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TWN Info Service on Health and Biodiversity/Traditional Knowledge
22 May 2024
Third World Network
www.twn.my
WHO: EU’s hypocrisy and double standards create trouble in PABS negotiations
Geneva, 22 May (TWN) – The European Union’s (EU) stance in discussions for a Pathogen Access and Benefit Sharing (PABS) System in the context of the WHO Pandemic Agreement negotiations is fraught with hypocrisy and double standards, needlessly complicating the PABS negotiations.
This strategy, commonly perceived as a classic negotiating tactic used by the EU, seems designed to hinder progress in the PABS negotiations. Its ultimate goal appears to be to deflect responsibility for any negotiation setbacks onto developing countries, often through mainstream media channels.
The proposed WHO Pandemic Agreement is currently being negotiated in Geneva, at the WHO Headquarters, through an Intergovernmental Negotiating Body (INB) which is meeting for the 11th time in a bid to conclude the negotiations. The current session is scheduled to end on 24 May 2024.
Article 12 concerning the PABS System, has emerged as one of the most challenging aspects of the negotiations.
In contrast to other delegations, the EU has displayed remarkable inflexibility, frequently dismissing proposals that diverge from its own conception of a PABS system.
In December 2023, the EU proposed a multilateral ABS system, which was criticised. An analysis noted that the EU’s proposal “deviates from international norms established by the Convention on Biological Diversity (CBD) and its Nagoya Protocol, is expected to exacerbate inequity, discourage the timely sharing of specimens and sequences by WHO Members, undermine[s] national sovereignty, and erode[s] the intergovernmental character of the WHO”.
In early 2024, the EU’s proposal was rejected by developing countries as the basis for a PABS System.
Since then, the negotiation process has moved from discussing the details of a PABS system, to trying to reach agreement instead on an outline of a PABS System in Article 12, which will be further elaborated on by a future intergovernmental working group.
In the ongoing negotiations on Article 12, the EU has repeatedly insisted on text that reflects its specific vision for the PABS system, even as it counters proposals from developing countries, asserting that Article 12 text should be neutral and not prejudge future negotiations on the design of the PABS System.
According to a delegate involved in the negotiations, “the EU is not willing to accommodate any idea to their model of PABS from any delegation. They are sticking to their model of PABS without any show of flexibility or consideration for elements proposed by the other delegations”.
The EU’s assertive push to incorporate elements from its own proposal, coupled with its hypocritical stance, was vividly evident during the discussion on the PABS system on Tuesday (21 May).
EU seeks to delink access from benefit sharing, inconsistent with international and EU laws
In the Article 12 discussions, the EU has been promoting “voluntary” “benefit-sharing contracts” with manufacturers, refusing to regulate “access” to such pathogens and related information and to link access to benefit sharing. Although the EU has agreed to treat “access to pathogens” and “benefit sharing” “on an equal footing”, it insists on “mandatory” pathogen access obligations and “voluntary” benefit sharing.
For instance, the EU opposed Malaysia’s proposal that the sharing of pathogen biological materials and related information should be “based on national risk assessment” as required under the International Health Regulations 2005. The EU expressed its fear that the proposed text from Malaysia implies discretionary sharing of pathogen biological materials and information by State Parties.
At the same time, the EU argued for benefit sharing to be based on legally binding contracts between the PABS System and private entities that are to conclude such contracts “voluntarily”. It is evident that the EU’s intent is to ensure that access to pathogen materials and related information is not subject to the user agreeing to terms and conditions including on fair and equitable benefit sharing. The EU’s attempt to delink access from benefit sharing is very much based on its proposal presented at the end of 2023.
The EU also vehemently opposed the phrase “benefits arising therefrom (arising from shared materials and information)”, although such language is consistent with the CBD and the Nagoya Protocol which is also about sharing benefits arising from the utilization of genetic resources. Instead, the EU dangled the possibility of other voluntary benefits developing countries could obtain from not making the link between access and benefit sharing, such as personal protective equipment (PPEs).
However, the EU’s position was not shared by the United States (US), which, according to sources, is open to accepting the phrase and to focus on access to vaccines, therapeutics and diagnostics, products that arise from the use of pathogen materials and related sequence information that are shared, as envisaged by the CBD and the Nagoya Protocol. (The US is not a Party to the CBD and the Nagoya Protocol.)
The EU’s stance conflicts with its obligations under the CBD and Nagoya Protocol as well as its own ABS implementing regulation as a Party to both treaties.
Under the CBD, access is subject to prior informed consent and fair and equitable benefit sharing on “mutually agreed terms”. This means that access is subject to the user agreeing to specific legally enforceable terms and conditions with respect to the genetic resource accessed. The Nagoya Protocol, in its preamble states: “Acknowledging the linkage between access to genetic resources and the fair and equitable sharing of benefits arising from the utilization of such resources …”.
Above all, EU Regulation No 511/2014 on ABS also specifically recognizes the fact that benefits can be developed from the use of pathogens, importantly and clearly establishing a direct link between access to genetic resources, their use and benefits developed.
Interestingly, when a developing country proposed compromise language for Article 12 based on the EU’s own regulation, the EU opposed the suggested compromise.
EU undertakes no obligations under Articles 9 to 11, despite grand claim of wanting to share benefits not arising from use of pathogens and related information
In the PABS discussions, the EU has on several occasions expressed its desire to share more benefits than those arising from the use of shared pathogens and related information (i.e. vaccines, therapeutics and diagnostics), in particular those benefits that are not developed using shared pathogens and related information. And yet, the EU has not committed to any concrete obligations under any other provision of the proposed Pandemic Agreement such as Article 9 on Research and development, Article 10 on diversifying production, Article 11 on access to technologies and Article 20 on financing.
At the same time, the EU under Article 12 on PABS, is neither in favour of requiring a manufacturer to provide to WHO a minimum quantity of vaccines, therapeutics, and diagnostics nor in granting manufacturing licenses to developing countries to expand supply options, to address access needs during a public health emergency of international concern.
When developing countries proposed “manufacturing licences” as a benefit to be shared through the WHO, the EU queried whether WHO even had the capacity to contractually hold such licenses. The Secretariat clarified that WHO has such capacities.
According to a developing country delegate involved in the PABS negotiations: “The EU sounds patronising, by continuously telling us what we seek is not what we really want. If the EU wants to share benefits that are not arising from use of pathogens, why don’t they commit to such obligations under other provisions of pandemic agreement?”
EU claims WHO can decide for Nagoya Protocol Parties, but not for WTO Members
ABS elements can be multilateralised for specific genetic resources, through a “specialised international instrument”, provided that such instruments “are supportive of and do not run counter to the objectives of the (CBD) and this Protocol” [Article 4(4) of the Nagoya Protocol].
During the PABS discussions, the EU asserted that the PABS System established under Article 12 should be recognized as a specialised international access and benefit-sharing instrument (SII). The EU’s interest lies in the fact that such recognition will carve out pathogens with pandemic potential from the scope of the Nagoya Protocol and consequently from national ABS laws.
Developing countries opposed the proposal. They argued that such recognition was premature as the full PABS System had yet to be developed and become operational. They also explained that discussions were underway in the Nagoya Protocol on a process to recognize and de-recognize instruments as SII, based on certain criteria to be agreed upon by the Meeting of Parties (MOP) of the Nagoya Protocol. Taking a decision on SII in the WHO would prejudice the process under the Nagoya Protocol. Many stressed that the determination of the PABS System as an SII can only be made by the MOP of the Nagoya Protocol, based on the criteria and process established by the MOP, and thus the provision in Article 12 on SII should contain a clause on taking into account the decisions of MOP of the Nagoya Protocol,
However, the EU, Japan, and other developed countries opposed the compromise proposed by developing countries.
Ironically, these same delegations have during discussions on Article 11 (Transfer of technology and know-how for the production of pandemic-related health products) argued that WHO cannot establish a provision for automatic waivers of intellectual property rights during pandemics, because it is a matter upon which only World Trade Organization (WTO) Members can take decision on as well as that WHO Members should not prejudice any efforts that WTO might take in transferring health technologies to developing countries.
“If we recognize PABS as an SII here, it will set a wrong precedent in international law,” a developing country informed Third World Network.
EU intends to diminish WHO’s role in PABS implementation
Interventions by the EU on the PABS System clearly suggest an intent to undermine the role of WHO, according to various developing countries.
During Article 12 discussions, the EU revealed its plan to accord legal personality to the PABS System, that will enter into contracts with private entities, receive and distribute benefits such as vaccines, therapeutics and diagnostics, thereby side-lining the role of WHO.
Under the Pandemic Influenza Preparedness (PIP) Framework, WHO plays the central role in coordinating and administering the benefits including signing standard material transfer agreements with the manufacturers and other users that access influenza virus of pandemic potential. This mechanism is working.
The EU’s plan for the PABS System to be a multi-stakeholder entity, involving industry and other users in its governance, has previously been rejected by developing countries out of concerns of undue influence and conflicts of interest.
Despite opposition, the EU persists in promoting its ABS vision. Germany claimed confusion over whether WHO or the Global Supply Chain Logistics (GSCL) Network to be established under Article 13 should receive benefits.
The US proposed a compromise where WHO would receive benefits for distribution through the GSCL network, which most delegates accepted. However, the EU was unwilling to accept this compromise.
Some developing countries warned the EU that its approach will diminish the advantages of a multilateral system like the PIP Framework, citing the International Treaty on Plant Genetic Resources for Food and Agriculture as an example, where the Food and Agriculture Organization (FAO) is not a signatory to ABS contracts, resulting in limited benefit sharing.
Leaving PABS benefits undecided – Last nail in the coffin for equity
Negotiators have revealed that the EU is advocating for key aspects regarding the benefits of the PABS System to remain unresolved within the Pandemic Agreement. This maneuver significantly undermines the potential for achieving equitable access under the proposed agreement, particularly as Article 12 on PABS represents the sole remaining provision capable of offering enforceable commitments to ensure fairness.
Should developed countries succeed in leaving the benefits under Article 12 undecided upon the adoption of the Pandemic Agreement, it would mark the final blow to equity within the instrument. Observers express concern that the EU’s rigid stance will effectively drive this last nail, cementing a lack of dedication to fairness and equitable distribution of pandemic-related health products. In doing so the EU is violating the principle of good faith in international law negotiations.
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