Case 8 - The Human Body as Replicator

Summary

A.1. CASE

Amelie underwent gene therapy. As a result of the successful treatment, she is now producing a protein in her bone marrow that is patented by the company Cellgene. Does Cellgene have the right to prevent Amelie from giving her blood away for free?

A.2. COUNTRY REPORTS

(1) BELGIUM

I. Operative Rules

No, Cellgene cannot prevent Amelie from giving her blood away for free.

II. Descriptive Formants

It is not allowed for donors to make profit by donating their blood, on the basis of Article 5 of the Blood and Blood Derivatives Act.

Therefore, it is excluded in any case that Amelie would be allowed to commercially exploit her blood.

However, depending on the specific circumstances of the case, it might be conceivable that Amelie’s donations would fall under the private use and the research exemptions, as expressed in Article 28(1)(a) and (b) BPA (Art. XI.34§1 a) and b) BCEL). In addition, with regard to the proteins produced by Amelie’s body, Cellgene’s patent might be exhausted on the basis of Article 10 Biotechnology Directive (Art. 27quater BPA, now Art. XI.32 BCEL):

The protection referred to in Articles 8 and 9 (Arts. XI.30 and XI.31 BCEL) shall not extend to biological material obtained from the propagation or multiplication of biological material placed on the market in the territory of a Member State by the holder of the patent or with his consent, where the multiplication or propagation necessarily results from the application for which the biological material was marketed, provided that the material obtained is not subsequently used for other propagation or multiplication.

Even if Amelie’s donations fall outside the scope of the exemptions above, Cellgene could not forbid her to donate blood.

III. Metalegal Formants

The right to self-determination over one’s body is a widely accepted principle in Belgium. It means that nobody can control someone else’s body, or that everybody has the right to freely use his/her body. This right is in no way absolute, but it does include the possibility of blood transfer/donation. Everyone has the right to choose to donate blood or not, provided he/she respects the provisions of the Blood and Blood Derivatives Act.