INTRODUCTION
What is vaccine patent? Patents give vaccine manufactures/producers exclusive rights to prevent third parties from manufacturing, using, offering for selling or importing the shot/vaccine they developed. Patent owners are also free to charge a price that covers their research, development costs and profit margin.
But such deep profit margins can be controversial and insensitive during times of crisis, such as the ongoing COVID pandemic.
What is patent waiver? A patent waiver would legally allow any company with the required capacity to start manufacturing the shot/vaccine, even without an agreement or license from the patent owner or original developer.
WHY IS PATENT WAIVER NEEDED?
The need of the hour is worldwide vaccination which to be successful desperately needs temporary relaxations in intellectual property rights and patent rights.
The need for accessible and affordable healthcare has never been more crucial. Millions are getting infected and thousands are dying every day from the coronavirus. The entire world is facing a shortage of medical supplies. This situation may not get under control until much of the population is vaccinated against the novel coronavirus.
In this pandemic every country should have the right to make its own vaccines. That's the principle underpinning the campaign to temporarily waive intellectual property (IP) protection on coronavirus vaccines. The campaign was initiated by India and South Africa, and is being backed by more than 100 countries, along with international organizations including the World Health Organization and the United Nations AIDS charity, UNAIDS. The goal is to reduce the barriers to countries wanting to produce their own vaccines — particularly for the lowest-income nations.
At present, the proposal does not have the support of the pharmaceutical industry, nor that of most high-income nations. Instead, these countries are pledging to share more of their own vaccines with low-income nations and to provide more funding to charitable vaccine-provision schemes such as COVAX. However, in a surprising and welcome move earlier this month, the United States, Russia and China came out in support of an IP waiver on vaccines. An effective way to quickly ramp up vaccine production is to lift patents and transfer technology. The sharing of knowledge and technology can ensure more vaccines are produced as soon as possible for everybody everywhere across the globe.
DISADVANTAGES OF PATENT WAIVER
Patent waivers can discourage pharmaceutical companies from vaccine innovation, as a lot of time, research, resource, money, manpower and human-intellect are invested in its development. The biggest disadvantage of patent waiver is financial loss for the patent owner whose IP rights are at the stake. The proposal to waive the Covid-19 vaccine patents threatens to undermine the very pillar of the drug industry's business model - the patents protecting its innovations and giving companies a monopoly for several years over sales of the medicines based on the technology.
IP waivers to patent provide a short-cut to competitors looking to acquire expensive technology. Companies also say that IP relief will not accelerate vaccine manufacturing, because materials are in short supply and it can take several years to build up capacity from scratch.
Moreover, the governments opposing the waiver argue that current WTO rules already allow countries to apply for 'compulsory licensing' to override IP during emergencies. Right now, for example, Bolivia is applying to the WTO to use this process to allow it to manufacture Johnson & Johnson's COVID vaccine.
Also, COVID-19 vaccine includes mRNA technology which can be handled only by fine scientists and technicians. Even if, all WTO members were to unanimously decide that IP waiver should implemented for vaccines and their technology, the real obstacles at hand would be a worldwide shortage of raw materials, trained personnel, and other infrastructure necessary to make the lifesaving COVID-19 shots. Therefore, merely looking at the legal aspects and waiving-off IPs will not magically increase production overnight as patents are not the main or only roadblocks in ramping up the production. As mentioned, patents are considered to be a blueprint of an invention, merely providing blueprints of manufacturing vaccines to the generic pharmaceutical companies would lead to nowhere. There are already very real challenges to inoculating the world, including a widespread lack of proper refrigeration (let alone the ultracold storage required for some vaccines), a shortage of trained professionals to administer them and conduct follow-up evaluations, and a lack of patient compliance with the two-dose regimen for the Pfizer-BioNTech and Moderna jabs.
Merely waiving off the IP rights without transferring the know-how of the technology will make it difficult to scale up the production. Preparing biosimilar requires a similar skill set as preparing original vaccines. Further, India has strict regulations for biosimilar; it would take almost a year to set up the facilities with required technicians. It will also need strict monitoring to keep a check on the efficacy and safety of the biosimilar.
ALTERNATIVE TO PATENT WAIVER
1In pursuit of accelerated vaccine manufacturing and production across the globe, pharmaceutical companies have offered different alternatives to patent waivers. For instance, AstraZeneca, in June 2020, shared their licenses that vaccines can be manufactured at multiple sites to increase production. It forged agreements with Epidemic Preparedness Innovations (CEPI), Gavi the Vaccine Alliance and the Serum Institute of India.
2Moderna released a statement where it announced that it would not enforce its vaccine patents during the acute phase of the pandemic.
In January 2021, the French Pharmaceutical company Sanofi announced that it had arrived at an agreement with BioNTech — the biotech firm with which Pfizer has partnered to devise its vaccine, to supply its vaccines to the European Union. The French company will help manufacture 125 million doses of the shot.
In April 2021, Russia announced that it would be offering free technological transfer of its Covid-19 vaccine - Sputnik V, to India.
CONCLUSION
Rapid and equitable distribution of Covid-19 vaccines is absolutely critical to bring the pandemic to an end. But sacrificing the innovation ecosystem in order to achieve this end would be a myopic policy. Despite this, monetary funds or legal aspects should not hinder the increase of the supply of vaccines. Hoarding of vaccines by developed countries will not and cannot curb the spread of the virus as if even one human is unsafe, then no human is safe. It is time for all countries to come together and share the technical knowhow, technicians, facility to scale up the production of vaccines, raw materials, or donate the vaccines.
Footnotes
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