‘TRIPS Waiver’ must be agreed now, says MSF

With the TRIPS Waiver negotiations formally resuming this week at the World Trade Organization (WTO), Médecins Sans Frontières (MSF) called on the European Union (EU), the UK and Switzerland to swiftly adopt the landmark Waiver, which would lift Intellectual-Property (IP) monopolies on COVID-19 medical tools, and is currently supported by over 100 Low- and Middle-Income Countries (LMICs). MSF also urged the US to show concrete leadership to accelerate the negotiations and to broaden the scope of its support beyond only vaccines to include medicines and diagnostics, MSF said in a statement.

“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 LMICs where we work, while wealthy countries which have hoarded vaccines are now buying up much of the supply of new treatments,” said Yuanqiong Hu, senior legal and policy adviser for MSF’s Access Campaign in the statement. “The EU, the UK and Switzerland should heed the call of LMICs to endorse this ground-breaking waiver that could promote access, local production and self-reliance,” he added.

Alongside the continued vaccine access inequity, access to COVID-19 treatments remains a challenge. The recent World Health Organization (WHO)-recommended oral treatment, baricitinib, is widely patented in more than 50 countries, and priced out of reach in most LMICs. These patents would only start expiring in 2029, and are likely to continue blocking generic production and supply in countries where granted. 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. Eli Lilly’s restrictive licence to Indian generic companies inhibits the supply of generic versions of the drug to any other countries outside of India. The case of bariticinib demonstrates the urgent need to adopt the waiver so that countries are not reliant on Eli Lilly’s pricing and supply schedules, the statement further said.

It also mentioned that another case of inequity 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 Pfizer and the Medicines Patent Pool for the treatment nirmatrelvir/ritonavir. This means those countries will not be allowed to buy generic versions of this oral 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 will leave countries solely dependent on Pfizer’s supply and pricing decisions. Local production and supply of generic nirmatrelvir/ritonavir in Latin American countries would need to be supported by removing the main IP barriers, which could be accomplished by adopting the TRIPS Waiver.

“The impact of the pandemic in many Latin American countries, including Brazil, Bolivia, Colombia and Peru was devastating, with 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,” said Felipe Carvalho, MSF Access Campaign Coordinator in Latin America.

“As countries in Latin America continue to live in fear of the emergence of newer variants that may threaten the efficacy of the 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,” Carvalho further said.

Increasing evidence has demonstrated that IP is among the potential barriers to ensure local production and supply of COVID-19 vaccines and treatments in countries. For instance, 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, and 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. A waiver focusing only on vaccines, while ignoring other COVID-19 medical tools, will be a failure,” said Hu.