TWN Info Service on Biodiversity and Traditional Knowledge (Mar22/06)
14 March 2022
Third World Network

CBD: Non-Paper on biodiversity and health undermines benefit sharing norms

Geneva, 14 March (Nithin Ramakrishnan) – An informal paper that will be the basis of discussion by Parties to the Convention on Biological Diversity (CBD) this week regrettably undermines the fair and equitable benefits sharing norms arising out of access to, and use of, genetic resources and their derivatives.

The Non-Paper on biodiversity and health will be discussed by a “contact group” during the CBD’s resumed 24th Session of the Subsidiary Body on Scientific, Technical and Technological Advice (SBSTTA 24) that is taking place in Geneva from 14 to 29 March 2022.

The concern is that dilution of benefit sharing norms would lead to the monopolisation of health products including vaccines, therapeutics and diagnostics, which are developed using genetic resources such as pathogens, thus compromising the equitable access to health care products, technologies and know-how.

[The first part of the SBSTTA 24 meeting was held online from 3 May to 9 June 2021.The decisions and recommendations developed by SBSTTA will be considered by the CBD’s 15th Conference of Parties (COP15) to be held in the third quarter of 2022 in Kunming, China. The contact group, an informal negotiation setting in the United Nations system, is currently scheduled to meet on 15 to 16 March, after which the documents will be forwarded for consideration and adoption to the SBSTTA plenary scheduled for 19 March.]

SBSTTA 24 will discuss the non-paper that contains a draft decision and a draft global action plan for mainstreaming biodiversity and health (“action plan”), with an objective to reach a consensus for its adoption at upcoming COP15.

The non-paper is the result of a process initiated under COP decision 14/4 in 2018, which requested the CBD’s Executive Secretary to prepare a draft Global Action Plan, by collaborating with World Health Organization (WHO) and other members of the Inter-agency Liaison Group on Biodiversity and Health and partners. This agenda item was not discussed beyond a first reading during the first part of the SBSTTA 24 meeting in 2021.

The non-paper, which includes a draft decision, will be considered during the 2nd part of the meeting, which begins today (14 March). The non-paper claims to be reflective of the discussions that happened during the first reading of the agenda item in the first part of SBSTTA 24 to aid the discussions of the contact group.

The draft decision seeks the endorsement of the draft global action plan from COP15. Operative Paragraph 3 reads:

“Endorses the global action plan for biodiversity and health annexed to the present decision, encourages Parties, and invites other Governments and relevant stakeholders, to implement this plan, including through the mainstreaming of biodiversity and health linkages into existing and future policies, plans, and strategies, as appropriate and in accordance with national priorities and circumstances, and the reinforcement of collaboration among ministries and agencies responsible for all the sectors identified in the global action plan for biodiversity and health, with a view to enhancing the implementation of the three objectives of the Convention, the post-2020 global biodiversity framework, and the 2030 Agenda for Sustainable Development, with the full and effective participation of indigenous peoples and local communities, women, youth and older persons”.

Apart from the introduction the action plan contains the following parts viz. strategic objectives and rationale of the action plan, principles of the action plan, key elements of the action plan and the monitoring of the action plan. Six key elements of the action plan are:

1. Cross-sectoral mainstreaming of biodiversity and health linkages in health, biodiversity and environment-related policies,
2. Sector-specific mainstreaming of biodiversity and health linkages,
3. Education and awareness raising of biodiversity and health linkages,
4. Surveillance and monitoring to address health threats,
5. Research on biodiversity and health linkages,
6. Capacity-building and funding.

Activity 4.1.6 under key element 4 i.e. surveillance and monitoring to address health threats, recommends Parties and other relevant stakeholders to “enable the timely, open and secure sharing of pathogens, specimens, sequence information and relevant meta data which are essential for the rapid development of medical biotechnology, diagnostic assays, therapeutic interventions, vaccine development and prophylactic measures”.  

Activity 4.1.7 requires them to “design, implement and ensure the use of early warning systems for eventual invasions, by alien species, including through E-DNA analysis and monitoring, and warning systems such as the WAHIS and WAHIS-Wild developed by the World Organisation for Animal Health (OIE), the Global Outbreak Alert and Response Network-(GOARN) developed by the World Health Organization (WHO), and the implementation of International Health Regulations (IHR)”.

The only reference to benefit sharing, on the other hand, is the footnote to activity 4.1.6 in relation to the health element of surveillance and the accompanying activities. Although the footnote mentions “in line with the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilisation and the International Health Regulations” it is accompanied by a document developed jointly by the Secretariats of the CBD, the Food and Agriculture Organisation (FAO), the OIE and the WHO. The document in its page 8 reads as follows: 

“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.”

These suggested activities under element 4 asks Parties to facilitate the sharing of “pathogens, specimens, sequence information and relevant meta data” without any corresponding obligation or legal guarantee to share the benefits emerging out of the products developed from such sharing.

Pharmaceutical companies need to access pathogens, specimens, sequence information and relevant meta data to develop vaccines, therapeutics, or diagnostics. Often these pharmaceutical companies obtain intellectual property on the products developed from pathogens, sequence information and relevant meta data, and refuse to share the technology or even products with countries who shared the relevant genetic materials or their associated information. This violates the provisions of the CBD and its Nagoya Protocol on access and benefit sharing (Nagoya Protocol).

Though there are other references to benefit sharing in the action plan, which was absent in the earlier version, the language dilutes the requirement of benefit sharing. For example, activities 2.3.1.bis, 2.3.1.ter, and 2.4.5.bis under element 2, i.e. sector specific mainstreeting of biodiversity and health linkages,  refer to benefit sharing. They are:

2.3.1.bis Promote access to genetic resources and the fair and equitable sharing of benefits arising from their utilization consistent with the Convention and the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity;

2.3.1.ter Support the implementation of access and benefit sharing measures, where appropriate, within the health sector to promote compliance with international and national obligations;

…

2.4.5.bis Promote compliance across economic sectors with international agreements and national provisions on access and benefit sharing, to ensure timely access and increase benefit sharing arising from health-related economic activities.

It must be noted here that activity 2.3.1 is using a best endeavor language and activities 2.3.1 ter and 2.4.5bis dilute the legal requirement of benefits sharing with the terms “where appropriate” or “increase” benefit sharing” with no use of the term “fair and equitable” to condition the benefit sharing. These references to benefit sharing are further rendered meaningless by the specific activities  4.1.6 and 4.1.7, which clearly recommend the sharing of genetic resources and associated information without any corresponding requirement of benefit sharing.

According to Paragraph 20 of the action plan, “The action plan should be implemented mindful of the International Health Regulations and in a manner consistent with the [WHO’s] function to stimulate and advance work to eradicate epidemic, endemic and other diseases, and recognizing the leading roles of the WHO and the
[OIE]), as well as their regional and representation offices, and other relevant regional health organizations”.

This direction on the implementation of the action plan bears the danger of setting up a regime for sharing of pathogens and associated information without corresponding concrete obligations on the pharmaceutical companies and their home countries on fair and equitable benefit sharing with countries which provide pathogen samples or their associated information.

The USA has already submitted a proposal to make it mandatory for IHR State Parties to provide the genetic sequence data of pathogens in case of disease outbreak. Similarly, WHO initiatives like Bio-hub or the Hub for Pandemic and Epidemic Intelligence are silent on the benefit sharing from use of digital sequence information.

It must be highlighted that sharing of genetic sequence information can generate benefits, even without sharing of the physical genetic materials, and open sharing of such information has left the providers without receiving benefits as they would have through a material transfer agreement with terms and conditions.

Third World Network has previously reported on how US pharmaceutical company Regeneron developed an Ebola drug using the digital sequence information of an Ebola virus strain from the clinical sample of a Guinean patient but avoided benefit sharing. This case highlights a serious gap in efforts to ensure that the benefits arising from the use of genetic resources are fairly and equitably shared.

In short it is concerning that the CBD non-paper that the contact group will discuss this week does not focus on the centrality of the benefit sharing conditions in ensuring fair and equitable benefit sharing emanating from the use of genetic materials and associated information in the development of healthcare products like vaccines, diagnostics and therapeutics.

Further, the 2 main objectives, 3 strategic operational objectives and 3 supporting objectives of the draft action plan (paragraphs 13,15,16) do not currently mention benefit sharing, including access to essential health products or technologies. The seven Principles and their short commentaries that are included in Paragraph 17 of Section V, also do not speak about benefit sharing.

Apart from the list of activities, the key elements of the action plan contain 30 milestones that do not have a single reference to the quality and quantity of benefit sharing standards. Such specific milestones would have made benefit sharing more measurable.

Furthermore, certain other recommendations in the non-paper have potential to negatively affect the benefits sharing principles. For instance, activities 2.2.2.4, 2.2.2.5 and 2.2.2.6 refer to animal health and management of wildlife diseases. These activities attempt to address the invasion of pathogenic agents even before an outbreak occurs in human societies.

However, these activities have the potential to classify pathogens in various categories such as those with potential to infect humans, those which have already infected humans and those which do not have the potential to infect humans etc. These categories will create gaps in the benefits sharing frameworks, thereby further reducing the certainty of the benefit sharing. For instance, the current draft action plan itself mentions benefit sharing only when it comes to mainstreaming biodiversity in the health sector (Activity 2.3.1.ter), but not when it comes to mainstreaming of biodiversity-health linkages in ecosystem, wildlife and land/sea use management, including in the context of climate change. There is a differential use of the benefit sharing principle implied in this approach.

Another activity having potential to impinge upon benefit sharing is activity 2.3.2, which states:

“… promote the sustainable use and avoid the illegal use, management and trade of plants and animals used in traditional medicine, as well as the integration and sharing of knowledge and experiences, based on prior and informed consent, and the fair and equitable sharing of benefits between traditional medical practitioners and the broader medical community, and consistent with the regulatory framework of the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES)”.

The above activity identifies a limited number of stakeholders such as traditional medical practitioners and the broader medical community for benefit sharing. This has the potential of excluding those who are not mentioned explicitly.

In short, the non-paper on biodiversity and health requires a major rework, by bringing fair and equitable benefit sharing and access to health care products and technologies into the forefront as one of core components of the biodiversity and health linkage.

SBSTTA 24 is scheduled to discuss the non-paper on 15-16 March.+