The US Department of State is being accused of inappropriately interfering with efforts by the United Nations and two countries to ensure access to affordable medicines for poor people.

In a blunt letter sent on July 20, dozens of patient advocacy groups charged that State Department officials questioned the premise of a UN panel devoted to exploring wider access, pressured the Colombian government not to sidestep the patent on a Novartis (NVS) cancer drug, and pressed India to adopt policies that could result in higher drug prices and eliminate the production of lower-cost generics.

And so they asked US Secretary of State John Kerry to detail “whether the State Department sees these incidents as coherent with US government policy and (to clarify) State Department commitments and position on the right of governments to use (World Trade Organization treaties) to protect public health and access to medicines.”

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We asked the State Department for comment and will update you accordingly.

The move comes amid rising tension over the cost of prescription medicines around the world. Beyond the United States, where the issue has become a talking point in the presidential election, patient advocacy groups regularly charge that the pharmaceutical industry relies on Washington to persuade other countries to improperly enforce patent rights and trade policies that would diminish access.

The letter, however, is an attempt to ratchet up criticism of US policy. For the most part, complaints about moves by Washington have been largely confined to specific incidents involving specific government agencies, usually the US Trade Representative’s Office. The advocacy groups are now trying to gain wider notice by directing their ire at top administration officials.

[UPDATE: A State Department official later sent us this: “Access to medicines is a complicated and multi-faceted challenge. Corruption, inadequate infrastructure and distribution systems, insufficient health care facilities and providers, lack of education, and unfavorable tax and tariff regimes figure among core factors limiting access to medicines.”]

In their letter, the groups say this heavy-handed approach was on display this past spring, when the Colombian health minister signaled plans to sidestep the patent on Gleevec, a Novartis cancer drug, because the company refused to lower its price. Patient advocates say the per-patient cost of the drug in Colombia is roughly twice the Colombian gross national income per capita.

Leaked memos showed that staffers from both the US Senate Finance Committee and the US Trade Representative’s office met with Colombian embassy officials in Washington D.C., and suggested the Obama administration might pull support for a free trade agreement and $450 million in backing for a peace initiative between the Colombian government and Marxist rebels.

And after the Colombian health minister last month indicated he would proceed with his plans, Colombian news outlets aired remarks by the US Ambassador to Colombia Kevin Whittaker, who told reporters that it is “very important” that the Colombian government consult with the US on this decision (go to the 12:20 mark).

“We were surprised and dismayed by Ambassador Whittaker’s remarks, which were interpreted, in Colombia and elsewhere, as unwanted interference with a domestic dispute over the price of a drug” sold by Novartis, the groups wrote. Among the groups signing the letter were Public Citizen, Oxfam, the National Physicians Alliance, and the AFL-CIO.

“The United States State Department should not interfere with the government of Colombia’s efforts to increase access to affordable medicines. Colombia is under no obligation to consult the United States on a decision to use its national law, when its actions are consistent with trade agreements binding both the United States and Colombia,” according to the letter.

Similarly, the groups are upset with the State Department reaction to the creation last fall of the UN High-­Level Panel on Access to Medicines. In remarks this past February, State Department official Ann Blackwood argued the panel review will be “narrow” and questioned the “premise that the rights of inventors, international human rights law, trade rules, and public health are ‘misaligned.’”

“Such a sentiment is out of touch with the reality faced every day by patients in developing countries around the world and here in the United States faced with rising drug prices and lack of innovation for critical medical needs, such as antibiotic resistance and Zika,” the groups wrote to Kerry.

“Policies that lead to higher prices create barriers for access. If governments rely upon high prices to fund innovation, then they have to accept limited and unequal access to new medicines, as well as no innovation when high prices through sales are not an option to recover R&D costs. In what sense does the Department of State see that as coherent and good policy?”

The advocacy groups also complained that the US administration is leaning heavily on India to alter policies and laws that the pharmaceutical industry maintains do not sufficiently protect intellectual property. One example cited is ongoing debate over compulsory licensing, which a WTO treaty allows countries to use to override patents so lower-cost generics can be produced.

The idea behind compulsory licensing is to allow countries to mitigate health crisis, although the WTO treaties provide governments with wide latitude in deciding when to issue a license. Nonetheless, brand-name drug makers argue that compulsory licensing can be a stalking horse for governments that wish to promote their own domestic pharmaceutical industries at the expense of global players.

The letter notes, in any event, that the US Embassy in New Delhi “regularly provides a forum” for industry officials to address Indian policymakers and stakeholders and works with the US Patent and Trademark Office to “coordinate pressure on key officials, and delivers speeches designed to publicly push the Indian government to adopt restrictive intellectual property policies.”

“Any policies or practices that India adopts to expand patent rights on medicines, restrict the use of compulsory licensing or other exceptions to patent rights, or introduce new exclusivity rules for data would have dramatic and negative implications for people across the globe that desperately need access to affordable life­saving medicine,” the groups wrote.

And in case Kerry might have missed the significance, the letter noted such moves may affect US patients, too. An estimated 88 percent of all prescriptions that are filled in the US are now written for generics, according to the IMS Institute for Healthcare Informatics.

This story was updated to include a response from the State Department.

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  • Language matters Ed. You frame this as “ensure access to affordable medicines for poor people” which is one way of looking at it. How about speaking in terms of reinforcing intellectual property rights? If this was some other technology, that idea would be unimpeachable, but if the US doesn’t speak up for IP here, it lacks credibility when it stands up against software piracy. India in particular has a history of not respecting IP. I don’t think we can have it both ways.
    Gleevec will be generic soon, if it isn’t already. In the meantime, everyone needs to negotiate with the IP holder, and shame them if necessary while respecting IP.

    • Hi Ted,

      Fair point, although I was reporting what these groups accused the State Dept of doing. So while not endorsing or disagreeing, I wrote what I did because access to medicines was the crux of the complaints.

      I agree that there must be a balance with IP protection, but if the State Dept disagrees with the criticisms or explain its actions, it could have done so.

      I’ve had the letter since July 20 and repeatedly asked the State Dept for a reply. I was told a few times that would a response would be coming, but it never did. A lost opportunity.

      Anyway, thx for taking the time to write.

      Ed

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