Proposals for adjusting intellectual property rules and practices to augment production and promote global access to vaccines and other technologies have provoked controversy. Promoting voluntary sharing of intellectual property and knowhow makes more practical sense than waiving intellectual property rights, argues Charles Clift
The gross inequity currently evident in the global distribution of vaccines against covid-19 has produced a search for urgent solutions to increase production to meet the overwhelming demand, and to ensure each country can access the vaccines it needs as soon as possible.
Much of the current debate centres on a proposal made by South Africa and India to the World Trade Organization (WTO) to waive covid-related intellectual property (IP) rights during the covid-19 pandemic, which would allow manufacturers anywhere to produce vaccines or other products without obtaining a licence from the originator company. Another initiative is the COVID-19 Technology Access Pool (C-TAP) promoted by the World Health Organization (WHO) which seeks to accelerate product development and manufacturing of tools needed to combat covid-19, including vaccines, through the open and voluntary sharing of IP, data, and know-how.
Last week, 175 former world leaders and Nobel laureates, wrote to US President Joe Biden urging him to support both proposals in relation to vaccines. One of the Nobel laureate signatories, Joseph Stiglitz, tweeted “Intellectual property rights for covid-19 vaccines must be suspended to boost inoculation rates around the world. It’s that simple.”
But for most people familiar with the complexities of vaccine manufacture it is not at all simple. Unlike therapeutics, which are mainly chemical substances usually easily replicable by those with the knowhow, vaccines are biological products which are far more challenging to manufacture to the required standards of quality, safety, and efficacy. Most importantly, transferring the technology, skills, and materials necessary for production requires the active participation of the originator.
Paul Fehlner, a former Global Head of Intellectual Property at Novartis, while supporting the voluntary sharing of IP, technology and know-how through C-TAP, does not believe a waiver will work: “Breaking patents will not result in technology transfer needed to ensure faster manufacturing of covid-19 vaccines and other products. Instead, it will slow access to the approved vaccines by provoking resistance and a reduction in cooperation by private sector companies.”
Last year Moderna waived its covid-related patents, but this has not resulted in any transfer of technology. And one patent used in the Moderna mRNA vaccine, but owned by the US government, could be used to leverage companies to share the technology with other manufacturers.
In the WTO, the mainly rich country governments opposed to the waiver argue that, “there is no concrete indication that intellectual property rights have been a genuine barrier to accessing covid-19 related medicines and technologies, and that intellectual property was only one aspect of many that affected the manufacture and distribution of the new vaccines.” Pharma companies have been predictably opposed.
Apart from doubts about the wisdom of the proposal, negotiations in the WTO are always very slow – taking years rather than months. The vaccine shortage, or even the pandemic, might be over before a waiver could become operational.
Given these divergent views, the new head of the WTO, Ngozi Okonjo-Iweala, has proposed that there should be a “’third way’ on intellectual property that preserves the multilateral rules that encourage research and innovation while promoting licensing agreements to help scale-up manufacturing of medical products.” The problem with this is that her “third way” currently sounds very much like the status quo – Ngozi quotes approvingly current licensing deals such as that between AstraZeneca and the Serum Institute of India.
But a “third way” could be to revive the fortunes of C-TAP. C-TAP seeks to build on the successful example of the Medicines Patent Pool (MPP) which obtains licences from originators of therapies, mainly to date for HIV and hepatitis C, allowing it to sub-license generic manufacturers to produce and distribute the licensed products in an agreed list of countries. Since 2010, MPP has agreed licences with 10 patent holders, sub-licensed to 22 generic manufacturers, and covering 141 developing countries. It estimates it has facilitated the supply of 14.6 billion doses of treatments, and as a result of competition between generic producers, has saved nearly $1.7 billion in treatment costs.
While pharma companies, after initial hesitation, were willing to work with the MPP to extend availability and global access to HIV therapies, they have so far been openly hostile to C-TAP, arguing that it might undermine incentives to innovate and that IP was not a barrier to “R&D, public-private collaborations or access to covid-19 products.” With only lukewarm interest from most governments, C-TAP has so far stalled.
With the right leadership from governments, this could be the opportunity to reconfigure C-TAP on the lines of the MPP to act as a platform for the voluntary sharing of IP and know-how to boost production. On current indications, there may be a need for annual covid vaccinations, including tweaks to the vaccines to address new variants, and C-TAP could provide the means to develop a network of producers around the world to provide equitable global access in the coming years. WHO’s recent announcement of its intention to establish a technology transfer hub between manufacturers particularly in developing countries and owners of vaccine technologies is a welcome step in this direction.
Charles Clift is a senior consulting Fellow at the Centre for Universal Health at Chatham House.
Competing interests: CC works as an independent consultant in the field of global health. He was previously a board member of the MPP and has been a consultant to C-TAP.