In an unexpected move last week, the Office of the United States Trade Representative (on behalf of the Biden-Harris Administration) announced its support for a waiver of intellectual property protections afforded by the TRIPS Agreement for Covid-19 vaccines.
The announcement represents a shift in position by the US which (along with the EU, UK, Japan, Switzerland, Brazil and Norway) resisted a similar proposal submitted by India and South Africa in October 2020.
A waiver of patent protection for Covid-19 treatments is supported by India, South Africa and 57 other World Trade Organisation Members. Further, both Labour and the Liberal Democrats have urged the UK government to support a waiver. The UK is yet to formally announce its position.
Proponents of a waiver argue that suspension of patent rights in Covid-19 vaccine technology will assist in improving supply to developing nations by removing barriers to the ramping up of global manufacturing capacity. US Trade Representative, Ambassador Katherine Tai, stated “this is a global health crisis, and the extraordinary circumstances of the Covid-19 pandemic call for extraordinary measures.”
In response to the US announcement, EC President Ursula von der Leyen stated that the “EU is ready to discuss any proposal that addresses the crisis in an effective and pragmatic manner,” but did not formally support the waiver.
Scope of the proposal
Whilst the US government has indicated that it is now in favour of some form of waiver, it is not clear precisely what scope of waiver it would support. Its recent statement was not accompanied by any detailed proposal, and refers only to Covid-19 vaccines – the US had previously opposed the Indian / South African proposal that would have also applied to non-vaccine therapeutics and diagnostics.
Opposition to a waiver
There is no doubt that facilitating access to Covid-19 vaccines in developing countries is a critical step in ending the global pandemic. However, it is not clear that a waiver will achieve that aim. Opponents of a waiver argue that patent rights are not the limiting factor in increasing vaccine supply, and that other issues need to addressed in order to increase production.
Following a summit of European leaders late last week, European Council President Charles Michel stated that, “On intellectual property, we don’t think in the short term that it’s the magic bullet but we are ready to engage on this topic as soon as a concrete proposal will be put on the table.”
Other European leaders expressed greater reservations about the idea. German Chancellor Angela Merkel stated that, “I don’t believe that the waiver of patents is a solution to provide vaccines for more people. Instead, I believe that we need the creativity and innovative force of companies, and for me, this includes patent protection.”
Opponents of a waiver point to a number of issues that they consider are more critical to improving vaccine supply including:
- Know-how: Covid-19 vaccines are complex biologics and their manufacture is not straightforward. The companies that have developed the vaccines have amassed substantial know-how which is required for their effective manufacture, and dissemination of that information would not be assisted by a waiver of patent rights. Following the summit of European leaders last week, a French diplomatic official was quoted by Politico as saying “Lifting the IP certificates is well and good but without transferring technology it’s like having the recipe for a meal but not having a pan, a saucer, a knife.” Many opponents of a waiver argue that increased licensing and collaboration between innovator companies and contract manufacturers would be a more effective means to scale up production as it would facilitate use of the innovators’ valuable know-how.
- Supply of materials: Manufacture of the various Covid-19 vaccines requires a large number of different materials (in at least one case up to 280 different ingredients and components) sourced from countries around the globe. Ramping up production will require sufficient supply of all of these materials. However, at present some countries – including, notably, the US – are blocking the export of critical raw materials. Following the US announcement of its support for a waiver, French President Emmanuel Macron stated that, “If we want to work quickly, today there isn’t one factory in the world that can’t produce doses for poor countries because of intellectual property. The priority today is not intellectual property — it’s not true. We would be lying to ourselves. It’s production,” and, “ I am calling very clearly on the U.S. to end their export ban of vaccines and components that prevent production.” The CEO of the Serum Institute of India, which has partnered with AstraZeneca to produce its vaccine for low and middle income countries, has also called on the US to lift its ban on the export of critical raw materials.
IP protection facilitates innovation
Critics of a waiver argue that in the absence of the incentive provided by patent protection, development of improved vaccine technology, both for Covid-19 and for potential future disease outbreaks, will be stifled. Indeed, much of the technology that has been employed in developing the current Covid-19 vaccines arose out of research and development stemming from the previous SARS and Middle East Respiratory Syndrome (MERS) coronavirus epidemics. The importance of IP protection in supporting future innovation has been emphasised by the German Government, which stated in response to the US announcement that, “The protection of intellectual property is a source of innovation and must remain so in the future.”
It remains to be seen whether consensus for a waiver can be reached at the WTO and, if implemented, whether such a waiver will increase global vaccine supply. If WTO negotiations are to result in consensus for a waiver a careful balance will have to be struck to ensure that innovator companies are adequately compensated for their investment in researching and developing the vaccines, and that platform technology used in the development of Covid-19 vaccines remains protected in non-Covid contexts.