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.
AstraZeneca’s website states: “Our response to the COVID-19 pandemic, with a focus on low and middle-income countries, is one example of our equitable access strategy in action.”
In its response to our questionnaire, the company mentions its collaboration with the Bill and Melinda Gates Foundation to enhance equitable access to Covid-19 medical products, and the fact that two thirds of its vaccines have gone to low- and middle-income countries, as well as 250 million doses delivered through COVAX. This is not published in a dedicated global access plan on their website.
AstraZeneca states that it is guided by the United Nations Guiding Principles on Business and Human Rights, the Universal Declaration on Human Rights, and the UN Global Compact (UNGC).
“We commit to the Guiding Principles to respect human rights by acting with due diligence to avoid infringing on human rights and to address negative impacts. “We have ensured that the UNGC and its ten Principles have become part of our strategy, culture and day-to-day operations, and they will remain vitally important in the years ahead” — Pascal Soriot, AstraZeneca CEO in a recommitment letter to the UNGC.
In its response to our questionnaire, AstraZeneca mentions that it is a member of Pharmaceutical Supply Chain Initiative (PSCI), and supports its principles for Responsible Supply Chain Management for ethics, labour, health and safety, environment, and related management systems. Finally, AstraZeneca also conducts human rights due diligence to assess the human rights risks of its activities.
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.
When asked about AZ’s support of MPP or C-TAP at an IFPMA forum in May, CEO Pascal Soirot stated that ‘’intellectual property is a fundamental part of our industry and if you don’t protect IP, then essentially, there is no incentive for anybody to innovate.’’ AZ has not demonstrated any factual support to a responsible licensing mechanism.
Their response to our questionnaire had a similar message: Vaccines are highly specialized, complex biological products which are subject to rigorous testing and quality standards and processes during their development. Our approach has been to share our technology and know-how with experienced vaccine manufacturing organizations in countries where production can be set up or ramped up at scale. We believe this offers a more effective way of scaling up production and supporting innovation, and our model has enabled us to supply more than 2.5 billion doses to 170 countries around the world in just over a year since the first international approvals. To do this we enabled technology transfer to more than 20 different supply partners, including four sublicense agreements. Our sub-licensing agreement with Serum Institute of India (SII) supports the supply to India and to low and lower-middle income countries. Each of our sub-licensing agreements is thought out in detail to ensure it supports the best strategy for broad and equitable access. Waiving IP rights completely would not solve the challenge of rapidly scaling up manufacturing to meet global demand. Rate-limiting factors include the time it takes to transfer the technical knowledge, skills and expertise to produce the vaccine, as well as the lack of specialized producers that can quickly set up the industrial capacity to make a safe and effective vaccine at scale.
See also Statnews article on this.
In its response to our questionnaire, AstraZeneca mentions that it has enabled technology transfer to over 20 supply partners across 15 countries, but this does not equate to a commitment not to enforce patents overall.
AstraZeneca was the first pharmaceutical company to sign an agreement with COVAX in June 2020. It has agreements with the Serum Institute of India (SII), CEPI and GAVI to supply 400m doses to 92 AMCs through COVAX.
AstraZeneca states in its response to our questionnaire: “As of 14 January 2022, over 257 million AZ/SII doses have been delivered through COVAX to 130 countries. Over 204 million (79.36 %) of these doses have been delivered to LMIC/LICs. We put broad and equitable access at the heart of our response to the pandemic with approximately two thirds of our global supply of 2.5bn doses going to low and lower middle income countries. We have facilitated the donation of over 200 million vaccines worldwide.”
AstraZeneca has technology transfer agreements with over 20 different supply partners in over 15 countries, including 4 sublicensing agreements (FioCruz, SK Bioscience, R-Pharm, Siam Biosicence, Serum Institute of India, CEPI/GAVI)
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]
AstraZeneca agreed with Oxford University and Vaccitech to operate at a non-for-profit basis for the duration of the pandemic. Licensing agreement with FioCruz does however contain a provision saying that AstraZeneca may declare the pandemic over by 9 July 2021.
Now AstraZeneca is making a ‘modest’ profit – vaccines priced between 2 and 6 USD /dose. This remains affordable for most middle-income countries, and also includes a tiered pricing model which continues the commitment to provide the vaccine at no profit to low-income countries.
See also Donato Paolo Mancini and FioCruz & AstraZeneca, Technological Order Agreement Term № 01/2020.
AstraZeneca has sold only 23.6% of its doses to high-income countries (HICs). In their response to our questionnaire, they stated that the majority of the 3 billion doses would be directed towards low- and middle-income countries (LMICs). The current LMICs/HICs rate reflects that majority.
No information. The response to our questionnaire is vague: “The vaccine IP is owned by the University of Oxford and AstraZeneca has an exclusive license to develop and manufacture the vaccine globally.”
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.
AstraZeneca declares its research and development costs in its annual 2021 report p21: 7152 million USD overall (28.2% of total revenue), but these are not specific to the Covid-19 vaccine.
AstraZeneca claims that it will not make any profit from the vaccine for the duration of the pandemic. However, a provision in the licensing agreement with FioCruz holds that AstraZeneca may declare the pandemic over by 9 July 2021. The influence of AstraZeneca on this provision is unclear.
AstraZeneca’s annual 2021 report discloses a profit of 2219 million USD from Covid-19 vaccine: ‘Total Revenue, predominantly comprised of Product Sales, amounted to $2,219m in the year to date reflecting the delivery of c. 580m doses worldwide by AstraZeneca. Sales in Europe were $736m, Emerging Markets sales were $1,139m, and in Established RoW sales amounted to $344m.’ (p21)
The deal with Oxford allows AstraZeneca to make 20% on top of the cost of goods for manufacturing the vaccine, according to people with knowledge of the contract. AstraZeneca has also stated that incurring costs are in excess of $1 billion and include clinical development, regulatory, distribution, pharmacovigilance and other expenses. Their response to our questionnaire held that the purchase price depends on the supply chain in question and a number of other factors including volume, input and manufacturing costs, upfront investment etc.
AstraZeneca states in its response to our questionnaire: “In 2021 AstraZeneca and our partners released for supply 2.5 billion COVID-19 vaccine doses to more than 170 countries worldwide.”
AstraZeneca has not published statements itself on their website. To our questionnaire, they answered as follows: ‘We have signed a number of agreements with a number of governments around the world in order to share the risk of manufacturing vaccines ahead of approval. Governments in the most part are pre-funding the purchase of vaccines and have asked that details of each agreement are kept confidential. The most significant agreement for direct government support for development of the vaccine was disclosed here.” the amount of BARDA funding was published by the company (1 billion US dollars).
AstraZeneca’s licensing text with Brazillian partner FioCruz is published but contains highly redacted clauses. Other licensing agreement texts are not published.
AstraZeneca registers its clinical trials plus results on clinicaltrials.gov.
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