ON May 3, 2022, World Trade Organization (WTO) members the European Union, India, South Africa, and the United States agreed on a proposed waiver on intellectual property (IP) protections for Covid-19 vaccines. The proposal was made to facilitate vaccine production and increase access to vaccines in developing nations.
One of the core principles underpinning the campaign to waive IP protections for Covid-19 vaccines is that every country should have the right to produce its own vaccine(s) during a global health crisis. Drug-producers globally should be allowed access to trade secrets on how Covid-19 vaccines are produced. The goal is to reduce obstacles which may impede developing or less developed countries from producing their own vaccines.
Whilse the waiver of IP protections may allow cheap and expeditious production of vaccines for less privileged countries in the long-term, the real challenge lies in the actual production of such vaccines. Covid-19 vaccines are inherently complex, and their production involves much secret know-how, which may not be disclosed in the patents filed.
It is an understatement to claim that heavy investment in highly specialised equipment, infrastructure, raw materials, and technical processes are required for the successful production of any vaccine. It will be difficult or impossible to replicate vaccines without the assistance of companies that developed them, to the extent that industry experts have likened the waiver of IP protections to the act of handing out a recipe with the ingredients but without the cooking method.
In July 2021, the World Health Organization (WHO) established a technology transfer hub in Afrigen, South Africa to build capacity in low and middle-income countries to produce mRNA vaccines. WHO officials touted this move as providing half the solution to the issue of vaccine production and accessibility in low and middle-income countries. They took the view that it will help to remove the issue of “practical knowledge restrictions”, leaving only legal IP restrictions to contend with.
However, this simplistic view fails to consider the fact that there is much specific technical know-how and practical knowledge applicable to each type of Covid-19 vaccine and it is not “one size fits all”.
In view of this, the waiver of IP protection may not be the best approach to resolve the issue of supply and access to Covid-19 vaccines in low and middle-income countries.
A more viable approach is probably to actively engage with pharmaceutical companies (which possess the relevant patents and technical know-how) to accept other time-tested solutions available within the IP framework such as voluntary licensing, non-exclusive licences or technology transfer agreements, similar to what AstraZeneca and Novavax have established with the Serum Institute of India.
Vaccine companies can also be compelled to license their patent with certain conditions under the legal scheme of “compulsory licensing”.
In Malaysia, compulsory licensing is permitted under the Malaysian Patents Act 1983, where it allows third parties to produce a patented product or process without the patent owner’s consent, in specific situations.
A public health emergency such as the global pandemic or national emergency falls squarely within this.
In fact, the Agreement on Trade-Related Aspects of Intellectual Property (Trips Agreement) provides for an additional type of compulsory licensing, which stemmed from the recognition that countries unable to manufacture pharmaceuticals should be able to obtain cheaper versions produced under compulsory licences elsewhere if necessary, and is specially for production in one country, for export, to meet the public health needs of another country.
A further reason as to why a waiver of IP protection for Covid-19 vaccines is not the best approach to the issue of vaccine supply and access is that it may undermine risk-taking and the spirit of innovation. The IP framework, particularly the patents system, is key to incentivising innovation and is intended “to promote the progress of science and useful arts”.
The waiver of IP protections for Covid-19 vaccines will inevitably dampen the zeal and enthusiasm for innovation within the pharmaceutical industry, where innovation and financial investments made the rapid development and production of Covid-19 vaccines possible in the very first place.
Finally, resorting to absolutely expropriating the rights of IP owners under the auspices of solving a supply problem may be counter-productive in the long run. The authorities in Malaysia (and other countries) should fully utilise the well-established mechanisms outlined above under their respective IP regimes to overcome this issue of production and access to vaccines while concurrently protecting the rights of IP owners.
This article is contributed by Teo Jer Ning of Christopher & Lee Ong.
Source: The Sun Daily
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