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As technology advances, the laws surrounding human tissue use need to be reviewed

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Professor Letlhokwa George Mpedi is the Vice-Chancellor and Principal of the University of Johannesburg.

There are glaring gaps in the legislation regarding human tissue use that need to be addressed. For instance, regulations around human tissue research could be greatly improved to ensure more ethical approaches.

In 1801, the French anatomist Xavier Bichat introduced the concept of tissue as a central component of human anatomy in his book Anatomie Générale. By the 20th century, tissue had transformed from an object of analysis to a valuable resource for experimentation.

Tissue grafting took hold, and the tissue culture techniques were developed. By the 1980s, debates raged about the commodification of tissues against patient autonomy as the field of bioethics emerged. Subsequently, human tissue legislation has taken shape worldwide as a balance.

In the Fourth Industrial Revolution (4IR), we are seeing remarkable developments in reproductive technology, regenerative medicine and even the development of vaccines.

Yet, as Michael Sean Pepper and M Nőthling Slabbert assert, “human tissue legislation is complex. It is characterised by an ever-changing landscape in which advances in science and medicine need to be accommodated… However, it is generally accepted that the law has struggled to keep pace with advances in science and technology.” 

In South Africa, legislation governs the control and use of human tissue. In particular, the National Health Act of 2003 regulates human tissue use for medical, scientific or therapeutic purposes while protecting the rights of donors and their families.

Under the National Health Act, removing or using human tissue from a living or deceased person without their permission or the consent of their next of kin is illegal. The act also establishes a national system for the donation and transplantation of human organs and tissues, which the South African National Blood Service manages. It regulates human tissue storage, use and disposal for research and therapeutic purposes.

Regulation of embryo adoption could help ensure that all parties involved are fully informed about the process, the risks and benefits, and their legal rights and responsibilities.

The act also sets out rules for importing and exporting human tissue and prohibits buying and selling human organs or tissue. Similarly, under these laws, human tissue use is determined by a donor’s consent.

If a person has not been able to give consent or permission for tissue to be used for medical or scientific purposes before their death, then their next of kin can decide to donate their tissue. This provides a framework for the rights of donors and their families to ensure that human tissue is used for legitimate and ethical purposes.

Furthermore, it should be noted that the theft of and trade in human tissue, especially for use in traditional medicine or muti, is punishable by law. In addition to these laws, ethical guidelines established by the South African Medical Research Council govern the use of human tissue, with particular attention paid to informed consent, confidentiality and the protection of vulnerable populations.

Yet, as Pepper and Slabbert’s assertion suggests, the law is still lagging behind.

It is apparent that as technology progresses, there are glaring gaps in the legislation that need to be addressed. For instance, regulations around human tissue research could be greatly improved to ensure more ethical approaches.

As TL Beauchamp and JF Childress argue, there needs to be a framework in place for medical ethics that emphasises the autonomy and self-determination of the patient; calls for beneficence, or a moral foundation that considers the risks, costs and benefits to a patient; is non-maleficent and avoids causing harm; and a just and fair approach that ensures access and equality.

Additionally, there could be enhanced protection of donor rights, particularly around informed consent, confidentiality and privacy.

Moreover, there is scope to expand the definition of human tissue to stem cells or genetic material, particularly as technological developments gain pace. Currently, the National Health Act defines “tissue” as “human tissue, and includes flesh, bone, a gland, an organ, skin, bone marrow or body fluid, but excludes blood or a gamete”.

Recently, I wrote about embryo donation or adoption – the legal adoption of embryos donated and frozen by families. In the discussion around human tissue legislation, for example, no specific legislation in South Africa governs embryo adoption. This may create ambiguity and uncertainty for couples and individuals considering this option.

Read more in Daily Maverick: Medical progress is critical, but so are the ethics surrounding the harvesting and use of human cells

Regulation of embryo adoption could help ensure that all parties involved are fully informed about the process, the risks and benefits, and their legal rights and responsibilities. It could also establish standards for the screening of donors and recipients and the handling, storage and transfer of embryos. Such standards should align with the values and rights enshrined in the Constitution of South Africa.

As we explore the opportunities technology presents in the field, the law fraternity has to keep pace. As Pepper and Slabbert state, “legislation in its broadest sense should be seen as a permanent work-in-progress requiring ongoing review”.

This is how we continue to break barriers and explore the unknown ethically. DM

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