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.
Finlay has agreed to collaborate on vaccine trials and to open licensing for other countries to produce Soberana 02. Venezuela has taken up the offer. Its open licensing, open patents approach will contribute to global access to the vaccine.
The ‘our values’ section on Finlay’s website refers to ‘good practices for the production of vaccines with a business, social and environmental security approach’. There is no mention of 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.
At the Summit for Vaccine Internationalism (led by the Global South) Cuba committed to open licensing technology for Soberana 2 (including patents & know-how). KEI encouraged Cuba to collaborate with C-TAP. Hopefully Finlay will commit to one of these licensing mechanisms once Soberana 02 receives WHO regulatory approval.
Cuba’s biotech sector is public and it has declared itself to be favourable to the general waiving of monopolies for Covid-19 products. Its patents are therefore public and ‘free to facilitate tech transfer’. Soberana 02 is known as an ‘open-source vaccine’ and the effect of this is equivalent to the company not enforcing its exclusive patent rights.
Cuba is currently ‘assessing the possibility of Cuban participation’ in Covax and is in talks with the Coalition for Epidemic Preparedness Initiative (CEPI).
Finlay has made offers of open licensing, and stated that they would be ‘open to licensing the intellectual property around the vaccines with a small profit margin’. Iran is already producing the vaccine, and Vietnam, Argentina and Mexico have stated that they hope to produce the Cuban vaccines soon.
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]
Finlay has committed to full technology transfer to the Iranian Pasteur Institute for production of Soberana 2 (Jan 08, 2021). It has also signed a letter of Intent with Argentina to collaborate on vaccine R&D; technology transfer, including active materials needed to make the vaccine, to Ghana.
Cuba’s Vice Minister for Health said the vaccines will be ‘affordable and will benefit those most in need’, and has suggested that it will adopt a tiered pricing approach, offering the vaccines free or at cost to poorer nations, and charging more to developed countries. The vaccine is non-profit domestically
70 million doses of Soberana will go to Vietnam, Iran, Pakistan, India, Venezuela, Bolivia, and Nicaragua (middle-income countries and low-income countries in Asia, Latin America & the Caribbean). 5 million doses were shipped to Vietnam on September 25th 2021; 3 5 000 000 doses to Nicaragua. Cuba has stated that it will favour exports to countries with which it has existing healthcare agreements.
All supplies have therefore been sold to low- and middle-income countries.
Finlay does not enforce TRIPS+, as the company has made offers of open licensing and collaboration on vaccine trials.
Finlay’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.
Finlay has not published its research and development costs.
A statement by Cuban officials said that Cuba would license the vaccine with ‘a small profit margin to subsidise the country’s universal healthcare system’. The margin was not specified.
No information was found on this criterion.
Finlay stated last year that it expected to produce 100 million doses in 2021. It hoped to immunize the Cuban population – 11million people – by the end of last year (to date, 88% of the Cuban population has been fully vaccinated with either Soberana 02 or Abdala, another Cuban-produced vaccine).
Finlay lists its ‘sources of monetary support’ here: they include the Finlay Vaccine Institute; Cuban Fund for Science and Innovation (FONCI) from Ministry of Science, Technology and Environment (CITMA) – both government-funded; entirely state-owned biopharmaceutical industry. MediCuba Europe (a group of nonprofit organisations) provided Cuba with funding for covid vaccine testing.
Finlay has not published the texts of any licensing agreements.
Finlay has published all of its clinical trials in the Cuban Public Registry of Clinical Trials.
Never miss an update from the Pharmaceutical Accountability Foundation!
