A public law approach to health research in South Africa

Abstract

The resolution of health research problems has over the years generally been guided by private law approaches, mainly under the laws of contract and delict. The dominance of private law approaches has mainly been evident in the context of health research litigation. This study is therefore about the plausibility or otherwise of a public law approach (PLA) to the resolution of health research problems. The study argues that the PLA is more plausible, and in particular better enhances the protection of health research participants. In doing so the study, after examining the historical evolution of the thinking and frameworks relevant to bioethics, examines the existing legal and ethical theories, and their adequacy in the resolution of health research problems. The theories, on the whole, have been found not to be adequate in this regard, more particularly when used in isolation. The study further examines existing SA law, including some ethical instruments. The possible adequacy of this framework in the resolution of health research problems, as well as its consistency with a PLA, is also examined. The study further examines the comparability of the SA law with the UK and US laws, as well as the consistency of the three jurisdictions’ frameworks with the PLA. The study has however found that though there is some, though incoherent, presence of some public law elements in the three jurisdictions, these have not yet found application in the context of health research litigation in these jurisdictions. The study further had to examine the international legal position (including the African, European and Inter-American regional frameworks) and its consistency with the PLA. Despite that, on the whole, the international legal framework does tend towards the PLA, the framework has yet to be used in the context of health research litigation. A paradigm shift is therefore required, both theoretically and pragmatically. A ‘Public Law Approach’ is therefore proposed. Such a proposed framework shall therefore ensure that public law approaches are also used alongside, as a supplement to or, where applicable, as an alternative to, private law approaches, further enhancing protection for research participants.

Malembe yo tala lama hundzeke ku ahluriwa ka swiphiko swa ndzavisiso wa swa rihanyo wu ve ngopfu ehansi ka milawu ya ta (vuxaka bya) vanhu ntsena (private law), ngopfu-ngopfu milawu ya tikontiraka na ya dilikti. Tirhelo ra swa milawu ya ta vanhu ntsena ri tikombisile ngopfu eka swa milandzu ya swa ndzavisiso ya swa rihanyo. Hikokwalaho ka sweswo ndzavisiso lowu wu langutanaka na ku amukeleka ka matirhelo ya swa milawu ya ta vanhu na mfumo (Public law approach) (PLA) eku ololoxeni ka swiphiko swa ndzavisiso wa swa rihanyo. Ndzavisiso lowu wu koxa leswaku tirhelo ra PLA ra amukeleka swinene, no tlhela ri antswisa ku sirheleriwa ka vanhu lava va nghenelaka eka ndzavisiso wa swa rihanyo (health research participants). Ku fikelela sweswo ndzavisiso lowu, endzaku ka loko wu xopaxopile matimu ya maendlelo yo karhi lama fambisanaka na bayo-ethiki, wu tlhela wu lavisisa tithiyori leti ti nga kona ta xinawu na xiethiki, leti ti fambelanaka na ku ahluriwa ka swiphiko swa ndzavisiso wa swa rihanyo. Ku eneteleka ka matirhelo lama ku thlela ku langutisisiwa. Tithiyori leti ti kumekile, hi ku angarhela, leswaku a ti enelanga, ngopfu ngopfu loko ti tirhisiwa ti ri toxe ku ololoxa swiphiko swa ndzavisiso wa swa rihanyo. Ndzavisiso wu tlhlela wu langutisisa nawu wa Afrika-Dzonga, ku katsa na tiethiki ta rona. Ku enetelaka ka tirhelo leri eku ololoxeni ka swiphiko swa ndzavisiso wa swa rihanyo na ku fambisana ka rona na PLA na swona swa langutisisiwa. Ndzavisiso lowu wu tlhela wu fananisa tirhelo ra nawu wa Afrika-Dzonga na tirhelo ra milawu ya UK na US, no tlhlela wu langutisisa ku fambelana ka matirhelo lama (ya matiko manarhu) na PLA. Ndzavisiso lowu wu tlhela wu kuma leswaku hambiloko ku ri na vukona byo karhi bya PLA, hambi byi tsekatseka, eka milawu ya matiko lamanharhu, PLA a yi se tirhisiwa eka matiko lama, etikhoto, hi mayelana na swa ndzavisiso wa swa rihanyu. Ndzavisiso a wu fanele ku tlhela wu langutisisa tirhelo ra milawu ya matiko ya misava (international law), ku katsa na matirhelo ya tikontinente ta Afrika; Yuropa na Americas, na ku fambisana ka matirhelo lama na tirhelo ra PLA. Hambileswi nawu wa matiko ya misava wu voyamelaka ngopfu eka tirhelo ra PLA, tirhelo leri a ri se tirhisiwa etikhoto, hi mayelana na ndzavisiso wa swa rihanyo. Ku cinca ka matirhelo, hi mavonelo na hi ku tirhisiwa ka wona, swa laveka. Hikokwalaho, tirhelo ra PLA ra laveka. Tirhelo rero ri ta vona leswaku matirhelo lama ya voyamelaka eka nawu wa ta vanhu na mfumo (public law approaches) ya tirhisiwa swin’we, kumbe ku tlhandlekela eka, kumbe ku tirhisiwa handle ka, matirhelo ya nawu wa ta vanhu ntsena (private law approaches). Leswi swi ta antsiwa ku sirheleriwa ka lava va nghenelaka eka swa ndzavisiso wa swa rihanyo.