Gamaleya Vaccine - Product Scorecard

Company: Gamaleya Research Institute

Type: Covid-19 Vaccine
Product (brand name): Gam-COVID-Vac (Sputnik V)
0%
compliance
with criteria
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Explore the results of PAF’s research into the behaviour of Gamaleya Research Institute . Each section is given an overall score; individual criteria are also scored (see icon following the criteria heading).

Click on ‘Explanation about the score’ sign next to each entry to expand and learn more.

Category A: Commitments and Accountability

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.

A1: Does Gamaleya Research Institute publish a global access plan for its product?

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.

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A2: Does Gamaleya Research Institute commit to comply with human rights standards in relation to product development and marketing?

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.

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Category C: International cooperation

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.

C1: Does Gamaleya Research Institute commit to C-TAP or MPP?

Gamaleya does not commit to C-TAP or the MPP.

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C2: Does Gamaleya Research Institute commit to not enforcing the exclusive rights of Covid-19 related patents?

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.

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C3: Does Gamaleya Research Institute supply to, or signs agreements with, the vaccines or therapeutics pillar of the ACT Accelerator?

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.

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C4: Does Gamaleya Research Institute agree to license its Covid-19 medical products to other companies?

Gamaleya has adopted an open licensing approach (quality control concerns), and as such, has signed non-exclusive license agreements with 27 manufacturers.

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Category E: Equality, non-discrimination & equity

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.

E1: Does Gamaleya Research Institute make the active ingredient available on reasonable grounds? [Only for therapeutics]

[Only applies to vaccines]

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E2: Does Gamaleya Research Institute commit to full technology transfer to other manufacturers?

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’.

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E3: Does Gamaleya Research Institute commit to non-profit, ‘fair’, or differential pricing?

Gamaleya has not committed to non-profit pricing (Sputnik V is priced between 9.95 and 19 US dollars per dose).

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