MAPGuideⓇ Commentaries

GHIAA’s Comments on the Bureau's Draft
of the Pandemic Accord

On June 2, 2023, the WHO released an updated draft of the WHO convention, agreement or other international instrument on pandemic prevention, preparedness and response (commonly known as the Pandemic Accord). This latest draft, referred to as the ‘Bureau’s text’, incorporates input received on the zero draft from Intergovernmental Negotiating Body (INB) members, and in some cases presents options for consideration by the INB during its next meeting on June 12 – 16, 2023.

GHIAA echoes the concerns voiced by many members of the global health community regarding the weakening and removal of language related to equitable access in comparison to the zero draft. The comments and recommendations below seek to contribute to the ongoing dialogue with a focus on the sections most relevant for the access conditions that should be attached to public funding for the development and procurement of pandemic-related products. In particular, we address:

1. Transparency of Agreement Terms

2. Access Conditions for Publicly Funded R&D

3. Benefit Sharing under a Standard Material Transfer Agreement (MTA)

1. Transparency of Agreement Terms

Extracts from the Bureau's Text

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: […]

(b) publish the terms of government funded R&D agreements for pandemic-related products, as appropriate, including:

    • research inputs, processes, and outputs;
    • pricing of end products, or pricing policies for end products;
    • licensing, to enable development, manufacturing, and distribution, especially in developing countries; and
    • terms regarding affordable, equitable and timely access to pandemic-related products at the time of a pandemic;

Option 11.B

5. In the event of a pandemic, each Party shall, in accordance with national laws:

(a) make available non-exclusive licensing of government-owned technologies on mutually agreed terms as appropriate that can be used for development and manufacturing of pandemic- related products and publish the terms of these licenses at the earliest reasonable opportunity and to the fullest extent possible;

(b) promote the publication, by private rights holders, of the terms of voluntary licensing agreements or technology transfer agreements for pandemic emergency response-related products, at the earliest opportunity and to the fullest extent possible;

Option A for paragraph 2: 2 bis. The Parties shall support the Network’s development and operationalization, and participate in the Network, including through sustaining it at all times, both during and between pandemics. The Network shall: […]

(d) [promote transparency in cost, pricing, and all other relevant contractual terms along the supply chain] / [In its government-funded purchase agreements for pandemic-related products, each Party shall, to the fullest extent possible and in accordance with applicable laws, exclude confidentiality provisions that serve to limit disclosure of terms and conditions]; […]

3. Each Party shall, at the earliest reasonable opportunity, and in accordance with applicable laws, make publicly available online the terms of government-funded purchase agreements for pandemic-related products in those instances where the Party is directly entering into the purchase agreement.

Comments

We welcome the language related to public disclosure of the terms of R&D, licensing and procurement agreements. However, as noted in articles recently published in the BMJ and Health Policy Watch, these commitments are weakened by language including “as appropriate, taking into account the extent of public funding” (Article 9), “promote” (Article 11), and “in accordance with applicable laws” (Article 13). There is a risk that interpretation of these caveats, alongside differences in current national public disclosure laws, would result in only limited transparency over agreement terms. 

The three articles addressing agreement publication also differ in the level of specificity regarding what should be disclosed and when. Article 11, Option B states “at the earliest reasonable opportunity and to the fullest extent possible.” Article 13, paragraph 3 refers to “the earliest reasonable opportunity” but lacks any statement regarding the extent of the information to be disclosed.  Meanwhile, Article 9 includes a list of terms that must be disclosed but with no associated timeframe.

Greater transparency is more likely to be achieved if all parties are required to disclose the same level of information within a specified period of time; such an approach provides the opportunity to create a more level playing field in relation to agreement negotiations, with all countries having access to comparable information.

Recommendations

1. All Parties should commit to publishing the terms of all agreements related to the use of government-owned intellectual property and public funds for the R&D and purchase of pandemic-related products. The GHIAA MAPGuideⓇ includes examples of provisions that permit the disclosure of agreement terms – these may serve as a useful reference for the negotiators, and eventual implementers, of the Accord.

2. Reiterating our recommendation on the zero draft, product developers and manufacturers receiving public funding should be required to publish the terms of the license and technology transfer agreements that impact the fulfillment of equitable access obligations. This will both help to hold countries accountable for enforcing the terms of their funding agreements and provide direct transparency over the activities of entities that have received public funds.

3. Ideally, full, unredacted agreement terms should be published. However, recognizing the likely need to protect some sensitive information, the parties should commit to minimal and fully justified redactions. In keeping with other transparency commitments related to the global supply chain and logistics in the accord, the Parties should not be permitted to redact pricing, volume and delivery schedule information.

4. Reiterating our recommendation on the zero draft, disclosure of contractual terms should be performed within a defined timeframe and through an easily discoverable and publicly available route. The relevant public entities should be responsible for proactive disclosure of the contracts, without the need for members of the public to make freedom of information requests.

2. Access Conditions for Publicly Funded R&D

Extracts from the Bureau's Text

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: […]

(c) promote public dissemination of the results of government funded research for the development of pandemic-related products, in accessible languages and formats;

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;

  1. In the event of a pandemic, the Parties shall: […]

(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.

Option 11.B

  1. At all relevant times, particularly during pandemics, each Party shall, subject to its national laws:
    • 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;
    • 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
    • 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.
  1. In the event of a pandemic, each Party shall, in accordance with national laws:
    • make available non-exclusive licensing of government-owned technologies on mutually agreed terms as appropriate that can be used for development and manufacturing of pandemic- related products and publish the terms of these licenses at the earliest reasonable opportunity and to the fullest extent possible;
    • promote the publication, by private rights holders, of the terms of voluntary licensing agreements or technology transfer agreements for pandemic emergency response-related products, at the earliest opportunity and to the fullest extent possible;
    • promote the voluntary engagement, by private rights holders, with established regional or global technology transfer hubs or other multilateral mechanisms or networks for voluntary licensing and voluntary transfer of technology on mutually agreed terms as appropriate for pandemic emergency response-related products;

 

Comments

We note that the language related to the sharing of results for publicly funded R&D (Article 9) remains similar to language used in the zero draft – it requires only the ‘promotion’ of public dissemination ‘taking into account the extent of public funding’, rather than a concrete obligation to share. Similarly, we note that the language in Article 11 (Options A & B) states that Parties will ‘encourage’, ‘urge’, and ‘promote’ the grant of licenses, engagement in technology transfer and royalty waivers on ‘mutually agreed terms’. This does not establish any concrete commitments, nor set any expectations as to what reasonable terms would be. Large, commercial organizations should not be able to use their greater negotiating power to establish terms that limit steps to achieve equitable access.

The language in Article 11, Option A relating to the waiver of royalties also remains similar to that used in the zero draft. While governments may be limited to ‘encouraging’ independent organizations to waive or reduce royalties, such requirements can, and should, be established at the outset in public R&D funding agreements. The inclusion of these obligations when an agreement is first signed is preferable to the time- and resource-intensive process of trying to renegotiate terms when a pandemic occurs. This is just one example of equitable access planning that should be implemented as early as possible in the product R&D and funding process, regardless of whether it begins during an ‘inter-pandemic’ or ‘pandemic’ time.

We also note that Options A and B for Article 11 should not be viewed as mutually exclusive alternatives – language between the two options could instead be combined in different ways for greater impact. For example, the licensing of ‘government-owned technologies’ (i.e., technologies in which a government holds IP rights) and engagement with technology transfer hubs included in Option B could also be included in Option A. Similarly, the ‘royalty-free’ license referred to in Option B could be substituted for language requiring royalty waivers in the event of a pandemic, per Option A.

Finally, we are disappointed to see the removal of the language from the zero draft establishing the inclusion of access terms related to pricing and allocation in public R&D funding agreements. While the language in the zero draft required clarification, it was a step in the right direction that has now been reversed.

Recommendations

1. The accord should make a clearer distinction between the concrete obligations that can, and should, be placed on the recipients of public R&D funding, and where governments are limited to only ‘encouraging’ (or perhaps better ‘incentivizing’) engagement from organizations acting independently of public funding.

2. Reiterating our recommendation on the zero draft in relation to the sharing of data and results, parties to the WHO CA+ should make use of the established Plan S framework for open access, which a number of governments already support. Open access requirements should be a standard obligation for all public R&D funding, regardless of funding level. The GHIAA MAPGuideⓇ includes a number of examples of open access obligations across a range of funding agreements which can be referred to for guidance.

3. Engagement in licensing and technology transfer activities should be established as a requirement for inclusion in public R&D funding agreements. Licensing and technology transfer obligations are discussed further in our commentary on intellectual property rights management in funding agreements.

4. Additional obligations to ensure equitable access to publicly funded pandemic-related products should be reestablished, building on the outline included in the zero draft. These obligations should include affordable pricing and volume commitments, as well as the development of an access plan. Provisions addressing these critical building blocks of equitable access are discussed further in our Equitable Access Pyramid.

5. Reiterating our recommendation on the zero draft, we recommend clarification of the expected mechanism for royalty waivers or reductions based on common approaches in existing agreements. The GHIAA MAPGuideⓇ includes analysis of tiered royalty structures that establish different royalty rates depending on country income levels, as well as royalty waivers triggered in the event of a pandemic.

6. An annex to the accord should identify the required conditions for publicly funded R&D agreements in a single list which consolidates the obligations currently set out in different articles. Expectations for the terms of licensing and technology transfer agreements (including royalty conditions) should similarly be clearly established in an annex. This will facilitate implementation of, and compliance with, the obligations.

7. Access-related conditions should be included in public R&D funding agreements regardless of whether the agreement is signed in an ‘inter-pandemic’ or ‘pandemic’ time. The agreement can then distinguish between the provisions that apply on an ongoing basis, and those triggered only upon the declaration of a pandemic.

3. Benefit sharing under a Standard Material Transfer Agreement (MTA)

Extracts from the Bureau's Text

Option 12.B

6. Multilateral benefit-sharing:

(a) The Parties agree that the benefits, both monetary and non-monetary, arising from facilitating access to pathogens with pandemic potential shall be shared fairly and equitably, in accordance with the provisions of the PABS [WHO Pathogen Access and Benefit-Sharing] system. Accordingly, it is understood that the production of pandemic vaccines or other pandemic-related products, irrespective of the technology, information or material used, implies the utilization of pathogens with pandemic potential, their genomic sequence, components and related information.

(b) Facilitated access shall be provided pursuant to a Standard Material Transfer Agreement, the form of which shall be set out in the PABS system and shall contain the benefit-sharing obligations that the access to pathogens with pandemic potential is subject to.

(c) Three options are presented for subparagraph 6(c) of Option 12.B.

Option 6(c).X: The benefit-sharing obligations [of 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, in order 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 6(c).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 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 the increased production capability of pandemic-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 6(c).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 organize 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 of ensuring availability and affordability in access to pandemic-related products, and to this effect shall make all possible efforts to ensure that pandemic-related product manufacturers reserve:

(a) no less than […] % of their production of such pandemic-related products on a quarterly basis for sale to Parties that are least developed countries; and

(b) no less than […] % of their production of such pandemic-related products on a quarterly basis for sale to developing country Parties.

Comments

Our comments below relate to option 12.B for the access and benefit sharing article. Option 12.A avoids establishment of the PABS System as part of the accord and does not include sufficient details as to the expectations for benefit sharing or how it will be achieved.

Option 6(c).X – benefit sharing obligations

We are pleased to see that the concrete benefit sharing obligations related to volume allocation from the zero draft have been retained, although we are concerned that they are now indicated as an option that could be removed. We do also acknowledge that this benefit sharing approach shares the potential implementation challenges of the Pandemic Influenza Preparedness (PIP) Framework upon which the PABS System provision has been modeled.

Defining those responsible for fulfilling the benefit-sharing mechanism is key to understanding how the PABS System can be implemented in practice. The current, optional, text states: “The benefit-sharing obligations [of manufacturers of pandemic-related products developed from the utilization of pathogens with pandemic potential] will include…” However, applying the obligation directly to the manufacturers of a final product may not be straightforward in practice. For example, if an academic institution is the signatory of the MTA with WHO, it is likely that the R&D process for any final product resulting from the material transfer would involve multiple other entities, and the eventual ’manufacturer’ would not be the signatory of the MTA. The Parties must therefore consider how obligations flow through the product lifecycle.

Option 6(c).Y – conditions for purchase agreements

The commitments of the Parties regarding the terms of purchase agreements are addressed only as an option to an option under the access and benefit sharing provision. However, it does not seem logical for options 6(c).X and 6(c).Y to be considered as an “either/or” – commitments made by independent organizations under an MTA are different to those made by governments in a purchase agreement. Moreover, the access conditions required in a publicly funded purchase agreement may be better highlighted as a separate commitment under the accord, rather than solely as a part of the PABS System.

Exactly what these terms should include also requires some further consideration. In particular, while “promoting or incentivizing” increased production capability should be considered even at the purchase agreement stage, it is not clear what tools – other than financial incentives – governments might use to encourage organizations to begin voluntary licensing and technology transfer at this point in the product life cycle. Indeed, this challenge was clearly illustrated for COVID-19 counter-measures where repeated calls for pharmaceutical companies to share their technology have not achieved the desired response. For a greater chance of success, licensing and technology transfer obligations need to have been attached to products earlier on in the R&D process.

Similarly, the use of global access plans (Option 6(c).Y(iv)) needs to be considered from the outset of product R&D. Challenges such as the cold chain requirements for some COVID-19 vaccines cannot be rapidly addressed if they are not considered until a final product is ready for distribution. Access plans must be established at the outset of new product development and then monitored and updated throughout the product lifecycle in order to achieve maximum impact.

Additionally, the ability of Parties to effectively exercise a right to donate products to other territories will be dependent upon the indemnity and liability management mechanisms outlined under Article 10. In particular, a globally accepted approach is required to address indemnification and liability for vaccine-injury claims for novel products used for pandemic response.

Option 6(c).Z – best efforts

Considering the lack of timely product donations by national governments during the COVID-19 pandemic, the ‘best efforts’ language in Option 6(c).Z seems likely to result in a limited contribution to equitable access. The commitments to donate pandemic-related products could, however, be used to supplement other articles, rather than being adopted solely as a weaker standalone option. In particular, ensuring the right to donate products under Option 6(c).Z could be combined with a commitment to then exercise that right and make donations to countries most in need.

It is also not clear how governments could require product manufacturers to reserve a proportion of their production volumes for least developed and developing countries if those manufacturers are not state-owned and have made no prior commitment to take such actions. Rather than governments waiting to make such requests of this nature only when a pandemic occurs, it is more likely that manufacturers will fulfill volume commitments if they are established as enforceable obligations in R&D funding agreements. Given the learnings of the COVID-19 pandemic, obligations placed on manufacturers must further be accompanied by commitments on the part of governments not to reserve production capacity for national use to the extent that it is not possible for manufacturers to reserve the required proportions for underserved populations.

Recommendations

1. The benefit sharing obligations under Option 6(c).X should include additional detail regarding who the obligations will apply to, and the process for implementing them. The Parties will also need to establish an MTA tracking and compliance monitoring mechanism to ensure fulfillment and enforcement of the obligations.

2. Commitments to include access-related provisions in publicly-funded purchase agreements should be addressed in the accord in addition to the benefit sharing obligations under the PABS System (i.e., Options 6(c).X and Y should not be considered as mutually exclusive).

3. The establishment of global access plans should be integrated into all agreements related to the use of public funds or government-owned intellectual property, as well as into the MTA under the PABS System. Access planning should not be left until the purchase agreement stage.

4. The language under Option 6(c).Z is insufficient as a standalone alternative to options X and Y. The commitments drafted under option Z should instead be additive to the obligations included in other articles.

Conclusion

Agreement provisions are a critical step on the path to facilitating and accelerating equitable access to pandemic-related products. Governments can and must do more than just ‘encourage’ organizations receiving public funding to act in a manner that supports equitable access. Instead, equitable access obligations must be a core element of publicly funded contracts.  The Pandemic Accord should include concrete commitments by the Parties to implement, monitor and enforce these obligations.

The Accord must also be clear that the use of public funding for pandemic-related products takes a number of forms, and that equitable access conditions must apply throughout. In particular, the Parties must recognize the importance of planning for access from the very beginning of the product R&D process – the obligations established early on have a direct impact on the achievement of equitable access further down the line. Those responsible for drafting and negotiating the accord must therefore address access terms as a continuum, from early R&D funding and MTAs through to purchase agreements for final products, rather than as disconnected items.

Authors: Bridie Telford, Julia Barnes-Weise

First Publication Date: June 13, 2023