Access To Vaccines: Overcoming Challenges And Exploiting Opportunities

Gabriella Chan for the TRP | March 2021

“A global pandemic requires a world effort to end it – none of us will be safe until everyone is safe”.

Ursula von der Leyden, President of the European Commission

As the 2019 SARS-CoV-2 induced Corona Virus Disease (COVID-19) pandemic continued to rage at the end of 2020 and concerns about equitable access to vaccines against the disease escalated, World Trade Organization (“WTO”) members India and South Africa expressed concern that intellectual property (IP) rights may prolong the pandemic by hindering access to precious limited resources in the midst of a global public health emergency.

To that end, on October 2 they sent a joint letter to the WTO Council on the Agreement on Trade-Related Aspects of Intellectual Property Rights (“TRIPS”) requesting that WTO member states (“Members”) waive (i.e. suspend) the implementation, application, and enforcement of certain IP provisions under Part II of the TRIPS Agreement. The suspension of copyright, industrial design, patents, and protection of undisclosed information for goods related to prevention and containment of SARS-CoV-2 infection and treatment of COVID-19 was billed as a means to an end – namely to achieve equitable access to a disease-fighting arsenal and blunt the pandemic. The waiver, which requires unanimous Member consent to be adopted, would be reviewed yearly and remain in effect for a yet-to-be-determined length of time, potentially until we reach global herd immunity.

However, as 2020 drew to a close, support for the waiver encountered headwinds in TRIPS Council meetings, particularly from developed nations with strong IP rights regimes. Some Members either completely opposed the waiver – citing existing licensing deals between AstraZeneca and large vaccines manufacturers such as the Serum Institute of India and the willingness of other companies to grant similar licenses to ramp up manufacturing  – or sought to better understand the specific IP-related challenges faced by other Members in addressing COVID-19.

Although it will take a worldwide effort to end the pandemic, in which each of us needs to do our part, the practical implementation of this unprecedented waiver would face significant challenges at the national level. The monumental legal and economic ramifications of a blanket IP rights waiver imposed on private entities – and the ensuing counterproductive delays – beg for a second sober look at this utopian but impractical option. When further coupled with the near-certain failure to reach the requisite unanimous Member consent to pass the waiver, we must focus on finding other means to the same end, as time is of the essence.

Compulsory licenses provide one alternative path forward. Compulsory licenses are an exception to the general rule of IP law which provides that an IP owner has the right to exclude others from using its IP and has the sole discretion to license that IP to others on terms and for consideration negotiated by the parties. By contrast, compulsory licenses bypass the IP owner’s consent to allow another person to use that IP and the owner receives a fixed licensing fee which is determined by applicable IP legislation. In fact, Article 31 of the TRIPS Agreement and its amendment, Article 31bis, which came into force on January 23, 2017, in response to the 2001 Doha Declaration, layout a compulsory licensing mechanism. The Doha Declaration explicitly reaffirmed Members’ right to include compulsory licensing provisions in their IP legislation for use during public health crises. This license mechanism, while still imperfect, is routinely used for access to pharmaceuticals and can be used to supplement existing and future traditional bi-lateral licensing agreements between Members and vaccine manufacturers.

Although opponents of the compulsory license mechanism focus on its imperfections and cite, among others, procedural complexity, the potential for pharmaceutical company retaliation, the need for a new pricing model for vaccines, and quantity limits on production, unlike a waiver, each Member retains control over its compulsory license provisions in its IP legislation and may choose to implement COVID-19 specific amendments to address those concerns.

While the debate over vaccine access has disproportionately focused on IP, it failed to highlight a collaborative alternative that respects IP rights. In April 2020, a partnership of governments, philanthropists, businesses, scientists, and global health organizations including the Bill & Melinda Gates Foundation, Coalition for Epidemic Preparedness Innovations (“CEPI”), FINDGaviThe Global FundUnitaidWellcome, the WHO, and the World Bank, launched the Access to COVID-19 Tools (“ACT”) Accelerator. Its goal, which precisely mirrors the end goals outlined in India’s and South Africa’s letter to the WTO, is to accelerate equitable access to diagnostics, treatments, and vaccines for COVID-19 without the complexity of waiving IP rights.

In June 2020, the ACT Accelerator launched its vaccine pillar, the COVAX Facility (“COVAX”) which is co-led by Gavi, CEPI, and the WHO and is co-chaired by representatives from Canada, Indonesia, and Ethiopia. COVAX aims to end the acute phase of the pandemic by actively managing a diverse vaccine portfolio and distributing at least 2 billion vaccine doses by the end of 2021, primarily to nations in the southern hemisphere.

COVAX is financed through the Gavi COVAX AMC, which supports 92 countries and recently announced several deals to secure access to new vaccine candidates and a plan to roll out vaccines in the first quarter of 2021. More importantly, it developed the Principles for Dose-Sharing, which provides a framework through which developed nations can make vaccines equitable available to other AMC participants through bilateral deals within COVAX. As of the date of writing, most developed nations (other than the United States) were COVAX participants and major contributors to the Gavi COVAX AMC. Ironically, these are some of the same nations, including Canada, who have been accused of hoarding vaccines because in early 2020, before any vaccine candidates were approved by regulatory agencies, they pre-emptively placed large vaccine orders.  To date, at least for Canada, the majority of those orders have not been delivered.

In the end, only a concerted world effort in which each of us does our part and takes personal responsibility for our actions, coupled with leveraging all tools at our disposal while simultaneously preserving IP rights, will end this pandemic. Strong IP rights protections are the bedrock of innovation and the primary reason that a handful of vaccine developers managed to produce several safe and effective vaccines against a novel pathogen within a record-setting pace of months rather than years. Without that protection, we risk exacerbating vaccine nationalism, prolong the end of the pandemic, damaging economies, and fraying relationships.