The Access To Medical Countermeasures – The
Lynchpin Of The Reforms To Health Emergencies
GovernancePriti Patnaik
Geneva Health Files, March 2023

As countries head deeper into the negotiations of the Pandemic Accord, they
are beginning to tackle the some of the most difficult lessons from COVID19, namely the access to medical products, among a range of other competing
priorities from matters on compliance, financing to prevention andpreparedness measures. While discussions are getting technical and more
specific, the suggestions on potential provisions from stakeholders, experts
and countries themselves reveal a rich array of possibilities. WHO member
states will convene for the fifth meeting of the Intergovernmental Negotiating
Body in Geneva next week.
A number of dedicated intersessional meetings on specific articles of
the Zero Draft of the Pandemic Accord, were conducted this month by the
INB, set up to establish a pandemic accord. While these discussions werebehind closed doors, Geneva Health Files, has been able to review some ofthe sessions, based on information shared by those present in these
discussions.
The intersessional meetings delved into issues including predictable global
supply chain and logistics network [Art.6]; One Health and the Quadripartite[Art.18]; Access to technology: promoting sustainable and equitably
distributed production and transfer of technology and know-how [Art.7];
WHO Pathogen Access and Benefit Sharing System [PABS], with thePandemic Influenza Preparedness Framework as an example [Art.10].
In this story we look in detail on the various facets to the access question in
the pandemic accord discussions. We also bring you opinions from experts at
the IP discussion held at the Informal Focused Consultations from Octoberlast year. [We will follow up on PABS in the coming weeks]We try to capture the emerging narrative on some of the key issues on
supply, production, intellectual property, tech transfer, licensing, among
others. These matters are mostly articulated in Chapter III on equity,
including Articles 6, 7 in the zero draft of the pandemic treaty.
(Also see ours earlier: Pandemic Accord Negotiations: Away from Public
Glare, but Center of Attention; The Zero Draft of the Pandemic Accord: A
Discursive Journey into Equity)

Image Credit: Photo by Anni Roenkae, Pexels

SUPPLY CHAIN
Article 6 on global supply chain and logistics network, proposes to establish“The WHO Global Pandemic Supply Chain and Logistics Network” and todevelop a mechanism “to ensure the fair and equitable allocation ofpandemic-related products based on public health risks and needs”.

According to sources, much of the discussion during the intersessionals on
supply chain focused more on the issues of logistics, especially on shipments
and delivery. Experts deeply involved in the operational aspects of theinternational response to COVID-19, acknowledged that the commercial
sector on logistics clearly collapsed during the pandemic. However, they alsoemphasized the reliance on commercial actors while designing the supply
chain network.
Issues of production were discussed and there have been suggestions thatoutcomes on production must be incorporated into the legal texts especiallywhen it comes to new products.
Questions were raised on how the supply chain network will connect to theMedical Countermeasures Platform that is being proposed potentially as an“end-to-end” solution for health emergencies.
Among those who presented were, Paul Molinaro, Chief, Operations Supportand Logistics at World Health Organization. World Health Organization; andShanelle Hall, Founder of The Yellow House, a consulting firm with anemphasis on global public health and former UNICEF Deputy Executive
Director, as well as Director of UNICEF’s Supply Division.
Participants also highlighted the need for a minimum agreed and guaranteed
stockpiling of medical products, and to find a way to ensure a predictable
response irrespective of commercial dynamics. Suggestions were also madefor a greater coordination role for WHO. There were also calls for“unhindered access” to medical products during emergencies.

WAIVERS OF IP RULES AS A POLICY TOOL
Waivers of intellectual property rules during health emergencies have been
proposed by a number of countries. And this was extensively discussed at theintersessional. Although the TRIPS Waiver discussions at the WTO did not
succeed in contributing to a faster access to COVID-19 medical products, the“waiver-approach” is very much on the agenda for WHO member states.
(The decision adopted by the WTO in June 2022, was a shadow of what
was originally proposed.)

While developing countries do want the Pandemic Accord to automaticallytrigger a waiver, experts are not convinced about the feasibility of doing so.
But it has been suggested that the Accord could have commitments for all
countries to support a waiver, at international and national levels.
WTO, WIPO and WHO, made interventions on this topic during thediscussion, even as it was pointed out by one of the co-chairs of the INB thatthe representatives are bound by the organizations they represented.
South Centre, an intergovernmental organization with 55 developing
countries as members, asked of the three organizations for a more precise
wording for the obligation under this provision [Art. 7]. The suggested
language from South Centre is: “to require that each party suspend theenforcement of IPRs that may create barriers to manufacture and supply of
products during a pandemic, and that no Party shall challenge these measures
based on international obligations that the Party suspending the obligation
may have. (The latter would cover for FTAs and investment agreements.)
INTERVENTION BY WTO

Speaking on the inequities witnessed during the pandemic, a WTO official
pointed out the countries do not agree on the precise causes of the inequities.
He said that access and the flow of technology is determined by a wide rangeof complex interlocking factors. “No single one of which can be the entirely
the cause of the inequity.”
While the high concentration of production capacity needs to be addressed,
but the means to diversify production capacity requires coordination,planning, cooperation in both establishing and maintaining this capacity, headded.
He also pointed out that technology, transfer and intellectual property
dimension of access this will be most effective when undertaken in
combination with procurement and financing strategies, regulatory
cooperation and facilitating the flow of inputs and finished products acrossborders as well as strengthening domestic health infrastructure.

Experts also pointed out the lack of clarity around the status of patents as the
pandemic unfolded. Where patents are in force it presents a legal obstacle forgeneric production, but this subject to different contexts and jurisdictions.
“The scope, availability, and actual implementation of measures to curb or
limit or override the exclusive effect of pattern rights can come into play.
This is the array of interventions which are generally clustered together under
the term flexibilities,” the expert said.
It was recognized that the use of these measures have been a contentious andpolitically sensitive debate and raised questions on the adequacy of themeasures for a pandemic response.
Speaking on the waiver proposal at the WTO, the expert emphasized theimportance of the capacity of national governments to take action. And that a
waiver mechanism, seeking suspension of certain obligations, was not selfexecuting and that governments need to take action within domestic legal
systems.
“Ultimately the impact of the IP system, and even of international rules, will
depend on choices made and implemented within domestic laws andjurisdictions,” he explained.
He also raised questions on the uncertainty about their legitimate scope ofsuch measures. “…about how and when they can and should be
implemented, and even about their very legal character within domestic law,which can be quite diverse; and it depends on very much on domestic
circumstances and constitutional considerations.”
Explaining the TRIPS decision, the expert said that it is legitimate within the
TRIPS framework to provide parallel mechanisms under domestic law toenable patented technology to be used without the patent holders consent. He
also said that the TRIPS decision recognizes that countries will still beinterdependent when it comes to the diversified production of vaccines. In
other words, equitable access entails opening new pathways between
potential exporters and importers.”

He also explained the Ministerial decision addressed the availability question
from a supply perspective, than from a demand point of view. “If importing
countries did work together, especially in the context of pooled orcoordinated procurement to notify their expected import needs as soon as
those needs are identified that would itself open up via viable alternative
pathways for it equitable access.” But the difficulty in predicting andmanaging supply and demand during the pandemic was also pointed out.
Any waiver of international obligations require connected action, if they are
to have any practical effect, he added.
INTERVENTION BY WIPO

While there are references to the technology transfer hubs such as the mRNA
hub in the zero draft, the representative from WIPO cautioned against“duplication of efforts” at tech transfer hubs. “We need to avoid duplication
or creating structures that complicate the innovation process and intent
access,” the expert said. WIPO also sought clarity on “the legal content ofcertain expressions such as the waiver”.
In prior interventions at INB meetings, WIPO has also emphasized its role inthese matters. “Enabling access to the fruits of innovation while preserving
incentives to innovate cuts to the core of the international intellectual
property framework of which WIPO and WTO agreements form part.
References to intellectual property in any future international instrument
should therefore be guided by these existing international agreements anddecisions, as relevant. We support the reference, in Article 2, to consistency
with existing international instruments and respect for the competencies ofother organizations and treaty bodies,” according to one intervention at aprevious meeting of the INB.
INTERVENTION BY WHO

At the meeting, the expert from WHO spoke about the trilateral collaboration
between WTO, WIPO and WHO. The WHO official also laid out
mechanisms that place public health over trade objectives.

“The lack of access to health products, is not only due to a single
factor…The IP system is at the center of the debate on innovation and access.
So how IP is managed, can determine its impact on health and particularly inpandemic times, when global access of key products is needed in a timely
and affordable manner.” The expert added that “IP challenges should also be
solved in a different manner in the future.”
The expert suggested a number of safeguards built into the IP system topursue public health objectives. Apart from TRIPS Flexibilities, shesuggested mechanisms such as IP transition periods for Least Developed
Countries; IP exhaustion regimes; refining criteria, making available pre- andpost-grant oppositions; exclusions, exceptions and limitations to patentrights. She also mentioned the use of competition policy and law would also
be effective to promote innovation and support access.
She noted that manufacturers from different continents indicated theirreadiness to produce, but they needed licenses or transfer of how to scale up.
The expert also discussed the COVID-19 Technology Access Pool that was
set up in early 2020, to promote voluntary technology transfer, licensing of
IP and sharing know-how. But it has not been used much in the current
pandemic. She pointed out that public research institutes had demonstrated
more commitment towards the Pool and more licenses are being currently
negotiated. The mechanism is being reviewed currently to see how it can be
developed for future needs, she added.
(Some countries have pointed to language in the WIPO Marrakesh Treaty for
the Blind, which mandates its members to use exceptions in intellectual
property rights permitted in existing international trade agreements andtreaties, to enhance global access to works made accessible to persons whoare blind or have other disabilities.) [Article 4: National Law Limitations andExceptions Regarding Accessible Format Copies.]

TECH TRANSFER:
Article 7 on Access to technology: promoting sustainable and equitably
distributed production and transfer of technology and know-how,acknowledges the role of equitably, geographically and strategically
distributed manufacturing capacity.
We reported earlier that significant parts of the provisions in this article isweak with riders such as mutually agreed terms. Voluntary licensing
approaches characterized the response to COVID-19 pandemic, with lessthan-optimal outcomes for equitable access, many have said, given that themodel favors manufacturers to determine the terms of such arrangements.
A number of questions were raised during these discussions on having
binding obligations on tech transfer.
At the session, an official from the Medicines Patent Pool said, that one of
the learnings during the pandemic was that MPP’s traditional licensing model
took too long (Low-and-Middle Income Countries had availability one year
after availability in High Income Countries). The only way to shorten thetime is to start earlier getting a licence before phase 3 and to sub-license, asenior official from MPP said, also suggesting that generic companies haveindicated a willingness to develop at risk. “This might mean having alicensing template and an already agreed set of generic companies (different
for different types of products) ready to go,” the expert said.
It was also revealed that in the early days of COVID-19, MPP was “asked totake a backseat”, allegedly because its licensing model was not appropriate
for vaccines.
On the Zero Draft, MPP pointed out that licensing only gets one mention in
Article 7 (royalties are mentioned with no reference to licensing) and thatshould be corrected, the expert said.
NGOs such as Médecins Sans Frontières also raised questions ontransparency in licensing, and tech transfer. It also cautioned on the scope forpotential confusion in the interpretation of tech transfer provisions in interand intra-pandemic time periods.
Others asked on how a treaty could articulate obligations on voluntary
licensing and whether tech transfer obligations would apply to other global
health agencies such as CEPI, for example.

TECH TRANSFER HUBS

To prevent inequities in the access to medical products, regional anddistributed manufacturing in low and middle income countries is gaining
support from a number of different stakeholders in these discussions. The
most debated model is WHO’s mRNA hub.
A senior WHO official explained the significance of the hub in South Africa.
He indicated that generic mRNA vaccine technology is being shared with 15
countries and these spokes in the model will have know-how abilities in the
coming months. He also highlighted the many barriers to local
manufacturing, especially for biologicals like vaccines. From infrastructure
to investments, from workforce to sustainability, from regulatory capacity tolocal IP regimes, these were some important considerations while thinking
about distributed manufacturing, apart from choices on what to produce, andhow to deal with questions of acquiring technology.

THE POOLING OF RIGHTS AS A PROVISION
There are also discussions at incipient stages on expanding the concept ofpooling of IP rights taking off from the C-TAP at WHO. Experts believe thatgovernments should consider structurally changing the rules of the game forthe future pandemics by expanding mechanisms such as C-TAP for pandemic
preparedness in the international treaty.
KEI, for example, has made a case for a Tech-Sharing pool. See below.
“Article X. Pooling of rights in and access to inventions, data, biologic
resources and how-how
1. Parties recognize the value of global sharing of rights in and access toinventions, data, biologic resources and know-how, and also the need toprovide both mandates and incentives to share. 10 WHA72.8 1(4). 9
WHA72.8, 1(3). 8 WHA72.8 1(2) 7 Declaration of Helsinki (2013), and
WHA72.8. 6 WHA72.8 1(1). 5 WHA72.8 2(3); 2(4) and 2(6). 9 of 13

2. The WHO shall create a technology sharing pool for rights in and accessto inventions, data, biologic resources and know-how, known as theTechnology Sharing Pool (TSP).
Global Public Goodsa. One component of the TSP shall be for global licenses, where the rights ininventions, data, biologic resources and know-how are considered royalty
free public goods.
Remunerative licenses
b. One component of the TSP shall be for global licenses, where the rights ininventions, data, biologic resources and know-how are licensed to qualified
manufacturers subject to reasonable remuneration.
Share-and-share-alike licensesc. One component of the TSP shall be for an opt-in cross-license ofgovernment rights in inventions, data, biologic resources and know-how
relevant to pandemic preparedness and response. This component will bereferred to as the share-and-share-alike pool. The cross licenses will allow
any party that joins the pool to use or have used the rights in a field of use
for pandemic preparedness and response, and in a geographic area that islimited to the parties that join the cross licensing pool.
To join the share-and-share-alike pool, a government would have to commit
to a standard cross licensing agreement in a field relating to pandemic
preparedness and response for all federal level R&D funding.
3. Parties agree to levy a fee on all products that are not licensed to TSP,
and use that revenue solely to compensate developers of products that arelicensed to the TSP. The amount of the levy shall be set and periodicallymodified by the Governing Body.]

LINKING TECH TRANSFER TO PRODUCTIONCAPACITYDuring the intersessionals, senior WHO officials also pointed out that muchof the production capacity in the world was not fully utilized to solve theproblem during this pandemic, and that was a function of often corporate
decisions, but also by some countries.
At the peak of acute access challenges faced by developing countries, experts
had repeatedly called for linking technology transfer to production capacity.
Many believe that the access to technology has been one of the central
failures in the COVID-19 response.
At a session organized by WHO exclusively to discuss IP issues, at
an informal focused consultation, in October last year, Carlos Correa fromthe South Centre said, “There is an absolute need to address the access totechnology and intellectual property in the Treaty; otherwise the Treaty
would not provide a real solutions to the problems as we have seen.”
Key developed countries including Switzerland, Japan, UK, the EU, havepressed for evidence on IP as a barrier to access. Correa drew attention tonumerous litigations between big vaccine manufacturers. “It is quite clearthat manufacturing vaccines raises the issue of patent protection and patent
litigation and therefore, there is need to address them. There is a need to haveconcrete provisions on this. I would say that the Pandemic Treaty gives amajor opportunity to overcome the major fragmentation of international law
system,” Correa said during the session last year.
Padmashree Gehl Sampath, who also spoke at the October session that was
webcast, said, “One of the key things that we can say confidently after the
pandemic, which we couldn’t say before is that the question the intellectual
property is very closely linked not just to innovation but also to supply andproduction.”
Sampath is also Chair of the C-TAP Secretariat. She argued that there is atendency to view technology transfer as something that is end-product related
and needs to be shared by company or institute that invested in R&D. And
called for a broader view that links to production, innovation and supply.

“There are undeniable links between innovation choices, production
capacities and access. New vaccine technology and drug technologies that wehave today, like the DNA and mRNA platforms, they provide a basis forgeopolitic or more oligopolistic production capacity globally. It would
continue to impact global demand for years if not decades to come. So,
options like compulsory licenses that we have gone to always and relied on
are not sufficient. What we really need is a broader focus on initiatives fortechnology transfer with a strong focus on not just licensing the end products
but looking at blocks of technologies at various stages of development
because it helps to create a level playing field for all new entrants who are
not incumbent companies, not just from the developing world but also fromthe developed world. Thus, in such a context the role of technology sharing isto level the field, to increase the competition, to increase innovation and thenalso increase access to medicine.”
The link between scarcity and concentration of manufacturing was also
pointed out. Citing data on export bans and stock-piling during the pandemic,
Sampath said, “Those countries that didn’t have production capacity didn’t
have bans, they didn’t stock pile but those countries that have production
capacity were the ones that had export bans and stock piled which simply
means that the only way to solve this is to set up the diversified production
capacity so that different regions in the world can actually have that
production capacity and we don’t have illusion of limited capacity that leads
to stock piling of life-saving medicines, therapeutics and diagnosis in thetime of need.”
THE MEDICAL COUNTERMEASURES PLATFORM

Given the evidence of the limitations of existing approaches during COVID19, many stakeholders hope that the international community will take theright lessons forward while conceptualizing and putting in place mechanisms
for the future.
As we reported last month, WHO and partners are working towards a new
medical countermeasures platform. A prototype of this mechanism is now
being put together. (See the description of a job announcement to lead on thework around the MCMs put out by WHO.)

While this is being referred as an interim mechanism, there are expectations
that this will tie into the on-going negotiations at the INB and work of theWorking Group on the amendments to the IHR. (“This interim platform
could be activated in the near term, if needed, but then adjusted, based on theoutcomes of the INB and WGIHR negotiations,” according to FAQs on theplatform, seen by Geneva Health Files).
The process led by WHO, has powerful backers with high-level support fromG7 and the G20.
It appears this process has divided civil society actors – while some believethat lessons of the ACT Accelerator can be taken to build a new platform,
while others calling for a clean break from the past.
Focusing on stockpiling will not address the unpredictable needs that a healthemergency brings. Any mechanism must tackle the questions on IP, and evenpathogens access and benefits-sharing, experts say.
Nishant Sirohi contributed to this article.