Comments & Recommendations

Public R&D funding represents a substantial portion of total investments in the development of pandemic-related health products. The inclusion of equitable access provisions in publicly funded R&D agreements, as outlined under Article 9.5, is therefore a key tool for facilitating equitable access to these products. We highlight the following points for the INB’s consideration as it continues working toward consensus on effective and implementable language for Article 9.5:

1. Development & implementation of policies: We welcome the requirement for the Parties to develop and implement policies related to the provisions to be included in public R&D funding agreements. However, we are concerned by the following proposed limitations and caveats to such a commitment:

• • “Each Party shall develop and implement [,as appropriate,]” – The appropriateness of policies is open to broad and subjective interpretation and could result in some Parties determining that the development and/or implementation of policies is not appropriate. 

• • • Recommendation: Remove “as appropriate.”

• • “…policies [regarding the inclusion of] /[to include]/[on the inclusion of]” – The proposed options for “regarding the inclusion of” and “on the inclusion of” pose a risk of weakening the obligation such that the Parties could develop policies that only consider whether equitable access provisions could be included in funding agreements, or conclude that such provisions will not be included. 

• • • Recommendation: This language should read “policies to include…”

• • “… [in [publicly funded research and development agreements][particularly with private entities]/[with private and budgetary entities]/ [in research and development agreements in case of public-private partnerships/contracts] DEL]” – As noted in our previous commentary, the reference to publicly, rather than government, funded R&D agreements should be retained. Further, Article 9.5 should apply to public R&D funding to any type of entity, regardless of whether the funding recipient is considered to be part of the public or private sector. Many different types of organizations are involved in the development of pandemic-related health products, and the attachment of equitable access obligations to public funding to all of those organizations is critical for the goal of achieving equitable access to the resulting products. 

• • • Recommendation: The language should read “provisions in publicly funded research and development agreements…”. Any reference to agreements with private entities should be stated as “including with” so as not to exclude other types of entities from the scope of the provision.

• • “…access to such products [during [public health emergencies of international concern and DEL] pandemics/[pandemic emergencies] DEL]…” – As highlighted in our previous commentary, equitable access to pandemic-related health products must be considered in the context of preparedness and prevention, not just in the context of pandemic response. 

• • • Recommendation: The restriction to promoting access during public health emergencies or pandemics should be removed, and the definition of pandemic-related health products under Article 1(d) must capture products for prevention, preparedness, and response.

2. Publication of terms: We are pleased to note that the requirement for the publication of the equitable access terms of publicly funded R&D agreements has been retained with the removal of the caveat “relevant” from the previous text, but encourage the Parties to consider extending the publication commitment to terms beyond specific equitable access obligations.

• • • Recommendation: The Parties should commit to promptly publishing the terms of publicly funded R&D agreements with minimal redactions through easily discoverable and accessible routes.

3. Example Equitable Access Provisions: We welcome the inclusion of examples of different types of equitable access provisions under Article 9.5, but reiterate proposed clarifications outlined in our previous commentary, in particular:

• • “(i) licensing and/or sublicensing, preferably on a non-exclusive basis” and “(iii) [voluntary] technology transfer [on mutually agreed terms]” – Licensing and a commitment to technology transfer often need to be undertaken together. On one hand, it is likely that a manufacturer will need a license to use at least some of the information and materials included in a technology transfer for the purpose of manufacturing and commercializing related products; on the other, it is likely that a license for a complex technology will need to be accompanied by technology transfer to enable a manufacturer to successfully use the licensed technology to manufacture and commercialize related products.

Further, the additions of “voluntary” and “on mutually agreed terms” to Article 9.5(iii) appear unnecessary in this context because an organization entering into a publicly funded R&D agreement would be doing so voluntarily and with full knowledge of its obligations upfront. The circumstances under which licensing and/or technology might take place from the funding recipient to a third party could be agreed upon as part of the funding agreement negotiation process. Examples of such negotiated provisions from existing R&D funding agreements are available in GHIAA’s Equitable Access Toolkit.

• • • Recommendation: The language should recognize the link between, and purpose of, licensing and technology transfer, as well as the linkage with Articles 10 and 11 of the proposed text. For example: “Such provisions may include: (i) entering into licensing and/or technology transfer agreements, as applicable, on reasonable terms and preferably on a non-exclusive basis, to geographically diversified manufacturers and/or technology transfer hubs in support of the objectives of Articles 10 and 11 herein…”

• • “(ii) affordable pricing policies” – In GHIAA’s experience, R&D funding agreements tend to contain affordable pricing obligations or commitments, rather than policies, to indicate clear expectations that products developed using public funding will be made affordable, rather than just developing policies for affordable pricing–which may or may not be implemented.

• • • Recommendation: For greater clarity, the language should read “(ii) affordable pricing commitments.”

• • “(v) adherence to product allocation frameworks adopted by WHO” – For coherence across the provisions of the Pandemic Agreement, Article 9.5(v) would benefit from linkage to the Global Supply Chain and Logistics Network (GSCL Network) established under Article 13. The language could also be broadened to consider other factors that may impact the goal of ensuring availability, such as timely regulatory approval and product registration submissions.

• • • Recommendation: The language could read “(v) facilitation of timely and sufficient product availability, particularly for developing countries, for example through product registration strategies and cooperation with the activities of the GSCL Network as established under Article 13 herein.”

• • We also note that the examples of equitable access provisions for purchase agreements outlined under Article 13bis (see below) include “global access plans.” Access plans can include many elements related to the affordability, availability, accessibility, acceptability, and sustainability of a health product – these considerations need to be integrated into decision making throughout the product R&D process, rather than being left until the product reaches the commercialization phase. We therefore urge Parties to include the development, monitoring, and update of access plans in the national policies developed under Article 9.5.

Comments & Recommendations

1. Licensing and technology transfer for publicly-funded, government-owned, and privately-owned technologies: The proposed text for Article 11.1 includes references to a range of licensing and technology transfer commitments, requests, and/or incentives for a mixture of publicly funded, government owned, and privately owned technologies. The current presentation of the text leaves gaps in the commitments or requests made for each of these technology categories, and misses opportunities for strengthened requirements through connection with the commitments under Article 9.5. In particular:

• • Article 11.1(a) refers to promoting, facilitating or incentivizing technology transfer “for technologies that have received public/government funding for their development], through a variety of measures such as licensing… incentives or conditions linked to research and development, procurement or other funding…” This provision would benefit from clear linkage to Article 9.5, which references licensing and technology transfer as equitable access conditions that may be included in public R&D funding agreements.

We also reiterate our statements from previous commentaries that, when pandemic-related health products or technologies are developed with the use of public funds, governments have the leverage to require (not just “promote” or “incentivize”) licensing and technology transfer to facilitate equitable access to those products or technologies.

• • We welcome the return of a commitment by the Parties to make available licenses to government-owned pandemic-related technologies under Article 11.1(b), but note that this does not make reference to any technology transfer that may be required to support successful application of the technology. This is inconsistent with other provisions under Article 11 which emphasize the importance of technology transfer to “enable the sustainable and geographically diversified production of pandemic-related health products.” Similarly, there is no reference to reduced royalties or engagement with technology transfer hubs, both of which will be promoted or encouraged from private rights holders under Articles 11.1(d) and (e).

Further, the proposed qualifier “seek to” at the start of Article 11.1(b) should be omitted. The language already states that licensing will be “in accordance with national or domestic, and international law.” The obligation to make licenses available does not mean that licenses must be granted if there are no suitable licensees.

• • While we support the inclusion of commitments by the Parties under Article 11.1(d) to encourage patent holders to charge reasonable royalties to “increase the availability and affordability of such products to populations in need,” this provision would also benefit from a clearer linkage with the need for a license and/or technology transfer agreement which would form the basis for the royalty charges. Related to our comments on Articles 11.1(a) and (b), where the patent in question is government-owned or related to a publicly funded R&D agreement, commitments by the Parties related to reasonable royalties can be stronger than “[Encourage/urge /request].”

The Parties may also wish to consider that royalty terms are not the only element of a licensing and/or technology transfer agreement that would need to be “reasonable” in order to achieve the goals of increased availability and affordability. Other terms that may have an impact on this goal include the licensed sales and manufacturing territories, other fees that are not classified as “royalties” (e.g., lump sum technology transfer fees, pass through of patent filing costs), and the extent of, and support for, technology transfer.

• • • Recommendation: The provisions under Article 11 could be restructured to make clearer that, to enable sustainable and geographically diversified production and increased availability and affordability of pandemic-related health products, the Parties will, among other commitments: 

• • • • Include requirements in public R&D funding agreements for licensing and technology transfer on reasonable terms (including reasonable royalties) and preferably on a non-exclusive basis, from the funded entity to geographically diversified manufacturers and/or technology transfer hubs in accordance with the national policies established under Article 9.5;

• • • • Make available licensing and/or technology transfer agreements for government-owned intellectual property on reasonable terms (including reasonable royalties) and preferably on a non-exclusive basis, to geographically diversified manufacturers and/or technology transfer hubs in accordance with national and international laws and policies; and

• • • • Encourage and incentivize private rights holders for pandemic-related health products and/technologies not developed with public funding to make available licensing and/or technology transfer agreements on reasonable terms (including reasonable royalties) and preferably on a non-exclusive basis, to geographically diversified manufacturers and/or technology transfer hubs.

2. Publication of licensing agreements: We are pleased to note the inclusion of commitments by the Parties under Article 11.1(c) to publish the terms of licensing agreements. As stated in our previous commentaries, we encourage the Parties to consider including requirements in the policies developed under Article 9.5 to extend such publication obligations to license and technology transfer agreements for publicly funded pandemic-related technologies and health products.

3. National policies and legislation: We note the addition of Article 11.6 which proposes that each Party “review and consider amending” national legislation to ensure that it is able to implement Article 11 “in a timely and effective manner.” As noted in our previous commentary, it is likely that commitments related to the licensing of government-owned technologies will require the development and implementation of supporting regulations, policies, procedures, and/or practices that consider how to best facilitate and monitor the achievement of equitable access through agreement provisions. We therefore encourage the strengthening of Article 11.6 such that the Parties commit to amending legislation if required, as well as developing and implementing related policies.

• • • Recommendation: The language in Article 11.6 should state that the Parties will “review, and if required amend, its national and/or domestic legislation, as well as developing and implementing appropriate policies…”