MAPGuideⓇ Commentaries

GHIAA’s comments on the INB 8 Refined Negotiating Texts for the Pandemic Agreement

On February 15, 2024 Health Policy Watch published some of the refined textual proposals (“Refined Negotiating Text”) for different articles of the WHO Pandemic Agreement (“Agreement”) to be used in the eighth round of INB negotiations. On February 19, 2024, Health Policy Watch also published the Proposed Design Elements for a Pathogen Access and Benefit-Sharing (“PABS”) mechanism from the negotiating subgroup focused on this article of the Agreement. These latest texts follow the previous Negotiating Text (October 2023), Bureau’s Text (May 2023), and Zero Draft (February 2023).

The comments and recommendations below seek to contribute to the ongoing dialogue on the provisions of the Pandemic Agreement, with a focus on the sections most relevant to the inclusion of access conditions in the formation of partnerships and agreements related to publicly funded R&D, licensing & technology transfer, access to biological materials and genetic sequence data (GSD), and the procurement of pandemic-related products.

A. General Comments

Lack of firm commitments: Echoing our comments on previous drafts, we note an overarching concern that a number of provisions related to access conditions for pandemic-related products are weakened by using language such as “promote” and “support” rather than “require” and “commit “.

Transparency: We are pleased to note the inclusion of provisions related to the publication of terms for publicly funded R&D, licensing, and procurement contracts, although note that these requirements are not included for the contracts referenced under Article 11 (geographically diversified production) or Article 12 (PABS). We encourage the Parties to include consistent transparency commitments throughout the relevant sections of the Agreement.

B. Publicly Funded R&D

Extracts from the Refined Negotiating Text (emphasis added throughout)

To achieve the objective of the WHO Pandemic Agreement and to implement its provisions, the Parties will be guided, inter alia, by the following: […]

5. Equity – Equity is at the centre of pandemic prevention, preparedness and response, both at the national level within States, among and within countries or regions, and at the international level between States. Equity includes, but is not limited to, the unhindered, fair, equitable and timely access to safe, effective, quality and affordable pandemic-related products and services, information, pandemic-related technologies and social protection, taking into account specific measures to protect persons in vulnerable situations.

1. To prevent, prepare for and enable a rapid, effective and equitable response to pandemics, the Parties shall cooperate to build, strengthen and sustain national, regional and international capacities and institutions for research and development (R&D), particularly in developing countries, and shall promote scientific collaboration for the rapid sharing of information and access to research results, including through open science approaches.

[…]

4. Each Party shall develop and implement national policies to support the transparent, open public sharing of research inputs, outputs and processes from publicly funded pandemic related products R&D.

5. Each Party shall, in accordance with its national laws and considering the extent of funding provided:

(a) include provisions to promote equitable access to pandemic-related products in government-funded R&D agreements and in licensing of government-owned technology for such products; and

(b) publish relevant terms of government-funded R&D agreements for pandemic-related products, in particular, information on pricing policies for end-products; licensing to enable the development, manufacturing and distribution of pandemic-related products; and terms promoting equitable and timely access to such products during a pandemic emergency.

Comments

  • Compared to the Negotiating Text, we are encouraged to see some movement towards the inclusion of equitable access conditions in agreements for publicly-funded R&D. However, the language in Article 9.5(a) is missing any indication of the types of provisions that would “promote equitable access.” Article 9.5(b) does include some examples of access-related agreement terms that should be published by the Parties; it seems logical that example terms could also be included in Article 9.5(a).

We also note that the commitments of the Parties under Article 9.5(a) are further weakened by the inclusion of the caveat, “considering the extent of funding provided.”

  • The reference to provisions for the licensing of government-owned technology under Article 9.5(a) risks overlap with Article 11, and should be considered separately from R&D funding to product developers. Governments have control over licensing of technology that they own and should commit to licensing approaches that support equitable access. These can either be equitable access obligations directly in an agreement – with reversion of the rights if the obligations are not fulfilled – or ensuring a reservation of rights, even in otherwise exclusive licenses to allow licensing to other parties for the purpose of achieving equitable access to the technology.
  • We are encouraged to see the commitments in Article 9.4 to develop and implement national policies for the transparent sharing of research inputs, outputs and processes, although note that such policies will need to be implemented, monitored and enforced.

Recommendations

  • Reference to equitable access conditions for publicly funded R&D should be included in the overall framing for the R&D section of the Agreement under Article 9.1, in line with the guiding Equity principle set out in Article 3.5.
  • Article 9 should include at least some high level indications of the types of equitable access conditions that should be attached to publicly-funded R&D. As stated in our previous commentary on the Negotiating Text, such conditions should consider the affordability, availability, accessibility, and appropriateness (“the 4 As”) of pandemic-related products developed with public funding. The concrete actions needed to achieve the 4 As should be coordinated through an equitable access plan.
    The inclusion of additional details regarding expected equitable access conditions regarding publicly funded R&D in the Agreement would be an important contribution to the development of global norms, setting upfront expectations for product developers and facilitating coordination between funders.
  • Any consideration of the “extent” of funding provided in determining equitable access obligations should be expanded beyond the contribution of a single government to all public and philanthropic R&D funding received for a particular product. We would also argue that monetary value does not always provide a complete picture of the impact of the funding on the development of a product. For example, early-stage R&D funding often comes from public funders, who are willing to accept a high risk of failure when commercial entities are not. This early-stage funding may be a small proportion of the full development cost of a product, but without it the product may never be developed in the first place.
  • As a consideration for implementation of the commitments under Article 9.4, the Parties will need to ensure that R&D funding agreements include binding commitments for product developers to comply with the relevant policies. The Parties should also consider appropriate monitoring and enforcement mechanisms to identify and act upon any instances of non-compliance.

C. Licensing, Technology Transfer and Geographically Diversified Production

Extracts from the Refined Negotiating Text (emphasis added throughout)

1. The Parties, in collaboration with WHO and other relevant entities, with a view to achieving a more equitable geographical distribution of the global production of [product placeholder/ pandemic-related health products] and thus increasing equitable access to such products, thereby reducing the potential gap between supply and demand, shall endeavour to:

(a) take measures, in cooperation with regional arrangements, to identify and/or designate support, maintain and strengthen production facilities at national and/or regional levels, particularly in developing countries, and to facilitate production of product placeholder, as appropriate;

(b) in cases where the production capacity does not meet demand during a pandemic, take measures to identify and contract, as appropriate, with facilities other than those referred to in sub-paragraph (a) for scaling up the production of product placeholder; including through promoting and incentivizing public and private investment aimed at creating or expanding economically viable manufacturing facilities of relevant health products

(c) take measures, and encourage international organizations, to establish long-term contracts and make investments, especially in developing countries’ facilities preferably with a regional scope of operation, that generate predictable demand for product placeholder produced by local and regional manufacturers. For this purpose, the Parties, as appropriate, should act individually and jointly by means of grants, loans, blended finance, taxation and other incentives and promotion measures.

(d) facilitate the continuous and sustainable operations of the facilities referred to in Paragraph 1.a of this Article, including through transparency of relevant data [unprotected] information on pandemic-related health products and raw materials, across the value chain;

(e) facilitate the transfer of relevant technology, know-how and licenses pooled in the mechanism referred to in Paragraph 2 of Article 11, to facilities referred to in Paragraph 1.a of this Article;

1. In order to enable sufficient, sustainable, and geographically-diversified production of pandemic-related products, each Party [especially developed countries], shall collaborate towards:

a) promoting and otherwise facilitating or incentivizing the transfer of technology and know-how for pandemic-related products on voluntary and mutually-agreed terms, including through the use of licensing and collaboration with regional or global technology transfer hubs partnerships and initiatives, and in particular for technologies that have resulted from public funding;

[…]

c) license, on a non-exclusive basis and for the benefit of developing countries, government-owned pandemic-related technologies, on mutually agreed terms, and shall publish the terms of these licenses at the earliest reasonable opportunity and to the fullest extent possible in accordance with each Party’s laws and regulations;

[…]

3. During pandemics, in addition to the undertakings in paragraph 1 of this Article, each Party shall encourage holders of relevant patents related to the production of pandemic-related products, in particular those who received public funding, to waive/forgo or otherwise charge reasonable royalties to developing country manufacturers for the use, during the pandemic, of their technology and know-how for the production of pandemic-related products.

4. The [XX Committee / [Conference of Parties / Governing Body of the CA+] shall develop and adopt guidelines on the identification of technologies and know-how necessary to attain the objectives of this Agreement.

Comments

  • There are significant interdependencies between the activities outlined in Articles 10 and 11, but there is currently insufficient recognition in the Agreement of the critical linkages between them. In particular:
    • The investment and other support for regional production facilities referenced in Articles 10.1(a) and (c) requires the production facilities to have in-house R&D capabilities and/or to have access to intellectual property and technology transfer support from another entity. While Article 10.1(e) refers to facilitation of technology transfer and licenses by the Parties, there may be limited actions that they can take in this regard if they are not the owners of the relevant technology and have not obtained rights at an earlier time.
      Article 10.1(b) refers to contracting with an additional production facility for scale-up in the event of a shortfall in capacity during a pandemic, but it is unclear how this mechanism could operate without rights and access to the intellectual property and know-how required to manufacture the relevant product. We also suggest that such manufacturing contracts, including related license and technology transfer agreements, be put in place before an actual shortfall occurs to reduce the time before additional supply becomes available.
    • From the reverse perspective, the licensing and technology transfer activities under Articles 11.1 & 11.3 can only take place if there has been sufficient investment in sustainable regional production capacity such that the recipient organization(s) are in a position to effectively receive and use the transferred rights and knowledge.
  • Echoing our comments on previous draft texts, we note that Article 11.1(a) is lacking a clear requirement for product developers that have received public R&D funding to collaborate in licensing and technology transfer activities to facilitate timely and equitable access to a funded product. This is an obligation that should be considered in connection with Article 9.5(a) (see Section B above).
  • We are encouraged to see the retained commitment by the Parties in Article 11.1(c) to license government-owned technologies, although note that this provision could benefit from clearer alignment with the overall objectives of Articles 10 & 11. For example, explicit references could be made to granting licenses to support regional production facilities under Article 10, and as a contribution to technology transfer partnerships under Article 11.1(a).
  • We note that Article 11.3 retains a language similar to that from previous draft texts regarding “encouraging” patent holders, including those for publicly funded products, to waive or charge reasonable royalties for use of their technology and know-how during a pandemic. We reiterate our previous comments that requirements for waived, reduced or tiered royalties can and should be built into the conditions for publicly funded R&D and stand ready to be triggered in the event of a pandemic. This is another obligation that should be considered in connection with Article 9.5(a).
  • It is also important to note that any royalty considerations need to be linked to an actual license grant and technology transfer. The reduced royalty principle may therefore be better integrated into Articles 11.1(a) & (c) instead of being a standalone provision.
  • It is not clear how the guidelines on the identification of technologies and know-how referred to in Article 11.4 are intended to interact with the commitments made elsewhere under Article 11, which generally refer to licensing and technology transfer for “pandemic-related products”.

Recommendations

  • The Parties should ensure that there is a clear understanding of the critical interconnections between Articles 9, 10 & 11 so that the provisions of these articles are drafted and implemented in a coordinated and coherent manner to achieve their joint goals.
  • As a consideration for implementation of the Agreement, we recommend that governments assess the practical steps needed to fulfill the commitments made under Article 11.1(c). For example, they will need to ensure that any exclusive licenses granted for government-owned technology include the necessary rights reservations for the grant of subsequent licenses if required to facilitate equitable access and/or geographically diversified production.
  • We note that neither of Articles 11.1 or 11.3 refer to consideration of the costs and human resource constraints incurred by a product developer when they conduct a technology transfer to a third party, which may impact the sustainability of the product developer’s own activities. The Parties should consider mechanisms to ensure reasonable compensation for these costs, for example through public R&D funding, as part of “reasonable” royalties under a licensing agreement, and/or through funding under capacity development programs.
  • We urge careful consideration and clear articulation of the intended impact of the provisions of Article 11.4 on the commitments under the Agreement, particularly those related to public R&D funding, licensing and technology transfer, and geographically diversified production.

D. PABS

Extracts from the Proposed Design Elements (emphasis added throughout)

3.1 Manufacturers (including those under licensing agreements) commercially producing vaccines, therapeutic or diagnostic products for pathogens with pandemic potential will provide:

3.1.1 Annual monetary contributions, of an amount based on the size and nature of the manufacturer, to support the PABS system and strengthen pandemic prevention, preparedness and response capacities in countries in line with Articles 19 and 20; and

3.1.2 In kind contributions, based on the size and nature of the manufacturer, such as capacity-strengthening activities, arrangements for transfer of technology and know-how in line with Article 11, and/or scientific and research collaborations; and

3.1.3 During a PHEIC or a pandemic, real time contributions of relevant diagnostics, therapeutics and/or vaccines (X% free of charge and X% at not-for-profit prices), to be made available upon request by WHO and delivered, through the mechanisms set out in Article 13, for equitable allocation on the basis of public health risk, need and demand.

These contributions will be set out in legally binding standard PABS contracts.

3.2 Those who use shared biological materials and GSD for commercial purposes that are not manufacturers will be expected to consider voluntary contributions to support management and implementation of the PABS System.

3.3 Those who use shared biological materials and GSD for non-commercial purposes will be required to appropriately acknowledge, in presentations and publications, the laboratories/Parties providing biological materials and GSD; and expected, as appropriate, to actively engage in scientific and academic collaborations, training and capacity strengthening activities, contribute to public dissemination and transparency of research results, and consider voluntary contributions to support management and implementation of the PABS System.

Comments

  • We welcome the added reference to a legally binding standard PABS contract. However, it is not clear how the proposed design elements for the PABS provisions are intended to address the different pathways that can result in: (i) manufacturing of a viable final product; (ii) generation of commercial benefits by a user of shared biological materials and GSD. As an example scenario for consideration:
    • The entity that initially accesses shared biological materials and GSD is a university, which is generally not considered as a manufacturer
    • The university develops an innovation using the shared materials, which it then licenses to a biotechnology company for later stage clinical development.
    • The biotechnology company then grants a further license to a pharmaceutical manufacturer which produces a final product.
    • While the proposed text states that the binding PABS obligations apply to “manufacturers (including those under licensing agreements)”, the university that initially accessed the materials would appear not to fall under any binding obligations, including any requirement to pass through provisions in any subsequent license agreements. If the manufacturer only accesses shared materials via the university or biotechnology company rather than directly from the PABS System, and the license agreements do not include any PABS provisions, it is not clear if or how the PABS obligations under 3.1 could be enforced.
    • Further, the university and the biotechnology company are likely to receive commercial benefits in the form of royalty payments or other licensing fees, but would appear not to be under any binding obligation to share any of those benefits back to the PABS System.

Recommendations

  • The proposed design elements for the PABS provisions should be further developed with clear definitions of the types of organization and activity that would fall under the legally binding commitments as opposed to voluntary contributions. As highlighted in our comments on the Negotiating Text, the PABS provisions also provide clarity over the required flow-through of obligations to subsequent actors in the product development process, so that the obligations remain enforceable and attached to the use of the shared materials.

E. Procurement

Extracts from the Refined Negotiating Text (emphasis added throughout)

2. Each Party, in accordance with national laws, shall include provisions in government-funded purchase agreements for pandemic-related products that promote timely and equitable global access to such products, such as provisions that:

a) permit the donation of such products outside of its territories;

b) facilitate potential modifications (e.g., delivery swaps and schedules, in order to address supply gaps around the world;

c) incentivize or otherwise encourage licensing and other transfer of technology, in particular for the benefit of low-and middle-income countries;

d) incentivize or otherwise encourage the formulation and sharing of global access plans for the products.

Comments

  • We are pleased to note that language related to equitable access provisions in national procurement agreements has been reinstated from one of the options presented under the Bureau’s Text. However, as stated in our comments on the Bureau’s Text, we emphasize the importance of considering global access plans throughout the product development process, not just at the procurement stage. Similarly, while the inclusion of provisions in procurement contracts to incentivize and encourage licensing and technology transfer could be beneficial, particularly if an effective incentive can be provided at this stage, such requirements are more likely to have the desired impact if they are considered earlier on in the product development process.

Where next?

As the May 2024 deadline for the Agreement edges ever closer, we encourage the Parties to take the recommendations above into account in the ongoing negotiations and drafting process. We also encourage the Parties to begin consideration of the practical steps that will need to be taken at a national level to ensure that policies and contracting processes are aligned with the commitments made under the agreement. We hope that the Parties will find GHIAA’s open access resources to be a valuable resource for their implementation activities, and our team remains available to provide further input.

Authors: Bridie Telford

First Publication Date: February 29, 2024