A new “Zero+” version of a proposed World Health Organization pandemic accord being negotiated by member states has dropped previously strong language that conditioned use of public R&D funds to private sector commitments to price transparency and tech transfer of end products, among other measuress.

However, the updated draft text, obtained by Health Policy Watch, still contains ‘optional’ language linking developing countries’ sharing of pathogen information to a guaranteed supply of drugs, vaccines and other health tools that they would access a WHO distribution scheme.

While not a formal part of this week’s World Health Assembly (WHA) proceedings, the text drafted by the “Bureau” of six member states guiding the talks is being circulated this week as they prepare for another round of  negotiations over the new accord, scheduled by the Intergovernmental Negotiating Body (INB) 12-16 June.

The latest draft of the “WHO Convention, Agreement or other International Instrument”, dubbed WHO CA+, offers a range of “options” where there are diverging opinions between member states with consensus yet to be reached.

Roland Driece, co-chair of the negotiations, highlighted equity, the sharing of pathogens, improving logistical systems, better coordination of research and development and fundraising for all of the accord’s provisions, as the key issues facing the Intergovernmental Negotiation Body (INB).

Driece, who was addressing an official WHO roundtable Monday on pandemic preparedness at the WHA, said the draft would become public during the course of the week. He added that the use of options indicated areas where there were “divergent views”.

Text likely to meet stiff opposition from both civil society and pharma

However, both civil society and pharma appear likely to oppose parts of the updated text – for very different reasons.

“The R&D text is much weaker,” said Suerie Moon, director of the Global Health Centre of Geneva Graduate Institute, pointing to Article 9 of the update. “We’ve lost the proposal to put conditions on public funding [of pharma R&D].

“In the old Article 9 there was this very clean and clear clause establishing conditions for publicly-funded research and development,” she said.  That text made much stronger reference to requirements for the transparent publication of prices of pharma products; data sharing and technology transfer,” in the case of products emerging from publicly-funded R&D.

In the new text, however, such provisions are more cautious and conditioned, stating for instance, that “each Party, when providing public funding for research and development for pandemic prevention, preparedness, response and recovery of health systems, shall, in accordance with national laws and as appropriate taking into account the extent of public funding,” promote transparency around R&D results, tech-sharing, and equitable dissemination of health products.

“It’s basically a huge step back from countries wielding the power of the law to regulate, and more reliance on voluntary measures,” said Moon.  “There are a lot more references to ‘as appropriate’ – I think the phrase is used some 47 times.”

Pharma object to continued link between pathogen access and benefit-sharing 

On the other side of the fence, the new text still contains references linking pharma’s access to pathogen samples or genomic data with the sharing of “benefits” from health products produced as a result.

That is something that has been hotly opposed by pharma leaders -who have said that unconditional access to pathogen data is critical to creating new drugs quickly in response to emerging threats.

While couched in the language of multiple “options”, one proposed clause also preserves a “Zero draft” reference to a 20% ‘set-aside’ of new pharma products for low-income countries, to be distributed through WHO, stating:

“The benefit sharing obligations [by manufacturers of pandemic-related products developed from the utilization of pathogens with pandemic potential] will include, but not be limited to: (i) real-time access by WHO to a minimum of 20% of the production of safe, efficacious and effective pandemic-related products, to support their equitable distribution through the WHO allocation mechanism, in particular to developing countries, [according to public health risk and need]/[that are Parties to this WHO CA+].

“The pandemic-related products shall be provided to WHO on the following basis: 10% as a donation and 10% at affordable prices to WHO; and (ii) collaboration with manufacturers from developing countries and WHO initiatives to transfer technology and know-how and strengthen capacities for the timely scale-up of production of pandemic-related products.”

Other alternative versions of the same clause, however, would rely on purely on voluntary measures to fill supply gaps in low-resource settings.

‘One size-fits-all doesn’t make sense’

While countries need a new “social contract” to ensure more equity in responding to the next pandemic, establishing such a fixed set-aside formula ‘doesn’t really make sense,’ asserted Thomas Cueni, Director General of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA).

Countries need different types of products and some hotspots might need more products while others less, Cueni told Health Policy Watch at an IFPMA event innovation to prevent pandemics, convened on the sidelines of  WHA.

“Vaccines, treatments and tests are also totally different. Therefore a fixed number for vaccines, the same as tests and treatments doesn’t really make sense. A fixed number for any pandemic doesn’t make sense,” Cueni said.

He added that industry also would continue to oppose any linkage between their access to pathogen samples or genomes, and so-called “benefit sharing” of finished health products.  Such clauses, he contends, could hinder the speed at which pathogen data is shared.  

Cueni stressed, however, that a new “social contract” between countries is indeed required to ensure that vaccines, medicines and diagnostics are more equitably distributed in the next pandemic. 

The pre-purchase of COVID vaccines by North American and European countries in quantities many times the population size, left other, less developed states high and dry when initial vaccine rollout began, Cueni acknowledged, speaking at the IFPMA event.  Then, India’s export ban on COVID vaccines, which had been pre-purchased by the UN-supported COVAX facility to supply Africa, left the continent high and dry.

“It’s obvious when you look at the experience in COVID, rollout was not fast enough,” he said. “I personally believe that we need to act on two fronts,” Cueni observed.  

“You need a signing of a kind of social contract… From the industry side, you have a commitment from CEOs from all of the major companies, and also from small biotech companies.. Committing to putting aside part of available production in real time, from rollout to demand, wherever they are. 

“But this will only work if the manufacturing countries, from the US to India, will also sign up to that commitment because if they say yes, you can have access to whatever we have, but only after you have vaccinated every signal one of our citizens, then that social contract is broken.”

The advancement of more regional manufacturing hubs for vaccines and drugs, particularly in Africa, is also critical so that developed countries – or large emerging economies like India and China – don’t monopolize supplies.   

“We need to work together on some geographic diversity of manufacturing,” Cueni added. “But I believe the only way that promises success is voluntary.“  

Pathogen spillover on farms, wild animal markets and in waste – another sticking point

Another obvious sticking point in the text that has received less attention refers to measures to prevent pathogen risks from emerging, as contained in Article 4.

One text option, dubbed “Option 4.B” refers explicitly to key risks that countries would commit to address.  Specifically, that text commits countries to “develop, strengthen, implement, periodically update and review comprehensive multisectoral national infection prevention and control measures, to:

• ensure access to safe water, sanitation and hygiene;
• ensure the implementation of infection prevention and control measures;
• strengthen efforts to ensure the sound management of wastes from health facilities, veterinary practices, and live animal markets.

The reference to prevention in the farm sector is particularly detailed, commiting countries to: “strengthen animal disease preventive measures, including, but not limited to, on farms, transport of animals, live animal markets, trade in wild animals and in veterinary practices both for food-producing and companion animals taking into account the relevant international standards.

“Those measures include water and feed hygiene, infection prevention and control measures, farm sanitation, hygiene and biosecurity and animal welfare support measures.”

But ‘Option 4.A’  is far more succinct. And the choice between the two, in effect, illustrrates the stark choices facing member states regarding just how rigorous a pandemic accord they may decide to negotiate.

Limited to just one single sentence, Option 4.A states simply: “the Parties shall take prevention and surveillance measures that are consistent with and supportive of effective implementation of the International Health Regulations”.

Then it adds: “Article ends here.”

Image Credits: Photo by Maksym Kaharlytskyi on Unsplash, WHO, Nana Kofi Acquah, Ricardo Castelan Cruz / Eyepix Group/Future Publishing via Getty Images, Nature .