With the news that a leaked draft text on the COVID-19 TRIPS Waiver has now been formally tabled by the Director-General of the World Trade Organization, we explain why this flawed proposal will not deliver what’s needed to save lives during this pandemic and beyond. This blog first appeared in Business & Human Rights Resource Centre.
Intellectual property (IP) rules agreed at the World Trade Organisation (WTO) have come under renewed scrutiny during the COVID-19 pandemic. These longstanding rules give pharmaceutical companies control over lifesaving medical products through patents and other monopolies. Despite the pandemic, these rules have remained unchanged and threaten global access to essential health products such as vaccines and treatments. As the pandemic continues, these IP rules are coming under fire for protecting the profits of pharmaceutical corporations over public health.
In October 2020, India and South Africa proposed a temporary waiver of the WTO agreement which underpins these rules, the Trade-Related Intellectual Property Rights (TRIPS) agreement. Wealthy countries and regions such as the EU, the UK, the US and Switzerland positioned themselves firmly against the waiver, following lobbying by pharmaceutical corporations. After months of stalled negotiations, in mid-March 2022 a new draft text was leaked after discussions between the EU, the US, India and South Africa.
But the new draft text falls far short of a meaningful TRIPS waiver that would improve people’s access to COVID-19 medical tools. Instead it is a very narrow proposal that will cost lives. We therefore urge WTO members to reject this new text, and continue building consensus on the original TRIPS waiver proposal, which has overwhelming support from more than 100 countries, international organisations, Nobel laureates, and civil society.
Why reject the draft text:
1. It’s limited to vaccines
The draft text only includes COVID-19 vaccines in its scope. It fails to address IP barriers on other critical COVID-19 medical tools such as treatments and tests, which are equally essential and potentially lifesaving products.
Access to COVID-19 treatment remains a key challenge. Baricitinib is an oral treatment recently recommended by the World Health Organization to treat severe COVID-19. Baricitinib is widely patented in more than 50 countries, blocking access to generic versions until at least 2029. Generic versions of baricitinib can be made available for under US$7 per 14-day treatment course in India and Bangladesh, which is significantly less than patent-holder Eli Lilly’s prohibitive price of $1,109 per 14-day treatment course in the US. Due to Eli Lily’s restrictive licensing conditions for Indian generics, the supply of generic versions of the drug outside India is not possible.
Furthermore, MSF analysis shows that access to new COVID-19 treatments in other countries and regions, such as Latin America, will be significantly impacted by pharmaceutical monopolies and IP barriers.
As such, any meaningful waiver should include the full range of medical products needed to tackle this pandemic.
2. It arbitrarily excludes countries
The eligibility criteria in the draft text are restricted to developing countries which exported less than 10% of world exports of COVID-19 vaccines in 2021. Under these criteria, China would be excluded, despite accounting for more than 30% of world exports of COVID-19 vaccines, mainly to developing countries. It is contradictory to exclude the main supplier of vaccines to developing countries, while claiming that the process seeks to increase vaccine production and supply.
Furthermore, the draft text should clarify that least-developed countries are included in the waiver.
3. It’s only limited to compulsory licenses on patents
The draft text only addresses issues related to compulsory licensing — a mechanism by which governments allow manufacturers to produce a ‘patented’ product without the patent holder’s consent. Under international law, this is a legitimate and lifesaving mechanism that can protect public health.
While critical to safeguard and expand the use of compulsory licensing, a narrow focus on this measure is insufficient. Indeed, there are other monopoly protections that go beyond patents, such as confidential manufacturing information and trade secrets, which also need to be addressed to accelerate the development and supply of medical products.
All relevant provisions in the TRIPS Agreement need to be waived entirely to enable access to information required by manufacturers and suppliers to effectively tackle the pandemic.
4. It contains onerous requirements
The draft text enforces onerous requirements on countries which want to use it. For example, one of the proposed requirements for issuing compulsory licensing is that the applicant lists all relevant patents. In practice this is very difficult since some products are covered by hundreds of patents, many of which may not yet be published or identified.
The text also prevents countries from re-exporting vaccines they have imported. This threatens the ability of countries to donate vaccine doses to other countries and puts coordinated vaccine procurement and distribution in jeopardy.
What we need: unanimous support for the original TRIPS waiver proposal
MSF’s experience in public health emergencies has made it clear a range of medical tools, including vaccines, diagnostics and treatments, are essential to save as many lives as possible. If we are to tackle COVID-19 successfully, all medical tools must be available in all countries, free from monopolies.
Diluting the essence and limiting the scope of the original TRIPS waiver will have a detrimental impact on the lives of millions of people. We urge the original proponents of this waiver, India and South Africa, alongside 60 co-sponsoring developing countries, to stand their ground. We call on the UK and other countries to support the original proposal. These countries consistently insist they would like to do everything they can to end the pandemic — here is their chance.