Suchergebnisse

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 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