The legal and philosophical issues relating to the concept of ownership of various kinds of human biological material has been hotly debated. This is an emotive topic that requires balancing societal and commercial interests with individuals' rights, such as the constitutional right to bodily and psychological integrity, which includes the right not to be subjected to medical research or scientific experiments without giving informed consent.
South African common law, which is based on Roman-Dutch law, provides that the human body is outside the commercial sphere and thus cannot be owned. Conversely, separated biological materials are, under common law, considered to be res nullius (ie, belonging to no one) until brought under the control of the first party that obtains them. However, the common law can be legislatively superseded.
In South Africa, the National Health Act (61/2003), particularly Chapter 8, and the relevant regulations govern the use of human biological materials (including genetic material) and research with human participants. The act includes restrictions around the sampling and use of human biological materials – for example, they:
- cannot be removed without informed consent;
- can be donated only to prescribed institutions; and
- can be used only for restricted purposes.
However, there are no provisions concerning ownership or proprietary rights of human biological materials per se.
Only the regulations relating to the artificial fertilisation of persons deal with ownership. A gamete donated to an authorised institution for artificial fertilisation is first owned by the authorised institution which removed the gamete. After the gamete is received by the authorised institution which will effect artificial fertilisation, that institution takes ownership. Alternatively, a gamete donated for the artificial fertilisation of a spouse is owned by the donor spouse prior to artificial fertilisation. After artificial fertilisation, it is owned by the recipient spouse.
Altruism versus benefit sharing
Notably, the National Health Act and the relevant regulations specifically prohibit any person who has donated human biological material, including genetic material, from receiving any form of financial or other reward for such donation, except the reimbursement of reasonable costs incurred to provide such donation. Non-compliance with this provision amounts to an offence, for which a convicted person may receive a fine, up to five years' imprisonment or both. The regulations do provide for potential incentives or benefits to be provided to donors – including the possible provision of beneficial products or interventions post-research – but this should be carefully managed so as not to be considered a financial or other reward for the donation.
Informed consent relating to future research
The National Health Act and its regulations on research with human participants provide that it is necessary to obtain prior informed consent from a human participant about whom a researcher obtains data or specimens or identifiable private information through intervention or interaction with that person. This means that such a participant:
- must be provided with sufficient information that allows them to understand, among other things, the nature and purpose of the research and use of their biological materials; and
- has the right to decide whether to consent to such use and freely withdraw their consent without penalty or reason.
It was previously unclear whether there was a requirement for additional informed consent to be obtained in respect of subsequent research performed by research institutions that were provided human biological material from a research institute to which the participant had initially given consent. However, the material transfer agreement of human biological materials (MTA), published on 20 July 2018, must now be executed by all providing and recipient institutes of human biological materials for use in research or clinical trials under the auspices of the registered Human Research Ethics Committees (HRECs). This agreement defines 'informed consent' as a formal agreement that a donor (with legal capacity to do so) signs to permit the donation of human biological materials and related data after being informed about the project. This includes an ongoing information sharing process which allows the donor to consent to participate and determine whether and how their biological materials and data will be used in heath research projects, as approved by the HREC from time to time.
Clause 10 of the MTA specifically requires providing institutes to obtain informed consent from human participants to provide materials to recipient institutes to undertake a project and that, should there be secondary uses of their materials for research other than that consented to in the originally approved protocol, additional informed consent must be obtained by the providing institute for any such secondary uses.
The South African courts have never considered the question of ownership of human biological materials. They may consider foreign case law should there ever be litigation relating to this subject in future, but as there is no clear precedent in this regard, the outcome of any future litigation remains uncertain.
For further information on this topic please contact Joanne van Harmelen at Edward Nathan Sonnenbergs Inc by telephone (+27 21 410 2500) or email ([email protected]). The Edward Nathan Sonnenbergs Inc website can be accessed at www.ensafrica.com.
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