MAPGuideⓇ Commentaries

GHIAA’s Comments on the Zero Draft
of the WHO CA+

The zero draft of the WHO international instrument on pandemic prevention, preparedness, and response (referred to as the “WHO CA+”) was published on February 1, 2023. As an organization that advocates for the inclusion of equitable access terms in global health agreements, GHIAA welcomes the sections of the text related to the “conditionalities” that should be attached to the use of public funds for medical products. We also welcome the important additions made since the conceptual zero draft that have started to lay the foundation for exactly what these “conditionalities” should be. However, as others have already said,–now the real work begins. Below we make recommendations on the further development of several sections of the zero draft for consideration by the Intergovernmental Negotiating Body (INB) ahead of the negotiations scheduled to start on February 27, 2023.

1. ‘Encourage’ and ‘endeavor’ should be strengthened to establish clear commitments

A number of the provisions that we have highlighted below refer to ‘encouraging’ recipients of public funding to undertake certain activities, as well as ‘endeavors’ to address equitable access and transparency conditions. We echo the statement made by STOPAIDS that this language should be strengthened and made into clear requirements. We further recommend that the expected vehicles for these ‘encouragements’ are clarified; the most likely avenues for this are the terms of R&D funding agreements and/or national legislation applicable to a developer or manufacturer that receives funding.

2. Licenses to ‘capable manufacturers’ should include equitable access provisions

Article 7. Access to technology: promoting sustainable and equitably distributed production and transfer of technology and know-how

1. The Parties recognize that inequitable access to pandemic-related products (including but not limited to vaccines, therapeutics and diagnostics) should be addressed by increased manufacturing capacity that is more equitably, geographically and strategically distributed.

2. The Parties, working through the Governing Body for the WHO CA+, shall strengthen existing and develop innovative multilateral mechanisms that promote and incentivize relevant transfer of technology and know-how for production of pandemic-related products, on mutually agreed terms, to capable manufacturers, particularly in developing countries.

3. 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, licences to capable 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;

Recommendations

We welcome the statement in item 1 of Article 7 that recognizes the need to address inequitable access through increased and more equitably distributed manufacturing capacity. However, we recommend that the subsequent text regarding license grants in item 3(c) is strengthened to ensure that the goal of addressing equitable access is reflected in the terms of licensing agreements. Product developers and manufacturers should be required to grant licenses under terms that support the timely, affordable, and equitable supply of licensed products. For example, product developers and manufacturers should not be able to require prioritization of supplies for more profitable high-income markets, as was the case with some COVID-19 vaccine production.

3. Obligations to waive or manage royalties should be clarified

Article 7. Access to technology: promoting sustainable and equitably distributed production and transfer of technology and know-how

4. In the event of a pandemic, the Parties:

(c) shall 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) shall 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.

Recommendations

We support the use of waived or reduced royalties to facilitate equitable access to pandemic response products, and to medical products more generally. However, we recommend clarifications to items 4(c) and 4(d) of Article 7 to identify the expected mechanism through which royalty rates will be agreed upon between the relevant parties (usually a license agreement), and to define ‘manage as appropriate’. A common approach is to use tiered royalty structures that establish different royalty rates depending on country income levels. Royalties can be waived for sales to the low-income countries and/or for all countries for a defined period of time such as the duration of a pandemic. We have analyzed some examples of tiered royalty structures here. 

Further, the potential complexity of patents covering a single medical product means that multiple upstream and downstream royalties spanning multiple licensors and jurisdictions would need to be waived or reduced. Advance planning is therefore required to facilitate rapid implementation in the event of a pandemic. We recommend that the INB consider incorporating such planning into mechanisms to be established during inter-pandemic times. 

4. Equitable access conditions for publicly funded research require further development

Article 9. Increasing research and development capacities

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, taking into account the extent of the public funding received:

(a) promote the free, public dissemination of the results of publicly and government-funded research for the development of pandemic-related products;

(b) endeavour to include terms and conditions on prices of products, allocation, data sharing and transfer of technology, as appropriate, and publication of contract terms;

(c) ensure that promoters of research for pandemic-related products assume an appropriate level of the associated risk;

(d) promote and incentivize technology co-creation and joint venture initiatives; and

(d) establish appropriate conditions for publicly funded research and development, including on distributed manufacturing, licensing, technology transfer and pricing policies.

Recommendations

We welcome the inclusion of obligations for free and public dissemination of results, particularly since this is already a common practice requirement for research conducted with public and philanthropic funding. Parties to the WHO CA+ should make use of the established Plan S framework for open access, which a number of governments already support. 

We also support the initial references to obligations that should be attached to public funding in Sections 2(b) – 2(e) of Article 9. However, the article is missing a clear statement that these obligations should facilitate equitable access to final products, in addition to promoting knowledge sharing. Further, we recommend the addition of explanations of the intended outcomes of each of the requirements mentioned. For example:

  • References to ‘prices of products’ or ‘pricing policies’ should be expanded to include the development and implementation of affordable pricing strategies, with a definition of what constitutes ‘affordable’.
  • References to ‘allocation’ should be expanded to incorporate requirements for product developers or manufacturers to reserve a proportion of their manufacturing capacity to supply vulnerable populations and/or certain procurement agencies in a timely manner. A recent report from the International Pandemic Preparedness Secretariat highlights that IPFMA’s Berlin Declaration has laid the foundation for such capacity reservation requirements.
  • References to ‘licensing’ and ‘technology transfer’ should include minimum expectations for the terms of those licenses and technology transfer activities, as well as expected engagement with developing country manufacturers in order to achieve ‘distributed manufacturing’.
  • We encourage the INB and government stakeholders to consider the examples of product affordability, product availability and licensing provisions discussed in our Equitable Access Toolkit.

Finally, we welcome the reference to ‘publication of contract terms’ in section 2(b), as well as  the requirements for transparency over the terms of public procurement terms addressed in Article 9(3). We recommend that these requirements are strengthened and clarified with the following details: 

  • The contractual terms of funding or investment agreements for research and development should be publicly disclosed. Transparency over these contracts is required to facilitate monitoring of countries’ compliance with obligations to include equitable access and knowledge sharing terms. 
  • The contractual terms agreements entered into by product developers and manufacturers receiving public funding to fulfill their equitable access obligations (e.g. license and technology transfer agreements) should be publicly disclosed. 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 in receipt of public funds.
  • Disclosure of contractual terms should be performed in a timely manner and through an easily discoverable and publicly available route. Product developers and manufacturers or 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.

We look forward to following the continued development of this promising initial draft of the WHO CA+ and hope to see the recommendations above reflected in future iterations. Looking ahead, we also hope that GHIAA’s Equitable Access Toolkit will provide useful insight and guidance for governments as they consider how to implement and enforce equitable access commitments in their funding agreements.

Authors: Bridie Telford, Julia Barnes-Weise

First Publication Date: February 7, 2023