Include Malaysia And Other Middle-Income Countries in All Licensing Agreements For Covid-19 Diagnostics, Treatments, And Vaccines — MHC & DNDi

Gilead excluded Malaysia, among other middle-income countries, from distribution of Remdesivir to 127 nations under voluntary licensing.

The signatories of this Joint Statement are a group of health professional societies, non-profit organisations, advocates, policymakers and citizens. We hold the strong position that the global fight against Covid–19 will be won only if all stakeholders play their part.

We note Gilead Inc’s announcement on 13 May 2020 that they have signed non-exclusive voluntary licensing agreements (VLs) with five generic pharmaceutical manufacturers to expand the supply of Remdesivir to 127 countries. We also note Malaysia and other middle-income countries’ absence from that list, and that Remdesivir is not currently approved in any country for any indication.

Therefore, we urge all global diagnostics, pharmaceutical and vaccine companies, including Gilead, to meet the following recommendations 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 can import from VL generic manufacturers if necessary

Malaysia has made significant progress towards universal health coverage, but gaps remain. One, 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.

Two, reinforcing this argument is 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.

Three, based on Malaysian Department of Statistics data, 3.1 million residents in Malaysia (9.5% of the total population) are non-citizens such as migrants, refugees and stateless persons with relatively lower healthcare access compared to citizens. The number of non-citizens is likely to be under-estimated, and all residents need equal care during Covid and non-Covid periods. Therefore, any VL by any company for any diagnostics, pharmaceuticals and vaccines during the Covid–19 pandemic should include Malaysia.

Be transparent with decision-making criteria for all VLs and apply these criteria consistently.

We fear a fragmented future landscape of inconsistent decision-making criteria adopted by multiple companies deciding the levels of health care access for sovereign states in non-transparent, non-accountable and unfair ways.

Therefore, we urge industry associations like the International Federation Pharmaceutical Manufacturers Associations (IFPMA), Pharmaceutical Research & Manufacturers of America (PhRMA) or European Federation of Pharmaceutical Industry Associations (EFPIA) to publish criteria for inclusion in these licences and ensure that decision-making takes into account real and meaningful country differences, rather than operating purely on the basis of World Bank categorisations of country income status based on GNI per capita.

We also urge these industry associations to formally acknowledge, embrace, and incorporate thinking around Covid–19 technologies as global public goods, in line with the assertions contained in WHO’s Call to Action for Covid–19 and the European Commission’s Coronavirus Global Response.

There are crucial ethical, humanitarian, medical and public health reasons to make diagnostic technologies, pharmaceuticals and vaccines widely available during this worldwide pandemic. International law under the World Trade Organization’s Doha Declaration on TRIPS & Public Health allows for compulsory licensing for national emergencies or circumstances of extreme urgency, among other grounds.

While we recognise the relevance of the global intellectual property frameworks, we urge patent-holders to adopt global voluntary licensing arrangements to allow all of humanity to defeat this unprecedented pandemic.

Overcoming this pandemic requires a whole-of-humanity effort. The Secretary-General of the United Nations has stated that human health, vaccines, therapeutics and diagnostics are global public goods. There is an opportunity for global companies to take their place in history by ensuring widespread access to all potential Covid–19 vaccines, therapeutics and diagnostics.

It is time to prioritise public interest and make decisions for global common good. History provides one timeless example: Sabin’s polio vaccine was never patented.

The Malaysian Health Coalition (MHC) is an apolitical coalition of 46 Malaysian health professional societies, health professionals and citizens dedicated to improving the health of Malaysians, strengthening the Malaysian health system, and supporting Health in All Policies.

The Drugs for Neglected Diseases initiative (DNDi) is a not-for-profit research and development organization working to deliver new treatments for neglected diseases as well as treatments for neglected patients. Since its inception in 2003, DNDi and its partners have delivered eight innovative treatments to improve the quality of life and health of patients.

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