On 12 December 2023 the US Health and Human Services Department (HHS) posted a notice and request for comments on “the implications of access and benefit sharing (ABS) commitments/regimes and other proposed commitments being considered under a WHO convention, Agreement or other international instrument on pandemic prevention, preparedness and response.” The notice focussed on Articles 9, 10, 11, 12 and 13 of the last published draft of the negotiating text of WHO pandemic agreement.
Medicines Law & Policy provided comments on questions HHS posted related to Articles 9, 10 and 11. The full submission is available here. Below is a brief summary of the submission:
- Transparency is crucially important to instil and strengthen public confidence in measures taken to combat or prevent a pandemic as well as confidence in pandemic countermeasures. This includes transparency of the terms and conditions of public funding for the development and supply of pandemic products.
- Government funded research and product development should contain conditions that ensure the sharing/licensing of intellectual property, know-how, and materials such as cell-lines necessary to product the products that are the result of the funded project.
- It might not be advisable to advocate for royalty-free licences. Reasonable royalties can be helpful to incentivise licensing and counter resistance to sharing of IP and know-how by rights holders.
- For the purpose of licensing and technology transfer, the WHO Covid-19 Technology Access Pool (C-TAP) should be expanded and sufficiently resourced for the purpose of increasing production capacity for pandemic preparedness. Collaboration with the Medicines Patent Pool, which played an important role in securing licences for therapeutics during the Covid-19 pandemic and in supporting the mRNA technology transfer hub in South Africa, will be essential.
- Collaboration by rights and technology holders with pooling mechanisms should be compulsory when needed to respond to a pandemic.
- The pandemic agreement should include a provision that Parties will refrain from challenging the use of the TRIPS flexibilities, including the security exception when used for pandemic preparedness and response.
- The current negotiating text lacks a provision to compel the sharing of necessary undisclosed information with third party manufacturers during a future pandemic. This can be remedied by including the following article:
“Where the Director-General of the World Health Organization has determined that: (i) a pandemic outbreak, or the threat of a pandemic outbreak, represents a public health emergency of international concern (PHEIC); (ii) the urgent production by qualified third parties of a pharmaceutical product is necessary to respond to the pandemic outbreak, or the threat of the pandemic outbreak; and (iii) the manufacture is prevented or hindered through lack of access to undisclosed information as defined in Art. 39.2 TRIPS possessed by one or more entities located in one or more Parties, that or those Parties shall compel that or those entities to share the undisclosed information with the third parties.”
This provision preserves the ability of originators and third party manufacturers to reach voluntary agreements. However, if they fail to do so, when the necessary tests are met, the provision obliges the Parties to compel the necessary sharing. For a more detailed discussion of this provision please see the following Medicines Law & Policy documents: “The WHO pandemic instrument must address the sharing of know- how/trade secrets: a proposal for a new measure” and “Sharing know-how/trade secrets during a pandemic: We must be planning for it now”.
