It’s called the Berlin Declaration. A statement made by large bio-pharmaceutical companies, about three months ago, to be prepared for the next pandemic.

In the first year of the Covid-19 pandemic, the world witnessed the fastest development of a vaccine. But that said, the world continues to witness stark inequities as well, as some countries roll-out their fourth dose of vaccine, while others fall short of supplies.

The battle for access to Covid-19 vaccines, treatments, diagnostics and other tools has, over two years, been fought across fora – be the World Trade Organisation or other heath summits. Several public health personalities and nobel laureates too weighed in on the discussion, calling for a better model to get vaccines and diagnostics to all who need it.

This discussion is critical, as it sets a precedent for future public health emergencies. And for that reason, the Berlin Declaration from large bio-pharmaceutical players and its recent endorsement from two trade bodies, including one representing vaccine-makers from developing countries – has created a stir of sorts.

Preparing for future global emergencies

The Berlin Declaration from the IFPMA (International Federation of Pharmaceutical Manufacturers and Associations) was born, mid-July. And last week, the Biotechnology Innovation Organization and the Developing Countries Vaccine Manufacturers’ Network (DCVMN) cast their lot behind the Declaration. In a joint announcement, they said, the Declaration framework outlined strategies, including reserving an allocation of real-time production of vaccines for distribution to priority populations in lower-income countries for future global pandemics.

The latest endorsement of the Declaration has added fuel to an already fractious and high-octane discussion. Concerns are being raised over vaccine-makers from developing countries aligning themselves with Big Pharma’s approach, and not the needs of economically-backward regions.

Rajinder Suri, DCVMN Chief Executive, refutes such perceptions. The organisation “stands tall without leaning left or right”, he says, speaking for 43 vaccine producers from developing countries, including India’s Serum Institute, Bharat Biotech, Biological E and Panacea Biotec. DCVMN representatives are as much part of the industry, as are large bio-pharmaceutical players, he says, adding that all of them were needed for solutions during the pandemic. He points to 350 industry collaborations, inked to facilitate access through voluntary licenses and tech-transfers.

The Declaration involves multiple approaches, including allocating a percentage of production for priority populations, diversifying manufacturing (and looking at end-to-end supplies involving raw-material, packaging), training people to handle biological products, and nudging governments to prepare the ecosystem to absorb new technologies for production or distribution, explains Suri.

Nearly 16 billion doses of Covid-19 vaccines have been produced, the trade bodies said. And in the first year of the pandemic, 11 billion were produced of which 1 billion were for Covax to distribute in lower income countries. While innovations, collaborations and manufacturing scale-ups succeeded, “efforts to achieve equitable access were not fully realized”, they admitted.

Dependant on good will

Dr Mohga Kamal-Yanni, Policy co-lead of The People’s Vaccine Alliance (PVA), is disappointed that DCVMN has endorsed the Declaration. The Alliance is a coalition of about 100 organisations supported by nobel laureates, economists and public health experts.

She cites a PVA report, that said, the Declaration “normalises” the control pharmaceutical companies exercise on technology and knowledge essential for the manufacturing of medical products during a pandemic. The control, established over supply, allocation and price, keeps people in developing countries “reliant on companies’ good will”, it said, adding, “This is not a way to respond to (a) health crisis.”

Without sharing technology and intellectual property, generic producers will face manufacturing challenges and would be “totally reliant on the originator company’s desire to issue a bilateral license and dictate its conditionalities,” she added.

Favouring rich nations

Questioning the 300-plus industry collaborations, she said, “If 300 licences were really working, developing countries should be flooded with vaccines! Clearly this is not the case.”

Pointing to the AstraZeneca–Serum Institute alliance to supply Covax and others, she said, “One company is not a sound public policy because one company cannot provide all the doses required even for LMICs (low and middle income countries) only. People in Africa did not know when they would get the 2nd dose. Governments did not know what number off doses, of which vaccine, would arrive to their shores. And when India faced its own COVID-19 crisis and stopped export, there were no vaccines for Africa!”

Vaccines diverted

Referring to the Johnson & Johnson–Aspen collaboration, she said, the idea was to provide Africa with the one-dose vaccine. “However, the first millions of doses were exported to the EU,” she alleged. Further, she pointed out, DCVMN members are “spokes” of the mRNA hub in South Africa. The Declaration would hinder their work as potential producers of the mRNA vaccine, she added.

On its part, the PVA proposes seven measures to ensure equitable distribution is enshrined in preparedness and response to health crisis at national and global levels. These include ensuring public financing for biomedical research and development (R&D), creating conditions for government-funded R&D including equitable allocation, technology transfer and sharing IP; mandating technology transfer of products relevant to the pandemic and ensuring transparency on all aspects of innovation and access.