[Ip-health] South Africa breaks the silence procedure: UN Political Declaration on tuberculosis

Thiru Balasubramaniam thiru at keionline.org
Fri Jul 27 22:37:12 PDT 2018


South Africa breaks the silence procedure: UN Political Declaration on

Posted on July 27, 2018 <https://www.keionline.org/28579> by Thiru

On 26 September 2018, the United Nations’ General Assembly will convene the
first high-level meeting on tuberculosis; the theme of the meeting is
“United to end tuberculosis: an urgent global response to a global
epidemic”. In preparation for the United Nations High-Level Meeting, the
Ambassador of Antigua and Barbuda to the United Nations (H.E. Mr Walton
Alfonso Webson) and the Ambassador of Japan to the United Nations (H.E. Mr.
Koro Bessho) were appointed to serve as co-facilitators to “lead the
intergovernmental consultations and negotiations on the modalities and
outcomes of the High-Level Meeting on the Fight against Tuberculosis”
https://www.un.org/pga/72/wp-content/uploads/sites/51/2018/07/TB.pdf). The
co-facilitators presided over a two-month negotiation over the text of a
Political Declaration on the Fight Against Tuberculosis: An Urgent Global
Response to a Global Epidemic. The final text of the declaration can be
found here

Early on in the negotiations, KEI noted the following:
"The European Union and the United States are hell-bent on purging the
political declaration of the UN High Level Meeting on Tuberculosis from
references to the WTO Doha Declaration on the TRIPS Agreement and Public
Health and the use of TRIPS flexibilities. The marked-up text from the
negotiations in June 2018 show that the EU and US are determined to delete
the one reference in operative paragraph 13 to the “importance of delinking
the cost of investment in research and development from the price and
volume of sales to facilitate equitable and affordable access to new tools.
This does not portend well for the upcoming UN negotiations on
noncommunciable diseases.”

Politico Europe, Stat News, IP-Watch, and The Wire have provided good
coverage of attempts by the United States to rollback language in the
operative part of the declaration reaffirming previous commitments to
protect public health and promote access to medicines through the use of
the public health safeguards of the TRIPS Agreement (including compulsory
licensing) and exploring new models of innovation that would delink the
cost of R&D from the price of health technologies.

References to TRIPS safeguards and delinkage were expunged from the
operative elements of the final text ofthe UN Political Declaration on the
Fight Against Tuberculosis. On 20 July 2018, the co-facilitators presented
the final text; the text remained under “silence until 6 pm” New York time
on 24 July 2018. On 24 July 2018, the President of the General Assembly,
Miroslav Lajčák, informed the General Assembly that the “the silence
procedure [had] been broken“. South Africa broke the silence procedure thus
opening up the text for renegotiation.

In its explanation for breaking the silence procedure, South Africa
expressed the following concerns expressing strong support for the
inclusion of language on TRIPS flexibilities and delinkage. KEI is in the
process of obtaining South Africa’s full statement on breaking the silence

"It is regrettable that we find ourselves in this position where we have
had to break silence in order to have our voice heard. This was not an
option which we preferred or which we took lightly, but the importance of
this matter and its potential for saving millions of human lives,
necessitated it. We wish to take this opportunity to explain our position.


In our experience, we have learned that a critical balance is needed
between the right to health and intellectual property rights to ensure that
medicines, vaccines and diagnostics are available and accessible for all in
need. Today South Africa has the biggest antiretroviral program in the
world because of the changes made to the patent laws which significantly
brought down the price of medicines, by an estimated 96% since 2000.

Drawing from our lessons on HIV/AIDS and TB, the South Africa Government is
currently focusing on strategies to increase affordable access to cancer
treatments with emphasis on new models for innovation on TB R&D that
de-link R&D costs from prices.:

In relation to the operative elements of the text, South Africa provided
the following perspicacious observations:


South Africa notes with great concern that the final draft has departed
from the global consensus reached in Doha on the Trade Related Aspects of
Intellectual Property Rights and its flexibilities as agreed to in the
World Trade Organisation Ministerial Declaration in 2001. Since then, this
global consensus has been reaffirmed in numerous resolutions and outcome
documents of the United Nations General Assembly as well as the World
Health Organisation.

The omission of the reference in PP19 to the acknowledgement “that
protection and enforcement measures for intellectual property rights should
be compliant with the World Trade Organisation Trade Related Aspects of
Intellectual Property Rights”, severely hinders Member States’ ability to
provide life-saving drugs in the interest of public health and towards the
achievement of universal health coverage as envisaged in the 2030 Agenda
for Sustainable Development.

Furthermore, the recent consensus reached in the 2016 Political Declaration
on antimicrobial resistance (AMR) on the need to “delink 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 other results
to be gained through research and development”, has been weakened and
undermined by the current draft text in OP22."

In its explanation of its momentous decision, South Africa did not mince
words on how the current text failed to meet the scale of ambition required
to tackle tuberculosis:

"As it currently stands, the draft outcome of the first UN High-Level
Meeting on TB falls well short of providing millions of our fellow human
beings, who are dying from this preventable, treatable and curable disease,
with affordable access to the medicines they so desperately need. It
further erodes gains made in addressing other co-morbidities and
co-infections such as HIV and AIDS as well as AMR. South Africa has long
held the view that the duty of States to safeguard public health is not
inconsistent with their concomitant responsibility to honour international
treaty obligations with regards to intellectual property rights as
recognized in the Doha Declaration.

Despite South Africa’s constructive efforts throughout the negotiations as
well as numerous bilateral engagements with the co-facilitators and key
actors to explain its position in maintaining consensus language on the
above issues, the current text failed to take into account the concerns
raised by the delegation of South Africa.

South Africa’s bold leadership provides the United Nations the opportunity
to course correct and achieve an outcome that will deliver for TB patients
the world over."

Reactions from civil society.

*James Love, Director, Knowledge Ecology International* – “South Africa is
standing up for people who are poor and sick. South Africa has pointed to
the direction that needs to be followed to resolve the conflict between
innovation and access. Governments need to delink R&D incentives from drug

*Els Torreele, Executive Director of Médecins Sans Frontières’ (MSF) Access
Campaign* – “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 draft declaration of
the UN High-level Meeting on TB.

For almost two months, negotiators have been in heated talks that resulted
in a draft declaration that widely diverged from language in previous UN
declarations on health and access to medicines, which had recognized the
need to promote public-interest-driven research and development (R&D) and
ensure that resulting health products are affordable and available for
people. This aggressive push by several countries backed by big pharma
lobbies would severely undercut needed guarantees to protect access to
vital tools and medicines for people living with TB.

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. Countries
must also push to retain the full rights to use internationally agreed
public health safeguards enshrined in Trade-related Aspects of Intellectual
Property Rights (TRIPS) agreement for access to affordable, generic
versions of all TB medicines, especially the newer all-oral treatments
needed to scale up treatment of the disease.

It is critical that leaders remember this declaration won’t just live on
paper; it will have real-world consequences for millions of people who need
affordable lifesaving TB medicines.”

*Professor Brook Baker, Senior Policy Analyst, Health GAP* – “It’s no
surprise that South Africa, a country staggering with the burden of
under-treated and disease-resistance TB, would break the code of silence
and challenge the Trump administration’s preposterous opposition to
including language within the UN Political Declaration on Tuberculosis
acknowledging what is already clear under international law – that
countries have an untrammeled right to use TRIPS-flexibilities to access
more affordable medicines for treating the world’s most deadly infectious
disease. Even though the monopoly-based patent system provides almost no
incentives for R&D in diseases like TB mainly impacting the poor, the US is
intent on preserving Big Pharma’s monopoly powers over life and death.
South Africa and dozens of other countries need access to the two newest TB
medicines and to other TB medicines in the pipeline other than through
limited donation and price-concession agreements. Important language on
delinkage and other incentive systems for TB innovation and on full use of
TRIPS flexibilities should be included in the operational text of the
Political Declaration and we applaud S. Africa for standing up to US

*Chee Yoke Ling, Director of Programmes, Third World Network* – “Third
World Network lauds South Africa for breaking the silence procedure, a
procedure that itself is inconsistent with the transparency practices of
United Nations negotiations since the early 1990s. It is shocking that mere
references to the WTO Doha Declaration on the TRIPS Agreement and Public
Health have to be fought out again and again in every negotiation text. The
lessons from HIV/AIDS and hepatitis C have proven the life-saving benefits
of TRIPS flexibilities when governments exercise their legal rights. The
urgency of affordable TB medicines demands no less.”

*Tim Reed, Executive Director, Health Action International* – “This was the
boil that needed to be thoroughly lanced. South Africa have shown that UN
Member States can stand up in the face of unilateral pressure aimed simply
at defending private interests over public health. It is nothing short of
short of heroic.”

*Dr. Mohga Kamal-Yanni, Senior Health and HIV Policy Advisor, Oxfam* –
“Oxfam warmly welcome South Africa’s action to defend the rights of
patients to access to the medicines that can save their lives. All
countries signed the Doha Declaration which states that the “TRIPS
Agreement does not and should not prevent Members from taking measures to
protect public health”. The TB and NCDs political declarations must include
text that emphasizes countries’ legal rights enshrined in the TRIPS
agreement to use the TRIPS flexibilities to protect public health. This is
critical if world leaders are serious about combating the deadly TB and
NCDs and improving the health and well being of their populations. ”

*Speech delivered by TAC Chairperson Sibongile Tshabalala and TAC General
Secretary Anele Yawa at #AIDS2018 at a session titled: “Seizing the moment
for TB” *–

“Comrades, I come from the Treatment Action Campaign in South Africa

I thank my comrade from India, Blessi Kumar for giving us an opportunity to
have our voice heard at the TB session.

Comrades – what is killing our people with HIV today – it is TB – so yes,
we must seize the moment as this session says.

But far away from all of us, from community groups, in New York, a document
is being negotiated that will affect how our governments “seize the moment”
– could any of us have imagined that the objective of one of the countries
would be to seize our medicines.

You all have heard about the UN High Level Meeting on TB which is to take
place in September 2018 and there will be a declaration signed by all

The HLM and the political declaration will form the basis of my government,
your government, all our governments to commit political will and resources
to fight TB.

But language that will ensure access to affordable generic TB medicines,
vaccines and diagnostics may not be in the Declaration now.

When our lives were in danger in the 1990s our President Nelson Mandela was
sued by big pharma to stop generic medicines from reaching our people.

We came on the streets – the whole world came on the streets and at the
World Trade Organisation all the countries including the United States
signed the Doha Declaration – this Declaration recognises the right of our
governments to take legal measures to ensure access to generic medicines.

That language has been in every HIV declaration in the past two decades.

That language is in the sustainable development goals.

Why should it not be in the TB High Level Meeting declaration.

Why is the United States bullying our governments to take this language
out? Ambassador Goosby you were leading the US response on HIV for many
years, why have you not spoken out on what the US is doing? As UN
Ambassador we call on you to immediately support language in the
declaration on using TRIPS flexibilities to ensure access to affordable TB
medicines, vaccines and diagnostics.

Why is the EU silently supporting the US?

Why is the government of the Netherlands that is hosting us, that has
pledged to put their power and political will behind HIV staying silent on

Do you not know what is killing people with HIV?

Or is your only concern that we will get on flights and bring TB to you?

That you do not really care whether we live or die?

Whether we get TB treatment or not?

My government, South Africa, has stood up and broken the silence. My
government is demanding that language on access to affordable generic TB
treatment is including in the HLM.

We call on all of you, all other governments, all our panelists to join us
and our government in protecting our right to affordable TB medicines.

Viva South Africa Viva!



Do we not know who is behind all this?

Johnson and Johnson said in an interview yesterday that they have the same
goals as all of us!

No my friend we do not!

Our goal is to save our lives and those of our comrades.

Your goal is to make money off of our suffering.

We know that bedaquiline can be available for less than a hundred dollars –
so don’t expect us to be happy with the 400 USD price – don’t expect us not
to fight for our comrades in other countries where you are charging even
higher prices – up to 30,000 USD in some countries!

So if you think you can use the US government to keep the language ensuring
access to generic medicines out of the declaration – my friend you cannot
keep us – the community, the patients, the ones whose lives are at stake
out of the declaration!

We will stop your patents from being granted.

We will have compulsory licenses issued on your medicines.

Community property not intellectual property.

People not patents.

All the power, to the people!


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

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