MSF: No time to lose on landmark TRIPS waiver

Khayelitsha Field Hospital Activity

South Africa 2020 © Rowan Pybus/MSF

US government must remain committed to WTO waiver negotiations, broaden its scope beyond vaccines

NEW YORK/GENEVA, FEBRUARY 22, 2022—With the TRIPS waiver negotiations formally resuming this week at the World Trade Organization (WTO), the international medical humanitarian organization Doctors Without Borders/Médecins Sans Frontières (MSF) called on the European Union (EU), the United Kingdom (UK), and Switzerland to swiftly adopt the landmark intellectual property (IP) waiver on all COVID-19 medical tools. MSF also urged the United States (US) to show concrete leadership to accelerate the negotiations and broaden the scope of its support beyond waiving IP on vaccines only.

If adopted at the WTO, this waiver—which is currently supported by more than 100 low- and middle-income countries—would lift IP monopolies on medical tools for the duration of the pandemic and help ensure access to COVID-19 vaccines, treatments, and diagnostics for everyone, everywhere.

“With almost six million lives lost nearly two years into the COVID-19 pandemic, it is heartbreaking for us to continue to witness outrageous inequity in access to COVID-19 medical tools in many of the low- and middle-income countries where we work,” said Yuanqiong Hu, senior legal and policy advisor for MSF's Access Campaign. “At the same time, wealthy countries that have hoarded vaccines are now buying up much of the supply of new treatments. The EU, UK, and Switzerland should heed the call of low- and middle-income countries to endorse this groundbreaking waiver that could promote access, local production, and self-reliance.”

Alongside the continued vaccine access inequity as fewer than 13 percent of people in low-income countries have received even a single dose, access to COVID-19 treatments also remains a challenge. The World Health Organization recently recommended oral treatment baricitinib—made by US-based Eli Lilly—for people with severe and critical COVID-19 infections. However, it is widely patented in more than 50 countries—and priced out of reach in most low- and middle-income countries. These patents will only start expiring in 2029. Generic versions of baricitinib are available for under $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. Indian generic companies are not allowed to supply generic versions of the drug to countries besides of India because of Eli Lilly’s restrictive licensing.

Another case of inequity that could be softened if the waiver is adopted is being witnessed in Latin America, where a majority of countries are facing limited access to new COVID-19 treatments due, in part, to patent barriers and restrictive licensing deals controlled by pharmaceutical corporations. For example, most Latin American countries have been excluded from the deal signed by US-based Pfizer and the Medicines Patent Pool for the treatment nirmatrelvir/ritonavir (Paxlovid). This means those countries will not be allowed to buy generic versions of this oral and easy-to-administer drug that are produced under the deal. The drug also has patents pending in most Latin American countries, which, if granted, would not expire in many countries until 2041. This would leave countries solely dependent on Pfizer’s supply and pricing decisions for decades.

“The impact of the pandemic in many Latin American countries including Brazil, Bolivia, Colombia, and Peru was devastating,” said Felipe Carvalho, MSF Access Campaign coordinator in Latin America. “There were a very high number of deaths and treatment providers struggling to support COVID-19 patients in severe and critical condition, with limited oxygen and intensive care units. As countries in Latin America continue to live in fear of the emergence of newer variants that may threaten the efficacy of existing preventive tools, access to affordable generic medicines such as baricitinib and nirmatrelvir/ritonavir will be key to treat the most vulnerable people and those contracting severe forms of the disease. It’s high time that opposing countries endorse the TRIPS waiver to facilitate affordable generic production and supply of these medical tools in as many countries as possible.”

Increasing evidence has demonstrated that IP is among the potential barriers to ensuring local production and supply of COVID-19 vaccines and treatments in countries across the world. For instance, US-based Moderna has secured broad patents in South Africa on mRNA vaccine technology, posing legal risks to alternative producers that would aim to bring their vaccines to market.

Given the ongoing glaring inequities in access to COVID-19 vaccines, medicines, and tests, MSF has clearly outlined that the final agreed TRIPS waiver must cover not only vaccines, but all essential medical technologies, including treatments and tests. MSF is also demanding that the duration of the waiver is at least five years in order to allow for the manufacturing and supply of COVID-19 medical tools, including needed materials and components, to be prepared, scaled up, diversified, and sustained.

“Our experience working in public health emergencies and in some of the most difficult situations in the world has made clear that diagnostics and treatment are essential to infectious disease prevention and mitigation, and most fundamentally, for saving lives,” Hu said. “A waiver focusing only on vaccines, while ignoring other COVID-19 medical tools, will be a failure.”