KUALA LUMPUR: A group of more than 50 health-related organisations and individuals is urging American biopharmaceutical company Gilead Sciences to allow Malaysia to import generic versions of remdesivir, an anti-viral drug used to treat Covid-19 patients.
The generic versions of remdesivir, which was originally developed to treat Ebola, are from manufacturers Gilead has given voluntary licensing (VL) agreements to.
According to Gilead's website, it signed non-exclusive VL agreements on May 13 with five companies to manufacture remdesivir for distribution in 127 countries, mainly low- and middle-income countries as well as those with obstacles to healthcare access.
Under the licencing agreements, the companies have a right to receive a technology transfer of Gilead's remdesivir manufacturing process and to set their own prices for the generic version of the drug produced.
However, Malaysia is not in the 127-country list.
Remdesivir is also only approved for emergency use in the United States and Japan but is not registered in any country.
The statement, issued jointly by the Malaysian Health Coalition (MHC) and the Drugs for Neglected Diseases initiative (DNDi) on Tuesday (May 19), also urged all manufacturers to provide access to generic VL medical products, to ensure that "all of humanity will have people's vaccines, people's medicines and people's diagnostics".
"Ensure Malaysia and all middle-income countries are able to import from VL generic manufacturers if necessary," they said.
They said that Malaysia has made significant progress towards universal health coverage, but gaps remain and the financial and economic impact of the Covid–19 pandemic will further strain national resources and widen access gaps, especially when Malaysia is under-spending on health.
"Similar to many other countries, Malaysia has limited fiscal space for additional spending," they said.
They also pointed out a World Bank projection that the poverty rate in Malaysia may increase by up to 16% as a direct result of the Covid–19 pandemic.
Malaysian Statistics Department data also revealed that 3.1 million residents in Malaysia (9.5% of the total population) are non-citizens with less access to healthcare.
"The number of non-citizens is likely to be under-estimated, and that all residents need equal care, any voluntary licencing by any company for any diagnostics, pharmaceuticals and vaccines during the Covid–19 pandemic should include Malaysia," they argued.
They also urged pharmaceutical companies to be transparent with the criteria set for all VLs and apply them consistently.
They urge industry associations to publish criteria for inclusion in these licences and ensure that decision-making takes into account real and meaningful country differences rather than just basing it on the World Bank categorisations of country income status based on GNI per capita.
"There are crucial ethical, humanitarian, medical and public health reasons to make diagnostic technologies, pharmaceuticals and vaccines widely available during this worldwide pandemic," they said.
They also reminded pharmaceutical companies that the World Trade Organisation's Doha Declaration on Trade-Related Aspects of Intellectual Property Rights and Public Health allows governments to invoke compulsory licensing for national emergencies or circumstances of extreme urgency.
"While we recognise the relevance of the global intellectual property frameworks, we urge patent-holders to adopt global VL arrangements to allow all of humanity to defeat this unprecedented pandemic.
"Overcoming this pandemic requires a whole-of-humanity effort," they said.
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