Bharat Biotech Vaccine
Fair Pharma Scorecard
Applying human rights to pharma
Menu
Click on ‘Explanation about the score’ sign next to each entry to expand and learn more.
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.
CIGB has not mentioned a global access plan for its product, but Cuba’s biotech sector is public, and Cuba has adopted an open licensing, open patents approach for its vaccines, which will contribute to global access to Abdala.
CIGB does not mention human rights on its website.
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.
CIGB does not commit to C-TAP or the MPP.
The patent for Abdala has been shared with Venezuela, which shows willingness to not enforce patent exclusivity relating to Abdala. Moreover, Cuba’s commitment to ‘share its vaccines through open licensing’ implies non enforcement of the exclusive rights of patents.
In order to participate in COVAX, Covid-19 medical products must be approved by the WHO/FDA/EMA. Abdala has not yet received any of these approvals. Cuba in general has declined to participate in Covax.
CIGB has licensed Abdala to Venezuela.
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 therapeutics]
CIGB has signed a technology transfer agreement with Venezuela, which is due to start manufacturing the vaccine in April 2021.
Vietnam paid 32.6 million US dollars for 5 million doses, which equates to approximately 6.50 US dollars per dose. Compared to other vaccines, this is relatively affordable for low- and middle-income countries. The vaccine is non-profit domestically, but not for other countries. It is likely that Cuba will apply differential pricing for low- and middle-income countries, but no official statement to this effect has been made yet.
CIGB has sold 25.500.000 doses in total, all to low-income countries.
Cuba has committed to open licensing for its Covid-19 vaccines. CIGB is a state-run pharmaceutical company and Abdala is thus included in this offer.
Cuba’s commitment to open licensing and full technology transfers to other companies imply an agreement to waive rights in regulatory test data.
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.
CIGB has not published the research and development costs for Abdala.
CIGB has not disclosed any profit margin, but it seems to be selling at non-profit or a very low price (around 6.5 dollars per dose). Moreover, Cuba’s biotech sector is entirely state-owned, “free of private interests, with […] no profit-seeking in the domestic market.” However, the company has not published a clear statement on whether it will make a profit on Abdala internationally or not.
The average and/or marginal costs of producing Abdala are not published.
Cuba has stated that it has the capacity to produce 100M doses of Soberana, Soberana II and Abdala vaccines combined.
The company is entirely State-run, which implies that Abdala was financed mostly with public money. Other countries have also donated funds to Cuba’s biotechnology sector, as Cuba has been under US embargo for 60 years.
CIGB has not published the texts of any licensing agreements.
CIGB registers its clinical trials plus results in public clinical trial databases
Never miss an update from the Pharmaceutical Accountability Foundation!
