This week, Politico reported that after a grueling 18 months of negotiations on an intellectual property (IP) waiver for COVID-19 vaccines, tests, and treatments — to enable producers around the world to make and maximize access to these life-saving tools — a compromise had been reached by a limited group, including the co-sponsors, South Africa and India, and key governments, the US and EU.
It comes with the pandemic now in its third year and still only 10% of people in low-income countries, and 14% of people in Africa, having received primary vaccination against COVID-19 (typically two doses or one dose of the Johnson & Johnson vaccine). Weighted by population, high-income countries have already given out over twice as many third/booster shots as low-income countries have given out in total.
Lower testing capacity in poorer countries has also factored into researchers estimating that the true COVID-19 death toll is three times more than the confirmed count of over 6 million. And just as with vaccines, there are already concerns about a looming global equity gap in access to treatments.
So what’s included in the compromise? Will it work? What happens next at the World Trade Organization (WTO) where the decision will be made?
We recognize this step forward, but we need a #TrueTRIPSwaiver that also covers treatments & tests and waives other critical IP, not just patents.@Bundeskanzler@EmmanuelMacron@Palazzo_Chigi@EU_Commission, please support a #TrueTRIPSwaiver.https://t.co/XmWGmC9Mlc— Global Citizen Impact (@GlblCtznImpact) March 16, 2022
Vaccines, Not Tests and Treatments
Glaringly, the compromise only addresses the IP surrounding COVID-19 vaccines (for a period of three or five years), not tests and treatments.
If it were implemented, a separate decision could be taken by the WTO within six months to extend it to cover those tools, but it’s painful to think of how many lives could be lost in that period and how many have been lost in the many months up to now. In the last six-month period, a recorded nearly 270,000 people in low- and lower-middle-income countries died of COVID-19.
Country Eligibility Limits
The agreement would be geographically limited to developing countries that exported less than 10% of world exports of COVID-19 vaccines in 2021. This seems aimed at excluding China, but it could also exclude other countries with manufacturing capacity that could help increase access.
Only Patents, Not Other Critical IP
The compromise document appears to only cover patents, not other key forms of IP like undisclosed clinical data and trade knowledge that would expand and accelerate additional manufacturing. While this would help eliminate legal risk around a producer attempting to make use of patented information, it wouldn’t go the extra step of actively enabling them to engage in additional manufacturing.
Politico did report that the European Commission said companies in developing countries that take up this opportunity could “rely on data produced through earlier trials, without having to re-produce this data themselves.” But as Knowledge Ecology International pointed out, the key restrictions around trade secrets and clinical data in the WTO’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) were excluded from the compromise. Therefore it’s unclear if and how this IP would be made accessible by governments to enable and fast-track the process.
This is all especially relevant in the case of the WHO-backed mRNA Technology Transfer Hub based in South Africa. The Hub has made remarkable progress since being established mid-last year, even reverse-engineering a prototype of the Moderna-NIH vaccine using publicly available patented information. But it lacks access to the data needed to avoid duplicating clinical trials as well as know-how needed to scale up manufacturing. With this information, the Hub estimates it could reduce the time it would take to have an approved vaccine ready for mass production, from three years down to one year.
Notably, the compromise would allow vaccines produced locally by eligible countries to be exported to other eligible countries. This is a step beyond what’s in the existing TRIPS “flexibilities” that allow a country to grant a compulsory license to make a product, but only for domestic use, which is too limited and ineffective in response to a global pandemic. No further export would be permitted, but this is among the kind of measures needed to make an IP waiver effective.
Where We Go From Here
While this compromise has reportedly been agreed to by the US, EU, India, and South Africa, to take effect it would have to be approved by all EU member countries, including Germany, which strongly opposes a waiver, as well as the wider WTO membership, including other opponents such as the UK. It’s therefore possible that this agreement will be either watered down further or never actioned at all. At the same time, it’s an opportunity for other countries in the WTO to demand a broader and more effective waiver.
While vaccine supply access to lower income countries through COVAX has increased in recent months, the World Health Organization warns that COVID cases are increasing globally once again and that the pandemic is not over, so countries should remain vigilant. We also don’t know if another dangerous variant may yet emerge from the billions of people that remain unvaccinated.
That’s why we need leaders to finally act to expand local production and unlock local ownership and distribution authority across all COVID medical tools to increase access for all. Key to that is a comprehensive IP waiver that works.