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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 ~clusrviy: 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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182 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.