Pathogen Access And Benefits Sharing: The Fulcrum
On Which Equity Objectives Rest?
Priti Patnaik & Nishant Sirohi
Geneva Health Files, April 2023
Pathogen access and benefits sharing will be a near-fulcrum around whichconcrete provisions to address equity objectives for future healthemergencies could be realized.
New rules in global health on facilitating access to pathogens and the sharingof benefits will likely feature in both - a new Pandemic Accord and in theInternational Health Regulations.
The form this set of provisions could take is still not clear, with a range ofoptions being discussed including a new dedicated multilateral mechanism togovern PABS applicable to both regimes; as an annex to the Pandemic
Accord; as a separate set of rules under Article 23 of the WHO constitution
modeled around the Pandemic Influenza Preparedness Framework; andbuilding on existing provisions in other legal instruments.
Irrespective of which form these rules take, the legal effect and the kinds ofobligations these rules could result in, will be important in determining notjust whether access to information on pathogens will be streamlined. It will
have implications for guaranteed access to countermeasures in return forsharing information, promise of greater support for researchers and capacity
building in weaker health systems among others.
This story looks at some of these options more closely as discussed also at anintersessional meeting on PABS organized by the INB bureau last month. Do
note that some of the analysis is based on existing provisions suggested to
the Zero Draft of the Pandemic Accord. A new Bureau’s Text of thePandemic Accord is currently in the works, and is expected to be released on
May 22, that might feature additional provisions on PABS.

Image Credit: Photo by Mikhail Nilov, Pexels

WHAT HAS BEEN PROPOSED SO FAR?
Both the proposals to the amendments to the IHR and the suggestions to thePandemic Accord feature provisions for access to pathogen information andsharing of benefits.
PABS IN THE PANDEMIC ACCORD [ZERO DRAFT]

WHO Pathogen Access and Benefit-Sharing System

Article 10 of the equity chapter is dedicated to the WHO Pathogen Accessand Benefit-Sharing System. In one of the more decisive aspects of the Draft
Text, a set of provisions dedicated to accessing information on pathogens andsharing resulting benefits have now been fleshed out, that will serve as abasis for negotiation.
It is not clear yet whether detailed provisions on Access and Benefits-Sharing[ABS] will be a part of this instrument, or will it follow in an annex, as many
WTO agreements are structured.
The article lays down how information should be shared and suggests that it
operate synergistically with other relevant access and benefit-sharing
instruments. There is specific language on what should be shared; who sharesit; who handles such information; prevailing laws governing suchinformation; the frameworks or contracts that must be place to facilitate suchtransfer of information [a Standard Material Transfer Agreement focused on
PABS].
The Draft Text suggests how benefits resulting from information on
pathogens can be shared – such as sharing a percentage of all production of
medical products with WHO.
(Also see more here on provisional application of rules: The Zero Draft of
the Pandemic Accord: A Discursive Journey into Equity)
The EU has also suggested additional provisions on ABS in a more recent
submission to the Zero Draft of the Pandemic Accord. The EU for example
has suggested that such rules should be concluded within two years of the
instrument coming into force. (See more on this here: Price Caps, Tiered
Pricing, Stockpiling, in the EU's Textual Proposals for Pandemic Accord. Its
Imprint on the WHO Medical Countermeasures Platform)
IHR AMENDMENTS

Similarly a number of proposals in the IHR suggest amendments to include
secure and transparent exchange of genetic sequence data; refer to digitaltechnologies to improve secure global exchange of health data; among
others.

WHY DO WE NEED NEW RULED ON PABS?
Several stakeholders believe that the prevailing system of rules has no clear
obligations to ensure the access to pathogens and the sharing of information.
And hence countries see these on-going negotiations as an important
opportunity to craft new rules on these issues specific to global health.
In general, countries and stakeholders are divided on whether the access to
information on pathogens should be bartered with ensuring the sharing of
benefits on account of providing such information. Largely some developed
countries are not in favor of such a “transactional mechanism”, while fordeveloping countries this is a key negotiating chip to guarantee fair access to
not only countermeasures, but also to deliberate on issues of sovereignty andagency.
It is widely acknowledged that while samples and information on Sars-Cov-2
were shared during the pandemic, medical countermeasures that weredeveloped using those samples and information were not shared resulting inserious inequities.
Note that the existing version of the Zero draft treats the issue of access andbenefits on an equal footing. It is not clear whether this will continue to be soin the coming months. Also, experts have pointed out the access provisions
as they stand in the Zero Draft are subject to compliance mechanisms morestrongly than provisions to monitor the sharing of benefits (See Article 22 ofZero Draft).
While some countries are insisting on obligations on sharing information on
pathogens, others are less enthusiastic on signing up to such obligations,particularly in the absence of clear obligations on ensuring benefits. Someeven argue that there are de facto obligations to share information already,and caution against additional obligations on sharing information on
pathogens. During COVID-19, information has been readily shared, experts
acknowledge.
Needless to say, there are several parameters to determine such complex
provisions including what constitutes pathogen information, how should it beshared, in what form, under what circumstances, on the intellectual property
implications of such information; and separately, what constitutes benefits
and how can states craft obligations on the same. Several experts have also
called for transparency considerations in the kind of information shared, howdata flows, who owns the data, how is it stored, among other factors.
There are examples from other legal regimes in other forums, that is shaping
some of the current deliberations, most notably from the Convention on
Biological Diversity.
LESSONS FROM CBD

Speaking at the intersessional briefing on PABS last month, Kathryn
Garforth from the Secretariat of the Convention on Biological Diversity said:“From our experience under the Convention and the Nagoya Protocol, it isvital to have balance between commitment to access on one hand andcommitment to benefit sharing on the other. There is a need to create
incentives for all countries that participate in the systems that facilitatesharing of samples and data. These incentives come through benefit sharing.
And by benefit sharing, I mean the sharing of monetary benefits - yes, butalso capacity building, technology transfer, the development of indigenous
research, capacity, collaboration on research activities and a whole range ofother activities often refer to as non-monetary benefits.
It is only by having some certainty that benefits will be shared that theinternational community can build the trust needed to improve access tosamples and data. We very much understand the importance of rapid access.
Our experience, though has been that calls for rapid access and open accessare most constructive if they are matched with a willingness and acommitment to share benefits. Without such sharing, open access, canreinforce inequities and create feelings of what's yours is mine, and what
mine is mine.”

HOW CAN PABS BE CRAFTED?

Discussions at WHO and outside, are focused on how some of theseprovisions can be balanced to receive consensus from the widest group of
member states.
Some believe that access to information is crucial for surveillance purposes,
and to contribute to research and development at the time of emergencies. In
return, the sharing of benefits should not only include access tocountermeasures developed as a result of information shared, but also accessto technology.
Scholars such as Suerie Moon, Co-Director of the Global Health Centre at
the Geneva Graduate Institute, who addressed member states during theintersessional briefing, also suggested a committee to negotiate benefits forcommercial use of samples or GSD on a case-by-case basis. She pointed to
the Oceans Treaty that has established a Access and Benefits Committee.
(See The Biodiversity Beyond National Jurisdiction or the High Seas Treaty).
She also cited the weaknesses in the PIP Framework, where pharmaceuticalcompanies while choosing to donate products as contractually obliged, havenot chosen to share intellectual property, technology, know-how.
On intellectual property implications, Moon said, “The current limits on theability to claim intellectual property on samples or data I find quite narrow.
So, you cannot patent, for example, they cannot claim intellectual property
on data or samples, as they would be shared. However, if you can imagine
developing a vaccine, a diagnostic or a drug using the samples or that data, as
I understand it, you could claim intellectual property protections on what you
develop based on that use. Since you do not have this kind of reach throughprovision, that would free or ensure an open access to that kind of technology
or knowledge in the event of a pandemic.”[Art 10 (3) of Zero Draft: “(d) Recipients of materials shall not claim any
intellectual property or other rights that limit the facilitated access topathogens with pandemic potential, or their genomic sequences orcomponents, in the form received; and (e) Access to pathogens withpandemic potential protected by intellectual and other property rights shallbe consistent with relevant international agreements and with relevant
national laws.”]

Moon also presented a schematic on potentially how a PABS system canfunction.
The suggestion foresees a set of commitments for governments including
sharing samples, sharing GSD, sharing benefits, committing to transparency,
supporting capacity building, providing sustainable financing. One option
stated was to establish a multilateral, multi-pathogen system.
More information on how such a mechanism can operate has been describedhere in a briefing by the Geneva Graduate Institute’s Global HealthCentre: What Are the Options? Pathogen-, Gsd- And Benefit- Sharing In An
International Instrument: December 2022
According to this paper, “The operation of the multilateral system would
begin with the Member States sharing the pathogen samples withinternational lab networks and the GSD with international databases. The
samples and GSD could then be shared for non-commercial use under
SMTA2 with WHO and Government Agencies for the purpose of
information and surveillance. The onward use of that data would be governed
through SMTA2 [Standard Material Transfer Agreement] and could
generate benefits such as co-authorship, collaboration, information andcapacity building. Both samples and GSD could also be channelled tocommercial actors under SMTA3 for the purposes of countermeasure R&D.
The transfer for commercial use under SMTA3 could result in benefits suchas commitment to share a certain part of the production with WHO, as wellas tech transfer, IP and know-how for local production. It could also result inroyalties which, along other streams of funding, could be used to finance thefulfilment of other commitments. Ultimately, the benefits would flow back to
the Member States that provide the samples and GSD. The alternatives would
be to preserve the status quo of patchwork arrangements, to expand
individual instruments or to establish a minilateral (multi-pathogen) systemamong the likeminded countries.”

Source: Global Health Centre, Geneva Graduate Institute What Are The
Options? Pathogen-, Gsd- And Benefit- Sharing In An International
Instrument: December 2022

WHAT SHOULD BENEFITS LOOK LIKE?
While these are relatively early days in these negotiations, there are already alot of questions on the specificity around the kinds of benefits that must flowfrom the sharing of information on pathogens.
There is appetite among countries and stakeholders to move beyond
prevailing non-monetary benefits sharing including academic credits,
research collaborations, although such practice should also be standardized
and codified under new rules.
(See our earlier interview with Bangladeshi scholar "The idea of pathogen
sharing is based on power dynamics": Q&A with Senjuti Saha, September
2021 by Divya Venkatesh)
The current negotiations present a real opportunity to put in place obligations
for monetary benefits. But this will be subject to a number of factors,
including governance, financing and many other considerations as other legalregimes show. (See more below on benefits-sharing on digital sequence
information in the context of CBD.)
To illustrate just how much is at stake when it comes to monetary benefits,
Moon explained why this can be so complicated. “…Where things get morechallenging is around the commercial benefits….this can be money, it can be
intellectual property, it can be sales of products, reduced prices, stockpiles,
know-how,” Moon said.
Two scenarios were presented: one where a company is able to supply to
WHO and affected countries in the event of a small outbreak, and the second,such as the pandemic of COVID-19 with a global demand for medical
products, one that cannot be serviced by a few entities. It is in the latter casethat technology transfer and related benefits become critical, Moon said. The
suggestion is to established governance mechanism and to have a benefits
committee to determine how this could function in the event of an
emergency. She also cautioned that while there have been precedents on
obliging tech transfer in other forums including at the WTO, these have beendifficult to monitor.
It was also pointed out that when an outbreak becomes a large-scale
epidemic, the market is enormous and hence it is very difficult to induce
technology transfer given the huge upside for companies. And therefore theneed for governments to establish rules on benefits, given also that publicmoney funds research and development.
Sangeeta Shashikant, a legal advisor at Third World Network with extensive
experience of working on these issues, pointed out at the intersessional
meeting, emphasized the need to have a commitment on sharing technology
and medical products right at the beginning and not after a crisis has hit. She
called on member states to negotiate benefits before contracts become
operational.
“It will be too late for a benefits committee to decide when a crisis hits,
because we know for a fact, as we have seen [during COVID19], manufacturers may not agree to sign any kind of agreement at that point.
For instance, the manufacturers did not want to commit to contribute to theWHO COVID Technology Access Pool. So, these are not issues that shouldbe left at the later stage. These are issues that can be determined, as we haveseen in the PIP framework, while improving on the contracts…but these are
all decisions that have to be negotiated by the WHO membership.”
FINANCING AND INCENTIVES

Another key area countries will address is on financing such a mechanism.
Some have suggested a “subscription model” based on user fees.
Incentivizing participation from the private sector to make the PABS system
work is another area that is being discussed. Experts highlighted that given
the large scale investments by governments such as during the COVID-19
pandemic, the question of incentives, while important, has been addressed toan extent.
At the briefing, Moon said, “…it's public funding that largely pays for R&D
prior to an outbreak. This is a good thing; this is what should happen. Thereis too much risk and uncertainty for the private sector to take this on that's
why the public sector takes it on but because there is public money paying
for this, this is the incentive. Essentially, governments are paying companies
to do this, and you have a number of particularly small and medium
enterprises. They are the dominant actors in this area, it is where most of theinnovation is coming from and this is where these companies basically manyof them rely on government funds. That is their bread-and-butter source ofrevenue until an outbreak occurs, and they can sell a product and makemoney. So, I think there are already financing mechanisms and incentives inplace for companies to engage in R&D.”
WHAT DOES INDUSTRY SAY?

For the pharmaceutical industry, the rapid access to pathogens is a priority.
The industry also believes that pathogens should not fall under the scope of
CBD, since the instrument focuses on the conservation of biodiversity. In thecontext of these discussions it has lamented the politicization of the sharing
pathogens.

(See industry commissioned report: Global Disease Surveillance andPathogen Sharing; and also ‘Transactional’ Pathogen Sharing Undermines
Global Health Security: Health Policy Watch)
THE INFRASTRUCTURE OF PABS: THE INTEGRITY OF DATABASES

These negotiations on PABS also bring into sharp focus the role of databasesin the system of accessing and sharing information. WHO member states willneed to address this in the context of these discussions to improvetransparency, accountability and governance mechanisms to undergird the
PABS system.
There have been concerns on the integrity of databases, and the protection
offered by prevailing systems. Experts are now calling for oversight of WHO
member states in these processes before committing on obligations for global
sharing of sequence data. Questions on data ownership and permissions will
also need to be negotiated.
Some experts point out that while the emphasis on benefits is important, thefocus on access conditions is also crucial. There is a price to access, and anumber of determinations on what kind of access and the types of
information that countries will be obliged to share under these potential newrules.

WHAT NEEDS TO BE RESOLVED?
Some of the most important questions, of the many, facing negotiators, iswhat constitutes digital sequence information, how should they be governedin the realm of global health.
Also important will be the status of the new set of rules in relation to the
Nagoya protocol.
DIGITAL SEQUENCE INFORMATIONIn December last year, the Conference of the Parties to the Convention on
Biodiversity, adopted a decision on digital sequence information on genetic
resources or DSI, similar to genetic sequence data. CBD experts at theintersessional explained that under this decision, the parties agreed thatbenefits from the use of digital sequence information should be shared fairly
and equitably. Further, there was consensus to develop a solution for the
sharing of benefits arising from the use of DSI. The decision (para 9 & 10)contains criteria that such a solution should meet including that it should nothinder research and innovation and that it should be consistent with open
access to data.
The expert from CBD also discussed a multilateral mechanism for benefit
sharing from the use of DSI, including a global fund, that was decided by the
COP. The Kunming-Montreal Global Biodiversity Framework sets out aprocess to further develop and operationalize the mechanism which is to be
finalized at the COP’s next meeting in October 2024. Work on this process is
now under way.
THE IMPORTANCE OF TERMINOLOGY
WHAT IS DSIIn the zero draft of the Pandemic Accord, (a) “genomic sequences” means
the order of nucleotides identified in a molecule of DNA or RNA. They
contain the full genetic information that determines the biologicalcharacteristics of an organism or a virus”. (This definition is already undernegotiation among WHO member states)
In comparison, Garforth explained that in the context of the CBD, the COP
agreed to keep using the term digital sequence information on genetic
resources, but did not define the term. “There isn't an agreed definition of it.
So then, what it means, I think, it is up to interpretation,” Garforth said.
She also described that these discussions have progressed in the CBD, also
steered by a technical expert group that has categorized different definitions
to capture the complexity and breadth of genetic information including
related to DNA and RNA, proteins, metabolites and macro molecules,
traditional knowledge associated with genetic resources and other biotic
factors in the environment.
A broader definition leaves scope for implementation when it comes tosharing of benefits.

Garforth said, “…I can certainly see that a definition of the as it is in the
Zero draft which is quite specific, it does give an indication of for the limitsof the type of information the use of which would require benefit sharing;whereas with these some of these other broader groups that I have identified
as possibly being part of digital sequence information that that could be abroader scope.”
There is also another practical implication that does not favor defining
information in such clinical terms. Garforth said, “Certainly, part of ournegotiations, there was a very conscious awareness among the Parties, of adesire not to try and start with sub-dividing digital sequence information into
different categories, because that is not how the ecosystem of digital
sequence information functions in practice in the databases where thisinformation is stored or not distinguishing between different types of digital
sequence information coming from different sources, and to be used for
different purposes. They tend to be very integrated.”
She therefore underscored the need for consistency in the way suchinformation is treated across instruments and forums. (See more below on thelink between the Nagoya Protocol and a potential new system on PABS at
WHO.)
BENEFITS-SHARING FROM DIGITAL SEQUENCE INFORMATION

Notwithstanding the somewhat broad understanding of such information,
Parties to the COP at CBD have agreed that benefits from the use of DSI
should be shared.
Garforth also drew attention to the provisions on benefit sharing in the
recently concluded Treaty on Biodiversity in Areas Beyond National
Jurisdiction, that also recognizes that the modalities of monetary benefits
sharing under that agreement should be mutually supportive of and adaptableto other ABS instruments.
The decision by the CBD COP lays out criteria on what such benefits could
look like. For a fair and equitable benefit sharing on the use of DSI, solutions
should be efficient, feasible, and practical, Garforth said. It should generate
more benefits, including both monetary and non-monetary benefits, than

costs. It should be effective; it should provide certainty and legal clarity forproviders and users of DSI. It should not harm research and innovation. Itshould be consistent with open access to data, she added. There is also
language in the decision around capacity building, technology, transfer
and technical and scientific cooperation.
A potential establishment of a multilateral approach for benefit sharing fromthe use of DSI will take into account a wide range considerations such as
governance of such a fund; trigger points for benefit sharing; contributions to
the funds; the potential to voluntarily extend the multilateral mechanism togenetic resources; questions on the disbursements of monetary benefits; on
non-monetary benefit sharing; working with industry and academia; rights,
and interests of indigenous peoples and local communities; linkages between
research and technology and the multilateral mechanism; principles of data
governance among others, Garforth explained.
DSI ACROSS INSTRUMENTS

Garforth from CBD also explained that the COP decision also recognizedthat any solution for the fair and equitable sharing of benefits from the use of
DSI should be usually supportive of an adaptable to other instruments andfora, for recognizing that other forum may develop specialized approaches.

THE NAGOYA PROTOCOL AND A NEW PABS SYSTEM
One of the legal questions facing negotiators at WHO, is also the status of a
new set of PABS rules relative to the commitments of states under the
Nagoya Protocol affiliated with the CBD.
The Nagoya Protocol on Access to Genetic Resources and the Fair andEquitable Sharing of Benefits Arising from their Utilization to theConvention on Biological Diversity is an international agreement which aims
at sharing the benefits arising from the utilization of genetic resources in afair and equitable way.
Article 4 of the protocol addresses the relationship of the Protocol withinternational agreements and instruments. (This appears to be causing someheart-ache amongst global health lawyers.)

The crux is in defining the “nature” of the other instruments that might beconsidered a specialized international ABS instrument. Experts suggest that
Nagoya Protocol will not apply in so far as “a specialized international accessand benefit-sharing instrument applies that is consistent with, and does not
run counter to the objectives of the Convention and this Protocol” as per Art
4 of Nagoya.
So, whether a new PABS system will be considered a specializedinternational instrument (the concept of lex specialis), will need to beaddressed. Experts say that the Nagoya Protocol accounts for different andspecial considerations that Parties are to take into account in theirimplementation of the Protocol. It has been pointed out that the IHR for
example has been referred to in the Preamble of the Protocol.
Some believe that a new PABS system could be an opportunity to improveupon how benefit-sharing is articulated for global health. “Nagoya is not
great on benefits. So, it should not be referred as a standard while discussing
PABS in global health,” one international law expert told us.

THE LEGAL BASIS OF THE PABS
Some countries are seeking an independent multilateral mechanism on ABS,
that can be referenced in both the IHR and the INB instruments.
Some legal experts suggest Article 23 of the WHO Constitution for the new
ABS mechanism, as opposed to Article 21, that underpins the IHR. (Article
23 is the basis of the Pandemic Influenza Preparedness Framework, often
cited as a potential model for a new ABS framework)
We reported in detail last week on the importance of the legal basis of PABS
– what kind of provisions should support such a mechanism, to what extent
should it be binding. One proposal is to have a separate set of regulations for
PABS, as we discussed here.
Some suggest on agreeing to principles on PABS and to negotiate on thedetails later. They also point to the interconnectedness of the PABS
provisions to other aspects such as on research and development, intellectual
property and tech transfer.

Shashikant, from TWN pointed out, “…if you look at the how the PIP
framework was negotiated, and the benefit sharing was negotiated, all thedetails, access and benefit sharing were actually negotiated together and I
think this is why we have a rather unique framework. So, I would say that
equal footing principle is to be upheld and equity is to be developed. We
should actually negotiate the details of access and the details of benefit,
sharing at the same time, and not to leave it to be developed at a much laterstage.”(While the PIP Framework is being held out as a model for the PABS,
experts also acknowledge the need to tighten contracts in the PIP system toensure better benefits and stronger commitments from the private sector.
GSD for example does not feature in PIP contracts.)
TAILPIECE: HOW HISTORY IS RECOUNTED.

It is also interesting to observe how history is recounted. For many, Indonesia
withholding samples of H5N1 in 2007, has been a painful reminder of why
obligations on access are important.
And for others, they see the episode as a decisive turning point in the way theworld talks about access to information and the sharing of benefits.
So, the way you read history, or consume history is very determined bywhere you are from. This has implications on how countries approachnegotiations on PABS.