Bharat Biotech Vaccine
Fair Pharma Scorecard
Applying human rights to pharma
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The company should publicly commit to human rights in relation to product development and marketing, by adopting an official human rights policy statement recognising the right to the highest attainable standard of health. The company should endeavour to integrate human rights into its strategies, policies, programmes, projects, and activities.
The company should also have a publicly available global access plan for their Covid-19 product, based on human rights standards, with measurable targets and lines of accountability.
Gilead has not published a global access plan for its product.
In its response to our questionnaire, Gilead states: ‘In the developing world, we have entered into non-exclusive voluntary licensing agreements with nine generic manufacturers to further expand access and supply of Remdesivir. These agreements serve 127 countries classified as lower-income or that face significant obstacles to healthcare access. We recognize the need to help countries in regions of high need that are not currently covered by the voluntary licensing agreements. We are exploring a number of innovative strategies to support access to remdesivir in these countries.’
Gilead has published a code of ethics. It has also joined the UN Global Compact, a voluntary initiative for businesses to align their practices with human rights.
The company should constructively engage with international initiatives for the equitable distribution of vaccines and therapeutics, such as the Covid-19 Technology Access Pool (C-TAP) or the Medicines Patent Pool (MPP), and the ACT Accelerator (COVAX). The company should also publicly commit to not enforcing the exclusive rights of Covid-19 related patents, and enter into non-exclusive, transparent licensing agreements for its Covid-19 products with other companies.
Gilead is ‘in active discussions with the MPP […] to license Remdesivir for developing countries’.
In its response to our questionnaire, Gilead stated: “We are aware of proposals for manufacturers to license their intellectual property under various pooled arrangements and have not made any determination on these proposals.”
Gilead has signed non-exclusive voluntary licenses with 127 (mostly) low- and middle-income countries; but the terms are secret and there is no explicit commitment not to enforce patents.
Gilead stated in its response to our questionnaire: “There is no evidence that intellectual property is a barrier to access.”
Gilead has not signed an agreement with the ACT Accelerator so far. In its response to our questionnaire, Gilead states that “Gilead’s extensive investments in remdesivir research and development, manufacturing production and access have already addressed for remdesivir the challenges that the ACT Accelerator is intended to overcome.”
Gilead has signed non-exclusive voluntary license agreements with 9 Indian/Pakistani companies for supply to 127 (mostly) low- and middle-income countries.
Public Citizen comments: “Gilead Sciences today announced a licensing arrangement with five generics manufacturers to facilitate international manufacture and distribution of remdesivir, the experimental treatment for COVID-19. According to Gilead’s statement, the licenses would allow sales from these other manufacturers in certain countries but exclude others. The more than 70 countries excluded would have to buy remdesivir from Gilead at its monopoly price or overcome Gilead’s claimed patents. The terms of the licenses have not been made public.”
The press release on Gilead’s website detailing the licensing agreements has been removed; see here.
The company should engage in efforts to further equitable distribution of Covid-19 vaccines/therapeutics, by equitably distributing its supplies globally, devising fair pricing strategies, and making the active ingredient for its product available to other manufacturers. The company should also engage in full technology transfer to other manufacturers, including the necessary transfer of skills, legal components, knowledge and intellectual property. Where applicable, the company should agree to waive rights in regulatory test data, and refrain from enforcing TRIPS+ measures.
Almac Sciences was awarded 500 000 USD by the Covid-19 Therapeutics Accelerator (BMGF & Mastercard) ‘towards developing cost effective, scalable processes for the production of the active pharmaceutical ingredient (API) of the drug remdesivir’
Gilead appears to have donated active ingredients to India to scale up the manufacturing of Remdesivir.
Gilead has signed non-exclusive licenses with 9 generic companies for supply to 127 countries, under which the companies have a right to receive a transfer of technology. However, the press release on Gilead’s website which gives details of this is no longer available
Gilead states in its response to our questionnaire: “Gilead has completed remdesivir technology transfers with nine generic manufacturers, and they are actively supplying countries in the developing world. Early in the pandemic, we provided licenses to generic manufacturers in Egypt, India and Pakistan as a means to ensure patient access to remdesivir in 127 countries that are classified as lower-income or that face significant obstacles to healthcare access. These licenses are royalty-free during the pandemic.”
According to Public Citizen, the licensing agreements are narrow and the terms secret.
Gilead is pricing Remdesivir lower than they would usually do to developed countries at $390,- per dose. The price for low- and middle-income countries is ‘much lower’, although Gilead does not state which exact price low- and middle-income countries will pay. The profit margin is unclear, but seems to be lower than usual. See here.
Gilead is charging developed countries between $390 per vial to $520 per vial—or $2340 per patient to $3120 per patient. However, the cost of manufacturing Remdesivir at scale with a reasonable profit is $0.93 per dose.
Gilead stated in its response to our questionnaire: “We have set a price for remdesivir that is significantly below the potential value that the medicine delivers to help patients recover faster, resulting in immediate cost savings for healthcare systems.”
