Eight Reasons Why The Intellectual Property (IP) Waiver For COVID-19 Vaccines and Treatments Will Work
On 5th May, 2021, the USA under President Joe Biden joined a global, progressive movement at the World Trade Organisation (WTO) to suspend certain Intellectual Property (IP) protections for COVID-19 vaccines.
“These extraordinary times and circumstances call for extraordinary measures,” the US Trade Representative Ambassador, Katherine Tai, said. “The US supports the waiver of IP protections on COVID-19 vaccines to help end the pandemic.”
Ireland and EU countries, however, have not followed suit while there has been a predictable push-back by spokespeople for the pharmaceutical industry.
Here, we address some of their main arguments:
1. Opponents of the waiver state:
Intellectual Property (IP) rights are not a significant barrier to the production of COVID-19 vaccines and treatments, and a waiver of IP rights at the WTO would not result in increased production of COVID-19 vaccines and treatments worldwide.
We say:
This waiver would be a first but important step to enable increased manufacturing capacity worldwide. In Canada, India, Bangladesh, Indonesia, South Africa, Ghana, Turkey, Brazil, Argentina, the United Arab Emirates, China and Russia, there are pharmaceutical companies with the capacity to produce many more vaccines. Waiving IP rights would pave the way for increased manufacturing of vaccines for the duration of the pandemic, in all our interests.
2. Opponents of the waiver state:
IP is the incentive for innovation and, if it is undermined, this will stifle future innovation.
We say:
The success of COVID-19 vaccine research and development (R&D) is a reflection, in large part, of public funding related to vaccine research and development. Public funding accounted for 97% of the R&D costs of AstraZeneca and most of the funding of Moderna. Real innovation in vaccine manufacturing is taking place in public institutions, like universities, or is being funded by public R&D money in private institutions. This should be recognised in any conversation about incentives and innovation, as should the vast profits being made by COVID-19 vaccine makers.
3. Opponents of the waiver state:
There are no other manufacturers capable of carrying out the complex manufacturing process for effective COVID-19 vaccines and treatments.
We say:
Generic production of other medicines has expanded supplies and reduced prices throughout the world. While the manufacturing process for COVID-19 vaccines may be complex, there is nothing so exceptional about the process that would prevent generic manufacturing taking place. In fact, the manufacture of mRNA vaccines has been said to closely resemble biologic medicines where mass production already takes place. On the other hand, cooperation on technology transfer and expertise by rights-holding companies would help expedite the process of increasing levels of production, such as through mechanisms like the WHO’s COVID-19 Technology Access Pool (C-TAP), if such companies showed a greater willingness to co-operate.
4. Opponents of the waiver state:
Raw materials are a scarce resource and one of the real bottlenecks. A widespread scramble for raw materials will limit existing producers still further.
We say:
There are indeed some problems in the supply chain for vaccines. However, bottlenecks are inevitable in the rapid development of production and the response should be to address that specific problem. Current trade barriers are amongst the biggest barriers and these need to be addressed.
5. Opponents of the waiver state:
We don’t need to touch IP - just remove trade barriers and export controls to increase the distribution of raw materials worldwide.
We say:
There is no evidence that such actions will result in the degree of upscaling that is required. Because a three-fold increase in production in COVID-19 vaccines is required, from roughly 3.5 billion to 11 billion doses, a much more aggressive approach is required to increase production – and in the continued absence of engagement from industry in voluntary initiatives like C-TAP to share IP, know-how and data to address the pandemic, mandatory mechanisms are needed. The WTO IP Waiver proposal provides a vital element of that approach. By all means, reduce trade barriers and improve distribution, but these methods in themselves will be insufficient to address the global need for vaccines.
6. Opponents of the waiver state:
Generic manufacturing would jeopardise quality.
We say:
Quality control in Higher income Countries (HICs) is maintained by national regulatory authorities who are on the WHO’s List of Stringent Regulatory Authorities (SRAs). In middle and lower income countries, quality is assured by the World Health Organisation’s (WHO) pre-qualification programme. The objective of this pre-qualification process is that vaccines and treatments from middle and lower income countries can be placed on an equal footing with those from higher income countries.
7. Opponents of the waiver state:
Big Pharma do it better and they already are doing so.
We say:
Heart-rending scenes of death and destruction have emerged in India as the pandemic rages, while other developing countries remain vulnerable to next waves. Furthermore, the emergence of more variants threatens the entire world’s progress against COVID-19. ‘Big Pharma’ (in this case, the companies with approved vaccines who are exercising their intellectual property protections) only collaborates with a small group of hand-picked corporations to produce their vaccines worldwide. This is an untenable situation and one which history will judge very harshly, if it continues.
8. Critics of the waiver state:
This statements of support for the WTO Waiver proposal by the USA and New Zealand only covers vaccines for COVID-19, but not also treatments and diagnostics. Therefore, it is insufficient.
We say:
On this, we fully agree. The weakness in the US and New Zealand statements about the WTO intellectual property waiver is not simply that they are limited to vaccines, excluding treatments and diagnostics, but that this suggested change to the original proposal by the US and New Zealand may delay the whole negotiation process for the waiver at the WTO. The original proposal to waive IP rights, made by India and South Africa to the WTO last October, included treatments and diagnostics which are vital to frontline battles where the pandemic rages. It is essential that this original form of the proposal is maintained.
Conclusion:
The WTO Waiver proposal offers an opportunity to shorten this pandemic and save millions
of lives.
Let’s not waste any more time.
The Irish Government should urge the EU as a bloc to support it.
No one is safe until everyone is safe.