TWN Info Service on Health, Intellectual Property and Biodiversity
5 November 2023
Third World Network
www.twn.my

WHO: Pandemic Access & Benefit Sharing System in Proposed Text flawed 

Geneva, 5 Nov (Sangeeta Shashikant) – The proposal for the negotiating text of the WHO pandemic agreement A/INB/7/3 (proposed text) released in preparation for the 7th meeting of the Intergovernmental Negotiating Body (INB) reveals significant shortcomings in the access and benefit-sharing provisions, potentially resulting in a fragmented and ineffective system.

The INB meeting to draft and negotiate a WHO Convention, Agreement or other International Instrument on Pandemic Prevention, Preparedness and Response will take place in Geneva on 6 – 10 November 2023.

Article 12 of the draft text establishes a multilateral system for access and benefit sharing (ABS) known as the WHO Pathogen Access and Benefit-sharing System (WHO PABS System).

An effective ABS system is crucial for achieving equity, as demonstrated by the success of the Pandemic Influenza Preparedness Framework (PIP Framework), which has been in operation for over a decade in the WHO.

The PIP Framework, established in response to the inequities observed during the H5N1 outbreak in 2005, focuses on sharing influenza viruses with pandemic potential. It uses Standard Material Transfer Agreements (SMTAs) to govern access to biological materials, including sequence information, by WHO-designated laboratories and other entities such as manufacturers of vaccines, diagnostics and pharmaceutical.

The PIP Framework which is limited in scope to influenza virus of pandemic potential has generated approximately $300 million in monetary benefit sharing, enabling WHO to support 131 countries to start or improve their laboratory and surveillance systems.

Additionally, key manufacturers, including GSK, Sanofi, and CSL Sequirus, have contractually committed to supply WHO with vaccines and antiviral medications in the event of a flu pandemic. Over 400 million vaccine doses have been set aside for WHO in the event of a flu pandemic, as a result of these contracts.

In March 2023, Reuters reported WHO as saying mechanisms were being developed “so that countries can work together – not in competition with each other” to respond to such a crisis and that it was “fully confident” manufacturers and Member States would meet their obligations”.

However, several elements that contributed to the PIP Framework’s success are notably absent from the proposed PABS system outlined in the proposed Article 12. Furthermore, the PABS system lacks the necessary measures to operationalize fair and equitable benefit sharing, including diversifying production and expanding supply options during public health emergencies of international concern (PHEIC) or a pandemic.

The missing SMTA

Sharing biological materials between laboratories is typically governed by a material transfer agreement (MTA). Similarly, within the PIP Framework, the sharing of PIP biological materials among WHO-designated laboratories, collectively known as the Global Influenza Surveillance and Response System (GISRS), is subject to specific terms and conditions outlined in a Standard Material Transfer Agreement (SMTA 1).

These terms and conditions encompass various requirements, such as the obligation to adhere to the specified SMTAs when transferring PIP biological material and refraining from pursuing intellectual property rights on the shared materials.

Furthermore, as outlined in the SMTA, GISRS labs are expected to carry out their activities within the established parameters of agreed terms of reference. These terms of reference define the scope of the technical work that laboratories can undertake using PIP biological material.

Article 12, unfortunately, does not make any reference to SMTA 1 or the terms of reference for the WHO Coordinated Laboratories Network (WCLN). This oversight creates a significant gap, allowing the activities and behaviours of WCLN laboratories to remain unregulated and without clear obligations.

For instance, there are no binding commitments imposed on WCLN providers and recipient laboratories to refrain from making intellectual property claims over the shared PABS materials, or to ensure full compliance with the requirements of the PABS system. There is also a lack of commitment to use the PABS Materials for specific purposes, as defined in the Terms of Reference.

The absence of SMTA 1 opens the door to potential abuse and misuse by better resourced advanced WCLN laboratories within the PABS system, leaving it vulnerable to exploitation.

Flawed Approach to SMTA Operationalizing Benefit Sharing

When a Party shares PABS materials with a recipient such as manufacturers of vaccines, diagnostics, pharmaceuticals etc., research institutions and academic institutions, it is expected to use a SMTA which may be concluded through electronic means. This is stipulated in Article 12.4(a) in the proposed text.

The SMTA is not annexed, thus its details are unknown, raising substantial uncertainties regarding how the benefit-sharing obligation required of the recipients will be effectively operationalized. At first glance, it appears that there are significant deficiencies in the suggested approach. In addition to the notably insufficient benefit-sharing choices outlined in the text (as discussed below), it appears that the approach taken is for each Party (rather than WHO) to sign a SMTA with the recipient.

[Note: It is unclear if reference to SMTA refers to a standard agreement jointly developed by Parties for use by all Parties or if it refers to each Party developing and using its own standard agreement.]

According to the proposed text, Parties can also introduce supplementary benefit-sharing options, which, as detailed below, are somewhat lacking in robustness. Presumably Parties can also include other terms and conditions that may potentially hinder the timely delivery of the committed benefits. Consequently, the fulfilment of the contractual benefit-sharing commitments will heavily rely on the willingness of a specific Party to pursue contract enforcement.

The proposed approach differs significantly from the PIP Framework, where an SMTA containing benefit-sharing commitments agreed by all WHO Members is used by WHO to enter into agreements with recipients. In this setup, the WHO assumes a central role in engaging with recipients, signing SMTAs with recipients, monitoring the committed benefits, and ensuring their delivery during a PHEIC or a pandemic.

Weak PABS multilateral benefit sharing

The section on PABS multilateral benefit sharing introduces a benefit-sharing commitment for recipients of PABS materials, stipulating that “in the event of a pandemic,” they must grant real-time access to a minimum of 10% as a donation and 10% at an affordable price of the production of safe, effective pandemic-related products.

Notably, the text excludes commitment to supply during a PHEIC and to WHO stockpiles in preparation of a PHEIC, thereby failing to address inequity during such critical periods, even though ensuring an adequate supply before a pandemic is a prerequisite for preventing one.

Further, the proposal lacks a clear definition of “affordable price” and access to the 10% at an affordable price is contingent on the WHO having sufficient funds to procure these products, which is a constant struggle for WHO. For example, in the first 10 months following the launch of the Access to COVID-19 Tools Accelerator (ACT-A) in April 2020, it was severely underfunded. A key conclusion of an external evaluation of ACT-A is that “[f]unding was not mobilized at sufficient speed”.

Another implication of this proposal is the suggestion that manufacturers are only required to make 10% of their production available at an affordable price. This raises the question about the remaining supply to the developing world; will it not be made available at an affordable price?

Given these challenges, one wonders why the proposal does not reflect the Africa Group’s proposal that at least 20% of the real time supply should be donated, and such donation be available during a PHEIC and a pandemic.

The paragraph also states that “each Party with manufacturing facilities producing pandemic-related products in its jurisdiction shall take all necessary steps to facilitate the export of such products, following agreed timetables with the WHO.” However, it does not address the potential challenge of manufacturing facilities located in non-Party jurisdictions and how they would be compelled to enable benefit-sharing.

The non-monetary benefit-sharing section lacks an obligation for recipient manufacturers to license their proprietary technology and know-how to manufacturers in developing countries during a PHEIC and a pandemic. Such an obligation was included in the Africa Group’s PABS proposal but has been omitted by the INB Bureau. This omission is significant given that a key lesson from COVID-19 failures is the importance of diversifying and scaling up production to meet global demand.

Instead, the Bureau’s text introduces optional language that parties may include in the SMTA such as “encouragement of manufacturers from developed countries to collaborate with manufacturers from developing countries through WHO initiatives to transfer technology and know-how” and “tier-pricing,” which does not guarantee licensing nor affordable prices.

Interestingly, a recently release report of the United States International Trade Commission (USITC) confirms the inadequacy of voluntary licenses and tier-pricing in meeting the access needs of developing countries. See USITC Report Confirms Inadequacy of Voluntary License, Tier Pricing, International initiatives to Support Access in Developing Countries available at https://www.twn.my/title2/intellectual_property/info.service/2023/ip231101.htm

The proposed text mentions monetary benefit-sharing in the form of “on an annual basis, contributions from Recipients, based on their nature and capacity.” However, it lacks specific details about the formula or methodology for determining these monetary contributions. This lack of clarity could lead to disputes or uncertainties in its future implementation and consequently no collection of monetary benefits.

Genetic Sequence Data (GSD)

Article 12 of the proposed text stipulates that each party shall “upload the genetic sequence of such WHO PABS Material to one or more publicly accessible database(s) of its choice, provided that the database has put in place an appropriate arrangement with respect to WHO PABS material.”

However, the proposed text lacks clarity in defining what constitutes an “appropriate arrangement” and who would be responsible for determining its appropriateness. This ambiguity presents a significant loophole in the PABS system, allowing users, including manufacturers, to potentially evade their fair and equitable benefit-sharing obligations and potentially exploit shared GSD through the intellectual property system, which could deter the prompt sharing of GSD.

The Africa Group, and some other developing countries, in their PABS proposal, suggested the use of “click-wrap” SMTA agreements to govern access to GSD. These agreements would outline specific terms and conditions that ensure fair and equitable benefit-sharing. Such a system would promote multilateral transparency, accountability, and incentivize the timely sharing of GSD.

The concept of imposing access and use of GSD under standard terms and conditions is not novel. For instance, the Global Initiative on Sharing All Influenza Data (GISAID), a commonly used database for uploading COVID and flu sequence data, grants access to individuals who agree to identify themselves and adhere to the GISAID sharing mechanism as governed through its Database Access Agreement. However, it is important to note that GISAID’s private, donor-dependent structure has faced criticism for unilateral decision-making and the absence of a fair, transparent, and accountable governance framework.

Intellectual Property (IP)

On IP, a proposed provision states that “Recipients of WHO PABS Material shall not seek to obtain any intellectual rights on WHO PABS Material”. But with the suggested definitions for “recipient” and “PABS Material”, this provision will do very little in restricting IP claims.

The proposed text defines PABS Material as “a pathogen with pandemic potential, as defined herein, and the genetic sequence data of such pathogens with pandemic potential”.  Existing biological material including existing whole pathogens or sequences would in any case generally not qualify for patents.  Parts of the pathogens or the sequence may be modified, with patent claims made on their modified form or their use in development of vaccines etc. The suggested text would not cover these instances.

Major Components Are Absent

As explained above, key components of the PABS system are either uncertain due to the lack of specifics or simply omitted. Also absent is clarity on the role of WHO in the implementation of the PABS system, application of the PABS system to other WHO Members that may not be Parties and to other PHEIC pathogens that may be shared by WHO Members.

Paragraph 7 of the proposed Article 12 states that “Parties shall ensure that all components of the WHO PABS system are operational no later than 31 May 2025”. The stated deadline itself is impractical given that the pandemic agreement is unlikely to have entered into force by then.

Delaying finalization of key aspects of the PABS system bears the danger that Parties will be expected to share PABS Material such as GSD, even though there is no agreement among WHO Members on components needed to deliver fair and equitable benefit sharing i.e. monetary and non-monetary benefit sharing.

It is also difficult to understand how the proposed text considers such a flawed PABS system to be consistent with the requirements of the Convention on Biological Diversity and its Nagoya Protocol and thus amounts to a specialised ABS instrument of the Nagoya Protocol, given that major components that are critical to the effective working of the PABS are missing.+