Human tissue legislation is complex. An exhaustive understanding of the law, thorough understanding of human tissue biology and pathophysiology and an appreciation of the diversity of the areas covered in this field, is critical. The importance of interdisciplinary co-operation in the drafting, interpretation and implementation of legislation in this area cannot be overemphasised. Several factors underscore this, including the complexity and volume of the information involved, rapid advances in science, reciprocal dependence of the law and science on one another for relevance and accuracy, and above all the need to ensure that the patient's well-being and safety are not compromised. The development of technology also must be encouraged in a non-obstructive legislative setting.
The establishment of a cell therapy programme in South Africa has the potential to contribute to the alleviation of the country's high disease burden and also to contribute to economic growth. South Africa has various positive attributes that favour the establishment of such a high-profile venture; however, there are also significant obstacles which need to be overcome. We discuss the positive and negative features of the current health biotechnology sector. The positive factors include a strong market pull and a highly innovative scientific and medical community, while the most problematic features include the lack of human resources and education and limited funding. The South African Government has undertaken to strengthen the biotechnology sector in general, but a focus on cell therapy is lacking. The next important step would be to provide financial, legal/ethical and other support for groups that are active and productive in this field through the development of a local cell therapy programme.
The introduction of no-fault or strict liability by the Consumer Protection Act 68 of 2008 (CPA) poses serious problems in the health care context. With a patient as a 'consumer' in terms of the CPA, health care practitioners may find themselves as 'suppliers' or 'retailers' as part of a supply chain, and potentially liable for harm and loss suffered by a patient in terms of the new no-fault liability provision. The claimant (patient) can sue anyone in the supply chain in terms of this provision, which places the health care practitioner who delivered the care in a very difficult position, as he or she is the most easily and often only identifiable person in the supply chain. Although the causal link between the harm suffered by the complainant will still need to be established on a balance of probabilities, the traditional common law obstacle requiring proof of negligence no longer applies. The article argues that this situation is unsatisfactory, as it places an increasingly onerous burden on certain health care practitioners.
AbstractIntroductionTo date, very little programmatic data has been published regarding serial antiretroviral (ARV) levels in infants exposed to maternal treatment and/or infant prophylaxis during the first months of life. Such data provide the opportunity to describe the proportion of infants exposed to virologically suppressive levels of ARVs and to gauge adherence to the prevention of mother‐to‐child transmission of HIV (PMTCT) programme.MethodsFrom August 2014 to January 2016, HIV‐exposed infants born at Kalafong Provincial Tertiary Hospital in Pretoria, South Africa were enrolled as part of an observational cohort study. Plasma samples from HIV‐exposed uninfected infants were obtained at birth, 6‐weeks, 10‐weeks and 14‐weeks of age and quantitative efavirenz (EFV) and nevirapine (NVP) drug level testing performed using liquid chromatography‐mass spectrometry, irrespective of maternal ARV regimen. Descriptive analysis of EFV and NVP levels in relation to self‐reported maternal and infant ARV exposure was performed. EFV levels >500 ng/mL and NVP levels >100 ng/mL were reported based on studies suggesting that trough levels above these thresholds are associated with virological suppression and PMTCT respectively.ResultsAmong 66 infants exposed to maternal EFVin utero, 29 (44%) had virologically suppressive plasma EFV levels at birth, with a median level of 1665 ng/mL (IQR: 1094 to 3673). Among infants who were exclusively breastfed at 6‐, 10‐ and 14 weeks, 13/48 (27%), 5/25 (25%) and 0/21 (0%) had virologically suppressive EFV levels. Among 64 infants whose mothers reported administering daily infant NVP at time of their 6‐week HIV PCR test, only 45 (70%) had NVP levels above the minimum prophylactic trough level.ConclusionsDuring the first 10‐weeks after delivery, a quarter of breastfed infants born to women on an EFV‐containing treatment regimen maintained virologically suppressive EFV plasma levels. This finding highlights the importance of both careful monitoring of ARV side effects and repeat HIV PCR after the first few months of life among HIV‐exposed uninfected infants. As 30% of infants had inadequate NVP plasma levels at 6‐weeks of age, adherence counselling to caregivers regarding infant prophylaxis needs to be enhanced to further reduce mother‐to‐child transmission of HIV.
The capacity for social media to influence the utilization of re-purposed medicines to manage COVID-19, despite limited availability of safety and efficacy data, is a cause for concern within health care systems. This study sought to ascertain links between social media reports and utili-zation for three re-purposed medicines: hydroxychloroquine (HCQ), ivermectin and colchicine. A combined retrospective analysis of social media posts for these three re-purposed medicines was undertaken, along with utilization and clinical trials data, in South Africa, between January 2020 and June 2021. In total, 77,257 posts were collected across key social media platforms, of which 6884 were relevant. Ivermectin had the highest number of posts (55%) followed by HCQ (44%). The spike in ivermectin use was closely correlated to social media posts. Similarly, regarding chlo-roquine (as HCQ is not available in South Africa), social media interest was enhanced by local politicians. Sentiment analysis revealed that posts regarding the effectiveness of these repurposed medicines were positive. This was different for colchicine, which contributed only a small number of mentions (1%). Of concern is that the majority of reporters in social media (85%) were uniden-tifiable. This study provides evidence of social media as a driver of re-purposed medicines. Healthcare professionals have a key role in providing evidence-based advice especially with unidentifiable posts
With increased complexity in various global health challenges comes a need for increased precision and the adoption of more tailored health interventions. Building on precision public health, we propose precision global health (PGH), an approach that leverages life sciences, social sciences, and data sciences, augmented with artificial intelligence (AI), in order to identify transnational problems and deliver targeted and impactful interventions through integrated and participatory approaches. With more than four billion Internet users across the globe and the accelerating power of AI, PGH taps on our current augmented capacity to collect, integrate, analyse and visualise large volumes of data, both non-specific and specific to health. With the support of governments and donors, and together with international and non-governmental organisations, universities and research institutions can generate innovative solutions to improve health and wellbeing of the most vulnerable populations around the world. In line with the Sustainable Development Goals, we propose here a road map for the development and implementation of PGH.
