Patenting COVID-19 vaccine: Contrary to International obligations?

Introduction

The past year has not been easy for most of people across different nations. The novel coronavirus made 2020 difficult and tiring for most of the people. Every country has been trying to come up with an effective and efficient vaccine to eliminate the coronavirus from the grassroot level. Many countries have succeeded in launching their own COVID-19 vaccine with India proudly being one of them. This might appear to be a light at the end of the tunnel but the next bigger issue is ensuring availability, affordability and accessibility of the vaccine in an equitable proportion. It can be said that developing a vaccine is not the only complex and tough task for the countries and companies worldwide, but spreading and making them available to the masses is equally difficult and challenging. The challenge that accompanies the distribution is free or equal access to all.

It looks like the vaccines are ready and continuing to protect the millions and billions of citizens of the world’s richest and developed countries. But protecting the rest of the states does not seem to overshadow the necessity of intellectual property rights. It is clear that companies are putting their profits before the safety of people. The question coming in as a sidekick here is whether patenting the technology or methodology of devising COVID-19 vaccine will help the countries in increasing the availability of the vaccine or not. Patenting a particular technology or method restricts its free and equitable use by other underdeveloped countries because of their inability to pay the requisite amount. Thus, patenting may not ensure that the masses get equitable access to the COVID-19 vaccine. If the disease does not discriminate amongst the masses, then why should the vaccine producers restrict equitable distribution and use of the same vaccines?

With the birth of the World Trade Organization in 1995, most member states agreed to bind themselves and abide by the Agreement on Trade Related Intellectual Property Rights (TRIPS), which ensures intellectual property rights applicable to new innovations including vaccines and medical supplies.     

1.  International Obligations

Nations worldwide have certain obligations towards each other. Some countries are signatories to certain international treaties as well. Such states also have an implied obligation to respect the other states, human rights, and promote peace in the world. As stated, the states have an obligation  to protect and act towards the development of the human rights of the citizens worldwide. Providing equal opportunities to the citizens of developed, developing and underdeveloped countries is also a part of the obligation of protecting human rights. The United Nations in its UN Human Rights Charter also promotes indiscrimination on any basis. The 1946 WHO Constitution entails “…. the highest attainable standard of health as a fundamental right of every human being.” The 1948 Universal Declaration of Human Rights also recognizes health as a part of the right to an adequate standard of living under Article 25. Further, under Article 12, the right to health was defined in General Comment 14 of the Committee on Economic, Social and Cultural rights as cluster of four components- availability, accessibility, acceptability and quality. Thus, it is quite clear that states in International community have the obligation to promote quality of health.

2.  Patent Ownership

At the global level, the companies comply with the IP incentives and rights enshrined in the TRIPS agreement. The provisions provide a full-fledged system of company specific protection along with a particular period of monopoly in the market. The advocates of this protection argue that Intellectual Property protection in certain products for companies is necessary so that these firms can recover the investments made in resources and research and enhance their  innovation and invention culture.

However, these rights may often clash with other goals and obligations including protection of public health and human rights to health. There have been constant controversies and arguments regarding the protection period of patents and the reasonable amount of profits that the company should get to cover its research expenses. The major question that arises is that given that the prices of drugs and medicines are higher due to patents, are patents even essential or feasible in the context of a global pandemic?

The novel coronavirus has led to unprecedented situations in the world and the race to develop vaccines for COVID-19 has ended for some countries but is still continuing for the others. The efficiency and effectiveness of these vaccines are yet to be determined after use by certain people and authorities. This surely appears to be a silver lining in the darkness spread all over the world, but the aspect of availability and accessibility of vaccine is still in question. It is certain that the countries producing their own vaccine need not worry about the production and subsequent distribution but other countries having no access to the vaccine would face problems.  

US Pharma giant Pfizer and German BioNTech were the first to announce on 9^th November that ‘BNT162b2,’ the vaccine developed by their collaborative efforts, had shown ninety percent accuracy and efficiency after the conclusion of Phase III trials. The companies have decided to ensure mass production of this vaccine by the end of 2021. But the point here is that the price of this vaccine as decided is US$39 (approximately INR 3000), which is hefty.

In early October, 2020, India and South Africa requested the World Trade Organization TRIPS Council to consider a temporary waiver suspending TRIPS obligations on all medical products that can be helpful in controlling the pandemic. During the same time, forty WTO members discussed the proposal. The proposal was discussed by way of votes and contentions. Mostly the developing nations supported the waiver but most of the developed nations opposed the same. The developed countries including Canada supported profits and gains over public health. There has been no decision as such on the subject but the companies are continuing to use an impose their intellectual property rights. A step taken by Moderna to waive off its patent rights is well appreciated and has been found to be in line with human rights and protection of public health.

3.  Why waiver?

The waiver proposed would only apply to the drugs and medicines that are currently helping in combating the pandemic. The proposal clearly mentions that the waiver shall be time-limited and would end when majority of the population will get vaccinated. It shall help in creating a global herd for immunity and shall not influence any other TRIPS policy or regulation. The waiver requires a three-fourth majority and the proposal shall allow the WTO member states to neither grant nor enforce patents or other TRIPS rules in case of COVID-19 prevention tools. The member states can then easily and effectively research, innovate and formulate essential measures for the same. It can also scale up the distribution process of the vaccines and the required drugs. The developed countries criticise the proposal by stating that the TRIPS agreement already has flexibilities for the member states to exercise discretion. The flexibilities already allow the countries to issue compulsory licenses for less expensive drugs and medicines and also allow countries to import the generics to suffice their manufacturing capacity. But practically, it becomes difficult to implement such strategies. The prime reason is because the importing countries will have to bargain and negotiate to receive the drugs at reasonable prices. Moreover, the ability to agree to a voluntary license rests with the patent holder and it might act as a short-term solution.

Further, the patent holders’ actions can create a negative influence by having private governance over the patented technologies and resources. It is true that some holders might issue license for a fee-based royalty or a reasonable amount but other may not do the same. Given the nature of the pandemic and patent holders’ rights, the global biomedical community should scrutinise the patent rights for COVID-19 more deeply.   

4.  Need for Technology Sharing

It is quite clear from the above averments that the governance role of patent holder has significant implications on the health technologies which are often overlooked. Such issues are heightened in the times of pandemic because general interest is at stake. Thus, the companies and in fact the countries should come at an amicable solution to curb the pandemic.

The physical procurement of vaccines can be a multi-layered challenge and thus, an alternative way to ensure equitable access is by sharing technological know-how with local manufacturers across the world to pump the supply. The World Health Organization also made an attempt to facilitate a COVID-19 Technology Access Pool for the countries to share their technological ideas but it only included forty countries. In the situation where the developed and high-income countries have pre-booked the vaccines, it is essential to ensure technology sharing to foster equitable access. Moderna has already pledged to give up its patent rights for a particular time but what good is a time-barred pledge when the company does not share its technology. An initiative taken by AstraZeneca of signing local manufacturing agreements with the worst affected countries like Mexico and Argentina shall help the company to share the vaccines with the Latin American countries.

COVAX has emerged as a ray of light for the countries in the global south which is a collaboration headed by CEPI, GAVI and WHO. It has developed an equitable allocation mechanism that enhances the manufacturing capabilities and timely supply of 2 billion doses to be fairly distributed across 172 member states at subsidized costs. But there are flaws attached to the scheme. The initiative only assures vaccination of 20% of the national population and then, on the need-based weighted approach. It might leave a stratum of poor people in the low-income countries unattended. Thus, COVAX is the only option that appears for the global south countries but it might yield desired results in the long term.   

Suggestions and Conclusion

Patenting COVID-19 vaccine is clearly detrimental to the international obligations as it prevents equitable access to third-world or low-income countries. Every state in the international community has taken an implied pledge to protect and support humankind in any way possible. Waiving off the patenting rights is one of such responsibilities. The researchers suggest that the developed countries should share their technology and the useful resources with other countries to ensure that the countries can manufacture locally and supply in abundance. In a pandemic, the companies and countries must keep their profits and gains at one side and focus on fighting the pandemic. The countries in the global south also face a logistical challenge because of lack of electrification required to sustain the vaccine storage at ultra-cold temperatures. High efficacy rates and no-patent enforcement pledges might not prove to be beneficial for third-world countries if they are forced to scramble over the leftover supplies after the rich and developed nations have accumulated their buffer stocks. With the persisting challenges, the nations are coming together for patent suspension which will not only prevent the pharma companies to suspend the patent rights but also pose a serious impediment in achieving the goal of equitable access.    

The nations must understand that this is not a contest among themselves but a war between COVID-19 and human race. The respective governments and private multinationals must come up with solutions keeping aside the hatred or distrust and political insecurities. Staying united and supporting each other irrespective of the nationalities is what matters and is needed the most now.