Therapeutic:
Molnupiravir
(MK-4482, EIDD-2801)

MSD Therapeutic Summary Scorecard

Note: While the therapeutic Molnupiravir was developed with the support of Ridgeback Biotherapeutics, this scorecard evaluates only MSD’s practices.

A: Commitments and AccountabilityScoreC: International cooperationScore
A1 The company publishes a global access plan for its productC1 The company commits to C-TAP or MPP
A2 The company commits to comply with human rights standards in relation to product development and marketing C2 The company commits to not enforcing the exclusive rights of Covid-19 related patents
C3 The company supplies to, or signs agreements with, the vaccines or therapeutics pillar of the ACT Accelerator
C4 The company agrees to license its Covid-19 medical products to other companies
E: Equality, non-discrimination & equityScoreT: TransparencyScore
E1 The company makes the active ingredient available on reasonable ground. [Only for therapeutics]T1 The company publishes its R&D costs.
E2 The company commits to full technology transfer to other manufacturersT2 The company publishes its profit margin.
E3 The company commits to non-profit, ‘fair’, or differential pricingT3 The company publishes the average and/or marginal costs of production.
E4 The company equitably distributes supplies globally. [Only applies to vaccines]T4 The company publishes its production capacity.
E5 The company does not seek protection beyond the minimum criteria in TRIPS, or enforces TRIPS+ measures [where applicable]T5 The company publishes the public subsidies it received during product development and/or testing.
E6 The company agrees to waive exclusive rights in regulatory test data [where applicable].T6 The company publishes the text of licensing agreements.
T7 The company registers its clinical trials in public repositories.

MSD Therapeutic Detailed Evaluation

Explore the results of PAF’s research into MSD’s behaviour. Each section is given an overall score; individual criteria are also scored (see icon following the criteria heading). Click on the ‘+’ sign next to each entry to expand and learn more. 

A: Commitments and Accountability

Overall score:

A1 The company publishes a global access plan for its product
  • Voluntary licensing agreements with 5 generic companies in India and the Medicines Patent Pool allowing to sell Molnupiravir in over 100 LMICs – non-exclusive voluntary licensing agreements.
  • Score:
A2 The company commits to comply with human rights standards in relation to product development and marketing
  • MSD has a comprehensive human rights policy which includes adherence to the UNGPs, the International Bill of Rights and the OECD Guidelines for Multinational Enterprises, among others.
  • Score:

C: International Cooperation

Overall score:

C1 The company commits to C-TAP or MPP
  • Yes, 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 LMICs
  • Score:
C2 The company commits to not enforcing the exclusive rights of Covid-19 related patents 
  • MSD has made available 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)
  • Score: 
C3 The company supplies to, or signs agreements with, the vaccines or therapeutics pillar of the ACT Accelerator
  • 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 LMICs in the first half of 2022.
  • Score:
C4 The company agrees to license its Covid-19 medical products to other companies
  • Issuing of non-exclusive, voluntary licenses to 105 countries 
  • Score:

E: Equality, non-discrimination & equity

Overall score:

E1 The company makes the active ingredient available on reasonable ground

 

  • 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 not actively making the API available to other manufacturers)
  • Score:
E2 The company commits to full technology transfer to other manufacturers
E3 The company commits to non-profit or ‘fair’ pricing
  • MSD has stated that it will adopt a tiered pricing approach for the countries included in the license – many MICs have to pay around 40x more than what the generic companies are charging (US: 700 USD; Thailand 300USD; India (generic) around 20USD – costs around 8USD to produce). This tiered pricing strategy is good for LICs, but it excludes many MICs that are unable to pay the full price.
  • Score:
E4 The company equitably distributes supplies globally. [Only applies to vaccines]

[Only applies to vaccines]


E5 The company does not seek protection beyond the minimum criteria in TRIPS, or enforces TRIPS+ measures [where applicable]
  • No information.
  • Score: 
E6 The company agrees to waive exclusive rights in regulatory test data [where applicable] 
  • No information.
  • Score:

T: Transparency

Overall score:

T1 The company publishes its R&D costs
  • Publishes overall R&D costs in annual and quarterly financial reports, but not specific to Molnupiravir.
  • Score: 
T2 The company publishes its profit margin
  • MSD publishes that they made 952 Million USD sales of Molnupiravir in 2021, but no mention of a margin (sources in the public domain have published an estimate of the company’s profit margin)
  • Score: 
T3 The company publishes the average and/or marginal costs of production
  • MSD does not publish the average and/or marginal costs of producing Molnupiravir.
  • Score:
T4 The company publishes its production capacity
  • Yes, 10 million courses by the end of 2021, and 20 million courses expected to be produced in 2022.
  • Score:
T5 The company publishes the public subsidies it received during product development and/or testing
  • 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.”
  • Score:
T6 The company publishes the text of licensing agreements
  • The MPP license is published and transparent; the license with the US government was obtained by KEI but not published by MSD.
  • Score: 
T7 The company registers its clinical trials in public repositories
  • Yes, clinical trials are published on clinicaltrials.gov. The company is now evaluating molnupiravir in the prevention setting in our MOVe-AHEAD study.
  • Score: