The Biotechnology Innovation Organization (BIO) and Developing Countries Vaccine Manufacturers’ Network (DCVMN) have thrown their weight behind the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) proposal to improve access to vaccines in future pandemics.

The proposal, known as the Berlin Declaration, outlines how the pharmaceutical industry would reserve an allocation of real-time production of vaccines for priority populations in lower-income countries in future global pandemics.

In exchange, the industry wants their intellectual property protected, and for governments to “guarantee the immediate and unhindered sharing of emerging pathogens and their associated data to all researchers”, as well as committing to unrestricted trade, no export bans, and expedited processes for import and export during a pandemic.

The three pharma associations –  representing vaccines innovators as well as manufacturers – announced their agreement on Monday following a meeting in India hosted by DCVMN.  They called upon the G20, G7 and multilateral organizations to implement their part of the proposed bargain, etched out by the Berlin Declaration. 

Trade bodies representing vaccines innovators and manufacturers who have collaborated closely to bring their collective expertise & know-how in response to #COVID19 unite behind proposal for better access to vaccines for future pandemics. @IAmBiotech | @IFPMA | #DCVMN

— IFPMA (@IFPMA) October 23, 2022

“By supporting the vision for equitable access in pandemics, vaccine innovators and manufacturers acknowledge that while innovation, business-to-business voluntary collaboration and manufacturing scaling up succeeded in an unprecedented way during COVID-19, efforts to achieve equitable access were not fully realised,” the three bodies acknowledged.

“The three trade bodies invite the G7, G20, as well as multilateral organizations and other decision-makers to accept this practical solution and include it in their future pandemic preparedness response plans, whilst impressing upon governments that for the proposal to succeed the health systems in lower-income countries need to be better prepared to absorb and deliver vaccines and treatments, while high-income countries need to provide the necessary political and financial support,” according to the statement.

Industry ‘power-grab’?

However, the People’s Vaccine Alliance once again denounced the industry’s offer.  A policy brief on the Berlin Declaration, issued by the alliance last week described it as “a continuation of a consistent ‘third way’ campaign by the biopharmaceutical industry to maintain exclusive intellectual property (IP) protections and monopoly control over the medical technologies needed to defeat the pandemic”.

The alliance, which is made up of over 100 civil society organisations, has taken issue with a number of clauses including the declaration’s insistence on IP protection, pointing out that  “decades of publicly funded research” was behind the development of mRNA vaccines.

​​“Waiting for pharmaceutical companies to voluntarily supply life-saving medicines and vaccines to people in developing countries has not worked in the AIDS pandemic, it has not worked in the COVID-19 pandemic, and it will not work in future pandemics,” said Winnie Byanyima, executive director of UNAIDS and co-chair of the People’s Vaccine Alliance, in a media release.

“Governments negotiating a pandemic treaty need to resist the siren calls of industry. The profiteers of this pandemic must not set the rules that govern the preparations for the next pandemic. The world needs an international agreement that guarantees fair and equitable access to medical products for everyone, everywhere, not a power grab by big pharma,” she added.

The World Health Organization (WHO)’s intergovernmental negotiating body (INB), established to guide member state discussions on developing a pandemic accord for future pandemics, is currently refining the current working draft of the initial agreement, referred to as document A/INB/2/3. This will be presented as a “conceptual zero draft of the accord” at the INB’s third meeting in December.  Framing of equity and medicines access in the zero draft will set the stage for how member states negotiate over these charged issues in their attempts to reach a binding international accord.  

The INB will submit a progress report to the Seventy-sixth World Health Assembly in 2023 and the final accord is expected to be presented for consideration at the Seventy-seventh World Health Assembly in 2024.

Vaccine price hikes

Meanwhile, the People’s Vaccine Alliance also condemned the announcement by Pfizer that it will increase the price of its COVID-19 vaccine fourfold, to around $110-$130 after the US government’s federally-sponsored purchase programme for the vaccine expires at the end of this year.  Currently, the vaccine is sold for $30 a dose to the US government and provided for free.  As of 2023, the vaccine will be provided through the usual US public and private insurance channels, Pfizer said, in a statement that justified its price-hike to weakened demand for the vaccine. 

However, in a statement to Health Policy Watch, a Pfizer spokesperson said that the “company comments made regarding potential future vaccine pricing were specific to the United States.”

The spokesperson added: “We have government contracts in many developed markets outside the US, valid through 2023. And as such, have agreed prices for those markets.  During the pandemic, we priced our vaccine and oral treatment to ensure equitable global access for all countries, regardless of income levels… This tiered pricing, which provides to low and middle-income countries at cost, remains in effect.”

A People’s Vaccine Alliance spokesperson said that at its current US sale price, the vaccine already is priced nearly 30 times above its manufacturing cost – even at current US rates: “Experts have estimated that Pfizer’s vaccine costs just $1.18 per dose to make. Charging $130 per dose would represent a markup of more than 10,000%. This is daylight robbery. Governments must not stand by while companies like Pfizer hold the world to ransom in a global pandemic,” said alliance policy advisor Julia Kosgei.

Cost price estimates, she said. are based on Oxfam analysis of studies of mRNA production techniques, carried out by Public Citizen with engineers at Imperial College. Public Citizen and Imperial College’s analysis suggests that it could cost $9.4 billion to produce 8 billion doses of the Pfizer/BioNTech vaccine ―$1.18 per vaccine.

“While health workers and the vulnerable continue to go unvaccinated in developing countries, Pfizer is shamelessly fleecing the public for ever-greater sums of money. This latest obscene price hike is truly a mask-off moment for one of the great profiteers of this pandemic,” said Kosgei.

Not just about vaccines

“This isn’t just about vaccines. Right now, people in developing countries are dying without access to Paxlovid, an antiviral COVID-19 treatment for which Pfizer is charging hundreds of dollars per course. But there is a proposal at the World Trade Organization that would make it easier for poorer countries to produce generic doses. It’s time for governments to stand up to pandemic profiteers and support it.”

With regard to Paxlovid, the Pfizer spokesperson said that the company had established “a comprehensive strategy with governments, international global health leaders and global manufacturers to optimize overall supply and access to all parts of the world. ”

That, the spokesperson said, includes: a voluntary license agreement with the Medicines Patent Pool to allow generic production of the treatment, sublicensed to 38 manufacturers in 13 different countries; agreements with the Global Fund and UNICEF to supply some 10 million treatment courses through their channels; and collaborations with WHO and its partners to enable supply to reach “more vulnerable populations.

In a separate channel, World Trade Organization members are still negotiating over a proposal to extend a limited intellectual property waiver on vaccine manufacture, approved by the WTO in June, to treatments as well. The 17 June agreement calls for a WTO decision on whether to extend the waiver to diagnostics and treatments “no later than six months from the date of this decision.”

Image Credits: Pfizer, Medicines Patent Pool .