Bureau’s Text: Weaker Language on Public Funding Disclosures, Intellectual Property Waivers, but Leaves Door Open For Pooling of Tech, Recognition of Differentiated Responsibilities & Debt Relief
Newsletter Edition #26 [Treaty Talks]
Hi,
Consensus is a zero-sum game. The Pandemic Accord discussions are tending in that direction.
We bring you a comprehensive analysis on the bureau’s text in today’s edition. We will continue to look at this process as countries pick apart politics and the provisions in the coming weeks. No doubt we are heading into a tense summer.
If you find our work valuable, support us! Tracking closed-door negotiations is tough and expensive. Help us in raising important questions, and keep an ear to the ground on how deals will be struck in Geneva. Readers paying for our work helps us meet our costs.
Until next week!
Best,
Priti
Feel free to write to us: patnaik.reporting@gmail.com or genevahealthfiles@protonmail.com; Follow us on Twitter: @filesgeneva
I. STORY OF THE WEEK
Bureau’s Text: Weaker Language on Public Funding Disclosures, Intellectual Property Waivers, but Leaves Door Open For Pooling of Tech, Recognition of Differentiated Responsibilities & Debt Relief
The Bureau of the Intergovernmental Negotiating Body set up to work towards a new Pandemic Accord has presented its version of a text building on the zero draft, and that, to an extent, draws on some of the newer suggestions provided by WHO member states. But in doing so, some say, the Bureau has had to make political choices in moving these sensitive negotiations forward.
None of this is surprising. A process as political as this one, will not please everybody. In fact, early reactions to the Bureau’s Text suggest that countries, the industry, activists and scholars have been disappointed. The process already risks being seen as a potentially unfulfilled promise that a new Pandemic Accord has come to embody.
The text shows weaker language on a number of key provisions including public funding disclosures, intellectual property waivers, but does contain potentially far-reaching provisions on pooling of tech, recognition of differentiated responsibilities and debt relief.
It is unclear whether the Bureau’s Text as it is being referred will form the basis of negotiations between countries. The text that was shared with member states on May 22nd last week, during the 76th World Health Assembly. Some media had already published the unedited version online. The process of how this text was communicated has been fascinating in itself. For one, the text (42 pages) does not show country positions, unlike a longer compilation document (208 pages) that reflects all the suggestions made by countries and their positions on other proposals.
While some countries have not been in favor of revealing country positions, and in fact have desired that the negotiations be strictly behind closed doors, in a decisive move, the bureau released the text to member states, albeit without country positions.
In this story, we closely examine the Bureau’s Text that includes diametrically opposite options for some of the more contentious provisions, suggesting the distance between member states on key issues.
THE BUREAU’S TEXT: REALPOLITIK IN ACTION?
The new text has a set of 41 articles, in addition to annexes across three chapters. The first chapter on introduction contains among others, objective and scope, general principles and approaches; a second chapter on equity has a set of 16 provisions including those on surveillance, one health, health workforce, preparedness reviews, research and development, transfer of technology, supply chains, regulatory strengthening, financing. It also contains text on “implementation, acknowledging levels of development”, loosely understood as Common but Differentiated Responsibilities.
The third chapter is on institutional arrangements and final provisions including on elements on governance, implementation, compliance, experts’ committees on scientific advice benefits-sharing and on pandemic related products.
In this section we will focus on a few key contentious provisions, and look at some of the new additions in this version of the draft in comparison to the zero draft since countries made several suggestions to text in the interim period. Note however, that many of the suggestions from countries (as displayed in the compilation text) did not make it to the Bureau’s Text.
DEFINITIONS:
The text offers a number of definitions as before. On the definition of a pandemic, a fundamental for this instrument, a footnote says: “The INB is encouraged to conduct discussions on the matter of the declaration of a “pandemic” by the WHO Director-General under the WHO CA+ and the modalities and terms for such a declaration, including interactions with the International Health Regulations and other relevant mechanisms and instruments.”
PRINCIPLES
Among principles, two issues are to an extent new: one on Common but Differentiated Responsibilities and the second on One Health. For both of these, the Bureau has presented options, that include suggested language, and the other option to not include text on these at all.
For CBDR, the suggested language comes in the form of two options, one that not only recognizes unequal development in different countries, it also obliges “Parties that hold more capacities and resources relevant to pandemics should bear a commensurate degree of differentiated responsibility regarding global pandemic prevention, preparedness, response and recovery.”
(See our earlier analysis on why CBDR is being discussed in a pandemic accord)
On One Health, the text says suggests one option: “Multisectoral and transdisciplinary actions should recognize the interconnection between people, animals, plants and their shared environment, for which a coherent, integrated and unifying approach should be strengthened and applied with an aim to sustainably balance and optimize the health of people, animals and ecosystems, including through, but not limited to, attention to the prevention of epidemics due to pathogens resistant to antimicrobial agents and zoonotic diseases.”
The other option is to not include any language at all.
SUBSTANTIVE PROVISIONS
SURVEILLANCE
In the second chapter on equity, a new article on pandemic prevention and public health surveillance [Art.4] volunteers a set provisions on surveillance measures including those addressing water, sanitation, hygiene; antimicrobial resistance; infection prevention and control; management of wastes; bio-safety and bio-security. (These are based on EU’s substantial provisions, see our earlier story on EU’s suggested text here).
The other option is to not to include these provisions on surveillance.
R&D, IP AND TRANSPARENCY
One of the most important provisions in the equity chapter that are most contentious with the most divergent options include those on intellectual property, technology transfer among other areas.
Compared to the Zero Draft, the Bureau’s Text reflects weaker provisions on obligations resulting from public funding of research.
See excerpts from Article 9 of the Bureau’s Text below that contains diluted language including “as appropriate”. See excerpt below.
“2. With a view to promoting greater sharing of knowledge and transparency, each Party, when providing public funding for research and development for pandemic prevention, preparedness, response and recovery of health systems, shall, in accordance with national laws and as appropriate taking into account the extent of public funding: [**emphasis ours]
(a) promote public dissemination of the results of government funded research for the development of pandemic-related products, in accessible languages and formats;
(b) publish the terms of government funded R&D agreements for pandemic-related products, as appropriate, including: i. research inputs, processes, and outputs; ii. pricing of end products, or pricing policies for end products; iii. licensing, to enable development, manufacturing, and distribution, especially in developing countries; and iv. terms regarding affordable, equitable and timely access to pandemic-related products at the time of a pandemic;…”
ON TRANSPARENCY
Similarly on transparency:
Art. 9:
“3. Each Party shall increase, as appropriate, the transparency of information about research and development for pandemic-related products by:
(a) sharing information on research agendas, including national research and development priorities, during pandemic emergencies, as appropriate;
(b) sharing information on national efforts and plans for building or strengthening national, regional and global research and development capacity, including building and maintaining a skilled research workforce, research infrastructure, and research supply chain needs to rapidly mount and scale research responses during pandemic emergencies…”
ON LIABILITY
There is also a separate article on Liability Risk Management, also with somewhat watered-down language.
Sample this: “Each Party shall endeavour to ensure that in contracts for the supply or purchase of vaccines developed for response to pandemics, buyer/recipient indemnity clauses, if any, are exceptionally provided as a last resort arrangement, and are reasonably time-bound with the end date expressly defined from the outset. The Parties further agree that such buyer/recipient indemnity clauses should be accepted for novel products only.”
Recall that liability provisions were highly problematic during the pandemic, not only for many countries, but especially in humanitarian settings.
An article on technology transfer now called “co-development and transfer of technology and know-how” shows unenforceable language with riders such as mutually acceptable terms.
POOLING OF TECHNOLOGY:
There is new text on pooling of technology, extending the concept behind the COVID-19 technology access pool. “Article 11 [Option 11 A]…2. The Parties, working through the Conference of the Parties, shall strengthen existing and develop innovative multilateral mechanisms, including through the pooling of knowledge, intellectual property and data, that promote relevant transfer of technology and know-how for production of pandemic-related products, on mutually agreed terms as appropriate, to manufacturers, particularly in developing countries.”
ON TECH TRANSFER AND IP WAIVERS
A key article on tech transfer and waivers of protection on intellectual property rights, the text presents two options.
Article 11. Co-development and transfer of technology and know-how.
Excerpts:
Option 11.A
4. During inter-pandemic times, all Parties commit to establish these mechanisms and shall:
(c) encourage entities, including manufacturers within their respective jurisdictions, that conduct research and development of pre-pandemic and pandemic-related products, in particular those that receive significant public financing for that purpose, to grant, on mutually agreed terms as appropriate, licences to manufacturers, notably from developing countries, to use their intellectual property and other protected substances, products, technology, know-how, information and knowledge used in the process of pandemic response product research, development and production, in particular for pre-pandemic and pandemic-related products;
ON WAIVERS
The language suggesting suspension of the protection of intellectual property protection is hedged by the use of terms such as “encourage”.
“Art. 11. 5. In the event of a pandemic, the Parties shall:
(a) take appropriate measures to support time-bound waivers of intellectual property rights that can accelerate or scale up manufacturing of pandemic-related products during a pandemic, to the extent necessary to increase the availability and adequacy of affordable pandemic-related products;
(b) apply the full use of the flexibilities provided in the TRIPS Agreement, including those recognized in the Doha Declaration on the TRIPS Agreement and Public Health of 2001 and in Articles 27, 30 (including the research exception and “Bolar” provision), 31 and 31bis of the TRIPS Agreement;
(c) encourage all holders of patents related to the production of pandemic-related products to waive, or manage as appropriate, payment of royalties by developing country manufacturers on the use, during the pandemic, of their technology for production of pandemic-related products, and shall require, as appropriate, those that have received public financing for the development of pandemic-related products to do so; and
(d) encourage all research and development institutes, including manufacturers, in particular those receiving significant public financing, to waive, or manage as appropriate, royalties on the continued use of their technology for production of pandemic-related products.”
ON TRIPS FLEXIBILITIES IN TRADE & INVESTMENT AGREEMENTS
There is also suggested language on the use of TRIPS flexibilities in trade agreements:
“6. The Parties shall ensure, when engaged in bilateral or regional trade or investment negotiations, that negotiated provisions do not interfere with the full use of the flexibilities provided in the TRIPS Agreement, including those recognized in the Doha Declaration on the TRIPS Agreement and Public Health of 2001.”
Option 11.B
A second option suggests licensing terms for technology transfer with basically no obligations.
Excerpts:
…. “3. At all relevant times, particularly during pandemics, each Party shall, subject to its national laws:
(a) take steps to urge manufacturers of pandemic-related products, such as but not limited to, diagnostics, vaccines, and therapeutics, to grant, subject to any existing licensing restrictions, on mutually agreed terms as appropriate, a non-exclusive, royalty-free licence to any such manufacturer, to use its intellectual property and other protected substances, products, technology, know-how, information and knowledge used in the process of pandemic-related product development and production, in particular for pre-pandemic and pandemic diagnostics, vaccines and therapeutics for use in agreed developing countries;
(b) urge manufacturers of pandemic-related products, such as but not limited to, diagnostics, vaccines, and therapeutics, to transfer, under mutually agreed terms as appropriate, relevant technologies, skills, knowledge and know-how, to countries without such manufacturing capacities, particularly developing countries; and
(c) actively support, participate in and or implement, as appropriate, relevant WHO technology transfer programmes and initiatives aimed at enabling developing countries to produce their own vaccines, medicines and diagnostics to address health emergencies, including strategies to build new production facilities in developing and/or industrialized countries and through transfer of technology, skills and know-how.”
On waivers two options under 11.B are suggested:
“Option A for 5(e): suspend the application of intellectual property rights, through time-bound waivers, in order to facilitate scaling-up production, manufacture and supply of products which are especially meant for a pandemic. Neither Party shall challenge these measures based on any international obligations that the party suspending the obligation may have.
Option B for 5(e): not to include 5(e)”
ACCESS TO INFORMATION AND SHARING OF BENEFITS
The Bureau’s Text also presents two options on access to information on pathogens and the sharing of benefits. The text refers to CA+ Biological Material to broadly refer to genetic sequence data and relevant information]/[digital sequence information.
One reflects newer language suggested by the developed countries including the EU and the US, the other reflects earlier provisions suggested by developing countries.
Excerpts:
Option 12.A
… “2. The Parties agree to establish such a system(s), consistent with applicable and relevant national, regional and international laws and regulations, and existing international instruments, and implementable at all times, both during and between pandemics. This will provide certainty and legal clarity for providers and users of Biological Materials, and strengthen, expedite, and not impede research and innovation. Recognizing that biological materials sharing and multilateral benefit sharing are equally important parts of the collective action for global public health, the Parties are mindful that the system(s) could be structured as either a unified system or two mutually supportive systems, and all, or parts thereof, could be adopted under Article 21 of the WHO Constitution, should such an approach be agreed. The Parties will ensure that such system(s) is/are consistent with, supportive of, and do not run counter to, the objectives of the Convention on Biological Diversity, and the Nagoya Protocol thereto.”
Option 12.B
1. The Parties recognize that global pandemic prevention, preparedness and response requires multilateral, fair, equitable and timely sharing of, on an equal footing, pathogens with pandemic potential, including their genomic sequences, components and related information, and benefits, monetary and non-monetary, including access to pandemic-related products, [arising therefrom] / [that arise from the utilization of such pathogens]. [emphasis ours]
SHARING OF BENEFITS
Under Option 12.B, there are a set of options suggested to govern benefits-sharing:
“6. Multilateral benefit sharing
c) Three options are presented for paragraph 6I of Option 12.B
Option 6I.X: The benefit sharing obligations [by manufacturers of pandemic-related products developed from the utilization of pathogens with pandemic potential] will include, but not be limited to: (i) real-time access by WHO to a minimum of 20% of the production of safe, efficacious and effective pandemic-related products, to support their equitable distribution through the WHO allocation mechanism, in particular to developing countries, [according to public health risk and need]/[that are Parties to this WHO CA+]. The pandemic-related products shall be provided to WHO on the following basis: 10% as a donation and 10% at affordable prices to WHO; and (ii) collaboration with manufacturers from developing countries and WHO initiatives to transfer technology and know-how and strengthen capacities for the timely scale-up of production of pandemic-related products.
Option 6I.Y: In accordance with national laws, each Party shall include provisions in government-funded purchase agreements for pandemic-related products that promote timely and equitable global access to such products, including, as appropriate, provisions that:
i. permit the donation of products outside of its territories;
ii. facilitate potential delivery swaps or other modifications in order to address supply gaps around the world, including in developing countries;
iii. promote or incentivize increased production capability of pandemic[1]related products, for example through subcontracting, licensing, or technology transfer on voluntary and mutually agreed terms as appropriate; and
iv. incentivize or otherwise encourage the formulation and sharing of global access plans for the products.
Option 6I.Z: In case the Director General of the WHO declares a pandemic in accordance with Article XX:
i. the Parties in a position to do so shall make all possible efforts to donate pandemic-related products to countries in need, without prejudice to the possibility for the Parties to organise direct donations to countries in need; and
ii. in case pandemic-related products are in scarce supply, the Parties shall cooperate and take coordinated actions with the aim to ensure availability and affordability in access to pandemic-related products, and to this effect shall make all possible efforts to ensure that pandemic[1]related product manufacturers reserve:
• no less than […] percent of their production of such pandemic[1]related product on a quarterly basis for sale to Parties that are least developed countries, and • no less than […] percent of their production of such pandemic[1]related products on a quarterly basis for sale to developing country Parties.
7. Each Party which has manufacturing facilities that produce pandemic-related products in its jurisdiction shall facilitate the shipment to WHO of such pandemic-related products, according to schedules to be agreed between WHO and manufacturers
OTHER PROVISIONS
More than half a dozen provisions are suggested under the article for One Health, under one of the options. Having no provisions for One Health, is also suggested by one of the options. Similarly, language is suggested for preparedness monitoring and functional reviews, including specifically for a Universal Health Preparedness Review. One of the options is to not include provisions on peer reviewed mechanisms.
NEW ARTICLE ON LEVELS OF DEVELOPMENT
The Bureau’s text features a new article that recognizes various levels of development. There are three options suggested under Article 17. Implementation, acknowledging differences in levels of development. One is to not include any text at all, other options suggest language including linking financial assistance to differentiated obligations, while referring to national sovereignty. One of the options makes implementation conditional to receiving financial assistance.
Excerpts from A and B options are presented for Article 17:
“Option 17.A
1. All Parties shall fully implement the WHO CA+, recognizing their different levels of development, and respectful of their national sovereignty.
2. The specific needs and special circumstances of developing country Parties to support implementation of the provisions of this WHO CA+, should be given full consideration for financial and technical assistance, technology transfer, and support for sustainable capacity building….”
Option 17.B
1. The provisions contained in this WHO CA+ shall be implemented by developing country Parties in accordance with this Article.
2. The specific needs and special circumstances of developing country Parties, especially those that are particularly vulnerable to the adverse effects of pandemics and other public health emergencies of international concern and of those that would have to bear a disproportionate or abnormal burden under the Convention, should be given full consideration.
3. Financial assistance, technology transfer, technical assistance, and support for capacity building shall be provided by developed country Parties to help developing country Parties to implement the provisions of the WHO CA+. The extent and the timing of implementation of the provisions of the WHO CA+ shall be related to the implementation capacities of developing country Parties, recognizing that enhanced support for developing country Parties will allow for higher ambition in their actions. Other Parties are encouraged to provide or continue to provide such support voluntarily.
4. Where a developing country Party continues to lack the necessary capacity, implementation of the provision(s) concerned will not be required until implementation capacity has been acquired. Where a developing country Party continues to lack the necessary primary health care and hospital care capacities to the resilience levels as determined under Article 6, implementation of other capacity building shall not be required in such a manner that investments will be diverted away from primary health care or hospital care capacities.
5. The extent to which developing country Parties will implement their commitments under the WHO CA+ will depend on the effective implementation by developed country Parties of their commitments under this Article related to financial resources, transfer of technology, technical assistance, and support for capacity building for developing country Parties and will fully take into account administrative and institutional capabilities as well as that economic and social development and poverty eradication are the first and overriding priorities of the developing country Parties.
6. Developing country Parties shall have full flexibility in the implementation of the WHO CA+ in light of their capacities, avoiding undue burden and respectful of their national sovereignty. In accordance with their national capacities and priorities premised upon sovereign prerogatives.”
FINANCING:
There are also more fleshed out provisions on financing the Bureau’s text, including specific language on debt relief, under Article 19.
“3. The Parties agree to establish funding mechanisms to support implementation of this WHO CA+. The mechanisms should avoid duplication and ensure complementarity and coherence among the utilization of the funds within the mechanisms and other existing funds. The mechanisms shall ensure provision of adequate, accessible, new and additional and predictable financial resources and shall include:
(a) A fund that shall be funded, inter alia, through the following sources:
i. Annual contributions by Parties to the CA+, within their respective means and resources;
ii. Contributions from pandemic-related product manufacturers;
iii. Voluntary contribution by Parties and other stakeholders.
(b) A voluntary fund for pandemic prevention, preparedness, response and recovery of health systems with contribution from all relevant sectors that benefit from good public health (travel, trade, tourism, transport)
(c) The aforementioned fund will provide resources to assist Parties, in particular developing countries, in meeting their obligations under the CA+, in particular with regards to capacity building, strengthening of health systems and laboratory capacities for pandemic prevention, preparedness response and recovery of health systems, R&D for pandemic related-products and technology transfer. The fund will also finance the WHO allocation mechanism, as well as the Secretariat of the CA+.”
ON DEBT RELIEF:
The text has language on debt relief in the context of PPR.
Two options are presented for paragraph 6 of Article 19
“Option 19.A
6. The Parties agree that funding models for pandemic prevention, preparedness and response need to take into account national financial capacity and capabilities, and to this extent shall:
(a) establish programmes that convert debt re-payment into pandemic prevention, preparedness, response, and recovery investments in health to be attained under individually negotiated “debt swap” agreements; and
(b) commit to expanding partnerships with development finance institutions in providing additional funding to developing countries, through prioritized debt relief, debt restructuring, provision of grants rather than loans that will guarantee that programs protect essential health and related spending from encroachment and to take advantage of economic benefits of frontloading finance for prevention and preparedness or support investments.
Option 19.B: not to include paragraph 6”
(See related report from the Geneva Global Health Hub on these issues: Financial Justice for Pandemic Prevention, Preparedness and Response.)
THE TEMPERATURE ON THE PROCESS - CORRIDOR TALK
Preliminary indications suggest that for a variety of reasons, there seems to be “treaty-fatigue” setting in already, among not only countries, some of whom have sought to buy additional time. Even activists championing the Pandemic Accord are beginning to come to terms with the limitations of reaching far-reaching provisions on equity that some groups had set out to advocate for, particularly in terms of matters of access to medicines and intellectual property.
THE ROLE OF THE BUREAU
Some countries also suggested, that they were not happy with the INB Bureau. Many countries want the Bureau to take leadership in driving these negotiations. And yet, the Bureau is also keen to be led by member states, sources familiar with the dynamics say. Many developed and developing countries are not happy with the way the Bureau has managed the process, although these are relatively early stages in these discussions.
Experts point to climate negotiations and the role of France – as a host country – to forge the Paris agreement. “There is no host country here,” one developed country diplomat told us.
Some activists blame the Bureau for “wasting time”, and for catering to the needs of developed countries.
To be sure, the Bureau is tasked with the nearly impossible – to draw up a text while balancing competing political interests of member states. For some, that countries across the board are disappointed, shows the delicate balance of power among the six Bureau members.
In private conversations, countries point to the efficiency and coherence in the negotiations on the targeted amendments to the IHR. Many believe, this is a somewhat unfair comparison, given that the starting point for INB Bureau is a carte blanche for a legal instrument with very many different elements. Although the IHR discussions are also contentious for the very same reasons such as the sticking points at the INB on equity and IP for example, the Bureau of the WG-IHR has undoubtedly a relatively easier task in terms of amending existing rules, or weighing to expand the technical nature of these regulations.
MEMBER STATES AT THE WHA ON THE INB-IHR PROCESS
A number of countries sought greater coordination and complementarity between the two tracks of negotiations including New Zealand, Indonesia, Japan among others, in their statements during the just-concluded WHA.
Small island developing states emphasized the difficulties with maximizing engagement and called for mitigation against “unintentional exclusion.” Russia said it was concerned with ambitious deadlines for agreements on instruments, especially given pace of negotiations. It suggested a shorter framework document with only declarative principles.”
Countries hoped to conclude negotiations in time for May 2024.
In his closing remarks at the World Health Assembly this week, DG Tedros said: “Our challenge as Member States is to negotiate a strong accord for approval just 12 months from now. This is a generational opportunity that we must seize. We are the generation that lived through the COVID-19 pandemic, so we must be the generation that learns the lessons it taught us, and makes the changes to keep future generations safer…”
WHAT’S NEXT?
A joint session of the two bureaus of the INB and the WG-IHR is expected on June 5. Sources said that there will be deeper linkages between the two processes during the consecutive meetings of the INB and the WG-IHR in July.
Ahead of those July meetings, the INB is scheduled to meet for a week-long drafting group meeting during 12th-16th June. It is not clear whether countries will begin negotiating on the basis of the Bureau’s text. Sources that countries will push for additional text to the Bureau’s proposal - especially those elements that have been left out of the compilation text that contains all of proposals from member states.
A number of countries would prefer a “good solid first draft” even if it takes the time – some developed country diplomats told us.
But countries, especially developing ones are keen to continue with the momentum to ensure these negotiations remain on track.
There continues to be deep trust issues between countries especially on matters of equity. “If developing countries are assured that their concerns will be treated fairly, they will be less insecure”, a source close to the Bureau’s processes told us.
WHO ELSE IS DISAPPOINTED?
Shoa Moosavi contributed to this story
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