What kind of financial transactions are legitimate for human biological samples? There is some uncertainty about the correct answer to this question. There are also some differences of opinion.
The Oviedo Convention
The Council of Europe’s Oviedo Convention (1997) is the first international legally binding instrument to protect human rights across the whole biomedical field. Article 21 of this high-level convention states that:
‘The human body and its parts shall not, as such, give rise to financial gain’.
Petrini and Ricciardi (2018) noted that people interpret article 21 in different ways. They suggest this is not due to any lack of clarity in the text. Instead, it is because people apply the convention to very different situations.
Evers et al. (2012) stated that ‘European law is based on principles that categorically prohibit selling parts of the human body’.
However, Lenk and Beier (2011) point out that:‘… the ban on commercialisation of body material is not as strict as it may appear at first sight, leaving room for the commercial practice of tissue procurement and transfer’.
Explanatory Report To The Oviedo Convention
An explanatory report supplementing the Oviedo convention states that: ‘… technical acts (sampling, testing, pasteurisation, fractionation, purification, storage, culture, transport, etc.) which are performed on the basis of these items may legitimately give rise to reasonable remuneration.’
Comment
Under European law, it is legitimate for biobanks to expect reasonable remuneration for human biological sample processing. So what is reasonable remuneration? Unfortunately, the law does not answer this question. However, a cost-recovery fee for sample supply must qualify as reasonable, because if a biobank were to charge any less, it would make a financial loss.
For more on biobank cost recovery and sustainability click here.
References
Petrini C, Ricciardi W. The Convention on Human Rights and Biomedicine twenty years later: a look at the past and a step towards the future. Ann Ist Super Sanita. 2018 Jul-Sep;54(3):171-173. doi: 10.4415/ANN_18_03_01. PMID: 30284541.
Evers K, Forsberg J, Hansson M. Commercialization of biobanks. Biopreserv Biobank. 2012 Feb;10(1):45-7. doi: 10.1089/bio.2011.0041. Epub 2012 Jan 17. PMID: 24849753.
Lenk C, Beier K. Is the commercialisation of human tissue and body material forbidden in the countries of the European Union? Journal of Medical Ethics 2012;38:342-346.
Other posts on this Biosample Hub blog include:
- Why Academic / Hospital Biobanks Should Provide Biosamples to Industry
- Ensuring Public Support For Biobank Cooperation With Industry
- The Main Actors Providing Biosamples To Industry
- Biosample Needs of Different Industry Players
- Acceptable Transactions in Biobanking
- What is Commodification?
- Why Biobank Access Policies Should Be Publicly Available
- Biospecimen Provenance: What Researchers Need To Know
