TWN Info Service on Health Issues (Mar24/08)
19 March 2024
Third World Network

Pandemic Draft Text on Pathogen Access & Benefit Sharing – Not Fit for Purpose

Geneva, 19 March (Sangeeta Shashikant) – The recently unveiled draft text of the pandemic agreement includes 14 paragraphs dedicated to the Pandemic Access and Benefit Sharing (PABS) system. However, it faces criticism from several developing country delegates who, speaking anonymously, assert that the proposed text continues to fall short of meeting their expectations and the intended purpose.

As a result, discussions on Article 12 of the pandemic agreement are anticipated to be heated during the 9th session of the Intergovernmental Negotiating body (INB), that commenced on Monday, 18 March.

The draft text largely mirrors (with a few additions and changes) the Vice-Chair's proposed text presented at the 8th INB session, which was deemed a non-starter and unacceptable by the Africa Group and other developing countries. [See “Chair’s Text on Pandemic Access and Benefit Sharing Unacceptable to Developing Countries” published 5 March.

Despite enjoying substantial cross-regional support, proposals concerning the PABS system put forth by developing countries have been disregarded and side-lined.

During the previous INB session, 70 civil society organizations urged the Vice-Chair and Co-facilitators of the PABS sub-group to embrace the proposals by the Africa Group and Group of Equity as key elements of the PABS system and ensure fairness and impartiality in the process.

However, this plea has gone unheard, and the comprehensive PABS proposal from the Africa Group and Group of Equity continues to be ignored.

In contrast, the draft text presents a deficient PABS system riddled with gaps, loopholes, and flaws. If left unaddressed, these issues can render the system dysfunctional.

Consequently, the PABS system, which is considered crucial for operationalizing equity during a public health emergency of international concern (PHEIC) and a pandemic, remains grossly inadequate for its intended purpose.

Sharing PABS biological materials, without SMTA or any contract

The customary legally binding instrument utilized by laboratories for sharing physical samples is the Material Transfer Agreement (MTA). This document delineates the terms of usage for the physical sample by the recipient, encompassing any commitments regarding benefit-sharing.

Within the World Health Organization's Pandemic Influenza Preparedness Framework (PIP Framework), which serves as a multilateral access and benefit-sharing mechanism for influenza viruses of pandemic potential (IVPP), Standard Material Transfer Agreements (SMTAs) are employed. These SMTAs are applicable to sample sharing among WHO Global Influenza Surveillance and Response System (GISRS) laboratories and between GISRS laboratories and entities external to the GISRS system.

However, the draft text diverges from this approach, proposing a questionable instrument termed "legally binding terms of reference" (TOR). By their inherent nature, terms of reference are not typically binding. It remains unclear how these TORs will attain legal enforceability and which parties will be party to such TORs. Additionally, the distinction from SMTAs, an approach advocated by the African Group (yet disregarded) and implemented within the PIP Framework, remains unclear. Notably, under the PIP Framework, the sharing of biological materials is subject to SMTAs, with a TOR referencing all tasks of the respective laboratories.

Even the WHO’s regulations for study, scientific groups, collaborating institutions, and other collaboration mechanisms governing WHO's relationships with laboratories and other entities, refers to "agreement" rather than "terms of reference."

Approach towards Sequence Data Undermines Benefit Sharing & the PABS system

On the issue of genetic sequence data (GSD), the draft text states, “Parties will be required to upload the GSD and relevant metadata to one or more PABS sequence databases (SDBs) which meet the legally binding terms of reference. As mentioned above, the use of terms of reference as a legally binding instrument is highly questionable. The text further states that once uploaded, the data will be tagged with a label “PABS GSD” which “will follow through to the end products and/or publications and shall notify the users of GSD of the benefit sharing provisions under the PABS system”.

Users are not required to register, provide any contact details or accept any terms and conditions, when accessing GSD. Without information on the users of GSD, the WHO Secretariat will have to “hunt” for the users and even if users are found, they can refuse to comply with the requirements of the PABS system, arguing that they never accepted the terms and conditions of the PABS system. This glaring loophole will undermine compliance with the requirements of the PABS system including the operationalization of fair and equitable benefit sharing.

In the digital realm, it is standard practice for access to be contingent upon user logins and agreement to terms and conditions. This approach is adopted by GISAID, a private database housing COVID-19 and flu sequences, widely utilized by scientists globally. However, concerns persist regarding the transparency and accountability of GISAID's operations.

Introducing a practical measure where anyone accessing data through a sequence database provides verifiable contact details and agrees to terms and conditions is a matter of basic common sense. This would enable the WHO to promptly identify users of GSD, verify their credentials, and ensure their compliance with the terms and conditions for accessing GSD. Despite repeated calls from developing countries during the 8th INB session, this measure has yet to be included in the text.

The absence of such a measure will perpetuate anonymous access to sequence data, as currently facilitated by databases of the International Nucleotide Sequence Database Collaboration (INSDC), thereby impeding the realization of fair and equitable benefit-sharing. Nevertheless, even INSDC databases are beginning to revise their approach.

For example, the terms of use as of 5 February 2024 of a database of INSDC-EMBL-EBI state, “International Nucleotide Sequence Database Collaboration prevail over these Terms of Use” and that “EMBL-EBI itself places no additional restrictions on the use or redistribution of the data available via its Data Resources and Tools other than those provided by the original data owners, unless otherwise specified in these Terms of Use”.

This clearly shows that WHO Members as data owners have the right to require additional terms for allowing access to genetic sequence data including mandating the user to provide user information (name, contact details etc) and subjecting access to additional terms and conditions.

The absence of measures in the draft text that will ensure transparency and accountability to WHO Members concerning access to and use of GSD is a major impediment to concluding negotiations on Article 12.

Proposed text only concerned about notifying users about benefit sharing; no role for Parties in determining user terms and conditions

The draft text merely proposes to notify the users about the benefit-sharing provisions of the PABS system. The text does not anticipate that the user of biological material or GSD will have to formally accept any terms and conditions. This omission can create significant challenges in the implementation of the PABS system, especially in enforcing its requirements such as biosafety standards, intellectual property and other essential aspects. Mere notification alone may not suffice to establish an enforceable legal obligation.

Moreover, the text highlights that all users “shall have obligations under PABS regarding benefit sharing”. In paragraph 5, it is stated that “WHO shall develop in accordance with the relevant templates to be developed by the Parties, legally binding terms of reference for the CLNs (WHO-coordinated laboratory networks) and SDBs (WHO-recommended sequence databases) with arrangements to notify the user of biological materials and GSD of the benefit-sharing provisions of the PABs system. This suggests that the user will not be required to comply with other terms of the PABS system (other than benefit sharing), for e.g. with respect to further transfer of the shared biological material, biosafety, biosecurity, intellectual property etc., which are also essential “terms of use” that users should abide by.

The draft text further states that the “templates for the PABS contracts to be signed with the manufacturers and the legally binding terms of reference agreements with CLNs and SDBs shall be developed by the Parties”.

There is however no mention of the role of Parties in developing the terms and conditions applicable to the user of biological materials and GSD. The lack of clarity about what the terms and conditions that bind the users, and who will develop these terms and conditions, bears the risk of inadequate user terms and conditions, with the potential to create friction between the providers and users of biological material and GSD, and subsequently demotivate the sharing of materials and GSD.

Sharing outside of the PABS system

The draft text also permits Parties to share biological materials and GSD outside the PABS system. Such a provision harbours the potential for abuse of the PABS system. For example, a developing country laboratory may share a clinical specimen with a developed country laboratory that is part of CLN thinking that it is contributing to the PABS system. The latter laboratory isolates the pathogen and shares the pathogen outside the PABS system and further shares the data outside the SDBs. This scenario constitutes a breach of trust of the originating laboratory in developing countries. It also undermines the integrity of the PABS system, particularly its benefit-sharing components, as entities accessing materials and data outside the PABS system may argue that they are not bound by its requirements.

Validating monopolisation of shared biological materials and GSD

The draft text also endorses the continuation of the appropriation and monopolisation of shared biological materials and GSD through the intellectual property system. The draft text proposes that “Parties agree that intellectual property rights may not be sought on such materials and GSD”. But such a proposition is firstly optional as it states “may” and does not adequately capture the trends in the types of patent claims made related to pathogens of pandemic potential and its GSD. It is also incorrectly addressed to Parties and not the users of biological materials and GSD.

A recent paper on “Some Intellectual Property Claims Related to Pathogens That Can Cause Public Health Emergencies” revealed wide-ranging claims encompassing the pathogen materials and GSD. The paper sheds light on the appropriation of native sequences and virus samples, wherein patents are sought over either portions, or modified versions, of these sequences. Patent applications also may not claim native sequences per se but native sequences may be modified and patent claims made over artificial sequences i.e. modified sequences.

Further, the paper exposes that scientists were able to obtain the necessary biological material by accessing the GSD of the viral isolate from databases like GenBank, without directly obtaining a sample from the countries such as Bangladesh, Malaysia and in Africa. Moreover, the scope of the patent claims frequently covers products like antibodies, vaccine compositions and other medical products, generated using virus samples from patients. 

The majority of patent claims originate from both public and private entities as well as academic institutions in developed nations, notably the United States, positioning them to own the majority of "inventions" derived from these pathogens and GSD. This is particularly noteworthy considering that the primary countries affected by the pathogens under scrutiny in this study are predominantly developing nations.

The paper concludes that the proposition put forth by developing countries better captures the range of patent claims that should not be permitted, to prevent the exploitation of the PABS system. The proposal presented by the Africa Group and Group of Equity read: "no IP claims shall be sought on WHO PABS biological material, including its GSD, or parts thereof, in any form including any modified form or for any use" by the recipient of the material and GSD. This provision also reflects a critical effort by developing countries to remove monopolies that can hinder further R&D as well as barriers to the diversification of the production of medical products.

Lacking in meaningful non-monetary benefits for PHEIC and pandemic response

A significant point of contention on Article 12 is the lack of meaningful benefit-sharing. Developing countries have consistently emphasized the need for tangible benefits to effectively respond to Public Health Emergencies of International Concern (PHEIC) or pandemics. However, the current text presents a vague and ambiguous list of benefits, falling short of the expectations of many developing nations.

The text mandates "manufacturers" to provide real-time contributions of relevant diagnostics, therapeutics, and vaccines, with "10% free of charge and 10% at not-for-profit prices" during PHEIC or pandemics, to be made available "based on public health risks, needs, and demands".

This provision has drawn criticism from numerous public health experts for its perceived inadequacy in addressing the needs of developing countries, which constitute 86% of the world's population. Additionally, the suggestion of making only 10% available at not-for-profit prices implies that the remaining supply need not necessarily be affordable. Furthermore, the inclusion of "demand" as a criterion for distribution raises concerns, particularly in light of the contested notion of demand during the COVID-19 pandemic. The pharmaceutical industry often cited the lack of demand in developing countries as justification for their inability to provide affordable supplies.

 

The text also does not feature any obligation to provide licenses for manufacturing accompanied with technology transfer and know-how to developing country manufacturers during a PHEIC or a pandemic so that production may be diversified and supply options expanded to meet the surge in demand, which normally happens on the declaration of a PHEIC or a pandemic.

Most shocking is the persistent disregard of the proposals of developing countries on non-monetary benefit sharing that is to be provided by entities that develop and/or manufacture, diagnostics, therapeutics and vaccines.

The draft text reads:

“In the event of a public health emergency of international concern or a pandemic the Recipient Entity agrees to:

(a)        Donate at least 20% of its real-time production of each pandemic-related product manufactured, to WHO for distribution based on public health risk and need. The Recipient Entity shall comply with its commitment based on products and timetable determined by the WHO in consultation with the PABS Advisory Committee;

(b)        Supply vaccines, therapeutics, diagnostics and other pandemic-related products at affordable prices to developing countries, and to comply with WHO’s allocation plan, if such a plan is recommended by WHO. For the purpose of this paragraph “Affordable pricing” for developing countries means a price no higher than marginal cost per unit +10% profit margin, while for developing countries categorised by the United Nations as least developed countries at “no profit no loss”.

(c) Grant to WHO royalty-free, non-exclusive licenses on standard terms and conditions to use its intellectual property, and other protected technology, know-how used in the process of product development and manufacturing, for the production and supply of pandemic-related products, needed in developing countries. WHO shall sublicense these licenses to manufacturers especially in developing countries, on standard terms and conditions in accordance with sound public health principles with the aim to diversify production and expand supply options to facilitate prompt equitable access in developing countries.

For the purposes of this paragraph, the Recipient Entity shall on request by WHO share the complete regulatory dossier including the full technical know-how as well as any materials needed for the development and production such as cell-lines, hybridomas, plasmids, yeast, or mammalian cells, with the sublicensees of WHO.

5.3       Prior to the declaration of a PHEIC, with the aim to prepare for an early response, at the recommendation of the Director-General, the Recipient Entity shall donate a part of its real-time production, not exceeding 20% of its real-time production, to address access needs in developing countries including for purposes of WHO stockpile. Any affected country may also request the Director-General to operationalize this paragraph. The Director-General shall make the recommendation to this effect, in consultation with the affected countries and the Emergency Committee.”

Voluntary monetary benefit-sharing gives commercial users a free pass

According to the text, manufacturers shall be required to provide monetary benefit-sharing, and the annual amount, use and approach for monitoring and accountability shall be finalized by the Parties. 

However, the text paradoxically exempts other commercial users of biological materials and GSD, allowing them to essentially exploit the PABS system without mandatory monetary contributions.

Beyond manufacturers of pharmaceutical products, there are many other commercial users of the PABS system. For example Boehringer Ingelheim Animal Health USA is the owner of a patent claim using sequences from the native Nipah Virus Malaysia strain for the production of a recombinant vaccine that immunizes pigs against Nipah virus.

There is simply no logic to giving other commercial users a free pass, given that Parties entail significant costs in conducting surveillance, risk assessment and sharing materials and GSD with the PABs system. And yet the text proposes voluntary monetary and non-monetary benefit sharing with respect to other commercial users.

On this point as well, developing country proposals have been ignored. They have argued that any person or entity financially benefitting from the use of PABS system must contribute monetary benefit sharing. The Africa Group and Group of Equity have proposed the following formula for calculating monetary contributions: x% of total annual revenue for each product or service developed and commercialized using the PABS System. Neither the principle nor the formula for determining monetary contribution is represented in the draft text.

Non-commercial users have no benefit-sharing obligations

The text appears to favour non-commercial users, who stand to gain significantly from utilizing biological materials and GSD, as evidenced by numerous documented patent claims. However, in return, the text demands relatively little in terms of benefit-sharing. If a user genuinely operates on a non-commercial basis, should they not be obligated to publicly share all outcomes stemming from the utilization of biological materials and GSD? The proposed text merely mentions "contribute to public dissemination and transparency of research results," which may not sufficiently address the issue.

Relationship with the PIP Framework & the International Health Regulations

The draft text fails to address the relationship with the PIP Framework which also deals with access and benefit sharing pertaining to influenza virus of pandemic potential. This Framework which has been functioning for more than a decade should continue to apply to influenza virus of pandemic potential, while the PABS system can apply to other pathogens of pandemic potential as it remains unclear when the PABS system will become operational and its effectiveness in delivering a transparent and accountable ABS mechanism.

Further missing from the draft text is the understanding that the PABS system will apply to all WHO members irrespective of whether the Member is a Party to the pandemic agreement. While some components of the PABS system applies to non-state actors (e.g. manufacturers, and other users of biological materials and GSD) Parties will play a central role in ensuring compliance with the requirements of the PABS system and its operationalization. Hence, there should be an understanding that the provisions of the PABS system shall apply mutatis mutandis to State Parties of the International Health Regulations.

Flawed Approach to Specialised International Instrument of the Nagoya Protocol

The draft text mandates Parties to the Convention on Biological Diversity (CBD) and its Nagoya Protocol to recognise that the PABS System is “consistent with and does not run counter to the objectives of the Nagoya Protocol”, stipulating that it “shall function as a specialized international access and benefit-sharing instrument” requiring each Party to adhere to this recognition.

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However, the approach outlined in the text appears premature, considering that the CBD has yet to reach a consensus on the criteria for designating an instrument as a specialized international instrument under Article 4(4) of the Nagoya Protocol on access and benefit sharing. There is currently no consensus on whether an entity external to the Nagoya Protocol can acknowledge a multilateral access and benefit-sharing instrument developed by it as a specialized international instrument under the Nagoya Protocol.

Equally crucial is the recognition that the mere operation of a PABS system does not inherently ensure alignment with the objectives of the Nagoya Protocol; this can only be determined with time.