Legal Q&A: Can Human Biological Samples be sold?

BBMRI.at Legal Helpdesk Service answers

The BBMRI.at Legal Helpdesk Service – operated by legal experts from BBMRI.at partner UNIVIE- answers questions on legal and regulatory matters around biobanking and/or using biological samples and data. This service is offered to BBMRI.at partners to support them, as biobanking and research using biological samples and data (e.g. human, animal/veterinary, microbial, etc.) may raise legal questions. Answers provided by UNIVIE to legal questions are published in the BBMRI.at Knowledge Base.

QUESTION:

LEGAL Q&A: Can Human Biological Samples be sold?

ANSWER:

International European Union and Austrian Law

Biobanks, as custodians of samples and data of participants in research projects, must comply with general principles that govern scientific research in the European Union (EU). For example, the Charter of Fundamental Rights of the European Union (CFREU), specifically article 3(2)(c), sets out the prohibition on making the human body and its parts a source of financial gain.

Other legally binding international treaties such as the Oviedo Convention^[1] – namely article 21 of this international treaty – also sets out a prohibition of financial gain from the human body and its parts. Despite Austria not being a signatory State of the Convention – thus making it unapplicable in this country – the document helps set the scene for the global context of the permissibility of selling human biological samples.

Other EU legislation, such as the Tissues and Cells Directive^[2] “[…] does not cover research using human tissues and cells, such as when used for purposes other than application to the human body” (recital 11, emphasis added). Nevertheless, for biobanks who store tissues and cells intended for human application, it is worth noting that article 12(2) of the Directive defines, as one of its principles governing tissue and cell donation, that “[…] Member States shall endeavour to ensure that the procurement of tissues and cells as such is carried out on a non-profit basis.” (emphasis added).

The SoHO Regulation[3] (due repeal the Tissues and Cells Directive, in accordance with article 85 of the act) is in line with this general principle. It maintains that the SoHO Regulation “[…] is not meant to cover research using SoHO when that research does not involve human application […]” (recital 60, emphasis added). Nevertheless, “[…] the donation of SoHO that will be exclusively for use in research without any human application should also comply with the standards concerning voluntary and unpaid donation set out in this Regulation” (recital 60, in fine). This reinforced within the body of the legal act, specifically in article 54(6).

However, these provisions (both EU and international) are only applicable “[…] between the first transferor (donor) and the first transferee […]”^[4], i.e., the prohibition of financial gain “[…] only concerns the human body and its parts, ‘as such’, which, according to the established interpretation, is an expression that refers to the human body and its parts when they have not been object of transformation”^[5]. The prohibition of financial gain would not apply if a biobank transformed or processed a human biological sample and transferred it to another biobank or research institution^[6].

As for the selling of samples between donors and biobanks (or other first transferees, for research purposes or commercial purposes thereof), there are legal arguments – namely based in the right to exercise private autonomy – to sustain the interpretation that a financial gain benefiting the donors would not be untoward^[7].