On 2nd October, India and South Africa sent a joint notice to the Council for Trade-Related Aspects of Intellectual Property Rights on the World Trade Organisation requesting a waiver of intellectual property rights for Copyrights, Industrial Designs, Patents, and Protection of Undisclosed Information concerning treating, preventing and containing COVID-19. The waiver has been requested for the duration it takes for the majority of the world’s population to develop immunity.
Some key points from the proposal:
• There are several reports about intellectual property rights hindering or potentially hindering timely provisioning of affordable medical products to the patients.3 It is also reported that some WTO Members have carried out urgent legal amendments to their national patent laws to expedite the process of issuing compulsory/government use licenses. Beyond patents, other intellectual property rights may also pose a barrier, with limited options to overcome those barriers. In addition, many countries especially developing countries may face institutional and legal difficulties when using flexibilities available in the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement). A particular concern for countries with insufficient or no manufacturing capacity are the requirements of Article 31bis and consequently the cumbersome and lengthy process for the import and export of pharmaceutical products.
• In these exceptional circumstances, we request that the Council for TRIPS recommends, as early as possible, to the General Council a waiver from the implementation, application and enforcement of Sections 1, 4, 5, and 7 of Part II of the TRIPS Agreement in relation to prevention, containment or treatment of COVID-19.
• The waiver should continue until widespread vaccination is in place globally, and the majority of the world’s population has developed immunity hence we propose an initial duration of [x] years from the date of the adoption of the waiver.
While initially proposed by India and South Africa, the proposal garnered support from many developing countries, various international NGOs, multiple UN agencies, and the Director-General of WHO.
But it faced opposition from the US, the UK, Canada, and the European Union (EU), among other richer countries. Unsurprisingly, most pharmaceutical firms have been opposing the move too. While some outrightly rejected the move, others sought further clarification on how IP rules posed challenges to procuring or manufacturing COVID-related diagnostics, equipment, vaccine, or therapeutics. There were also concerns raised over how the request of waiver of Industrial Design and Copyrights relates to addressing COVID-19.
Opposers of the waiver have been repeatedly arguing that the IP rights system has been crucial in the development of medicinal products including vaccines in record time. They have been reiterating that the existing flexibilities in the TRIPS agreement, WHOs vaccine pillar COVAX and ACT-A (Access to COVID-19 Accelerator) will be sufficient in providing global access to the vaccine.
How would the waiver help?
The waiver proposals cover all medical tools required to combat COVIS-19 and are not limited to just medicines as provided for by the existing flexibilities in TRIPS.
An efficient COVID response requires a wide range of medical products. Many of these products and their parts are covered by multiple IPRs like copyrights, industrial design, patents. Each of these is a hindrance to mass production.
Trade secret laws have resulted in various companies not sharing details about the safety and efficacy of their products in the public domain. Nature magazine recently reported that a worrying number of people around the world are refusing the vaccine because they are worried about rushed approvals and general distrust of pharmaceutical companies. This would mean they remain exposed to COVID and thereby prolonging the pandemic. Waivers in this domain would allow for some of this data to be used in the public interest.
Is IPR a barrier for COVID – 19 medical tools?
Even though argued to the contrary by parties opposing the waiver proposal, there have been various instances where this is true. For instance, South Africa faced accessing key chemical reagents for COVID-19 diagnostic testing. Patent holders threatened, producers of 3D Ventilator valves in Northern Italy with patent infringement.
Gilead Sciences had obtained a patent for remdesivir when it was considered efficient for treating COVID -19, which made it impossible for many countries to access it from alternative suppliers. (Please note remdesivir has now been delisted by WHO.)
Even with vaccines, precedents suggest that IPR will prove to be a hindrance. Pfizer’s aggressive patenting with 13-valent pneumococcal conjugate vaccines resulted in a South Korean company having to stop its development of the same. These patents deter competition, keep prices high and affect people’s access to vaccines, especially in developing and least-developed countries. The richer ones have managed to enter into advance multilateral agreements with pharmaceutical firms to procure sufficient vaccines for themselves.
Did IPR enable a breakthrough in COVID-19 medicines and vaccines?
The pharma industry and others have repeatedly stated the above. But India and Pakistan have replied to the same stating that public funding, philanthropy, and a common cause to eliminate the pandemic have been the propelling forces behind the breakthrough. It is common practice for pharmaceutical corporations to commercialise scientific breakthroughs achieved in public institutions and funded by the taxpayer.
Will Voluntary and Compulsory Licensing help?
The pharmaceutical industry collectively has decided not to contribute to WHO’s Technology Access Pool, an initiative that encourages the voluntary contribution of IP, technical know-how, and data to meet the global demand for COVID-related medical tools and products. Even though firms like AstraZeneca have entered into licensing deals with some countries to manufacture their vaccine, these deals are masked in secrecy. AstraZeneca’s deal with Brazilian public research body Fundação Oswaldo Cruz gives it the option of declaring the pandemic over by July 2021, which means it can charge a higher price for the vaccine from thereon.
The compulsory licensing flexibility is a territorial, case to case, product to a product-based system which is quite cumbersome and ridden with administrative and procedural delays.
Can the global initiatives such as ACT-A and its vaccine pillar – COVAX deliver vaccines effectively?
While the financial contributions by many opposing parties are significant and worthy of mention, it does not change the fact that these initiatives are handicapped by the limited capacity of existing manufactures. Also, pledging finances to advance supply by existing players is not the same as increasing supply by allowing new suppliers into the playing field.
Where does the waiver proposal stand now?
Despite eight discussions since its initial appearance in October 2020, WTO member states have failed to arrive at a consensus. But it is still not off the table as it has been agreed to discuss it twice in April before the WTO Council meeting in June.
During the initial days of the pandemic, governments across the globe worked together to tackle it. As the days went by it’s back to business as usual. In this, one must not forget that access in developing countries should not be defined by the existing manufacturing capacities and financial contributions of richer nations when alternative options are not even perused. The world across governments have a moral obligation is to safeguard the public’s health and provide access to requisite medical tools.