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10 February 2022Africa

MSF urges South Africa to open access to COVID-19 generics

Humanitarian organisation Médecins Sans Frontières (MSF) has called for the South African government to seek the revocation of COVID-19-related patents granted to Eli Lilly and Moderna.

In a press release issued on February 9, MSF and human rights organisation People’s Health Movement (PHM) urged the government to revoke the patents, and to take “urgent steps to reform the country’s outdated patent law that leads to the proliferation of unmerited patent monopolies”.

According to the organisations, Eli Lilly’s patent for baricitinib is limiting access to affordable generic versions of the medicine. In January, the World Health Organization strongly recommended baricitinib for patients with severe or critical COVID-19.

“Baricitinib is an oral drug that is easy to administer, especially in resource-limited settings, such as those where MSF operates,” said MSF and PHM. “Generic manufacturers in India and Bangladesh have made baricitinib available for under US$7 per 14-day treatment course, which is significantly less than Eli Lilly’s prohibitive price of $1,109 per 14-day treatment course in the US.”

The organisations added that Eli Lilly’s patent monopoly blocks production and access to these lower-cost generic versions in South Africa, so the price of baricitinib would remain prohibitive at $270 per 14-day treatment course.

Tom Ellman, director of MSF’s Southern Africa medical unit, said: “It is outrageous that people in South Africa are being denied access to lifesaving COVID-19 treatments like baricitinib because of patents.

“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.”

According to MSF, local production of COVID-19 mRNA vaccines may be affected by the fact that South Africa has granted Moderna at least three patents related to mRNA vaccines.

“Notably, several equivalent patents in other countries—Australia, Canada, China, India, Israel, Japan, Mexico, Singapore and South Korea—have been rejected by national patent offices or withdrawn, or abandoned by Moderna,” said MSF and PHM.

In October 2020, Moderna announced that it would not enforce patents related to its COVID-19 vaccine while the pandemic is ongoing, and that it is prepared to license the patents to others after the pandemic is over.

However, the organisations said that Moderna had created uncertainty at the time by stating that the pandemic might end within a year.

Candice Sehoma, MSF Access Campaign’s advocacy advisor for South Africa, said: “While South Africa continues to lead on the landmark ‘TRIPS Waiver’ proposal at the World Trade Organization, the government should also take immediate actions to address access to medicines barriers domestically, and prioritise patent law reform.”

Finally, MSF and People’s Health urged the government to reform the country’s patent law, noting that it has several shortcomings, including “weak patent application examinations and limited avenues for interested parties to challenge unmerited patents”.
The organisations warned that these shortcomings have led to the proliferation of “unmerited patents” on medicines and vaccines.

In 2013, the South African government committed to driving forward reforms to the patent law. It adopted a revised IP policy in 2018, but this will only be effective when signed into revisions of national law.

Lauren Paremoer, member of the PHM in South Africa, said: “The South African government needs to prioritise 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.”

In January, IP experts discussed the proposed IP waiver for COVID-19 vaccines and treatments during on LSPN Connect. Jim Pooley, independent attorney at  James Pooley PLC, and Sven Bostyn, associate professor of biomedical innovation law at the University of Copenhagen warned that the waiver will not work as intended.

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23 May 2022   South Africa’s Supreme Court has declared regulations on complementary medicines invalid, explain Kareema Shaik and Jenny Pienaar of Adams & Adams.
article
1 February 2022   A landmark proposal to suspend provisions of TRIPS for COVID-19 vaccines and treatments was first raised in October 2020. But, nearly a year and a half later, in January 2022, it seems there is no end in sight, with members of the World Trade Organization failing to reach consensus.
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8 March 2022   Moderna has stated that it will “never” enforce its COVID-19 patents in 92 low and middle-income countries.