Jan Schakowsky, who serves on the US-Mexico-Canada (USMCA) Working Group, described the administration’s initial proposal as “deeply flawed”.

“Among other things, the deal would have raised the price of pharmaceuticals across North America by locking in high drug prices and expanding big pharma’s monopoly,” Schakowsky said.

As it stands, big pharma companies enjoy 12 years market exclusivity for biologics in the US. In Canada, big pharma companies can be granted up to five years, while there is zero marketing exclusivity in Mexico.

Under the administration’s initial deal, all three countries would have to agree to a ten-year marketing exclusivity period.

“Over the past six months, my Democratic colleagues and I on the working group worked for a deal that helps America's patients, workers and all consumers,” Schakowsky said.

“First, we eliminated provisions that undermine congress's ability to change domestic policies that lead to high drug prices. The Trump administration tried to tuck in big corporate gifts to big pharma in the USMCA: ten years of market exclusivity for biologics.”

She said the new, improved, renegotiated deal “prevents big pharma from raising the price of prescription drugs across the United States, Mexico and Canada”.

She also alluded that the party would try to reduce the 12 years of marketing exclusivity that currently stands in the US.

“Though we currently have 12 years of exclusivity in the US, this trade bill would have tied congress's hands and prevented us from enacting legislation. I have a bill that would actually lower the exclusivity period, but that provision is now out of the trade deal. It is gone,” she said.

Schakowsky said that because of a “current prescription drug pricing crisis” in the US, many Americans often go to Canada and Mexico to get lower-cost drugs.

But the administration’s initial deal would have raised the cost of drugs across the hemisphere, causing prices of prescription drugs in Canada and Mexico to “skyrocket”.

She also addressed concerns about evergreening.

“The Trump administration also tried to gift big pharma with increased protections for secondary patents and evergreening—changing a little bit of a drug to get a new and extended patent—and those provisions are gone,” she added.

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More on this story

Big Pharma
3 December 2019   The Trump administration is considering shortening the period that big pharma companies’ biologic drugs are protected by marketing exclusivity from biosimilar competition.

More on this story

Big Pharma
3 December 2019   The Trump administration is considering shortening the period that big pharma companies’ biologic drugs are protected by marketing exclusivity from biosimilar competition.