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Pharmaceutical

Learning from COVID-19: Public Funding of Drug Development

The covid-19 vaccine patent waiver: a crucial step towards a “people’s vaccine”, BMJ blog, May 10, 2021, By Gregg Gonsalves and Gavin Yamey

“An IP waiver would allow other producers to step in and make raw materials for export for all the current vaccines, industrial parts, and components. It would also simplify agreements for eventual production of more doses. But an IP waiver alone will not solve the covid-19 vaccine access challenge. Two further steps will need to be taken to reach a people’s vaccine. Step two is a transfer of technical know-how from vaccine makers in the global north to regional hubs or directly to manufacturers in the global south. Step three is vast subsidization of manufacturing in LICs and LMICs. 

Thousands of lives can be saved immediately through a donation model. But at the same time, we need to get going now on a people’s vaccine, since the ramp-up of vaccine manufacturing will take time. Companies in LICs and LMICs are hungry to get going. When the WHO recently announced it was seeking LIC/LMIC manufacturers who want to produce mRNA COVID-19 vaccines, it was inundated with proposals. Right now, the world’s scientists and politicians need to pull together to figure out how to get the next steps done. Technology will need to be transferred to a set of potential new producers, which will require experts to be mobilized for this task, many at the originator companies themselves. New financial resources must be mobilized to support building new factories or retrofitting old ones and to coordinate supply chains and other operational tasks at a global scale. The sooner we start, the faster we bring an end to the pandemic.”

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Comment by Adam Gaffney

Two weeks ago, England saw zero deaths from COVID-19, a testament to the efficacy of vaccines and to the NHS’ efficient vaccination campaign. Similarly, with a majority of its population vaccinated, Israel (but not the neglected Occupied Palestinian Territories) has seen a remarkable retreat of SARS-CoV-2. And the US appears to be following — my state of Massachusetts announced zero COVID deaths on May 10th. Meanwhile, the pandemic is continuing its horrifying course in nations including India and Brazil. Global vaccine apartheid is, in part, to blame for these divergent paths.  

COVID-19 vaccines should have been delivered and distributed, on the basis of need, to every nation on Earth; instead, rich nations (including the US) have signed contracts with pharmaceutical firms allowing them to horde vaccine supplies far in excess of population needs.  

As public health experts Gregg Gonsalves and Gavin Yamey noted in the British Medical Journal, vaccine donations to low-income nations could save lives immediately. However, as they also argue, controlling the pandemic worldwide requires ramping up global production of a “People’s Vaccine” unrestrained by patent protection.  

Intellectual property regimes have long resulted in artificial shortages of needed pharmaceuticals. The COVID-19 pandemic is no exception, but this could have been avoided.  As Physicians for a National Health Program’s 8-point COVID-19 response plan noted more than a year ago,

“…the US should eliminate intellectual property constraints like patents and trade agreements that might restrict the low-cost production and distribution of essential drugs and vaccines, including those developed from publicly-funded research.”

The Biden administration took a step in the right direction last week when it endorsed a waiver of patent rights on COVID-19 vaccines. However, as Gonsalves and Yamey note, this is not enough. While removal of patent protections allows generic drug manufacturers around the globe to cheaply produce small molecule pharmaceutics, the production of more complex biologic agents, including vaccines, additionally requires a transfer of technology, e.g.. the knowhow and trade secrets that go into the production process, as well as financial support. But this is something that we can do — indeed, it should have begun already.

Some have questioned the utility of this approach, or decried “patent busting” more broadly. However, as James Love’s Knowledge Ecology International (KEI) has shown, “companies with pre-existing drug and vaccine manufacturing capabilities can start producing COVID-19 vaccines relatively quickly, if technology transfer is made.” KEI has compiled a database of outsourcing agreements involving technology transfer for COVID-19 vaccine production, and concluded: “In almost all of the cases where information is available the manufacturer said that they were going to make the first delivery, or actually started delivering [vaccines], within six months from the deal announcement date.” 

The lessons to be drawn from this episode should extend beyond the pandemic. A drug development system driven by windfalls from intellectual property ownership is neither just nor efficient — nor is it necessary. We already publicly-fund much of the basic research that underlies drug development; we could publicly-fund the whole pipeline — including clinical trials — as well. As PNHP’s comprehensive pharmaceutical proposal, published in the British Medical Journal in 2018, set forth, we need a path of full public funding of pharmaceutical development by the National Institutes of Health. Such a program would deliver agents that would be in the public domain immediately — for the benefit of the entire global community.

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