PATENT WAIVER FOR COVID VACCINES

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The World Health Organisation in March 2020, declared coronavirus as a ‘pandemic’.

The pandemic hit and the world came to a standstill. Whether it was the people, the governments of the nations, the pharmaceutical industry, the medical staffs and workers everyone was combatting the situation in their own way. The issue, however, was that no one was familiar to this widespread situation and how to tackle it.

The developed nations, the developing nations and the underdeveloped nations and their people were all under the wrath of the pandemic. The outbreak of the pandemic had shattered the world and left it in utter chaos. Doctors, nurses were all working day and night to fight this virus which was spreading like a wildfire. At the same time every nation and its government was on board to fill up the shortage of  adequate medical infrastructure and facilities needed to deal with the outbreak. Pharmaceutical industry and researchers were working on medicines, making vaccines with all their might. Every sector was majorly affected and were trying to deal with this huge setback. No one was sure as to what would work and kept trying everything they could to flatten the curve and the fight the virus spread. This however took a lot of time and experimenting and outbreak of COVID-19 cost every nation millions of life and indeed was a tragedy for humans.

After almost a year of this nightmare, various nations and their pharmaceutical organisations were successful in producing the vaccine. The COVID-19 vaccinations were the only ray of hope in the dark. Some of these vaccines were approved by national authorities and some of them were approved by WHO (World Health Organisation).

With the pandemic continuing to exist and being way out of control with nations facing second and third waves of the virus, the vaccination drives started to take off in full swing in many of the developed and developing nations. However with so many people suffering and to bring so many under the fully vaccinated cover was quite a task with new set of challenges along with it.

With nations finding their way out through multiple phases of social distancing, complete lockdowns and curfews, shortage of medicines and injections , the necessity of oxygen for patients, the scarcity of beds and medical infrastructure, development of vaccines was a sigh of relief. The situation in developed or developing nations with their own vaccines invented was much better than the situation in the under-developed nations. These nations were suffering terribly at each step of the fight to overcome the spread of virus and challenges posed by the pandemic.

This is where the proposal by India and South Africa came into the picture.

India and South Africa’s Proposal :

India along with South Africa proposed that WTO waive the application of certain provisions of TRIPS Agreement during the pandemic at the WTO’s TRIPS Council in October 2020. The intention behind this proposal was to provide wider and open access to all technologies for the production of medicines and vaccines.

The proposal states, “Given this present context of global emergency, it is important for WTO Members to work together to ensure that intellectual property rights such as patents, industrial designs, copyright and protection of undisclosed information do not create barriers to the timely access to affordable medical products including vaccines and medicines or to scaling-up of research, development, manufacturing and supply of medical products essential to combat COVID-19.”1

Considering the situation of nations, India and South Africa suggested that the WTO members unite to fight the pandemic. The proposal solely focuses on the urgent need to address the issue of rising demand of medicines and medical products required for the effective treatment of the increasing number of patients and various other essential needs workers at risk and their acute shortage faced by nations.

The nations are in dire need of rapid access to the medicines and medical equipment and have also made efforts by increasing their domestic production but it hasn’t completely eased the situation. In addition to this issue, the proposal highlights its concern over several reports mentioning that intellectual property rights might hinder affordable and timely provision of medicines. Reports also include that few WTO member nations have already made amendments to their patent law so as to expedite the process of  issuing compulsory licenses/government use licenses.1

The biggest concern is that intellectual property other than patent may also become a barrier, nations might face legal or other difficulties while using the flexibilities in the Trade Related Aspects of Intellectual Property Rights Agreement (TRIPS Agreement).

In order to avoid the lengthy and tiresome procedure of import and export of pharmaceutical products and to put aside various requirements of Article 31 of the Agreement, the nations are suggesting to reconsider the global pandemic situation and to take measures accordingly in the proposal. It also put forwards a request to the Council to grant a waiver on application and bringing into effect Sections 1, 4, 5 and 7 in the second part of the agreement which deal with matters like copyright and related rights, industrial designs, patents and protection of undisclosed information.

After an extensive discussion and receiving the feedbacks on the proposed draft decision, the Council of TRIPS with the aim to proceed to text based discussions received a revised proposal of the draft decision text from India and South Africa with other 62 WTO member nations on 25th May, 2021.Text based discussions means the member nations or negotiators discuss and negotiate by floating draft texts of their own preferred wording and then reach a consensus.

The earlier proposal was too broad in terms of waiving of intellectual property rights in relation to prevention, containment and treatment of COVID-19. The revised draft decision text has now narrowed it down to “health products and technologies” for prevention, containment or treatment of COVID-19. Along with this, the earlier proposal didn’t mention the proposed duration, which was then proposed to be 3 years from the date of decision. It also mentions that if the exceptional circumstances cease to exist, the General Council can decide on the termination of waiver. 2

Breaking down the concept of Patent Waiver:

Intellectual property (IP) refers to creations of the mind, such as inventions; literary and artistic works; designs; and symbols, names and images used in commerce.3

There are various kinds of intellectual property rights such as copyright, trademark, industrial design, patent etc.

A patent is an exclusive right granted for an invention. Generally speaking, a patent provides the patent owner with the right to decide how – or whether – the invention can be used by others. In exchange for this right, the patent owner makes technical information about the invention publicly available in the published patent document.3

Under patent right, there are two types of patent granted to the inventor, it can be either process patent or product patent. The difference between these two patents is that in process patent, the exclusive right is granted for the process of manufacturing the product and the product patent grants the exclusive right for the final product manufactured and makes sure it is protected. If it is the process patent, the process can be slightly changed and the same product can be manufactured. Whereas under the product patent, the same product cannot be made even if the manufacturer changes the process.

Patent and other intellectual property rights waiver for vaccines, medicines and technologies for treatment of COVID-19 will ensure nations can exercise their right of producing their own vaccines and medicines. This waiver will ensure that these nations can work on production of vaccines without being under fear or pressure of being sued for using the technologies or processes required. Patent waiver will aid nations in increasing the production of vaccines leading to adequate distribution and tackling the shortage of these medical supplies. The patent waiver will open large scale production under the Emergency Use Authorisation (EAU) of the vaccines already developed.

Currently, the vaccine production and its import-export is mainly concentrated in few high income and middle income nations. These nations are indeed supplying their share to low income nations but it is not enough. The IP right holders i.e. the pharmaceutical companies in these high-middle income nations have already sold all of the vaccines produced or to be produced to their own governments or to government of nation with greater population. With the humungous challenge of bringing the entire global nation under the cover of fully vaccinated, the current demand-supply chain is not proving to be helpful. For every nation to have rapid access to vaccines and medicines for treatment, production of these in the ample quantity is very crucial. Intellectual property rights are in a way hindering or is more of a barrier for smooth flow of essentials for the treatment. Patent waiver will be a boon for pharmaceutical industries in underdeveloped nations as they will have access to these expensive technologies and raw materials for production of vaccines which will help ease the pandemic situation in these nations.

The process for the waiver is complicated. All 164 member nations of WTO should accept the proposal, any one member nation can veto it and the waiver won’t be granted. After the unanimous decision of all WTO member nations the developers, pharmaceutical companies, the researchers then will have to share all the details related to the production and manufacturing of the COVID-19 vaccines and medicines.

This will result in speeding up the production of these vaccines in the low and middle income nations.

The View and Counterview of Nations in respect of  Patent Waiver:

Commerce Secretary Mr. Anup Wadhwan said that India and South Africa’s proposal has achieved tremendous mileage and tremendous progression at a very fast pace.

With 62 other countries having supported the waiver decision in the initial revised draft decision text of the proposal, various other nations have come forward to show their support. Over the time, about 100 WTO member nations have agreed to the patent waiver, like USA, Russia and China, along with international organisations like World Health Organisation.

However, there are still nations like Japan, South Korea, UK and European Union members who didn’t back the proposal by India and South Africa. The latest development as of June 2021 shows that the EU member nations are still opposing the proposal. The EU nations have in turn proposed an alternative way out of the patent waiver and suggests to keep the provisions of TRIPS Agreement intact. The alternative proposal by EU focuses on compulsory licensing and making necessary changes to the restrictions put on vaccine exports.

The View:

The WTO member nations backing the patent waiver proposal think that the intellectual property rights involved in case of vaccines and medicine hinder the facility of affordable vaccines as well as medicines. It also proves to be the barrier for timely rapid access needed to these medicines and vaccines for treatment of the patients. Another argument put forward by these nations is that this waiver will be helpful for underdeveloped and developing countries and it will ensure access to technologies needed for the production of vaccines. It will definitely aid the nations to combat the situation of acute shortage of these essentials.

More importantly, a waiver would take away the manufacturers right to control and meddle into the production or access to raw materials needed for final products for treatment of COVID-19. It will ensure equal or rather equitable distribution of vaccines. The nations argue that even though there are TRIPS flexibilities (included sharing of knowledge and production of medicines) most of the countries are facing legal and institutional difficulties while using them, leaving the countries with nothing but a lengthy procedure to go through for the import and export of pharmaceutical products. Compulsory licensing of vaccines and medicines is neither the best option for low-income nations nor is it proving to be helpful. Compulsory licensing is basically a government allowing someone else to produce their patented process/product without the consent of the patent owner. Under compulsory licensing nations can use the process or technology for production of vaccines or manufacturing medicines but the low/middle income nations lack the raw material or skilled human resource required for it.

NITI Aayog Member and the Chair of National Expert Group of Vaccine Administration for COVID-19 (NEGVAC) V K Paul issued a statement saying, “Compulsory licensing for COVID-19 vaccines is not a very attractive option since it is not a ‘formula’ that matters and other aspects like sourcing of raw materials and training of human resources also need to be taken into consideration.”

All supporting member nations believe that waiver of certain provisions in part II of the TRIPS Agreement will help in fighting the global pandemic situation in a better way.

The Counterview:

 The EU nations are still against the waiver of IP rights for vaccines. The initial arguments put forward by some of the nations who were the against the proposal are their concerns for competitors trying to take the short -cut for acquisition of the expensive technology. They also believe that by simply waiving of the IP rights the nation cannot accelerate the production of vaccines as most of these underdeveloped of developing nations don’t have the raw material supply and the infrastructure required for manufacturing these vaccines, it may takes years to build up the infrastructure and normalise the short supply of raw materials in these regions. They believe that ‘Compulsory licensing’ facility provided by WTO can help the nations in need instead of completely waiving of the IP rights during emergencies. They also argue that most of the high-income nations who have a huge concentration of these vaccine productions and blocking the exports to the low-income nations. By relaxing the restrictions over the exports and imports of vaccines, the goal of equal distribution will be possible. The basic purpose of IP rights to provide incentives and encourage new inventions and that exactly what exclusive rights of patents, copyright, trademarks etc. has done in case of COVID -19 vaccines by providing public funds for production and various other aspects encouraging the pharmaceutical industries inventing the vaccines in record time. The process of vaccine production is difficult and complex, waiving patent rights in no way guarantee increase in production and supply. WTO Director-General Dr. Ngozi Okonjo-Iweala has suggested an alternative to increase vaccine access and has urged vaccine makers to make efforts to increase manufacturing capacity and to be accommodating and transparent on contracts and pricing and also focus more on increasing technology transfer.

Conclusion:

The proposal for patent waiver for vaccines is indeed a great initiative by nations which will surely help combat the current situation. However, by waiving off the IP rights completely the issue won’t be resolved. There are various other challenges waiting right in front of the nations. Scarcity of raw materials, ineffective supply chain, large scale manufacturing infrastructure, trade restrictions and many others will still persist after the waiver and the nations will have to figure out a way. With the world facing the global pandemic and doing everything in its hands, its a crisis that can dealt in a better manner if everyone comes together to fight it. The real challenges posed in front the world are complex and difficult to tackle. To put an end to Covid-19 and the pandemic is the utmost priority of all the at the moment. May it be the people, the governments, the pharmaceutical industry, the International Organisations, everyone has a common goal and are working towards it. While waiving of Intellectual Property Rights for Covid-19 vaccines seems to be the most effective option right now that is available for the nations, it still has its advantages and disadvantages. The global intellectual property rights need to be rethinked in these cases of emergencies and its better execution during future public health emergencies. To be able to respond to these global crisis is quite a task for nations which is why combatting the situation together by considering the global perspective and situation is the most effective way .

CITATIONS

1.World Trade Organization,(Communication from India and South Africa)IP/C/W/669

2. World Trade Organisation ( Communication from India and South Africa with other 62 co-sponsors.)IP/C/W/669/Rev.1

3.What is intellectual property, available at :https://www.wipo.int/about-ip/en/

(Last visited on 19th July, 2021)

Author: Gauri Sudhir Bhalerao, MMM’s Shankarrao Chavan Law College,Pune.

Editor: Kanishka VaishSenior Editor, LexLife India.

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