[Ip-health] The divisive issue stalling both NCD, TB negotiations

Claire Cassedy claire.cassedy at keionline.org
Tue Aug 21 07:40:19 PDT 2018


The divisive issue stalling both NCD, TB negotiations

By Jenny Lei Ravelo // 17 August 2018

MANILA — The United Nations high-level meetings on tuberculosis and
noncommunicable diseases take place next month, but member states are still
at the negotiation table.

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.

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.

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.

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.
Claire Cassedy
Knowledge Ecology International
1621 Connecticut Avenue NW
Suite 500
Washington, DC 20009
Tel.: 1.202.332.2670

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