South Africa breaks the silence procedure: UN Political Declaration on tuberculosis

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” (Source: 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: https://www.un.org/pga/72/wp-content/uploads/sites/51/2018/07/TB.pdf.

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 procedure.

    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.

    Excellencies,

    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:

Excellencies,

    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 and academia

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 prices.”

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 and Professor of Law, Northeastern University – “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 bullying.”

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.”

Dr. Bernard Pecoul, Executive Director of the Drugs for Neglected Diseases initiative (DNDi) – “We support South Africa in its commitment to reaffirm the right of countries to take measures, fully consistent with international trade rules and reiterated in the 2001 Doha Declaration on the TRIPS Agreement and Public Health, to protect public health and access to medicines and to ensure needs-driven R&D that disconnects the financing of innovation from high prices and volume based sales. The current UN negotiations pertain to tuberculosis, but ultimately, any precedent set in these negotiations will affect innovation and access for all areas of public health importance, from neglected tropical diseases to viral infections to serious drug-resistant infections including but not limited to TB.”

Chirag Mudaliar, Universities Allied for Essential Medicines (UAEM) – “Opposing TRIPS flexibilities to incentivise research while also excluding delinkage from the political declaration on the fight against tuberculosis is both an affront to logic and an attack on patients who are unable to afford life-saving antibiotics. As a student of medicinal chemistry from a developing country, South Africa’s stand fills me with hope.”

Ilona Kickbusch, Director of the Global Health Centre, Graduate Institute – “As global power shifts and multilateralism is under attack, health diplomacy has become an important tool for LMIC to defend their interests. On TB negotiations South Africa – as a highly affected country and a member of BRICS – has shown that it will not accept political pressure to place commercial interests above public health interests. The key reason for taking health issues to the United Nations is to gain high level political support to move forward on major global health challenges – but at present we witness a strategy that aims to achieve a systematic weakening of agreements already adopted.”


Alain Claude Muhunde, Chargé de communication
– “We applaud South Africa for having the courage to call for a re-opening of negotiations on the United Nations Political Declaration on Tuberculosis to include TRIPS flexibilities. We strongly encourage the other African countries to support South Africa’s position.”

As a reminder, the use of TRIPs flexibilities was unanimously approved by all WTO member States in the Doha Declaration. Therefore, we do not understand how these same signatory States can oppose the inclusion of these flexibilities in the UN Political Declaration on TB.

The use of TRIPS flexibilities ought to be the rule for all countries so as to ensure that their population have sustainable access to affordable and quality medicines.

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 countries.

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 this?

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!

——

Comrades!

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!

Amandla!”