As the Trump Administration formulates its "America First" plans for trade deals around the world, the pharma industry is pressing U.S. officials to focus on its patent-law and enforcement worries in more than a dozen countries.
The industry group PhRMA, in new comments to the U.S. Trade Representative, critiques patent regimes it considers problematic, with a recent dustup in Colombia making an appearance. The comments come as the USTR is formulating its annual report on IP regulations, which red-flags countries whose oversight officials consider sub-par.
Last year, Colombian officials forced a price cut for Novartis’ cancer med Glivec, after threatening to force the company to allow generics makers to produce cheap copies. PhRMA is recommending (PDF) Colombia be included on the USTR's Priority Watch List. The industry group said Colombia has “weak patent enforcement,” “increased regulatory barriers” and “arbitrary and non-transparent market access policies,” among other concerns.
Along with Colombia, countries including Canada, China and India made PhRMA’s list for inclusion in the Priority Watch List. PhRMA submitted its comments as part of an annual review for the USTR’s Special 301 report, which is to be published in April.
International trade deals—which typically include agreements on IP protections—are something Pfizer CEO Ian Read touched on during his company’s fourth-quarter earnings call. He said that he agrees with new U.S. President Donald Trump that, when it comes to “free riding on American innovation of pharmaceuticals,” current trade agreements “haven't been negotiated hard enough.”
But the nonprofit Knowledge Ecology International, a group that has frequently weighed in on pharma patent affairs, figures strict IP laws push up costs. Speaking with FiercePharma, KEI director Jamie Love said if Trump is serious about lowering U.S. drug prices, his administration shouldn't promote high costs around the world.
“They have to take a deep breath and ask themselves, is the U.S. interest equal to pharma’s interest, and we think it is not," he said.
U.S. concerns have prevailed in some cases. In a move seen as bowing to requests from the Obama Administration, India pledged to abandon its practice of issuing compulsory licenses to introduce cheap generics. That decision came after years of frustration for big drugmakers.
But according to PhRMA's latest commentary, the U.S. drug industry “remains concerned” about India, despite the positive developments there. It’s still worried about an “unpredictable IP environment,” “regulatory data protection failures” and high taxes, among other topics.
Meanwhile, in Canada, PhRMA is “extremely concerned” about new laws that have “created a new and heightened requirement for patentable utility for pharmaceutical patents.” Such regulations are “both inconsistent with common law and practice in other major countries and unpredictable in practice,” PhRMA said.
In an interview, KEI's Love pointed to Canada's inclusion in PhRMA's list as evidence the "standards are really arbitrary." And in the group's own comments to the USTR, the nonprofit said (PDF) that “policies at USTR are generally lobbyist driven.”
Pushing countries to increase IP protections, and thus drug prices, “would only increase access barriers in foreign countries,” KEI wrote. Instead, “our trading partners could be pressed to match our direct funding and subsidies [for] research and development.”
That, according to KEI, “would lower the net costs of drug development, and would be consistent with the objective of progressively delinking R&D costs from drug prices.”
Colombia made headlines last year when it moved to unilaterally cut the price on Novartis’ Glivec through a declaration of public interest following tough negotiations. At the time, leaked memos documented political pressure in Washington, D.C., for Colombian officials to call off the price cut.
KEI previously voiced concerns over the U.S. Army’s move to license a Zika vaccine candidate to French drugmaker Sanofi. Before that, the group urged the National Institutes of Health to “break taboo” to exercise march-in rights and reduce drug costs.