South Africa’s latest medically assisted reproduction draft regulations: close, but no cigar

Abstract

Medies-geassisteerde voortplanting in Suid-Afrika word tans gereguleer deur regulasies wat in 2012 gepromulgeer is ingevolge die Nasionale Gesondheidswet 61 van 2003. In Maart 2021 het die minister van Gesondheid nuwe konsepregulasies gepubliseer vir kommentaar. Hierdie artikel ontleed die nuwe konsepregulasies teen die agtergrond van groeiende regspraak in die gebied van medies-geassisteerde voortplanting, asook teen die agtergrond van nuwe tegnologiese ontwikkeling in hierdie gebied oor die afgelope dekade. In die eerste deel van die artikel word aspekte waarin die konsepregulasies verbeter het op die huidige regulasies uitgewys en ontleed, te wete (i) die nuwe, meer akkurate definisie van “gameetskenker”; (ii) die verhoogde perk op die hoeveelheid kinders wat verwek mag word met die gamete van ’n enkele skenker; (iii) die betrokkenheid van die direkteur-generaal in die vasstelling van vergoeding vir verskaffing van gamete; en (iv) die terugkeer na gemeenregtelike regulering van eienaarskap van gamete en in vitro embrio’s. Die tweede deel van die artikel word toegespits op aspekte waarin die konsepregulasies verbeter behoort te word, naamlik (i) inkonsekwentheid en onsamehangendheid van verskeie definisies; (ii) die beperking dat spermselle slegs deur self-stimulasie bekom mag word vir medies-geassisteerde voortplanting; en (iii) die gebrek aan regulering van menslike oorerflike genoom-redigering. Die derde deel van die artikel verskaf ’n oorsig van die drie bepalings van die 2012 regulasies wat tans die onderwerp is van ’n grondwetlike hofsaak en wys hoe die 2021 konsepregulasies poog om die knelpunte in die hofsaak aan te spreek. Hierdie drie bepalings is (i) die vereiste dat ’n paartjie (hetsy getroud of in ’n permanente verhouding) hulself moet onderwerp aan sielkundige evaluasie indien hulle mekaar se gamete wil gebruik vir medies-geassisteerde voortplanting; (ii) die verbod op voor-inplantingstoetsing van in vitro embrio’s vir nie-terapeutiese geslagseleksie; en (iii) die verbod op bekendmaking – deur énigiemand – van inligting oor mense wat gebruik gemaak het van medies-geassisteerde voortplanting, óf wat verwek is deur medies-geassisteerde voortplanting, óf wat gamete geskenk het vir medies-geassisteerde voortplanting. Die gevolgtrekking word gemaak dat die konsepregulasies ’n prysenswaardige poging is om op die bestaande regulasies te verbeter, maar dat dit nog in talle opsigte wesenlik tekort skiet. Ten einde hierdie tekortkominge aan te spreek, word omvattende aanbevelings gemaak oor hoe om die konsepregulasies aan te pas.

Recent Developments in the Regulation of Heritable Human Genome Editing

“…The Baylis study noted that South Africa did not have “any relevant information” regarding heritable human genome editing. However, research has shown that while gene editing is not expressly mentioned in extant law, there are two statutes which may possibly be applied to the technology in a regulatory fashion (Thaldar and Shozi 2022 ). The first is the Medicine and Related Substances Act 101 of 1965, where the definition of “medical devices” may be interpreted so as to include gene editing tools.…”

Reproducing the Conqueror’s South Africa: An Azanian Critique of the Constitutionalist Endorsement of Assisted Reproductive and Reprogenetic Technologies

“…He has systematically argued against various legal and ethical obstacles that threaten to, or actually impede the individual's use of these technologies. With the 1996 Bill of Rights in one hand (an instrument Thaldar likens to "a giant safety net that automatically provides a minimum level of legal protection to all natural subjects" [Thaldar 2020b, 6]), and the Universal Declaration of Human Rights in the other, he has criticised court decisions (Thaldar 2018(Thaldar , 2019a(Thaldar , 2019b(Thaldar , 2022a(Thaldar , 2023a(Thaldar , 2023b and policy (Jordaan 2007;Thaldar 2020aThaldar , 2022b for burdening or preventing prospective parents from using ARRTs as they see fit, and has suggested a number of changes that he argues will give proper effect to constitutional rights (Shozi and Thaldar 2022).…”

A golden opportunity for South Africa to legislate on human heritable genome editing

“…Proposed HHGE legislation 5 A1 The genomes of gametes and embryos may be edited only if such an edit is part of a preclinical trial or clinical trial that is: (a) approved by a health research ethics committee registered as such with the National Health Research Ethics Council, and (b) in the event of a clinical trial, registered with the South African Health Products Regulatory Authority. A2 Sub-regulation A1 shall cease to have e ect after 10 years from the date of promulgation of these regulations, unless the Minister of Health gives notice in the Government Gazette that the e ect of the sub-regulation is extended for a speci ed period not exceeding 5 years.…”

“…Regulating HHGE as an ART offers a fast track to the legislative agenda for HHGE. Thirdly, in response to the government's call for comments from the public on the revision of the ART regulations, a set of sub-regulations for inclusion in the revised ART regulations was formulated by Thaldar and Shozi [5] to specifically deal with HHGE. This proposed set of sub-regulations is presented in Fig.…”