The new draft of the pandemic agreement “is a step backwards rather than forwards”, according to Thomas Cueni, Director General of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). 

“It is critical that any agreement takes steps to ensure equity in access to medicines and vaccines in future pandemics, whilst preserving the innovation ecosystem that delivered a vaccine just 326 days after the SARS-CoV2 genome sequence was first sequenced,” said Cueni.

 Article 12 of the current draft proposes that manufacturers pay an annual subscription fee to a yet-to-be-formed World Health Organization (WHO) Pathogen Access and Benefit-Sharing (PABS) System.

In exchange, they would get “rapid, systematic and timely access to biological materials of pathogens with pandemic potential and the genetic sequence data (GSD) for such pathogens”.

The article also proposes that manufacturers provide “real-time contributions of relevant diagnostics, therapeutics or vaccines” with 10% free and 10% at not-for-profit prices during public health emergencies of international concern or pandemics.

‘Uncertainties will cause delays’

But Cueni was dubious: “Stringent requirements for accessing pathogen data would severely impact responses to future pandemics and basic research and development (R&D).

“Conditions, uncertainties, and negotiations surrounding pathogen access will cause delays in the developing medical countermeasures, leading to significant public health consequences, including loss of lives and unnecessary economic pressures. In the COVID-19 pandemic context, even a one-month delay could have meant an extra 400,000 lives lost.”

The pharmaceutical industry has warned that a mandatory financial contribution could dis-incentivise companies from joining the PABS system.

“The pharmaceutical industry is determined to continue to play our part in these final stages – sharing our experience, evidence and expertise to help deliver an agreement that will better protect the world when the next pandemic hits,” Cueni said.

This week, the biopharmaceutical industry published a statement on how companies can work between pandemics – as well as when a pandemic hits – to deliver equitable access to medical countermeasures on the basis of public health risks, needs and demands.”

The statement was signed by a broad range of trade associations aside from the IFPMA, including the Developing Countries Vaccine Manufacturers Network, DCVMN, Europe (EFPIA), the US (PhRMA) and Japan (JPMA), and the Biotechnology Innovation Organization (BIO).

The companies detail the commitments to pre- and during pandemic measures.  These include improving surveillance; research on pathogens of pandemic potential; voluntary licensing and technology transfer based on “mutually agreed terms to improve geographic diversity of manufacturing”; real-time allocation of part of production, and equity-based tiered pricing.

Companies are also engaged in ongoing activities to support health system preparedness, whether by building clinical trial and regulatory capacity and harmonization, health care worker and community health worker trainings, or the continual investment needed to establish and maintain new technologies and platforms.

“With a final draft of a pandemic agreement now published, negotiators should redouble their efforts to find consensus as there is still much work to be done before an agreement can be reached, added Cueni. 

Previously, Cueni warned that “It would be better to have no pandemic treaty than a bad pandemic treaty.”

Image Credits: AMR Industry Alliance, World Health Summit.