This blog is authored by Shivani Pattnaik a second-year student at National Law University, Odisha.
India has urged all members of the World Trade Organization (WTO) to go beyond their domestic interest to support a pragmatic joint proposal presented with South Africa on a temporary waiver of Trade-Related Intellectual Property Rights (TRIPS) to help bring the world out of the COVID-19 crisis.
In the joint statement, it was contended that the COVID-19 outbreak has led to a rapid increase in demand of medical equipment around the world, and many countries have faced severe medical equipment shortages, limiting their ability to respond effectively to the outbreak. The shortage of these products has endangered the lives of healthcare and frontline workers and has resulted in many preventable deaths. The longer the current global crisis persists, the greater the socio-economic impact divide will be as a result of the dearth. Therefore, international cooperation is urgently sought to solve the problem quickly.
It was presented that intellectual property rights hinder the rapid delivery of medical products to patients on time by restricting collaboration among the WTO members in manufacture and distribution of vaccines. Some of the WTO members reported urgent amendments to national patent law to accelerate the issuance of government orders/licenses. In addition to patents, it can create barriers with restricted ability to overcome other intellectual property rights as well. Moreover, many countries, especially developing countries, may face institutional and legal difficulties in using flexibility in trade-related intellectual property rights (TRIPS agreements).
The requirements of Article 31bis and consequently the cumbersome and time-consuming process of importing and exporting pharmaceuticals and medical supplies are of particular concern to countries with little or no production capacity. For instance, the NY Times reported that South Sudan had a greater number of vice presidents (five) than the number of ventilators (four) to cater to a population of 11 million. Glaring disparities such as this are the major concerns that led to the presentation of the joint proposal.
The World Trade Organization (WTO) is considering whether to remove some Intellectual Property Rights (TRIPS) rules to give more countries access to the vaccines and medical technologies needed to prevent, contain or treat COVID-19. If the waiver is granted, it could impact millions around the globe.
For starters, it would reduce procedural delays in relation to intellectual property rights of medical equipment, diagnostic and vaccines. With accelerated international cooperation, the manufacturing capabilities of developing countries would match the requirement of test kits, ventilators, vaccines, etc. The sooner all countries have access to these medical tools, the better equipped we will be at handling the pandemic.
Since the WTO is an intergovernmental body subject to the rules, and its actions are guided by a number of trade agreements (including TRIPS), some member states do not support the proposed waiver of TRIPS. These countries are the US, UK, Canada, Australia, Japan, Switzerland, Norway, EU and Brazil. Most are home to pharmaceutical companies that profit from extended patent protection under TRIPS. All have entered into advanced procurement agreements with vaccine companies.
Some countries, including Canada and the EU, use voluntary measures such as promises to provide vaccines to the WHO’s COVAX facility as a defence against the need for a waiver. COVAX now has a decent financial commitment to supply more than 1 billion doses to affordable developing countries by the end of 2021. However, supply is not enough to meet demand. The gist of non-supports’ arguments is to protect TRIPS patent rights and to ensure equitable global access to vaccines without a waiver.
How would the waiver help?
Originally proposed by South Africa and India, this waiver has garnered support from nearly 100 developing countries,many international NGOs, several UN agencies and the Director-General of the World Health Organization himself. However, there is resistance, especially in countries where large pharmaceutical companies are based. To dissipate this resistance, Indian and South African delegates have opened up dialogue on this matter to the public and have also sought support from other member states.
This means that the decision has not yet been made and discussions at the World Trade Organization are ongoing. Meanwhile, vaccinations are being rolled out in high-income countries that have had several bilateral agreements before buying, with pharmaceutical companies. Developing countries have to wait.
The waiver of TRIPS would allow WTO member states to choose to neither grant nor enforce certain sections of the TRIPS agreement. This would allow WTO countries to collaborate in the fair and equitable production, integration and delivery of COVID-19 vaccines and medical equipment.
Moreover, the waiver is temporary and lasts until the WHO declares the situation of the pandemic as normal. And it only applies to drugs, vaccines and medical equipment related to the prevention, containment or treatment of COVID-19. Making the waiver optional would further allow countries to opt out of it.
WTO members who are against the waiver contend that TRIPS’ current flexibility allows countries already experiencing a public health crisis to issue compulsory licenses to allow domestic pharmaceutical companies to produce generic (and cheaper) equivalents. The dissenters of the waiver rely on promises to supply the medical equipment and vaccines to the under developed countries. However, the rules for exporting essential licensed products to countries that do not have their own manufacturing facilities are so complex that this flexibility has been used only once. Countries that have tried to use this TRIPS flexibility in the past have been criticized and pressured by the United States and the European Union into not doing so.
Arguments for the waiver
During the debate at the WTO Meeting, the US emphasized the importance of innovation during the COVID-19 pandemic for safe and affordable healthcare solutions, regardless of the concerns raised by South Africa and India. Even the European Union does not see intellectual property rights as a barrier and argued that other factors such as medical infrastructure and equipment shortages are more important.
The South African stance was much different. In their proposal, they stated that “the protection and enforcement of intellectual property are not absolute and that Article 8 of the TRIPS Agreement allows the state to take necessary measures for the public health protection.” Furthermore, COVID-19 represents an unimaginable global pandemic that calls for prompt and decisive action. The pandemic is not over yet and there is no certainty whether vaccines will be available in sufficient quantities to ensure equality. Countering the European Union’s stance, the South African delegate at WTO stated that the proposal for TRIPS waiver demonstrates exceptional circumstances justifying the request for a waiver with clear conditions governing its application.
In addition to this, the proposed waiver does not propose a change to the substantive treaty obligations and will be limited to a temporary period of time because the members have suspended them for an agreed transitory period. The scope of the waiver has been clearly defined in relation to “the implementation, application and enforcement of Sections 1 (Copyright), 4 (Industrial Designs), 5 (Patents), and 7 (Protection of Undisclosed Information) of Part II of the TRIPS Agreement which are aspects critical to the diagnosis, prevention, containment and treatment of COVID-19.”
South Africa also clarified that the waiver will continue to apply until a wide range of vaccines are introduced worldwide and the majority of the world’s population develops immunity.
It is noteworthy that approving the waiver will not immediately solve all access issues. The waiver is, after all, not a panacea to inequitable distribution of vaccines and medical equipment. Underfunded and limited healthcare systems in developing countries continue to remain a challenge in the 21st century. For instance, an unprecedented development took place in Florida. On account of getting vaccinated, wealthy international tourists from Latin American countries flew to the U.S. This is being termed as ‘vaccine tourism.’ This incident showcases the inequitable distribution of vaccines for COVID-19.
While the proposal is being discussed at length on official and public forums, the merits of the proposal are hard to miss. The joint proposal of the two developing countries is a landmark move at the global platform of WTO. Even during the COVID-19 pandemic, the member states must fulfil their basic obligations to protect public health and make medicine accessible to everyone. It is also recommended to take a step beyond TRIPS to properly address legal hurdles to manufacture and provide the medical products needed to optimize the treatment and prevention of COVID-19. Countries that do not support the waiver may choose not to use it without interfering with the WTO consensus process.
In the end, the TRIPS Council was unable to make a decision on this proposal at the meeting, but in the statement above, the South African delegate requested that the joint proposal be made public for debates and discussion. As uncertainty approaches, it will only dissipate once the TRIPS Council takes a stance on this issue in its next meeting in March.