The pandemic has brought with it a catastrophe to the public health care system and continues to devastate the global economy. Thus, it becomes the need of the hour to look for a permanent solution that can emerge as prevention and critically end this deadly disease. During the second half of 2020, various vaccine technologies started being developed in the purview of the major commitment made by the global pharmaceutical industry to effectively address Covid-19. Where thousands of deaths are being reported on daily basis due to the ill effects of the virus the development of vaccine seems to be the only ray of hope to reduce the mortality rate all over the world.
But the sudden emergence of all these vaccines at a global level has sparked a row of legal and regulatory issues outlining its safety and effectiveness; such as the challenge of bringing new vaccines in the market, global acceptance/rejection of the vaccines, risks of clinical trials to investigate the efficacy of the vaccines, status of patent rights concerning the vaccines, dilemma regarding liabilities and compensation arising out of the vaccine injuries, etc.
The legal issues flared due to vaccine development and usage may be ignored temporarily, but cannot go unresolved for a longer time. Hence, it becomes vital to keep a check upon the various legal aspects around the vaccination drive and resolve the same expeditiously.
The Fast track and accelerated approvals by regulatory authorities questioned the credibility, safety and potency of the vaccines.
While introducing the vaccines in the market countries need to look for striking a balance between the prompt introduction of vaccines in the market along with ensuring the safety and viability of the same. Once the vaccines are produced the next big challenge which comes into consideration is the grant of approval for its use by the respective regulatory authority. Before introducing and administering any new drug in the market, it has to go through a lengthy process of clinical trials, which is time taking because it is done in several phases to ensure the safety of the consumers.
In the last few months, the Indian government has been making major regulatory relaxations concerning covid vaccines development and approval processes. The ‘New Drugs and Clinical Trial Rules 2019’ is acting as a primary regulatory framework to govern the clinical trials and testing of vaccines. The rules also elaborate upon the certain requirements and conditions necessary to successfully conduct the clinical trials and other associated activities. The vaccines developed so far will be considered as ‘New Drugs’ under these rules and will also act as a regulatory pathway for the clinical trials, import, sale or, distribution of vaccines. The Drug Controller General of India will seek the key approvals, which comes within the ambit of the Central Drugs Standard Control Organisation (CDSCO), the national regulatory authority for drugs and medical devices. Once the vaccines are developed, they also require approval from the review committee set up in the Department of Biotechnology, under the Ministry of Science and Technology protected by the Environmental Protection Act, 1986.
Recently in June, CDSCO issued guidelines regarding the vaccines approved and certified for emergency use by the regulatory authorities of various countries and are also listed in WHO EUL (Emergency Use Listing Procedure). The guidelines states that such pre-approved vaccines need not undergo any post approval process as far as the Indian Regulatory framework is concerned.
Covid-19 is causing high morbidity and mortality rate largely disrupting the economies worldwide. There are various types of vaccines in the market where the acceptance and rejection level look incalculable. People all around the world are having their perceptions regarding the efficacy and safety of the vaccine which is further influencing their decisions.
The vaccine literacy rate is very low amongst the societies which are leading to massive inevitable problems. After this aspect is discovered the question of how potential the vaccines are is not dependent upon their efficacy and safety but, relies upon the acceptance and rejection of the same.
Various surveys conducted as of now reflect that the countries like Malaysia, Indonesia and China have the highest vaccine acceptance rates whereas, on the other hand, countries like Kuwait, Jordan, Italy, Russia, Poland, U.S.A and France show up the lowest rate of vaccine acceptance. Overall, globally, the rate of acceptance of vaccine is below 70%, indicating that 30% – 35% of the population is still rejecting the vaccine.
Various factors are contributing towards the vaccine hesitancy rate amongst which the some known common grounds are rejections made based on traditional reasons or, on philosophical/ individual reasons or, rejections made in the purview of right to information where people are seeking to gain more and more information related to the vaccines or, nullifying the need of vaccine due to safety concerns is causing huge havoc to the vaccination drive programme and regulatory framework designed to vaccinate the maximum population.
This acceptance and rejection globally gave rise to the issue which can be purported to be Risk vs. Benefits. People seem to be failing while calculating the risk factor while keeping in mind the benefits of the same as well. Looking forward to the public health threat largely such acceptance and rejection due to various factors might lead to the big failure of the intent of the developers behind inventing such vaccines for the benefit of people.
In India, the Serum Institute of India (SII), one of the world’s largest vaccine manufacturer, is demanding from the government to indemnify the vaccine makers from any liability, whereas, on the other hand, countries like UK and Australia have agreed to provide immunity and indemnify some vaccine makers and the US already had the statutory law to provide indemnity to the vaccine makers to promote research and development.
Recently, vaccine manufacturers like Moderna and Pfizer agreed to supply covid vaccines to India provided the government give them indemnity against the liabilities arising out of the use of them. The ‘Indemnity clause’ is a major reason why these two vaccine manufacturers are hesitant to get into any supply agreement with India even though there is a massive vaccine shortage.
Given that various vaccines have secured approval from World Health Organisation for public usage under emergency use, how the vaccines impact the human body still needs to be thoroughly analysed and investigated. Providing indemnity to vaccine makers simply means providing free hands to the government and the vaccine makers regarding any injury claims arising out of vaccine usage. Such permission might discourage the vaccination programme and add to the pre-existing issues outlining the vaccination drive in India.
In a country like India where the population is enormous, the need for effective vaccines becomes the compulsion before the situation turns out to be extremely fatal.
The two major vaccines; Covaxin and Covishield in the Indian market have been approved at different stages of their trials thus, providing different recourse for compensation. Where people incurring injuries arising out of Covaxin may get the compensatory benefits under the New Drugs Rules as it got approval during its clinical trials on the other hand the injuries incurred by people as a result of Covishield may get a remedy through traditional litigation mode because it got standard approval for the mass usage.
India has no special mechanism to compensate for the injury arising out of the vaccination programme. In a case of an adverse event associated with the covid vaccine, the individual will have to seek remedy under the general laws.
Whereas, No-fault compensation programme is the first and only vaccine injury compensation mechanism operating at the international level where the eligible individuals in AMC (Advance Market Commitment) – eligible countries and economies shall get immediate, robust, fair and transparent mode to receive justified and appropriate compensation in case of adverse events associated with COVAX – Vaccination drive. AMC eligible countries are the ones that have low-income economies and cannot manage to arrange for effective covid vaccination strategies.
92 countries fall within this band and therefore, these countries are also provided with the added advantage of being compensated in case of any death or permanent disability caused due to the use of the respective vaccine.
There is no provision of compensation for recipients of Covid-19 vaccine against any kind of side-effects or medical complications.” While the government’s purchase order with vaccine-makers says the pharmaceutical firms will be liable for all adversities and refuses to indemnify them against any casualty, individuals will have to go to court to seek damages in case of serious adverse events. Unlike for clinical trials conducted in India where there are specific rules defining compensation for participants, there is no mechanism under the Drugs and Cosmetics Act to provide compensation against any adverse event after receiving a vaccine approved for restricted emergency use. Such people can explore legal options. In such cases, the liability will be of the vaccine-maker.
Another important concern to be addressed in India and globally is the increasing barriers imposed by Intellectual Property on Covid medicines and technologies. Earlier in 2020, India and South Africa submitted the proposal before World Trade Organisation (WTO) to waive off certain IP rights such as Industrial Designs, Patents, Copyright and the undisclosed information under the TRIPS agreement until the vaccine is administered to the maximum population and the relevant immunity is developed worldwide. The patent barriers are causing hindrances in the ongoing process of research and development of vaccines, manufacturing process, usage methods and related technologies. In a situation like this, asking for a grant of patents and copyrights might add to the delay of production and supply of vaccines.
Although the TRIPS agreement has various flexibilities available such as the right to issue a Compulsory License, strict patentability criteria and right to introduce pre-grant patent opposition systems etc., which may be effective to safeguard the public health but, shall not be an effective solution to control pandemic and its negative impacts. The ongoing scenario needs the government to drive the situation diplomatically to ensure public health safety and availability of vaccines and other drugs to combat covid-19 in respective countries. The grant of TRIPS waiver by WTO might be an advantage in terms of removal of IP barriers in manufacturing of covid vaccines but, at the same time might also discourage the vaccine development process.
Until the vaccine was not developed and introduced in the market, prevention and combating the disease were a big challenge for the countries. There was no remedy available for the people to seek for. But now, even after the vaccines are available, people are still deprived of the same.
The reason behind it is a major implementation problem. The higher authorities have established the policies after investing good time of research and strategized well to eliminate covid and its negative impacts at the global level, but there are several implementation challenges to be addressed at lower levels. Due to the absence of proper implementation check on the part of the policymakers, there has been an immense violation of ‘Right to Life’, a Fundamental Right ascertained by the Indian Constitution.
The mode through which the country’s legal system performed its functions during the pandemic made it very difficult for the illiterate class of the society to reach out to the judiciary to seek remedy as the justice delivery mechanism was hampered to a larger extent.
In a country, like India where a good percentage of the population is underprivileged concerning access to technology there, bringing on the idea of functioning online is a huge obstacle.
As per the new vaccination policy, people are expected to get themselves mandatorily registered on the COWIN app to avail the vaccine, which has brought major regulatory and legal complexities along with it. Such a step will create a huge digital divide because if one could not get themselves registered through the app, they will be deprived of access to their basic right that is ‘Right to life and Personal Liberty’. Mere drafting of policies and certain vaccination schemes is not the only agenda in times of pandemic rather the major impediment is the making of policies that serves as an effective solution to the ongoing legal and regulatory issues.
It is a stage of major dilemma to shift the day to day working from offline to online because pandemic has brought the world at extreme stagnancy level where nothing can be planned to be conducted offline whereas, on the other part shifting the process to the online mode is challenging because of the lack in digital literacy amongst the people.
First, we can expect legal challenges to any mandate. I would anticipate legal challenges alleging that a vaccine cannot be mandated under an EUA. There could be legal challenges demanding a religious exemption, and just direct challenges to the mandate based on personal autonomy. Second, there would be various implementation challenges.
When Pat Kuszler was asked about her opinion on the exemptions made with regard to the Covid-19 vaccines she stated “In terms of exemptions, there are basically three classes: medical, religious and philosophical. Medical exemptions are usually not controversial. Some people, including some who may be immunocompromised, pregnant or medically fragile may be more at risk for adverse reactions to vaccine. Generally a physician would attest to this exemption. This is the common requirement in most states. Religious exemptions are more complex and variable, state to state. In most states, the patient simply has to state that their religion opposes vaccination. Some states require some submission of evidence that this is religious dogma.
At present, religion is being privileged far more than in the past. Several big cases have carved out exceptions for religion in terms of compliance to civil rights and employment laws. I would expect that the religious exemption to vaccines will be given more credence than in the past. Philosophical exemptions are the most liberal “wild card” in terms of vaccine exemptions and are generally pretty loose: The patient simply has to assert them. However, there has been a partial rollback of these recently as rates of pertussis (whooping cough) and measles have increased. These infectious diseases had largely been tamped down by vaccination over the last half-century but recurred as herd immunity was lost. In Washington, the Legislature narrowed the philosophical exemption a few years ago by requiring those who seek the exemption to have been counselled by their physician. In 2019, Washington removed the philosophical exemption completely with respect to mandatory measles vaccinations.” U.S backed and agreed to waive off the patent protections for covid vaccines, in the purview of global crises and showed full support in removing the IP obstacles in vaccine productions.
Government, in the case of a pandemic like this, can set up priorities in terms of access. This is probably not “law” but is couched as recommendations. We see this in the current COVID pandemic with the recommendations that front-line health care workers and elderly be vaccinated first. These recommendations are likely to be generally adhered to by states and health care entities distributing the vaccine. However, there are unethical exceptions, some of which have cropped up in terms of testing, such as sports teams and celebrities having preferential access on the basis of wealth and fame. This is very discouraging in terms of distributive justice.
Every side has two aspects to be carefully looked upon. The step of faster clinical trials and approval of vaccines for mass usage though has helped the countries to get the vaccine faster in the market but if the other side of the story is carefully observed, it can be said that it has various negative aspects of its own.
The process of clinical trials and step by step approval process was introduced to ensure the safety and efficacy of drugs, but this instant process adopted in the case of covid vaccines and other related products might be extremely costly in terms of the lives of the people. Drugs used to treat medical conditions are a combination of certain chemicals that are developed after a long-term research and development process. But looking at the need of the hour, it became necessary to have vaccines be made available at the earliest, which means there is a good possibility that the required research and development process may not have been implemented efficiently.
This is a global health crisis, and the extraordinary circumstances of the COVID-19 pandemic call for extraordinary measures. The Administration believes strongly in intellectual property protections, but in service of ending this pandemic, supports the waiver of those protections for COVID-19 vaccines. As our vaccine supply for the American people is secured, the Administration will continue to ramp up its efforts — working with the private sector and all possible partners — to expand vaccine manufacturing and distribution. It will also work to increase the raw materials needed to produce those vaccines.
There have been cases where the covid vaccines have shown deadly impacts on people. The developers are trying to ensure the vaccine’s efficacy rate in the market, but no vaccine has been proposed to be completely effective. A covid vaccine is said to develop immunity in an individual, reducing the risk of developing illness and its related consequences. The accelerated speed of the approval of vaccines and developing the same within a year is exceptional and unprecedented. In the exhibit of the ongoing situation, it becomes the question of trust and existence for the people who are willing to accept the provision of the vaccination.
The most likely result of the proposed waiver would be a chaotic global patchwork of national laws that would linger at various stages of national implementation for years after the end of the pandemic.
Vaccine makers are demanding indemnity against any injuries arising out of the vaccination. This in itself becomes a question of law that by providing immunity to the vaccine developers is a concern of right vested with them or is it a subject of duty to be fulfilled by the respective governments. Indemnifying the vaccine makers on one part might protect them from any further foreseeable legal liabilities, but on the other hand, will hamper the rights of the people who are willingly getting themselves vaccinated and then incurring injuries as a result, especially in the countries were getting vaccinated is not a matter of choice but is moreover the compulsion for all. In such cases where the injuries have incurred who will be held liable and from where the individuals can seek compensatory benefits is debatable.
Proposed WTO TRIPS waiver seems to be a “False good idea” says Hans Sauer (Deputy General Counsel and Vice President for Intellectual Property for the Biotechnology Innovation Organization).
Where countries like India and South Africa are in favour of waiving off the IP rights on the other side countries like the United States, the Members of the European Union, Japan, Brazil, Chile, Singapore, the UK, Australia, Canada, and other developed countries have opposed the proposal on the basis that it lacks appropriate justification, looks infeasible, and is counterproductive, amongst other various reasons.
Before completely waiving off the IP rights it needs to be focussed upon what can be largely achieved if TRIPS waiver is implemented. The proposal before the WTO in itself brings along the associated issues such as the ways of implementation. Around 164 countries are members of the TRIPS agreement and such waiving of the rights would be challenging for all of them to implement same immediately, there is no clarity upon the way it will be largely executed whether by changing the existing statutory provisions or by adopting other ways of amendments.
Due to the uncertainty well reflected in the proposal, it would be difficult to understand that which product will lose the IP protection and what will be the time limit for the same. Majorly the problems would emerge in the U.S because there is no mechanism in the respective country to waive off the vested IP rights. Every statute has its connection with another one hence, it would not be wrong to say that all the laws are interconnected in nature. bringing about temporary changes in the laws might initiate other interpretation and overriding issues. Thus, it needs to be carefully investigated and then to be initiated.
The COVID-19 pandemic has shown the importance of data and science to build back more resilient health systems and equitably accelerate towards our shared global goals.
The widespread of covid has affected every aspect of life. The way the world operated has been completely changed and getting back to a previous lifestyle is a big challenge. Covid-19 is not only a battle of an individual but, is a battle of the whole world against this deadly disease. There have been several solutions identified by various experts, scholars, and regulatory authorities to fight against it. But the question is how well this will work and for how long? Vaccines have been successfully developed but, is it the only solution? Rights of the people have been curtailed, source of basic needs have been shut down, the economies are badly affected and much more has been taken over by Covid-19. Now the concern is how can we overcome this deadly disease and what is the permanent solution to this?
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