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 LMICs, as well as 250 million doses delivered through COVAX. This is not published in a specific 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.
“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.
AstraZeneca has not made a statement to not enforce patents.
AstraZeneca has not made an agreement to supply COVAX with Evusheld yet.
Evusheld was licensed to AstraZeneca by Vanderbilt, an agreement under which AZ pays royalties on any future sales.
AstraZeneca signed a manufacturing agreement with Samsung Biologics in Korea. It is unclear whether this deal goes beyond fill-and-finish.
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.
AstraZeneca does not make the active ingredient for Evusheld available to other manufacturers.
The manufacturing deal with Samsung Biologics is described as ‘large-scale commercial manufacturing for drug substance’. It is unclear whether this includes transfer of technology.
Evusheld will be priced commercially, unlike AstraZeneca’s vaccine. To date, it has supplied 1.7 million doses to the US for 855 million US dollars. There is no evidence of non-profit or differential pricing
[Only applies to vaccines]
No information was found on this criterion.
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 publishes in its 2021 Financial report: “Core R&D Expense increased in the year by 36% (33% at CER) to $7,987m with increases in both Reported and Core R&D Expense reflecting the Company’s continued investment in Vaxzevria and Evusheld, and other costs related to COVID-19, such as personal protective equipment and colleague COVID-19 testing across the Company. The increases also reflected the investment in several late-stage Oncology trials and the advancement of a number of Phase II clinical development programmes in BioPharmaceuticals, mainly in CVRM. In the year, grant income of $533m has been recognised, of which $309m has been offset against the US clinical trial costs for Vaxzevria and $224m offset against costs for Evusheld.”
These expenses are not specific to Evusheld.
AstraZeneca states that its total revenue from Evusheld in 2021 was 85 million US dollars, but does not mention a margin for Evusheld.
AstraZeneca does not publish the average and/or marginal costs of producing Evusheld.
AstraZeneca states that “there would be enough production capacity around the world to meet demand”, but a spokesperson from AstraZeneca would not disclose how many doses AZ can produce each month in an interview with Jama.
AstraZeneca published a press release, stating that “Evusheld is being developed with support from the US government, including federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority in partnership with the Department of Defense; Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense, under Contract No. W911QY-21-9-0001.”
The licensing agreement with Samsung Biologics is not published.
AstraZeneca registers its clinical trials plus results on clinicaltrials.gov
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