Opinion on Ethical Aspects of Patenting Inventions Involving Elements of Human Origin, Group of Advisers on the Ethical Implications of Biotechnology of the European Commission, Opinion No. 9 (May 28, 1997), reprinted in 49 International Digest of Health Legislation 406 (1998).

Requested by the Commission in April 1996.

Rapporteurs: Professor Gilbert Hottois and Professor Dietmar Mieth

Introduction

Following a Commission request, GAEIB examined the proposed Directive relative to the legal protection of biotechnological inventions (adopted on 13 December 1995), limiting itself to the case of inventions issued from elements of human origin.

At stake are the ethical principles of non-commercialization of the human body and the free and informed consent of the person from whom the samples are obtained, on the basis of which the invention will be developed.

The issue of the distinction between discovery (not patentable following patent law) and invention (patentable) concerning the application of knowledge related to the human body or its elements is raised on both ethical and technical grounds.

Extract

'... the simple knowledge of the complete or partial structure of a gene cannot be patented ... from the usual conditions of patentability, but also from the ethical principle of non-commercialization of the human body ... no patent can be given on the human body or on its elements ... no remuneration to the person from whom the samples are retrieved can be allocated ... . An invention based on the use of elements of human origin, having been retrieved without respecting the principle of consent will not fulfil the ethical requirements ... the granting of a patent is acceptable only if, on the one hand, the [invention] allows new possibilities ... and, on the other hand, if the intended use of the patent is sufficiently specific and identified ... . The affirmation of the citizen's rights in the European Union implies that the economic advantages derived from biotechnological developments should in no way affect the respect of ethical requirements ... .'