The COVID-19 pandemic has reignited the long-running debate over how to successfully balance corporate profits with public health. A large number of scholars and activists contend that World Trade Organization (WTO) intellectual property (IP) rules prevent developing countries from obtaining necessary pharmaceuticals. There are many who argue that intellectual property restrictions ought to serve as a driving force for pharmaceutical businesses. Currently, countries are arguing over whether to suspend WTO regulations in light of the pandemic. At the outset in October 2020, South Africa and India asked the World Trade Organization (WTO) to suspend regulations safeguarding trade secrets, patents, industrial designs, and copyrights in favour of “COVID-19 prevention, management, or containment up until vaccination campaigns have been implemented worldwide and the majority of people have acquired immunity.[1]For the length of the pandemic, India and South Africa seek to offer all WTO members the freedom to refuse to grant or enforce patents and other intellectual property rights pertaining to COVID-19 vaccines, medications, diagnostics, and other technology. India and South Africa submitted a waiver request, stating that prompt access to reasonably priced medical supplies, such as medical masks, diagnostic kits, ventilators, and other personal protective equipment, is necessary for an efficient response to the COVID-19 pandemic. Similarly required are immunizations and drugs for the care and prophylaxis of critically ill individuals. As per their declaration, “there are serious worries regarding how they will be made available promptly, in sufficient quantities, and at affordable prices to fulfill worldwide demand while novel COVID-19 diagnostics, treatments, and vaccinations are developed.[2] Later during October, the WTO members failed to come to the requisite consensus to move forward with the sought waiver. The European Union, the United States, the United Kingdom, and other wealthy countries opposed the request for waiver.[3]
20 years have passed since the prolonged fight over access to HIV/AIDS medications under the multilateral trading system came to an end. This is when the dispute regarding waiver of patents initially occurred. Many nations, particularly those in sub-Saharan Africa, were unable to afford the expensive HIV/AIDS medications that were invented by pharmaceutical corporations in affluent nations during the height of the epidemic at the turn of the century. The patent holders kept from reducing their prices since they had spent billions of dollars researching the drugs. The extended discussion regarding whether patent rights should override the provision of reasonably priced medications for individuals suffering from fatal illnesses deteriorated the reputation of the firms, including the nations endorsing them, and the WTO itself. Members of the WTO could, when establishing or modifying their regulations and laws, adopt measures that were considered necessary to protect public health, provided that these measures comply with the provisions of this Agreement,” as stated in Article 8 of the WTO Agreement on the Trade-Related Aspects of Intellectual Property Rights, or TRIPS Agreement.
Additionally, the TRIPS Agreement’s Article 7 states that intellectual property rights must be protected and enforced in a manner conducive to social and economic welfare.[4] It is arguable that these two WTO IP standards are considerably broad enough to include any reasonable health precautions that a WTO member would implement in the event of a pandemic or other medical emergency. However, there was confusion among the participants over the specific application of these regulations during the HIV/AIDS pandemic. Typically, licensing is used to “resolve the inherent tension between the protection of intellectual property and the need to make and distribute affordable medicines,” as noted by Jennifer Hillman of the Council on Foreign Relations. This allows the patent holder to allow others to make or trade the protected product, usually at a price and with some supervision from the patent holder to ensure control.[5] The Doha Ministerial Declaration from 2001 has been interpreted by the WTO as granting each member the authority to issue mandatory licenses for pharmaceuticals and medicines. WTO members approved a waiver in 2003 that released developing nations from TRIPS Agreement requirements and permitted them to import less expensive generic medications from nations with patent protection. After being revised in 2017[6], this waiver is still an important component of the WTO’s compromise between defending intellectual property rights and guaranteeing access to necessary medications. Although private medicine makers oppose compulsory licensing, it is an essential component of the WTO agreement.
The WTO treaty strikes a compromise by allowing mandatory licensing in cases of medical emergency. The arguments made in favor of the proposed COVID-19 waiver have mainly been the same and are reminiscent of the discussion surrounding HIV/AIDS. Early on in the worldwide search for a vaccine, the pharmaceutical corporations made it clear that they opposed the proposed transfer of intellectual property rights for the duration of the epidemic. They have issued a warning, stating that using forced licencing to prevent unauthorized copies of their COVID-19 vaccinations “would undermine innovation and raise the risk of unsafe viruses.[7] At first, wealthy nations objected to the idea, particularly the United States. The Joe Biden administration then changed its mind and declared its support for a vaccine IP waiver in May 2021 in response to pressure from activists and Democratic politicians. Later The coalition of poor nations requesting the waiver put forth an updated proposal that same month that was almost identical to the initial one. Vaccines, diagnostics, treatments, and personal protective equipment (PPE) relevant to pandemics were among the “health products and technologies” to which the waiver would be extended. There would be a chance for an extension during the waiver’s minimum three-year term.
Arguments
Advocates claim that the exemption might increase the output of immunizations and other life-saving goods. A basic degree of intellectual property protection, including twenty-year patents and protections for copyrights, trade secrets, and industrial designs, is guaranteed by members of the WTO under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The rules, according to supporters of the waiver, are impeding the production of vital medical items by businesses other than the inventors. The idea that all medications ought to be considered “global public goods,” held by a large number of individuals globally, is at the center of the current trade controversy. Such a notion leaves little opportunity for any intellectual property rights to be taken into account. The right to the best possible standard of health for everyone cannot be compromised by the pursuit of profit, as stated by a group of UN human rights experts. This includes decisions regarding vaccination access, necessary diagnostics and treatments, and all other medical supplies, goods, and services.[8] India and South Africa provided an example of a bottleneck of this kind in their initial proposal: during the early stages of the epidemic, the United States experienced a shortage of N95 respirators, which prompted Kentucky Governor Andy Beshear to request that the manufacturer release its patents. The public should have more access to vaccines, even if it means fewer profits, according to proponents of the waiver, who also cite the large government assistance that pharmaceutical companies got to aid in the development of COVID-19 vaccines. Governments retain the power, in the absence of a waiver, to permit businesses to manufacture a patented product without the rights-holder’s approval in cases of public health emergency — referred to as compulsory licensing. The procedure, according to those who are in favour of a waiver, is overly onerous and fragmented. Furthermore, wealthier nations like the United States have a negative opinion of and frequently put pressure on nations that issue obligatory licenses. This is a narrow-minded perspective. It is one thing to temporarily subordinate IP rights to urgent public requirements in the event of a pandemic or other international health emergency. Another is to completely remove the concept of “profitability” from all policy decisions that concern access to vaccines, essential tests and treatments, and all other medical goods, services and supplies.[9] Unquestionably, this perspective has a surface-level ethical allure. If a “human rights” strategy fails to address the pressing demands of the public, does this moral argument still stand? Opponents view the waiver as a bait and switch that will reduce incentives for research while doing little to boost the distribution of vaccines around the world. Patent firms, medical professionals, and certain governments contend that intellectual property laws—as well as the revenues they permit—help to advance the creation of ground-breaking innovations like the COVID-19 vaccine. Furthermore, it is asserted that the primary obstacle to worldwide vaccination efforts is not patents but rather inadequate production capacity. Some argue that without the technical know-how of the inventors or access to essential chemicals that are currently in short supply, many countries would not be able to create the vaccines even if the patents were repealed. In the meanwhile, a few US politicians Many analysts are wary of giving competing nations like China access to vital intellectual property.
Conclusion:
A new, protracted, passionate international deadlock within the WTO is not the answer. International cooperation in organizations and initiatives outside the World Trade Organization is the answer. Developing nations are requesting a WTO waiver because to the slow progress and unclear outcomes in those other international venues. They ought to intensify their joint efforts to find solutions in those other areas rather than persevering in their demand for an unneeded WTO waiver. And in order to achieve that goal, the United States, the European Union, the United Kingdom, and other developed nations ought to cooperate with them more. When a pandemic is raging over the world and has already claimed over a million lives and is expected to kill millions more, intellectual property rights should never be allowed to stand in the way of everyone’s early access to reasonably priced medications. Moreover, WTO members should never take any actions that would remove the incentives necessary to spur the inventions that enable the development of new medications.
A balance that gives all nations enough latitude to safeguard intellectual property rights and facilitate access to life-saving medications is what makes the WTO trade regulations on intellectual property just right.[10] It is currently not proven that this balance does not exist for COVID-19 medications. In the struggle to stop this pandemic, preserving this equilibrium has to be the WTO’s continued priority as well as the goal of all transnational cooperative efforts.
Author: Nidhi N Anand
Please contact us at info@origiin.com to know more about our services (Patent, Trademark, Copyright, Contract, IP Licensing, M&A of companies)
Subscribe to YouTube Channel HERE
Join LinkedIn Group: Innovation & IPR
WhatsApp: +91 74838 06607