[Ip-health] IP-Watch: UN Political Declaration On TB Finalised: No Commitment To TRIPS Flexibilities

Thiru Balasubramaniam thiru at keionline.org
Tue Jul 24 07:10:11 PDT 2018


UN Political Declaration On TB Finalised: No Commitment To TRIPS


Members of the United Nations concluded negotiations on the draft of the
Political Declaration on the Fight Against Tuberculosis on 20 July. After
weeks of heated negotiations over the inclusion of references to TRIPS
flexibilities in the operative paragraphs, with the Group of 77 pushing for
inclusion and the United States against it, the final text of the political
declaration reflects the deadlock of these positions. Due to the inability
of member states to reach agreement, the final text does not include
substantive reference to TRIPS flexibilities.

If no countries object, this final draft of the Political Declaration on TB
will be adopted by the General Assembly at the High-Level Meeting on
Tuberculosis, which will take place on 26 September at the United Nations
in New York, and will serve as the authoritative agreement from which
action plans will be drawn. According to sources, countries have until
tonight in New York to decide whether to object, and G77 nations are
considering their options.

United Nations headquarters in New York

The Political Declaration on TB should be an ambitious document “endorsed
by Heads of State that will strengthen action and investments for the end
TB response, saving millions of lives,” according to the World Health
Organization website.

The 20-page draft text, seen by Intellectual Property Watch, lists prior
agreements and other relevant instruments, and details the problems of
tuberculosis inequitably afflicting poor populations and those suffering
from other diseases such as HIV/AIDS, and the rise of multi-drug
resistance. The draft declaration commits nations to specific targets for
numbers of patients diagnosed and treated worldwide, a rapid scale-up in
testing, and a range of ways to address the ongoing problems. These include
health systems strengthening, community efforts, intensive research and
development efforts, and a commitment of billions of dollars in funding for
prevention, diagnosis, treatment and care, as well as research. A key group
in the effort is the Stop TB Partnership.

The co-facilitators responsible for leading the drafting and negotiating of
this document are Walton Alfonso Webson, ambassador and permanent
representative of Antigua and Barbuda to the UN, and Koro Bessho,
ambassador and permanent representative of Japan to the UN.


The final draft text of the Political Declaration on TB makes no reference
to the flexibilities contained in the 1994 World Trade Organization
Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS)
in the operative paragraphs. But it does include what seems to be a strong
reference to TRIPS flexibilities, and the corresponding 2001 Doha
Declaration on TRIPS and Public Health, in the preamble.

In an interview, Leonardo Palumbo, regional advocacy manager for Central
Asia at Médecins Sans Frontières (MSF, Doctors Without Borders), explained
the significance of this text being in the preamble rather than in the
operative paragraphs.

“The drawback of this being in the preamble, is that the preamble text is
meant to be descriptive. But in the text of the document, there is no
corresponding operative paragraph or commitment to be agreed upon and acted
upon by Member States. So, this definitely would not stop states from
making use of TRIPS flexibilities, but it is just that the political
declaration would not be another tool for countries to do so.”

The reference to TRIPS flexibilities in the preamble of the final draft of
the political declaration reads as follows:

“PP19 Recognize the critical importance of affordable medicines, including
generics, in scaling up access to affordable tuberculosis treatment,
including multidrug-resistant and extensively drug-resistant tuberculosis
treatment, and further recalling the 2001 WTO Doha Declaration on the TRIPS
Agreement and Public Health which recognizes that intellectual property
rights should be interpreted and implemented in a manner supportive of the
right of Member States to protect public health and, in particular, to
promote access to medicines for all, and that intellectual property rights
are an important incentive in the development of new health products;”

Palumbo noted, however, that there is a compromise in this text. The last
sentence of this text was changed in the final draft to emphasise only the
role of intellectual property as an incentive for R&D, without mentioning
the use of other incentive mechanisms.

The World Health Organization Global Strategy and Plan of Action on Public
Health, Innovation, and Intellectual Property (GSPA-PHI) [pdf], recognised
that intellectual property rights alone are insufficient to incentivize R&D
for drugs that do not promise high profit. It states: “Intellectual
property rights are an important incentive for the development of new
health care products. This incentive alone does not meet the need for the
development of new products to fight diseases where the potential paying
market is small or uncertain” (GSPA-PHI p7).

The WHO further clarifies that the “price of medicines is one of the
factors that can impede access to treatment” (GSPA-PHI p7), and that
proposals for R&D should include “a range of incentive mechanisms,
including, where appropriate, addressing the delinking of the costs of
research and development and the price of health products” (GSPA-PHI p6).


When reviewing the member state positions in the earlier drafts of the
political declaration, it appears that the US formed the sole opposition to
each reference to TRIPS flexibilities in the operative paragraphs.

Palumbo explained, however, that while you only see the US objections on
paper, there is a possibility that other countries shared the US position.

Many other groups, including the European Union, opted instead for
including text referencing TRIPS flexibilities, as is evident in earlier
versions of the draft. This was made clear by the amendments the EU added
to the TRIPS reference in OP14 of the 10 June draft, detailed below, which
was subsequently removed from the final draft of the political declaration.

“OP14 (former OP7 quat G77): [USA delete para: Commit to urgently removing
obstacles that limit the capacity of countries to provide affordable and
effective tuberculosis prevention, diagnosis and treatment [G77: as well as
treatment for comorbidities and coinfections] and to reducing costs
associated with care [G77: and multidrug-resistant treatment] including by
amending national laws and regulations, as deemed appropriate by respective
Governments, [EU: while assuring the full respect of each countries
international obligations, in particular those under the World Trade
Organization] so as to optimize:

The use to the full, of existing flexibilities under the Agreement on
Trade-Related Aspects of Intellectual Property Rights (TRIPS) specifically
geared to promoting access to and trade in medicines; and ensure that
intellectual property rights provision in trade agreements do not undermine
existing flexibilities, as confirmed in the Doha Declaration on the TRIPS
Agreement and Public Health;

By encouraging all states to apply measures and procedures for enforcing
intellectual property rights [EU: in line with the TRIPS Agreement and the
Doha Declaration] in such a manner as to avoid creating barriers to the
legitimate trade in medicines and innovation, and to provide for safeguards
against the abuse of such measures and procedures;

Addressing barriers, regulations policies and practices, including
regulatory strategies, that prevent access and use to affordable and
effective tuberculosis diagnostic and treatment; and

Encouraging the use, where appropriate [EU: and in line with the TRIPS
Agreement and the other regulations pertaining to data protection], of
voluntary mechanisms such as collaborative R&D platforms, open licensing
and sharing of data and patent pools, including through entities such as
the medicines, patent pool, [EU: and product development partnerships] to
help to promote competition to reduce treatment costs and shortage and
encourages development of new tuberculosis drug regimens;]”

The G77, representing low and middle-income countries, formed the primary
bloc of countries in favour of including references to TRIPS flexibilities
in the draft of the political declaration.

On 27 March, in a formal statement on the High-Level Meeting on TB, the G77
expressed that

“An urgent global response is required, notably by facilitating access to
affordable medicines and technologies, encouraging innovation in the
prevention and treatment of this epidemic, as well as scaling up financing,
including at the international level. Clearly, the international community
should not miss our common aim to end tuberculosis by 2030.”

UN Hearing and the US Position

The UN General Assembly hosted an interactive civil society hearing, in
preparation for the High-Level Meeting on TB, on 4 June at the UN in New
York. The interactive civil society hearing can be viewed here on UN Web
TV, and a summary can be found here [pdf].

The representative of the US mission at the hearing made the following
statement that communicates the official reasoning behind US opposition to
TRIPS flexibilities in the negotiations.

“According to recent reports, the United States government’s funding for
global TB R&D makes up almost 60% of the world’s investment. We would like
to take this opportunity to point out that most existing treatment drugs
for TB are off patent and inexpensive and that of the two newer drugs, one
is donated, and the other currently has limited use according to WHO

Given the vast number of people with TB, that the vast number of people
with TB are undiagnosed and that this is a treatable disease, it would seem
to be a better use of global efforts to focus on improving health systems,
preventive measures, and development of new tools, rather than be
distracted as we often are into a discussion of access to medicines,
intellectual property flexibilities, or compulsory licensing. Investing in
reaching the neglected or overlooked populations appears to be the main
action needed globally but even more importantly at national levels.”

It is noteworthy, however, that the US government position on TRIPS
flexibilities is not uniform.

For instance, US Senator Sherrod Brown (D-Ohio), in a letter [pdf] to US
Secretary of State Michael Pompeo, strongly encouraged him to “preserve
language in the declaration text regarding the affordability of new tools
and diagnostics, as well as preserve language acknowledging the importance
of delinking the cost of investment in research and development from the
price and volume of sales so as to facilitate equitable and affordable
access to new tools and advancements.”

Brown went on to encourage the US “to support efforts to improve global
collaboration in research and development, as well as improve data-sharing
in an effort to bring new drugs to market faster.”


While the exclusion of text referencing TRIPS flexibilities from the
Political Declaration on TB represents a missed opportunity for a new point
of leverage in the promotion of affordable access to medicines, it does not
in any way prevent the use of TRIPS flexibilities, explained Palumbo.

He pointed out that this is “one political declaration, and that the right
for countries to make use of public health safeguards included in TRIPS has
been constantly reaffirmed for the past 20 years. So, it is important not
to lose sight of where it has been recognised, and ensure that it is not a
pretence for why these rights cannot be used in the future.”

However, when asked about the implications of the absence of references to
TRIPS flexibilities in the operative paragraphs of this text, Palumbo noted
that “this will probably be used as a reason why TRIPS flexibilities should
not be included in the operative paragraphs of the non-communicable
diseases declaration, that is also in the process of being negotiated right

The UN is also negotiating a declaration for a high-level meeting on NCDs
to be held on 27 September at the UN in New York (IPW, Health & IP, 6 July

He added “that we will probably see next year, at the World Health Assembly
[in May], further pushes to reduce references to TRIPS flexibilities.”

David Branigan graduated in May 2018 from the Studley Graduate Program in
International Affairs at The New School. His research is focused at the
intersection of technology, public policy and human rights.

Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International
41 22 791 6727
thiru at keionline.org

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