Regional production of vaccines and other pandemic-related products – and sharing the technical know-how to enable this – features strongly in the much-anticipated first draft of the global pandemic treaty proposed by the World Health Organization (WHO) to guide future pandemics.

WHO member states will be briefed on the conceptual “zero-sum” draft on Friday in preparation for the Intergovernmental Negotiating Body’s (INB) meeting from 5-7 December, which will kick off formal negotiations.

The draft advocates for regional and country “strategic stockpiles” of pandemic response products, particularly active pharmaceutical ingredients that could be facilitated by “multilateral and regional purchasing mechanisms”.

It also suggests “international consolidation hubs, as well as regional staging areas” to ensure the streamlined transportation of supplies.

Intellectual property hot potato

Intellectual property is the most obvious hot potato. The draft offers four proposals on IP, all of which recognise the negative impact IP protection can have on prices. 

Three proposals affirm the importance of protecting IP while the more radical fourth option simply recognises that IP poses a “threat and barriers to the full realization of the right to health and to scientific progress for all, particularly the effect on prices, which limits access options and impedes independent local production and supplies”.

Various proposals are included on the TRIPS waiver, with some recognition of the need for “time-bound waivers of the protection of intellectual property rights that are a barrier to manufacturing of pandemic response products during pandemics”.

The importance of “trilateral cooperation” between the WHO, World Trade Organization and World Intellectual Property Organization (WIPO) on IP, public health, and trade, is also highlighted.

Public funding and price disclosures

The draft also proposes measures to “encourage, incentivize, and facilitate” the private sector’s “voluntary transfer of technology and know-how through collaborative initiatives and multilateral mechanisms”. 

But where there has been “public financing of research and development for pandemic response products”, the draft proposes that measures need to be adopted to ensure “more equitable access and affordability” of these products.

These could involve “conditions on distributed manufacturing, licensing, technology transfer and pricing policies”.

In addition, public financing of R&D could result in “measures to limit indemnity or confidentiality clauses in commercial pandemic response product contracts between countries and manufacturers”.

Secret deals were a cause for serious concern for many countries and health activists at the height of the COVID-19 pandemic when vaccines were in short supply and being sold at different prices without any transparency.

Article 8(d)(ii):"recommendations to make it compulsory for companies that produce pandemic response products to disclose prices and contractual terms for public procurement in times of pandemics." @WHO #pandemictreaty pic.twitter.com/CN1DudFYRw

— Balasubramaniam (@ThiruGeneva) November 17, 2022

The draft also proposes that “promoters of research for pandemic response products assume part of the risk (liability) when the products or supplies are in the research phase, and that making access to such pandemic response products or supplies conditional on a waiver of such liability is discouraged”.

Pfizer and Moderna in particular made countries sign onerous indemnity clauses before they agreed to supply them with COVID-19 vaccines.

‘A shopping list,’ says IFPMA

However, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) has already indicated that it is against the draft, saying in a statement on Friday that it “does not meet the test of preserving what worked well and it is questionable whether the proposals to address the shortcomings faced in the current pandemic would work”.

“The text, while containing elements which can form a good basis to be better prepared for future pandemics, reads as a shopping list of multiple agendas and ideas which have been brought together in one document and therefore lack coherence,” added the IFPMA.

“If the draft were implemented as written today it would most likely undermine rather than facilitate our collective ability to rapidly develop and scale up counter measures and ensure its equitable access.”

It believes that a more constructive approach would be to identify and build on what worked well during the COVID-19 pandemic, such as “the R&D ecosystem”.

“The private sector developed multiple safe and effective vaccines and treatments against COVID-19 and scaled up their production in record time,” said the IFPMA. “We need to make sure that the IP-based innovation ecosystem is not undermined.  Innovation resulting in safe and effective vaccines in record time and scaling up manufacturing to historic levels involving hundreds of voluntary partnerships leaning on the capabilities available around the globe worked, together with rapid pathogen sharing were key elements of the rapid response to the COVID-19 pandemic.”

Areas of improvement include health systems strengthening and resilience and the equitable distribution of the vaccines, “which was hampered by resourcing challenges both financial and logistical, as well as the free movement of supplies and vaccines”, added the IFPMA.

 Sharing pathogens

The draft also advocates for “early, safe, transparent and rapid sharing of samples and genetic sequence data of pathogens” – a measure supported by the pharmaceutical industry – but simultaneously calls for “the fair and equitable sharing of benefits”.

In addition to international and regional anti-pandemic measures, the draft advocates that member states increase domestic funding, particularly to support strong primary health care and universal health coverage.

Intensive process 

Since the WHO’s special health assembly resolved to negotiate a pandemic ‘instrument’ almost a year ago, the INB has engaged in an intensive consultation process.

The draft is the result of inputs from member states, regional meetings, relevant stakeholders, two public hearings that were open to anyone, informal, focused consultations and two INB meetings. 

Any areas covered by the International Health Regulations (2005) are not contained in the draft. 

Responding to the draft text, Mohga Kammal Yanni, policy co-lead for the People’s Vaccine Alliance, said that it “shows that negotiations are at a crossroads”. 

“A treaty could break with the greed and inequality that has plagued the global response to COVID-19, HIV/AIDS and other pandemics. Or, it could tie future generations to the same disastrous outcomes,” said Yanni.

“The treaty gives world leaders a chance to prevent this inequality through increasing the pharmaceutical manufacturing capacity of developing countries and sharing of technology and know-how. It needs to mandate this sharing and commit countries to waiving intellectual property rules for relevant products in future pandemics. This would avoid the current inequitable access to essential medical products needed to deal with pandemics.”

The zero draft will be discussed at the third INB meeting in December, and an even more intensive process of negotiations will begin.

The INB will submit a progress report on its deliberations to the 76th World Health Assembly in 2023, and the final draft for consideration at the 77th World Health Assembly in 2024.

* This story was updated to include the IFPMA response.

Image Credits: Zhang Meifang/Twitter, People's Vaccine Alliance.