Affording patients the right to access experimental stem cell treatment: a comparative analysis of the legal and ethical consequences.

Abstract

Despite revolutionary advances in the medical field, with specific reference to stem cell technologies and therapies, South African laws do not adequately address gaps that currently exist when it comes to legally accessing the various forms of experimental therapy. The Constitution of South Africa does make provision for the right to access health care, however most stem cell therapies are not yet approved or registered by the relevant authorities and can therefore not be considered as accessible health care. Patients are increasingly becoming aware of their rights when it comes to health care which may be partially linked to the advances in, and knowledge of medical professionals diagnosing and treating auto immune and other previously incurable diseases. While conventional treatments yield positive results, there are a number of incurable and novel diseases that cannot be managed with approved treatments. Stem cell therapies, currently still in its experimental phase have shown some great promise in treating and managing various diseases. The fact of the matter is that that access to such experimental therapies is limited. The rationale behind this is reasonable and justified. The safety and interests of patients are protected by numerous laws and ethical principles as such, if the safety and efficacy of medical treatments have not been clinically proven, it is not in the patient’s best interests to be subjected to such treatment. However, the principle of patient autonomy does support the position that a patient should be able to choose whether or not he or she wishes to be subjected to experimental medicines, such as stem cell therapies or not, on condition that they are fully informed about the risk and consequences of doing so. Against this background, other countries, such as the United States, have enacted laws to address the lack of access to potentially lifesaving treatments. Considering that the benefits of stem cell therapies are becoming more and more evident, access to these therapies whilst not yet fully clinically approved and registered as a medicine or therapy, should, in certain circumstances, be an option for those patients who have exhausted all legally available medicine and treatments without success. Laws that afford access to experimental medicine are seen as both controversial and progressive. A balance must therefore be struck between the individual patient’s right to access and his or her safety. Although expanded access programs have been around for a while, the restrictive nature of these programs often does not necessarily result in access to experimental therapies. It is important that there are viable, legal and ethical ways to access experimental stem cell therapies, whether through right to try laws or through expanded access programs.