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TWN Info Service on Health, Biodiversity and TK
17 March 2022
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Biodiversity: Proposed criteria for “Specialised Instruments” on access and benefit sharing raise concerns

17 March, Geneva (Nithin Ramakrishnan and K M Gopakumar) – A draft recommendation prescribing indicative criteria for specialized international access and benefit sharing instruments (SII) that would “carve out” the application of the Nagoya Protocol on access and benefit sharing, raises concerns.

The proposed criteria can undermine legal certainty of sharing of benefits arising out of access and utilisation of genetic resources as guaranteed by the Convention on Biological Diversity (CBD) and its Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilisation.

Paragraph 4 of Article 4 of the Nagoya Protocol states: “This Protocol is the instrument for the implementation of the access and benefit-sharing provisions of the Convention. Where a specialized international access and benefit-sharing instrument applies that is consistent with, and does not run counter to the objectives of the Convention and this Protocol, this Protocol does not apply for the Party or Parties to the specialized instrument in respect of the specific genetic resource covered by and for the purpose of the specialized instrument.”

The draft recommendation contains a draft decision to be considered by the 4th meeting of the Conference of Parties serving as the Meeting of Parties (MOP-4) to the Nagoya Protocol and an annex containing the indicative criteria explaining what qualifies an instrument to be an SII in the context of Article 4(4) of the Nagoya Protocol.

[During the negotiations of the Nagoya Protocol, there were extensive often contentious discussions on whether there should be any carving out of categories of genetic resources from the obligations of the Protocol thereby undermining efforts for fair and equitable benefit sharing. Article 4(4) was the resulting compromise although most developing countries had reservations.]

The draft recommendation is now part of the outcomes of the 3rd Meeting of the Subsidiary Body on Implementation (SBI-3) of the CBD and its Protocols. It is contained in an L document/final document (CBD/SBI/3/L.6) and is available on the CBD website.

The resumed SBI-3 is going on in Geneva from 14 to 29 March 2022. The first part of SBI-3 was held online from 16 May to 13 June 2021. The recommendations developed by SBI-3 will be considered by MOP-4, scheduled to be held in the third quarter of 2022 in Kunming, China.

In 2018, the Parties to the Nagoya Protocol adopted decision NP-3/14, and agreed to reconsider the potential criteria for identifying SIIs in the context of Article 4(4) of the Nagoya Protocol at MOP-4. Parties and other Governments were requested to submit information and views on the criteria.

That first set of potential criteria was developed through a study commissioned by the CBD Executive Secretary pursuant to an earlier decision NP-2/5. The study was conducted by a research team at the Strathclyde Centre for Environmental Law and Governance, University of Strathclyde (UK) and financially supported by the European Union.

Other relevant information as requested in the decision NP-3/14 were included that led to a document (CBD/SBI/3/14) for SBI-3, which also contained a draft recommendation and a modified version of the potential criteria.

However, the current entire final document, after taking into account the views of Parties (CBD/SBI/3/L.6), remains in square brackets, at the behest of the African Group, indicating no consensus yet.

At the first part of the SBI-3 meeting, which was held online, it was apparent that the virtual format of discussions had laid bare the digital inequities experienced by African Parties, stymieing their effective participation. The Group thus felt it was necessary to safeguard its interests by bracketing all SBI-3 documents related to the post-2020 global biodiversity framework (GBF), which would allow the Group to revisit the documents in their entirety, if necessary, when African Parties are finally able to participate properly at a face-to-face meeting. The African Group considered this agenda item of SII as relevant to the GBF, given the discussion therein on the target addressing access and benefit sharing.

The draft decision invites “Parties, and other Governments to take into account each of the indicative criteria in the annex “in developing and/or applying access and benefit-sharing measures and/or in endorsing international instruments that include provisions on access and benefit-sharing”,

Similarly, it also invites “relevant international organizations and intergovernmental processes to take into account the indicative criteria in their efforts to develop or [when agreeing on] [implement]specialized international access and benefit-sharing instruments”. Though there are two brackets it is clear that the indicative criteria are applicable when an international organisation like the World Health Organisation (WHO) develops an instrument, whereby it has to fulfil the criteria to get the status of SII under the Nagoya Protocol.

Although Paragraph 1 of the Annex states that the indicative criteria are to “contribute to strengthening coordination and mutual supportiveness between the Nagoya Protocol and other international access and benefit-sharing instruments, without creating a hierarchy among them”, the indicative criteria provided thereafter in the annex threatens the fair and equitable benefit sharing norms under the Nagoya Protocol at least on three counts: (i) it undermines the legal nature of the SII; (ii) it compromises the legal certainty on benefit sharing principles; and (iii) it neglects the process of recognition of an SII.

Undermining the Legal Nature of SII

First indicative criterion in the Annex says the instrument should be “intergovernmentally or internationally agreed”. However, the definition of “intergovernmentally or internationally agreed” that follows in the Paragraph 2 of the Annex not only undermines the effective participation of countries in developing such instruments but also undermines the legal nature of SII, frustrating the very purpose of Nagoya Protocol. The definition states “the instrument is agreed through an intergovernmental process and/or is endorsed by States and/or Governments. The instrument may be binding or non-binding”.

The phrase “and/or” after the “intergovernmental process” in the above quote makes it clear that the intergovernmental process is not necessary to qualify an instrument as an intergovernmentally or internationally agreed instrument. An instrument developed by the Secretariat of an international organisation such as WHO and subsequently endorsed or agreed to by member states would seem to be enough to make it as an intergovernmental or international instrument. Similarly, an instrument of a non-binding nature could also fall under this definition.

It must be noted that in organisations like the WHO there is no clear criteria or specified process to obtain agreement from Member States on the documents or schemes developed by the Secretariat. Often, the WHO Secretariat presents instruments in the form of reports of trial project or as proposals before the governing bodies, and request Member States to take note of the same. Documents taken note of by Member States in the governing bodies are then treated as a document agreed upon by the States. This often sidesteps the effective participation of Member States in shaping the content of the instrument in question. The SBI-3 draft decision on SII would mean that if such documents handle sharing of genetic resources and the related matters, then they would be considered as SIIs in the context of Article 4(4).

It is noteworthy that the WHO Secretariat has already initiated projects such as Bio-Hub, Hub for Pandemic and Epidemic Intelligence etc. without a prior decision from the governing bodies, which undermines fair and equitable sharing of benefits derived from pathogens and genetic resources. The above definition of “intergovernmentally agreed or internationally agreed” will pave the way for legitimising such initiatives or for endorsing documents pertaining to practices followed in such initiatives as SIIs under Article 4(4) of Nagoya Protocol.

The addition of “endorsement by states and governments” to the definition of the first indicative criterion also accentuates the above concerns. This addition came up through the European Union submission. This again reduces the rigour with which an SII is developed or prepared. The EU has reportedly submitted as follows:

“It was not always relevant that the instrument be developed through an intergovernmental process, but it was indeed important and appropriate that States or Governments endorse such instruments. For example, according to this submission, an international instrument could result from a formal process within a specific international organization and then be adopted in accordance with its rules and procedures. It could also be possible that specialized international instrument would develop as a result of existing practice, and then be endorsed by an international organization, or as a result of informal cooperation, such as a regional cooperation initiative.”

While the example provided by the EU only refers to intergovernmental agreements or instruments developed as a result of the inter-state/ inter-governmental relationship, the scope of the definition of the first indicative criterion can include instruments developed or evolved in the private sector as well. The phrase “and/or” after “an intergovernmental process” opens the door for such an effect.

Furthermore, a mere endorsement by States or Governments could provide the status of SII to instruments, by-laws, operational guidelines developed by international multi-stakeholder institutions thereby excluding the application of the Nagoya Protocol to the genetic resources covered by such agreements. For instance, a sharing of genetic resources through a platform like GISAID can be exempted from the application of the Nagoya Protocol through a governmental endorsement of the platform’s standard terms and conditions by a few states. Programmatic schemes such as the ACT-Accelerator programme may also claim to be similarly exempted from the application of Nagoya Protocol obligations or safeguards. One can even argue that an instrument developed by a non-state actor like a private sector entity could be eligible to qualify as a specialised instrument.

Such a clause also has the potential for misuse by powerful states and their multinational business entities seeking post-transaction endorsement of their private arrangements from smaller or weaker developing states.

Furthermore, the explanation provided in the definition of the first criterion, i.e. “the instrument may be binding or non-binding” frustrates the entire purpose of the Nagoya Protocol. This criterion first appeared in the study funded by the European Union. Although the intention of the researchers, who conducted the study, was to include resolutions or decisions adopted by international organisations like WHO, which are often popularly referred to as “non-binding”, the use of such language in the indicative criterion has far-reaching consequences.

A non-binding legal instrument cannot satisfy the requirements of Article 4(4) because it will then grossly undermine the purpose of the Nagoya Protocol. It must be noted that Article 4 of Nagoya Protocol uses both the terms “international agreement” or “instruments”. These are generally understood as capable of generating legal obligations, and especially within the context of Article 4 of the Nagoya Protocol, the instrument has to be legally binding. The first sentence of Article 4(4) refers to the Nagoya Protocol itself as an “instrument”.

SII in the context of the Article 4(4) is an instrument based on which application of the Nagoya Protocol is excluded, and it should not run counter to the objectives of the CBD and Nagoya Protocol. Such an instrument should be comparable to the Nagoya Protocol, and therefore it has to be an international binding instrument.

Article 4(4) provides for an exception to the Nagoya Protocol in order to enable State Parties to come up with international treaties or legal instruments which can provide them specialised and purposive provisions relating to a specific genetic resource or to a specific sector like health or climate change. It is therefore all the more important that an SII should not be used to limit or avoid legal obligations on benefit sharing. Nevertheless, the first indicative criterion provided in the annex provides for such a negation of the very purpose of the Nagoya Protocol.

Compromising Legal Certainty of Benefit-Sharing

The third criterion, “mutually supportive”, provided in paragraph 4 of the annex of the draft recommendation threatens the legal certainty of benefit sharing in SIIs. The paragraph identifies a number of essential elements (sub-criteria) for the following criteria to make an instrument mutually supportive of the Nagoya Protocol. It reads:“… consistent with and supportive of, and does not run counter to, the objectives of the Convention on Biological Diversity and the Nagoya Protocol”:

(a) Consistency with biodiversity conservation and sustainable use objectives;
(b) Fairness and equity in the sharing of benefits;
(c) Legal certainty with respect to access to genetic resources or traditional knowledge associated with genetic resources, including, as appropriate, the application of prior informed consent, and to benefit-sharing;
(d) Full and effective participation of indigenous peoples and local communities concerned;
(e) Contribution to sustainable development, as reflected in internationally agreed goals;
(f) Other general principles of law, including good faith, effectiveness and legitimate expectations

Though it refers to “fairness and equity in the sharing of benefits” as the second sub-criterion, the third sub-criteria (c) on “legal certainty” dilutes the fair and equitable benefit sharing requirement. It states: “… legal certainty with respect to access to genetic resources or traditional knowledge associated with genetic resources, including, as appropriate, the application of prior informed consent, and to benefit-sharing”.

Thus, sub-criteria (c) requires that the special instrument should provide “legal certainty” with respect to access to genetic resources or traditional knowledge associated with genetic resources, while it does not require to provide such certainty with regard to the application of prior informed consent and benefit sharing.

In other words, by using the phrase “as appropriate” (which was absent in earlier versions of the potential criteria), the document opens up the possibility of having specialized instruments in certain areas or sectors in which requirements of prior informed consent or benefit sharing obligations may be waived by postulating such requirements as not appropriate. For instance, in the case of health emergencies or pandemics, it may be argued that it is not appropriate to wait for prior informed consent or to provide for sharing of benefits until the “terms of sharing” are mutually agreed.

A document developed jointly by the Secretariats of the CBD, the Food and Agriculture Organisation of the United Nations (FAO), the World Organisation for Animal Health (OIE) and the World Health Organization (WHO) is relevant here, where it reads:

“Implementation of the Nagoya Protocol may impact the sharing of pathogens if, for example, it entails multiple, complex and/or time-consuming processes. Some laboratories have expressed concerns about challenges they may face in complying with a variety of different national ABS processes and requirements in order to access pathogens. This in turn could impact the comprehensiveness and speed of risk assessment as well as the timely development of effective vaccines, diagnostics and other medical countermeasures (page 8).”

The U.S. proposed amendments to the International Health Regulations 2005, currently under discussions in WHO, are an attempt to make the sharing of genetic sequence data mandatory. This could be interpreted as a situation where there is a legal certainty to provide access to genetic resources, but then appropriately decide on the requirements of prior informed consent and fair and equitable benefit sharing on a later occasion.

Further it is important to note that the term “fair and equitable” before “benefit sharing” is also missing in the sub-criterion (c).

Neglect of the Process for Recognizing SII under Article 4(4)

Neither the draft decision nor the indicative criteria in the Annex sets out a process for recognizing an SII under Article 4(4) of Nagoya Protocol. This allows for a free space for all stakeholders to come out with their instruments and claim them to be SIIs under Article 4(4) of the Nagoya Protocol. When read with the indicative criteria found in the Annex, these instruments could be non-binding, and need not provide a concrete legal commitment on benefit sharing. A likely scenario would be then the Secretariat will list out all these instruments, either submitted to them or identified by them as an SII under Article 4(4) without any State Party’s oversight.

Although the study commissioned by the CBD Executive Secretary discussed the various scenarios of recognizing an SII under Article 4(4) of the Nagoya Protocol, the Parties while adopting decision NP-3/14 did not call for a process of recognizing SII under Article 4(4) that would not undermine the Nagoya Protocol. This is a serious gap given the way the negotiations on the indicative criteria are progressing. Without an agreed process, the law and practice of access and benefit sharing will be fragmented.

Therefore, both the draft recommendation and the indicative criteria on SII is highly elusive of any obligations relating to fair and equitable sharing of benefits arising out of utilization of genetic resources. The implication is so strong that in lieu of a binding legal instrument like the Nagoya Protocol, any another international document which is not binding or legally certain about fair and equitable benefit sharing, can be applied to transactions involving sharing of genetic resources. This is detrimental to the interests of all developing countries and the interests they have fought hard to protect through the negotiations and implementation of the CBD and Nagoya Protocol.+

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