Part II: Beyond the Tip of the Iceberg: Delving into the Entanglements of the PABS Annex
SpicyIP
Part II: Beyond the Tip of the Iceberg: Delving into the Entanglements of the PABS Annex
In Part I, the blog post dived into suggestions proposed in the paper (authored by Stephanie Switzer, Adam Strobeyko, Mark Eccleston-Truner, Sylvain Aubry, and Michelle Rourke), and evaluated each one of them with added insights. Taking from there, this blogpost aims to focus on the considerations put forth in the article. The aim is to appreciate the concerns of different Member States with respect to the considerations discussed below, and reflect on how the IGWG might approach these issues while negotiating over them to build a framework that is capable of addressing future public health emergencies. The blog post does not intend to settle the debate surrounding these questions but rather add to it to bring more clarity to the readers.
Considerations
Determining the scope of pathogens
The scope of pathogens needs to be defined precisely since this has future consequences and will eventually determine the obligations of its signatories too. The paper poses that the IGWG must answer whether zoonotic and environmental pathogens fall within this scope, and whether the PABS mechanism include all pathogens with pandemic potential or limit it to a narrower set. Article 12.1 of the PA mentions that sharing of material on pathogens with pandemic potential will be governed by the PABS system. But the question comes up – who decides if a specific pathogen has pandemic potential or not?
The article in discussion provides a chart-based approach to this question based on the IHR’s flowchart which State Parties use when considering whether to notify the WHO of a potential PHIEC. It suggested that a similar flowchart can be used which would trigger the obligation to share samples and sequence data based on defined criteria. Negotiators are also reportedly considering having a descriptive list for determining the scope of pathogens (see here).
The problem with such a list-based or chart-based approach is that it might be too rigid and lack the flexibility required to anticipate new or emerging pathogens, leading to under-coverage of the PABS system. The issue is not solely with under-coverage but a broader definition, the article posited, can overburden the PABS mechanism. Even China believes that an expansive list “would dilute [the] focus” of the PA. To the contrary, Garford observes that broader categories could ensure a more inclusive and equitable sharing framework. Further, it ensures that emerging pathogens are not excluded from the ambit of PABS.
In my view, an impact-based definition suits the equity-oriented vision of the PA where those pathogens that are highly transmissible, highly virulent and have the potential for cross-regional spread, and to evolve into a global emergency should be included. A list of such pathogens can guide this assessment but should be flexible enough to include other pathogens as and when required based on its impact. Not exactly in this format, but the suggestions put forth by the United Kingdom, Australia, Canda, and New Zealand align with this flexibly-structured approach.
Identifying what benefits should be shared
The paper discusses that the IGWG has to grapple with the question of what all kinds of monetary and non-monetary benefits are to be provided in return of the access to genetic material. Now, the piece under discussion does not delve into the benefits-sharing commitments which can be explored – understandably so, since it does not have a clear-cut solution and is dependent on financial, logistical as well as political considerations.
Article 12.6(a) of the PA lays down the provision obligating the manufacturer to make available to the WHO “20% of their real-time production of safe, quality and effective vaccines, therapeutics, and diagnostics for the pathogen causing the pandemic emergency”. Out of this, a minimum 10% is to be donated to the WHO and the rest to be supplied at affordable prices. The production does not address how “real time” will be measured and what “affordable prices” refer to – a notoriously elastic term. This fixed percentage acts as a blind spot since it does not guarantee that those most in need will be prioritized, requiring IGWG to ponder over an allocation criterion.
Additionally, Article 12.6(b) provides for distribution of vaccines on the basis of “public health risk and need” – the question remains what this criteria mean, a point also raised by the United Kingdom, and what scope does it envision.
That said, it is in this backdrop, I believe that the need is to understand benefit-sharing as a holistic concept and not restrict it to material assistance or financial inputs, but also include information sharing, capacity building, local manufacturing initiatives, among others. Vaccine equity is not only a question of distributing doses fairly but also of ensuring wealth and knowledge sharing to enable a model of capacity-building in developing countries, especially during PHIEC.
This is evident from the case of COVAX – built on a public-private initiative, it endeavoured to deliver vaccines to the developing countries, however, in the long run, it fell short of effectively addressing the demand. This demonstrates that while supply of pandemic essentials is a part of the solution, capacity building constitutes the other half.
Most importantly, the PABS-related obligations and their corresponding benefits must be carefully calibrated by the IGWG to balance each other in a manner that it should not overburden participants as excessive obligations can disincentive engagement – a breadth in itself difficult to traverse.
Balancing sovereign rights over genetic material and IPR over resulting benefits
The paper under discussion notes that States have asserted sovereignty over their genetic material, and throughout the negotiations, the Global South has been unwilling to relinquish its rights over the genetic material. Further, it highlights the related question of IP rights over the developments resulting from the PABS material.
A closer look reveals that if State Parties retain their sovereign rights over their biological resources, and the PA is not recognized as an SII, then the PABS system risks being undermined. In such a scenario, States could still engage in bilateral transfers of pathogens despite contributing to the PABS which would allow pharmaceutical companies to access genetic sequences outside the multilateral system, making it redundant. As seen in the example of COVAX, parties will readily revert to bilateral negotiations if the multilateral system does not suit their needs in an emergency.
A further concern for developing countries is the use of IP rights over products of medical emergencies, which, if provided, would further perpetuate inequity. An earlier draft proposal for the PA restricted the ability of users to assert IP rights on materials resulting from PABS material, however, the EU suggested that IP should not be sought on genetic material but any modified form is eligible for IP protection.
This is problematic – awarding IP rights on developed products under PABS will reinforce structural disparity and fall into the same spiral of bilateral or multilateral negotiations over IP of medical products. The very premise of the PABS system is to facilitate fair and equitable benefit-sharing and allow IP claims on modified materials to effectively sever the link between pathogen contribution and public health returns.
The tension at the ends of the rope is intense – one side wanting to retain its rights over the genetic material while the other, demanding IP over produced products. In addition, the IGWG might have to think about whether the benefits extend only to products directly derived from PABS material, or extend more broadly to all medical countermeasures during a public health emergency..
As one potential approach, the Group for Equity proposed that manufacturers that are part of the PABS should grant non-exclusive licenses to the WHO that can be sub-licensed to manufacturers in developing countries. They suggested that the license should cover “full regulatory dossier, technical know-how, and any necessary material.” Such an expansive nature of sub-licenses is essential because merely awarding patent licenses is insufficient. This is because patents do not disclose all the information required, and trade secrets, along with other undisclosed information, together form the ‘intellectual property stack’, which hinders the process of production of patented health technology. If incorporated, the proposal can help make the Annex move beyond symbolic access to genuine technology transfer.
Scope of Participants
In my view, a further concern, apart from those mentioned in the paper, lies in the set of obligations, which under Article 12.7 of the PA is only for ‘participating manufacturers’. This exempts other commercial as well as non-commercial users of GSD, allowing other manufacturers to exploit the PABS system without contributing to it. This is so because generally, GSD uploaded to the PABS system is publicly accessible. This information can be used by any entity, even those that fall outside the scope of PABS, without contributing to benefit-sharing commitments. Any entity benefiting, especially those financially, from the strain, must contribute to the benefit sharing otherwise, the PABS mechanism risks falling prey to free-riding. For this, the definition of eligible participants must be accordingly curated to avoid exploitation of the PABS system.
China recently suggested, in an attempt to define the scope of eligible participants, that access to the PABS material for pharmaceutical companies should be contingent on the home country being a party to the PA. While not referring to this specific suggestion, Russia also insisted on restricted access to pathogen and related material, emphasizing the need to regulate beneficiaries. The issue this specific suggestion raises is that it can deter major pharmaceutical companies, whose home countries are not parties to the PA, including the USA who stepped out of the WHO, from engaging with PABS and weaken its global reach. The attempt should be to include more players and not narrow its scope.
Concluding Remarks
COVID-19 exposed deep fault lines in the governance of the global health system. The disaster was not entirely a result of the viral outbreak and was compounded by the structural failures of TRIPS and the inequitable distribution of vaccines.
The PABS Annex form the core of the PA and now, it is up to the IGWG to address concerns of the State Parties – low-income and high-income countries, and through a balancing act, formulate an Annexure that caters to the said concerns and embed stronger accountability and fairer benefit-sharing. Whether this chance is seized, only future can answer!