As an interim step to a first draft of the World Health Organization (WHO) Pandemic Treaty, a new text has recently been released that was intended to reflect proposals that countries had submitted and to serve as a framework for the deliberations of the Intergovernmental Negotiating Body (INB)[1] at its meeting from 12 to 16 June 2023. While the updated text mentions equity as a principle and recognises the importance of ensuring fair access to pandemic-related health products, medicines and technologies, it fails to clearly set out the set of legal obligations required to achieve this objective, and many of the options put forward are geared towards maintaining the status quo rather than progressing towards a new paradigm. Chapter II deals with the articles most directly related to equitable access.
Salud por Derecho would like to draw attention to the following areas that need to be improved in the text:
- While the text continues to be clear that open science should be the mechanism of choice for sharing information about research results, there is a perceived backtracking on equity, with no clear mandate as to how this will be accomplished. Specifically, the language is softened with extensive use of the wording “as appropriate”, which would leave any kind of compromise very much open-ended.
- The previous draft proposed incorporating conditions for publicly funded R&D from manufacturing to knowledge transfer and pricing. However, the new text has reduced these ideas to prioritising investments in products “that can promote equitable access” and publishing the terms of government-funded R&D agreements for pandemic-related products but adding “as appropriate”. This wording, used repeatedly, leaves a major exercise in transparency to the discretion of the ratifying parties and strays away from ensuring the public interest in R&D funding.
- Regarding the coordination and management of R&D priorities for developing health products and technologies to cope with the pandemic, the text falls far short of establishing a clear mechanism for defining the research agenda, as well as the WHO’s role in this process.
- The new text takes a step backwards when it comes to liability risk. It is more in line with industry requests and proposes to include indemnity clauses in procurement contracts for innovative products, such as those that were carried out during the COVID vaccine procurement contracts.19 These clauses made the provision of vaccines conditional on purchasers agreeing to exempt pharmaceutical companies from liability related to potential damages or lawsuits surrounding their products. This practice only contributes to further unbalancing the risks assumed by the public sector in contrast to the enormous rewards received by the private sector over the course of the biomedical R&D process.
- On the issue of technology transfer, the new text preserves the voluntary aspects of the initial draft, a fact that does not imply any progress in terms of reinforcing the connection between technology transfer and improving equitable access. Specifically, the new text proposes that vaccine, medicine and diagnostics manufacturers be strategically and geographically distributed to maximize access without providing information on how this will be achieved. Given the significant role that technology transfer, know-how, and trade secrets (which remain absent from the text) play in developing regional production capacity, it is difficult to imagine how this can be accomplished without ensuring mandatory technology and knowledge transfer.
- The subsequent point that the current text includes represents a much less ambitious scenario, not only because it fails to include any obligation for health technology producers and companies to transfer their technology, but also because it raises the prospect of not including any provisions on temporary suspensions of intellectual property rights, which could prove to be fundamental during a global public health crisis.
- When it comes to equitable benefit sharing, the text provides options that would further limit access rather than expand it. Specifically, it suggests decoupling access to pathogens or genomic sequence data from the obligation to share any benefits that may arise because of this access. One probable option is to make pathogen sharing mandatory. However, the provision of benefits as payback to sharing parties would be postponed.
- The current text keeps the option that was already included in the zero draft to require producers to share 20% of their doses with the WHO to ensure a more equitable distribution. Salud por Derecho has already expressed its position on this issue and once again we repeat that 20% does not seem to be a figure that is proportionate to the amount of the beneficiary population. On the other hand, the incorporation of intellectual property, know-how and technology transfer aspects, which are equally necessary for a fairer, more sustainable and equitable global response, continue to be excluded from this mechanism.
- Lastly, the new text refers to the need to promote transparency in terms of costs, prices and all other relevant contractual provisions along the supply chain, as well as the exclusion of confidentiality provisions in publicly financed agreements. This approach to transparency should also be extended along the innovation pipeline, covering the entire product life cycle.
This negotiation process will be critical when it comes to laying the foundations for how to handle future public health crises. Neither the States nor multilateral spaces can lose this opportunity by agreeing to a document that preserves the current status quo. We are also concerned about the failure to include public participation in this process. The contributions that can be made from this space are essential for the common good and cannot and should not be overlooked. Therefore, we once again call on the Member States to reconsider their position on this aspect.
At Salud por Derecho we would like to emphasize again what we consider to be the main points that should be included in subsequent drafts:
- Further strengthen the language by avoiding vague wording and opting for precision in terms to craft a treaty that is robust in its commitments and clear in its mandate.
- Establish the necessary interconnections in the provisions and the relationship between the different aspects of the text, coherently addressing all content and taking how the different aspects are interrelated into account.
- Ensure the necessary funding with clear and ambitious targets, as well as shared governance among all treaty parties in an equitable way, addressing the challenges of the treaty in the multilateral as well as national space. Also, go back to the previous text’s initial focus on the conditions for public financing.
- Strengthen accountability mechanisms to ensure that the roadmaps for ratifying parties are clear in their goals, commitments and implementation.
- Strengthen transparency throughout the health product and technology pipeline, from R&D to pricing.
- Regarding intellectual property, it is important to guarantee all forms of transfer, beyond voluntary transfer, and to ensure the application of TRIPS.
- Particular attention should be paid to the specific needs of the groups that are identified as vulnerable in the text, particularly those of migrants.
[1] In December 2021, the WHO established an Intergovernmental Negotiating Body (INB) to draft and negotiate an international treaty to strengthen pandemic prevention, preparedness and response. Since then, the INB has met regularly to discuss the draft texts that are under development. Intergovernmental Negotiating Body (INB) (who.int)
Photo: WHO
