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.
MSD has entered into non-exclusive voluntary licensing agreements with 5 generic companies in India and the Medicines Patent Pool, generating access to Molnupiravir in over 100 low- and middle-income countries.
MSD has a comprehensive human rights policy which includes adherence to the UN Guiding Principles on Business and Human Rights, the International Bill of Rights and the OECD Guidelines for Multinational Enterprises, among others.
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.
MSD signed an agreement with the MPP on 27 October 2021 granting it permission to sublicense the new oral Covid-19 treatment Molnupiravir to supply 105 low- and middle-income countries.
MSD has entered into non-exclusive, voluntary licences to 105 countries through the deal with the MPP. However, for countries not included in the MPP deal, patents are enforced normally (no statement of non-enforcement has been made).
MSD signed a long-term supply agreement on January 17 2022 to supply UNICEF and the ACT Accelerator Therapeutics Partnership with 3 million courses of Molnupiravir to be made available to low- and middle-income countries in the first half of 2022
MSD has issued non-exclusive, voluntary licenses to 105 countries through its deal with the MPP.
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.
The deal with the MPP obligates licensees to enter into additional supply agreements to supply Merck with Molnupiravir at the cost of production plus a “reasonable” mark-up (Clause 3B 1.2) MSD is therefore not making the active ingredient for Molnupiravir available to other manufacturers.
The voluntary licensing agreements with Indian manufacturers entered into through the MPP deal includes an agreement to transfer the technology for producing Molnupiravir.
MSD has stated that it will adopt a tiered pricing approach for the countries included in the license – many middle-income countries have to pay around 40x more than what the generic companies are charging (US: 700 US dollars; Thailand 300 US dollars; India (generic) around 20 US dollars. The drug costs around 8 US dollars to produce).
This tiered pricing strategy is good for low-income countries, but it excludes many middle-income countries that are unable to pay the full price.
[Only applies to vaccines]
No information has been found on this criterion.
No information has been 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.
MSD publishes its overall research and development costs in its annual and quarterly financial reports, but these are not specific to Molnupiravir.
MSD publishes that they made 952 million US dollars of sales of Molnupiravir in 2021, but makes no mention of a margin (sources in the public domain have published an estimate of the company’s profit margin)
MSD does not publish the average and/or marginal costs of producing Molnupiravir.
MSD plans to produce 10 million courses by the end of 2021, and 20 million courses are expected to be produced in 2022.
In its response to our questionnaire, MSD states: “Molnupiravir was invented at Emory University. Drug Innovation Ventures at Emory (DRIVE), LLC, which was formed by Emory to develop early-stage drug candidates for viral diseases of global concern, advanced Molnupiravir through IND submission. Emory/DRIVE received some research funding from the U.S. Department of Defense and the U.S. National Institutes of Health. Molnupiravir is being developed by MSD in collaboration with Ridgeback Biotherapeutics. Ridgeback received an upfront payment from MSD and also is eligible to receive contingent payments dependent upon the achievement of certain developmental and regulatory approval milestones. Since licensed by Ridgeback, all funds used for the development of molnupiravir have been provided by MSD and Ridgeback.”
However, Knowledge Ecology International (KEI) comments on the fact that “Wendy Holman, the CEO of Ridgeback, participated in a webinar centered on discouraging the use of the U.S. government’s publicly-funded inventions to expand access to COVID-19 vaccines and treatments.”
The MPP license is published and transparent; the license with the US government was obtained by KEI but not published by MSD.
MSD registers its clinical trials on clinicaltrials.gov. The company is now evaluating Molnupiravir in the prevention setting in our MOVe-AHEAD study.
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