Opinion on Products Derived from Human Blood or Blood Plasma

Opinion on Products Derived from Human Blood or Blood Plasma, Group of Advisers to the European Commission on the Ethical Implications of Biotechnology, Opinion No. 2 (Mar. 12, 1993)

Own initiative.

Rapporteur: Professor Margareta Mikkelsen
Introduction

In 1989 the European Community adopted a directive on medicinal products derived from human blood or human plasma. The directive triggered protests in France.

By referring to human blood and human plasma as starting material and blood derivatives as 'medicinal products', the Directive appeared to make them tradeable goods, which conflicted with the principle that the human body was not a marketable commodity and offended human dignity.

Extracts

' The following ethical principles should be stressed in the Directive:

* the donee's health (availability and quality of blood supplies);
* the donor's human dignity (anonymity, voluntary donations);
* non-marketability of the human body (donations to be unpaid) .

The expression "medicinal products" as applied to products derived from blood should not be rejected as these products are used as therapeuticals, and this term gives a guarantee of quality to the products through the authorization process related to medical products.'