Would a Patent Waiver for COVID-19 Vaccines be Effective? There has been much discussion in the press in recent months of a patent waiver in respect of COVID-19 vaccines. But what does this actually mean, and could it ensure equitable access to COVID-19 vaccines for everyone? Development of vaccines for new diseases typically takes decades. However, less than 11 months after the sequence of SARS-CoV-2 was published, the United Kingdom gave temporary regulatory approval to the mRNA COVID-19 vaccine developed by Pfizer and BioNtech. The Oxford University and AstraZeneca vaccine followed shortly thereafter, with the Moderna vaccine now also approved. COVID-19 vaccination programmes have been implemented at an impressive speed in, for example, Israel, the UK and the United States, but the pace of vaccination in developing countries has been far slower. In many cases, those countries home to pharmaceutical companies that have developed vaccines have been ahead of the curve in deploying them. This is in part due to being first in the queue to place orders and in part due to contractual obligations being enforced, requiring that supply agreements with home nations be fulfilled first.
Given the cost of vaccine development, it is not a surprise that companies will utilise the patent system to recoup some of that investment. However, a clear picture of the patent landscape is difficult to ascertain, with patent applications not being published until 18 months after they have filed. Furthermore, the work to develop the vaccines has built on previous vaccine development and mRNA virus manufacturing is known to be patent protected.
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Richer nations acknowledge the global nature of the pandemic and agree that the incidence of the virus in other populations poses a continuing risk to them despite their own vaccination success. As a result, the COVID-19 Vaccines Global Access (Covax) program is a worldwide initiative initiated by the World Health Organisation where higher-income countries pay for vaccine doses and lower-income countries receive vaccines paid for by donations. Pharmaceutical firms are also expected to make concrete pledges to increase supplies in these developing countries. Nevertheless, vaccine inequality remains, and some have pointed to the world of intellectual property as a cause. 4
vaccine inequity? The principle underpinning the notion to waive patent protection is that every country should have the right to make its own vaccines during a pandemic. The campaign was initiated by India and South Africa as early as October 2020 and is being backed by more than 100 countries. The argument is essentially that a temporary patent waiver would allow multiple parties to start production sooner, rather than manufacturing being concentrated in a small number of companies holding patents that serve as a block to others. The relevant legal basis for a World Trade Organisation (WTO) decision would be the Agreement on
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Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), which was concluded by the members of the WTO in 1994. Earlier this year, the Biden administration announced that the US would support a proposal to waive patents on COVID-19 vaccines in response to the need for more global supply. Members of the European Parliament also proposed to start negotiating a temporary waiver of the TRIPS Agreement on patents to improve global access to affordable COVID-19-related medical products and to address global production constraints and supply shortages. However, Germany and the UK remain against the move, along with the drug industry. In the UK, statutory provisions exist for gaining access to patented intellectual property. So-called “Crown Use” under section 55 of the Patents Act 1977 (Patents Act) provides for the government to order the making of a patented product or use of a patented process without consent from the patentee, rather than allowing a third party to do so upon request. This can be seen as a more extreme measure than compulsory licensing (where a third party can apply for a compulsory licence at any time after the expiration of three years from the date of grant) and was drafted specifically for use in emergencies, which would include a pandemic. Compensation for patent holders whose patents have been subject to Crown Use is provided for in section 57A of the Patents Act. The above UK provision is in line with the TRIPS Agreement. Any country that is a WTO member is already able to enact such legislation and
