Why South Africa needs better laws for stem cell research and therapy

This article is part of a series The Conversation Africa is running on stem cell research and therapy. Read the rest of the series here.

South Africa has a patchy array of laws dealing with stem cells. While it does have legislation in place, like many other countries its laws have failed to keep pace with developments in science.

Many countries have implemented strict legislation that will govern how stem cells can be used. If South Africa wants to be a competitive player in the global stem cell research and therapy sphere, it must amend its laws to provide updated, modern and unambiguous legislation. The legislation must have appropriate context, detail and clarity to stipulate what is allowed and what is not.

Stem cells are classified as biological medicines since they have been derived from living organisms or tissues. They have been used for therapeutic purposes for several decades in South Africa and abroad. Recently research in the stem cell field in South Africa has seen a marked increase which is likely to be sustained.

South Africa has a National Health Act which provides a legal framework for the use of human tissues, including stem cells. It also has the Medicines Control Act, which defines the application of this framework in the clinical setting.

But the current legislation is not adequate. There are several important areas which remain unregulated. There is also a lack of harmonisation between the different pieces of legislation. And some of the definitions related to the technology are frankly incorrect.

Adult stem cells

Adult stem cells, which include those derived from the bone marrow, are regulated principally by Chapter Eight of the National Health Act. These are regularly used in bone marrow transplants for diseases such as leukaemia and myeloma.

The existing legislation covers the harvesting, storage, import and export and processing of stem cells.

But more detail is needed in the form of specific guidelines on harvesting, storage and processing as well as the clinical application of these cells.

Embryonic stem cells

Embryonic stem cells, which are harvested from a five-day-old embryo in a laboratory and can develop into any one of the 200 cell types in the body, are governed principally by sections of the National Health Act dealing with the human embryo. According to the act, the derivation and use of these cells is permitted only with ministerial authorisation.

Because they can develop into all the body’s cell types, embryonic stem cells have the potential to be used for the treatment of many diseases. Currently they are used in research and for drug screening. There are, however, a few clinical trials underway aimed at assessing the usefulness of these cells for the treatment of blindness.

Because human embryonic stem cells are obtained from a five-day-old embryo, and since this results in the destruction of the embryo, the harvesting of these cells has met with strong objections on religious, moral and ethical grounds.

Embryonic stem cells can be derived by several means – one of which requires fertilisation, also known as conception. The existing legislation covers this area. But another way to create these cells is by a process called somatic cell nuclear transfer, which does not require fertilisation.

Since the definition of an embryo in the National Health Act is “a human offspring in the first eight weeks from conception”, embryonic stem cells produced by a process which does not require conception are not regulated.

Induced pluripotent stem cells

Current legislation does not cover induced pluripotent stem cells, which are derived using a groundbreaking technology in which adult stem cells are reprogrammed to an embryonic stem cell-like state.

To date, induced pluripotent stem cells have been created from a wide range of cell types and differentiated into an equally broad range of cell types. These stem cells are used to understand disease processes and for drug discovery. One clinical trial has been initiated in Japan for the treatment of blindness, but this has been temporarily suspended.

Among the cell types that can be derived from induced pluripotent stem cells are gametes (egg and sperm). How this will be regulated is not clear, although the legislation does cover some aspects of gametes per se.

Other challenges

In addition to the legislative challenges around stem cells, there is the phenomenon of gene editing. Gene editing, which began more than a decade ago, involves changing the DNA of a cell in a laboratory. The idea behind the modification is to be able to remove or repair a mutation in the cells of people with genetic and other diseases including HIV, cystic fibrosis and immunodeficiencies, among many.

One of the limitations in the process of gene editing is the unknown degree of “off-target” effects, where in addition to the modification of the gene interest, other unintended sites in the genome are also modified. This may have negative consequences.

Gene editing is the focus of great deal of debate globally particularly in the context of germline engineering. The debate has resulted in scientists across the globe proposing a moratorium on germline editing in humans until the implications of this type of research are better understood.

In the South African context, there are only a limited number of researchers that are applying gene editing in the laboratory for [research purposes.

From a global perspective, there is virtually no legislation governing the application of this new technology in the clinical setting. It would however be good to initiate a debate on this topic in the country.

Improving stem cell regulation

In South Africa, patients are protected from possible harm from medical treatments including stem cell therapy through the rights enshrined in the Constitution. But detailed legislation defining the scope, limits and requirements for the everyday practice in the field of stem cell research and therapy is limited.

In addition, South African law in general does not address the problem of stem cell tourism, where bogus treatments are applied to vulnerable patients.

There is an urgent need to establish a national oversight and regulatory body to provide guidance on the legal regulation of stem cell research and cell-based therapy. This body would provide timely and effective input on matters that often require a prompt legislative response.

And although many of the country’s health practitioners engage in self-regulation, formal endorsement from the National Department of Health of the guidelines that have been established is needed.

This article based on a paper published in a special South African Medical Research Council Flagship edition of the South African Journal of Bioethics and Law.

Michael Sean Pepper receives research funding from the South African Medical Research Council, The National Research Foundation of South Africa and the National Health Laboratory Services Research Trust.

Janine Scholefield receives parliamentary grant funding and is supported by the Department of Science and Technology

Melodie Slabbert works for the College of Law, University of South Africa.

Robea Ballo receives funding from the South African Medical Research Council and the National Research Foundation of South Africa.