Bharat Biotech Vaccine
Fair Pharma Scorecard
Toetst farmaceutische bedrijven op mensenrechten.
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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.”
[Only applies to vaccines]
No information was found on this criterion.
No information was found on this criterion.
The company should be as transparent as possible, by publishing its research and development costs, profit margin, average costs of production, and production capacity for its Covid-19 product. It should also disclose the amount of public subsidies received during product development and/or testing. Licensing agreements should also be made publicly available and clinical trials should be registered in public repositories.
Gilead declares its research and development costs in its quarterly reports, but these are not specified for Remdesivir: “R&D expenses for the full year 2021 were $5.4 billion compared to $5.0 billion in 2020.” (28% of revenues)
In its response to our questionnaire, Gilead states: ‘In 2020 alone, we invested more than $1 billion to quickly ramp up the development and manufacturing of Remdesivir.’
In footnote 35 of the GAO report ‘Information on Federal Contributions to Remdesivir’, Gilead specifies its redesivir investments, as of December 2020, at $1.3 billion. According to the company, of the $786 million in R&D costs, Gilead spent $215 million on the discovery and development of remdesivir prior to 2020, of which $175 million is attributable specifically to R&D costs and $40 million to costs of supplying remdesivir for use in NIH clinical trials and other clinical and research settings. Gilead told GAO that in addition to the R&D costs the company spent $147 million to supply remdesivir for use in clinical and research settings and $318 million to expand remdesivir manufacturing and distribution capabilities, as of December 2020.
The same GAO report states in table 1 on page 15 that the NIH allocated $109.2m for remdesivir clinical trials in 2020.
Gilead has not mentioned a clear profit margin, but it has stated that the $390,- per dose price of Remdesivir is much below the value of the product that they normally charge. They have also stated that they will charge governments of low- and middle-income countries much less for Remdesivir.
“Total full year 2021 revenue of $27.3 billion increased 11% compared to 2020, due to increased demand for Veklury.” (full year 2021 report). Verklury generated 3640m US dollars in sales in 2021, but doesn’t mention a profit margin.
Gilead does not publish the average and/or marginal costs of producing Remdesivir. In its response to our questionnaire, Gilead states: ‘we have set a single government price for remdesivir in developed countries that is significantly below the potential value that remdesivir delivers’.
Gilead does not state its exact production capacity, but is very transparent about where it produced Remdesivir and whether its production capacity meets demand. Exact production capacity might be difficult to calculate because of the many voluntary licenses.
Gilead acknowledged that there “. . . there is no assurance that we will be able to meet global supply needs for remdesivir.” which led to shortages in the US due to monopoly
Public investment in research and development (R&D) for Remdesivir already began years before R&D on its effectiveness against Covid started. During the pandemic, Gilead has not published a press release on public investment in R&D on Remdesivir.
In its response to our questionnaire, Gilead states: ‘Portions of the preclinical research of remdesivir were conducted in collaboration with scientists at the University of North Carolina and Vanderbilt University, undertaken in connection with a multi-university consortium focused on identifying potential treatments for a variety of emerging diseases. Because many of the federal grants used to support the consortium were for a broader spectrum of work in terms of both compounds and viruses, we are unable to determine what portion of those grant awards were used to fund research associated with remdesivir in general and specifically in coronaviruses.’
It refers to a report of the Government Accountability Office (GAO) on the federal government’s involvement in the research and development of Veklury® (remdesivir) last March:
The report finds that although public agencies contributed around 162 million USD in research funding; this research did not ‘generate new inventions’. However, the government funded clinical trials for Remdesivir.
Gilead has not published the texts of any licensing agreements. In its response to our questionnaire, Gilead states: “While these agreements are similar to our previous generic licensing agreements for HIV and viral hepatitis drugs, we do not believe that disclosing the specific contractual terms is appropriate at this time. We may make this information available in the future.”
Gilead registers its clinical trials plus results in public clinical trial databases.
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