Brook Baker, Health GAP, Link
With the world racing to find new vaccines and therapies to respond to the escalating COVID-19 pandemic, the world’s biggest economies are pursuing nationalistic policies, racing to the front of the line with sweetheart deals to fund research and development in exchange for preferential access to life-saving health products. These same countries (along with others) have also imposed selfish and unnecessary export controls limiting supply of needed health supplies to other countries.[1] This unbridled nationalism, interlinked with a broken, profit-driven pharmaceutical system risks obstructing access to life-saving medicines worldwide. This should be a moment for transformative, systemic change, but instead of an innovative response and true global solidarity we’re seeing the same old business-as-usual.
The Trump administration has consistently, even proudly, espoused and practiced “America First” with efforts to steal vaccine manufacturing from Europe,[2] rules preventing foreign aid recipients from buying U.S.-manufactured personal protective equipment and devices,[3] vaccine-funding/preferential-supply agreements negotiated by Biomedical Advanced Research and Development Authority (BARDA),[4] and Operation Warp Speed capturing manufacturing capacity.[5] Not only does the U.S. want to claim the prize of scientific primacy, it wants to locate vaccine manufacturing capacity in the U.S. and gain first dibs to guaranteed vaccine doses.[6] As confirmed by the Washington Post, China is equally engaged with the U.S. in the race for research bragging rights and, equally importantly, for secured access to initial vaccine doses in order to restart their economies.[7] Although China has made vague promises about sharing its vaccine as a global public good, particularly to “Belt and Road” countries, it will likely do so only after meeting domestic need.[8]
Europe is also engaged in the race to lock up manufacturing capacity and secure first supplies of vaccines, with Germany, France, the Netherlands, and Italy having already announced a new “vaccine alliance.” Similarly, the European Commission has asked its 27 members to fund vaccine manufacturers and simultaneously negotiate advance purchases and reserve supplies to meet EU needs.[9]
Europe’s turn to nationalistic and regional scrambling is particularly duplicitous given its recent espousal of equitable global access to COVID-19 health products in its resolution adopted by the World Health Assembly on May 18[10] and its launch two weeks earlier of the Access to COVID-19 Tools (ACT) Accelerator where it explicitly committed to “the shared aim of equitable global access to innovative tools for COVID-19 for all.”[11]
Rich countries are investing in COVID-19 research and development and manufacturing to (1) de-risk R&D for Pharma (capitulating to Big Pharma’s scare tactic that it is not commercially promising for them to invest in a pandemic disease, especially a vaccine); (2) spur additional investments to expand manufacturing and locate it domestically; (3) secure preferential access to vaccines and therapeutics through advance purchase agreements; and (4) secure political favor by appearing to do something/anything to address the pandemic, especially in light of their many policy failures in preparation, testing, and lockdowns. In essence, rich countries have made a pact with devil – “speed research and give us guaranteed first supplies and you can keep your monopolies, prices be damned and stale crumbs to the rest of the world.”
Instead of accepting the narcissistic, nationalistic impulse of some demagogic and hypocritical leaders to hoard global public goods, damning the rest of the world to the long wait at the back of the line, there are specific counter-measures that must be taken to ensure equitable access is a reality – not a lie.
First, efforts to overcome or bypass Big Pharma monopolies on the information, data, intellectual property, and biological resources needed to prevent and treat COVID-19 via voluntary and compulsory measures must be intensified. On the positive front, the WHO and 37 country partners launched the COVID-19 Technology Access Pool on May 29, which has the express mandate to seek rights to any and all COVID-19 related information, data, and intellectual property.[12] Utilization of the pool could enable faster and higher quality open-science research and product development. More significantly, open licensing of all rights needed to allow full technology transfer would greatly expand supply beyond the limitations of single-source suppliers. Allowing licensed manufacturers to expand production would help counteract the impulse to hoard and accelerate equitable distribution globally.
Although the technology pool is promising in theory, it is disappointing and frankly outrageous that no biopharmaceutical company has contributed to the pool, though one company, AbbVie, has agreed not to assert its patent rights on a potential antiviral treatment, lopinavir/ ritonavir, after Israel issued a compulsory license.[13] Gilead, in contrast, entered into grossly limited voluntary licenses on remdesivir with five generic companies that exclude 48% of the global population, including people from 30 low- and middle-income countries.[14] It is not surprising that the multinational drug industry banded together at the launch of the technology pool to condemn even voluntary efforts geared towards global access.[15]
In addition to pressing for effective voluntary measures, countries can and should use lawful TRIPS flexibilities, including compulsory and government use licenses. Indeed, countries excluded from voluntary licenses should immediately collaborate to issue simultaneous compulsory licenses. Countries should also use national security declarations to suspend enforcement of COVID-19 monopoly rights or amend their law to allow automatic or mandatory issuance of compulsory licenses on critical COVID-19 medical products, as activists and academics are challenging South Africa to do in the face of one of the worst COVID-19 epidemics in sub-Saharan Africa..[16]
Second, the ACT-Accelerator should immediately pivot and commit to support conditions alongside its funding agreements that require its grantees to license new COVID-19 medical products to ensure expanded manufacturing capacity and equitable supply globally. Along with WHO, the ACT-Accelerator should also adopt a global framework for equitable distribution, with initial supplies shared according to agreed, population-group and epidemiological priorities. Although these requirements and frameworks have not yet been developed, there are some early signs that the ACT Accelerator will take tentative steps to ensure supply in some low- and middle-income countries. On June 4, 2020, Gavi, the Vaccine Alliance (Gavi), the Center for Epidemic Preparedness Initiative (CEPI), and AstraZeneca announced a commitment by AstraZeneca to supply 300 million doses of an Oxford vaccine candidate and a further agreement to license the Serum Institute of India to produce 1 billion doses to supply low- and middle-income countries on an at-cost basis.[17] Even so, AstraZeneca had previously promised a disproportional 400 million vaccine doses to the U.S. and UK. In addition, the new umbrella COVID vaccine pillar within the ACT Accelerator and its linkage with the Gavi Advance Market Commitment for COVID-19 Vaccines (Gavi Covax AMC) are woefully non-transparent and unspecified.[18] Billions of dollars are being given away with no transparency on access terms, price, and countries that will be supplied with some suspicion that upper middle-income countries will once again be excluded.
Third, there must be a much greater commitment to transparency and accountability, especially with respect the vast sums of money that governments are paying to support COVID R&D and to supply purchases. Figures on public and charitable funding must be supplied to the WHO Global Observatory. Funding agreements should be transparent. Companies should be required to document and publish public/charitable subsidies and grants, their own R&D investments, costs of productions, and pricing to all buyers. It is simply outrageous, that money is being poured into company before and after product development and that there is no data or control over pricing decisions.
Fourth, there must be a firm and enforceable commitment to actual equitable access – everywhere to everyone – matched with condemnation of export controls on COVID-19 medical products and components and of preferential advance procurement and supply agreements that result in early, disproportionate supply to some countries and delayed, inequitable supply to others. WHO is believed to be working on a normative guidance allocation policy pertaining to equitable distribution of COVID-19 diagnostics and eventually vaccines and therapeutics. However, regrettably at this point, there is no global body that can force a non-consensual agreement barring stockpiling by countries. But a global framework for equitable access appropriate for this and future pandemics must be built quickly and firmly. In the meantime, activists must call out nationalistic hoarding as a vicious violation of human rights and an unconscionable undermining of global solidarity. Politicians are claiming to support a COVID-19 response that ensures vaccines and therapeutics are treated as “global public goods.” But early policy moves indicate a dangerous complacency. The wealthiest countries are showing they have no desire to disrupt the status quo, even as they raise unprecedented amounts of public funding for COVID-19 medical technologies. We must focus on what can be done to secure the up-front conditions that will guarantee COVID-19 vaccines and therapies truly benefit everyone, no matter where they live. Lessons from global AIDS treatment activism show that unless equitable access is set in stone early, countless people will die as a result of a system where charging as much as the richest markets will bear and supplying them preferentially is the order of the day. The good news is, nationalistic hoarding does not have to prevail. In fact, global solidarity is not naive – it is a necessity
[1] World Trade Organization, Export Prohibitions and Restrictions (April 23, 2020) (noting such restrictions in 80 countries), https://www.wto.org/english/tratop_e/covid19_e/export_prohibitions_report_e.pdf.
[2] Germany confirms that Trump tried to buy firm working on coronavirus vaccine, Politico (March 19, 2020), https://www.politico.eu/article/germany-confirms-that-donald-trump-tried-to-buy-firm-working-on-coronavirus-vaccine/
[3] US adds restriction on foreign aid funding for COVID-19 supplies, The New Humanitarian (April 29, 2020), https://www.thenewhumanitarian.org/news/2020/04/29/USAID-bans-masks-and-gloves-NGO-grants.
[4] Emergent BioSolutions, BARDA reach $628M deal to manufacture COVID-19 vaccine hopefuls, Fierce Pharma (June 1, 2020), https://www.fiercepharma.com/manufacturing/barda-emergent-biosolutions-reach-628m-contract-to-manufacture-covid-19-vaccine.
[5] Trump Administration Announces Framework and Leadership for ‘Operation Warp Speed’, Health and Human Services (May 15, 2020), https://www.hhs.gov/about/news/2020/05/15/trump-administration-announces-framework-and-leadership-for-operation-warp-speed.html.
[6] Zain Rizvi, A People’s Vaccine, Public Citizen (June 4, 2020), https://www.citizen.org/article/the-peoples-vaccine/.
[7] Global race for a coronavirus vaccine could lead to this generation’s Sputnik moment, Washington Post (June 3, 2020), https://www.washingtonpost.com/health/2020/06/03/coronavirus-vaccine-global-race/
[8] Amid High Stakes, China is Fast-Tracking COVID-19 Vaccine Efforts, NPR (May 20, 2020), https://www.npr.org/2020/05/20/859071659/amid-high-stakes-china-is-fast-tracking-covid-19-vaccine-efforts; In Race for COVID-19 Vaccine, China Tries for a Coup, Wall Street Journal (June 5, 2020), https://www.wsj.com/articles/in-race-for-covid-19-vaccine-china-tries-for-a-coup-11591354803.
[9] Europe May Join Race for Early Vaccine Access with Deals, Bloomberg (June 3, 2020), https://news.bloomberglaw.com/health-law-and-business/europe-may-join-race-for-early-vaccine-access-with-deals-1
[10] COVID-19 Response, A73/CONF./1 Rev.1 (May 18, 2020), https://apps.who.int/gb/ebwha/pdf_files/WHA73/A73_CONF1Rev1-en.pdf:
PP7 Recalling the United Nations General Assembly resolutions A/RES/74/270 on “Global solidarity to fight the coronavirus disease 2019 (COVID-19)” and A/RES/74/274 on “International cooperation to ensure global access to medicines, vaccines and medical equipment to face COVID-19;
PP13 Recognizing the need for all countries to have unhindered timely access to quality, safe, efficacious and affordable diagnostics, therapeutics, medicines and vaccines, and essential health technologies, and their components as well as equipment for the COVID-19 response;
OP4 Calls for the universal, timely and equitable access to and fair distribution of all quality, safe, efficacious and affordable essential health technologies and products including their components and precursors required in the response to the COVID-19 pandemic as a global priority, and the urgent removal of unjustified obstacles thereto;
OP6 Recognizes the role of extensive immunization against COVID-19 as a global public good for health in preventing, containing and stopping transmission in order to bring the pandemic to an end, once safe, quality, efficacious, effective, accessible and affordable vaccines are available;
OP8.2 Work collaboratively at all levels to develop, test, and scale-up production of safe, effective, quality, affordable diagnostics, therapeutics, medicines and vaccines for the COVID-19 response, including, existing mechanisms for voluntary pooling and licensing of patents to facilitate timely, equitable and affordable access to them …;
[11] Access to COVID-19 Tools (ACT) Accelerator: A Global Collaboration to Accelerate the Development, Production and Equitable Access to New COVId-19 diagnostics, therapeutics and vaccines (24 April 2020), https://www.who.int/who-documents-detail/access-to-covid-19-tools-(act)-accelerator.
[12] WHO, Solidarity Call to Action (May 29, 2020), https://www.who.int/emergencies/diseases/novel-coronavirus-2019/global-research-on-novel-coronavirus-2019-ncov/covid-19-technology-access-pool/solidarity-call-to-action.
[13] AbbVie waives all worldwide restriction on making generic copies of its Kaletra HIV pill, STAT (March 23, 2020), https://www.statnews.com/pharmalot/2020/03/23/abbvie-hiv-kaletra-generics-coronavirus-covid19/.
[14] Gilead, Voluntary Licensing Agreements for Remdesivir (May 12, 2020), https://www.gilead.com/purpose/advancing-global-health/covid-19/voluntary-licensing-agreements-for-remdesivir.
[15] Pharma leaders shoot down WHO voluntary pool for patent rights on COVID-19 products, STAT (May 28, 2020), https://www.statnews.com/pharmalot/2020/05/28/who-voluntary-pool-patents-pfizer/.
[16] Fix the Patent Laws Campaign Letter to President Ramaphosa (May 14, 2020), https://www.fixthepatentlaws.org/wp-content/uploads/2020/05/FTPL-Letter-to-Ramaphosa-140520.pdf;
AN APPEAL TO PRESIDENT CYRIL RAMAPHOSA BY ACADEMICS, RESEARCHERS AND TEACHERS TO EXPEDITE THE AMENDMENTS TO THE PATENTS ACT 57 OF 1978, IN LINE WITH THE INTELLECTUAL PROPERTY POLICY PHASE I APPROVED BY CABINET IN MAY 2018 (May 18, 2020), http://ndabaonline.ukzn.ac.za/UkzndabaStory/Vol8-Issue17/Academics%20Call%20for%20Amendments%20to%20the%20Patent%20Law%20in%20Response%20to%20COVID19.
[17] AstraZeneca takes next steps towards broad and equitable access to Oxford University’s COVID-19 vaccine (June 4, 2020), https://www.astrazeneca.com/media-centre/press-releases/2020/astrazeneca-takes-next-steps-towards-broad-and-equitable-access-to-oxford-universitys-covid-19-vaccine.html.
[18] Gavi launches innovative financing mechanism for access to COVID vaccine, Gavi (June 4, 2020), https://www.gavi.org/news/media-room/gavi-launches-innovative-financing-mechanism-access-covid-19-vaccines.
