On 31st January 2020 the World Health Organization declared the outbreak of a new coronavirus disease, COVID-19, to be a Public Health Emergency of International Concern and In March 2020, WHO made the assessment that COVID-19, can be characterized as a pandemic. Various international organizations and governments are taking required actions to prevent the spread of coronavirus. Since the beginning of the pandemic, world has acknowledged that such contagious disease can only be prevented by inoculating people all around the world and for that vaccine production started at a huge level. Various vaccines such as Covishield, Covaxin, Pfizer, Moderna, Sputnik, Novavax etc. are developed. But these big vaccine developers monopolized the market by enforcing IP rights hampering the global vaccine accessibility. Therefore India and South-Africa had asked waiver of IP rights on all covid interventions at World Trade Organization to facilitate scale up of production and global equity and accessibility. The IP rights waiver would be the emergence of light at the end of a long dark tunnel for India and rest of the world.
Keywords: – Covid-19, IP Rights Waiver, World Health Organization, Vaccines, Global Vaccine Accessibility.
In Indian culture, there is a famous saying ‘Health is wealth’ showing that Indian culture has always given enormous importance to the good health. At global level United Nation has adopted Sustainable Development Goal titled “Ensure healthy lives and promote wellbeing for all at all ages” which aims to achieve good physical as well mental health and well-being, equitable access to health care facilities and effectively & efficiently combat communicable disease. Our objective to achieve these goals by the end of 2030 have received a huge setback by the outbreak of Coronavirus which is an infectious disease caused by a new coronavirus named as ‘SARS-CoV-2’. The disease is a contagious disease which transmitted from human to human affecting millions of people all around the world. The disease has been declared as a pandemic by world Health Organization on 11th March, 2019. Since the beginning of the pandemic the world is focusing a lot on effective vaccine to fight against the Covid-19. In the past also we have successfully battled against the infectious disease by inoculating people across the world. Generally from our past experience, it is noted that on an average 10 years are invested for producing a novel vaccine but this time our collective, effective and rapid steps have reduced the time of vaccine development significantly and within a year the world has developed various vaccines to protect, prevent, control and contain the spread of virus. In the present scenario, the vaccine production is highly monopolized by big multinational companies by using intellectual property rights. IP rights are enforceable legal rights given to person or company over the creation of new product or service for 20 years. It includes patent, copyright, trademark, undisclosed information, trade-secrets etc. These rights prevent the others from copying the novel product. In current pandemic situation, the intellectual law and public health is confronting with each other as the majority vaccine manufactures are located in developed countries use IP right to decide the price of drugs & vaccines, control the supply and accessibility of medical instrument according to their discretion which make the lower and middle income countries more vulnerable and put the health of people from these countries at danger. Such dominance by vaccine manufactures is sought to reduce by waiving the IP right. So that other manufactures having the capacity to build vaccine can utilize their untapped capacity. IP right waiver will enable the other manufactures to be free from legal complexities and will motivate them to produce more vaccine to fulfill the demand of vaccine. The waiver of the IP right is the need of hour to provide the affordable, accessible and qualitative vaccine at global level. In this research I have tried to find out the application of national and international legal framework for sorting out the problem of vaccine shortage. Further I have also delved into the barriers in achieving the true goal through IP waiver and sought to find the solutions to these problems. Lastly I have also given the recommendations for winning the battle against coronavirus.
Legal Framework about Intellectual Property Right at National and International Level
India is having a long legal background for regulating the patents and other IP rights. The first act on protection of inventions was passed in year 1856 which was based on British Patent Law 1852. Further as the society and situation evolved, various changes brought into the legal system regulating the IP rights and in 1970, Indian Parliament passed ‘The Patents Act 1970’. The aim of the act was to promote research and development and provide strong protection to innovators and consolidate the law related to Patent. Further, in 2002 & 2005 significant amendments were brought into picture to make the India’s patent law in consonance with the TRIPS Agreement under Doha Declaration. At international level World Trade Organization is the only organization which makes the rules and regulations for international trade and makes it smoother, quicker and least cumbersome. It also regulates intellectual property rights for which all the nation members of WTO signed an international agreement named ‘TRIPS’. Trade Related Aspects of Intellectual property Rights was came into existence on 1st January, 1995. The objective of the agreement is to protect the interest of IP rights holders and put obligation on signatory nations to enforce the IP rights and provide adequate and effective protection of these rights. Moreover in the month of November, 2001 Doha Declaration was adopted by member nation of WTO which focuses on effectively combating HIV/AIDS, tuberculosis, malaria and other epidemics affecting many developing and least-developed countries and promoting a balanced interpretation and implementation of the provisions of the TRIPS Agreement. The effective implementation of national and international regulations about IP laws may help to overcome various problems arising out of this pandemic.
Need for Intellectual Right Waiver on Covid Vaccine
Currently India is facing the devastating second wave of the Coronavirus Pandemic which created an atmosphere of chaos and mayhem in our country. Our country is facing shortage of covid vaccine, oxygen cylinder, ventilators, remdesivir injection and other medical drugs, and various important medical equipments for the treatment of the disease. It had imposed a great burden on are medical system which seems to be totally collapsed. However, a special task force is established to ensure the supply of oxygen and covid vaccines from different countries are also imported but these steps solely can’t solve out this humongous problem. Other developing and underdeveloped countries are also facing severe consequences of the pandemic. The developed countries and vaccine manufacturers located in these countries are making money out of this hard time by restricting the export of vaccine and other raw materials and enforcing intellectual property rights. Following graph shows that over purchasing of vaccine by developed nations is the reason for unavailability of vaccine in less developed countries which ultimately increase the death rate in such nations.
Further, various experts have told that it is hard to achieve the herd immunity within coming few months in india making alarming sound for government that instead of focusing on herd immunity it needs to inoculate people as soon as possible. But India’s vaccine supply is also very less which makes a large section of the society unvaccinated. Following picture represents the alarming situation.
Another important reason for removing the IP rights is that enforcement of these rights hampers the fair access to affordable, qualitative vaccine all around the world. Moreover, a recent survey conducted by people’s alliance found that within a year the virus will mutate to that extent that current vaccines will render ineffective and we will need novel covid vaccines. So as the India is far away from herd immunity, virus is spreading to villages & far flung areas, virus is mutating rapidly, and death toll is increasing day by day creating a panic situation in country, India needs to increase vaccine production and supply rapidly. To increase the production intellectual rights waiver is the need of hour. Although only the waiver will not solve the problem but waiver can be a significant opening shot for increasing the vaccine production. Hence India and South Africa have proposed for intellectual property rights waiver for Covid-19 Vaccine, PPE kits, Ventilators, diagnostic kits, novel therapeutics and other medical technologies for the prevention and control of coronavirus disease. The proposal is backed by more than 100 countries and final decision will be taken by the majority of ¾ of the total members of the WTO. The proposed waiver will end the monopoly on production and supply of medical product and facilitate the scale-up of production of diverse manufacturers. India has followed the idea of ‘Vasudhaiv kutumbkam’ by asking for waiver at international level so that vaccine can be made accessible to all the countries, especially to middle and lower income countries.
Issues related to the waiver of Intellectual Property Rights
The waiver of legally enforceable IP rights seems to be quite promising but there are various issues attached to it which may make the waiver a counter-productive measure. The first major argument raised in against of waiver is that waiver will undermine the importance of research and development and will weaken the global response against Covid-19. Patent which is a vital IP right is granted to an inventor by one or more patent offices, with specification documentation made public, and which is protected exclusively under TRIPS for 20 years. The inventor takes huge risk and put huge amount in research and development and in other processes for producing such novel product and patent prevents the other person from producing the same. In case of waiver of such IP right, other person or entity can easily replicate the product without high investment which will infringe the interest of real inventor. In present scenario, the waiver will weaken the investment in R&D and innovations and will not create positive incentives for innovation in future. It will discourage others from undertaking research on competing product and will undermine the global response to the pandemic. Further it was stated that in the case of absence of Patent, other manufacturers will produce the same vaccine, so there will be several manufacturers of a vaccine which may undermine the public confidence about the vaccine safety as various manufacturers other than original one will be producing it. It will create confusion among general public that whether the product is qualitative and efficacious and whether all the required guidelines are followed while manufacturing. Secondly it was argued that waiving the IP rights will not rapidly scale-up the production of vaccines in developing countries which is the need of hour. The developing and less developed countries are not having adequate manufacturing capacity to produce millions of doses of vaccines. They are also not having strong supply chain for production and distribution of vaccines. The middle and lower income countries are not having high-standard quality checks which are very much required to ensure the safety and efficacy of vaccines. Further there is shortage of raw material for producing vaccines. The high income countries have imposed the export restrictions on raw materials, so that they can acquire most of the supplies. The limited availability of raw material is big barrier in increasing the production of vaccines. Since the beginning of the pandemic, U.S. for a long period of time restricted the supply of raw material which greatly hampered the production of medical products including Covid vaccine. Therefore we can say that in the absence of raw materials, the waiver will not have any meaning. Recently U.S. supported the waiver of Patent on Covid Vaccine to make fair, affordable and universal access of vaccine but only patent waiver will not be sufficient in scaling up the production. The production of vaccine is quite complicated. The technology transfer, skilled workforce, experience, data transfer and vaccine know-how is very important for producing vaccines. The patent waiver will enable the manufactures to replicate the product and be free from legal issues arising out of infringement of such rights but such waiver will not increase the production until and unless the technology is not transferred and data is not made accessible for producing vaccines. Currently we are having covid vaccines either based on mRNA technology or on adenovirus. Moderna and Pfizer are two mRNA technology based vaccine and for producing the mRNA technology based vaccine, the waiver of IP rights will not be sufficient because the process of formulation of these vaccine is very complex. To produce mRNA technology based vaccine, vaccine manufacturer need to share technology, provide legal rights and specific training to staff at new manufacturing plant. Specialized medical equipments also need to be supplied. Moreover, in the whole vaccine production process various intellectual property rights are concerned such as patent, trade-secret, copyright, trade-mark and undisclosed information etc. So waiving the patent only will not solve the problem. Additionally World Health Organization has initiated a mechanism called ‘Covid-19 Technology Access Pool’ (C-TAP) to facilitate the scale up production of vaccines, medical kits and other medical products and make them affordable and accessible by all people. It is one stop shop for all the covid interventions, where vaccines, therapeutics kits, drugs developers will voluntary license their technology, regulatory approval data, know-how, intellectual property to potential manufacturers. But the issue with this initiative is that it has received very little support from developed countries and big pharmaceutical companies. These companies have resisted from sharing their technology, know-how and legal rights to who designated manufacturers and the developed countries have not provided adequate funding for its successful functioning. These MNCs are entering into highly unilaterally conditioned bilateral agreement with a limited number of vaccine manufacturers, to generate profit only. This vaccine profiteering is putting c-tap at the verge of failure. Lastly the government in developing countries are not taking proper stand on intellectual property rights waiver and also not investing in local manufacturing plants for scaling up production. All these reasons are the barriers in achieving the real essence of IP waiver.
Solutions for Making IP Waiver a Successful Step
First of all, it is necessary to waive IP rights to facilitate scale up of production and equitable accessibility of vaccines. The waiver will be a successful step because it will unhindered the affordable vaccine availability in developing countries, bring new competitors in market, reduce the cost and price. In the absence of these waivers, the interested manufactures needs to enter into bilateral deals with vaccine manufactures for producing vaccines and they charge very high licensing cost from these future manufactures which ultimately increase the price of health technologies. But in case waiver potential producers need not to pay high licensing cost rather they only need to pay royalty which is decided by government, so the price of drugs and vaccines will not go out of the reach of common man and at the same time inventors will receive remuneration in form of royalty. Therefore this approach is balancing the interest of common man as well as of vaccines developers. Other than IP waiver, there are various measures available which needs to be taken into consideration for facilitating fair affordable accessible vaccine all around the world. For instance governments in developing countries needs to fund its local manufacturers for expanding the production capacity and also needs to invest in R&D and make the availability of essentials required, so that health technologies including vaccines can be produced. We have recently seen that Indian government had invested $400 million in Serum Institute of India, to scale up the production of vaccines. Such steps are having great potential to combat the pandemic but we need more efforts like this to globally combat this pandemic. Further the argument that developing countries are not having adequate production capacity is totally baseless. India after its reformative patent act 1970, changed its approach from product patenting to process patenting which helped a lot in growing generic industry and increasing production capacity in India. Currently India is producing around 21% of the global vaccine and it can produce even more than it is currently producing. So manufacturing capacity can’t be a hurdle in vaccine production. Further an important argument raised was that production of a vaccine by different manufactures will undermine the quality and efficacy of the vaccine but this issue can be resolved by the active regulation of regulatory authority. The regulatory body in every nation required to keep the quality control of vaccines and drugs manufactured by companies. It also needs to ensure that companies are following the quality checks and other necessary instruction so that quality and efficacy of the drug and vaccine can be established and maintained. Active functioning of regulatory bodies will end the confusions among people and win their faith. For example in India, DGCI needs to keep the quality control for pharmaceuticals and medical products. Talking about supply chain, to a certain extent it is true that developing countries are not making optimum utilization of their supply chain or they are having weak supply chain but this problem can be sort out by harmonizing collaboration among Central-state-local government. To ensure a effective and efficient supply chain, government needs to establish and maintain a sufficient and quality cold storage, dry storage and transport storage capacity to accommodate all vaccines, diluents and injection supplies needed for the national immunization program. A big reason for unavailability of vaccines is supply nationalism which exacerbated the pandemic and contributed to the total failure of the global supply chain. In this hardship times, not even a single country should restrict the export of raw materials and other medical products. Also it is also imperative to build international political solidarity to limit unilateralism, especially by the richest countries which have a greater capacity to obtain the vaccines. All the countries should develop consensus about global vaccine equity. Moreover, at global level WHO has established a COVAX facility to ensure that each and every country gets affordable, fair and quality vaccine on time. All the developed countries need to fund the COVAX program and also people who can donate for this program should also donate. Various international groups such G-7, G-20, QUAD etc. should come forward and call for donation and support to the COVAX program. Another global response to scale up production and transfer technology is ‘C-TAP’. This initiative can be made successful if pharmaceutical companies and research institutions share their technology, clinical data, know-how to make vaccine, IP rights and voluntary license to UNITAID backed Medical Patents Pool under C-TAP. Under this initiative WHO will establish technology transfer hub in lower and middle income countries to transfer a comprehensive technology package and provide appropriate training to interested manufacturers. 98 developed and 92 developing or under developed countries are part of this program. This transfer of technology mechanism will proved to be a major step towards increase in production and equitable availability of vaccine all around the world. Further countries should invoke their national legislation on IP rights by way of waiving the IP rights. In India, the Patents Act, 1970 empower the central government can issue compulsory license to interested manufacturer to replicate the vaccine or any drug without the permission of patent holder during the national emergency, public urgency or for government purposes. Similar provision is also made under TRIPS agreement. The ongoing novel coronavirus pandemic certainly qualifies as a national emergency under section 92 of the Patents Act. Through these flexibilities vaccines production can be increased and India can fulfill its national and international obligations. Further such flexibilities will lower down the price of vaccines and drugs making medical products accessible for all. In India there are previous incidents where compulsory license is issued by government to produce drugs. In the case of Natco v. Bayer , Supreme Court of India affirmed the decision of the Controller General of Patents who for the first time granted the compulsory license to Natco for producing Nexavar patented by Bayer. In the present scenario also if any interested manufacturer who can ensure quality assured vaccines and drugs, ask for compulsory license than the Court should consider its previous instance. Other than compulsory license, government and vaccine manufactures must share the technology and know-how for producing vaccines and other covid interventions. Combination of IP waiver under compulsory license and tech-transfer will not only help the future manufacturers to overcome legal restrictions imposed by patent law but also help them to produce scale up production as quickly as possible and produce new vaccines and drugs and other medical technologies. So IP waiver, compulsory license, technology transfer, political support, invocation of legislative regime, COVAX, C-TAP, and MPP are all the measure which needs to be implemented for combating against the coronavirus pandemic.
The waiver was proposed in October 2020 and the decision on the proposal will be taken in WTO’s ministerial conference which is scheduled from 30th November to 3 December, 2021. So now it is the high time for all the member nations need to accord the proposal for being adopted. Countries need to call for global equity, solidarity and accessibility. As the global health is a subject of SDG, U.N. should come at frontline for achieving global health by mandating its signatories to fulfill their obligations ensuring good health to all. Big pharmaceutical companies needs to voluntary license their technology, clinical data and know-how to make vaccine for ramping up the production. Instead of promoting profiteering, world needs to prioritize humanity. Further, wealthier countries shouldn’t undermine the global actions such as COVAX, C-TAP, and TRIPS Flexibilities. They must change their policy of ordering excessive and unreasonable amount of vaccine, lift embargo on raw materials and other medical technologies, bring clinical data into public domain and incentivize local manufacturers through various incentive schemes. In addition to this, at national level Indian government needs to compulsory license the Covaxin technology and other medical products to all potential producers and scale up production. Recently Indian government filed an affidavit in Supreme Court stating that “any discussion or a mention of exercise of statutory powers either for essential drugs or vaccines having patent issues would have serious, severe and unintended adverse consequences in the countries efforts being made on global platform” contradicts it own stance of waiving the IP rights and also undermines its goodwill and negotiating capabilities. Therefore Indian government needs to change its position over waiver at local level. To end this pandemic, the most urgent need is to scale up production of vaccines and especially of mRNA technology based vaccines because being programmed with a genetic code, they are easily adaptable to new strains. All these steps are required to be implemented for boosting the production and fighting the future outbreak.
The temporary and reasonable suspension of intellectual property rights will be a key in achieving vaccine equity and global health security. The virus killed millions of people all around the world and death toll is increasing day by day in India and in rest of the world. The pandemic is having severe socio-economic consequences. In such a hardship times immediate rapid deployment of vaccines is essential to reduce suffering and death, alleviate the pressure on the healthcare system and accelerate the re-opening of society. The waiver of IP rights can be a significant move in this direction. It will lower the cost and entail lower prices in the final market. Priority should be given to humanity over vaccine profiteering. India’s more realistic approach of creating pressure on seasoned player such as US, EU etc. to support IP waiver and creating goodwill by exporting a large proportion of vaccines will have higher impact on pandemic. Lastly the waivers, transfer of personnel, know-how, tech-transfer, supply of raw materials and equipments, expansion of manufacturing capacity in the developing nations is necessary for achieving global vaccine equity because nobody is safe in the world till everybody is safe.
- Sagar Kishore Salve, ‘Intellectual Property Right’ (October 2018)
- Fabio Montobbio, ‘Intellectual Property Rights and Knowledge Transfer From Public Research to Industry in the US and EUROPE: Which Lessons for Innovation Systems in Developing Countries? (The Economics of Intellectual Property)
- Lalit Jajpura, Bhupinder Singh and Rajkishore Nayak, ‘An Introduction to Intellectual Property Rights and their Importance in Indian Context’ (Journal of Intellectual Property Rights Vol 22, January 2017, pp 32-41)
- Carlos M. Correa, ‘Intellectual Property and Access to Science’ (South Centre July 2016)
- Bhadra Sinha, ‘Invoking Patents Act for production of Covid vaccines, drugs can have consequences: Govt to SC’, The Print (New Delhi, 10 May 2021)
The Research Paper is written by Mayank Gandhi, First-year B.A.LL.B (Hons.) Student at Maharashtra National Law University, Nagpur.