Therapeutic:
Tocilizumab (Actemra)

Roche Therapeutic Summary Scorecard
Note: While the therapeutic Tocilizumab was developed with the support of Genentech, this scorecard evaluates only Roche'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.

Roche Therapeutic Detailed Evaluation

Explore the results of PAF’s research into Roche’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
  • Roche is working urgently to accelerate manufacturing capacity to maximize production of Actemra wherever possible with the goal of increasing available supply globally. While Roche is ensuring a coordinated, global overview of additional supply requests, provision of medicines is managed on a country level according to local rules and regulations and in close collaboration with the authorities.” 

  • Also: “ Roche is calling on governments across the world to work closely with industry to keep manufacturing and supply running, and to help us meet demand across the globe: Ensure the free flow of vital goods across national borders to keep manufacturing and supply running; Consider pragmatic temporary adjustments to regulations on packaging, reviews, customs etc, to expedite delivery of urgently needed medical supplies; Work together across governments internationally, in order to balance global needs.” 

  • Score:
A2 The company commits to comply with human rights standards in relation to product development and marketing
  • Supports the UNGPs, the UDHR and others
  • Risk-based due diligence; right to a remedy (grievance mechanisms); impact assessments

  • Very comprehensive HR strategy

  • Score:

C: International Cooperation

Overall score:

C1 The company commits to C-TAP or MPP
C2 The company commits to not enforcing the exclusive rights of Covid-19 related patents
  • Roche and Chugai, holders of Tocilizumab-related patents, announced they would not be asserting any patents against the use of the drug during the Covid-19 pandemic in LMICs
  • Also proved good faith by not pursuing legal dispute with Hetero over tocilizumab patent rights and backing the Indian EUA for treatment of Covid-19  
  • However, continues to pursue evergreening strategy and enjoys de facto monopoly over the market (secondary patents)  
  • Non-enforcement of patents is only in LMICs – partial.
  • Score: 
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
  • Commercialization and distribution deals with Cipla (India) 

  • Non-enforcement of patents allows other manufacturers to produce Actemra without having to ask for a licence

  • Score:  

E: Equality, non-discrimination & equity

Overall score:

E1 The company makes the active ingredient available on reasonable ground
  • Yes, agreement with Novartis for tech transfer to produce Actemra API
  • Score:
E2 The company commits to full technology transfer to other manufacturers
  • Patent waiver allows other companies to produce the drug without having to ask for licenses or pay for it. 

  • However, other intellectual property and information is necessary to test and make the drug 

  • Roche indicated it would cooperate – agreement with Novartis for tech transfer to produce Actemra API

  • Score: 
E3 The company commits to non-profit or ‘fair’ pricing
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 evidence of enforcing TRIPS- or not enforcing TRIPS+
  • “Roche fully supports the international standards of IP protection outlined in TRIPS.[…] and supports the §6 solution of the Doha Declaration (compulsory licensing)” 
  • Score: 
E6 The company agrees to waive exclusive rights in regulatory test data [where applicable] 
  • No data
  • Score: 

T: Transparency

Overall score:

T1 The company publishes its R&D costs
  • Publishes overall R&D costs but not specific to Actemra (increase of 14% partly due to Covid-19 products). See 2021 financial report
  • Score: 
T2 The company publishes its profit margin
  • 27% increase in sales of Actemra since FDA approval for Covid-19 use (see 2021 financial report)

  • Not a specific profit margin for Actemra

  • Score:
T3 The company publishes the average and/or marginal costs of production
  • No
  • Score:
T4 The company publishes its production capacity
  • There are many reports of shortages 

  • Says it is increasing its production & manufacturing capacity when faced with supply constraints in 2021 but has not published a number

  • Score:
T5 The company publishes the public subsidies it received during product development and/or testing
  • Roche’s Tocilizumab was researched and developed with considerable public funding, but Roche does not publish this on their website
  • “Tocilizumab was invented in Japan on grants from the Japanese government, and has been marketed since 2005 under the brand name Actemra and RoActemra . Between 2010 to 2019, Roche earned 13.644 CHF billion in Actemra sales, including 2.311 CHF billion in 2019, an increase of 7 percent over 2018. The invention and early development and nearly all of the research on tocilizumab specifically as a treatment for COVID-19 is being funded by governments or other non-industry institutions. Roche is currently identified as the sole funder of two COVID-19 related trials, and as a co-funder of four additional trials. In contrast, the NIH lists “other”, a category that includes non-US governments and non-profit research institutes and charities, as the sole funder of 34 trials and the co-funder of another six trials. The U.S. government is funding two trials and co-funding another. To the extent that tocilizumab is found to have utility for the treatment of COVID-19, the public sector, in the United States and elsewhere, have funded the key research.”
  • Score:
T6 The company publishes the text of licensing agreements
  • Does not publish the text of licensing agreements.
  • Score: 
T7 The company registers its clinical trials in public repositories
  • Registers clinical trials plus results in public clinical trial databases
  • Score: