Members call for cooperation over pathogen research, access

Why in the News

The New Delhi Declaration adopted at the 18th BRICS Summit calls for constructive engagement in negotiations for the Pathogen Access and Benefit Sharing (PABS) Annex to the World Health Organization (WHO) pandemic agreement. The Declaration attaches a condition to that call, reaffirming the sovereign rights of States over their biological resources and the sovereign right to legislate and implement laws, including national access and benefit sharing legislation. The pandemic agreement itself was adopted at last year’s World Health Assembly, and this one annex is what still holds it short of ratification. The unresolved question is whether a country that shares a dangerous pathogen sample must be guaranteed a share of whatever is developed from it.

What is the Pathogen Access and Benefit Sharing Annex?

1. Purpose of the Annex: The PABS Annex will set out a roadmap for the sharing of dangerous pathogens and of the medicines, diagnostics or vaccines developed from them.
2. Status as an annex to the pandemic agreement: It is an annex to the WHO pandemic agreement rather than a standalone instrument, so it has no effect independent of that agreement.
3. The remaining bar to ratification: Once agreement is reached on the PABS Annex, the pandemic agreement can be approved or ratified by member states.

Why is one annex holding up an adopted agreement?

1. The parent agreement was already negotiated: Amid the Covid-19 pandemic the WHO planned a legally binding pandemic agreement for better response to any future pandemic, and it was adopted during last year’s World Health Assembly.
2. Adoption is not ratification: One annex continues to hold the agreement hostage, and member states cannot approve or ratify until it is settled.
3. The single disputed question: Countries are yet to agree on whether the sharing of pathogen samples should be linked mandatorily with the sharing of the benefits developed.

What position did the New Delhi Declaration take?

1. Call for constructive engagement: The Declaration calls for constructive engagement in the PABS negotiations rather than endorsing either side of the mandatory linkage question.
2. Sovereign rights over biological resources: It reaffirms the sovereign rights of States over their biological resources.
3. The right to national access and benefit sharing law: It reaffirms the sovereign right of States to legislate and implement laws, including national access and benefit sharing legislation.
4. Effect of the combined position: A call for engagement paired with an assertion of sovereign control keeps the option of conditioning sample sharing on domestic law open.

Challenges to the Pathogen Access and Benefit Sharing Annex

1. Sharing and benefit are separated in time: A sample is needed within days of an outbreak while a vaccine takes many months, so a country is asked to give first and trust later. Eg. Indonesia withheld H5N1 avian influenza samples from the WHO network in 2007 after finding that vaccines developed from them were priced beyond its reach.
   The Fix: Write a pre agreed allocation percentage of real time production into the Annex itself, so entitlement is fixed before the sample is shared rather than negotiated after a product exists.
2. Genetic sequence data escapes any physical sharing rule: A pathogen’s genome can be uploaded and used to design a product without the physical sample ever changing hands, which makes a sample based obligation easy to bypass. Eg. Covid-19 vaccine design began from a published genome sequence rather than from a transferred isolate.
   The Fix: Bring genetic sequence information expressly within the Annex’s definition of pathogen material, with database access conditioned on the same benefit sharing terms.
3. Manufacturing capacity is concentrated in a few countries: A guaranteed share of output is worth little to a state that cannot produce, fill or distribute the product it is promised. Eg. Most African countries imported nearly all Covid-19 vaccines rather than producing any.
   The Fix: Pair the benefit share with a technology transfer obligation through the WHO mRNA technology transfer hub model, so capacity is built alongside the entitlement.
4. A sovereignty first reading can slow outbreak response: Treating pathogens as national property lets a state delay sharing while it negotiates terms, and an outbreak does not wait for that negotiation. Eg. The Nagoya Protocol on access and benefit sharing was drafted for genetic resources generally and its permit procedures were not designed for an epidemic timeline.
   The Fix: Create a standing fast track permit under the Annex, valid on notification of a public health emergency, so sharing proceeds while the commercial terms are settled separately.
5. Compliance rests on no enforcement mechanism: A treaty annex binds only those who ratify it, and a manufacturer outside a ratifying state carries no obligation at all. Eg. The pandemic agreement takes effect only once member states ratify it, and ratification is voluntary.
   The Fix: Route access to the WHO coordinated laboratory network through a binding contract with each participating manufacturer, so the obligation attaches to the user of the sample rather than only to its government.

Conclusion

The agreement is complete except for the one question that decides who benefits from it, which is why the annex and not the treaty is where the negotiation now sits. The grouping’s formal position does not resolve that question, since a call for constructive engagement alongside an assertion of sovereign control over biological resources is compatible with either outcome. What it does record is that a large bloc of developing countries will not accept an unconditional sharing obligation. The marker to watch is the next World Health Assembly, since the annex has to be settled there before any state can ratify the pandemic agreement.

Back2Basics: World Health Assembly

1. The WHO’s decision making body: The decision making body of the World Health Organization, attended by delegations from all WHO member states.
2. Meeting schedule and venue: It meets annually, usually in May, at Geneva.
3. Functions of the Assembly: It determines WHO policies, appoints the Director General, supervises financial policies and reviews and approves the programme budget.
4. Relevance to the PABS Annex: It is the forum that adopted the pandemic agreement and the forum in which the PABS Annex has to be settled.

Matching Previous Year Question

“[2020, GS2, 10 marks] Critically examine the role of WHO in providing global health security during the Covid-19 pandemic.”