Pub Date : 2021-12-31DOI: 10.7196/sajbl.2021.v14i3.782
P. Naidoo, V. Rambiritch
Clinical trials are essential to establish the safety and efficacy of investigational products, contributing to risk/benefit assessments that ultimately determine whether these products meet the criteria for market authorisation. Clinical trials are also an important source of revenue and expertise generation for countries in which they are conducted. In developing countries, they represent substantial foreign direct investment. In spite of the substantial capital input that clinical trials require, the issue of funding post-trial access to beneficial therapies remains contentious, especially in resource-limited settings. In this article, we explore this situation and propose mechanisms to establish ‘win-win’ situations where both patients and clinical trial sponsors derive benefit from post-trial access programmes in low- and middle-income countries.
{"title":"Mechanisms for sustainable post-trial access: A perspective","authors":"P. Naidoo, V. Rambiritch","doi":"10.7196/sajbl.2021.v14i3.782","DOIUrl":"https://doi.org/10.7196/sajbl.2021.v14i3.782","url":null,"abstract":"Clinical trials are essential to establish the safety and efficacy of investigational products, contributing to risk/benefit assessments that ultimately determine whether these products meet the criteria for market authorisation. Clinical trials are also an important source of revenue and expertise generation for countries in which they are conducted. In developing countries, they represent substantial foreign direct investment. In spite of the substantial capital input that clinical trials require, the issue of funding post-trial access to beneficial therapies remains contentious, especially in resource-limited settings. In this article, we explore this situation and propose mechanisms to establish ‘win-win’ situations where both patients and clinical trial sponsors derive benefit from post-trial access programmes in low- and middle-income countries.","PeriodicalId":43498,"journal":{"name":"South African Journal of Bioethics and Law","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2021-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45619428","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-12-31DOI: 10.7196/sajbl.2021.v14i3.717
M. Swanepoel, S. Mahomed
The involuntary admission or treatment of a mentally ill individual is highly controversial, as it may be argued that such intervention infringes on individual autonomy and the right to choose a particular treatment. However, this argument must be balanced with the need to provide immediate healthcare services to a vulnerable person who cannot or will not make a choice in his or her own best interests at a particular time. A study carried out in Gauteng Province, South Africa (SA), highlighted the fact that the annual rate of involuntary admissions increased by almost double from 2007 to 2008. This could indicate that healthcare providers are not treating patients without their consent only when this is absolutely necessary. Alternatively, it could indicate that healthcare professionals are more aware of the provisions of the Mental Health Care Act and relevant national policy guidelines. Or it could suggest that more patients are presenting with mental illnesses or disorders that require their involuntary admission. It remains for strategies to be developed that change negative perceptions and inequities for individuals with mental illness. Above all, the strategies should be underpinned by inalienable respect for mentally ill individuals – a concept that was blatantly disregarded in the Life Esidimeni case. In this article, we highlight the functions of mental health review boards and their accountability where involuntary admissions are concerned, while emphasising the protections for mentally ill persons as a vulnerable population group, as set out in the SA Constitution.
{"title":"Involuntary admission and treatment of mentally ill patients – the role and accountability of mental health review boards","authors":"M. Swanepoel, S. Mahomed","doi":"10.7196/sajbl.2021.v14i3.717","DOIUrl":"https://doi.org/10.7196/sajbl.2021.v14i3.717","url":null,"abstract":"The involuntary admission or treatment of a mentally ill individual is highly controversial, as it may be argued that such intervention infringes on individual autonomy and the right to choose a particular treatment. However, this argument must be balanced with the need to provide immediate healthcare services to a vulnerable person who cannot or will not make a choice in his or her own best interests at a particular time. A study carried out in Gauteng Province, South Africa (SA), highlighted the fact that the annual rate of involuntary admissions increased by almost double from 2007 to 2008. This could indicate that healthcare providers are not treating patients without their consent only when this is absolutely necessary. Alternatively, it could indicate that healthcare professionals are more aware of the provisions of the Mental Health Care Act and relevant national policy guidelines. Or it could suggest that more patients are presenting with mental illnesses or disorders that require their involuntary admission. It remains for strategies to be developed that change negative perceptions and inequities for individuals with mental illness. Above all, the strategies should be underpinned by inalienable respect for mentally ill individuals – a concept that was blatantly disregarded in the Life Esidimeni case. In this article, we highlight the functions of mental health review boards and their accountability where involuntary admissions are concerned, while emphasising the protections for mentally ill persons as a vulnerable population group, as set out in the SA Constitution.","PeriodicalId":43498,"journal":{"name":"South African Journal of Bioethics and Law","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2021-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41853464","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-12-31DOI: 10.7196/SAJBL.2021.v14i3.772
M. Steytler, D. Thaldar
COVID-19 exposed flaws in the law regulating the sharing of data and human biological material (HBM). This poses obstacles to the epidemic response, which needs accelerated public health research and, in turn, efficient and legitimate HBM and data sharing. Legal reform and development are needed to ensure that HBM and data are shared efficiently and lawfully. Academics have suggested important legal reforms. The first is the clarification of the susceptibility of HBM and HBM derivatives to ownership, including, inter alia, the promulgation of a revised version of the South African Material Transfer Agreement (SA MTA) by the Minister of Health. This would remove uncertainty regarding the current SA MTA’s perpetual donor ownership clause. The second is the development of data trusts, the adoption of open access to research data, and the creation of an African ‘data corridor’. This would ensure that data are protected while allowing for the efficient transfer of data between researchers for the collective good and in the interest of the public. The third is the amendment of the Space Affairs Act to extend the powers of the Council of Space Affairs to include the management of data collected through the utilisation of Earth observation and geographical information systems. This would ensure the protection of outer space data, legislating its use and sharing once it lands on Earth. The implementation of these legal reforms and developments will better prepare SA to face future epidemics from a health research perspective.
{"title":"Public health emergency preparedness and response in South Africa: A review of recommendations for legal reform relating to data and biological sample sharing","authors":"M. Steytler, D. Thaldar","doi":"10.7196/SAJBL.2021.v14i3.772","DOIUrl":"https://doi.org/10.7196/SAJBL.2021.v14i3.772","url":null,"abstract":"COVID-19 exposed flaws in the law regulating the sharing of data and human biological material (HBM). This poses obstacles to the epidemic response, which needs accelerated public health research and, in turn, efficient and legitimate HBM and data sharing. Legal reform and development are needed to ensure that HBM and data are shared efficiently and lawfully. Academics have suggested important legal reforms. The first is the clarification of the susceptibility of HBM and HBM derivatives to ownership, including, inter alia, the promulgation of a revised version of the South African Material Transfer Agreement (SA MTA) by the Minister of Health. This would remove uncertainty regarding the current SA MTA’s perpetual donor ownership clause. The second is the development of data trusts, the adoption of open access to research data, and the creation of an African ‘data corridor’. This would ensure that data are protected while allowing for the efficient transfer of data between researchers for the collective good and in the interest of the public. The third is the amendment of the Space Affairs Act to extend the powers of the Council of Space Affairs to include the management of data collected through the utilisation of Earth observation and geographical information systems. This would ensure the protection of outer space data, legislating its use and sharing once it lands on Earth. The implementation of these legal reforms and developments will better prepare SA to face future epidemics from a health research perspective.","PeriodicalId":43498,"journal":{"name":"South African Journal of Bioethics and Law","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2021-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45700094","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-12-31DOI: 10.7196/SAJBL.2021.v1431.794
A. Dhai
-
-
{"title":"The omicron hodge-podge: Travel bans, vaccine mandates, children and vaccine equity","authors":"A. Dhai","doi":"10.7196/SAJBL.2021.v1431.794","DOIUrl":"https://doi.org/10.7196/SAJBL.2021.v1431.794","url":null,"abstract":"<jats:p>-</jats:p>","PeriodicalId":43498,"journal":{"name":"South African Journal of Bioethics and Law","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2021-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42649393","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-12-31DOI: 10.7196/sajbl.2021.v14i3.693
R. Rheeder
It is clear that corruption as the abuse of power is an enormous bioethical issue in the public health sector in SA, but as a challenge, it has not elicited much discussion from a global bioethical perspective. The Universal Declaration of Bioethics and Human Rights (UDBHR) on corruption considers three matters. First, the existence of corruption as a problem of power is recognised in the health environment and condemned (article 18). Second, corruption is indicated as an immoral phenomenon that harms the interests of the patient (article 4), ignores vulnerable people (article 8) and neglects social responsibility (article 14). Third, it can be concluded that the UDBHR expresses the opinion that corruption has to be combated by a process of ethical decision-making (article 18.2-3), the use of ethics committees (article 19) and ethics education (article 23.1).
{"title":"Corruption in the public health sector in South Africa: A global bioethical perspective","authors":"R. Rheeder","doi":"10.7196/sajbl.2021.v14i3.693","DOIUrl":"https://doi.org/10.7196/sajbl.2021.v14i3.693","url":null,"abstract":"It is clear that corruption as the abuse of power is an enormous bioethical issue in the public health sector in SA, but as a challenge, it has not elicited much discussion from a global bioethical perspective. The Universal Declaration of Bioethics and Human Rights (UDBHR) on corruption considers three matters. First, the existence of corruption as a problem of power is recognised in the health environment and condemned (article 18). Second, corruption is indicated as an immoral phenomenon that harms the interests of the patient (article 4), ignores vulnerable people (article 8) and neglects social responsibility (article 14). Third, it can be concluded that the UDBHR expresses the opinion that corruption has to be combated by a process of ethical decision-making (article 18.2-3), the use of ethics committees (article 19) and ethics education (article 23.1).","PeriodicalId":43498,"journal":{"name":"South African Journal of Bioethics and Law","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2021-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47729323","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-12-31DOI: 10.7196/sajbl.2021.v14i3.761
T. Kamwendo, B. Shozi
Over the past few years, developments in the science of precise editing of human genomes using CRISPR-Cas9 have led many countries that lack specific laws in this area, such as South Africa (SA), to contemplate legal reform. Thaldar et al. recently published five principles to guide legal reform in SA on heritable genome editing. In a similar vein, concerns about the global impact of human germline genome editing have led to calls for a global regulatory mechanism. This is what the World Health Organization has tried to achieve with the recently published ‘Draft governance framework for human genome editing’. In this article, we compare the policies proposed by the draft framework to the current SA legal position, as well as the five guiding principles. The article concludes that SA law is in need of reform in order to meet the global standards that the draft framework seems to be moving towards.
{"title":"Is South Africa ready for the future of human germline genome editing? Comparing South African law and recent proposals for global governance","authors":"T. Kamwendo, B. Shozi","doi":"10.7196/sajbl.2021.v14i3.761","DOIUrl":"https://doi.org/10.7196/sajbl.2021.v14i3.761","url":null,"abstract":"Over the past few years, developments in the science of precise editing of human genomes using CRISPR-Cas9 have led many countries that lack specific laws in this area, such as South Africa (SA), to contemplate legal reform. Thaldar et al. recently published five principles to guide legal reform in SA on heritable genome editing. In a similar vein, concerns about the global impact of human germline genome editing have led to calls for a global regulatory mechanism. This is what the World Health Organization has tried to achieve with the recently published ‘Draft governance framework for human genome editing’. In this article, we compare the policies proposed by the draft framework to the current SA legal position, as well as the five guiding principles. The article concludes that SA law is in need of reform in order to meet the global standards that the draft framework seems to be moving towards.","PeriodicalId":43498,"journal":{"name":"South African Journal of Bioethics and Law","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2021-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43759417","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-08-16DOI: 10.7196/SAJBL.2021.V14I2.00750
S. Murphy, A. Dhai
Background The use of Extracorporeal membrane oxygenation (ECMO) in Critical Care is gathering momentum internationally. There is interest in it being included within the offering of Critical Care services in South African State Hospitals. Objectives Most discussions about ECMO's appropriateness in State hospitals have been focused on healthcare economics and cost: benefit. To date, the bioethical considerations of this topic have not been comprehensively addressed. This research aims to articulate some of the normative ethical considerations to be considered when making decisions about government funding of medical therapies in general and costly life-sustaining therapies, such as ECMO specifically, within a limited resource environment. Methods Using a standard normative/philosophical design and the application of the ethical theories of Responsive Communitarianism and Ubuntu (African Moral Theory), to interrogate whether it is morally justifiable for Intensive Care Units in South African State Hospitals to be implementing ECMO programmes, at present. Conclusions Both Responsive communitarianism and Ubuntu (African Moral theory) advocate that when considering expensive therapies that extend or save lives such as ECMO, it is essential to consider the collective effect of such therapies on the community large – both the benefits as well as burdens. Accordingly, considering the National Department of Health's current state, it is ethically unjustified for ECMO to be included in the current critical care service in State Hospitals at present.
{"title":"Extracorporeal Membrane Oxygenation (ECMO) Therapy in Intensive Care Units (ICU) in South African State Hospitals: A Normative Study.","authors":"S. Murphy, A. Dhai","doi":"10.7196/SAJBL.2021.V14I2.00750","DOIUrl":"https://doi.org/10.7196/SAJBL.2021.V14I2.00750","url":null,"abstract":"Background The use of Extracorporeal membrane oxygenation (ECMO) in Critical Care is gathering momentum internationally. There is interest in it being included within the offering of Critical Care services in South African State Hospitals. Objectives Most discussions about ECMO's appropriateness in State hospitals have been focused on healthcare economics and cost: benefit. To date, the bioethical considerations of this topic have not been comprehensively addressed. This research aims to articulate some of the normative ethical considerations to be considered when making decisions about government funding of medical therapies in general and costly life-sustaining therapies, such as ECMO specifically, within a limited resource environment. Methods Using a standard normative/philosophical design and the application of the ethical theories of Responsive Communitarianism and Ubuntu (African Moral Theory), to interrogate whether it is morally justifiable for Intensive Care Units in South African State Hospitals to be implementing ECMO programmes, at present. Conclusions Both Responsive communitarianism and Ubuntu (African Moral theory) advocate that when considering expensive therapies that extend or save lives such as ECMO, it is essential to consider the collective effect of such therapies on the community large – both the benefits as well as burdens. Accordingly, considering the National Department of Health's current state, it is ethically unjustified for ECMO to be included in the current critical care service in State Hospitals at present.","PeriodicalId":43498,"journal":{"name":"South African Journal of Bioethics and Law","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2021-08-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43051442","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-08-16DOI: 10.7196/SAJBL.2021.V14I2.00776
L. Hansen, I. V. Wyk, M. Fouché
{"title":"Expression of concern (4 June 2021)","authors":"L. Hansen, I. V. Wyk, M. Fouché","doi":"10.7196/SAJBL.2021.V14I2.00776","DOIUrl":"https://doi.org/10.7196/SAJBL.2021.V14I2.00776","url":null,"abstract":"","PeriodicalId":43498,"journal":{"name":"South African Journal of Bioethics and Law","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2021-08-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47205459","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-08-16DOI: 10.7196/SAJBL.2021.V14I2.00697
M. D. Roubaix
There is a great need for responsible parenthood in a country such as South Africa (SA), where the vast majority of pregnancies are unplanned and unwanted, and a large proportion of children experience abject poverty. Human reproduction is a complex issue, and there are numerous reasons why humans want and need children. These can be placed into two broad categories: reproduction is the result of our preintellectual ‘nature’ (instinct); and secondly, it satisfies social and personal needs. Reproductive choice is a human right that our membership of the human race inalienably entitles us to – indirectly guaranteed in the SA Constitution. At a social level, it may be argued, though not very convincingly, to be a duty, while the contra-duty not to procreate is more compelling, when having more children may overburden already large and needy families and lead to child neglect. In contemporary society, reproduction should be argued as a privilege. This opens the door to responsible parenthood. In a country such as ours, there is a particular need to balance reproductive rights, social needs and responsibility.
{"title":"Human reproduction: Right, duty or privilege? South African perspective","authors":"M. D. Roubaix","doi":"10.7196/SAJBL.2021.V14I2.00697","DOIUrl":"https://doi.org/10.7196/SAJBL.2021.V14I2.00697","url":null,"abstract":"There is a great need for responsible parenthood in a country such as South Africa (SA), where the vast majority of pregnancies are unplanned and unwanted, and a large proportion of children experience abject poverty. Human reproduction is a complex issue, and there are numerous reasons why humans want and need children. These can be placed into two broad categories: reproduction is the result of our preintellectual ‘nature’ (instinct); and secondly, it satisfies social and personal needs. Reproductive choice is a human right that our membership of the human race inalienably entitles us to – indirectly guaranteed in the SA Constitution. At a social level, it may be argued, though not very convincingly, to be a duty, while the contra-duty not to procreate is more compelling, when having more children may overburden already large and needy families and lead to child neglect. In contemporary society, reproduction should be argued as a privilege. This opens the door to responsible parenthood. In a country such as ours, there is a particular need to balance reproductive rights, social needs and responsibility.","PeriodicalId":43498,"journal":{"name":"South African Journal of Bioethics and Law","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2021-08-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44639945","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-08-16DOI: 10.7196/SAJBL.2021.V14I2.00779
A. Strode, W. Freedman, Z. Essack, H. Rooyen
{"title":"Re: Response to the Stellenbosch University’s Research Ethics Committee: Social, Behavioural and Education Research expression of concern","authors":"A. Strode, W. Freedman, Z. Essack, H. Rooyen","doi":"10.7196/SAJBL.2021.V14I2.00779","DOIUrl":"https://doi.org/10.7196/SAJBL.2021.V14I2.00779","url":null,"abstract":"","PeriodicalId":43498,"journal":{"name":"South African Journal of Bioethics and Law","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2021-08-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44716257","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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