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1 Summary The Committee on Public-Private Sector Relations in Vaccine Innova- tion was established on the premise that maintaining and extending the control of infectious diseases through immunization is an important national health objective. In compliance with its charge, it under- took a comprehensive study of vaccine research and development, production and supply, and utilization. It paid particular attention to the institutional arrangements and interactions required to ensure vaccine availability and use, and reviewed previous efforts to identify and resolve problems in these areas. The committee found that vaccine development and immunization efforts are dependent on an intricate system in which many public and private participants have traditional roles and responsibilities. Although some of these participants communicate regularly, the system lacks any formal means to coordinate the establishment and attainment of goals in the effort to combat infectious diseases. The committee identified a variety of problems that result from the absence of such a mechanism. The history of previous ad hoc groups convened to address problems related to vaccine availability has been discouraging. In general, their recommendations for specific actions have not been implemented, for a variety of reasons unrelated to the potential utility of the recommendations. When these groups dissolved, interest in the topics they studied waned. Unfortunately, the problems remained and, in some areas, worsened. In light of that experience, the committee chose to emphasize the need for establishment of a continuing body to anticipate and resolve problems in vaccine development, supply, and use; it recommends the creation of a national vaccine commission. To aid in the activities of such an oversight body, the committee conducted a broad analysis of current scientific, economic, legal, and ethical concerns related to vaccine availability. Two fundamentally different approaches to ensuring vaccine availability are possible--(l) direct government production and (2) continued reliance on supply by the private sector, domestic and/or foreign. The committee believes that, at present, solutions to vaccine supply problems should employ the facilities and expertise already existing in the domestic commercial vaccine 1

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2 industry; however, the committee's analysis identified a variety of deterrents to commercial interest in vaccines that could endanger the viability of this approach. Paramount among current concerns is the pressing need for a consistent and just approach to the issues of liability for vaccine- related injury and of compensation for those who are injured. The committee's investigation showed that the handling of vaccine-related injury liability by the courts has left manufacturers apprehensive and uncertain about the extent of their responsibilities beyond proper manufacturing and labeling. These apprehensions act as a deterrent to vaccine production and thereby threaten the public's health, particu- larly because the nation is dependent on sole distributors for many of its most-used vaccines. Action is urgently needed to reduce the uncertainty faced by manufacturers with regard to liability for vaccine-related injury; however, such action should not shield those who may be suspected of misconduct. The committee believes that the goal of controlling infectious diseases by immunization should be pursued in as just and fair a manner as possible. Persons who respond to government promotion of or legal requirement for vaccination often benefit others in society, as well as themselves, because of reduced disease transmission. Those who are injured as an unfortunate consequence of immunization programs should be provided reasonable compensation in a rapid and equitable manner. The common law tort system does not satisfy these require- ments. The general objectives of providing equitable, rapid compensation in a consistent fashion and reducing uncertainty for manufacturers can be achieved by a wide range of approaches. The committee concluded, therefore, that its most useful contribution would be to define a range of possible options and to identify factors that should be considered in the design of workable solutions. It urges political decision makers to consider these options and to act as rapidly as possible on these questions and the establishment of the proposed national vaccine commission. Only with action on all of these fronts will the current threat to the public's health be permanently relieved, and the potential of new technologies be fully realized. OVERVIEW The committee examined the history of vaccine production and regulation in this country and the manner in which today's products progress from research, through development and production, to utilization. The first vaccines were developed solely on the basis of empirical evidence. Scientists in the nineteenth century knew little or nothing about microbiology, mechanisms of infection, or immunity; yet their observations led to major advances in the control of smallpox, diphtheria, and-other important diseases. Newer vaccines, generally based on greater knowledge of pathogens

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3 and host responses, have contributed to the near eradication of paralytic poliomyelitis in the United States and have reduced dra- matically the incidence of measles, mumps, and rubella. The safety and efficacy of existing vaccines could be improved, however, and vaccines are not yet available to combat many pathogens. Early in the history of vaccine development, physicians and others recognized that vaccine administration, like most medical procedures, carried risks as well as benefits. To reduce these risks, first local and then federal regulatory bodies established safety standards. The current generation of standards and vaccine licensure requirements, which specify production and testing procedures, are administered by the Office of Biologics Research and Review (OBRR) of the Food and Drug Administration. The availability of vaccines depends almost entirely on the willingness of commercial manufacturers to produce them. The process of vaccine innovation (from basic research to commercial availability) rarely begins in industry, however. The basic research necessary to identify pertinent characteristics of the pathogen and host response, often extremely time-consuming and expensive, usually is conducted in federally funded academic or government laboratories, such as those of the National Institute of Allergy and Infectious Diseases and the Department of Defense (for vaccines required by the military). If the evidence indicates that available techniques might produce a safe and effective immunizing agent, manufacturers begin to consider other aspects of the decision to develop a vaccine. These are based on assessments of the impact of the infectious disease; of the estimated cost of the disease and the projected costs of development, production, and administration of the vaccine; and of the vaccine's ranking among other health care priorities. Potential utilization, which is dependent both on acceptance of the vaccine by the public and the enthusiasm of physicians and other health care providers, is of major importance to commercial manufacturers. After the extensive and complex background work has been completed and it appears that the proposed vaccine offers promise of safety and efficacy, permission may be sought from the OBRR for studies in humans. By regulation, this involves filing a permit referred to as an IND (Notice of Claimed Exemption for Investigational New Drug). The investigators must complete three sequential phases in the evaluation of the vaccine. If the IND sponsor decides that the product is marketable, it files a license application. The OBRR reviews this document, conducts testing of the product, and may convene one or more meetings of the Vaccines and Related Biological Products Advisory Committee to provide advice regarding licensure. If the OBRR is satisfied that the product is safe and effective and that the directions for use developed by the manufacturer are adequate, a license can be granted. Each marketed vaccine requires a license, as does each vaccine manufacturer. Although hundreds or thousands of individuals may have received a vaccine prior to full licensure, these numbers are insufficient to identify rare untoward events resulting from the vaccine. Therefore, the OBRR encourages continuing surveillance of vaccine recipients.

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4 Any reports of untoward events must be made available by the manufacturer for review by the OBRR. Recommendations for vaccine use in the United States are made by several advisory groups, most notably the Immunization Practices Advisory Committee of the U.S. Public Health Service, the Committee on Infectious Diseases of the American Academy of Pediatrics, and the Committee on Immunization of the Council of Medical Societies, American College of Physicians. The Department of the Army oversees efforts to develop vaccines needed to protect military personnel (and others at risk) from a range of pathogens not generally encountered by the U.S. civilian popula- tion. These include tropical disease pathogens and potential biological warfare agents. Recommendations for the use of these vaccines are developed by the Armed Forces Epidemiological Board. As with vaccines for general public use, the ultimate availability of these vaccines depends on the willingness of a commercial manufacturer to undertake final development and production. Recent advances in all aspects of biotechnology, and particularly gene manipulation, offer powerful new approaches to many previously intractable problems. These technologies, combined with a better understanding of the immune process, have opened a new era in vaccine development. Effective vaccines for meningitis, diarrhea! diseases, malaria, and other parasitic diseases (responsible for enormous morbidity and mortality) may be technically feasible within a decade. Full utilization of these new techniques may be forestalled, however, by the same problems that deter the development of vaccines by traditional methods. These include technical problems, high research and development costs, the expense and logistics of clinical testing and surveillance of reactions, the risk of litigation over untoward events associated with vaccine use (whether causally related or not), and limited sales. These problems must be resolved before the full public health benefits of new approaches to vaccine development can be achieved. VACCINE AVAILABILITY: MAJOR BARRIERS AND IMPEDIMENTS Concerns about the supply of vaccines and the factors that affect it are not new. The National Immunization Work Groups, convened by the Office of the Assistant Secretary of Health, made recommendations to resolve problems in these areas in 1977. Two years later, the congressional Office of Technology Assessment also studied these issues and presented a series of options, but no significant actions resulted from either effort. The manufacture of vaccines can be interrupted by a variety of technical problems that arise with biological products and the processes by which they are produced. These include potency variations; stability problems; quantitative imbalance of microbial components in combination vaccines; variations in responses to

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5 inactivation processes; excessive undesirable biological activity, e.g., neurovirulence; and inadvertent contamination. Vaccine manufacturing requires major investment in a techno- logically advanced production plant and the establishment of teams with multidisciplinary expertise in the large-scale production of biological products. The decision by vaccine manufacturers to cease production of a particular product results in the dispersion of these teams and, perhaps, the disassembly of the production facilities. Reversal of this process cannot be achieved cheaply or rapidly, as might be necessary in the case of a vaccine shortage or a vaccine needed for military personnel. The United States is heavily dependent on sole suppliers (either sole manufacturers or distributors). Two commercial companies (who do not compete with each other) dominate the markets for the major pediatric vaccines. The withdrawal, during 1984, of two manufacturers from the distribution of DTP vaccine and technical problems encountered by the one remaining producer resulted in a shortage of it in early 1985, and in a recommendation by the Centers for Disease Control to delay the usual fourth and fifth doses of the vaccine until supplies returned to normal. One of the manufacturers later decided to resume distribution, but this series of events highlights the dangers inherent in the current U.S. vaccine supply situation. Stockpiling of vaccines has begun to a very limited extent and can provide some protection against brief interruption in the supply of a vaccine. It does not provide protection against the possibility that a single supplier will cease production or distribution of a vaccine. The committee is not aware of any contingency plan for dealing with a situation in which no U.S. commercial manufacturer is willing to produce a major childhood vaccine. It regards this possibility with grave concern because of the threat of resurgence of these infectious diseases should vaccines become unavailable. Sole reliance on foreign manufacturers for vaccines does not offer a practicable solution: problems could arise from geographic distance, with related communications and distribution delays; from possible language barriers, which could hamper the resolution of highly technical issues; from political considerations; and from differences in regulatory requirements. Reliance on foreign manu- facturers also is not practicable because few firms abroad will compete in the U.S. market--the liability situation is cited as a factor in such decisions. The supply of vaccines could be ensured if the federal government were willing to become the manufacturer of last resort or to enter into guaranteed contracts with manufacturers for needed vaccines. The possibility of federal vaccine production raises many complex policy questions, however, including the issues of how vaccine injuries from federally produced vaccines would be compensated and whether the facility would compete with commercial manufacturers. The committee did not consider itself an appropriate forum to resolve these issues, but did review other aspects of potential federal production. For example, a government production bureaucracy in the role of a sole

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6 supplier might not be subject to the market pressures that often lead to innovation and the application of new technologies. The committee believes that, at present, solutions to the problem of ensuring vaccine supply should employ the facilities and expertise already existing in the commercial vaccine industry. It recommends, however, that the national vaccine commission proposed in Chapter 7 should develop contingency plans and recommendations, on a case-by- case basis, for ensuring vaccine availability. These plans should include the possibility of direct federal involvement in vaccine supply if commercial manufacturers find continued "open market" operation no longer viable. Impediments to Vaccine Innovation The success achieved by immunization may appear to diminish the need for continuing vaccine innovation. However, vaccines are not yet available for many diseases of importance in the United States and abroad. The attack on many tropical diseases has barely begun. AlSo' some existing vaccines are not optimal and should be improved. Modern vaccine development requires a firm scientific foundation, based on an understanding of the pathogen and the host (human) response to it. Limitations of funding for basic research and training, especially in disease pathogenesis, may contribute to delays in acquiring the necessary knowledge. Vaccine improvement also may be impeded by lack of basic knowledge, because if an empirically derived but effective vaccine exists there is a tendency to direct resources to the control of other pressing disease problems. Hence, basic research on the pathogenesis of the preventable disease may be neglected. The fact that much of the acquisition of basic knowledge required for vaccine development is federally funded previously may have limited commercial interest in collaborations during this phase, because of subsequent problems in clarifying property rights, but changes in government funding policies (with respect to patents) may be reducing this deterrent. The willingness of manufacturers to produce a new or improved vaccine also depends on evidence of an appropriate market. The achievable market for a vaccine may not reflect its true public health benefits because certain features of the health care system and of vaccine providers and recipients contribute to vaccine underutiliza- tion. One possible cause of inadequate market size may be the systematic undervaluation of preventive care in the United States. Vaccines also may be underutilized when viewed from a societal perspective because the total benefits that accrue to society at large (including reduced disease transmission) are greater than the sum of benefits to vaccinated individuals. Behavioral research indicates that the widespread diffusion of new technologies depends on their successful adoption by Opinion leaders" in the relevant medical communities. This suggests that spreading

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7 scarce resources across all providers to increase awareness of new approaches (including the use of new vaccines) may not be as successful as concentrating on those who exercise opinion leadership. Considerable empirical evidence supports the usefulness of the Health belief models in accounting for individuals' health-related decisions. Efforts to maximize public participation in immunization programs should begin with a survey of intended vaccine recipients to obtain information on their perceptions of the disease and the vaccine. Those promoting the vaccine can then develop and implement campaign that addresses and modifies the Misperceptions most likely to act as obstacles. ECONOMIC CHARACTERISTICS OF THE VACCINE INDUSTRY Although the available data are incomplete, certain conclusions can be drawn about the current economic situation of the United States vaccine industry. The number of manufacturers has declined steadily. During the 1970s and early 1980s, the proportion of the total pharmaceutical industry R&D investment in biologics also declined (data are not yet available to determine whether this trend continued after 1982~. In addition, the pattern of new vaccine introductions has been consid- erably different from that of drug introductions in recent decades. Manufacturing of vaccines is highly concentrated and competition is very limited. Also, the sole-supplier situation poses a threat to the continued supply of some vaccines. Typically, a decline in the growth of an industry and in the number of manufacturers signifies one of two events in its life cycle: either it has matured or it is experiencing problems. If the decline is the result of natural changes in demand patterns, efficiency is enhanced. Alternatively, a decline may reflect distorted incentives. Economic disincentives to vaccine innovation and production include: the complexity of development, production, and quality control the cost of research and development in relation to anticipated sales a perception that vaccines historically have received less effective patent protection than drugs apprehension over the liability situation The effects of recent changes in the patent law and in government funding policies (related to patents) are difficult to predict, but should generally enhance protection of innovations. The liability situation is discussed in detail in Chapter 6. Additional disincentives exist on the marketing side: the need for a vaccine to deliver lifelong or long-lasting immunity is at odds with the prospect of multiple or repeat sales, and prospects for export sales are poor. The impact on profits of bulk purchases by government agencies (at prices lower than those paid by private purchasers) is uncertain.

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8 VACCINE INJURY The committee reviewed scientific data on major adverse reactions to commonly used domestic vaccines for children and adults. It then examined the factors that impede efforts to establish clear cause-and- effect relationships in cases of vaccine-related injury and the problem of determining the frequency of adverse~effects among vaccinees. Temporal associations between the administration of vaccines and the onset of many conditions similar to vaccine-related events further complicate these efforts. The vaccines that are currently licensed provide excellent protection to society against their target diseases and are safe for an overwhelming proportion of recipients. They are not, however, universally effective or completely safe. The judgment as to what is adequately safe is difficult; decisions on the urgency with which improvement of vaccines needs to be pursued depends on the undesirability of the risks of vaccination in relation to the risks of the disease, and on other health needs. Adverse events following immunization are reported to the Food and Drug Administration by manufacturers, pharmacists, physicians, and the military, and to the Centers for Disease Control by the parents or guardians of children who receive federally funded vaccines. Although these reporting systems are useful, neither of them provides an adequate basis for estimation of the total number of events that occur, in part because reporting is voluntary. Even if reporting were mandatory, however, the data would not allow determination of the number of events actually caused by, rather than coincidental to, the administration of vaccines because information on similar events in unvaccinated individuals is not collected. Conclusions about cause and effect and rates of adverse reactions to vaccines should be drawn only from carefully designed and controlled epidemiological studies. Knowledge about the reasons for adverse reactions to vaccination and how to identify individuals who will respond atypically is incomplete. Hence, there is no way totally to avoid injuries caused by current vaccines manufactured according to approved procedures and administered in accordance with recommended medical practices short of the total suspension of vaccine use, which is unacceptable because of the increased risk of morbidity and mortality. Maintaining and extending awareness of contraindications to specific vaccinations among health care providers and the public are important in minimizing the potential for vaccine-related injuries. Every effort should be made to promote the availability to potential vaccine recipients (or their parents) of information on the risks and benefits of vaccination. Responsibilities for identifying vaccine-associated risks, pro- moting awareness of contraindications to vaccination, and completing all of the steps required for vaccine improvement are now poorly defined and coordinated. THE LEGAL SITUATION AND ITS CONSEQUENCES Under well-established legal principles, a vaccine manufacturer is

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9 not liable for injuries caused by a properly manufactured and labeled vaccine. In recent years, however, a few courts have acted contrary to these principles and found manufacturers liable for such injuries, possibly because the injured individual had been urged (or required) by the government to participate in the immunization program and appeared to have no other recourse for compensation. In general, these vaccine injury claims have been decided on the basis of the doctrine of the duty to warn. This doctrine provides that prior to the use of an unavoidably unsafe product, the user must be warned of the risks associated with it. In the case of medicines administered by health professionals, the courts generally have placed this responsibility on the health care provider. For vaccines, however, some courts have ruled that the duty to warn resides with the manufacturer, even though the manufacturer is not involved in administration. It is unclear whether the courts that have ruled in this fashion would permit the manufacturer to avoid such respon- sibility by obtaining a formal agreement from the purchaser stating that a warning would be given prior to administration. In two very recent cases (now on appeal), the plaintiffs prevailed by advancing theories of liability that went beyond the adequacy of the warning and asked juries to rule on issues of social benefit and harm, and on the underlying scientific factors that contribute to the basic public policy decision to use a particular vaccine. In one of these cases, punitive damages were awarded; however, punitive damages generally have not been a significant factor in vaccine-related injury litigation. The committee is not aware of any cases holding health care providers liable for vaccine injury, except in situations involving failure to follow accepted medical procedures. The committee does not presently recommend any change in the rules applicable to health professionals because liability for improper administration is appropriate;* it recognizes, however, that if any proposal limiting recovery against manufacturers were adopted without provision for reasonable compensation, lawsuits might be redirected from the manufacturer to the administering professional. This could have deleterious effects on the willingness of health care providers to participate in immunization programs. Such a situation would require careful monitoring. Tracking shifts in litigation and recommending remedial action would be one of the functions of the proposed vaccine commission {Chapter 7~. CONSEQUENCES OF THE STATE OF VACCINE INJURY LIABILITY LAW FOR VACCINE PRODUCTION AND INNOVATION Clear legal rules notwithstanding, the manner in which claims against manufacturers alleging liability for suspected vaccine-related *The committee recognized that malpractice claims, in general, represent a major concern of the medical profession, but it did not feel that the malpractice issue was within the scope of its charge.

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10 injuries have been handled by the courts does not provide reliable guidelines for predicting the limits and magnitude of their liability. This combines with other organizational and scientific factors to create a situation in which vaccine supply may be threatened. Causation is difficult, if not impossible, to determine with certainty in specific cases, and there is usually no other recourse to compensation for injured individuals. In the committee' judgment, this has led to a situation in which jurors and courts may be inclined to view tort awards as a means of providing compensation, irrespective of misconduct or scientific considerations. These circumstances require the manufacturer of a vaccine known to have certain adverse effects to engage in a gamble with very large financial stakes. If an increasing number of courts impose liability, the costs will be enormous, because claims average several million dollars per case. The only way to eliminate the risk is to stop manufacturing the vaccine. If the manufacturer chooses to continue to market the vaccine, its only options are to attempt to settle claims, a strategy that could produce a general expectation of liability, or to resist claims in litigation, with the risk that unfavorable outcomes could establish liability. The cost of either strategy will be high (even if claims are defended successfully) and will have to be passed on to consumers in price increases. To determine the exact nature of concerns over potential liability for vaccine-related injury, the committee conducted an informal survey of vaccine manufacturers. The goal was to solicit information (much of which was commercially sensitive) on the number and size of vaccine injury claims and settlements over the past decade, and on the provisions made by manufacturers for dealing with such eventualities (e.g., insurance). The committee received information from most major companies actively involved in vaccine production. The manner in which the information on these issues was available did not always permit comparisons or aggregation for publication (which was an agreed upon condition of providing such data). For these reasons, the information summarized below should not be taken as a totally comprehensive picture of the situation. At the time of the initial survey (spring 1984), 166 suits were pending against the four responding manufacturers. The total amount paid in settlements in the previous decade for completed cases (settled or finished with the appeal process) had been $2 million, and about another $1.8 million had been spent on legal defense, not in all cases including salary and expenses of "in-house" counsel. The information gathered in a follow-up effort (spring 1985) revealed that about 65 additional suits had been filed in the intervening year (only a few of the previous total had been settled, some for amounts averaging $1 million; some trial verdicts were on appeal). Legal costs for the 1-year period ranged up Lo n several million dollars" for some manufacturers. Time series information supplied by two manufacturers indicated a sharp increase in the number of claims filed: their experiences varied considerably, but the total number of reported claims filed against them in 1983 was more than twice that filed in 1980.

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11 Over the past two decades, pharmaceutical companies have been - withdrawing from vaccine manufacturing and marketing. Increasingly, the liability situation and its consequences (i.e., litigation costs or difficulty in obtaining insurance coverage) have been cited as major factors in the decision to withdraw. These decisions seem to indicate that present or anticipated vaccine-related injury liability expenses are seen as an unreasonable burden (or an unacceptably risky gamble) in relation to the costs of product development and the income from sales. Manufacturers are apprehensive that without some means of compensation for unavoidable vaccine injury and temporally related conditions, the present unclear state of the law will continue to allow them to be held liable for such conditions and penalized financially. The future behavior of the courts and the responses of the manu- facturers cannot be predicted with certainty, but the committee is concerned that the apprehensions themselves might have a negative effect. Earlier withdrawals from the market have created a situation in which the United States is almost totally reliant on one manu- facturer for polio and DTP vaccines (Lederle), and on another for measles, mumps, and rubella vaccines (Merck Sharp & Dohme). If apprehensions about the current unclear state of the law caused these manufacturers to withdraw, the vaccine supply and immunization programs could be jeopardized, leading to possible resurgence of these diseases. Also, the apprehensions discussed above are a disincentive to investment in the development of new (or improved) immunizing agents and to competition from new or foreign firms. Proposals to remedy the compensation and liability problems connected with vaccine injury are discussed below. A NATIONAL VACCINE COMMISSION The lack of a formal mechanism to promote cooperation in the innovation, production, and use of vaccines limits the benefits obtainable from existing immunization programs and hampers the development of new programs. The problems associated with the absence of such a mechanism are primarily those of omission rather than commission: they include delay or inefficiency in achieving desired outcomes and failure to tackle problems for which no existing group has direct responsibility. To overcome these difficulties, the committee recommends the establishment of a-national vaccine commission. This commission would monitor all aspects of immunization efforts in the United States. One of its primary responsibilities would be early identification of potential problems affecting vaccine supply. It also-would help to educate and inform the public, physicians, and government decision makers about the effects of various immunization actions and policies. When necessary, the commission would become an impartial broker to-promote the availability of needed vaccines and to coordinate collaborative activities for which no suitable mechanism exists.

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12 Based on its analysis of the options and its knowledge of the fate of previous recommendations, the committee favors establishment of the commission as a congressionally chartered, nonprofit corporation. However, certain other loci for its operations are not altogether incompatible with the purposes of the commission. The committee suggests that the vaccine commission should be supported at least in part by federal appropriations. It should report at least annually to the Congress and the President, and on other occasions if immediate action is required to avert threats to the public health. Recommendations for membership on the commission's board of directors should be sought from groups representing health care providers, lawyers, pharmaceutical manufacturers, the insurance industry, public interest organizations, universities, and the inter- national health community. Representatives of relevant government agencies would be appointed as liaison members. The mode of operation of the commission should be determined by the commission itself. Possible activities include monitoring the availability of existing vaccines; monitoring the need for improvement of existing vaccines and setting priorities in this area; monitoring vaccine innovation activities in the public and private sectors; monitoring the vaccine needs of developing countries and promoting efforts to meet those needs; evaluating the potential applications of advances in basic biotechnology to vaccine development; evaluating the application of knowledge from the behavioral sciences in the design of campaigns to promote vaccines; reviewing the effectiveness of pro- motional campaigns; monitoring and evaluating patterns of infectious disease as an aid to determining priorities; monitoring the training of personnel needed to ensure continued vaccine innovation; and monitoring and evaluating legal issues related to vaccine development and use. COMPENSATION AND LIABILITY FOR VACCINE-ELATED INJURY A variety of methods exist for dealing with the problems arising from vaccine-related injury, the most serious of which are the need to compensate injured individuals and the need to reduce deterrents to vaccine manufacturing. The committee evaluated eight individual options and two combined approaches from the range of possible actions--some address only one aspect of this complex situation and others address a broader range of issues. The 10 alternatives are: a supplementary (nonexclusive) compensation system a compensation system with restricted tort options mandatory claim review by a compensation board with tort option a vaccine supply public insurance program promotion of no-fault insurance for vaccine-related injury a supplementary compensation system and a vaccine supply public insurance program a vaccine supply public insurance program and promotion of no-fault insurance for vaccine-related injury

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13 . changes in the tort law relating to liability for vaccine-related injury (two examples are described) federal assumption of liability for all vaccine-related injury acceptance of vaccine price increases to cover liability costs The committee believes that the goal of advancing the control of infectious diseases with vaccines should be pursued in as just and fair a manner as possible. Those who respond to the government's promotion of or legal requirement for vaccination confer benefits on other members of society because they reduce the risk of disease in the community. If vaccination results in an injury, the injured individual should be certain of receiving rapid and adequate compensation. The common law tort system cannot be relied on to provide such compensation because each claim requires an extended, costly, and complex adjudicative procedure to establish liability. The results of these procedures are erratic and unpredictable, and therefore inequitable. The committee urges political decision makers to develop a compensation system for vaccine-related injury with the features outlined in this report. It also recommends that action be taken to reduce the serious deterrents to vaccine manufacturing and innovation that arise from the unpredictable nature of the current liability situation {such action should not shield those suspected of possible misconduct). The information and analysis presented in this report should help guide policymakers in the choice of appropriate solutions.