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Changing trade rules to ensure equitable access to COVID-19 vaccines and treatments for low-income countries

Deborah Gleeson MPH PhD

Associate Professor in Public Health

La Trobe University

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International Trade and Health Conference, 24-26 November 2021

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Outline

  • TRIPS
  • The TRIPS waiver proposal: a brief history
  • The revised proposal (May 2021)
  • The case for the TRIPS waiver
  • Debunking the myths
  • Necessary but not sufficient

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TRIPS Agreement

  • Requires WTO members to provide minimum standards of intellectual property protection including:
    • Patents on products and processes, at least 20 years
    • Other IP protections (e.g. copyright, trademarks, geographical indications, industrial designs, undisclosed information)
  • Allows for compulsory licensing
    • exploitation of a patented product or process without the permission of the patent holder
    • time consuming and difficult to use

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The TRIPS waiver: a brief history

  • Proposed by India and South Africa (2 October 2020)
  • Gradually gained support of more WTO members (over 100 by March 2021)
  • US announced support of a waiver for vaccines (5 May 2021)
  • Revised decision text 21 May 2021, formally sponsored by 63 countries (clarified scope and duration)
  • Counter-proposal from the EU (4 June 2021)
  • Agreement to move to text-based discussions (10 June)
  • Stalemate continues: EU (Germany), UK and Switzerland remain opposed
  • Ministerial Council meeting (MC12) 30 Nov – 3 Dec
  • Draft WTO declaration on trade and health for MC12 fails to mention waiver, denounced by civil society

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The revised proposal (May 2021)

  • Product scope:
    • Health products and technologies to prevent, treat and contain COVID-19 (e.g. vaccines, therapeutics, diagnostics, devices, PPE)
    • And their materials or components, & methods and means of manufacture
  • IP scope:
    • Application, implementation and enforcement of TRIPS provisions on copyright, industrial designs, patents and protection of undisclosed information (e.g. manufacturing information in regulatory dossiers, protected as trade secrets)
  • Duration:
    • At least 3 years from date of decision (then annual review)

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The case for the waiver

  • Inequities in access to COVID-19 medical products
  • Vaccine nationalism
  • Failure of COVAX
  • IP barriers

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Inequities in access to COVID-19 medical products

  • Vaccines:
    • By Nov 2020, countries accounting for 14% of global population had pre-purchased 51% of the first 7.5 billion doses (So & Woo, 2020)
    • By 25 Nov 2021, 53.5% of the global population had received at least one dose, but only 5.2% of people in low-income countries (Our World in Data)
    • Now HICs stockpiling for booster shots; likely to have ~1 billion doses left over by end 2021 even after boosters (Lovett, 2021)
  • Therapeutics:
    • E.g. REGEN-COV: US $820 in India, US $2,100 in the US; patent applications in 11 LMICs (Santos, 2021)
  • Diagnostics:
    • HICs: 603 tests per 100,000; LICs: 5 per 100,000 (TRIPS Waiver communication 30 Sept)

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Vaccine nationalism

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Australia’s vaccine purchases and donations

  • Doses ordered for Australians:
    • 126 million Pfizer
    • 25 million Moderna
    • 53.8 million AstraZeneca
    • 51 million Novavax
    • 25 million doses through COVAX for Australians
  • Total doses ordered: 280.8 million
  • Population: 25.9 million
  • 10.8 doses per person
  • Investment: $8 billion

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  • Donations through COVAX
    • $130 million to COVAX AMC
  • Bilateral commitments:
    • $523 million for regional Vaccine Access and Health Security Initiative (120,000 vaccine doses + rollout support)
    • $100 million contribution to Quad vaccine partnership (with US, India & Japan
    • Up to 20 million Australian doses to be shared with Asia Pacific
    • +extra 40 million pledged in Sept 2021 (up to end of 2022)

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Source: https://indopacifichealthsecurity.dfat.gov.au/vaccine-access

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Failure of COVAX

  • Initially aimed to deliver 2 billion doses by end of 2021 (20% of population in 92 LICs)
  • Forecast wound back to 1.425 billion in September
  • By 25 Nov 2021, less than 538 million doses delivered

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IP barriers: the example of remdesivir

  • Gilead Sciences owns patents in more than 70 countries
  • Price for 5-day course of treatment: US $2430
  • Cost of production ~$1 per day
  • Development underpinned by at least $70.5 million public funding
  • Gilead negotiated voluntary licenses with companies in India, Pakistan & Egypt BUT licenses limited exports to 127 mainly low-income countries
  • US Government bought up almost all of the first 3 months’ supply

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IP barriers: mRNA patents

Gaviria, M., Kilic, B. A network analysis of COVID-19 mRNA vaccine patents. Nat Biotechnol 39, 546–548 (2021). https://doi.org/10.1038/s41587-021-00912-9

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Lack of voluntary engagement of pharma

MSF (2021) MSF Briefing Note: Share mRNA Technologies, Save Lives. https://msfaccess.org/sharing-mrna-vaccine-technologies-save-lives

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Myth 1: IP is necessary to stimulate innovation

  • Normal market dynamics don’t apply when it comes to pandemics.
  • Development of COVID-19 vaccines and therapeutics has been underpinned by huge injections of public funding.
  • MSF reported in November 2020 that “the six front running vaccine candidates have had a total of over US$12 billion of tax payer and public money poured into them”.
  • Development of Oxford/AstraZeneca vaccine 97% publicly funded (Cross et al, 2021)
  • Projected revenue: Pfizer: $36 billion; Moderna: $18.4 billion (Kollewe, 2021)

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Myth 2: Insufficient manufacturing capacity

  • Established vaccine manufacturers in Africa, Latin America, Asia
  • E.g. at least 7 accredited sterile injectable manufacturers in Africa with capacity to make mRNA vaccines within months (MSF, 2021)
  • Centres selected in Argentina and Brazil as mRNA hubs by PAHO

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Myth 3: Supply chain issues

  • Shortages of raw materials are certainly part of the problem
  • IP rights contribute to the shortages of raw materials by excluding competitors from the market making it more difficult to scale up the supply
  • e.g. plastic bioreactor bags used in vaccine manufacturing
    • produced by a small number of companies (4 main players)
    • heavily protected by patents (Stoller, 2021)

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Myth 4: Compulsory licensing will do the job

  • Only applies to patents
  • Would need to be applied for on a case-by-case, product-by-product basis
  • Time consuming and onerous to use
  • Pressure exerted by HICs
  • Bolivia notified intention to use CL to import COVID-19 vaccines from Canadian company Biolyse but Canadian Government refused to issue a license

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TRIPS waiver: necessary, but not sufficient

  • What would it achieve?
    • Companies could freely produce covered COVID-19 health products and use technologies without fear of litigation over IP infringement
    • Leverage to encourage cooperation towards other solutions

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  • What else is needed?
    • Donations of funds and products
    • Pressure on pharmaceutical companies to share their IP, technology and know-how
    • Investment in manufacturing capacity in LMICs

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References