MSF and South Africa’s People’s Health Movement also call for long overdue patent law reform
NEW YORK/JOHANNESBURG, FEBRUARY 9, 2022—The international medical humanitarian organization Doctors Without Borders/Médecins Sans Frontières (MSF) and the People’s Health Movement (PHM) are calling on the South African government to revoke patents granted to pharmaceutical corporations Eli Lilly and Moderna for a COVID-19 medicine and an mRNA vaccine. These patents in South Africa will likely undermine people’s access to lifesaving treatments and vaccines and could prolong the pandemic for everyone, everywhere.
Despite acknowledging that patents can be a barrier for access to medicines through its leadership on the COVID-19 TRIPS waiver proposal at the World Trade Organization (WTO), South Africa granted a patent to US pharmaceutical corporation Eli Lilly for baricitinib that is currently limiting access to affordable generic versions of this medicine. Baricitinib—an oral drug that is easy to administer, including in resource-limited settings like those where MSF operates—was recently recommended by the World Health Organization (WHO) for people with severe and critical COVID-19.
“It is outrageous that people in South Africa are being denied access to lifesaving COVID-19 treatments like baricitinib because of patents,” said Dr Tom Ellman, director of MSF’s Southern Africa Medical Unit. “While rich countries have been hoarding COVID-19 tests, treatments, and vaccines, the South African government has failed to address domestic access to medicines issues.”
Generic manufacturers in India and Bangladesh have made baricitinib available for less than $7 per 14-day treatment course, significantly less than Eli Lilly’s price of $1,109 per 14-day treatment course in the US. Eli Lilly’s patent monopoly on baricitinib in South Africa blocks production and access to these lower-cost generic versions in the country. Meanwhile, the company has priced it at a prohibitive $270 per 14-day treatment course in South Africa. Licenses that Eli Lilly signed with Indian generic companies in May 2021 are restrictive and do not include South Africa and many other countries.
“It is time for the South African government revoke Eli Lilly’s patent on baricitinib so that lower-cost generic versions of this medicine are available to people who need them,” Ellman said. “South Africa also needs to reform its patent law and must pull through on commitments to closely scrutinize all patents going forward to remove barriers that may hinder access to lifesaving medical tools.”
In addition to patent barriers on COVID-19 treatments, local production of biosimilar COVID-19 mRNA vaccines may be blocked by at least three patents that South Africa has granted US-based Moderna for mRNA vaccines. These patents could make it legally risky for entities that acquire technologies from the WHO COVID-19 mRNA Vaccine Technology Transfer Hub in South Africa to make their own vaccines. Moderna announced in October 2020 that it would not enforce its patents related to COVID-19 mRNA vaccines during the pandemic but also created uncertainty at the time by stating that the pandemic might end within a year. With the pandemic still ongoing, it’s unclear when the company will start enforcing its patents and how forcefully.
“The patents granted to Moderna related to mRNA vaccines may jeopardize the success of the WHO’s mRNA Vaccine Technology Transfer Hub as well as the future of self-reliant vaccine production in South Africa, and should be immediately revoked,” said Candice Sehoma, MSF Access Campaign’s advocacy advisor for South Africa. “While South Africa continues to lead on the landmark TRIPS waiver proposal at the WTO, the government should also take immediate actions to address access to medicines barriers domestically and prioritize patent law reform.”
Patents are not just an issue with COVID-19 medical tools. The South African government must also take urgent steps to reform outdated patent laws that allow pharmaceutical corporations to secure unmerited patent monopolies that block affordable generic and biosimilar vaccine production. Currently, South Africa’s weak patent application examinations make it difficult to challenge pharmaceutical corporations’ unmerited patents. This has led to the proliferation of unmerited patents on medicines and vaccines in the country, preventing more affordable versions from entering the market.
In response to advocacy efforts by civil society organizations, the South African government committed to driving forward reforms to the patent law in 2013 and adopted a revised IP policy in 2018—but this will only be effective when signed into revisions of national law. It is unacceptable that this process continues to be delayed, especially during a global pandemic where patent law reform could foster local production and supply and make COVID-19 medical tools more accessible to people who need them.
“The global inequity in access to COVID-19 medical tools has made it abundantly clear that South Africa needs to focus on creating independent, local production and supply of vaccines and treatments in order to ensure access for people in this pandemic and beyond,” said Lauren Paremoer, member of the PHM in South Africa. “The South African government needs to prioritize people’s health over pharma corporations’ assured profits through patent monopolies and finally reform its patent law so that frivolous patents no longer block generic producers from entering the market to produce and supply more affordable medical tools. We’ve said it before, and we’ll say it again: medicines shouldn’t be a luxury.”