Member Article

Background

The legal and philosophical aspects relating to the concept of “ownership” with respect to human biological material of various kinds has been hotly debated. This an emotive topic and requires balancing societal and commercial interests and the rights of the individual, including the constitutionally enshrined right to bodily and psychological integrity, which includes the right not to be subjected to medical research or scientific experiments without the individual’s informed consent.

Common law

South African common law, based on Roman Dutch origins, provides that the human body is a thing outside the commercial sphere and so cannot be owned. On the other hand, separated biological materials are, at common law, considered res nullius, belonging to no one, until brought under the control of the first person who obtains possession of the separated biological materials. However, the common law can be legislatively superseded.

Statute

In South Africa, the National Health Act, 2003 (“NHA”), particularly chapter 8, together with the relevant regulations, governs the use of human biological materials, including genetic material and research with human participants. Although the NHA provides restrictions around the sampling and use of human biological materials which,inter alia, may not be removed without informed consent, may only be donated to prescribed institutions, and may only be used for restricted purposes, there are no provisions relating to 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 that removed the gamete, and after receipt of the gamete by the authorised institution that will effect artificial fertilisation, the gamete is owned by that institution. Alternatively, a gamete donated for artificial fertilisation of a spouse is owned by the donor spouse prior to artificial fertilisation, and after artificial fertilisation by the recipient spouse.

Altruism versus benefit sharing

It is important to note that the NHA and 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 for the reimbursement of reasonable costs incurred by him or her to provide such donation. Non-compliance with this provision amounts to an offence, for which a convicted person may be sentenced to a fine or imprisonment for not more than five years, 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 NHA 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 the participant must be provided with sufficient information that allows them to understand,inter alia, the nature and purpose of the research and use of their biological materials and they have the right to decide whether or not to consent to such use and to freely withdraw their consent to such use without penalty or reason.

Previously, it was unclear whether or not there was a requirement for additional informed consent to be obtained in respect of subsequent research performed by research institutions that were provided the human biological material from the research institute to whom informed consent had initially been given by the participant. However, in terms of the Material Transfer Agreement of Human Biological Materials (the “MTA”), published on 20 July 2018, informed consent is now required to be obtained 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 give permission for 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 utilised in heath research projects, as approved by the HREC from time to time.

Clause 10 of the MTA specifically requires that the providing institute must obtain informed consent from the human participant(s) to provide materials to the recipient institute to undertake the project and that should there be secondary use(s) 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 use(s).

Foreign precedent regarding ownership of human biological materials

The question of ownership of human biological materials has never been tested by the South African courts. It is possible that foreign case law may be considered by our courts should there ever be litigation relating to this subject in future, but there is no clear precedent based on foreign case law and so the outcome of any future litigation remains uncertain.

This article was first published on www.internationallawoffice.com.

Dr Joanne van Harmelen

patent attorney biotechnology IP [email protected] cell: +27 82 770 5396