The Mercury News Weekend

North America trade pact deals rare setback to Big Pharma

- By Paul Wiseman, Linda A. Johnson and Kevin Freking

A revamped North American trade deal nearing passage in Congress gives both the White House and Democrats a chance to claim victory and offers farmers and businesses clearer rules governing the vast flow of goods among the United States, Canada and Mexico.

But the pact leaves at least one surprising loser: the pharmaceut­ical industry, a nearinvinc­ible lobbying powerhouse in Washington.

To satisfy House Democrats, the Trump administra­tion removed a provision that would have given the makers of ultra-expensive biologic drugs 10 years of protection from less expensive knockoffs. Democrats opposed what they called a giveaway to the industry that could have locked in inflated prices by stifling competitio­n. Top examples of the injected drugs made from living cells include medication­s to fight cancer and immune disorders such as rheumatoid arthritis.

“This is one of the first times we’ve actually seen pharma lose,” said Rep. Earl Blumenauer, an Oregon Democrat who leads a subcommitt­ee on trade. “They have a remarkable track record because they are a huge political force. They spend lots of money on lobbying, on advertisin­g, on campaign contributi­ons. But we held firm, and we won on all counts.”

The removal of the provision also helped illustrate just how potent a political issue skyhigh drug prices have become. It was a re

minder, too, that President Donald Trump repeatedly pledged to work to lower drug prices.

Last week, drug manufactur­ers absorbed another — though likely only temporary — defeat when House Democrats passed legislatio­n, along party lines, that would authorize Medicare to use its influence in the marketplac­e to negotiate lower prices from drug companies. The bill is thought to have no chance of passage, though, in the Republican-led Senate.

Yet the revamped U. S.Mexico- Canada Agreement, Trump’s rewrite of the 25-yearold North American Free Trade Act, seems set to clear Congress without the biologics protection that the drug industry had sought. , the House The full House voted 385-41 on Thursday to approve it. The Senate isn’t likely to take it up until January.

“It’s not a mystery,’’ said Rep. Jan Schakowsky, an Illinois Democrat who helped negotiate with the administra­tion. “If you poll the American people, the cost of pharmaceut­icals is a really big deal. It’s at the top of the list.’’

The trade agreement the administra­tion reached last year with Mexico and Canada gave biologics 10 years of protection from cheaper near-copies known as biosimilar­s. Among the leading biologics are the anti-cancer drug Rituxan and Humira and Enbrel, which fight immune disorders.

The industry — and the Trump administra­tion — had argued that manufactur­ers of biologics require years of protection to profit from their drugs before biosimilar­s should be allowed to cut into sales. Otherwise, they contend, brand-name drug companies and biotech startups that rely on money from venture capital firms would have little incentive to invest in developing new medicines.

“The announceme­nt made today puts politics over patients,” the leading drug industry trade group, PhRMA, said in a statement last week. “Eliminatin­g the biologics provision in the USMCA removes vital protection­s for innovators while doing nothing to help U.S. patients afford their medicines or access future treatments and cures.’’

The industry also rejected the notion that the biologics provision would keep drug prices high and hurt consumers. Existing U. S. law, they noted, already gives makers of biologics 12 years’ protection, more than the proposed 10 years in the USMCA. But the provision the Democrats succeeded in removing would have forced Mexico to expand biologics’ monopoly from five years and Canada from eight, potentiall­y hurting U.S. consumers who seek lower drug prices in those countries.

 ?? ELISE AMENDOLA — ASSOCIATED PRESS ?? A backlash against the drug industry has grown after reports of people dying and rationing because of the cost of medicines.
ELISE AMENDOLA — ASSOCIATED PRESS A backlash against the drug industry has grown after reports of people dying and rationing because of the cost of medicines.

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