Gegenwärtige rechtliche Rahmenbedingungen für den Betrieb und die Nutzung von Biobanken: Teil 3: Eigentum und Nutzungsrechte

TY - JOUR

T1 - Gegenwärtige rechtliche Rahmenbedingungen für den Betrieb und die Nutzung von Biobanken: Teil 3: Eigentum und Nutzungsrechte

AU - Haier, J

PY - 2014/10

Y1 - 2014/10

N2 - The organizing institution of a biobank can be of public or private law in nature and the form can be freely selected. Biomaterials must be legally valued as objects whereby inalienable personality rights are still valid even if ownership is transferred. The treating physician does not automatically acquire a comprehensive right of ownership or utilization for the materials taken during the treatment. The biobank acquires tangible property and user rights on the samples by a legal agreement between the donor and the biobank. Reutilization clauses in submission contracts should not be used due to the danger of a formularization development and surprise clauses. During the processing of biomaterials within the biobank substantially new characteristics can appear which have an effect on ownership and commercialization rights. The donor does not have a utilization right in the sense of a patent or copyright. If there are changes in the legal form and the use by third parties, the declaration of consent by the donor remains fully effective. There are special risks for the donor if the biobank transfers these biomaterials. This must be clarified before finalizing the agreement on sample transference and utilization in the sense of an informed decision.

AB - The organizing institution of a biobank can be of public or private law in nature and the form can be freely selected. Biomaterials must be legally valued as objects whereby inalienable personality rights are still valid even if ownership is transferred. The treating physician does not automatically acquire a comprehensive right of ownership or utilization for the materials taken during the treatment. The biobank acquires tangible property and user rights on the samples by a legal agreement between the donor and the biobank. Reutilization clauses in submission contracts should not be used due to the danger of a formularization development and surprise clauses. During the processing of biomaterials within the biobank substantially new characteristics can appear which have an effect on ownership and commercialization rights. The donor does not have a utilization right in the sense of a patent or copyright. If there are changes in the legal form and the use by third parties, the declaration of consent by the donor remains fully effective. There are special risks for the donor if the biobank transfers these biomaterials. This must be clarified before finalizing the agreement on sample transference and utilization in the sense of an informed decision.

KW - Biological Specimen Banks

KW - Contracts

KW - Germany

KW - Humans

KW - National Health Programs

KW - Ownership

KW - Private Sector

KW - Public Sector

KW - Specimen Handling

KW - Technology Transfer

KW - Tissue Donors

U2 - 10.1007/s00104-014-2813-z

DO - 10.1007/s00104-014-2813-z

M3 - SCORING: Zeitschriftenaufsatz

C2 - 25148768

VL - 85

SP - 918

EP - 928

JO - CHIRURG

JF - CHIRURG

SN - 0009-4722

IS - 10

ER -