Pharma fury as Trump's team reneges on biologic patent rules in trade talks

A key part of president Donald Trump’s strategy to cut drug prices was to attack global “freeloading” for pharmaceuticals, targeting countries pushing back against pharma companies trying to charge higher US-level prices for their products.

But in trade negotiations with Canada and Mexico, it looks like that the Trump administration has not followed through on the strong rhetoric set out in his drug pricing strategy published last year.

According to press reports Trump’s negotiating team have agreed to scrap provisions on exclusivity of biologics, allowing each country to decide when the patent protection period expires on biologics.

In the US, biologics typically get 12 years of exclusivity without patent thickets and the new trade pact was set to provide 10 years of protection across the three markets.

The decision was celebrated by Democrats, who argued that locking in the 10 year protection period would have prevented Congress on setting its own rules on drug prices in the future.

Democratic representative for Illinois’s 9th district Jan Schakowsky and drug price campaigner, said in a press conference: “The Trump administration tried to tuck in big corporate gifts to Big Pharma. This trade bill would have tied Congress’s hands and prevented us from enacting legislation. But that provision is now out of the trade deal. It is gone.”

But the changes did not wash well with the US pharma industry, which argued that the removal of the provision sets a “dangerous precedent” for future trade talks including with China.

By risking a potentially shorter period of patent protection on biologics, the new deal puts US jobs, intellectual property and leadership in medical innovation at risk, said the US Biotechnology Industry Organization.

President and CEO Jim Greenwood said in a press statement: “President Trump has promised to end foreign free-riding on American medical innovation, but by removing enhanced IP protections for biologic medicines, his administration just surrendered one of the most important tools that would help stop it.”

The issue of biologics pricing came up in leaked documents of post-Brexit trade negotiations between the US and UK.

According to the documents trumpeted by opposition leader Jeremy Corbyn in the run-up to the election, Trump’s representatives “pushed hard” for harmonisation of UK biologic patent laws with those in the US.

Biologics are complex drugs manufactured in living cells, and are often more expensive than conventional medicines made in factories.