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Final report of the keystone AIDS vaccine liability project
Report Final report of the Keystone AIDS vaccine liability project The Keystone Center
The Keystone Center is a non-profit organization that convenes and facilitates policy dialogues addressing complex and controversial public policy issues. The Center conducts such dialogues in six main substantive areas:environmental quality and health, natural resources, biotechnology and genetic resources, energy, food and agriculture policy and science and technology. The Center convinced a Dialogue group to address the liability issues related to the development and eventual marketing of AIDS vaccines at the request of several of the key interests concerned with these issues. The Dialogue group consisted of administrators of vaccine trials, manufacturers, insurers, consumer and user groups, academics, agency officials, members of the legal community, Congressional staff and dispute resolution professionals. There are three important ground rules which characterized the discussions of the group: 1 People participated in the discussions as individuals, not as formal representatives of an interest group or organization. 2 All conversations were off-the-record and not for attribution. 3 No documents produced in the course of the project or this final report were made public until agreed upon by the group as a whole. The Dialogue group believes their work should be seriously considered by those concerned with this issue, both due to the substance of its discussions and recommendations and, perhaps most importantly, because of the diverse composition of the group which formulated it.
Statement of the problem The Keystone Center convened this Dialogue group because of concerns that the product liability system is serving as an impediment to the development of a vaccine effective against AIDS. The goal of the group was to consider the validity of the problem and to seek a consensus on a solution. The tort system as a deterrent to A I D S
vaccine
This article is a summation of the complete Dialogue concensus report which is available from the Keystone Center, PO Box 606, 0175 Summit County Road No. 8, Keystone, CO 80435, USA 0264-410X/91/100703-07 (~': 1991 Butterworth-Heinemann Ltd
Throughout the process, the Dialogue group struggled with the lack of data. Nowhere was this more evident than in the consideration of the cause and effect relationship between the tort system and the research and development of vaccines. The group heard from several industry representatives in the group that liability was an important factor in decisions made by companies which have stopped or not begun vaccine development, but also learned that at least ten companies in the US are engaging in AIDS vaccine research and development. There are currently no comprehensive data, and it is unlikely there will ever be data that systematically establishes the linkage between the liability system and vaccine development because liability concerns are only one of many issues which companies must evaluate when making decisions regarding work on a potential vaccine. Manufacturers and insurers view the liability system as too open-ended to be able to predict possible liability exposure for a product as potentially risky as an AIDS vaccine. Further, they believe that the costs of vaccine development will be high, the chances of scientific success low, and commercial success uncertain, so the added concerns about open-ended liability without insurance coverage can weigh heavily against proceeding into this arena. In the field of vaccines as a whole, manufacturers are already concerned about large numbers of claims, high litigation and compensation costs, and a reduction in the number of vaccine manufacturers for other vaccines due to the perception by many manufacturers that it is nearly impossible to accurately assess the risks present in the product liability system. An AIDS vaccine can be expected to present similar, if not worse, liability problems. Despite the difficulty of assessing the scope of the problem, the Keystone Dialogue group proceeded to seek a consensus on a solution. The group felt it was worthwhile to address the issue of AIDS vaccine liability now, before a crisis occurs. Too often, our society does not anticipate problems and fails to plan ahead, often with poor results. The Dialogue group thought that problems could be avoided by proposing a legal framework to govern AIDS vaccine-related injuries. That framework could serve as a basis, or at least a starting point, for addressing liability issues in the future should the need arise. development.
INTRODUCTION
Overall goals o f a new legal f r a m e w o r k . The Dialogue group sought a consensus on a legal framework that would serve the societal interest in promoting develop-
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Keystone AIDS vaccine liability project: Keystone Center merit of a safe and effective AIDS vaccine and would fairly balance the interests of injured participants, wJccine manufacturers and clinical investigators among others. This balance meant a trade-off between predictability and reasonable limits on liability for the manufacturers and the level and nature of compensation for the injured. The group also sought a system that could handle claims fairly and efficiently. Probh, ms with A I D S vaeeines that make a solution d~l.lTcult. Lack of data again plagued the group during
its consideration of the elements of a possible new legal framework. It is nearly impossible to forecast the scope of the risks associated with the development and marketing of an AIDS vaccine. Although no viable vaccine has been developed yet, it is generally assumed that the risks associated with an AIDS vaccine may be less predictable and potentially more serious than the risks associated with other vaccines. The reasons for this perception are: 1 this virus is new and exceedingly complex, and established vaccine approaches are very likely to require modification: 2 animal models, including chimpanzees, are not optimal for testing AIDS vaccines; 3 the possibility of accelerated testing of experimental wlccines in healthy humans as a result of a pressing public health need to develop a vaccine; 4 the possibility that injuries associated with this virus will be especially severe: and 5 the latency period for injuries may extend for years, similar to the latency period of the disease that the vaccine aims to prevent. Such uncertainty about the risks while making the group's job difficult also made clear that a plan for addressing injuries was imperative. The group also discussed the fact that the uniqueness of the AIDS health crisis and related vaccine development process means that proposals to address this situation should not be setting a precedent for other vaccines, drugs, or products in general. The lack of an effective system to deal with liability concerns may impede progress and may lead researchers or manufacturers to conclude that the area is too risky to pursue or research subjects may prove to be unawfilable in sufficient numbers to complete clinical trials. Given the enormous public health implications of the AIDS crisis, society should strive to develop and market safe and effective vaccines. The Dialogue group hopes that the discussions and suggestions which follow will enable removal or reduction of potential liability obstacles. DISCUSSION AND RECOMMENDATIONS ON CLINICAL TRIALS The Dialogue group focused attention on developing a proposal to address AIDS vaccine liability concerns during the clinical trial phases. The proposal is intended to simultaneously address the perceived needs of several parties: 1, manufacturers who are concerned about the uncertainty of risks during clinical trials as well as the current unavailability of liability insurance for the clinical trials and the availability of sufficient numbers of participants in the trials: 2, research centre staff who
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conduct many of the trials, ~vho are also concerned ~ith liability implications, the availability of parlicipants in the trials and the preservation of the rcsearcher participant relationship during clmical trials: 3, recipients participants in the trials, who may be concerned with maintaining their anonymity as well as assuring themselves equitable treatment if injured as a result of their participation in a trial: 4, consumers interested in an expedited process to compensate injured participants as well as mechanisms for penalty provisions for 'unacceptable behaviour" (see section below): and 5, government personnel interested in creating a just framework that encourages the development of an AIDS vaccine and providing for treatment of recipients/participants in the clinical trials if injured, but reflecting concern about implications for the government's budget. The Dialogue group proposed a system that might begin to satisfy many of the concerns associated with clinical trials expressed by I)ialogue participants. The system is an exclusive, administrative remedy (except for cases of injury resulting from "unacceptable behaviour" for which a tort remedy is preserved). (Scc discussion of 'unacceptable behaviour' bclow.t 'Exclusive" in this instance means that claimants must go through this system for compensation except for cases of "unacceptable behaviour'.
Description of proposed system for clinical trials Following a thorough informed consent process, volunteers would enter a clinical trial. If an injury occurs, the volunteer would submit a claim. Causation and degree of disability would then be determined by a scientific panel selected by the Department of Health and H u m a n Services from a list provided by the National Academy of Sciences. The Dialogue group proposed that this be a standing panel of approximately ten to fifteen members. A subset of three to live would be responsible for determining individual claims. In the proposed system, a decision by the panel of three to five could be appealed by either the claimant or manufacturer to the full panel. Once causation and degree of disability had been determined, compensation levels would then be decided by a different fact-finder, the exact nature of which was not defined. An appeal of this determination also would be available. Because the system is an 'exclusive' remedy, it is important to build in mechanisms for review at the crucial decision points. Under the proposed system, compensation would be funded by the vaccine sponsors, with federal funds provided for excess insurance. Each w~ccinc sponsor would be responsible for claims brought by volunteers in its particular trials. The amount for which the manufacturer would be responsible could be set at a specified dollar amount or be limited to coverage for only certain categories of loss (e.g. unreimbursed medical expenses with excess insurance covering other costs such as economic losses or pain and suffering). Each company would post the amount for which it was responsible as a bond to ensure the availability of these funds, m case a manufacturer no longer exists at the time a claim is filed. Claims above that amount would be covered by a federal trust fund. In the event the fund was exhausted and Congress did not provide additional funds, a successful claimant would be able to obtain some compensation through other public programmes (e.g.,
Keystone AIDS vaccine liability project: Keystone Center OASDHI, the Old Age and Survivors Disability and Health Insurance programme of which Medicare is the health component). The following is a step-by-step discussion of the key elements of the proposed system.
Informed consent discussion and recommendations The informed consent process for the vaccine trial participant is an essential component of the planning and conduct of the trial. The informed consent process is the way to provide information to an individual about the rights and responsibilities he/she acquires by choosing to participate in a clinical trial. Informed consent includes information about the possibility of injury and compensation that is available. The goal is to make potential research participants aware of risks and benefits and other important information about the research so that they can make a decision about entering the trial. The Dialogue group recognized that the need to fully inform volunteers about all the relevant risks associated with their participation in a vaccine trial and the need to locate sufficient numbers of volunteers for vaccine trials are related. Several participants also noted that if too many 'outside' people and issues are brought into the informed consent process, it may strain the nature of the traditional subjectresearcher relationship. The Dialogue group agreed that other approaches may need to be used depending on the phase of the trial, types of personnel available to interact with potential participants in the process, and country in which the trial occurs. Several of the health care providers in the Dialogue group indicated that explanations of information about liability and legal rights should not be given by medical personnel because of a potential for its having a 'chilling' effect on the health care team's effectiveness, both in terms of the relationship with the volunteers and the ability of health care providers to adequately answer detailed legal questions. While the information provided to the volunteer should be detailed and comprehensive, it must be presented in plain language and in manageable amounts. The volunteer's relationship with clinic staff should provide a comfortable atmosphere for the exchange of information. Dialogue participants perceived an in-depth informed consent process as essential. Some Dialogue participants expressed concern about the impact of the information, particularly the exclusive nature of the remedy on volunteers. Some thought volunteers would be 'turned off' by the exclusive remedy and the possibility that 'latecomers' might find the compensation fund exhausted. It was pointed out, however, that the proposed system provides injured parties with a more sure and timely remedy than the tort system, while preserving the tort option in cases of 'unacceptable behaviour.'
Expert panel The Dialogue group suggested that the expert panel be a scientific body with responsibility primarily for deciding on causation. The group discussed the fact that causal relationships may be particularly difficult to establish due to the newness of the HIV system, the latency periods involved and the diverse organ systems that could be involved. Some suggested that the expert panel should also be
able to determine the degree of disability of a claimant. The panel might consist of clinicians and scientists, some of whom may not work in the HIV or disability fields. The group considered, but rejected, the possibility of including for credibility a non-scientist. However, because of the need for timely decisions and the need to keep the panel relatively small, but with a range of scientific expertise, the group concluded that the panel should be solely scientific. In cases where additional expertise was needed to make decisions, the expert panel would be expected to solicit the input of other experts in the appropriate fields.
Unacceptable behaviour Members of the Dialogue group differed in their views of the relative importance of providing 'deterrents' to 'unacceptable behaviour' on the part of vaccine manufacturers. Some in the group pointed out that, overall, the performance record of vaccine manufacturers has been extremely good. Others, while not necessarily disagreeing with that characterization, believe that it is important to preserve what they feel is the deterrent effect of the existing tort system in any new system that is developed. The group agreed that it is extremely difficult to craft language to specify the type of 'unacceptable behaviour' related to injuries that should be subject to a tort remedy. Terms such as 'gross negligence' and 'willful misconduct' have been interpreted with a great deal of latitude by courts in the past. Fundamentally, the group agreed that 'unacceptable behaviour' that would be subject to tort action should be restricted to behaviour which was an intentional violation of the law, conscious disregard for the rights or safety of others; or intentional conduct that was designed to deceive or conceal; and which was causally related to the injury in question. Given the monitoring which takes place during clinical trials, the group expects that behaviour leading to application of the tort exception during clinical trials will be rare. If the scientific panel (described below) found indications of this type of behaviour, it would report its suspicions to an appropriate agency, such as the FDA. If a recipient then brought a tort action in court, the judge would permit the suit if there was substantial evidence of 'unacceptable behaviour'. If an award was made as a result of a tort suit based on 'unacceptable behaviour', that award would be off-set by compensation that had already been granted.
Standards It is recommended that since the system is exclusive with the remedy restricted except for 'unacceptable behaviour', the panel should use a liberal causation 'standard'. The Dialogue group did not reach a consensus on an appropriate standard. However, the group did agree that the benefit of the doubt should be given to the claimant and that a list of compensable events should be developed as experience is gained.
Appeals The Dialogue group proposed that appeals (by either party) to the scientific panel's decision regarding causality, and perhaps degree of disability, should be made in the
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Keystone AIDS vaccine liability project. Keystone Center following way. There should be a standing panel (e.g. ten to fifteen mcmbers) from which a sub-pancl (e.g. three to five) would be drawn to decide individual cases. An appeal brought by either side would be heard by the full panel and would be subject to only limited formal judicial review.
Compensation The Dialogue group did not address specifically how determinations should be made as to the type and amount of compensation. Since the scientific panel would address only causation, and perhaps degree of disability, some other decision maker, such as an administrative law judge, would be needed to determine compensation levels. The Dialogue group agreed that either side should be able to appeal this decision. A lump sum method of payment was favoured over periodic payments because of administrative simplicity and the ability to better determine programme costs. Except for a death benefit, only the volunteer, and no third parties, would be eligible for compensation. A compensable injury would not include those resulting from HIV infection from external sources. In other words, the system is not guaranteeing thal the vaccine works and protects the volunteer from subsequent HIV infection. (This objective, after all, is what the trials are designed to determine.)
those found in the smaller trials. If this is lhc case. it would provide a statistical rationale for rcducing the pcr capita level of financial responsibility of each company.
Summary The concepts presented here represenl a difficult trade-oft" for manufacturers and clinical investigators involved in clinical trials of an AIDS vaccine. On the one hand, they would benefit from a cap on liability and limits on when tort suits could be filed. However, the proposal calls for broad elements of recovery such as unreimbursed medical expenses and unreimbursed lost wages, and, arguably, pain and suffering: relaxed standards of causation: the existence of a claims programme might induce claims: the bonds called for may be prohibitively expensive if awfilable at all: and there is still the possibility of tort suits with unlimited awards in cases where 'unacceptable behaviour' has occurred. Whether such a trade-off will reduce the likelihood of inappropriate deterrence to AIDS vaccine research wilt depend upon the risks perceived by vaccine developers as clinical trials approach, the levels of the proposed caps on awards, practical approaches to ensuring that insolvency and actual bankruptcies of small companies will not prevent the awfilability of funds for claims and the exact extent of the role to be played bv tort suits in the context of a claims programme.
Funding for the system Dialogue group members would prefer a self-insuring system, up to a cap, because they were concerned that vaccine development could be discouraged if manufacturers were responsible for injuries caused by their competitors' vaccines. In addition, the Dialogue group recognized that some, probably small, companies might not be in existence when injuries from clinical trials manifest themselves. Thus, the Dialogue group developed the following approaches: 1 Each company would be responsible for payments up to a maximum for each volunteer and would have to post a bond in that amount to assure future availability of funds (i.e., there is no pooling of risks for first dollar coverage). It was noted that the size of the bond would be an important factor considered by manufacturers in determining whether to support this approach. 2 The Federal Government would establish a trust fund to pay awards exceeding that maximum. 3 If this trust fund was to be exhausted and Congress failed to provide additional funds, a 'fallback' system of compensation would come into operation (e.g. claimants could become automatically eligible for O A S D H I and/or whatever special coverage Congress might have legislated in the interim for AIDS patients). The per capita method to determine first dollar coverage by each company is designed to reflect the degree of risk (more volunteers in trial, the greater the risk all other factors being equal). If the plan is to be affordable, the per capita dollar amount would probably have to be reduced (or other criteria used) in Phase III trials versus Phases I and II, because of the much larger number of volunteers participating in Phase Ill. Since there will be experience with side effects in the smaller Phase I and Phase II trials, there may be some assurances that the incidence/prevalence of injuries will at least be less than
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DISCUSSION AND ON MARKETING
RECOMMENDATIONS
Introduction The Dialogue group recognized that the liability concerns associated with the clinical trials are different from the concerns associated with the marketing phase of AIDS vaccine development. The relatively limited numbers of people involved in the clinical phase as well as the very close monitoring which characterizes vaccine clinical trials enabled the group to reach agreement upon a single approach, which would severely limit reliance on the tort system. The group agreed that the character of the marketing phase was more unpredictable and agreed to present two options for modifying the existing 'liability system' with respect to AIDS vaccine liability: an exclusive compensation system and a compensation system in conjunction with a modified tort approach. Decisions regarding which of the two options would be preferable could not be made by the Dialogue group. Those decisions must be made in the broader political arena when more mformation is gained regarding the nature of potential vaccines, including their efficacy and safety. Most importantly, such decisions must reflect the overall political climate regarding AIDS. Decisions regarding modifications to the liability system, while obviously motivated by a desire to address a critical international health problem, as a practical matter, will be considered in the context of the broader discussions of liability related to products in general and the political climate regarding the need to develop and market an AIDS vaccine. Therefore, the group decided to describe the trade-offs they perceived in the two options in the hope that this document will be as useful as possible to those who will be making the political decisions in the future.
Keystone AIDS vaccine liability project: Keystone Center
Basic principles The Dialogue group agreed that a set of basic principles should govern any system that is devised. The following basic principles should characterize either an exclusive compensation programme or a combined compensation tort approach. 1 Any approach needs to be fair and equitable to those injured by a vaccine. 2 At the minimum, a causal relationship between an injury and the administration of an AIDS vaccine must be established for an injured party to be compensated. The degree of proof of the causal relationship would vary depending upon the option utilized. 3 There are basic elements of compensation which should be seriously considered for inclusion in any compensation programme, such as medical and related expenses, lost earnings, and pain and suffering. 4 Transaction costs associated with the current liability system should be minimized in any new system formulated to address an AIDS vaccine. 5 Incentives must be sufficient to maintain high standards of safety and efficacy and to deter 'unacceptable behaviour' on the part of manufacturers and vaccine administrators. 6 The mechanism for financing any approach should be designed to provide the necessary funds to sustain the system over the long term.
Description of two options Exclusive compensation system. This system would provide compensation for certain, well-defined losses, including unreimbursable medical and related expenses, lost earnings, and pain and suffering. An agreed upon cap on recovery for pain and suffering would be developed. To assure that the petitioner is fully compensated for economic and specified non-economic losses, additional payment for reasonable attorneys' fees would be authorized. Payments would be made from a trust fund (however financed), and the fund would be administered by an appropriate administrative agency with decisions to be made by an independent decision maker, whether judicial or administrative. Under this approach, the claimant need not show fault but must establish causation. The standard of proof of causation would be defined by statute, with the possibility of further refinement or modification of the standard by an administrative agency with proper scientific expertise and with public participation in the rule-making process. To maintain current high standards of behaviour by vaccine manufacturers and administrators, the trust fund would be subrogated* to the rights of the petitioner who has received compensation. 'Unacceptable behaviour' as described above by either the manufacturer or administrator would constitute grounds for exercising this right of subrogation. In instances of this type of behaviour, the fund could recover from the *This means that the trust fund would be able to enforce the rights which the petitioner would have had against the manufacturers and administrators. The petitioner's claims against those parties are not eliminated, but rather transferred to the trust fund.
manufacturer under specifically defined circumstances. 'Unacceptable behaviour' such as deliberate falsification of information submitted to the FDA, would also be actionable through the application of existing FDA procedures and penalties.
Non-exclusive compensation with modified tort law. Under this option, the injured party would make an irrevocable election to enter either the compensation or tort system. This decision would be made at the outset of the process to reduce litigation costs. A key to the success of this approach is the creation of sufficient incentives to encourage most injured parties to pursue the compensation option rather than the modified tort option. Parties must be assured of reasonable and efficient awards through the compensation system compared to the uncertainties, inefficiencies and higher burdens of proof in the tort option. One of the primary reasons for this approach is that it preserves the tort option for those cases strong enough to pass the hurdles of the 'tougher' tort system. The assumption is that those would be cases where 'unacceptable behaviour' had taken place. A second reason for retaining the tort system in this approach is that it does not set a precedent for eliminating the tort option. Some members of the Dialogue group were very concerned about the efforts in other areas of product liability law to eliminate the tort option. However, to implement this type of approach requires some changes in the tort system to provide the appropriate incentives for most people to pursue the compensation alternative. The precise mix of options was not developed by the Dialogue group. Several considerations that must be made in developing the overall plan, however, were outlined and are set forth below. There are trade-offs between people's willingness to accept changes in the tort system to create disincentives for its use and the scope and content of the compensation alternative which is developed. The compensation system could have the following types of elements: a 'low threshold' causation approach; be 'no-fault' in nature; result in awards being granted in an efficient and speedy way; and compensate for economic losses, such as medical expenses and lost wages, but include caps on pain and suffering and not allow punitive damages. The revisions in the tort system that were considered acceptable by proponents of this approach include: addressing the causation issue either through making the requirements for proving causation more stringent or changing the process used to determine causation; implementing a government standards defence or application of a rebuttable presumption of due care where the government standards are met; making the negligence standard more precise; and developing financial penalties for bringing inappropriate cases (e.g. requiring the payment of attorneys' fees by the losing party). Those supporting the non-exclusive approach did not favour limits on awards in the tort option. Others maintained that, for them to consider this approach, some limits on awards under the tort option would be necessary. A properly designed non-exclusive approach such as that described should offer manufacturers more certainty and predictability than the current system if the vast majority of claimants selected the compensation alternative. At the same time, the non-exclusive approach preserves the ability of injured parties in cases
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Keystone AIDS vaccine liability project. Keystone Center of "unacceptable behaviour' to pursue cases through a modified tort system.
Exclusive versus non-exclusive approach. One critical choice to be made in designing a compensation system is whether to make it the 'exclusive" remedy available to an injured person, cutting off the possibility of recourse to the tort system. There would not seem to be any particular difficulty in designing either an exclusive or a non-exclusive compensation system; although, in the group's discussions, a substantial division of opinion existed as to which alternative would be preferable. The core disagreement between those supporting an exclusive compensation system and those supporting a non-exclusive approach is contained in the following question: Do the added predictability and reduced costs which characterize an exclusive system outweigh any safety disincentives and inequality that could result if some claimants are awarded less than they might have recovered under the existing tort system'?
Causation. Given the difficulties of proving that a particular AIDS vaccine may cause a particular injury and the desire to promote compensation rather than litigation in the non-exclusive option, proponents of that system propose a 'relaxed causation' standard under a 'no-fault' option. DiJficulO' of proving causation. Unlike the case of childhood vaccines where a 'vaccine injury table' has been established by law, it may be very difficult to determine what injuries are caused by an AIDS vaccine. In addition, this proposal assumes that compensation would be reduced based on other factors that contribute to the harm including the claimant's fault consistent with a defined standard of comparative fault. With no track record other than pre-marketing trials and with tremendous public pressure to market a vaccine as soon as possible, there may be inadequate scientific data for the foreseeable future to identify which injuries are 'caused' by the vaccine ('caused' as traditionally defined in tort litigation). To promote speedy resolution, limited compensation under the "no-fault' compensaiion should be available to plaintiffs who can meet a relaxed causation test. Costly, time consuming and complicated causation battles can be avoided in a 'no-fault' compensation claim if the plaintiff's evidentiary burden is limited to: 1, showing that the plaintiffreceived the AIDS vaccine; 2, presenting adequate scientific information to show that the AIDS vaccine can contribute to or cause the alleged injury; and 3, demonstrating that the plaintiff has sustained this injury. Proponents of the non-exclusive option believe that, under this relaxed causation standard, plaintiffs would have a strong incentive to accept limited compensation rather than go to trial and defendants would have a strong incentive to limit causation disputes to cases with the weakest scientific evidence. LimOs on awards. Experience with childhood vaccines led some in the Dialogue group to conclude that the uncertainty of open-ended liability has been a significant factor in manufacturers withdrawing from the market
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and a signiticant barrier to new entrants. Others are not convinced that liability-related concerns alone hax.e caused manufacturers to withdraw from the inarket. Those who believe that liability has had a significant impact on manufacturers maintain that limits on awards are necessary both to encourage the development and marketing of vaccines and to protect the compensation system from depletion by a small number of claimants. Some members of the group believe that limitations on awards would therefore be necessary in both exclusive and non-exclusive systems to ensure the viability of either approach. For them, the classical trade-offs such as prompt, sure, no-fault recovery in exchange for limited compensation are only subsidiary considerations. Others believe that clear incentives will be required in the non-exclusive approach to ensure that most people will select the compensation alternative and that limits on tort awards possibly are not appropriate. It is premature to consider the dollar amount of any limitations, although it is possible that appropriate dollar limitations may differ in exclusive and non-exclusive systems.
Funding options. Any compensation programme designed to address liability concerns must take into account the fact that the resources are not infinite. The Federal Government is unlikely to assume the role of a liability insurer. In the current fiscal environment, the Congress would be unlikely to approve any programme in which the Federal Government assumes potentially unlimited liabilities. From a policy standpoint, it seems clear that a 'fund' must be sufficiently solvent to compensate all those to whom it is responsible without regard for the order in which claimants are injured or assert their claims. None of the data needed to decide how much money will be required to adequately endow a fund are known today. While putting a cap on the maximum recovery fixes the range of one key variable, the absence of information as to what side effects can be expected and how often each will occur makes the exercise mcrcly speculative. The conclusion seems clear: neither side of the equation can be established at this time. Acknowledging these uncertainties, the Dialogue group believes that reasonable progress can still be made toward creating the ground rules for funding once information is available. The Dialogue group believes the following should be considered: 1 Provision for stable, long-term funding, perhaps through an excise tax on each dose of vaccine sold. The amount of the excise tax should be revisable as appropriate and set by an appropriate entity. 2 Initial funding may need to take the form of a loan or loan guarantee from thc Federal Government. The amount of the loan will depend on the ultimate recovery cap allowed, clinical experience as to adverse reactions, and projected first-year usage. 3 The Federal Government may need to consider guaranteeing purchase of a specified number of doses each year at market value. In California, under the AIDS Vaccine Compensation Programme law, this first purchase was agreed (arbitrarily) to be US$20 million. The benefits include the assurance of a floor to the market and market price, providing the government with a supply of vaccine to distribute
Keystone AIDS vaccine liability project: Keystone Center outside of the commercial market and assures minimum funding for the fund. CONCLUSION The Dialogue group ended, in part, where it started. The true scope of the problem is difficult to quantify and consensual solutions are not easy to reach; however, the issue of AIDS vaccine liability must continue to be addressed as science continues to make progress.
Liability issues may become more of a significant reality in the marketing phase. The trade-off of addressing the problem now at the inception of the clinical trial phase merits consideration so that a fair and efficient system balancing the needs of all concerned can be developed, as suggested in this report. The key is that dialogue continues as more information becomes available so that the foreseeable and emerging problems can be addressed as early as possible, consistent with the public interest in all aspects of the complex issues involved.
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The Keystone Center is a non-profit organization that convenes and facilitates policy dialogues addressing complex and controversial public policy issues. The Center conducts such dialogues in six main substantive areas:environmental quality and health, natural resources, biotechnology and genetic resources, energy, food and agriculture policy and science and technology. The Center convinced a Dialogue group to address the liability issues related to the development and eventual marketing of AIDS vaccines at the request of several of the key interests concerned with these issues. The Dialogue group consisted of administrators of vaccine trials, manufacturers, insurers, consumer and user groups, academics, agency officials, members of the legal community, Congressional staff and dispute resolution professionals. There are three important ground rules which characterized the discussions of the group: 1 People participated in the discussions as individuals, not as formal representatives of an interest group or organization. 2 All conversations were off-the-record and not for attribution. 3 No documents produced in the course of the project or this final report were made public until agreed upon by the group as a whole. The Dialogue group believes their work should be seriously considered by those concerned with this issue, both due to the substance of its discussions and recommendations and, perhaps most importantly, because of the diverse composition of the group which formulated it.
Statement of the problem The Keystone Center convened this Dialogue group because of concerns that the product liability system is serving as an impediment to the development of a vaccine effective against AIDS. The goal of the group was to consider the validity of the problem and to seek a consensus on a solution. The tort system as a deterrent to A I D S
vaccine
This article is a summation of the complete Dialogue concensus report which is available from the Keystone Center, PO Box 606, 0175 Summit County Road No. 8, Keystone, CO 80435, USA 0264-410X/91/100703-07 (~': 1991 Butterworth-Heinemann Ltd
Throughout the process, the Dialogue group struggled with the lack of data. Nowhere was this more evident than in the consideration of the cause and effect relationship between the tort system and the research and development of vaccines. The group heard from several industry representatives in the group that liability was an important factor in decisions made by companies which have stopped or not begun vaccine development, but also learned that at least ten companies in the US are engaging in AIDS vaccine research and development. There are currently no comprehensive data, and it is unlikely there will ever be data that systematically establishes the linkage between the liability system and vaccine development because liability concerns are only one of many issues which companies must evaluate when making decisions regarding work on a potential vaccine. Manufacturers and insurers view the liability system as too open-ended to be able to predict possible liability exposure for a product as potentially risky as an AIDS vaccine. Further, they believe that the costs of vaccine development will be high, the chances of scientific success low, and commercial success uncertain, so the added concerns about open-ended liability without insurance coverage can weigh heavily against proceeding into this arena. In the field of vaccines as a whole, manufacturers are already concerned about large numbers of claims, high litigation and compensation costs, and a reduction in the number of vaccine manufacturers for other vaccines due to the perception by many manufacturers that it is nearly impossible to accurately assess the risks present in the product liability system. An AIDS vaccine can be expected to present similar, if not worse, liability problems. Despite the difficulty of assessing the scope of the problem, the Keystone Dialogue group proceeded to seek a consensus on a solution. The group felt it was worthwhile to address the issue of AIDS vaccine liability now, before a crisis occurs. Too often, our society does not anticipate problems and fails to plan ahead, often with poor results. The Dialogue group thought that problems could be avoided by proposing a legal framework to govern AIDS vaccine-related injuries. That framework could serve as a basis, or at least a starting point, for addressing liability issues in the future should the need arise. development.
INTRODUCTION
Overall goals o f a new legal f r a m e w o r k . The Dialogue group sought a consensus on a legal framework that would serve the societal interest in promoting develop-
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Keystone AIDS vaccine liability project: Keystone Center merit of a safe and effective AIDS vaccine and would fairly balance the interests of injured participants, wJccine manufacturers and clinical investigators among others. This balance meant a trade-off between predictability and reasonable limits on liability for the manufacturers and the level and nature of compensation for the injured. The group also sought a system that could handle claims fairly and efficiently. Probh, ms with A I D S vaeeines that make a solution d~l.lTcult. Lack of data again plagued the group during
its consideration of the elements of a possible new legal framework. It is nearly impossible to forecast the scope of the risks associated with the development and marketing of an AIDS vaccine. Although no viable vaccine has been developed yet, it is generally assumed that the risks associated with an AIDS vaccine may be less predictable and potentially more serious than the risks associated with other vaccines. The reasons for this perception are: 1 this virus is new and exceedingly complex, and established vaccine approaches are very likely to require modification: 2 animal models, including chimpanzees, are not optimal for testing AIDS vaccines; 3 the possibility of accelerated testing of experimental wlccines in healthy humans as a result of a pressing public health need to develop a vaccine; 4 the possibility that injuries associated with this virus will be especially severe: and 5 the latency period for injuries may extend for years, similar to the latency period of the disease that the vaccine aims to prevent. Such uncertainty about the risks while making the group's job difficult also made clear that a plan for addressing injuries was imperative. The group also discussed the fact that the uniqueness of the AIDS health crisis and related vaccine development process means that proposals to address this situation should not be setting a precedent for other vaccines, drugs, or products in general. The lack of an effective system to deal with liability concerns may impede progress and may lead researchers or manufacturers to conclude that the area is too risky to pursue or research subjects may prove to be unawfilable in sufficient numbers to complete clinical trials. Given the enormous public health implications of the AIDS crisis, society should strive to develop and market safe and effective vaccines. The Dialogue group hopes that the discussions and suggestions which follow will enable removal or reduction of potential liability obstacles. DISCUSSION AND RECOMMENDATIONS ON CLINICAL TRIALS The Dialogue group focused attention on developing a proposal to address AIDS vaccine liability concerns during the clinical trial phases. The proposal is intended to simultaneously address the perceived needs of several parties: 1, manufacturers who are concerned about the uncertainty of risks during clinical trials as well as the current unavailability of liability insurance for the clinical trials and the availability of sufficient numbers of participants in the trials: 2, research centre staff who
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conduct many of the trials, ~vho are also concerned ~ith liability implications, the availability of parlicipants in the trials and the preservation of the rcsearcher participant relationship during clmical trials: 3, recipients participants in the trials, who may be concerned with maintaining their anonymity as well as assuring themselves equitable treatment if injured as a result of their participation in a trial: 4, consumers interested in an expedited process to compensate injured participants as well as mechanisms for penalty provisions for 'unacceptable behaviour" (see section below): and 5, government personnel interested in creating a just framework that encourages the development of an AIDS vaccine and providing for treatment of recipients/participants in the clinical trials if injured, but reflecting concern about implications for the government's budget. The Dialogue group proposed a system that might begin to satisfy many of the concerns associated with clinical trials expressed by I)ialogue participants. The system is an exclusive, administrative remedy (except for cases of injury resulting from "unacceptable behaviour" for which a tort remedy is preserved). (Scc discussion of 'unacceptable behaviour' bclow.t 'Exclusive" in this instance means that claimants must go through this system for compensation except for cases of "unacceptable behaviour'.
Description of proposed system for clinical trials Following a thorough informed consent process, volunteers would enter a clinical trial. If an injury occurs, the volunteer would submit a claim. Causation and degree of disability would then be determined by a scientific panel selected by the Department of Health and H u m a n Services from a list provided by the National Academy of Sciences. The Dialogue group proposed that this be a standing panel of approximately ten to fifteen members. A subset of three to live would be responsible for determining individual claims. In the proposed system, a decision by the panel of three to five could be appealed by either the claimant or manufacturer to the full panel. Once causation and degree of disability had been determined, compensation levels would then be decided by a different fact-finder, the exact nature of which was not defined. An appeal of this determination also would be available. Because the system is an 'exclusive' remedy, it is important to build in mechanisms for review at the crucial decision points. Under the proposed system, compensation would be funded by the vaccine sponsors, with federal funds provided for excess insurance. Each w~ccinc sponsor would be responsible for claims brought by volunteers in its particular trials. The amount for which the manufacturer would be responsible could be set at a specified dollar amount or be limited to coverage for only certain categories of loss (e.g. unreimbursed medical expenses with excess insurance covering other costs such as economic losses or pain and suffering). Each company would post the amount for which it was responsible as a bond to ensure the availability of these funds, m case a manufacturer no longer exists at the time a claim is filed. Claims above that amount would be covered by a federal trust fund. In the event the fund was exhausted and Congress did not provide additional funds, a successful claimant would be able to obtain some compensation through other public programmes (e.g.,
Keystone AIDS vaccine liability project: Keystone Center OASDHI, the Old Age and Survivors Disability and Health Insurance programme of which Medicare is the health component). The following is a step-by-step discussion of the key elements of the proposed system.
Informed consent discussion and recommendations The informed consent process for the vaccine trial participant is an essential component of the planning and conduct of the trial. The informed consent process is the way to provide information to an individual about the rights and responsibilities he/she acquires by choosing to participate in a clinical trial. Informed consent includes information about the possibility of injury and compensation that is available. The goal is to make potential research participants aware of risks and benefits and other important information about the research so that they can make a decision about entering the trial. The Dialogue group recognized that the need to fully inform volunteers about all the relevant risks associated with their participation in a vaccine trial and the need to locate sufficient numbers of volunteers for vaccine trials are related. Several participants also noted that if too many 'outside' people and issues are brought into the informed consent process, it may strain the nature of the traditional subjectresearcher relationship. The Dialogue group agreed that other approaches may need to be used depending on the phase of the trial, types of personnel available to interact with potential participants in the process, and country in which the trial occurs. Several of the health care providers in the Dialogue group indicated that explanations of information about liability and legal rights should not be given by medical personnel because of a potential for its having a 'chilling' effect on the health care team's effectiveness, both in terms of the relationship with the volunteers and the ability of health care providers to adequately answer detailed legal questions. While the information provided to the volunteer should be detailed and comprehensive, it must be presented in plain language and in manageable amounts. The volunteer's relationship with clinic staff should provide a comfortable atmosphere for the exchange of information. Dialogue participants perceived an in-depth informed consent process as essential. Some Dialogue participants expressed concern about the impact of the information, particularly the exclusive nature of the remedy on volunteers. Some thought volunteers would be 'turned off' by the exclusive remedy and the possibility that 'latecomers' might find the compensation fund exhausted. It was pointed out, however, that the proposed system provides injured parties with a more sure and timely remedy than the tort system, while preserving the tort option in cases of 'unacceptable behaviour.'
Expert panel The Dialogue group suggested that the expert panel be a scientific body with responsibility primarily for deciding on causation. The group discussed the fact that causal relationships may be particularly difficult to establish due to the newness of the HIV system, the latency periods involved and the diverse organ systems that could be involved. Some suggested that the expert panel should also be
able to determine the degree of disability of a claimant. The panel might consist of clinicians and scientists, some of whom may not work in the HIV or disability fields. The group considered, but rejected, the possibility of including for credibility a non-scientist. However, because of the need for timely decisions and the need to keep the panel relatively small, but with a range of scientific expertise, the group concluded that the panel should be solely scientific. In cases where additional expertise was needed to make decisions, the expert panel would be expected to solicit the input of other experts in the appropriate fields.
Unacceptable behaviour Members of the Dialogue group differed in their views of the relative importance of providing 'deterrents' to 'unacceptable behaviour' on the part of vaccine manufacturers. Some in the group pointed out that, overall, the performance record of vaccine manufacturers has been extremely good. Others, while not necessarily disagreeing with that characterization, believe that it is important to preserve what they feel is the deterrent effect of the existing tort system in any new system that is developed. The group agreed that it is extremely difficult to craft language to specify the type of 'unacceptable behaviour' related to injuries that should be subject to a tort remedy. Terms such as 'gross negligence' and 'willful misconduct' have been interpreted with a great deal of latitude by courts in the past. Fundamentally, the group agreed that 'unacceptable behaviour' that would be subject to tort action should be restricted to behaviour which was an intentional violation of the law, conscious disregard for the rights or safety of others; or intentional conduct that was designed to deceive or conceal; and which was causally related to the injury in question. Given the monitoring which takes place during clinical trials, the group expects that behaviour leading to application of the tort exception during clinical trials will be rare. If the scientific panel (described below) found indications of this type of behaviour, it would report its suspicions to an appropriate agency, such as the FDA. If a recipient then brought a tort action in court, the judge would permit the suit if there was substantial evidence of 'unacceptable behaviour'. If an award was made as a result of a tort suit based on 'unacceptable behaviour', that award would be off-set by compensation that had already been granted.
Standards It is recommended that since the system is exclusive with the remedy restricted except for 'unacceptable behaviour', the panel should use a liberal causation 'standard'. The Dialogue group did not reach a consensus on an appropriate standard. However, the group did agree that the benefit of the doubt should be given to the claimant and that a list of compensable events should be developed as experience is gained.
Appeals The Dialogue group proposed that appeals (by either party) to the scientific panel's decision regarding causality, and perhaps degree of disability, should be made in the
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Keystone AIDS vaccine liability project. Keystone Center following way. There should be a standing panel (e.g. ten to fifteen mcmbers) from which a sub-pancl (e.g. three to five) would be drawn to decide individual cases. An appeal brought by either side would be heard by the full panel and would be subject to only limited formal judicial review.
Compensation The Dialogue group did not address specifically how determinations should be made as to the type and amount of compensation. Since the scientific panel would address only causation, and perhaps degree of disability, some other decision maker, such as an administrative law judge, would be needed to determine compensation levels. The Dialogue group agreed that either side should be able to appeal this decision. A lump sum method of payment was favoured over periodic payments because of administrative simplicity and the ability to better determine programme costs. Except for a death benefit, only the volunteer, and no third parties, would be eligible for compensation. A compensable injury would not include those resulting from HIV infection from external sources. In other words, the system is not guaranteeing thal the vaccine works and protects the volunteer from subsequent HIV infection. (This objective, after all, is what the trials are designed to determine.)
those found in the smaller trials. If this is lhc case. it would provide a statistical rationale for rcducing the pcr capita level of financial responsibility of each company.
Summary The concepts presented here represenl a difficult trade-oft" for manufacturers and clinical investigators involved in clinical trials of an AIDS vaccine. On the one hand, they would benefit from a cap on liability and limits on when tort suits could be filed. However, the proposal calls for broad elements of recovery such as unreimbursed medical expenses and unreimbursed lost wages, and, arguably, pain and suffering: relaxed standards of causation: the existence of a claims programme might induce claims: the bonds called for may be prohibitively expensive if awfilable at all: and there is still the possibility of tort suits with unlimited awards in cases where 'unacceptable behaviour' has occurred. Whether such a trade-off will reduce the likelihood of inappropriate deterrence to AIDS vaccine research wilt depend upon the risks perceived by vaccine developers as clinical trials approach, the levels of the proposed caps on awards, practical approaches to ensuring that insolvency and actual bankruptcies of small companies will not prevent the awfilability of funds for claims and the exact extent of the role to be played bv tort suits in the context of a claims programme.
Funding for the system Dialogue group members would prefer a self-insuring system, up to a cap, because they were concerned that vaccine development could be discouraged if manufacturers were responsible for injuries caused by their competitors' vaccines. In addition, the Dialogue group recognized that some, probably small, companies might not be in existence when injuries from clinical trials manifest themselves. Thus, the Dialogue group developed the following approaches: 1 Each company would be responsible for payments up to a maximum for each volunteer and would have to post a bond in that amount to assure future availability of funds (i.e., there is no pooling of risks for first dollar coverage). It was noted that the size of the bond would be an important factor considered by manufacturers in determining whether to support this approach. 2 The Federal Government would establish a trust fund to pay awards exceeding that maximum. 3 If this trust fund was to be exhausted and Congress failed to provide additional funds, a 'fallback' system of compensation would come into operation (e.g. claimants could become automatically eligible for O A S D H I and/or whatever special coverage Congress might have legislated in the interim for AIDS patients). The per capita method to determine first dollar coverage by each company is designed to reflect the degree of risk (more volunteers in trial, the greater the risk all other factors being equal). If the plan is to be affordable, the per capita dollar amount would probably have to be reduced (or other criteria used) in Phase III trials versus Phases I and II, because of the much larger number of volunteers participating in Phase Ill. Since there will be experience with side effects in the smaller Phase I and Phase II trials, there may be some assurances that the incidence/prevalence of injuries will at least be less than
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DISCUSSION AND ON MARKETING
RECOMMENDATIONS
Introduction The Dialogue group recognized that the liability concerns associated with the clinical trials are different from the concerns associated with the marketing phase of AIDS vaccine development. The relatively limited numbers of people involved in the clinical phase as well as the very close monitoring which characterizes vaccine clinical trials enabled the group to reach agreement upon a single approach, which would severely limit reliance on the tort system. The group agreed that the character of the marketing phase was more unpredictable and agreed to present two options for modifying the existing 'liability system' with respect to AIDS vaccine liability: an exclusive compensation system and a compensation system in conjunction with a modified tort approach. Decisions regarding which of the two options would be preferable could not be made by the Dialogue group. Those decisions must be made in the broader political arena when more mformation is gained regarding the nature of potential vaccines, including their efficacy and safety. Most importantly, such decisions must reflect the overall political climate regarding AIDS. Decisions regarding modifications to the liability system, while obviously motivated by a desire to address a critical international health problem, as a practical matter, will be considered in the context of the broader discussions of liability related to products in general and the political climate regarding the need to develop and market an AIDS vaccine. Therefore, the group decided to describe the trade-offs they perceived in the two options in the hope that this document will be as useful as possible to those who will be making the political decisions in the future.
Keystone AIDS vaccine liability project: Keystone Center
Basic principles The Dialogue group agreed that a set of basic principles should govern any system that is devised. The following basic principles should characterize either an exclusive compensation programme or a combined compensation tort approach. 1 Any approach needs to be fair and equitable to those injured by a vaccine. 2 At the minimum, a causal relationship between an injury and the administration of an AIDS vaccine must be established for an injured party to be compensated. The degree of proof of the causal relationship would vary depending upon the option utilized. 3 There are basic elements of compensation which should be seriously considered for inclusion in any compensation programme, such as medical and related expenses, lost earnings, and pain and suffering. 4 Transaction costs associated with the current liability system should be minimized in any new system formulated to address an AIDS vaccine. 5 Incentives must be sufficient to maintain high standards of safety and efficacy and to deter 'unacceptable behaviour' on the part of manufacturers and vaccine administrators. 6 The mechanism for financing any approach should be designed to provide the necessary funds to sustain the system over the long term.
Description of two options Exclusive compensation system. This system would provide compensation for certain, well-defined losses, including unreimbursable medical and related expenses, lost earnings, and pain and suffering. An agreed upon cap on recovery for pain and suffering would be developed. To assure that the petitioner is fully compensated for economic and specified non-economic losses, additional payment for reasonable attorneys' fees would be authorized. Payments would be made from a trust fund (however financed), and the fund would be administered by an appropriate administrative agency with decisions to be made by an independent decision maker, whether judicial or administrative. Under this approach, the claimant need not show fault but must establish causation. The standard of proof of causation would be defined by statute, with the possibility of further refinement or modification of the standard by an administrative agency with proper scientific expertise and with public participation in the rule-making process. To maintain current high standards of behaviour by vaccine manufacturers and administrators, the trust fund would be subrogated* to the rights of the petitioner who has received compensation. 'Unacceptable behaviour' as described above by either the manufacturer or administrator would constitute grounds for exercising this right of subrogation. In instances of this type of behaviour, the fund could recover from the *This means that the trust fund would be able to enforce the rights which the petitioner would have had against the manufacturers and administrators. The petitioner's claims against those parties are not eliminated, but rather transferred to the trust fund.
manufacturer under specifically defined circumstances. 'Unacceptable behaviour' such as deliberate falsification of information submitted to the FDA, would also be actionable through the application of existing FDA procedures and penalties.
Non-exclusive compensation with modified tort law. Under this option, the injured party would make an irrevocable election to enter either the compensation or tort system. This decision would be made at the outset of the process to reduce litigation costs. A key to the success of this approach is the creation of sufficient incentives to encourage most injured parties to pursue the compensation option rather than the modified tort option. Parties must be assured of reasonable and efficient awards through the compensation system compared to the uncertainties, inefficiencies and higher burdens of proof in the tort option. One of the primary reasons for this approach is that it preserves the tort option for those cases strong enough to pass the hurdles of the 'tougher' tort system. The assumption is that those would be cases where 'unacceptable behaviour' had taken place. A second reason for retaining the tort system in this approach is that it does not set a precedent for eliminating the tort option. Some members of the Dialogue group were very concerned about the efforts in other areas of product liability law to eliminate the tort option. However, to implement this type of approach requires some changes in the tort system to provide the appropriate incentives for most people to pursue the compensation alternative. The precise mix of options was not developed by the Dialogue group. Several considerations that must be made in developing the overall plan, however, were outlined and are set forth below. There are trade-offs between people's willingness to accept changes in the tort system to create disincentives for its use and the scope and content of the compensation alternative which is developed. The compensation system could have the following types of elements: a 'low threshold' causation approach; be 'no-fault' in nature; result in awards being granted in an efficient and speedy way; and compensate for economic losses, such as medical expenses and lost wages, but include caps on pain and suffering and not allow punitive damages. The revisions in the tort system that were considered acceptable by proponents of this approach include: addressing the causation issue either through making the requirements for proving causation more stringent or changing the process used to determine causation; implementing a government standards defence or application of a rebuttable presumption of due care where the government standards are met; making the negligence standard more precise; and developing financial penalties for bringing inappropriate cases (e.g. requiring the payment of attorneys' fees by the losing party). Those supporting the non-exclusive approach did not favour limits on awards in the tort option. Others maintained that, for them to consider this approach, some limits on awards under the tort option would be necessary. A properly designed non-exclusive approach such as that described should offer manufacturers more certainty and predictability than the current system if the vast majority of claimants selected the compensation alternative. At the same time, the non-exclusive approach preserves the ability of injured parties in cases
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Keystone AIDS vaccine liability project. Keystone Center of "unacceptable behaviour' to pursue cases through a modified tort system.
Exclusive versus non-exclusive approach. One critical choice to be made in designing a compensation system is whether to make it the 'exclusive" remedy available to an injured person, cutting off the possibility of recourse to the tort system. There would not seem to be any particular difficulty in designing either an exclusive or a non-exclusive compensation system; although, in the group's discussions, a substantial division of opinion existed as to which alternative would be preferable. The core disagreement between those supporting an exclusive compensation system and those supporting a non-exclusive approach is contained in the following question: Do the added predictability and reduced costs which characterize an exclusive system outweigh any safety disincentives and inequality that could result if some claimants are awarded less than they might have recovered under the existing tort system'?
Causation. Given the difficulties of proving that a particular AIDS vaccine may cause a particular injury and the desire to promote compensation rather than litigation in the non-exclusive option, proponents of that system propose a 'relaxed causation' standard under a 'no-fault' option. DiJficulO' of proving causation. Unlike the case of childhood vaccines where a 'vaccine injury table' has been established by law, it may be very difficult to determine what injuries are caused by an AIDS vaccine. In addition, this proposal assumes that compensation would be reduced based on other factors that contribute to the harm including the claimant's fault consistent with a defined standard of comparative fault. With no track record other than pre-marketing trials and with tremendous public pressure to market a vaccine as soon as possible, there may be inadequate scientific data for the foreseeable future to identify which injuries are 'caused' by the vaccine ('caused' as traditionally defined in tort litigation). To promote speedy resolution, limited compensation under the "no-fault' compensaiion should be available to plaintiffs who can meet a relaxed causation test. Costly, time consuming and complicated causation battles can be avoided in a 'no-fault' compensation claim if the plaintiff's evidentiary burden is limited to: 1, showing that the plaintiffreceived the AIDS vaccine; 2, presenting adequate scientific information to show that the AIDS vaccine can contribute to or cause the alleged injury; and 3, demonstrating that the plaintiff has sustained this injury. Proponents of the non-exclusive option believe that, under this relaxed causation standard, plaintiffs would have a strong incentive to accept limited compensation rather than go to trial and defendants would have a strong incentive to limit causation disputes to cases with the weakest scientific evidence. LimOs on awards. Experience with childhood vaccines led some in the Dialogue group to conclude that the uncertainty of open-ended liability has been a significant factor in manufacturers withdrawing from the market
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and a signiticant barrier to new entrants. Others are not convinced that liability-related concerns alone hax.e caused manufacturers to withdraw from the inarket. Those who believe that liability has had a significant impact on manufacturers maintain that limits on awards are necessary both to encourage the development and marketing of vaccines and to protect the compensation system from depletion by a small number of claimants. Some members of the group believe that limitations on awards would therefore be necessary in both exclusive and non-exclusive systems to ensure the viability of either approach. For them, the classical trade-offs such as prompt, sure, no-fault recovery in exchange for limited compensation are only subsidiary considerations. Others believe that clear incentives will be required in the non-exclusive approach to ensure that most people will select the compensation alternative and that limits on tort awards possibly are not appropriate. It is premature to consider the dollar amount of any limitations, although it is possible that appropriate dollar limitations may differ in exclusive and non-exclusive systems.
Funding options. Any compensation programme designed to address liability concerns must take into account the fact that the resources are not infinite. The Federal Government is unlikely to assume the role of a liability insurer. In the current fiscal environment, the Congress would be unlikely to approve any programme in which the Federal Government assumes potentially unlimited liabilities. From a policy standpoint, it seems clear that a 'fund' must be sufficiently solvent to compensate all those to whom it is responsible without regard for the order in which claimants are injured or assert their claims. None of the data needed to decide how much money will be required to adequately endow a fund are known today. While putting a cap on the maximum recovery fixes the range of one key variable, the absence of information as to what side effects can be expected and how often each will occur makes the exercise mcrcly speculative. The conclusion seems clear: neither side of the equation can be established at this time. Acknowledging these uncertainties, the Dialogue group believes that reasonable progress can still be made toward creating the ground rules for funding once information is available. The Dialogue group believes the following should be considered: 1 Provision for stable, long-term funding, perhaps through an excise tax on each dose of vaccine sold. The amount of the excise tax should be revisable as appropriate and set by an appropriate entity. 2 Initial funding may need to take the form of a loan or loan guarantee from thc Federal Government. The amount of the loan will depend on the ultimate recovery cap allowed, clinical experience as to adverse reactions, and projected first-year usage. 3 The Federal Government may need to consider guaranteeing purchase of a specified number of doses each year at market value. In California, under the AIDS Vaccine Compensation Programme law, this first purchase was agreed (arbitrarily) to be US$20 million. The benefits include the assurance of a floor to the market and market price, providing the government with a supply of vaccine to distribute
Keystone AIDS vaccine liability project: Keystone Center outside of the commercial market and assures minimum funding for the fund. CONCLUSION The Dialogue group ended, in part, where it started. The true scope of the problem is difficult to quantify and consensual solutions are not easy to reach; however, the issue of AIDS vaccine liability must continue to be addressed as science continues to make progress.
Liability issues may become more of a significant reality in the marketing phase. The trade-off of addressing the problem now at the inception of the clinical trial phase merits consideration so that a fair and efficient system balancing the needs of all concerned can be developed, as suggested in this report. The key is that dialogue continues as more information becomes available so that the foreseeable and emerging problems can be addressed as early as possible, consistent with the public interest in all aspects of the complex issues involved.
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