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Appendix
E
VACCINE-INJURY COMPENSATION IN OTHER COUNTRIE S
This appendix describes vaccine injury compensation programs in
Denmark, the Federal Republic of Germany, France, Japan, Switzerland,
and the United Kingdom. The information was obtained either from
foreign government responses to a questionnaire designed by the
committee, or from information presented in a working paper from a
study titled "Comparison of Compensation Programs for Vaccine Injury,
conducted by Wendy K. Mariner of the Harvard University School of
Public Health. Professor Mariner's assistance is gratefully
acknowledged by the committee.
DENMARK
Compensation for Individuals Injured by Vaccines Act; Lovtidende,
March 8, 1978, No. 82, pp. 305-306
This act of 1978 provides "compensation to a person or dependents
for damages which in a reasonable probability may be considered caused
by a vaccination performed in Denmark against a disease included in
the Free Vaccination Against Certain Diseases Act." Characteristics
of the system include:
Vaccines covered: whooping cough, diphtheria, tetanus, polio, and
tuberculosis.
Compensable injuries: injuries that result in deterioration or
permanent loss of working ability, or death.
Eligibility requirements: not specified in statute.
Type of compensation: medical expenses for treatment,
rehabilitation aids, etc.; compensation for loss of working ability
and "lasting harm"; interim benefits for dependents; and compensation
for loss of provider.
Amount of compensation: not specified in statute but may be either
lump sum or periodic payments.
Exclusivity: nonexclusive; civil court remedy available independently.
State subrogation: not specified in statute.
Administrative entity: Danish Sikringsstrylrelse of the National
Social Security Office.
176
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177
Source of funds: general revenue.
.
Claims procedures: claims presented to Sikringsstrylrelse. All
.
physicians required to report probable injuries. The decision of the
Social Security Office may be brought to the Board of Social Appeal.
Proof of causation: probable consequence.
Between 1978 and 1983, 10 claims were made: 3 for smallpox, 1 for
whooping cough, 1 for BCG, one for DTP, 1 for tetanus, and 1 for
polio. Six were approved; those not approved included 1 for smallpox
and the 3 for whooping cough.
FEDERAL REPUBLIC OF GERMANY
Law on the Prevention and Control of Communicable Diseases in Man
Sections 51-62, December 18, 1979. Bundesgesetzblatt, Part I, No. 75,
pp. 2262, December 22, 1979, Corrigendum; Bundesgesetzblatt, Part I,
No. 6, p. 151, February 22, 1980
Legislation pertaining specifically to compensation for vaccine
injury is included in a larger statute that involves the control of
infectious disease (the Federal Communicable Diseases Act). Many of
the provisions in the legislation regarding administrative procedures
are dictated by another statute, the Federal Social Assistance Law.
The compensation program is administered by authorities in each Land,
the political subdivisions in the Federal Republic of Germany.*
Characteristics of the system include:
Vaccines cover _: mandatory and recommended vaccines.
Compensable injuries: adverse postvaccinal effect, defined as any
impairment to health exceeding usual extent of a postvaccinal reaction
and involving a live virus vaccine; impairment to health resulting
from contact with another person vaccinated with a live virus vaccine;
impairment to health resulting from accidents during traveling to or
from treatment.
Eligibility requirements: compensation is provided for a
compensable injury resulting from a vaccine that is required by law or
recommended by competent authority; ordered pursuant to the Act; or
required for reentry into country.
Type of compensation: social assistance for health and economic
consequences of injury or death benefit to survivors of victim of
· · .
vaccine Danbury.
Amount of compensation: pensions to be uniform with Federal Social
Assistance Act.
~-
*Mariner, W. 1985. Working Paper No. 1. "Preliminary Typology of
Vaccine Compensation Legislation." From the study "Comparison of
Compensation Programs for Vaccine Injury." Harvard School of Public
Health, Boston, Mass.
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178
Exclusivity: not indicated in the statute.
State subrogation: state subrogated to rights of victim against
third parties for the amount of social assistance provided.
Administrative entity: Lands or administrators of the Federal
Social Assistance Act.
Source of funds: pensions shall be paid by authorities responsible
for implementing the Federal Pension Law. Local responsibility is
determined by Land government authorities.
Claims procedures: according to Federal Social Assistanc e
· ~ ~ ~ ~
provisions, wit ~ some variations.
Proof of causation: probable cause.
FRANCE
Public Health Code; Article L.10-1, Law No. 64-643 of July 1, 1964,
as amended by Law No. 75-401 of May 26, 1975, Journal Officiel de la
Republique Francaise, July 2, 1964, pp. 5762-5763, May 27, 1975, p.
5267. The entire text of the law states:
Without prejudice to actions that could be instituted in
accordance with the corrunon law, the compensation of all damage
d irectly ascribable to a mandatory vaccination administered in
accordance with the [public health] code is paid for by the
State.
Up to the amount of the indemnity it has paid, the State
is, if applicable, subrogated to the rights and actions of the
victim against those responsible for the damage.
Characteristics of the system include:
Vaccines covered: mandatory pediatric or adult vaccines
administered in accordance with public health law ("accordances
elsewhere includes only iIIununizations given by a physician or, in some
cases, a midwife).
Compensable injuries: all damage directly attributable to
vaccination.
Eligibility requirements: as specified by type of vaccine
(mandatory) and circumstances of immunization (in accordance with
Public Health Code).
Type of compensation: not specified in statute.
Amount of compensation: not specified in statute.
Exclusivity: nonexclusive as expressly stated in statute.
State subrogation: France may succeed to the rights of the injured
party against any third party liable for damages to the extent that it
has paid compensation to the injured party.
Administrative entity: tribunals resolve disputes over claims.
Source of funds: not specified in statute.
C1 aims procedures: not specified in statute.
Proof of causation: not specified in statute, but probably
l
according to civil law liability rules.
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179
JAPAN
The Preventive Vaccination Law: the Vaccination Act of June 30,
1948, 68 Ministries of the Treasury and Welfare
The Preventive Vaccination Law was amended in 1976 to provide
relief for injury in cases in which, "through no fault of doctors or
other personnel, extremely rare cases of unavoidably [sic] abnormal
side effects result from preventive vaccination." Characteristics of
the system include:
Vaccines covered: all vaccines for diseases specified in Japan's
Preventive Vaccination Act and TB Central Law: pertussis, diphtheria,
poliomyelitis, measles, rubella, tuberculosis (BCG), influenza,
Japanese B encephalitis, Weil's disease, cholera, and smallpox.
Compensable injuries: satisfaction of one of the following: an
unusual reaction caused (or suspiciously caused) by vaccination;
sequelae resulting from a reaction caused (or suspiciously caused) by
vaccination; or death resulting from a reaction caused (or
suspiciously caused) by vaccination.
Eligibility requirements: injury or death as a result of mandatory
vaccination.
Type of compensation: compensation includes medical and/or funeral
expenses, disability pension, annuity for person caring for disabled
individual, and a death benefit.
Amount of compensation: no specified limitation.
E ~clusrvi·y: none~clus ive; tort law remedies available.
State subrogation: not indicated in statute.
Administrative entity: committee appointed by Minister of Health
and Welfare. Local governments also may have judgment committees.
This would enable an injured person to receive compensation from local
and/or national government.
Source of funds: national treasury (50 percent), prefectures (25
percent), and municipalities (25 percent).
Procedure for filing claims: claims are adjudicated by a committee
to determine whether a causal relationship exists between injuries and
vaccinations. The committee consists of experts from the fields of
pediatrics, psychopathology, neuropathology, and immunology.
Proof of causation: judgments are based on available clinical
information, interval between vaccination and onset of illness, and
report in literature of similar adverse reactions.
From 1977 to 1981 the following claims were made:
diphtheria - 1
diphtheria, tetanus - 13
diphtheria, pertussis, tetanus - 46
polio - 15
measles - 33
rubella - 1
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180
· influenza - 68
· Japanese encephalitis - 32
· tuberculosis (BCG) - 17
Of these 226 cases, 167 were approved, 45 denied, and 14 were
pending as of 1983.
SWITZERLAND
Federal Law on the Control of Communicable Diseases in Man,
December 18, 1970, 818.101
Swiss Federal Law provides for cantons (Swiss political
subdivisions corresponding to states in United States) to establish
compensation for injuries resulting from either required or officially
recommended immunizations. Cantons establish their own procedures to
carry out this federal mandate. Compensation may be denied if it is
available from another source.* Characteristics of the system include
Vaccines covered: mandatory or officially recommended (by cantons)
· ~
vaccinations.
Compensable injuries: all lesions arising subsequent to
vaccination (excluding self-inflicted injury).
Eligibility requirements: not specified other than by type of
vaccine (mandatory or officially recommended).
Type of compensation: not specified in statute but does indicate
that compensation may be denied if it is available from another source.
Amount of compensation: not specified in statute.
Exclusivity: not indicated in statute.
Administrative entity: cantons establish procedures to administer
program.
Source of funds: funds are provided by cantons, which receive a
federal subsidy of 20 to 25 percent of their expenses.
Claims procedures: not specified in statute.
Proof of causation: not specified in statute.
UNITED KINGDOM
Vaccine Damage Payments Act 1979; 1979 C. 17; Current Law Statutes
Annotated, 1979, pp. 17-17/13
*Mariner, W. 198S. Working Paper No. 1. "Preliminary Typology of
Vaccine Compensation Legislation. n From the study "Comparison of
Compensation Programs for Vaccine Injury. Harvard School of Public
Health, Boston, Mass.
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181
Characteristics of the system include:
Vaccines covered: vaccines for the following diseases:
diphtheria, tetanus, whooping cough, poliomyelitis, measles, rubella,
tuberculosis, smallpox (if received prior to its discontinuance on
August 1, 1971), and any other disease specified by the Secretary of
State.
Compensable injuries: injuries from vaccination resulting in
severe disability (80 percent or more as described by established
rules).
Eligibility requirements: persons who incur severe disability
after vaccination against specified diseases; as the result of a
vaccination given to his or her mother before his or her birth; or as
the result of a disease contracted through contact with a vaccinated
person if contact occurred after 4 days but before 60 days following
vaccination and the disabled person was caring for or was being cared
for by the vaccinee. The requirements also state that the person must
have received the vaccination in the United Kingdom or the Isle of Man
on or after July 5, 1948 (before August 1, 1971 for smallpox); was
less than 18 years of age (except polio and rubella), or was
vaccinated during an outbreak; or was more than 2 years of age on date
claim was made, or died after May 7, 1978 and was more than 2 years of
age when death occurred.
Type of compensation: flat-rate, lump sum; not considered
compensation for damages incurred but rather a benefit.
Amount of compensation: £10,000.
Exclusivity: injured persons may pursue civil remedy. However,
amount of any payment received by compensation scheme will be deducted
from court award. No claim considered if payment was made prior to
passing of statute. For claims denied by tribunals, an application
for reconsideration may be made within 6 years of date of
determination.
State subrogation: see above.
Administrative entity: Department of Health and Social Security
(DHSS) under Secretary of State.
Source of funds: public funds.
Claims procedures: claims must be made within 6 years of the
latter of these dates: the date on which the disabled person reached
the age of 2, the vaccination date, or May 9, 1978. Claimant must
provide information and evidence necessary to determine claim and must
undergo a medical examination by a physician appointed by the
Secretary of State or by a tribunal to determine relationship between
disability and vaccine (claims are adjudicated by DHSS physicians).
Claims denied at stage 1 are referred to a vaccine damage tribunal
appointed by the Secretary of State that consists of a lawyer as
chairperson and two medical practitioners. Determinations require a
majority tribunal vote and hearings are public unless otherwise
excepted. Tribunal decision sent in writing to claimant. Any person
making a fraudulent claim is liable for £1,000 fine (£400 in Isle of
Man).
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Proof of causation: determined on "balance of probability."
As of early 1983, 2,868 claims had been received. Most of these
were related to vaccinations containing a pertussis element, usually
in combination with one or more other vaccines. Of these claims, 370
awards were granted at stage 1 for the following: 165 against DTP, 64
against DTP and polio given concurrently, 63 against smallpox, 23
against measles, and 55 against other vaccines or combinations of
vaccines.
Representative terms from entire chapter:
social assistance
