The presentation of the study results consists two parts. The first part relates to the law objectives, as emerged from analyzing the content of legislative documents, including the Vaccine Injury Compensation Bill, and protocols documenting the legislative process in the Israeli Knesset.
The second part examines the question of whether the objectives of the law have been achieved and explores barriers to their fulfillment, according to the positions of the informants as emerged from the in-depth interviews.
Objectives of the Vaccine Injury Compensation Law, 1989
The explanatory notes to the Vaccine Injury Compensation Bill, 1988, open with the following sentence: “Aid to those injured as a result of mass vaccination policies has not yet been regulated by law” . This statement indicates that the legislature’s primary objective was to aid vaccine recipients who had suffered injuries. As will be clarified below, the legislature sought to aid the injured both in attaining monetary compensation and in streamlining and expediting the legal procedures involved.
Compensating vaccine recipients who had suffered injuries
During the 11th Knesset’s deliberations on the bill (on January 5, 1988), the goal of “allowing compensation for vaccine recipients who had suffered injuries" was explicitly set forth , and during the deliberations of the Knesset’s Labor and Welfare Committee (May 24, 1988), Knesset member Haim Ramon declared: “I have proposed a bill which will instate a mechanism to compensate the injured individuals” .
The justifications for awarding compensation to vaccine recipients who had suffered injuries were as follows:
Vaccination was in accordance with government policy: “Today, the situation is that children or adults who suffer disability or physical, mental or emotional impairment as a result of a vaccine administered as part of state policy are forced to…submit their case to court” .
Vaccination was an action for the common interest: “Vaccine coverage is a public interest of primary importance, it is done for the greater good and therefore there should be public liability for injury vaccines may cause to individuals” .
Vaccination may cause severe injuries, and there is a small number of cases in which such injuries occur: “Vaccine-related injury, especially that due to the trivalent vaccine, is generally severe – death, severe mental retardation, 100% disability, deafness, muteness, and so on. Often the parents also suffer… caring for a child with disabilities may lead to severe financial crisis within the family, on top of the personal crisis”; “Every year, a small number of children incur injuries from vaccines…I think there is little concern that there will be a flood of lawsuits due to the small number of injured [vaccine recipients] each year…compensation should be provided for that small percentage of people” .
To the Israeli legislators, aiding vaccine recipients who had suffered injuries to obtain compensation justified a law that would ease the burden of proof. It was clarified that claims filed as negligence-based tort actions would be dismissed, due to the difficulty of proving both negligence and a causal connection between the vaccine and the injuries incurred: “In every population of infants, a certain number of infants are sensitive to the vaccine. Their sensitivity cannot be determined until they receive the vaccine. No one is guilty” ;”As things stand today, a person injured as a result of vaccination, child or adult, must file a tort claim for compensation in civil court. To win his claim, the claimant must prove two things: one—a causal connection between the vaccine and the injury, and two—negligence in vaccine administration or a defective vaccine. In the vast majority of cases, it is nearly impossible to prove the two aforesaid factors in court proceedings, and the outcome is that the person injured, who often suffers severe injuries, up to 100% disability, is left without any compensation” .
Short and effective deliberation on vaccine injury claims
In addition to guaranteeing compensation for vaccine injury, the legislature also sought to aid the injured individuals by ensuring that their claims would be adjudicated expeditiously. During Knesset plenary deliberations on the bill, the injustice suffered by vaccine recipients who had suffered injuries as a result of prolonged and costly court proceedings was emphasized: “Such claims remain pending in court for years. They involve a lengthy and expensive judicial process…An enormous burden on all parties [is] involved to conduct a complex, costly and lengthy trial, requiring lengthy and complicated inquiry of experts. The courts view the imposition of such a burden on private citizens as unjust, considering the circumstances surrounding the children’s injuries” .
In accordance with the bill’s explanatory notes, the Committee of Experts established under the law is meant to facilitate “efficient and expeditious hearings on vaccine injury claims” and protect the families from “long and costly legal proceedings.” In its final clause, the explanatory notes highlight the necessity of “immediate compensation” for vaccine injuries .
Promoting vaccine compliance
Israel’s Vaccine Injury Compensation Law was motivated not only by the aforementioned objective to aid vaccine recipients who had suffered injuries but also by the objective to promote vaccine compliance. Assured compensation and expeditious judicial proceedings would serve to encourage vaccination compliance, rather than being end goals in and of themselves.
It is in this context that the explanatory notes to the Vaccine Victims’ Insurance Bill state that, “The importance of maintaining immunization coverage in Israel, which is among the best in the world, requires enacting State responsibility and immediate compensation to individuals affected by this practice” .
Were the Law’s objectives achieved?
As aforementioned, at this second part of the research the law objectives were presented to the informants, and the questions of whether the objectives have been achieved or what are the barriers to their fulfillment were examined by in-depth interviews.
As to the law objective of compensating vaccine recipients who had suffered injuries, the fact that the Committee of Experts has never ruled in favor of compensating vaccine recipients under the Vaccine Injury Compensation Law  led the majority of the study’s informants to conclude that the law had failed: “I think that the law, in the end—and actually many agree—did not live up to expectations…practically speaking, it is a resounding failure because it is not employed often enough” (public health researcher).
This study’s informants clarified that the evaluation of a causal connection between the vaccine and injuries according to scientific criteria is what led to the dismissal of claims: “One of the things that makes it difficult is the whole issue of the complexity of causation claims…even if it…may be linked to the vaccine, it could also be linked to a thousand other things that happened at the same time, and therefore it’s very hard to say what can be attributed directly to the vaccine…all the research around the world shows that all the side effects in question are not related to the vaccine but to other things…I need to act according to the science, not feelings” (a physician specializing in public health, employed by the Ministry of Health).
Another respondent, a retired judge who presided over cases of the appointed committee, echoed these observations: “In the claims submitted to me, no one was compensated because no one managed to pass the bar of proving a causal link…and this, in my opinion, is one of the law’s faults.”
In addition to the above specificity requirement of the connection between the vaccine and the injury mentioned by the informants, scientific causality is examined according to additional criteria: strength of association, consistency, temporality, biological gradient, plausibility, coherence, experiment, and analogy (the “Bradford Hill" criteria) . When it comes to vaccine damages, the difficulty in proving the above criteria for scientific causality leads to the dismissal of claims filed under the law, similar to the dismissal of claims arising under tort law that also require scientific causation.
Some of the informants suggested that “easier criteria” should be required to make a legal showing of a causal link than those required for drawing scientific conclusions. The reasoning behind this view was that a causal link needed to be established for legal rather than medical purposes: “The scales should lean in the direction that there is a reasonable likelihood of a causal link…after all, we know that there is a difference between causal links in law versus in epidemiology or public health” (an academic public health specialist). Another justification for reducing the difficulty of proving a causal link was that the law’s goal was to assist vaccine recipients who had suffered injuries in receiving compensation: “You have a country that wants to help those who suffered harm as a result of going and doing something for the good of the country, and all it wants to know is whether there is a high likelihood [of causation] and nothing more; it’s more likely than unlikely that [the injury] was caused by the vaccine, and in my view, this should be thoroughly sufficient” (attorney who represents claimants who claim vaccine injuries).
Among the ways for facilitating the establishment of a causal link, it was suggested that its determination could rely on circumstantial evidence as to an association: “I say we should get away from epidemiological causal links, and rather use common sense…" (public health researcher).
For cases in which a causal link between the vaccine and injury is proven, the Vaccine Injury Compensation regulations stipulate fixed compensation rates based on the degree of permanent disability. No compensation is awarded in cases of temporary disability, nor is there restitution for lost workdays, medical treatment, or third-party assistance.
Some informants voiced the opinion that the maximum sum set by the regulations does not correspond to the harm caused by severe vaccine-related injury: “In the end, if someone is really harmed, and we’re usually talking about significant harm from a vaccine, which may be neurological damage or even death…then because the State was afraid…and wanted to establish some sort of limit, this aspect is really inadequate” (public health researcher).
It was also argued that social legislation should compensate victims for temporary injuries: “In social legislation, compensation is provided for emotional suffering too. Say, if a person suffered side effects and was hospitalized, and that caused him suffering…he experienced trauma even if he fully recovered. And here, there’s no compensation for that…so there is no restitution for the hospitalization and suffering, lost workdays, anxiety and so on. I think that this is another problem with the law” (an academic public health specialist).
Finally, several informants noted that the statute of limitation under the law, of three years from the date of vaccination (or three years from the moment an injured minor reaches adulthood), also hinders the law’s objective to compensate recipients who had suffered injuries. They claimed that it was morally inappropriate to even set a statute of limitation considering the law’s social objectives: “There are administrative decisions. But morally speaking, if new information comes to light and you want to know the truth, should it matter how much time has passed?” (a physician who treats patients who have suffered adverse vaccine effects); “If you have a law, and it’s a social law, I think you should accommodate the injured individuals as much as possible… And that goes for the statute of limitation too” (a jurist specializing in healthcare ethics).
On the other hand, it was claimed that it is imperative to limit the period in which claims can be filed, in order to ensure the insurance company stability and financial security, and in light of the challenges facing the insurance company in uncovering the relevant evidence long after the vaccination was given.
Considering the Vaccine Injury Compensation Law’s objective to enable expeditious and efficient deliberations on claims, informants noted the challenges to filing a claim due to the lack of a clear and simple procedure and the informal demand to include an expert opinion with the claim. As one informant argued: “Not everyone has legal expertise or understanding, not everyone is an academic and not everyone knows how to proceed. They are in a difficult emotional state. For all these reasons, they should be able to fill out the simplest form in the world: I claim that on this and this day my son was injured after receiving a vaccine, then add a medical document that shows the clinical record” (an attorney who represents claimants who claim vaccine injuries).
In addition to the challenges in filing a claim, informants noted that deliberating claims in an adversarial procedure placed an additional obstacle to obtaining an expeditious and efficient hearing.
The law stipulates that the Committee of Experts will discuss claims and determine whether there is a causal connection between the vaccine and the injury, as well as the degree of disability. The law fails to address whether the committee is subject to the rules of evidence and procedures customary in court proceedings. However, informants clarified that, in practice, claims filed under the statute followed procedures similar to those in adversarial civil tort claims. They noted that a possible reason for employing the adversarial format was the presence of lawyers representing the Inbal Insurance Company, which manages the Internal Government Insurance Fund. The law does not specify any role for the Inbal company other than the payment of compensation to the injured parties in accordance with the Committee of Experts’ decision. Despite this, in practice, Inbal lawyers represent the State in presenting the defense arguments to the Committee of Experts: “Maybe here it would be preferable to not have…[legal] representation of Inbal. That is, I don’t know exactly what their influence is in this game…They serve as the State’s insurance company in this issue…It’s problematic…because it turns it back into a legal process” (public health researcher).
Relating to the law's objective to promote vaccine compliance, the informants noted that the adversarial proceeding, which is conducted as a confrontation between the injured individual and the Ministry of Health’s insurance company also undermines the public’s trust in the Ministry of Health (in addition to its negative effect on expeditious proceedings).
Trust diminishes since the deliberation does not allow for consideration of aspects of the injury other than the pecuniary damages: “In an adversarial procedure, the parties facing the family generally won’t give space to issues of emotional suffering and trauma” (public health researcher).
Moreover, the adversarial procedure inevitably places the State in the position of the injured “opponent,” giving them the feeling that the law is a mere token gesture: “I don’t really believe there can be trust-building in an adversarial procedure…I think that there are more—let’s call them conciliatory procedures, which I think would contribute to all parties involved and build trust” (public health researcher); “As long as the procedures are adversarial, I think the public feels that the law is just lip service, rather than something the State really stands behind” (a jurist specializing in healthcare ethics).
A legal guardian of a minor who claims to have suffered a vaccine-related injury added: “Why do I have to confront someone who doesn’t want to pay me?…It means that either I have to hire a lawyer at my own expense, which costs more than what I might receive here, or I have to show up alone and face some shark lawyer who’ll eat me alive, and that’s fine with everyone. What are they actually doing there?”.
Public confidence in the health authorities’ willingness to compensate vaccine recipients who had suffered injuries has been undermined also because of the law’s provision regarding choice of jurisdiction for bringing a claim, either through the Vaccine Injury Compensation law, or through a tort claim in court. A legal guardian of a minor who alleges having suffered vaccine-related injury noted: “They seem to be silencing [people] in a way…They hand you the compensation, but then you don’t have the option to sue the State even though it is responsible.”
The law’s lack of a requirement to publish cases in which compensation was given (by settlement as well), was also noted as a cause for undermined public trust in the health authorities. Committee deliberations on vaccine injury compensation are held in the Jerusalem Magistrate’s Court, and its judgements are published in Israel’s legal databases under the heading of “various civilian claims”. However, claims that result in monetary settlements ex gratia are not published at all, and people receiving compensation must confirm in writing that any compensation given to them does not constitute acknowledgement on the part of the State of a causal link between the vaccine and injury: “Some of the mistrust arises from concerns that information is being concealed…If the Ministry of Health’s decisions in vaccine injury claims were fully disclosed…I think this would reduce the sense of alienation between…vaccine policy and the public. I think that in order to create a less alienating atmosphere, improve trust between the public and the Ministry of Health, and avoid suspicions of conspiracy and so on, which sometimes arise among the public, I think it’s preferable to publish them” [settlements for compensating vaccine recipients who had suffered injuries] (a physician specializing in public health and employed by the Ministry of Health). On the other hand, concerns were voiced that knowledge of this compensation might deter the public from getting vaccinated.