The issue slowing the discussion is the inclusion of the flexibilities provided in the World Trade Organization’s “trade-related aspects of intellectual property agreement,” or TRIPS, which allows governments to override patents for medicines in the name of public health. Countries such as South Africa, burdened with high levels of TB and NCDs, want language on TRIPS to be included in the declarations, but the United States argues against it.
Co-facilitators for the high-level meeting on TB are still working with both parties to find agreeable language. The draft political declaration on TB was finalized on July 20 and submitted to the president of the General Assembly. Had no objections been filed, the draft would have been deemed final on July 24. However, South Africa raised concerns on the final language omitting reference to the TRIPS flexibilities, as well as language on delinking the cost of research and development from the sale of a drug or new technologies, prompting the reopening of the negotiations.
The U.S., meanwhile, is stalling negotiations on the NCDs declaration, in the hopes that weaker language in the TB negotiations would strengthen its position on TRIPS.
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TRIPS flexibilities is part of an agreement signed by World Trade Organization members under the Doha Declaration, recognizing the rights of member states to protect public health and promote access to medicines for all. Among the measures listed in the agreement is compulsory licensing, which allows governments to regulate or override patents to allow for the manufacture of lower cost drugs. The inclusion of TRIPS flexibilities in health agreements, however, has often been a point of contention. During negotiations on a World Health Organization resolution on access to medicines in January of this year, it was the subject of extended and heated debates among member states.
The U.S. is at the center of the debate. At a civil society hearing on TB last month, in preparation for the high-level meeting, the U.S. representative said the international community should focus its efforts on improving health systems and preventive measures, and investing in the research and development of new tools to address the global TB burden, “rather than be distracted as we often are into a discussion of access to medicines, intellectual property flexibilities, or compulsory licensing.”
Advocates argue the exclusion of TRIPS in the current NCD draft is driven by U.S. efforts to protect big pharma.
“The negotiations on both U.N. resolutions illustrate the degree to which the Trump administration is protecting drug companies from efforts to address the crisis in affordability and access to new medical technologies,” said James Love, director of Knowledge Ecology International. “The fact that the July 26, 2018 draft NCD resolution does not mention that prices for new drugs are too high and that access is currently both restricted and unequal is a public relations gift to big pharma, and an effective limitation on the mandate of U.N. agencies to address these problems.”
He is equally disappointed in developing countries’ “failure” to push for stronger language on drug pricing and access, including South Africa, Brazil and Uruguay, which have traditionally been very vocal on these issues, Love said.
TRIPS flexibilities language can be found in the declaration of the first U.N. high-level meeting on NCDs in 2011, the outcome document of the second high-level meeting on NCDs in 2014, as well as under the Sustainable Development Goals.
TRIPS and other issues
While several countries have successfully overridden drug patent monopoly through the use of TRIPS flexibilities in the past few years, they argue it is not without difficulties, and have repeatedly asked the World Health Organization to provide guidance on its implementation.
WHO could soon start promoting an innovative TB drug, bedaquiline, which is now more affordable after South Africa brokered a deal with a pharmaceutical company to slash the price by half.
Studies that have looked into countries’ application of the flexibilities also reveal much of its usage has been focused on medicines for HIV/AIDS. However, lessons from its successful implementation could help inform its application in other high priority diseases, including new medicines for TB, as well as for cancer and other NCDs for which voluntary licensing are not being provided at the moment, according to a study published earlier this year in the WHO’s Bulletin.
“Essential medicines, including generics, can mean the difference between life and death for those suffering from diseases, yet many remain inaccessible and unaffordable to those who need them most,” said José Luis Castro, chief executive officer and president of Vital Strategies. “Eighty percent of deaths from NCDs occur in low- and middle-income countries. Scaling up access to affordable treatments is critical to reducing the increasing prevalence of NCDs worldwide.“
Civil society organizations see the high-level meetings as a potential pivotal moment for TB and NCDs. They were hoping for specific, measurable commitments from heads of states to address long-standing issues of financing, access, and availability of prevention, treatment tools and measures, including diagnostics, and stronger accountability mechanisms.
Yet the draft declarations so far have fallen short of expectations.
Katie Dain, CEO of the NCD Alliance, acknowledged the current standstill over the TRIPS language in the current NCD declaration negotiations is a concern, but equally concerning is the “weak language” on fiscal measures, she said, including the nonrecognition of price and taxation as effective public health policies to address the burden of NCDs. The draft declaration didn’t include specific funding commitments nor proposals to establish a multidonor trust fund.
The draft also lacks commitments to establish independent and transparent accountability mechanisms, and “fails to recognize that people cannot make healthy choices if the environments in which they live do not provide such choices,” she said.
“This political declaration is not nearly as ambitious, innovative nor groundbreaking as it needs to be to deliver on the commitments that heads of state and government made at the HLMs in 2011 and 2014,” she said.
Nevertheless, the NCD Alliance and others in the NCD community plan to “apply pressure at all levels to strengthen the outcomes of the meeting” between now and the high-level meetings in September through different campaigns and by highlighting the voice of high-profile individuals known to be NCD champions.
“In addition to working toward stronger outcomes from the [high-level meeting], we will continue to press for the participation of heads of state and other high-level political leaders at the HLM, to ensure that the issue gets the public profile that it deserves,” Dain said.