Waivers of Patent Rights, Without More, Will Not Resolve Global COVID-19 Vaccine Access Issues
While discussions about “patent waivers” have flooded mainstream media outlets and social media posts, these commentaries often fail to recognize that a “patent waiver” does not magically produce vaccines or resolve the actual barriers to vaccine production.
Health experts widely agree that mass COVID-19 vaccination is likely the fastest and most effective path out of the current pandemic. As of the writing of this article, a total of 280 million doses have been distributed in the US and almost 130 million Americans (out of a total adult population of around 210 million) have been fully vaccinated. While some US communities continue to face vaccine access issues (in particular, isolated, rural, and low-income communities particularly for older adults and adults with disabilities), there is no longer a widespread vaccine shortage in the United States. However, only about 1.6 billion vaccines have been administered worldwide (of a total adult population of about 5 billion), and it is estimated that less than 5% of the world’s adult population has been fully vaccinated.
One mechanism to dramatically increase global vaccination rates is the direct supply of vaccine doses (or similarly the funds to purchase them on the market). Through COVAX (COVID-19 Vaccines Global Access), the World Health Organization (commonly known as WHO) is facilitating vaccine and financial donations from developed countries, the private-sector, and philanthropic organizations to 92 low- and middle-income countries in the developing world.
In parallel, governments are debating various intellectual property solutions upon the assumption that reducing barriers created by intellectual property (IP) rights would further improve access by increasing vaccine production capacity worldwide.
India and South Africa first proposed in October 2020 to waive certain IP protections of the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) with the stated objective of avoiding IP-related barriers to the timely access to affordable COVID-19 supplies including vaccines. While discussion about “patent waivers” have flooded mainstream media outlets and social media posts, these commentaries often fail to recognize that the “patent waiver” does not magically produce vaccines or resolve the actual barriers to vaccine production. Indeed, Moderna, for example, has pledged to temporarily suspend patent enforcement surrounding production of its vaccine. If patent rights alone were the sole issue or even the primary barrier to greater vaccine distribution, then the TRIPS waiver might be an effective approach.
However, concerns with the TRIPS IP waiver proposal include whether there is idle or underutilized manufacturing and supply chain capacity and whether the waiver involves a technology transfer (namely the know-how and other trade secret information) which is necessary for the vaccines (particularly the mRNA vaccines) to be manufactured. Building additional manufacturing and supply chain capacities will likely require substantial capital investment with or without a TRIPS IP waiver. On the other hand, if forced technology transfer occurs, this has long-term ramifications, particularly for those entities that have developed the mRNA technology that is at its infancy of commercialization.
While countries have started to push for IP waivers (which the US recently supported), many commentators have failed to note the existence of related agreements that could provide an alternative to waivers. Specifically, TRIPS not only allows for countries to grant compulsory licenses under circumstances such as a “national emergency” or “other circumstances of extreme urgency,” but also for other countries to export treatments to those countries without sufficient manufacturing capacities (though, few countries have enacted legislation to incorporate the relevant 2017 amendment to Art. 31 of TRIPS in this respect).
Moreover, the speed of action at the WTO for a TRIPS waiver may likely be one of the slower routes available. Take, for example, the 2001 Doha Declaration that sought to address public health problems such as those resulting from HIV/AIDS, tuberculosis, and malaria. The Doha Declaration created a mechanism by which WTO members could issue compulsory licenses to export generic versions of patented medicines to countries with insufficient or no manufacturing capacity. While the Doha Declaration was issued in 2001, it was not until 2017 that there was ratification of the amendment to Art. 31 of TRIPS allowing countries to export treatments to those countries without sufficient manufacturing capacities.
While compulsory licensing exists under TRIPS (and has been used in the past), a compulsory license alone does not address the supply chain and manufacturing issues, nor does it provide a manufacturer with the know-how and other trade secret information that would be essential for the production of safe, effective vaccines. Unlike small molecules that can be more easily reverse engineered, vaccines are incredibly more complex. Further, for the mRNA platforms, there is significantly less knowledge in the field in general given that the mRNA COVID-19 vaccines are the first of their kind to be produced.
Recognizing the shortcomings of compulsory licensing alone, legislation pending in Brazil (it has passed its Senate) proposes to amend its compulsory licensing provisions to also obligate patentees to disclose trade secret information and provide biological materials to compulsory licensees. If a patentee fails to comply with such requirements, the patentee risks revocation of a patent or denial of a patent application in Brazil. Of course, such compulsory licenses only come into play if a patentee is not able to meet the domestic demand through direct use of the protected technology in Brazil, voluntary licensing, or a transparent sales agreement of the protected product. This proposed legislation, by strengthening and expanding the compulsory licensing requirement, may instead have a primary purpose of encouraging either direct manufacturing in Brazil, voluntary licensing, or sufficient sales to meet Brazil’s vaccine needs. However, the additional obligations being proposed for Brazil’s compulsory licensing scheme – particularly compelled disclosure of trade secret information -- are cause for serious concern. Potentially affected businesses would be wise to actively pursue voluntary licensing and local manufacture to address the crisis before the lower house of Brazil’s Congress takes action.
The business solution of voluntary licensing, as well as generally operating within the bounds of TRIPS and the Doha Declaration, formed the basis of the declaration agreed to by all G20 members on May 21, 2021. The G20 declaration states support for "voluntary licensing agreements of intellectual property, voluntary technology and know-how transfers, and patent pooling on mutually-agreed terms." The G20 declaration also focuses on general cooperation to address production bottlenecks and expansion of production capabilities.
And as the WTO and TRIPS Council negotiate whether TRIPS is sufficient to address this global COVID-19 pandemic, whether certain IP provisions need to be waived, or whether greater flexibilities in compulsory licensing under TRIPS are needed, it seems likely that such discussions may have the greatest relevance to the next global health crisis, not the present one. This is so because vaccine manufacturers have stated that they expect to produce 11 billion doses by the end of this year – “enough to vaccinate the world’s adult population.” There are hurdles that industry has identified. However, their five-point plan to address this crisis includes facilitation of dose sharing, increasing production through additional collaborations, identification of trade barriers, working with governments to eliminate trade and regulatory barriers and facilitate cross-border supply chains, and support country readiness to deploy doses within their shelf life.
In the meantime, the next TRIPS Council meeting is scheduled for June 8-9: The world will be watching.
It is not often that the intricacies of international intellectual property law are debated in congresses and coffee shops worldwide. But perhaps this is just another example of how the global fight against COVID-19 has shaken the world in unexpected ways.