Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole.
Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter.
Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.
Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.
OCR for page 1
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
OCR for page 2
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
OCR for page 3
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.
OCR for page 4
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
OCR for page 5
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
OCR for page 6
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
OCR for page 7
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.
OCR for page 8
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
OCR for page 9
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.
OCR for page 10
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.
OCR for page 11
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.
OCR for page 12
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
OCR for page 13
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.
Representative terms from entire chapter:
vaccine development
