NEW YORK — The United States’ amendments to a forthcoming ministerial document on preventing and treating tuberculosis will likely result in a text that is not “actionable,” Médecins Sans Frontières is warning.
Pressure from the United States on BRIC nations and other governments could make it harder for developing countries to develop lower-cost, generic versions of necessary treatment medication for TB.
Governments were set to finalize the political declaration early last week, two months in advance of the first high-level TB meeting in New York on Sept. 26 — but following South Africa speaking out against some of the proposed U.S. government changes, negotiations were again re-opened on Wednesday.
The U.N. high-level event will coincide with the opening of the U.N. General Assembly. Limitations in the document, however, are dampening expectations for the meeting’s outcome.
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“It makes the declaration less actionable, so countries who would want to make use of this would not necessarily reference the political declaration,” said Leonardo Palumbo, the U.S. advocacy adviser for MSF’s Access Campaign.
A July 10 draft of the document states that governments would recognize the “critical importance of affordable medicines, including generics, in scaling up access to affordable multidrug-resistant and extensively drug-resistant TB treatment.”
It also calls for compliance with the Trade-Related Aspects of Intellectual Property Rights, an international legal agreement on intellectual property rights. TRIPS allows governments to override patents in the interest of public health, offering lower cost versions of drugs.
The U.S. has threatened to pull out of the agreement over inclusion of TRIPS language, which the G-77, European Union, Norway, South Africa, and Russia supported. South Africa broke its silence and spoke out against these proposed changes last week, according to MSF, re-opening the negotiations.
“MSF applauds South Africa’s courageous decision to speak up and demand stronger commitments to ensure that existing and future TB diagnostics, treatments, and vaccines reach the hands of the people who need them, leading to the reopening of negotiations on the UN High-Level Meeting on TB draft declaration,” Els Torreele, executive director of MSF’s Access Campaign, said in a statement on Friday.
“We ask countries negotiating the text to urgently provide political support for the inclusion of language on affordability and ‘de-linkage’ in the draft to reflect that investments in TB R&D must be separated from the expectation of financial returns through sales or high prices.
The latest July 20 version of the document commits to providing diagnosis and treatment, with the aim of treating 40 million people with TB from 2018-2022, but excludes all mention of TRIPS.
Kelley Currie, the U.S. representative on the Economic and Social Council at the U.N., said recently that a “better use of global efforts” would focus on improving health systems and new tools, and should not involve discussion of “access to medicines, intellectual property flexibilities, or compulsory licensing.” She spoke during the June interactive civil society hearing on TB at the U.N.
While the Millennium Development Goals tuberculosis interventions helped save an estimated 37 million lives from 2000-2013, the contagious, airborne disease is still among the top 10 causes of death worldwide, and responsible for the greatest share of HIV/AIDS related deaths.
And new challenges, like the rise of multidrug-resistant TB, are pushing eradication of the disease further out of reach, as about 600,000 new cases of drug resistant TB are estimated to emerge each year, according to the World Health Organization.
Only two treatment drugs have been released in the last 40 years. The few available drugs on the market require treatment for up to two years, and have serious potential side effects that include blindness, one factor in patients often not completing the full regimen of drugs. Access and cost are two other issues — about 40 percent of people newly affected by TB are missed by public health systems.
“It was something we were trying to almost depoliticize, just because the U.S. objections to the inclusion of the language, at times, were not 100 percent accurate,” said Palumbo, referring to the notion that treatment remains affordable for most TB patients.
Part of that argument includes the fact that Johnson & Johnson has a donation program for bedaquiline, one of the two widely used TB medications. Johnson & Johnson has a tiered pricing donation program for the drug, resulting in as little as $900 for low-income countries for a six-month treatment course.
In April 2015, it also offered 30,000 treatment courses over four years to countries eligible for support from the Global Fund to Fight AIDS, Tuberculosis and Malaria. But the donation program will end in March 2019.
The other new drug, delamanid, costs $1,700 for a six-month treatment course through the Global Drug Facility, the largest provider of TB medications and supplies, for Global Fund-eligible countries.
“We were trying to highlight the political declaration needs to be forward-looking and not just what is currently available. We need to ensure incentives for the pharmaceutical industry,” Palumbo said. “Because TB strains become resistant, we need to have a constant stream of new drugs coming to market. According to our analysis, of the patients around the world who could benefit from these new TB drugs, only 12 percent had access to them.”
Questions about the U.S. position on TRIPS has emerged during other presidential administrations. But it is now also part of a broader trend of retrenchment in international diplomacy.
“What is probably more new is, since during the time of the TB negotiations, the U.S. did not endorse a G-7 declaration and pulled out of the Human Rights council. Member states took threats from the U.S. more seriously as a push against multilateralism and not access to medicines,” Palumbo said.
“We hope countries can take measures to ensure access to medicines for all, regardless of the text of the declaration.”