In several European jurisdictions, as in the United States, discussions are ongoing concerning compensation for patients who have contracted the hepatitis C virus (HCV) via the administration of blood or plasma-derived medicinal products. Patients' groups have asked that state compensation schemes be established along the lines of those created in some countries as a consequence of HIV (human immunodeficiency virus) infections caused by blood products in the early 1980s (some of which have required that significant contributions be made by pharmaceutical companies). Patients have sought settlements from the pharmaceutical companies which manufactured HCV-infected products, and have simultaneously initiated civil, criminal or administrative proceedings in order to exert pressure on the companies and on public authorities.

In Germany, patients' groups have not generally had any significant success in this regard. Pharmaceutical companies and government bodies have been reluctant to acknowledge responsibility, because of a lack of scientific knowledge concerning HCV in the 1970s and early 1980s, when most infections occurred (the virus was only identified in 1989), and because there were then no virus inactivation procedures available that would have effectively countered HCV.

As of August 2 2000, however, one specific group of HCV-infected patients in Germany has been able to claim compensation under the Act on Assistance for Patients Infected with the Hepatitis C Virus by Anti-D Immunoglobulins, which was enacted with retroactive effect on January 1 2000. In 1978 and 1979 in the former German Democratic Republic (GDR), a large number of women were infected with HCV as a result of compulsory post-partum administration of anti-d immunoglobulins, which were intended to offset any blood group incompatibilities between mother and child. Tests on frozen samples revealed that 15 batches of the immunoglobulin produced by the Bezirksinstitut für Blutspende und Transfusionswesen in Halle, a public body of the GDR, were contaminated with HCV. (The injections were administered with knowledge of their infectious character, and criminal charges were brought against doctors by former GDR prosecutors.) Today, approximately 2,300 people still suffer from infections linked with the receipt of this treatment. The legislation was enacted for their benefit.

The act provides for annuities and reimbursement of health care costs, as well as pensions and lump sum payments, for infected patients, "contact persons" most likely infected by them, and dependants. 'Contact persons' are defined as children born after infection, stepchildren, adopted children and children in care, as well as husbands and partners or any other children who belonged to the household of the infected parties for a period of time which is deemed to be "more than temporary". Where an annuity is claimed, the maximum amount payable per month is currently Dm2,000.

Pensions and lump sum payments are granted only where the infection has reduced the person's ability to work. Lump sum compensation may range from Dm7,000 to Dm30,000, the amount being contingent on the extent to which the individual's working ability has been impaired. Pensions of between Dm600 and Dm1,000 per month may be claimed by dependants (spouses or children) of deceased infected patients. In the case of spouses they must be claimed within 60 months of the infected person's death. Children will be supported until the age of 18 or until they have completed their education, at the latest by their 27th birthday.

The costs of compensation under the act are borne jointly by the Federal Republic of Germany (50%), the states in which the immunoglobulin was administered (12.4%) and the former western states (37.6%), with the exception of lump sum payments, which are borne by the Federal Republic of Germany alone (approximately Dm15 million in total).

Claims under the act must be brought before the competent authority in the state in which the claimant resides. Any legal disputes arising out of the claim, for example where the relevant authority refuses the claim or fails to make a timely decision, are to be brought to the social courts. Although payment of a claim under the act does not expressly bar other claims against the manufacturer of the immunoglobulin, or against physicians, hospitals, states or the Federal Republic, such claims would most likely be barred in any event as a result of the expiry of the three-year statutory limitation period.

For further information on this topic please contact Ina Brock or Detlef Hass at Lovells by telephone (+49 89 290 120) or by fax (+49 89 290 12 222) or by e-mail ([email protected] or [email protected]).

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