Salud por Derecho welcomes the first draft of the Pandemic Treaty, a necessary instrument that should be the main international route map to address the major large pandemic challenges facing global health over the coming years. The debates that will take place within the INB[1] in the coming months will therefore be crucial to improve a text that still has a long way to go.
The document consists of an introductory and preambular part in which many of the elements that will later be included in the articles themselves are acknowledged. Elements related to the recognition of human rights, the WHO’s leadership, universal health coverage, the need for global healthcare funding, access to healthcare products and intellectual property, and the “whole government approach” are some of the elements that are included. The treaty is then divided into 8 chapters which contain the 38 articles.
From its reading and analysis positive conclusions are drawn, such as the recognition of intellectual property barriers, the lack of local manufacture of health technologies in many regions, the need for global efforts to facilitate access and knowledge transfer, as well as the need for public R&D that incorporates conditionalities and provisions to ensure access to the final product. This is pertinent because from the outset the treaty recognises many of the cracks in the current system, which conditioned a better response to the COVID-19 crisis, preventing the healthcare technology which we used to recover from the pandemic from reaching everyone independent of their place of residence. However, the initial intention is not fully anchored in the articles, which greatly weakens the possibility of delimiting what the ratifying parties are committing themselves to. Moreover, it would have been desirable to also include references to open science and the direct relationship between intellectual property, trade secrets and know-how.
Chapter III of the treaty covers the application of the principle of equity in Articles 6 to 10, which deal with the supply chain, access to technology transfer and intellectual property, regulatory issues, R&D and elements related to mechanisms through which genome and pathogen sequences are shared and benefit sharing arising from their use.
In general terms, despite being key topics, the language used is vague and imprecise. Add to this the fact that the treaty lacks elements for an accurate accountability exercise, and many issues are likely to be watered down in its implementation. The terms to be used should not be “empowering” or “motivating”; it should be clear that the parties are expected to ratify in a clear manner and not in terms where “anything goes”. Future drafts would therefore need to use stronger language that makes clear the mandate of the parties and the scope of their commitments. In addition to the way the current document is constructed, the chapters and articles are very compartmentalised. In other words, in many cases the articles are interdependent on each other and this coherence should be reflected in the text with references where appropriate.
In aspects as important as the transference of technology, the text tends to reinforce aspects more closely linked to voluntariness (“mutually agreed terms”) rather than the obligation to share such technology. In addition, no reference is made in any of the sections of chapter 3 to the category of trade secrets, of utmost importance in healthcare technology such as vaccines.
Moreover, the text introduces an element in Article 7.5 which predefines the manufacturer of such health technologies as qualified to do so. While agreeing with the need for this to be the case, instruments need to be put in place in many regions to enable these manufacturers to address the economic obstacles and the necessary regulatory support. This implicitly requires: 1) working with many of these manufacturers in periods between pandemics and 2) streamlining and strengthening all the resources necessary for prequalification procedures, including those of the WHO itself. In the same terms, Article 8, related to the regulatory system, should also recognise the need to strengthen the processes in all countries by generating guarantee mechanisms that both allow health technologies to be available in a timely manner in all countries and ensure that no one is affected by delays.
Article 10.h contains the benefit sharing derived for the use of previously shared genomes and pathogens. Ensuring this aspect is crucial, however, the mechanisms set out in the text may be insufficient and may not be extrapolated to all contexts. The first of these as noted in the draft is to secure 20% of the health technologies developed for the WHO, with 10% to be donated and the other 10% to be purchased by the WHO at an affordable price. However, it does not include other elements which obligate the sharing of intellectual property or the transfer of technology. Nor does 20% seem a proportionate figure when we see that rich countries set immediate vaccination goals of 70%. What’s more, each case may depend on the virus itself, characteristics, infections etc.
In terms of public funding, access provisions and conditionalities are included to ensure equitable access to results. Elements such as the transparency of such funding or prices are important, however, the treaty does not establish how to make this effective if, in addition, we take into account that in many cases we are talking about mixed capital funding. The elements that will prevail in such cases are not determined in the draft. What’s more, it is necessary to establish a clear distinction between public funding identified as R&D per se, and that which is identified as funding in the form of subsidies such as advance purchase commitments.
Furthermore, Salud por Derecho would like to make specific mention of the need to analyse the particularities of the vulnerable groups included in the definition of terms. Such specifications must be taken into account and here we underline those directly related to migrants. In this case, the text should emphasise the evidence that the WHO has already collected on migration policy practices and their impact on public health, as these have discriminated against these populations and have had a negative impact on migrants and on society as a whole. This emphasis should consider: 1) extending the duration of visas, residence and work permits to prevent their holders from falling into irregular status; 2) facilitating the regularisation of undocumented migrants to ensure safe access to health services; releasing migrants from detention centres and implementing non-custodial alternatives; 3) suspend forced returns and ensure the safe entry of migrants at sea and land borders and avoid implementing blanket border closures, as this measure lacks evidence regarding the prevention of the spread of disease.
Likewise, the Pandemic Treaty should make reference to other global health crises caused by the impact of climate change on the health of people and ecosystems. Many of the consequences of climate change on human health are already evident. Heart disease, respiratory illnesses, lung disease, infectious disease etc., as well as its impact on vulnerable groups such as the elderly, children, pregnant women etc. are a reality which should be reflected in this treaty. It should be recognised it both in its definitions and in the intervention with preventive and adaptive measures as well.
Finally, it is important, as mentioned at the beginning, that mechanisms for accountability are better defined and precise in terms of what is involved in both compliance and non-compliance and what the implications are. Clear goal management must also be established, defining a roadmap for the parties to measure progress in the implementation of each of the chapters.
In addition to all of these more specific recommendations, below is a series of general recommendations so governments, the INB and the Government of Spain in particular take the following revision on board:
GENERAL RECOMMENDATIONS
- Use more forceful language, avoiding vague terminology and committing to using precise terms, so a treaty that is robust in its commitments and clear in its mandate is articulated.
- Establish the necessary interdependencies in the articles and the relationship between the different aspects of the text by addressing the whole content of the text in a coherent manner and taking into account the interrelation of the different aspects.
- Secure the necessary funding with clear and ambitious targets, as well as shared governance among all ratifying parties in an equitable manner, to address the challenges of the treaty in both multilateral and national areas.
- Strengthen accountability mechanisms so that roadmaps for ratifying parties are clear in their goals, commitments and implementation.
- Improve transparency by assigning it its own space in the treaty to address all the elements that should be affected, from R&D funding itself, to intellectual property, pricing, clinical trials, contracts, technology transfer, etc.
- With respect to intellectual property, it is important to guarantee all forms of transference in addition to voluntary transfer. Contributions regarding the use of TRIPS should also be strengthened with initiatives that allow all signatory parties to adapt national laws to be used where appropriate.
- With regard to the conditions for public financing, the text must incorporate elements that make it much clearer what is being talked about, the modalities of application and the national public policies needed to make them effective.
- Special attention should be paid to the specific needs of the groups identified as vulnerable within the text and in particular those of the migrant
[1] INB – Intergovernmental Negotiating Body. Created in December 2021 with the mandate of redacting and negotiating a convention, agreement or other international instrument under the umbrella of the WHO to strengthen the prevention of, preparation for and response to pandemics. The INB’s work is based on principles of inclusion, transparency, efficiency, leadership of the member states and consensus. Intergovernmental Negotiating Body (INB) (who.int)