Pharma Pivot on Pandemic Agreement: ‘Free Access’ to Pathogens in Exchange for ‘Binding Obligation’ on Equity
Pandemic Agreement 21/03/2024 •
Thomas Cueni, director general, IFPMA at a briefing with UN press on Wednesday in Geneva.

Pharmaceutical giants could support a formula whereby companies are guaranteed free and immediate access to pathogens with pandemic potential in exchange for binding equity agreements as part of a proposed World Health Organization (WHO) pandemic agreement, says a leading industry figure.   

The statement by Thomas Cueni, director-general of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), aims to turn the classic formula for industry pathogen access in exchange for benefit-sharing (PABS) on its head. 

Cueni honed out key details of the offer to Health Policy Watch in an exclusive interview Thursday, following a press briefing for UN accredited journalists in Geneva on Wednesday where he outlined the main features of the offer. He spoke against the backdrop of intensifying debate among WHO member states meeting this week in the Intergovernmental Negotiating Body (INB) over the final shape of a pandemic accord, which is supposed to be ready for approval by May’s World Health Assembly. 

Instead of a PABS system that requires industry to pay a cash benefit outright to get pathogen samples or genetic material critical to new drug and vaccine R&D, as some civil society groups and low-income countries have proposed, he suggests focusing on “in-kind benefits” in the form of clear industry commitments for the allocation of drugs, diagnostics and vaccines. 

Depending on the final outlines of the agreement negotiated by member states, this could include mandatory set-asides of free or discounted drugs, vaccines and other countermeasures by companies that sign up to the WHO PABS system that is currently proposed as part of the draft agreement. 

“Commitment is what is voluntary. But industry offers to sign up to binding obligations if the system is workable. And for the system to be workable, it really needs to have this free access to pathogens,” Cueni said. 

He added that, effectively, the position acknowledges a linkage between access and benefits sharing – one that industry long sought to avoid – but in a different kind of paradigm. 

“The two go together,” he admitted, “because countries want industry to sign up in terms of mandatory obligations in terms of sharing medical countermeasures, and industry is ready to do that – but states very firmly that, in able to develop the medical countermeasures, we need this access to happen.”

In-kind benefits not cash 

SARS-CoV-2: Pharma argues pathogens should be treated differently from other biological resources, enabling swift and unhindered sharing of genetic sequences.

But Cueni also flatly rejected proposals for what he described as a  “sales tax” on industry participation in the PABS system,  saying commitments to donated drugs and vaccines or their tiered pricing would be more effective. 

“We are not willing to be a cash card,” he stated. 

As an example of the precedent that industry doesn’t want to imitate, Cueni pointed to the fees assessed to pharma now for accessing flu pathogens, under the WHO Pandemic Influenza Preparedness framework.  

“There’s a lack of transparency, there’s a lack of accountability, and you are relying on 2024 contributions based on industry sales in 2009 – which somehow doesn’t make you trust that this would work in the future,” Cueni said.

Moreover, the system is so bureaucratically awkward that only 14 sample sharing agreements have actually been signed over the past decade, he asserts. 

In contrast, for the PABS to ever be workable, a much wider range of pathogen sample sources and data types (e.g. genetic data and not only biological samples) need to be in play – with the system allowing for very rapid and transparent sharing in the R&D community.  

And governance as well as operational costs should be shared by all of the system’s stakeholders – and with industry also having a seat at the table in the governance mechanism that is developed..

“We think that the only way to do this is as a partnership,” Cueni declared.  We’ll have WHO as a central player.. You will clearly have a majority of member states. But it shouldn’t be a closed process,” he said, noting that along with industry representations, research institutions, particularly pathogen data banks, might also play an important role.   

Precedent for this exists, he said, noting that The Global Fund, and Gavi, the Vaccine Alliance, also have industry on their boards as well as civil society advocates.  

Backing by leading pharma manufacturers 

Cueni pointed to a little-noticed IFPMA statement on 11 March, backed by a number of leading pharma manufacturers, as laying out key elements of the industry plan. Those firms included BMS (Bristol Myers Squibb), Gilead, Sanofi, Roche, Pfizer and MSD (Merck, Sharp & Dohme).

Key to the statement is a commitment to:  “reserve a percentage of real time production volume of a relevant therapeutic or vaccine for equitable distribution on the basis of public health risks, needs, and demand. 

“This could include a portion expected as a donation to LICs [lower-income countries] and/or a portion negotiated under equity-based tiered pricing with the lowest tiers dedicated to LICs and LMICs.”

Elaborating further on the offer to Health Policy Watch, Cueni said that industry’s binding obligations in the PABS should include the “flexibility to respond to the dynamics of any pandemic based on medical need. 

“Looking at COVID, I really emphasize the medical need point,” he said, noting that the initial hotspots for the pandemic were in Europe, notably Italy, but later followed by India, “quite a few Latin American countries, and then parts of Africa.” 

Pandemic Accord provisions on pathogens should supersede Nagoya Protocol 

The Convention on Biodiversity (CBD) aims to protect the world’s biodiversity, mostly found in developing countries. But the CBD’s Nagoya Protocol provision allowing countries to demand compensation in exchange for accessing pathogens can harm vital R&D into medicines and vaccines, pharma leaders argue.

Finally, Cueni argues that one key incentive for industry to sign up to the proposed PABS in any  pandemic agreement arrangement would be its potential to “override” pre-existing provisions around access to pathogens and benefit sharing  in Article 4 of the Nagoya Protocol of the Convention on Biodiversity (CBD). 

This could be established by designating the PABS a “Special International Instrument” (SII) that would thus automatically override the CBD’s protocols and, by inference, related national legislation. 

National rules established following the Nagoya Protocol’s ABS provisions have, at times, greatly slowed down the development of vital drugs at critical moments such as the 2016 Zika virus outbreak in Latin America, Cueni contends.

“The benefit of signing up is that you would have legal certainty of not violating Article 4 of the Nagoya Protocol,” he says. 

“And if this system would bring open and free access to pathogens, there would be multiple countries from the global north and south, sign up to it and have access to the network of certified labs in the world which shares data and allows you to work on prototype vaccines.”     

Political fallout likely

Designating the PABS as a Special International Instrument that supersedes the Nagoya Protocol is likely to be controversial among those LMICs  that have already set up national ABS systems for pathogens, Cueni admits. 

At the same time, he maintains that sharing the benefits outright of drugs developed from dangerous pathogens to those countries most in need, makes more sense than creating a new international financial model that, effectively, makes the trade in pathogens profitable. 

“The attempts to monetize pathogens scares me, because at the end, monetizing, which means ‘I share if you give me money’ … means pathogens could become a business model. You do not really want that,” he said, speaking at Wednesday’s press briefing. . 

“I’ve been involved in Switzerland in the ratification of CBD and the Nagoya Protocol. Everybody wants to protect the beauty and richness, diversity of biodiversity –  whether it’s the Amazon rainforest, or melting glaciers in Switzerland, or forests. 

“I’ve never met anybody who is arguing to protect the diversity of pathogens. Pathogens, you know, can be dangerous, they can cause pandemics, they can kill people, therefore, the notion of treating pathogens in the ABS… [in the model of] I gave you the information if you give me money doesn’t really make sense.”

Cueni’s comments on the perverse nature of the ABS business model were met with resistance from some civil society voices who see the trade-off as one way to correct the imbalance between wealthy pharma firms and poor countries.  It is in developing countries where pathogens like HIV, Ebola and mpox that originally circulated among wild animals first began their journey into human bodies and communities. 

“Open pathogens and closed IP isn’t fair,” said Oscar Lizarazo-Cortés, a professor at the Universidad Nacional Colombia. But not everyone sees it that way either. As Jamie Love, head of Knowledge Ecology International (KEI), one of the leading civil society advocating for more pharma IP sharing and transparency, said in another X post:

“I agree with Cueni.  

“If you protect pathogens (not exactly what is going  on in the text, but in general), you are protecting pathogens, at least in the sense that knowledge about the pathogens is not open.  You may want to justify that, but it is what it is,” Love added.

 

Image Credits: Fletcher/HPW, NIAID-RML , Lubasi.

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