In the earlier part of vaccine development last year there was an extreme shortage of supply globally. The WHO chief warned that the complete world was on the brink of a “catastrophic moral failure” if the vaccines would incessantly be mopped up by the rich countries. Wealthy countries because of their vaccination drives were able to flatten the COVID-19 connected death curve considerably, whereas the dearth of access to the vaccine within the poor countries has created daily deaths statistics out of management there. The upper-middle-income countries have conjointly seen daily deaths start to decline, albeit with a wait, in tandem with international vaccine distribution statistics. There's the emerging realisation that without ramping up physical and financial access to the vaccine significantly, the world will not get out of the clutches of this pandemic.
The race to create vaccines for the novel coronavirus disease (COVID-19) and alternative helpful technologies accessible to folks around the world, has highlighted the strain between intellectual property rights and the promotion of public health once again. There's little doubt that the monopolies offered by exclusive rights like patents are necessary to incentivise pharmaceutical firms to take a position with vast resources and develop helpful drugs. These rights facilitate makers to recoup those investments. It's not only drugs and medical instruments like ventilators that are required but also essential technologies like copyright-protected virus-tracing code in order to protect the right to life, calls have been made for firms to voluntarily pledge to make their IP accessible to everyone to produce vaccines, medicine and medicine to fight the COVID-19 emergency. Many countries, including India, have approached the WTO to waive the TRIPS Agreement and provide for compulsory licensing of these vaccines so the countries can tackle the disease head-on.
Even, the Hon'ble Supreme Court of India took Suo-Motu cognizance of this matter and provided suggestions to the Central Government concerning the distribution and evaluation of vaccines, supply of oxygen to hospitals and production of medicines and injections accustomed to treat COVID-19 symptoms like Remdesivir, Favipiravir and Tolicizumab.
COVID-19 VACCINE SHORTAGE IN INDIA
Even though India was dislodged as its role as a major supplier of vaccines to the developing countries by a fateful second wave, it still appears to be creating clearly calculated moves towards international vaccine equity. One drawback with the nature of the COVID-19 vaccine shortage is that there's an enormous chance that ideal victories on paper won't translate into solutions on the ground fast enough even if the world wants them the most. Time is of the essence; and therefore, instead of just symbolically waiving IP on COVID-19; solutions, partnerships that square measure designed on voluntary licenses, technology transfer, and consolidation and growth of manufacturing capability within the developing countries would be much better parallel goal. While the Supreme Court emphasised removing domestic obstacles to the provision and production of such medical supplies, undercurrents of world diplomacy concerning vaccine distribution and access to medicines have conjointly played a role in India’s current health crisis. Apart from a few, like the Serum Institute of India, such partnerships haven't been forthcoming within the past.
INFORMATIONAL OPERABILITY OF PATENTS
Intellectual property rights, and particularly patent rights, are governmental grants embedded into national legal systems across the planet for utilitarian reasons: longstanding intellectual property (IP) theory and policy rests on the thought that the prospect of getting a patent can incentivize players in research and development (R&D) to invest in areas that may be otherwise underfunded. In exchange for obtaining this specific kind of IP rights, patentees disclose important data concerning the invention covered by the patent. On the one hand, a patent offers the inventor significant lead in the market for a long period of time (formally twenty years); on the opposite hand, by requiring that the patent applicant share data concerning the invention that is afterwards published by the Patent Office database, this system promotes the flow of scientific and technical data that may be utilized by alternative innovators within the field.
It is renowned by now that existing COVID-19 vaccines — as well as those that represent the application of a brand-new kind of vaccine technology, mRNA vaccines —are protected by multiple layers of patent rights. Proponents of a patent waiver for the COVID-19 vaccine emphasize the issues created by the exclusivity created by IP rights, and that they are correct in their diagnosis.
The patent applications on Covid-19 simply clear the substantive criteria made public in international and national patent laws and so, vaccine patent holders have the power to refuse to license their technology to others, even against a background of vaccine scarcity. A patent waiver has been given as a mechanism to beat this exclusionary ability that historically inheres to a patent in light of the tragic proportions of our shared public ill health, for a definite amount of time with the anticipation that alternative corporations are ready to 1) replicate existing vaccines and 2) manufacture at scale so significant that the additional doses of vaccine can begin flowing towards populations globally. These 2 propositions would be correct if the data disclosed in patents were enough to extend the supply of COVID-19 vaccines. Sadly, it is not.
WHY DID INDIA ASK FOR A WAIVER OF THE TRIPS AGREEMENT?
In October 2020, India and South Africa had submitted a joint communication titled “Waiver from certain provisions of the TRIPS Agreement for the prevention, containment and treatment of COVID-19” to the TRIPS Council at the WTO. This waiver of the TRIPS Agreement requested halting of enforcement of patent rights which might permit companies to domestically manufacture vaccines for COVID-19. Despite receiving sizable support from several developing and under-developed countries, the US, European Union and other developed countries had opposed the release. This was due to the fact that major pharmaceutical and technological giants hail from these countries, and their patents form a portion of their country’s investment in Intellectual property resources. The initial proposal was to cover patents, industrial designs, copyrights, and protection of trade secrets across vaccines, medicines and diagnostics. However, the change in the stance of these developed countries lead to an impasse at the WTO.
THE INFORMATIONAL LIMITATIONS OF PATENTS: WHY PATENT WAIVER OR COMPULSORY LICENSING IS NOT THE SOLUTION
Countries in the global South have had to implement IP regimes that for the most part systemise the business interests of the global North. It's in their best interest to use all legal and policy mechanisms out there to reduce the skewed allocative effects created by the present patent culture, particularly once patent rights cover a product that is critically required for public health reasons.
The TRIPS Agreement permits for the compulsory licensing of patented products in situations that embrace public health crises like a pandemic or epidemic. Compulsory licensing doesn't extinguish or suspend patent rights however rather consists within the governmental granting of licenses to third parties against the wishes of the patent holder. The licensee is then ready to use the patent-protected technology against the payment of a royalty.
Many years back, several countries within the global South issued compulsory licenses throughout the primary decade of the 21st century on medication required for the treatment of Hepatitis B, so that these drugs would be created and sold in their markets at a lower cost. The crucial distinction between the compulsory licensing dynamics within the context of Hepatitis B and the present situation is that compulsory licensing helped solve the matter faced by populations in these countries: crucial medication was being provided at unaffordable prices; compulsory licenses dislodged exclusivity problems; and third parties were ready to manufacture the relevant medication once a license was issued, bringing costs down. By distinction, a discharge of COVID-19 vaccine patents is that a wrong legal and policy tool as a result of it doesn't address the issue of dearth of information sharing nor the shortage of raw materials and producing capability. Moreover, the utilization of a discharge is politically fraught - as was the utilization of compulsory licenses within the context of Hepatitis B.
It is appealing to envision a patent waiver as a pretty short-term solution. Yet, even the short-term needs are too intense and therefore the challenges too complicated for waivers to totally address the infrastructural and data gaps, along with the additional downside of inequitable distribution of existing vaccines. There are further barriers that the waiver wouldn’t address. One is that some developing countries have entered into bilateral agreements, particularly with the United States of America, the EU and different industrialized nations. These have restricted the flexibility of generic producers to manufacture and distribute low-cost medicines.
Also, many trade agreements have introduced provisions that stop national drug regulatory authorities from registering and permitting the sale of generics if the drugs remain proprietary. This can be the alleged “patent linkage”. Among the countries that have signed these agreements are those that are a part of the Comprehensive and Progressive Agreement for TransPacific Partnership. They embrace the sultanate, Chile, Malaysia, Mexico, Peru and Vietnam.
Moreover, there are several practical limitations within the waiver of Intellectual Property Rights when a vaccine is concerned. The informational power of a patent doesn't cowl any tips or instructions that haven't been memorialized in writing, nor will it offer any access to the raw materials required to make a vaccine. Waivers, therefore, quickly take away exclusionary rights however don't address two basic sources of the present immunogen insufficiency downside.
First, we have a major informational downside. From a scientific perspective, vaccines are biological products, and, as such, their relative complexness makes them extremely smitten by specific producing processes and practices, several of that aren't disclosed in a patent. A significant amount of this data could also be kept secret by a corporation for competitive reasons; in these cases, lifting patent rights won't lead to increased informational disclosure, unless the patent holders themselves are willing to collaborate. A waiver, therefore, solves the exclusivity downside, however not the data issue that undergirds competition in vaccine manufacturing. It doesn't offer all the data which will be required to manufacture the required product, nor will it offer manufacturers the data that solely the original manufacturer possesses and isn't disclosed elsewhere.
Second, even though every type of legal restrictions on the utilization of vaccine technology were removed — or had never existed in the 1st place — there's merely not enough infrastructure (manufacturing facilities and equipment) nor raw materials (the elements required to manufacture and deliver vaccines) to provide and distribute COVID-19 vaccines as expected underneath current waiver We've long faced a world vaccine manufacturing problem that may not be totally resolved throughout the present pandemic. In the case of vaccines that require to be kept at ultra-cold temperatures, these issues intensify.
A patent waiver wouldn't address any of the present issues presently at the basis of tech transfer negotiations involving COVID-19 vaccine technology. Furthermore, there is no legal mechanism in place to ensure and compel the corporations that if a waiver is issued, it will compel the transfer of absolute technicality or trade secrets of a corporation to license its IP.
Finally, it's necessary to keep in mind that a waiver would be temporary: supporters of current waiver proposals ought to think about what's going to happen once the demand for vaccines begin to decrease and fewer manufacturers stay on the market. Moreover, they must think about the legal and sensible uncertainty that a waiver would introduce because it is unclear how technology transfer between corporations would stop (or continue) once the waiver expires.
CONTRACTUAL AND INFRASTRUCTURAL PROBLEMS: ACTUAL ISSUES THAT NEED TO BE ADDRESSED!
In the COVID-19 pandemic - the real issues are infrastructural and contractual. It's imperative that we address the present limitations on vaccine production capability before any future pandemics -a problem that many countries have already turned to by investing or planning to invest in the construction of infrastructure for vaccine production.
It is also important that, against the present backdrop of vaccine scarceness, we address the allocation issues that the globe has faced to this point, that has resulted in most accessible doses being given to populations within just the global North. We regard this as a contractual problem: presently, there's no legal mechanism that forestalls two parties – a rustic and a vaccine manufacturer –from subjecting negotiations involving pandemic vaccines to a similar negotiation and contractual dynamics that govern the assembly and allocation of most commodifiable products.
Setting aside cases of voluntarism, there aren't any enforceable legal necessities compelling higher-income countries able to appropriate giant amounts of vaccine doses to share them with alternative countries. But it is also the area where immediate policy efforts are presently best deployed. Rather than advocating for a waiver, countries within the global South, international organizations, activists, commentators and alternative interested parties ought to concentrate their efforts on mitigating the uncurbed effects of existing contractual frameworks by nudging governments within the global North to adopt an additional equitable approach to the worldwide sharing of vaccine doses. And this can be an area in which the US, with its regained commitment to international cooperation, ought to have begun to lead by example earlier in the pandemic.
Albeit the patents are expected to provide the details of the invention, in practicality, barely cowl a skeleton of the thought or idea. Patent waiver for the Covid-19 vaccine is welcome news once the globe is looking for some variety of respite from the harshness of the pandemic, however, the sensible reality and onerous truth is that it's not aiming to make much of a difference to the current pandemic. Though different manufacturers would look to utilise the waiver to ramp up vaccine production, precautions ought to be placed to make sure safety remains the best priority. Moreover, raw material shortage needs to be taken care of otherwise it might lead to another pandemic amidst the pandemic. We need to ensure that in our hurry to protect ourselves we do not hurt ourselves further.
Asutosh Kumar Singh
3rd Year B.Com LLB (Hons.)
University Institute of Legal Studies, Panjab University, Chandigarh, India