UN Political Declaration on TB finalised: no commitment 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.

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.

Preamble

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, advocacy advisor for Médecins Sans Frontières (MSF, Doctors Without Borders) USA, 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).

Negotiation

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:

1. 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;
2. 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;
3. Addressing barriers, regulations policies and practices, including regulatory strategies, that prevent access and use to affordable and effective tuberculosis diagnostic and treatment; and
4. 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 guidelines.

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.”

Implications

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 now.”

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 2018).

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

Source: Intellectual Property Watch