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.
Gamaleya has not published a global access plan for Sputnik V. Gamaleya does, however, adopt an open licensing approach (see C4), which will have a favourable impact on global access for its product.
The company has published a document in which they state that the Biomedical Ethics Committee is acting in accordance with various documents, including the Russian Constitution, which contains human rights. However, this does not make it an explicit commitment to adhere to 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.
Gamaleya does not commit to C-TAP or the MPP.
Gamaleya has not made a commitment not to enforce patents, but it does adopt an open licensing approach, which effectively entails non enforcement of the exclusive rights of patents.
Gamaleya has signed an agreement with UNICEF for a Long-Term Agreement (LTA) for 220 million doses of Sputnik V, conditional on approval by WHO regulator for Emergency Use Listing. As of March 2022, Sputnik V has still not received approval, however.
Gamaleya has adopted an open licensing approach (quality control concerns), and as such, has signed non-exclusive license agreements with 27 manufacturers.
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.
[Only applies to vaccines]
Gamaleya has signed manufacturing contracts with partners in different middle income countries, such as Brazil, China, India, Kazakhstan, Malaysia, South Korea and Russia. The company is also collaborating with AstraZeneca to combine their vaccines (which also requires the transfer of technology)
It has also shared the ‘regulatory dossier’ with multiple manufacturers, including Indian companies such as Dr Reddy’s, Panacea Biotech, Stelis Pharma, Hetero, Gland Pharma, Virchow, and the Serum Institute of India. Leena Menghaney from Médecins sans Frontières states ‘the sharing of dossiers is rarely done, due to trade secret and non-disclosure issues’.
Gamaleya has not committed to non-profit pricing (Sputnik V is priced between 9.95 and 19 US dollars per dose).
Gamaleya has signed supply agreements for 553.383.000 doses outside of Russia.
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.
Gamaleya has not published any research and development costs on its website.
Gamaleya states that the vaccine will cost around $10,- per dose, but does not specify whether there is any profit margin included in that price.
Gamaleya has not published the average and/or marginal costs of producing Sputnik V.
Gamaleya states that its production capacity will be 1 billion doses in 2021.
Gamaleya states that the Russian Direct Investment Fund is financing the development of the vaccine, but does not specify amounts.
Gamaleya has not published the texts of any licensing agreements.
Gamaleya has registered its clinical trials on clinicaltrials.gov and in the Lancet.
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