Covid shows the world it needs new rules to deal with pandemics

More than a year ago the World Health Organisation (WHO), with the support of 40 member states, established the Covid-19 Technology Access Pool (C-TAP). C-TAP offers a platform for the voluntary sharing of intellectual property (IP), including knowhow, technology, data, cell lines and whatever else may be necessary to accelerate the production and availability of products to respond to the Covid-19 pandemic.

WHO established C-TAP well before the first vaccines came out of the pipeline and hit the market. C-TAP’s scope was not limited to patents because it was understood that for vaccine production the knowhow gap needed to be closed and deep technology transfer would be needed. And companies were asked to join the initiative.

If there is proactive technology transfer, manufacturing on average can be up and running within six months

C-TAP was established at a time when world leaders were promising that “no one would own the vaccine” (Emanuel Macron) and that “Covid-19 vaccines would be global common goods” to benefit the whole of humanity (Angela Merkel). Governments were spending billions of dollars and euros on the development of Covid-19 vaccines. The counter stands on €93 billion. To expect that the holders of IP would be open to engage with C-TAP to rapidly scale up vaccine manufacturing capacity around the world was a reasonable one. After all, it would not be business as usual. But companies turned their backs on it and today the pool remains empty. High-income countries rushed to pre-order vaccines, leaving many developing countries at the end of the queue. Today, only 0.3 per cent of the vaccines administered globally have been given in the 29 poorest countries, where 9 per cent of the world’s population lives.

Witnessing an empty C-TAP and wealthy nations laying claim to the available vaccines, South Africa and India were prompted to propose on 2 October last year a waiver to the World Trade Organisation’s Trade-Related Aspects of Intellectual Property Rights Agreement (TRIPS). The proposal would allow countries to suspend the protection of IP for Covid-19 products for the duration of the pandemic. The TRIPS waiver proposal was met with opposition from high income countries and rights holders in the healthcare industry and other industries that rely on IP, such as Hollywood’s filmmakers.

On 5 May, the Biden administration surprised the world with an endorsement of a TRIPS waiver for vaccines. With this move, President Biden fulfils his campaign promise that he would not allow IP to stand in the way of worldwide access to vaccines. But he is also saying this time around it will not be business as usual.

The global health crisis caused by Covid-19 is unprecedented and requires an unprecedented response. Vaccinating the globe’s population is in everyone’s interest. But today the world has manufacturing capacity for 3.5 billion doses while 11 billion are needed to vaccinate 70 per cent of the world’s population. So there is certainly an element of self-interest in the US’s support for the TRIPS waiver. It is no coincidence that Biden’s waiver is limited to vaccines and does not cover therapeutics or diagnostic tools whose wide availability outside the US is of less interest.

The announcement was celebrated by many developing countries, the head of the WHO, the chairs of an independent panel on the Covid-19 pandemic response, other global health groups and the Pope. WTO’s director-general “warmly welcomed” the US’s “willingness to engage with proponents of a temporary waiver”, adding that “the world is watching and people are dying”.

But the US support for a WTO TRIPS waiver for Covid-19 vaccines provoked a swift negative but seemingly contradictory response from the pharmaceutical industry, which can be summarised as: a) waiving IP will not work and b) we are already doing it ourselves.

Waiving patents alone indeed is not sufficient to enable manufacturing of vaccines that are approved by stringent regulatory agencies. For that, technology transfer is needed. Vaccine production would be accelerated if originator companies collaborate in this technology transfer. Oxford University (and later AstraZeneca) reached an agreement with the Serum Institute India to transfer the technology to enable large-scale production of Covid-19 vaccines. Various other vaccine producers have entered into agreements with contract manufacturers that produce their vaccines for them or with each other. Important lessons can be learnt from existing agreements that show that if there is proactive technology transfer, manufacturing on average can be up and running within six months, including for mRNA vaccines. This data takes away a much heard concern that it would take too much time to develop new manufacturing capacity. In any case, companies were asked to plan for this more than a year ago when C-TAP was announced. That precious time is lost but this is not a reason to not play catch-up now.

Compulsory licensing provides a solution in situations where patents form the only barrier to produce and supply, and the patent holder refuses to license. This case is currently playing out in Canada. Biolyse, a biotech company in Canada, has asked J&J for a licence to produce its Covid-19 vaccines. This request remains unanswered and Biolyse has moved to apply for a compulsory license under Canada’s Access to Medicines Regime (CAMR), which is Canada’s implementation of the TRIPS article 31bis mechanism that allows it to produce predominantly for export to other countries. Bolivia has notified the WTO that it is seeking such imports. High-income countries in 2003 opted out of this special compulsory licensing mechanism, as importers, even in situations of emergency. This means that if for example the UK would want to import the vaccines Biolyse may produce in the future, under the current rules it cannot do so. A TRIPS waiver could temporarily undo this opt-out to enable import by the UK of products produced under a compulsory license elsewhere.

But the real question is do we really want to go back to the hand-to-hand combat over medicines patents that the world experienced at the height of the HIV treatment crisis about 20 years ago?

To combat a pandemic, global measures are needed. Such measures should ensure access to technologies to prevent and treat Covid-19 should not be burdened with monopolies. Sharing of knowhow and technology should be assured and not subject to controversy in the middle of a pandemic. Public financing for research and the development of vaccines and treatments should be abundant, predictable and provided on the conditions that the knowhow is open-sourced for others to use either in further research or to produce at-scale. Resulting products should be priced fairly. Vaccine production capacity should be created in the regions in the world that currently have no or insufficient production capacity. Such efforts will be easier when technology transfer is assured.

For this to happen the world needs new global norms and legal frameworks. Key to this is a binding commitment to fund research and share scientific and technological knowledge. The World Health Assembly, meeting this week, will consider a proposal for a new pandemic treaty. This must address these issues and contain provisions on intellectual property and technology sharing.

Without further delay, C-TAP needs to be fully operationalised and high-income countries should share the vaccines they have with less affluent nations.

Ellen ‘t Hoen is director of Medicines Law & Policy, an expert group advising organisations and governments (medicineslawandpolicy.org)

Photo: the German health minister visits BioNTech-Pfizer’s vaccine production plant near Hamburg (Christian Charisius/Shutterstock)