U.S. Torpedoes Extension of WTO TRIPS Decision to Include Tests and Treatments and Hides Behind the Façade of Needing to Study the Obvious

Nothing could be more cynical than the USTR’s announcement today that a decision must be delayed on whether or not to extend the WTO’s TRIPS decision to therapeutics and diagnostics.  Currently the decision only covers COVID-19 vaccines and is already so watered down as to have virtually no effect on overcoming the main intellectual property barriers to rapid market entry of generic manufacturers—vaccine trade secrets. But for other medical countermeasures like COVID-19 treatments, patents are a clear and present threat to affordable access. USTR’s assertion that the issue must undergo a protracted review at the United States International Trade Commission (USITC) before a U.S. position can be finalized is a shallow ploy.  USTR has shown its total capitulation to the strident demands of industry domestically and internationally to protect its biopharmaceutical intellectual property, no matter how minor the proposed adjustment and no matter the human cost. Indeed, the U.S. and other wealthy countries all currently have access to effective but expensive outpatient antiviral medicines while countries in the global South have virtually none.  

South Africa and India, eventually with formal support from 63 other developing country proponents, petitioned the WTO in early October 2020 (amended May 21, 2021) for a temporary but comprehensive waiver of intellectual property protections on all COVID-19 related health technologies and their components.  During a period of extreme supply shortages, high prices, and grossly inequitable distribution – properly labeled vaccine apartheid, the waiver could have accelerated technology transfer and the expansion of regional biopharmaceutical and diagnostic manufacturing capacity and helped ensure earlier supply of life-saving COVID-19 countermeasures. 

The European Union (led by Germany), U.K., Switzerland, and a handful of other rich countries consistently opposed any diminution of Big Pharma monopoly rights other than use of compulsory licenses under strict limits.  After initially opposing the waiver proposal entirely, in May of 2021, the new Biden administration stated its support for a full waiver with respect to vaccines, but refused to include tests and treatments.  But, in fact, the U.S. colluded with the E.U. and other opponents for an additional thirteen months eventually forcing a relatively meaningless decision focused on vaccine patents only and a limited relaxation of exportation restrictions affecting supplies to developing-country importers only. 

Although the WTO Decision will have virtually no effect in expanding access to vaccines given its exclusion of trade secrets–the critical category of intellectual property at play with vaccines–the Decision could give more equitable access for urgently needed therapeutics, especially the small molecule antiviral medicines that are much easier to duplicate without access to manufacturing know-how.  Pursuant to paragraph 8 of the Decision, an agreement on the extension was due to be made by December 17, 2022, and proponents filed an official proposal to extend the Decision—the same day that the U.S. announced its intent to delay any decision.

The issue of access to therapeutics and diagnostics has been before the WTO for 26 months. The Biden Administration’s decision, at the last hour, that the need for such access must be studied, yet again, ad nauseum, is a deadly contrivance.  Contrary to the USTR’s announcement of the inquiry, the facts are clear.

• Outpatient antiviral medicines are already in wide use in rich countries, but barely available in developing countries.  Tens of millions of people are at significant risk of disease progression in low- and middle-income countries, and will be over the foreseeable future, but their need goes unmet.
  • According to the Duke Launch & Scale Speedometer (Dec. 2, 2022), high-income developed countries have advance purchased over 30 million courses of treatment of Pfizer’s Paxlovid (nirmatrelvir+ritonavir) (the U.S. 20 million courses of treatment), while middle-income countries have advanced purchased 670,000 courses only.  High-income countries have purchased 8.3 million courses of treatment of Merck’s molnupiravir, whereas middle-income countries have purchased 1 million.
  • Additional option to purchase agreements have been made by “global entities,” mostly UNICEF and the Global Fund to Fight AIDS, Tuberculosis and Malaria, but according to the UNICEF dashboard and the WHO dashboard, as of late November 2022, only 79,012 courses of nirmatrelvir+ritonavir and only 63,800 courses of molnupiravir have been actually delivered to eligible low- and middle-income countries.
  • In comparison, the U.S. alone has administered 5,970,167 courses of treatment of Paxlovid between Dec. 17, 2021 and Nov. 27, 2022.

• The existing voluntary licenses granted to the Medicines Patent Pool on COVID-19 antivirals are vastly insufficient to guarantee equitable access and affordability for the many upper-middle-income countries excluded from those licenses. The licenses exclude access for approximately half the world. 
  • The MPP/Merck molnupiravir license only directly covers 106 countries.
  • The MPP/Pfizer nirmatrelvir license only directly covers 95 countries.
  • The MPP/Shionogi ensitrelvir fumaric acid license only directly covers 117 countries.
  • Excluded countries, mostly upper-middle-income countries, can be supplied by the originator only unless no patents or know-how rights would otherwise be violated or unless a compulsory license had been granted in the country of use/import.  Originators would maintain control over supply, price, and distribution in excluded countries and their tiered prices are likely to be unaffordable for most of the population or governments, e.g., reported price offer in Brazil was $250 per course of treatment for nirmatrelvir+ritonavir.
  • Originators currently limit supply to LMICs by their delay or reluctance to seek emergency use authorization/listing or marketing approval in most LMICs.
  • Efforts by civil society in countries excluded by MPP licenses to compel their governments to deploy existing TRIPS flexibilities such as compulsory licensing have not borne fruit–instead they have been met with foot dragging.
    
• There are multiple generic producers right now capable of rapidly scaling up manufacture of  quality-assured COVID-19 therapeutics but who are not yet licensed to do so or must do so under territorial restrictions.
• There are many other therapies in the R&D pipeline, some of which may be better than existing products and some of which may be appropriate for combination therapies.  It is far better to signal generic producers that they will be able to aggregate LMIC markets and export to multiple countries so that they are incentivized to enter the market and produce future covid medicines at efficient economies-of-scale.  
• Extending the TRIPS Decision to therapeutics will enable quicker and expanded access and encourage the robust generic competition that increases affordability of supply security.
• Innovator companies will not lose significant revenues because of the very narrow scope of the Decision.  The Decision would only allow export of unlimited quantities to eligible developing countries.  Thus, innovators will continue to have unimpeded control in the high-income markets where they sell at high prices and in large quantities.  For example, Pfizer earned $17 billion in Paxlovid sales in the first three quarters of 2022 and can expects as much as $81 billion in revenue 2021-2028. 

Despite factual clarity about the need to extend the Decision to cover diagnostics and therapeutics, the USTR nevertheless lists a variety of topics that it claims should be investigated by the USITC. Ironically, the USTR deliberately excludes important topics that, if investigated by USITC, would further clarify the need for a revised Decision such as: (1) a focus on costs of manufacture, price, and affordability for LMIC buyers, including innovators’ tiered pricing policies and tiered prices; (2) a study of existing licenses and technology transfer agreements, including geographic limitations on the same; (3) the impact of indemnification requirements on uptake; (4) the lack of transparency concerning supplies, purchase agreements, patent landscape, regulatory filings and landscape, and price point; and (5) unmet and evolving clinical need for testing and treatment as opposed to focus on artificially restricted demand. But including those topics would signal a good faith effort to get the best outcome, the quickest, for people in the global South forced again to wait in line for treatment, facing preventable death, disability, and protracted illness. 

President Biden and his wife Jill Biden, Anthony Fauci, Rochelle Walensky, and 6 million other Americans have received Paxlovid to treat outpatient COVID beginning in December of 2021.  One year later, almost to the day, the U.S. has the temerity to question whether people newly infected with COVID-19 need the same kind of access to rapid testing and treatments that is estimated to significantly reduce the risk of hospitalization and death, especially for older and other high-risk people, such as people with HIV and other complex chronic conditions. Newer evidence suggests that antiviral therapy might also reduce the risk of long COVID, and highlight the particular importance of access for people who are unvaccinated, who have immune compromise, and/or who are living with HIV.  The Biden administration is turning its backs on those communities with this cruel decision. The U.S. must drop its stubborn support for Big Pharma, its derailing of a decision on extending the Decision to cover tests and treatments, and its malign neglect of global populations suffering the continuing burdens of vaccine, therapeutic, and diagnostic apartheid.