Compensation Policy For Adverse Outcomes Following Immunization: Legal And Ethical Implications

Nature of Vaccines

The term ‘compensation’ refers to something awarded to someone mostly in monetary form, for any loss suffered or injury sustained. The obligation to make compensation to the aggrieved is embedded in the ethical principles of fairness and justice and in the human rights itself. Compensatory loss requires that when an injury is caused to others, it is the duty of the person causing such injury to apologize and compensate for the wrong or injury caused to the aggrieved person (Nadimpally et al., 2017). This research paper concentrates on the urgency for developing a compensation policy for those people who are subjected to the adverse outcomes following immunization in India. Even when compensation is accepted, in practice, its implementation is often hindered with complexities that are evident from the prevailing compensation frameworks. Such challenges have been discussed in the research further. This research paper entails argument pertaining to the necessity of providing compensation in case of serious adverse incidents following compulsory vaccinations despite considering whether the vaccine has led to such adverse outcomes, based on the concept of ‘no fault compensation’.  

In the context of medical research, compensation frameworks guarantees that if any problematic or inconvenient incident results or if any patient faces any untoward consequences while undergoing any medical treatment or trial, such patient shall be entitled to adequate compensation for the same (Jaybhaye et al., 2014). Vaccines are considered as a preventive medicine for public health as it helps to reduce mortality and morbidity. However, vaccines cannot be considered as an alternative to nutrition, sanitation, safe drinking water and clean environment, which are indispensable for ensuring good health in the end. India has readily adopted the policies of the World Health Organization (WHO) and the United Nations Children Fund (UNICEF) with respect to mass immunization.

Vaccines are usually administered to healthy people especially to children, on a mass scale, through the Universal Immunization Program (UIP) like other medicinal products or drugs. As per the policies, there are several types of vaccines amongst which the (UIP) for children, is the most essential national vaccine programs. The (UIP) includes 6 vaccines such as measles, polio, BCG, DPT, TT and DT. The vaccine for polio is considered as an indispensable vaccine for children by WHO as it aims at eradicating polio globally (Omer & Halabi, 2016). Therefore, these vaccines may often have an adverse impact on the people who take such vaccines. However, in the absence of insignificant and accurate statistics of such adverse events resulting from immunization, it fails to warrant compensation for those who suffers loss or sustains injuries due to such immunizations (Macintosh et al., 2017)..

Nature of vaccines and necessity for Compensation

Since vaccines are the only biological products that are administered on a mass scale, just ad man medical intrusions may result in adverse outcome, vaccination can also lead to adverse events following immunization (AEFIs) such as death, hospitalization and other severe injuries. The issue pertaining to compensating persons for the harm or injury caused to them due to the administration of vaccines is a globally controversial matter. This research paper emphasizes on the need for compensation and recommends the possible measures in the light of human rights and ethics for implementing such measures in India (Kirkland, 2016).

Immunization is considered as a cost effective public health intervention that endows public with effective and direct protection against the mortality and morbidity that is avertable. As discussed above, India relies on the public sector vaccine production and adopted polices of WHO and UNICEF. The Public Sector Units (PSUs) manufactures these vaccines although the closure of such PSUs in 2008 has had an adverse impact upon the affordability and availability of the vaccines. There are certain secondary vaccines that are known as Selective Immunization for hepatitis B, cholera, typhoid, yellow fever, etc that are necessary for specific age groups or certain special situations (Macintosh et al., 2017). Majority of these primary and the secondary medicines are required in large quantities by the Governmental agencies, however, a shortage of supplies often arises. Since the PSUs are not manufacturing these, the shortage is met by either imports or indigenous private sector.

Several vaccinations are indispensible for the women during their pregnancy, in particular such as tetanus, pertussis, diphtheria and chicken pox should be taken into consideration. The influenza vaccination is imperative for the mother while she is pregnant as this vaccination reduces the risk of respiratory illness, which prevents the infants from being affected with influenza up to 6 months of age. Vaccines such as rubella are necessary for postnatal contraception. Vaccination is an essential medical intervention that should be offered to all women all their lives and immunization should be regarded as an indispensible medical intrusion, forming an essential practice of gynecology and obstetrics (Macintosh et al., 2017). Women have been gifted with the capability of giving birth to a new life and children are the future foundation of any country, hence, it is mandatory to ensure that they are immune from diseases, especially those, which are preventable; otherwise, a bad health shall hinder the future of the children and development and growth of the country.

The Indian Context

Vaccines are said to be the most preventive intervention that safeguards people against infectious diseases and like any other medical interventions, which might have an adverse outcome, vaccines may also lead to adverse consequences as serious as hospitalization or even death. A patient may die due to side effects of the vaccine that may be known or unknown, which may happen with few or a large number of people. There may be other reasons such as improper manufacturing, distribution or storing process or inefficient administration of the vaccines that may cause death of the person who are administered with the vaccines.

Almost 19 countries have incorporated compensation framework either through the courts or through compensation scheme payout for compensating persons who sustained injuries following the vaccination. The elements of compensation in such countries include disability pension, funeral costs, death benefits, non-economic loss and lost wages. The national government determines eligibility of particular persons and the amount of compensation they are entitled to claim. The factors determining eligibility include period within which the claim is made, age, citizenship status and whether the vaccine was compulsory or recommended. The factors that are usually considered in the 19 countries, as significant factors for determining whether the vaccine is a mandatory vaccine or it was administered as occupational requirements.

However, in order to claim compensation for vaccine injuries, it is imperative to establish a causal relationship between the vaccine and the adverse events following the administration of the vaccine. In fact, it is important to assess whether compensation can be claimed without establishing any causal relation between the vaccine and its adverse event or there is a need to establish a causal association for becoming entitled to compensation for vaccine related injuries in India.

The government of India remains to be the sole largest buyer and maker of vaccines unlike drugs and therefore the government has a huge responsibility to determine the supplier and price of the vaccines in the best interest of public health. The government in large quantities obtains the vaccines that are required for state or national program; such vaccines either are subjected to price regulation or are reserved exclusively for the public sector. This is because, the public sector units are responsible for ensuring consistent supply and manufacturing of the affordable vaccines for the national programs. This would prevent the vaccines from being affected by the market variations. However, such vaccines are available at remunerative prices there is an assurance of government procurement and market commitments and prompt payment of such vaccines.

The private sectors may co-operate the public sectors in meeting the national programs while levying competitive prices on other vaccines to meet the foreign markets. This way the government of the country is capable of enabling the indigenous private and the public sector firms to have access to the overseas markets. Further, the Government of India is equally responsible for ensuring that the PSUs have necessary financial, managerial or administrative support that is necessary for complying with good laboratory practices or manufacturing practices and other regulatory norms that are essential for export and domestic markets.

However, the vaccines are useful only if it is available to people in need and in good condition as well. The proper administration of the vaccines is another essential factor and such administration of vaccine should be done at the right time. The government of the country has made huge investments for the purpose of strengthening the building capacities and infrastructure of the healthcare staffs responsible for administration of vaccines. However, despite such planning, there are huge gaps that are present between the planning and implementation of the program not only in large states but in rural areas in particular. The (UIP) has low coverage of primary vaccines, which reduces the efficacy of the vaccines and covers the true demand for vaccines.

While the therapeutic vaccines and antisera are administered only to patients who have been diagnosed with a condition that can improve with treatment such as Tetanus and anti-rabies vaccines, the preventive vaccines are administered are administered to normal population. However, there are certain Universal Vaccines but contrary to the description; the vaccines are applicable to children and pregnant women. Some of the vaccines that are described to be useful to adults but in reality, they are hardly of any use to all the adults and are often used for selective immunization of people belonging to high-risk groups.

Most of the vaccine related injuries results from the widespread of a vaccine merely because such vaccine is easily affordable and is safe and effective. A particular vaccine may not be as effective for all people as it is effective to any particular person (Roopa & Aravind, 2017). Vaccines are to administered only if they are recommended by the medical professionals or the vaccine s are of mandatory nature which is necessary for preventing avertable disease such as polio vaccines. The vaccines that are administered beyond UIP are considered as unethical and the promotion of such vaccines through advertising, aid agencies or advocacy by individuals is an unethical conduct.

In India, the measures taken to conduct surveillance of adverse events following the immunization revels data and reports that forms an important source for determining whether the injury that has resulted from the administration of vaccines is justified enough for the aggrieved person to claim compensation against the same. In regards to the compensation system relating to adverse events following immunizations, it is important to take into consideration whether there is any casual connection between the vaccine in issue and the injury suffered by the aggrieved person. In the absence of ‘markers’, it becomes difficult to prove the causal link between the vaccine and its related injuries. A detailed immunization report enables to determine the presence of causality and demonstrates an effective surveillance of the adverse events that results from the administration of the vaccines to assess whether any injuries complained against is a direct result of the administered vaccine.

In India, the government established a sub-committee with a view to strengthen the national AEFI surveillance system in the country and the committee is entrusted with the responsibility of determining the causality of vaccine related injuries. The sub-committee works under the guidance of the Immunization Division of the Ministry of Health and Family Welfare (MoHFW). This assessment procedure is based on the model of Causality Assessment Protocol of the World Health Organization (WHO). In legal action for tort brought by the aggrieved person for assessment of causality association between the vaccine and the injuries sustained by the defendant, it is imperative to establish a direct link between the injuries or death that are the outcomes of the vaccines administered to the aggrieved party or the deceased person(Roopa & Aravind, 2017).

The arguments in support of vaccine-injury the compensation include economic and political pressures, growing confidence and litigation threats in population-based programs and making certain of sustainability in vaccine supply. Nevertheless, an underlying principle of compensation scheme is the principle of justice and fairness. In the absence of any formal compensation scheme, the sole source of compensation is the court where the claim of the aggrieved person shall be based on tort law. According to the law of torts, the aggrieved party must establish that the defendant had committed a wrong against him/her and that the wrong was caused intentionally, amounting to the tort of negligence (Roopa & Aravind, 2017). The only issue with this process, in respect of vaccination, is that often there is no negligent party and compensation claimed before the courts can be both unpredictable and inequitable, resulting in high pecuniary awards to some parties while parties who do not seek any legal remedy does not become entitled to any compensation.

A compensation scheme for vaccine related injuries removes the uncertainty that is present in respect of liability under torts law for the manufacturers. A compensation scheme provides a more efficient, fair and stable approach for injured parties. Litigation is a costly and restricted way, which may be inaccessible for several vaccine recipients (Roopa & Aravind, 2017). Furthermore, compensation schemes usually avert divergence of the drug companies against people who receives vaccines by way of negative media coverage and litigation. Several countries have implemented compensation schemes as a gesture of community harmony. Michelle Mello, the ethicist, argues that the term ‘solidarity’ implies members of the society are not solely responsible for the risks that might result from solidarity.

Vaccines injuries vary from one person to another and can be complex. Children are more susceptible to the injuries related to vaccines, and must be taken care of, for their entire lives and they might not qualify for any other advantages under the accident insurance schemes. Under a vaccination program, the uninjured and the injured party pay unequal shares of the social expense that is incurred while ensuring social good of the entire community. According to Mello, given that the underlying principle of compensation scheme is fairness, justice and solidarity, the compensation schemes must be such that it safeguards the uninjured persons, thus, unintentionally ‘free riding’ on the injured parties(Demicheli, Barale & Rivetti, 2015).

Six elements are common to all the compensation schemes include administration and funding, process and decision-making, eligibility, litigation rights and elements of compensation. Most of the compensation schemes in the countries with established compensation programs are enacted and implemented by the government, which occurs at the national level. The source of funding compensation schemes for any vaccine related injuries demonstrates where the decision-making power lies within the country. In most of the countries, the compensation schemes are regarded as secondary source of funding for disability and medical expenses (Demicheli, Barale & Rivetti, 2015). Generally, patients receive primary support from private or national public insurers. Under such circumstances, compensation schemes can be cost-effective, as it does not have to cover the entire expense that might be taken into consideration in a product or tort liability case.

With respect to the eligibility of the vaccines that are covered by the compensation schemes, there are variations. Some schemes cover recommended or mandatory vaccines while other schemes cover all licensed medicines. However, such schemes require that their threshold injury be satisfied prior to making claims for compensation. For instance, in New Zealand, an injury should be severe in nature for claiming any compensation. The 19 countries except Sweden and Finland, have established compensation schemes have passed legislation to enact the compensation schemes and the governmental departments are responsible for operating programs in most countries (Demicheli, Barale & Rivetti, 2015).

The no-fault vaccine injury compensation program are based on the concept that the adverse outcome is not the result of a specific industry or individual but has resulted from an unavoidable risk associated with vaccines. However, the standard of proof that is required to be established to claim compensation is that there is a causal connection between the injury and the vaccine which has been alleged to have caused such injury.

In order to ensure that the claimants resort to compensation schemes to claim compensation for any vaccine related injuries, the compensation mechanisms must offer the claimants a compensation payments and a hassle-free procedure that is much easier and predictable than the litigation or the tort system (Roopa & Aravind, 2017). Several countries incorporate statutory provisions that permit the claimant to seek damages either through a compensation scheme or courts but they are not entitled to seek damages through both the schemes.

There is no official vaccine compensation program for injuries or deaths resulting from vaccines. The only remedy available to the aggrieved persons or the complainants is to approach the legal system of the country, which is not only an expensive process but also lengthy procedure that may take time from 10 to 15 years. In addition, it is very difficult to establish the causality connection between the injuries or deaths and the vaccine that is alleged to be the cause of such injuries or deaths (Singh, 2015).

In the case of Dr. Durga Nursing Home v Dhanasekaran [2003], the petitioner filed a petition in the District Consumer Court against the respondent for being negligent and using expired vaccines. The court awarded a compensation of INR 100,000 for hardship and mental distress and INR 5000 towards costs on the ground that the hospital did not have an adequate or an effective storage system and its ambulance service was also inadequate, hence the hospital lacked proper medical services and is liable. However, an appeal was made in the state consumer court where the court found that the evidence regarding the defected quality of the vaccines were adduced was not sufficient. Nevertheless, the court held that the instruments that were required were not sufficient and proper and the hospital lacked ambulance service as well. Hence, the court awarded compensation to the petitioner. This case is a landmark case that establishes the necessity to concentrate on the injuries that are claimed to be the consequence of the entire administration process of the vaccines, including the facilities for ambulances and storage.

In another case, the state of Gujarat made an appeal against a compensation that was awarded to the petitioner on the ground that a negligent administration of a triple vaccine has caused permanent disability and deformity to the petitioner. The appeal made by the state was upheld by the High court and the court reversed the decree, staying the money decree passed by the trial court in favor of the petitioner (Sheikh, George & Gilson, 2014). The High Court had dismissed the order passed by the trial court on the ground that the plaintiff had failed to establish the causality connection between the vaccine and the injury suffered, that is, there was no adequate evidence to establish negligence in the administration of the vaccine that caused such injury to the petitioner. It took 15 long years for the court to dive its decision since the petitioner had initiated the suit (Mirzoev et al., 2013).

These cases highlight the critical issues that arise when it comes to claim compensation for any injuries or deaths that results from vaccines or its administration process. One of the issues is that the tort system puts the burden of proving any adverse events following the vaccination (Francis et al., 2017). Consequently, it has an impact on the claim of the aggrieved parties to compensation. The countries that have an established compensation mechanism have also reported to face the same problem that is inbuilt in the legal system. Nevertheless, the nations upheld the fact that the state is ultimately responsible to the people who sustains injury and becomes subject to death (Macintosh et al., 2017).

Several reasons that causes hindrances in ensuring that the vaccine administration process is implemented properly. Since the vaccine administration takes place on a mass scale, geographical diversity, cultural diversity, politically diversity are certain factors in India that often hinders the implementation of vaccine administration properly (MacDonald et al., 2015). Given the significant proportion of population, it becomes challenging to reach out to the migrant population. There are inadequate hospital services as is evident from the cases. There is either lack of monitoring and surveillance, lack of micro planning at district level and lack of coordination between the central and state governments. These factors impede the opportunities to ensure effective administration of vaccines.

Vaccines are considered as universally accepted public health intervention and a profitable tool for the pharmaceutical manufacturing companies. There has been an incline in the increased rate of vaccine related injuries in India. Human Rights and Public health have an inherent connection and the implementation of the public health programs can be successful only if people’s rights are respected. A compulsory vaccine program usually ignores the rights of people that would give rise to ethical and legal issues with respect to vaccination (Jesani & Johari, 2017).

In regards to the compensation claim that could be made against any vaccine related injuries, it is mandatory to establish that there has been some connection between the vaccine and the injury sustained by the claimant. The claimant must establish that a vaccine can be said to be unsafe, only if it has caused illness, disease, injury or any form of harm to the aggrieved party. Hence, it becomes very important for the independent experts to analyze the safety date with respect to the vaccines and a proper contamination test should be conducted to ensure it safety prior to administration to the targeted public. In the event, the vaccine is for children, extra care should be taken to ensure that the vaccine is safe (Tozzi et al., 2013)..

The country gives more emphasis on research work relating to vaccines for the purpose of eliminating diseases. Huge expenses are incurred in conducting research for new vaccines with a view to include such vaccines in the Universal Immunization Program (UIP) or to recommend the use of such vaccines in the private sector, which would serve two-fold purposes. Firstly, such vaccines shall eradicate diseases and secondly, it would enable the vaccine manufacturing industry to earn long-tem financial gains (Okayasu et al., 2014).

Vaccination being a preventive healthcare measures is advantageous for both individual and public health proportionately but the risks and harm may have different impact on the individuals proportionately (Crawford et al., 2014). There is a common assumption that vaccines are completely safe but may not suit some people. This is because the administration of vaccine may result in adverse events or serious adverse reactions in some people. Therefore, there is a need to make proper assessment prior to the administration of the vaccines (Kahn et al., 2014).

Another significant legal issue that augments with respect to administration of vaccines is that some people who are affected by the vaccines usually feel reluctant to acknowledge the problem (Sarmiento et al., 2016). This is because, in India, there is no official established compensation scheme; hence, people are left with the option to approach litigation. The litigation system is an expensive and lengthy procedure that might take years to administer justice to the aggrieved person. Moreover, this legal issue often gives rise to an ethical dilemma that even if death or injury sustained by the claimant has resulted from the administration of vaccines, in most of the cases, the result of injury or death are found to be something else but vaccines. The authorities simply deny or manipulate with the results of the injuries by stating that the claims made against the injuries or deaths is not related to the vaccine (Tafuri et al., 2015). The injury caused by the vaccine or the administration process of the vaccine is not significant enough to establish that causality connection exists between the vaccine and the injury sustained by the aggrieved party. The legal issues and the necessity for an inquiry with respect to the death or injury sustained by the aggrieved person is simply set aside (Lahariya, 2014).

The infants and the adolescents are vaccinated against not only the common diseases or infections that infants are usually prone to, but they are also vaccinated for diseases that they may not be exposed to or where there are other easier procedures to prevent the child from such disease (Halabi, & Omer, 2017). The nations are eager to see a world that is free of diseases irrespective of the fact whether the child shall be exposed to such disease at all. Under such circumstances, the benefits that the individuals are subjected to is unknown because it is not certain whether individual has been protected from such vaccination or whether the person is merely lucky enough not to suffer from the virus (Ferrer et al., 2014).

Legal and ethical debates have arisen regarding the implementation of vaccination program whether informed consent should be taken of the people prior to the administration of the vaccines (Mastroianni & Henry, 2017). There is a fear that if people would inform the public about the vaccines prior to the administration, there may arise unnecessary fear about vaccine administration process. Informed consent is indispensible under the code of medical ethics and law. This is because vaccine is a medical intervention that is prone to risk of adverse events following immunizations, which may result in injuries or even deaths. It is essential that the rights and autonomy of an individual is respected and make public health strategies that are compatible with the dignity of human rights. Ethics and implementation issues may be addressed by adhering to the global standards (Kothia et al., 2015).

In the absence of necessities such as health, adequate safe drinking water and nutrition, medicines in developing countries augments the ethical controversies with respect to the priorities of the government health programs, especially when there is a shortage of resources and health is not given priority (Dickson et al., 2016). The developing countries faces two major hindrances, one is lack of resources for purchasing the vaccines and the other one is to implement a satisfactory vaccine program given the inadequate hospital facilities. In countries where healthcare is lagging behind and children are dying of malnourishment, it is expected that the government must establish effective compensation mechanism for enabling the claimant to claim compensation against injuries that has resulted from the administration process of the vaccine (Patel et al., 2011).

A national vaccine policy that is based on the principles of public health and primary health  care to prevent morbidity and mortality due to communicable diseases that affects large populations, especially women and children. The National Health program (UIP) cannot be implemented successfully in the absence of bureaucratic and political support at all levels.  The injuries that results from the administration of vaccines can be reduced largely with better monitoring and surveillance (Rodwin, 2014).

In regards to the no-fault compensation scheme against an adverse event following immunization, which is implemented in 19 countries, should be adopted in India, as the country does not have any official compensation scheme. This program shall be beneficial to as it includes disability pensions, medical costs and benefits for death or loss of non-economic nature. As discussed above, most of the countries permit the claimants to claim compensation either through courts or through the compensation schemes (Jenkins et al., 2016). In the absence of any compensation scheme, the aggrieved parties approach the courts and bring legal action on negligent tort. The compensation scheme is not as lengthy or expensive as the litigation procedure. The claimants must establish causal connection between the vaccine and the injuries resulting from it otherwise, the court shall not award compensation to the aggrieved person. However, the compensation scheme relieves the claimants from establishing the connection because the community shall be responsible for any injury resulting from the vaccination owing to the fact that it is ultimately the community that is being prevented from diseases by the vaccination program (Nadimpally et al., 2017).

Conclusion

From the above discussion, it can be inferred that it is essential to comprehend the public health issues in the context of human behavior, population’s vulnerabilities and the political, social, economic and cultural needs of each individual and country. It is important to connect the public health program to the human rights of those people who dwell in varied conditions suffering from peculiar disabilities, diseases and other health related issues (Vashishtha & Kumar, 2013). One vaccine may not be suitable to all the people, hence, it is important to address the ethical and legal issues that are associated with vaccines. It is equally important to address issues related to the development process of vaccines not only by training the concerned persons but also with the help of open and transparent regulation process, which also includes decision-making processes (Prince, et al., 2015).

Vaccine related injuries compensation programs have been gaining importance as an essential element of any successful vaccination program. These programs have been used for the last 50 years with the view to ensure protection of the interest of the entire community against any adverse events following immunization (Kahn et al., 2014). These programs ensure that the affected persons who claims for compensation for the injuries or loss sustained due to the vaccines are compensated adequately and are taken care of. There are various compensation schemes with distinct frameworks and approaches that are implemented worldwide such as the no-fault compensation program, which relieves the complainant from establishing a causality connection between the vaccines and the injuries, resulted from it, which is mandatory to become entitled to compensation in the traditional legal system (Shrivastwa et al., 2016). However, under this compensation scheme, since the vaccination program prevents the community from being affected by communicable diseases, hence, it is the responsibility of the community to safeguard the interest of the people by ensuring that they are compensated adequately.

The compensation schemes operate better and more effectively in a well-established, comprehensive national social welfare systems. The 19 countries which have adopted the compensation schemes have been reported to have a low costs in comparison to the expenses incurred in litigation. In the first decade of 21^st century, the acceptance of vaccine related injury compensation has been gaining popularity and these schemes are operational in countries that are not industrialized such as Europe and the United States (Vaidya & Hamde, 2016). The present scenario in India requires recognition of an injury that has resulted from vaccination, which makes it a necessary to form an appropriate compensation policy. This would enable the affected parties to have an option to claim compensation either by approaching the courts or through the compensation schemes. Despite the reluctance of the government to depart from the adversarial approach to provide compensation, there is a well-built argument that establishes the necessity of the universal implementation of the compensation scheme programs in the country.

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