The 1 Billion Dose Wager on the IP Waiver

Rich countries need to cough up 1 billion vaccine doses by September, and big pharma should significantly expand its network of voluntary license sharing and manufacturing – in order to avoid a vote by World Trade Organization members on a controversial proposal to waive all COVID-related intellectual property for the duration of the pandemic. 

That was the key message of former New Zealand Prime Minister Helen Clarke, at a debate Friday, co-hosted by civil advocacy groups Health Action International, Medicines Law & Policy, and Knowledge Ecology International

Former New Zealand Prime Minister Helen Clarke, who is also co-chair of The Independent Panel for Pandemic Preparedness and Response

“There has just not been a rapid enough scale up the production of vaccines to meet the urgent need of comprehensive global vaccination,” declared Clarke, co-chair The Independent Panel for Pandemic Preparedness and Response – which issued a crosscutting report this month.

 “And that is why the panel has called on the WHO and WTO to convene urgently a meeting of the major vaccine manufacturing countries and companies to crunch through….. licensing,  knowledge and technology transfer agreements for COVID-19 vaccines. 

“We say – if that can’t be achieved within three months, then a waiver of intellectual property rights under the proxy agreement should come into force, immediately.”

Clark spoke on the same day that 62 WO members submitted a revised proposal on the WTO IP waiver “from certain provisions of the TRIPS Agreement for the Prevention, Containment and Treatment of COVID-19”, as reported by KEI International. 

While not a major revision, the new draft of the proposal led by South Africa and India narrows the scope of the waiver more explicitly to COVID “health products and technologies”. It also makes it time-bound, calling for the waiver to remain in force “for at least 3 years from the date of this decision” with a review by the WTO General Council after that.

In her proposal, meanwhile, Clark echoed the offer of a ‘deal’ that was also raised Thursday by her Independent Panel co-chair, Ellen Johson Sirleaf – that countries flush with vaccines should share at least 1 billion doses with COVAX by 1 September, and two billion doses by the middle of 2022, to avoid a WTO vote on the waiver proposal. Said Clark: 

 “We’re all aware that the high income countries collectively have ordered far more vaccine doses than they would ever need to cover their populations.  

“So as they’re scaling up their vaccination rollouts, we call on them to provide, by September, at least a billion doses to the 92 low and middle income countries covered by GAVI [ the vaccine alliance]… and 2 billion doses in total by the middle of next year. 

“That redistribution will help cover the highest priority groups in low and middle income countries,” she said. 

With 62 sponsors now for the waiver deal, the possibility of an unprecedented vote on the waiver proposal looms as a real possibility for the WTO’s 164 members. 

Not Only Health Security – Pandemic Treaty Should  Focus On Access & Equity 

So far, an overriding focus of the pandemic treaty debate (see related story) has been the need for a stronger legal instrument to require countries to prepare for, transparently report on, and respond to outbreak risks, along with strengthening WHO’s investigative capacity. 

But any Treaty should also be a statement of equitable access to medicines, treatments and vaccines, proponents said:

“We can no longer afford to rely solely on a model of charitable giving, which proves inadequate in the face of global infectious threats,” said Clarke.

Pandemic Treaty mechanisms also need to go beyond the current donor-driven models of distributing vaccines and medicines to LMICs – to insure more stable global public-sector funded finance for their production and distribution, she and other panelists said.  

Said Anna Marriott, Health Policy Advisor for Oxfam: “long-term sustainable funding will be needed to invest and maintain manufacturing facilities,” especially in the global South where they are dire.

Broad in Scope 

The Pandemic treaty mechanisms must also be broad enough in scope to ensure that not only access to vaccines, but to also treatments and diagnostics, is more assured, said UNITAID’s Executive Director Phillippe Duneton. He described, for example, how the extreme shortages in oxygen supplies seen in South Asia and some Latin America countries is also exacerbating the coronavirus death toll. 

“We need to have all the tools, it’s about access to vaccines, it’s about access to treatments, about access to diagnostics. So, there is not only one [of those] that needs to be considered.”

And if voluntary licensing permissions for COVID treatments are struck with Pharma, those should not be limited to just certain countries or regions of the world – as they have been in the case of other treatments for HIV, hepatitis, and other diseases. Instead they should be available everywhere, including middle-income countries of Latin America and South East Asia, panelists added. 

Evergreen, Elastic Vaccine Manufacturing Capacity – Keys to Practical Success

Martin Friede, WHO’s Coordinator of the Initiative for Vaccine Research

On a more practical level, new regional vaccine manufacturing facilities, as they come into being, need to be build to adapt to changing market conditions – as well as being assured markets for their products in slack times – as well as during pandemic peaks, said WHO’s Martin Friede. 

“This will work if the [Pandemic] Treaty supports sustainable markets between pandemics as well as during pandemics,” he emphasized. 

Friede, a former biotech innovator and high-level pharma official, is leading WHO’s work on a mRNA technology transfer hub – to build regional capacity to produce new mRNA vaccines.

He cited the H1N1 pandemic as an example, where new manufacturing facilities that were created to fill the immediate needs of the pandemic survived only if they could also produce and supply markets for more routine vaccines in non-pandemic periods.  

“If a facility is not producing something that it is selling on a day to day basis, it will not be maintained,” said Friede, explaining that the incentives to maintain production capacity for goods that are rarely needed are weak. 

In addition, financial partners and buyers – from countries to big donor institutions – need to recognise that the medicines and vaccines produced by new, start-up facilities may be more expensive than those of well-established multinationals operating in Asia or the United States.  

So big global agencies as well as national governments need to recognize the long-term benefits of local procurement, and procurement from a healthy mix of suppliers – rather than always chasing after the lowest-priced options from the largest producers thousands of kilometers away, Friede stressed: 

“We are seeing facilities being closed down because the national government says we don’t need influenza vaccines’ or we can buy influenza vaccines on the international market cheaper than we can make them ourselves’.”

More Transparency Needed

Jamie Love, Director of Knowledge Ecology International

Greater transparency from the biopharmaceutical sector will also be needed to support the expansion of manufacturing capacity around the world, said Jamie Love from Knowledge Ecology International.

“It would be helpful if there was just more openness and transparency about what facilities are out there that have some capacity to manufacture,” he said, noting that on average, technology transfer takes about 6 months, based on previous agreements that have been sealed. 

“There are facilities which right now can manufacture without any changes, they’re ready to go. And then there are other facilities that would require some modifications and some changes in addition to whatever knowledge transfers is required…[it would be helpful to know] what facilities are out there, and what would it take in terms of time, money, and know how to get those facilities online.”

Image Credits: Sinopharm, Health Action International, Health Action International.

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