Rapid Approval of the Waiver is Imperative
On October 2, India and South Africa petitioned the World Trade Organization (WTO) to allow all WTO members to bypass granting or enforcement of patents, trade secrets, industrial designs, and copyrights on COVID-19-related drugs, vaccines, diagnostics and other medical technologies for the duration of the pandemic. The proposed “Waiver from certain provisions of the TRIPS Agreement for the prevention, containment and treatment of COVID-19” should be promptly and emphatically supported by governments, international institutions, global health initiatives, and all of civil society—from health workers, to academics, and access-to-medicines activists. We should expect vociferous opposition from the biopharmaceutical industrial and its supporters from wealthy country governments who have been claiming (confusingly and inconsistently) that IP is essential to innovation and that IP is not a barrier to the pandemic response. But the world desperately needs freedom to expand production of COVID-19 health products, secure lower prices, and speed their equitable distribution to all corners of the globe.
Article IX 3 and 4 of the Marrakesh Agreement establishing the WTO clearly states that WTO Member States have the right to establish a waiver from the recognition or enforcement of intellectual property rights under the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) in exceptional circumstances like those presented by the COVID-19 pandemic. The conditions on the waiver and its time duration will need to be finalized, but there is no doubt that South Africa and India have presented well-grounded justifications for the proposed waiver. The TRIPS Council meets October 15-16 and could approve the waiver and forward it for decision to the Ministerial Conference in June 2021. Given the urgent nature of the proposal, the waiver proposal should be forwarded to the WTO General Council even before then for an earlier decision. There is ample precedent—multiple previous intellectual property waivers have been granted by the WTO, including a waiver on the enforcement of Article 31(f) of the TRIPS Agreement and waivers of certain obligations under Article 70(8) and (9). Although the preference at the WTO is to reach consensus, countries can force a vote and a three-fourths majority will pass the waiver.
The most compelling justification of the waiver is that intellectual property rights do in fact present significant barriers to the scale-up and diffusion of manufacturing capacity to produce sufficient quantities of vaccines, medicines, diagnostic tests, personal protective equipment, and other medical technologies needed to diagnose, prevent, treat, and cure COVID-19. Unfortunately, efforts to secure voluntary cooperation have thus far been unsuccessful. Although Costa Rica and 40 other countries convinced the World Health Organization to establish the COVID-19 Technology Access Pool, which would accept voluntary transfer of exclusive patents, data, and information rights and thereafter license those rights to qualified producers, no biopharmaceutical company has offered such rights over the past four months. The restrictive, flawed voluntary licenses negotiated by Gilead for remdesivir, and by Oxford and AstraZeneca on their candidate vaccine are shrouded in secrecy and exclude sales in many countries.
The world needs this waiver: because IPR barriers are real; because voluntary measures are insufficient; and because vaccine, therapeutic, and diagnostic nationalism is leaving medical cupboards bare in the Global South. The world also needs the waiver for symbolic reasons – too many countries have bought the message that the TRIPS Agreement stands in the way of prioritizing public health and that they are powerless. But the waiver proposal is a mighty tool that they can use immediately to free themselves from the shackles of IP and market fundamentalism that is leaving so many so far behind. Passing the waiver will send a powerful message to industry that it should begin to share its technology voluntarily or it will be forced to do so involuntarily.
Countries must also take steps to implement the waiver domestically
Meanwhile, while countries sit on the sidelines and wait for voluntary relinquishment of IPRs by industry, rich countries have raced in and procured disproportionate supplies of promising medicines, vaccines, and diagnostics. As a result, low- and middle-income countries have had only 4% of the per person access to molecular diagnostic tests that rich countries have had. Likewise, the U.S. cornered virtually all of Gilead’s global supply of remdesivir through October 2020. And the U.S., U.K., E.U, and Japan, with just 13% of the global population, have negotiated advance purchases and options to purchase well over 50% of the projected global COVID-19 vaccine supply through the end of 2021.
However, the waiver will only open space for countries to act domestically. At a technical level, all the waiver will do is save countries from state-state dispute settlement under the TRIPS Agreement and provide authorization to take needed steps nationally. Countries must understand that the waiver is not self-effectuating, meaning that passing the waiver will not automatically empower countries to disregard nationally authorized intellectual property rights, rights established in existing patent, copyright, trade secret, and data protection laws. Countries will have to take resolute steps domestically to waive national recognition and enforcement of COVID-related intellectual property rights until immunity is achieved.
Fortunately, the TRIPS Agreement gives countries an easy mechanism to accomplish this as well.1 Article 73 of the TRIPS Agreement reads: “Nothing in this Agreement shall be construed … to prevent a member from taking any action which it considers necessary for the protection of its essential security interests … taken in time of war or other emergency in international relations.” It should be remembered as well that the Doha Declaration on the TRIPS Agreement and Public Health assures Member States that the TRIPS “Agreement can and should be interpreted and implemented in a manner supportive of WTO members’ right to protect public health and, in particular, to promote access to medicines for all. In this connection, we reaffirm the right of WTO members to use, to the full, the provisions in the TRIPS Agreement, which provide flexibility for this purpose.” Similarly, Article 7 and 8 of the TRIPS Agreement provide further support for the argument that Member States can act to promote public health and to prevent abuse of intellectual property rights, like that which occurs when biopharmaceutical companies refuse to voluntarily license their life-saving medicines, vaccines, and diagnostics. Countries will have to effectuate the permission granted by Article 73 through proper means established in national law. For some countries, resorting to executive action in the form of emergency declarations might suffice, but in other countries national legislative or parliamentary action might be needed on an expedited basis.
However, countries should also be reminded even now, at this exact moment, they have the power to issue compulsory licenses and government use licenses to qualified producers, domestically and abroad to source needed COVID-19 health products. Some countries have already taken steps to simplify and accelerate compulsory licenses and others have made their issuance automatic or mandatory. Countries must understand that they cannot stand idly by waiting for drug companies to act or for a WTO consensus to be reached. They have duties to secure the right to health for all people in their countries. They have opportunities to act nationally and collaborate with other countries regionally and globally to expand supplies, lower prices, and achieve equitable distribution of COVID-19 health technologies. There are no excuses for inaction on the global, regional, or national level.
Big Pharma’s monopolies are impeding the response to the COVID-19 pandemic
Major biopharmaceutical companies have been highly subsidized by public sector funding from the U.S. and Europe. They have invested tens of billions of dollars in speeding development, clinical trials, and initial supplies of COVID-19 health technologies. Despite these investments that have extensively de-risked the race for effective and safe vaccines, medicines, and diagnostics, companies have been enabled to maintain the intellectual property status quo – their monopoly empires are untouched. But their monopolies stand in the way of production of sufficient quantities of desperately needed health products. Their monopolies also result in unaffordable prices, such as Gilead’s $3120 price for remdesivir or Moderna’s $74 price for its yet unproven mRNA vaccine. Their monopolies have provoked waves of COVID-19 medical technology hoarding and nationalism that leaves crumbs on the table for smaller and poorer countries. Neglected populations are being pushed to the back of the line, where an interminable wait means more suffering and more death.
But countries are not powerless, although many are acting as if they are disarmed. If they join together in global solidarity and common cause to expand and share a growing list of COVID-19 medical technologies, we can confront the harms of pandemic profiteering. Countries must act swiftly to pass the waiver proposal at the WTO, and act simultaneously to declare COVID-19 IP emergencies domestically. We call on them to flex their muscles and issue compulsory and government-use licenses. Put pressure on global institutions like the ACT-Accelerator to deliver on their lofty rhetoric, and ensure that medicines, vaccines, diagnostics, PPE, oxygen, and other health supplies are distributed equitably, quickly, and in sufficient supply within and between countries. Every day countries wait, thousands more lives are lost, hundreds of thousands more people are infected, and billions of people continue to suffer from social and economic dislocation. The time to dismantle the COVID-19 IP empire is now.
1 Frederick Abbott, The TRIPS Agreement Article 73 Security Exceptions and the COVID-19 Pandemic, South Centre (2020), https://www.southcentre.int/wp-content/uploads/2020/08/RP-116.pdf.