Enshrined in the Bill of Rights of South Africa's Constitution are a number of rights that affirm the democratic values of human dignity, equality and freedom. Section 9(3) states that 'The state may not unfairly discriminate directly or indirectly against anyone on one or more grounds, including race, gender, sex, pregnancy, marital status, ethnic or social origin, colour, sexual orientation, age, disability, religion, conscience, belief, culture, language and birth.' Despite these rights, which are also embodied in policy and law at the highest levels internationally, lesbian, gay, bisexual, trans-gender and intersex (LGBTI) people are subjected to discrimination, abuse, violence and even death because they do not fit into the expectations of what certain sectors of society consider to be the 'norm'. ; http://www.samj.org.za ; am2016 ; Immunology
Enshrined in the Bill of Rights of South Africa's Constitution[1] are a number of rights that affirm the democratic values of human dignity, equality and freedom. Section 9(3) states that 'The state may not unfairly discriminate directly or indirectly against anyone on one or more grounds, including race, gender, sex, pregnancy, marital status, ethnic or social origin, colour, sexual orientation, age, disability, religion, conscience, belief, culture, language and birth.' Despite these rights, which are also embodied in policy and law at the highest levels internationally, lesbian, gay, bisexual, transgender and intersex people are subjected to discrimination, abuse, violence and even death because they do not fit into the expectations of what certain sectors of society consider to be the 'norm'.
The South African (SA) legislative framework follows a hierarchical structure aligned with the relevant level of government (national, provincial or local) responsible for applying and monitoring the legislation, with the overarching and progressive Constitution as the supreme law. Delegated legislation (also known as secondary or subordinate legislation, e.g. regulations) 'adds flesh' to Acts of Parliament, or other forms of original legislation. The control and use of human tissue in South Africa is primarily governed by the National Health Act and relevant regulations, although other national acts, in differing degrees, are also relevant to this complex field. These include, among others, the Medicines and Related Substances Act, the Consumer Protection Act, the Children's Act and the Inquest Act. Regulations generally only require ministerial and not parliamentary approval and are therefore (theoretically) easier to amend. In principle, the drafting of Acts should be preceded by policy documents, which contain broad foundational guidelines or a statement of intent in the area in question. Another useful source in the interpretation of legislation, albeit not officially recognised as legislation, is guidelines (sometimes referred to as standards), that may provide greater granularity than the regulations. Although neither policy documents nor guidelines are directly legally binding, a lack of compliance with the latter may have legal significance. In this article, the components of the hierarchical structure relevant to the legal regulation of human tissue in SA will be examined, with a specific focus on stem cell research and therapy. A critical analysis of the accuracy, relevance, redundancy and completeness (or lack thereof) of these components will be provided. Furthermore, recommendations outlining the procedures that should be undertaken to remedy the inadequacies of the current legislative framework will be suggested. Given the well-defined structure of this framework and the relative youth of human ...
Stem cell research and its potential translation to regenerative medicine, tissue engineering and cell and gene therapy, have led to controversy and debates similar to the calls nearly 25 years ago for a ban involving recombinant DNA. Global legislative efforts in this field have been characterised by many legal, ethical and practical challenges, stemming from conflicting views regarding human embryonic research and cloning. National policy and regulatory developments have primarily been shaped by different understandings of relevant scientific objectives, as well as those relating to the moral and legal status of the human embryo, which have been used to justify or limit a range of permissible activities. Legal obscurity in this field, a consequence of inconsistent or vague legislative responses at a national and international level, leads to negative results, which include, among others, ethical violations; lack of collaboration and co-operation among researchers across national borders; stunted scientific progress; lack of public trust in stem cell research; proliferation of untested 'stem cell therapies'; and safety issues. The purpose of this article is to explore the legal regulation of stem cell research and therapy globally, by comparing the permissibility of specific stem cell research activities in 35 selected jurisdictions, followed by a comparison of the regulatory approaches with regard to stem cell-based products in the European Union and the USA. A clearer understanding of the global regulatory framework will assist in formulating more effective legal responses at a national level and in navigating the uncertainties and risks associated with this complex and evolving scientific field. ; The Medical Research Council of South Africa in terms of the MRC's Flagships Awards Project SAMRC-RFA-UFSP-01-2013/ STEM CELL. ; http://www.sajbl.org.za ; am2015
The rate of mortality in developing countries due to communicable disease remains alarmingly high. The leading contributors to disease burden in these regions are the so-called "big three", namely HIV/ AIDS, TB, and malaria. The global prevalence of these diseases is over 250 million, and it should be noted that 71%, 28% and 88% of these cases, respectively, occur in sub-Saharan Africa alone (World Health Organization). African countries are continuously struggling to contain infectious diseases, and there is a need for governments to commit resources not only for treatment, but also towards research and development aimed at innovative approaches. ; The Institute for Cellular and Molecular Medicine and a Vice-Chancellor's post-doctoral bursary from the University of Pretoria. ; http://www.elsevier.com/locate/atg ; am2017 ; Immunology
Diseases resulting from mutations in mitochondrial DNA (mtDNA) are inherited by all offspring through the maternal lineage. Multiple organs are severely affected, no preventative treatments are available and most patients experience a poor quality of life or early death. With developments in mitochondrial transfer techniques, hope for preventing transmission of mutated mtDNA onto offspring is emerging. Many ethical issues have been raised regarding such treatments, which involve transfer of nuclear material into donated oocytes with healthy mitochondria, or the introduction of healthy donor mitochondria into affected oocytes. Blastomere, ooplasmic, pronuclear and spindle transfer have been explored. Ethical concerns relate to (a) the alteration of germ line genetics and (b) the dilemma of children inheriting DNA material from three instead of two parents. In contrast to gene therapy, where only the DNA of the treated individual is altered, these techniques involve the introduction of foreign mtDNA into the germ line that will be inherited by all children in downstream generations. Mitochondrial transfer has also been closely associated with reproductive cloning, which is regulated differently worldwide. Children born from these techniques might experience an identity crisis. Although three gametes are needed to produce a healthy embryo in this scenario, the child will inherit all nuclear DNA from the intending parents, while only inheriting mtDNA from the donor. Social and scientific values must be considered when introducing new healthcare technology. Many believe that some assisted reproductive technology techniques go beyond the limits of acceptable medical intervention. But who ultimately decides what is acceptable? We address the ethical and social issues surrounding this emerging new technology, legal developments regarding its clinical introduction in the UK and the USA, the future impact on technique and patient management, and relevant legislation in South Africa. ; The Medical Research Council of South ...
The debate over whether there should be a property or non-property approach with regard to human tissue is only the tip of the iceberg, because the issues involved are very complex, reflecting profound considerations on the nature of the self and the structuring of society; the balance of power between the citizen, the government and commercial interests; and human beings' perceptions of themselves and their bodies. This article responds to a publication by Donrich Jordaan titled 'Social justice and research using human biological material: A response to Mahomed, Nöthling-Slabbert and Pepper' in the July 2016 SAMJ. The original article to which Jordaan's critique refers and that provides the source for his response appeared in the South African Journal of Bioethics and Law in 2013, titled 'The legal position on the classification of human tissue in South Africa: Can tissues be owned?'. It is our contention that Jordaan's critique is based on a misinterpretation of the issues raised relating to the ownership of human tissue, an issue extensively debated in the academic sphere for many years. Jordaan's critique focuses on selected aspects of the original article and draws unjustifiable inferences from these. The purpose of this article is to contextualise Jordaan's critique and reaffirm the validity of the arguments made in the original article in 2013. There are, however, certain aspects of Jordaan's critique that we as authors of the original article acknowledge and appreciate in the spirit of academic discourse. ; http://www.samj.org.za ; am2017 ; Immunology
The past few years have seen a sharp rise in the propagation of unproven stem cell 'treatments', also known as 'stem cell tourism'. Patients suffering from a variety of diseases unresponsive to conventional medical therapy often travel to certain destinations to receive these therapies, mostly from bogus operators advertising various 'stem cell treatment cures' for a wide range of conditions, and in the process mislead vulnerable patients with unfounded promises of recovery. Stem cell tourism, made possible by legal lacunae or weak national regulatory frameworks, raises grave legal and ethical concerns, as patients not only receive treatments which are unproven, but often also unregulated, potentially dangerous and fraudulent. Existing proven therapeutic applications using stem cells are limited to those for blood and immunological disorders and are based on clinical trials that have demonstrated the efficacy and safety of these applications. As a result of weak legislative enforcement in this area, South Africa has unfortunately become an attractive destination for fraudulent stem cell operators. The purpose of this article is provide an update on the South African legal position relating to stem cell therapy by evaluating the effectiveness of the Medicines and Related Substances Act and other relevant legislative provisions in regulating cell-based therapies, drawing strongly on recent international developments and case law in this field. The article will make specific recommendations aimed at improving the existing position. ; The Medical Research Council of South Africa in terms of the MRC's Flagships Awards Project SAMRC-RFA-UFSP-01-2013/ STEM CELLS. ; http://www.sajbl.org.za ; am2015
South Africa (SA) is a country of contrasts, with abundant resources, hard-won civil rights and a diverse population. Woven into the fabric of our society is a large divide between its poorest and its wealthiest members. In this article we highlight the vulnerabilities in our society that have been amplified by the COVID-19 crisis. Based on recent projections, it is very likely that the healthcare system will be overwhelmed. We acknowledge the recognition by government and civil society of these vulnerabilities, and note that difficult decisions will need to be made with regard to resource allocation. Our plea, however, is to ensure that human dignity and the principle of distributive justice are maintained, and that when difficult decisions are made, vulnerable people do not suffer disproportionately. Furthermore, it is of great concern that there is no national directive guiding resource allocation, prioritisation and triage decisions in both public and private hospitals. The Health Professions Council of SA should, as a matter of urgency, issue guidance on priority-setting and triage decisions in the context of COVID-19, based on distributive justice principles. ; The joint Department of Science and Technology and National Research Foundation Doctoral Innovation Scholarship, the SA Medical Research Council and the University of Pretoria (through the Institute for Cellular and Molecular Medicine). ; http://www.sajbl.org.za ; am2021 ; Immunology
Containing the COVID-19 pandemic necessitates the use of personal information without the consent of the person. The protection of personal information is fundamental to the rights that ensure an open and democratic society. When regulations that limit the right to privacy are issued outside of the democratic process, every effort must be made to protect personal information and privacy. The limitation of human rights must be treated as an exception to the norm, and any regulations should be drafted to ensure minimum limitation of rights, rather than to the minimum acceptable standard. The contact tracing regulations included in the COVID-19 disaster regulations include some basic principles to ensure privacy; however, other important principles are not addressed. These include principles of transparency and data security. The envisaged future use of human data for research purposes, albeit de-identified, needs to be addressed by the COVID-19 designated judge appointed under the regulations. ; The joint Department of Science and Technology and National Research Foundation Doctoral Innovation Scholarship, the SA Medical Research Council (Flagship and Extramural Unit awards) and the University of Pretoria (through the Institute for Cellular and Molecular Medicine). ; http://www.sajbl.org.za ; am2021 ; Immunology
Genomic research has been identified in South Africa (SA) as important in developing a strong bio-economy that has the potential to improve human health, drive job creation and offer potential solutions to the disease burden harboured by low- and middle-income countries. Central to the success of genomic research is the wide sharing of biological samples and data, but the true value of data can only be unlocked if there are laws and policies in place that foster the legal and ethical sharing of genomic data. The introduction and entry into force of SA's Protection of Personal Information Act (POPIA) No. 4 of 2013 is to be welcomed, but the wording of POPIA as it pertains to consent for the processing of personal information for research purposes has sparked a debate about the legal status of broad consent. We argue that a purposive interpretation of the legislation would permit broad consent for the processing of personal information for research. Although there are ongoing debates surrounding the ethical use of broad consent in Africa, the objective of this article is not to engage with the ethics of broad consent itself, but rather to focus on the legal status of broad consent for genomic data sharing under POPIA. ; http://www.samj.org.za ; pm2020 ; Immunology
