Reaching the COVID-19 finish line: Exploring patents, the COVID-19 vaccine and industry-government collaboration

16 Jul 2021
By Helena Trang
Reaching the COVID-19 finish line: Exploring patents, the COVID-19 vaccine and industry-government collaboration
This year marks the expiration of the patent for HIV-prevention drug Truvada, allowing low-cost alternatives to be sold and improving access for American users. Twenty years on from the divisive issuing of the Truvada patent, the world is asking the same questions of the COVID-19 vaccine – have patents prevented effective treatment of global pandemics?
 
As the world grapples with the COVID-19 pandemic, pharmaceutical companies and governments must redefine their relationship in tackling both current and future pandemics. Pharmaceutical companies and governments have failed their customers and citizens with a slow and unequal vaccine roll-out. Key to overcoming the COVID-19 pandemic is rapid worldwide vaccination, which has become more pressing as new COVID-19 strains develop throughout the world. 
 
While developed nations lead the way in vaccine supply and uptake, vaccine inequality endangers poorer nations. It is imperative that the vaccine is spread equally and quickly to vaccinate a critical mass rather than individual countries. With the failure to contain and work cooperatively at the beginning of the virus hanging over the heads of multinational organisations and national governments, cooperation in vaccine roll-out has the potential to be efficient and equitable. 
 
What’s stopping vaccine rollout?
 
Global vaccine roll-out is faltering for two main reasons:
  1. Inadequate vaccine production has meant that supply orders to customers have not been met; and
  2. the distribution of the vaccine across the globe has been unequal
Vaccination production and supply is largely determined by pharmaceutical companies, who are best placed to develop the vaccine given their technical experience and capabilities. These companies have been supported by government funding for vaccine development. For example, Pfizer received over $3 billion US from the United States Government in order to fund its research and development efforts.
 
Governments are then in charge of distributing the vaccine to their citizens. However, given that this has been a globally unregulated process, developed countries have dominated the purchase of vaccines and have left almost no vaccines behind for developing countries. 
 
There have been some attempts at addressing this unequal supply of vaccines, including donations of the vaccine from developed countries to developing countries, the Covax initiative and a waiver of certain intellectual property rights on the treatment of COVID-19 by the World Trade Organization. However, these initiatives have fallen short as developed countries routinely prioritise vaccinating their citizens. This is of course understandable as the virus has been indiscriminate in its impact throughout the world. 
 
Leadership is needed to address unequal access vaccines in a global effort to end the pandemic. No matter how vaccinated a population is, if a new strain of the virus develops, people will continue to contract virus despite being vaccinated. For example, a study by Tel-Aviv University found that the South African variant of COVID-19 is able to break through the Pfizer vaccine. 
 
A concerted global effort needed to address unequal access to vaccines to end the pandemic. Two areas for immediate action are 1) an overhaul of patent regulations; and 2) heightened cooperation between pharmaceutical companies and government. 
 
Patent sharing will result in more vaccines
 
A greater supply of the vaccine is required to address the world’s demand. As pharmaceutical companies have failed so far in providing an adequate amount to meet global demand, governments must utilise compulsory licensing or negotiate voluntary licensing agreements to allow other vaccine manufacturers to begin producing the vaccine. Compulsory licensing allows a government to access and use intellectual property of an intellectual property holder in times of national emergency. Voluntary licensing agreements are entered between intellectual property holders and potential users to provide access to the intellectual property. 
 
Pharmaceutical companies have been unable to produce enough vaccines as they lack the resources to meet global demand.
 
These resources do exist elsewhere with Israel, Canada, Bangladesh, South Africa and Denmark, stating they have unused vaccine manufacturing facilities that can be used to fight COVID-19. The only thing that stands between these countries producing the vaccine are the patents held by pharmaceutical companies which restricts use of the patent. 
 
Pharmaceutical companies have pushed back on the release of patents, citing that even without these regulations, developing countries will not have the ability to produce the vaccine due to complex infrastructure and technical requirements. Furthermore, if patents were compulsorily licensed, there would be no incentive in the future to develop the vaccine. Recent developments have not lent credibility to these claims.
 
Vaccine development can instead occur in developed countries with vaccine-producing capacity and be sent to developing countries under Article 31 of the Trade Related aspects of Intellectual Property Rights Agreement Compulsory Licensing. Canada is already using this model, having obtained the patent for the Johnson & Johnson vaccine and garnering interest for supply from a number of small and medium sized countries. Therefore, compulsory licensing will improve vaccine availability for developing countries despite production limitations. Johnson & Johnson, AstraZeneca, and Moderna have all agreed not to profit from the vaccine, demonstrating that profit is not a motive for its production.
 
As experts warn that COVID-19 vaccinations may require annual doses, the quicker the patent is released to industry, the faster infrastructure can scale up to meet this demand.
 
The mRNA vaccine producer Moderna has capitalised on this idea with intellectual property academics suggesting that its voluntary licensing of the vaccine and encouragement of mass production is to build up mRNA capability for it to grow post-COVID-19. 
 
Long-term arrangements between pharmaceutical companies and government is needed to address future threats
 
Pandemics similar to COVID-19 will become increasingly common in the future as a result of globalisation and urbanisation. Gavi, the global vaccine alliance, has identified at least nine viruses that could become the next pandemic. Vaccinating against new viruses remains the most effective way of containing infection, so how vaccine production and roll out occurs in the future is of vital importance. 
 
Pharmaceutical companies remain best placed to produce the vaccine. Governments are similarly best placed distribute the vaccine. The relationship between how vaccines are produced and distributed, however, needs some consideration. It is recommended vaccine manufacturers should only be allowed exclusive use of COVID-19 vaccine intellectual property if they are able to meet global demand.
 
On the government end, multilateral agreements must be forged in relation to how vaccine roll-out is completed to ensure an equitable and swift end to pandemics. For example, in the Indo-Pacific region, an agreement can be made between countries that every country must be supplied enough vaccine for 70% of their population before countries can purchase for the rest of their population. 
 
At the recent meeting of the Quad, Australia, India, Japan and the United States agreed to cooperating on vaccine manufacturing and delivery resulting in 1 billion doses being produced in India. Although donating vaccines to other countries while Australians remain unvaccinated is a significant departure from our current state, it is entirely possible given Australia has already committed to buying 195 million doses of the vaccine, having sent one million doses already to Papua New Guinea to aid in its latest outbreak. 
 
These two numbers combined could vaccinate 70% of the population in Australia and all of its pacific partnersalone, demonstrating the potential for Australia to lead in the region to support its neighbours in vaccinating a critical mass of people.
 
To be sure, pharmaceutical companies do have a profit mandate in order to secure funding to continue costly research and development of vaccines and medication. However, these market considerations cannot, and should not, preclude governments and pharmaceutical companies from thinking differently when it comes time to address a crisis. 
 
When the world is being paralysed by the virus and time is of the essence in reducing the chance of mutation, it becomes unethical to prevent a vaccine for the sake of traditional intellectual property rights of a few.
 
COVID-19 has exposed the world to what happens when we are not prepared for a global crisis such as a pandemic. The virus has been indiscriminate in its infection and disregards borders, touching every corner of the world. The pandemic has revealed that structures and institutions must change in order to quickly meet the public health needs of a pandemic. An equitable vaccine roll-out is not simply an abstract issue; there are significant economic and health reasons for getting as much of the world vaccinated as soon as possible.
 
This pandemic was not the first and will not be the last. The world has the potential to come together to stop the virus but must first reconsider the current intellectual property system and governance of the vaccine roll-out. 

Authors

Helena Trang
Helena Trang
Helena Trang is a Research Intern at the Perth USAsia Centre. She is currently completing a Juris Doctor at the University of Western Australia.
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