Medicine and the Law.

Problems arise when a lawfully appointed surrogate decision-maker wishes to decide on a course of action on behalf of a mentally incompetent patient that is against the patient's best interests. This may arise: (i) where there is no advance directive, and the decision is made by the surrogate decision-maker on religious grounds; (ii) where the medical practitioners are of the opinion that the surrogate decision-maker's decision is not in the best interests of the patient; (iii) where the close relatives of the patient do not agree with the decision by the surrogate decision-maker; and (iv) where the surrogate decision-maker asks the medical practitioners to undertake treatment or a procedure on the patient that is unlawful or unethical. Suggestions are made regarding what doctors should do when faced with each of these situations.

Medicine and the Law.

The case involving Dr Tim De Maayer in Gauteng Province, South Africa (SA), raises the question whether there is a legal and ethical duty on public sector doctors whose complaints to hospital administrators have been ignored, to inform the public about harm to child patients due to intentional maladministration, negligence or indifference by the local and provincial authorities. An analysis of the SA Constitution, the National Health Act No. 61 of 2003, the Children's Act No. 38 of 2005, the Health Professions Act No. 56 of 1974 and the Rules and Guidelines of the Health Professions Council of South Africa (HPCSA) established in terms of the Health Professions Act indicates that Dr De Maayer acted both legally and ethically to protect the child patients at Rahima Moosa Hospital. As the complaints of harm caused to the patients because of conditions in the hospital were raised three times with the official functionaries concerned, and ignored by them, he was fully justified to try other measures to protect the patients. It seems that he hoped that by bringing the conditions at the hospital to the attention of the media, the public reaction would be such as to pressurise the administrators to redress the situation. The irony is that the officials who sought to discipline him were themselves guilty of violating the Constitution, the National Health Act and the Children's Act, and should be disciplined. Furthermore, if they are registered with the HPCSA, they should be reported and disciplined for violating the HPCSA's Ethical Rules of Conduct and its Ethical Guidelines on good practice.

Interferon-gamma modulates articular chondrocyte and osteoblast metabolism through protein kinase R-independent and dependent mechanisms.

Osteoarthritis (OA) affects multiple tissues of the synovial joint and is characterised by articular cartilage degeneration and bone remodelling. Interferon-γ (IFN-γ) is implicated in osteoarthritis pathology exerting its biological effects via various mechanisms including activation of protein kinase R (PKR), which has been implicated in inflammation and arthritis. This study investigated whether treatment of articular cartilage chondrocytes and osteoblasts with IFN-γ could induce a degradative phenotype that was mediated through the PKR signalling pathway. IFN-γ treatment of chondrocytes increased transcription of key inflammatory mediators (TNF-α, IL-6), matrix degrading enzymes (MMP-13), the transcription factor STAT1, and PKR. Activation of PKR was involved in the regulation of TNF-α, IL-6, and STAT1. In osteoblasts, IFN-γ increased human and mouse STAT1, and human IL-6 through a mechanism involving PKR. ALP, COL1A1 (human and mouse), RUNX2 (mouse), and PHOSPHO1 (mouse) were decreased by IFN-γ. The number of PKR positive cells were increased in post-traumatic OA (PTOA). This study has revealed that IFN-γ propagates inflammatory and degenerative events in articular chondrocytes and osteoblasts via PKR activation. Since IFN-γ and PKR signalling are both activated in early PTOA, these mechanisms are likely to contribute to joint degeneration after injury and might offer attractive targets for therapeutic intervention.

COVID-19 vaccine hesitancy and missed vaccine rollout targets: The case for using general practitioners.

The South African (SA) government's roll-out of the COVID-19 vaccine is behind its target, largely owing to concerns about the sideeffects and the effectiveness of the vaccines, and because they have been developed over a very short time frame. Another factor is a lack of trust in government policies regarding COVID-19 and its running of public health. One survey has indicated that for persons seeking a vaccination, the preferred vaccine site would be general practitioners (GPs). GPs have been used in Australia, the UK and elsewhere. In Australia, with a scattered rural population, 5 600 GPs have been vaccinating over one million patients weekly. Calls have been made by the South African Medical Association, among others, for GPs to be allowed to assist with the government's roll-out programme. If ~8 000 GPs in SA participated in a properly administered roll-out programme, and each GP were to vaccinate only 10 people a day, this would yield 400 000 vaccinations a week or ~1.6 million a month. The GPs could invite their patients and others to visit their room for a COVID-19 vaccination, as they do with the annual influenza vaccine.

Liability of doctors based on negligence for culpable homicide: No need to change the law concerning medical negligence or to establish special medical malpractice courts - use mediation and medical assessors instead.

Doctors' organisations have called for special legislation regarding the criminal charging of doctors for culpable homicide, and the need for special medical malpractice courts to deal with the huge increase in the number of medical malpractice cases. However, there are very few criminal prosecutions, because the prosecuting authorities generally accept that doctors do not intend to kill their patients, and are only likely to charge them for intentional or very serious deviations from the standard of a reasonably competent doctor in their profession. Doctors are also generally not held liable for mere errors of judgement. Although the call is for special legislation, the issues concerned can generally be dealt with administratively by existing legislation. For instance, the requirement of mediation before litigation could be introduced by the Chief Justice. Doctors need not fear making admissions during mediation proceedings in civil matters, because legislation provides that such admissions and evidence may not be used in subsequent civil actions. The Chief Justice can also issue a practice directive that all presiding officers must appoint medicolegal experts as assessors in medical malpractice cases. The medical profession can assist the process by arranging a panel of such experts who can be called upon to serve as assessors by the courts.

Refusal for religious reasons of a blood transfusion for her husband by wife as legal proxy ignored by the doctors - can the wife claim damages?

A scenario is presented in which a wife's request for religious reasons, and in accordance with her husband's wishes, that her husband not be given a potentially life-saving blood transfusion was ignored by the doctors. Her husband subsequently died. The question then arose whether her husband's estate, or she as his legal proxy, could bring an action for pain and suffering and sentimental damages against the doctors on behalf of her husband. When a patient dies and medical malpractice is involved, the patient's legal rights are extinguished, and their estate cannot begin or continue with a legal action for pain and suffering or sentimental damages - unless the pleadings in the case have been closed (litis contestatio). The result is that the estate or the spouse of a deceased patient may not sue for pain and suffering or sentimental damages on behalf of such patient. The spouse may only claim damages for pain and suffering and sentimental damages if he or she can show that the defendants' conduct regarding the deceased directly affected the spouse concerned. Where emotional shock was caused negligently, a spouse may only recover patrimonial damages and damages for pain and suffering. Where such shock was caused by intentional conduct, additional sentimental damages may also be claimed.

COVID-19: May hospitals in one province of South Africa reserve empty beds for patients from their province and turn down emergency requests from other provinces?

The new 501Y.V2 variant of COVID-19 has led to a rapid increase in the number of persons infected with the virus in South Africa, and state and private hospitals are having to turn patients away. Although it is common practice for patients to be transferred between provinces for specialist care, the upsurge in the COVID-19 pandemic has led to some hospitals considering reserving intensive care and critical care beds for COVID-19 patients from their province. The Constitution provides that nobody may be refused emergency medical treatment, nor may they be unfairly discriminated against. This is also implicit in the 'equitable' provision of healthcare services referred to in the National Health Act 61 of 2003. The Critical Care Society of Southern Africa COVID-19 guidelines, or other similar widely accepted guidelines, may be used, provided they do not unfairly discriminate against patients on the basis of age. According to the Constitution, a hospital that wishes to turn away an emergency treatment request from another province because it is reserving beds for COVID-19 patients from its home province will have to show that it is 'reasonable and justifiable' to do so. It will have to show that the other province's patient was being subjected to the same criteria for admission as its home province COVID-19 patients, because, for instance, occupation of the bed by another COVID-19 patient from the home province was imminent.

May a sample be legally removed or an autopsy undertaken without an advance directive or proxy consent to determine whether a critical care patient at risk of COVID-19 infection has died as a result of the virus?

It has recently been suggested that ethically and legally the obtaining of biological samples for research after death during the COVID-19 pandemic in South Africa justifies a waiver of consent followed by a deferred proxy consent. However, it is submitted that because deceased persons are not protected by the Constitution, and only partially protected by common law and statute law, such consent and the need for consent to autopsies may be dispensed with altogether under the common law doctrine of 'necessity'. It is pointed out that such information is in the public interest because it will inform critical care facilities on how to save lives of future patients and assist government in responding to the COVID-19 pandemic by adequate planning. It is also reasonably justifiable in the public interest to ascertain the COVID-19 status of deceased persons who may have been exposed to the virus, in order to protect their family, friends, healthcare practitioners, undertakers and staff members, and members of the public with whom they have been in contact. Finally, it is suggested that the law can be clarified by amending the Disaster Management COVID-19 regulations to do away with consent for such autopsies or tissue sample collections from deceased persons exposed to the risk of contracting the virus, subject to certain conditions.

COVID-19 and patient-doctor confidentiality.

Given the increasing numbers of ethical and legal issues arising from the COVID-19 epidemic, particularly in respect of patient-doctor confidentiality, doctors must explain to patients how the measures taken to combat the spread of the virus impact on their confidentiality. Patients must be reassured that doctors are ethically bound to continue to respect such confidentiality, but it should be made clear to them that doctors must also comply with the demands of the law. While the Constitution, statutory law and the common law all recognise a person's right to privacy, during extraordinary times such as the COVID-19 pandemic, confidentiality must be breached to a degree to halt the spread of the virus.

Parents refusing blood transfusions for their children solely on religious grounds: Who must apply for the court order?

The South African Constitution provides that children have the right to healthcare, as well as all other rights. Furthermore, in all matters affecting them, their best interests must be 'of paramount importance'. It seems common practice that, when parents refuse blood transfusions for their children solely on religious grounds, doctors and health authorities apply for a court order to overturn such refusals. However, since the implementation of the Children's Act of 2005, it may be that the onus is no longer on doctors and authorities to apply to court to reverse the decision of parents and guardians. It can be argued instead that the burden has shifted to the parents to apply to court for an order to overrule the decision of doctors, by proving to the court that alternative choices are available. Guidance is given for situations, particularly in the public sector, where alternative choices are not available.

Is the COVID-19 regulation that prohibits parental visits to their children who are patients in hospital invalid in terms of the Constitution? What should hospitals do?

This article deals with whether the COVID-19 regulation that prohibits parental visits to their children who are patients in hospital is invalid in terms of the Constitution of South Africa. The article contends that the ban on visits by parents to their children in hospital is a violation of the children's rights provisions of the Constitution regarding the 'best interests of the child', and the 'best interests standard' in the Children's Act 38 of 2005. The article also points out that the regulations are not saved by the limitations clause of the Constitution, because the restriction is not 'reasonable and justifiable' and a 'less restrictive means' can be used to achieve the same purpose of preventing the spread of the COVID-19 virus. The article concludes that the relevant regulation is legally invalid, and hospitals would be fully justified in allowing parental visits to child patients provided proper precautions are taken to contain the virus.

Do COVID-19 patients needing extended care in an intensive care unit fall under the 'emergency medical treatment' provisions of the South African Constitution?

Whether COVID-19 patients in need of extended care in an intensive care unit qualify for 'emergency medical treatment' is answered by considering the Constitution, the meaning of emergency medical treatment, and whether such patients are in an incurable chronic condition. Considering ethical guidelines for the withholding and withdrawal of treatment may assist a court in determining whether a healthcare practitioner has acted with the degree of skill and care required of a reasonably competent practitioner in his or her branch of the profession.

What should private-sector doctors do when relatives of deceased patients pressurise them to prevent medicolegal autopsies in cases of unnatural death?

This article deals with what doctors in the private sector should do if relatives of deceased patients refuse to consent to medicolegal autopsies and demand that the bodies be handed over to them. The law does not require consent by relatives for medicolegal autopsies, because the State has a compelling interest in ensuring that such deaths are properly investigated. Relatives of patients who have died an unnatural death may be criminally prosecuted if they attempt to obstruct doctors from carrying out their duties under the Inquests Act 58 of 1959 and the regulations regarding the rendering of forensic pathology services.

Would it be ethical or legal for doctors in South Africa to administer testosterone-reducing drugs to Caster Semenya?

The Court of Arbitration for Sport recently confirmed that the decision by the International Association of Athletics Federations to require hyperandrogenic female athletes such as Caster Semenya to reduce their testosterone levels to compete in certain races has been widely condemned. The World Medical Association has warned doctors not to assist in implementing the decision, as it would be unethical. The same would apply in terms of the Health Professions Council of South Africa's rules of professional conduct. Such treatment is 'futile' in medical terms, and does not serve the purpose of providing healthcare. Therefore, doctors may lawfully refuse to prescribe it. The decision is a violation of Semenya's constitutional rights and would be regarded as unethical should doctors comply with it. However, the prescription of such drugs would not be unlawful if Semenya gave informed consent to taking them. Such consent would not be a defence to a disciplinary hearing on unprofessional conduct, but would be a good defence to any legal action arising from unpleasant side-effects - provided they were explained to her.

Towards prevention of post-traumatic osteoarthritis: report from an international expert working group on considerations for the design and conduct of interventional studies following acute knee injury.

OBJECTIVE: There are few guidelines for clinical trials of interventions for prevention of post-traumatic osteoarthritis (PTOA), reflecting challenges in this area. An international multi-disciplinary expert group including patients was convened to generate points to consider for the design and conduct of interventional studies following acute knee injury. DESIGN: An evidence review on acute knee injury interventional studies to prevent PTOA was presented to the group, alongside overviews of challenges in this area, including potential targets, biomarkers and imaging. Working groups considered pre-identified key areas: eligibility criteria and outcomes, biomarkers, injury definition and intervention timing including multi-modality interventions. Consensus agreement within the group on points to consider was generated and is reported here after iterative review by all contributors. RESULTS: The evidence review identified 37 studies. Study duration and outcomes varied widely and 70% examined surgical interventions. Considerations were grouped into three areas: justification of inclusion criteria including the classification of injury and participant age (as people over 35 may have pre-existing OA); careful consideration in the selection and timing of outcomes or biomarkers; definition of the intervention(s)/comparator(s) and the appropriate time-window for intervention (considerations may be particular to intervention type). Areas for further research included demonstrating the utility of patient-reported outcomes, biomarkers and imaging outcomes from ancillary/cohort studies in this area, and development of surrogate clinical trial endpoints that shorten the duration of clinical trials and are acceptable to regulatory agencies. CONCLUSIONS: These considerations represent the first international consensus on the conduct of interventional studies following acute knee joint trauma.

What should doctors and healthcare staff do when industrial action jeopardises the lives and health of patients?

During the recent strikes by healthcare personnel in North West Province, South Africa, patients were prevented from accessing emergency medical care and doctors and nurses were ejected from hospitals. Such conduct violates the Constitution of the Republic of South Africa, 1996, and is unlawful, as health services are 'essential services' in terms of the Labour Relations Act No. 66 of 1995. Doctors, nurses and other healthcare personnel who are prevented from assisting patients by striking colleagues should take active steps to secure access to healthcare services for patients requiring emergency medical care.

Termination of pregnancy: Cultural practices, the Choice on Termination of Pregnancy Act and the constitutional rights of children.

The cultural practice of ukuthwala, the abduction for marriage of young girls, violates their constitutional rights and contravenes the Children's and Sexual Offences Act. The provisions of the Choice Act for the third trimester of pregnancy are more onerous than the former Abortion Act and violate the constitutional rights of girls and women who face a serious threat to their physical or mental health or have been raped or subjected to incest. The Choice Act should be amended accordingly. Until it is amended, healthcare practitioners should use the constitutional 'best interests of the child' principle as interpreted by the Children's Act when deciding whether or not to terminate the pregnancy of a child in the third trimester.