Bharat Biotech Vaccine - Product Scorecard

Company: Bharat Biotech

Type: Covid-19 Vaccine
Product (brand name): BBV152 (Covaxin)
0%
compliance
with criteria
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Explore the results of PAF’s research into the behaviour of Bharat Biotech. 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 Bharat Biotech publish a global access plan for its product?

Bharat Biotech has not published a global access plan for its vaccine.

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A2: Does Bharat Biotech commit to comply with human rights standards in relation to product development and marketing?

Bharat BioTech has a corporate social responsibility policy, but this does not mention 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 Bharat Biotech commit to C-TAP or MPP?

Bharat Biotech has not committed to a responsible licensing mechanism such as C-TAP or the MPP.

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C2: Does Bharat Biotech commit to not enforcing the exclusive rights of Covid-19 related patents?

The ownership of Covaxin is unclear – its development seems to be the outcome of a public-private partnership. In any case, the company has made no commitment to not enforce the exclusive rights of Covid-19 related patents.

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C3: Does Bharat Biotech supply to, or signs agreements with, the vaccines or therapeutics pillar of the ACT Accelerator?

Bharat BioTech is in discussions with the ACT Accelerator for possible use of its vaccine. On April 02nd 2022, the WHO ‘suspended supply through United Nations agencies of Covid-19 vaccine Covaxin, produced by India’s Bharat Biotech, to allow the manufacturer to upgrade facilities and address deficiencies found in an inspection.’

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C4: Does Bharat Biotech agree to license its Covid-19 medical products to other companies?

Covaxin was co-developed by the Indian Council of Medical Research (ICMR) and Bharat BioTech. Ownership of the vaccine is unclear: the Indian government has licensed the vaccine to the Haffkine Institute under a fill and finish arrangement.

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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 Bharat Biotech make the active ingredient available on reasonable grounds? [Only for therapeutics]

[Only applies to therapeutics]

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E2: Does Bharat Biotech commit to full technology transfer to other manufacturers?

Bharat Biotech has deals with other companies to produce the vaccine, but the details of these arrangements are unclear. The deal with the Haffkine institute seems to be for ‘fill-and-finish’, rather than full technology transfer. Moreover, Bharat Biotech has contested the Indian Council of Medical Research’s contribution to the vaccine development, and seems reluctant to transfer its technology to other manufacturers. See C4.

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E3: Does Bharat Biotech commit to non-profit, ‘fair’, or differential pricing?

Bharat Biotech intends to sell its vaccine abroad for around 19 US dollars per dose, making it the 3rd most expensive vaccine globally. Krishna Ella from Bharat Biotech famously declared last year that the vaccine would cost less than a fifth of the cost of a water bottle. The company has not declared any non-profit or tiered pricing strategy.

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E4: Does Bharat Biotech equitably distribute supplies globally? [Only applies to vaccines]

As of January 2022, Bharat Biotech has delivered 98% of its doses to middle-income countries (India, Mauritius, and the Philippines).

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E5: Does Bharat Biotech not seek protection beyond the minimum criteria in TRIPS, or not enforce TRIPS+ measures? [where applicable]

No information has been found on this criterion.

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E6: Does Bharat Biotech agree to waive exclusive rights in regulatory test data? [where applicable]

No information has been found on this criterion.

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Category T: Transparency

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.

T1: Does Bharat Biotech publish its R&D costs?

Bharat BioTech has not published the research and development costs for the vaccine.

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T2: Does Bharat Biotech publish its profit margin?

Bharat Biotech has not published a profit margin for the vaccine.

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T3: Does Bharat Biotech publish the average and/or marginal costs of production?

The costs of producing the vaccine are not published. It has been estimated that if production costs and a minimal profit is included, the amount for one dose would be 150 rupees (less than 2 US dollars). Covaxin is priced at 600 rupees (around 7-8 US dollars) for states, which gives it a profit margin of around 22.725 rupees (around 295 US dollars) for both doses.

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T4: Does Bharat Biotech publish its production capacity?

Bharat Biotech plans to produce 55-60 million doses per month, and 1 billion doses by 2022.

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T5: Does Bharat Biotech publish the public subsidies it received during product development and/or testing?

The vaccine was supposedly co-developed by Bharat Biotech and the Indian Council for Medical Research (ICMR), but the company does not publish the amount of public investment in research and development.

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T6: Does Bharat Biotech publish the text of licensing agreements?

Bharat Biotech has not published the texts of any licensing agreements.

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T7: Does Bharat Biotech register its clinical trials in public repositories?

Bharat Biotech has registered its clinical trials on clinicaltrials.gov.

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