Indonesia Issues Government Use Licenses for Remdesivir and Favipiravir

MMA urges all countries to suspend IP barriers on COVID-19 technologies as new variants emerge

Make Medicines Affordable Campaign and ITPC welcome the Presidential Decrees issued in Indonesia for government use licenses on remdesivir and favipiravir. Although both medications are used to treat other conditions, they have been used extensively in Indonesia to treat COVID-19 during the recent surge in South-East Asia.

Previously in 2020, the Indonesian President issued Regulation 77/2020 as an implementing regulation for the provisions on compulsory licenses under Indonesia’s Patent Law (13 of 2016) (original version; unofficial translation). Regulation 77/2020 specifically recognizes that government use licenses can be issued where there is an international public health emergency among other circumstances.

Presidential Decrees 100 and 101  (unofficial translation 100 & 101) note that COVID-19 is a global pandemic as declared by the WHO as well as a national disaster and accordingly issue government use licenses on the patents and patent applications on remdesivir and favipiravir in Indonesia.

Under the Decrees, the Ministry of Health will identify local pharmaceutical companies who will supply generic versions of the two medicines under the government use licenses. The royalty rate to be paid to the patent holders is set at 1% of net sales. With these government use licenses, Indonesia aims to ensure availability and meet the urgent need for COVID-19 treatments. The government use licenses are valid for three years, with the possibility of being extended if the pandemic does not end in that time.

According to MMA partners, Indonesia AIDS Coalition, the government uses licenses “to avoid Indonesia’s dependence on getting access to diagnostic tools, vaccines and medicines for COVID-19 as well as being a source of production for countries in the region that need it. Indonesia itself is known to have a very adequate production capacity to produce medicines and vaccines for COVID-19 if this is legally possible, especially in relation to the existence of patents that protect the production of medicines and vaccines for COVID-19.

Through these government use licenses, Indonesia continues its good practice of keeping pathways for unrestricted local production or imports of generic medicines open as it has done previously for treatments for HIV and hepatitis. Indonesia is included in several voluntary licenses that have been issued bilaterally or through the Medicines Patent Pool. But these licenses contain several restrictions and conditions that prevent local manufacturers in Indonesia and in several developing and least developed countries from benefitting from them.

The emergence of the latest variant, Omicron, has not only thrown the global response into chaos, it has once more raised the prospect that developed countries will continue to hoard supplies of vaccines and treatments for COVID-19. Indonesia’s government use licenses are setting a path and example for other countries to follow. Relying on limited, voluntary measures like licenses or donations that are just an extension of big pharma’s monopoly games is leaving countries at the mercy of the virus. All developing countries must immediately use every tool at their disposal – whether they are compulsory licenses or the use of national security exceptions to suspend all IP on COVID-19 health technologies. This is essential now to ensure that developing countries can access the tests, treatments and vaccines they need through local production or imports without restrictions or conditions.”, says Aditya Wardhana, Executive Director of the Indonesia AIDS Coalition.

MMA and ITPC join the Indonesia AIDS Coalition in congratulating the government of Indonesia and urge them to further expand the government use licenses to cover potential new COVID-19 treatments (molnupiravir and PF-07321332) as well as COVID-19 vaccines and diagnostics. With massive patient needs, export bans and global supply disruptions, unrestricted global manufacture and supply of COVID-19 treatments and vaccines is essential. And for any future pandemic and even for other diseases, local and regional self-sufficiency in the manufacture and supply of health technologies is needed now more than ever.