[Ip-health] Gilead donating 1.5 million individual doses and mobilizing global capacity - what price thereafter? and insufficient quantities

Baker, Brook b.baker at northeastern.edu
Mon Apr 6 08:37:50 PDT 2020


https://www.gilead.com/stories/articles/an-update-on-covid-19-from-our-chairman-and-ceo<https://nam05.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.gilead.com%2Fstories%2Farticles%2Fan-update-on-covid-19-from-our-chairman-and-ceo&data=02%7C01%7Cb.baker%40northeastern.edu%7Cf03cf97b4f1c47e1b43c08d7d98b9524%7Ca8eec281aaa34daeac9b9a398b9215e7%7C0%7C0%7C637217065861345495&sdata=Ibc%2Bjno9eaGLGwnQ4W8w6SyXY1d1QLeyTkGZ%2BflYPQk%3D&reserved=0>

https://www.bloomberg.com/news/articles/2020-04-04/gilead-to-donate-experimental-coronavirus-drug-for-140-000-cases<https://nam05.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.bloomberg.com%2Fnews%2Farticles%2F2020-04-04%2Fgilead-to-donate-experimental-coronavirus-drug-for-140-000-cases&data=02%7C01%7Cb.baker%40northeastern.edu%7Cf03cf97b4f1c47e1b43c08d7d98b9524%7Ca8eec281aaa34daeac9b9a398b9215e7%7C0%7C0%7C637217065861355490&sdata=weFcnRdYeUDUMVE%2FueWH5inY2nfv%2FV%2BF%2Fl01JObmtwE%3D&reserved=0>

The 1.5 million doses that Gilead will commit to its expanded emergency access program is enough to treat 140,000 people.  It say it will donate this quantity for free even if remdesivir is clinically approved before that quantity is exhausted.

Thereafter, Gilead expects to have 500,000 courses of treatment by October and a million by 2021.  It has made no commitment at this point on pricing of these additional quantities if and when remdesivir is approved.

Gilead has also been expanding its own manufacturing capacity and manufacturing processes and securing supply chains.  It has also entered into multiple supply contracts with other manufacturers.  In a separate statement it has said:

We have supplemented our internal manufacturing with significant additional capacity from multiple manufacturing partners in North America, Europe and Asia. Through these efforts, we believe we have created a manufacturing network capable of producing large volumes of remdesivir at the fastest pace feasible. Looking ahead, we are building a geographically diverse consortium of pharmaceutical and chemical manufacturing companies to help us meet and exceed these production goals by expanding capacity for raw materials and production beyond what any company could do individually.
https://www.gilead.com/purpose/advancing-global-health/covid-19/working-to-supply-remdesivir-for-covid-19<https://nam05.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.gilead.com%2Fpurpose%2Fadvancing-global-health%2Fcovid-19%2Fworking-to-supply-remdesivir-for-covid-19&data=02%7C01%7Cb.baker%40northeastern.edu%7Cf03cf97b4f1c47e1b43c08d7d98b9524%7Ca8eec281aaa34daeac9b9a398b9215e7%7C0%7C0%7C637217065861365486&sdata=e8O%2B7Lh1yD54EcJvPlAjhhqR7Cng1CTd0ZjpsqCVj9I%3D&reserved=0>

Although it might be expected that Gilead will offer concessionary pricing, like J&J has done on its investigational vaccine, I think demands that it relinquish its exclusive rights (patents, data/market exclusivity, manufacturing know-how, and data rights) worldwide are still needed.  There is no guarantee that its eventual price will be the lowest possible and yet health systems will need to conserve resources during and in the aftermath of the pandemic.  More importantly, even with its expanded production capacity, the quantities it describes could be too little, too late to meet emergency global needs if remdesivir is approved to be an effective remedy.

One alternative is for Gilead to indicate its willingness license its remdesivir IP, know how, and data rights to the WHO technology pool proposed by Costa Rica.

However, if Gilead and other companies maintain their monopoly controls or limit their licenses to only some countries, governments need to immediately strengthen and be prepared to use compulsory licensing mechanisms to address not only patents, but data/marketing exclusivity and trade secrets, to ensure mobilization of extra production capacity and access to proven medicines.

Brook



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