Free Trade Agreements with the US — Are they good for your health?

Through its participation in the South African Customs Union (SACU), South Africa has been involved in negotiations with the United States government on the finalization of a free trade agreement (FTA). Although the US-SACU negotiations eventually ground to a halt, they are more than likely to be reinstated some time soon, and the farreaching implications they portend will have to be confronted afresh. The concern of this contribution is the effect of the US insistence on stronger intellectual property protection for pharmaceutical patents in these bilateral agreements, the resultant impact on the prices of medicines for life-threatening conditions such as HIV/AIDS and related opportunistic diseases. This paper explores some critical issues related to FTAs, examines some of the pressure impacting on the negotiations, reviews the trends around the protection of pharmaceutical patents in some recently concluded agreements, and considers their implications for SACU countries

Learning from experience: the art and science of clinical law

Clinical law is a teaching discipline in terms of which students learn the skills, ethics and values necessary for the practice of law. Its mission is accomplished through the practical involvement of students in legal work, whether it is through simulated exercises or representing actual clients in their legal problems. Throughout this process, they are guided by teachers or supervisors who are practising lawyers within the law school. What is unique to this discipline is the employment of teaching methodologies which are experientially-based and geared towards problem solving, rather than ‘academic’ in nature. This contribution looks at some recent developments with regard to the regulation of the legal profession and suggests that clinical law is set to assume an even greater significance with the prospect that the period of vocational training is likely to be reduced, in terms of the draft Legal Practice Bill. Furthermore, the contribution argues that such an approach is a more effective form of teaching and learning, and that its methodologies should be integrated into other teaching disciplines. It also explores a model for implementing the notions expressed in this piece. Finally, based on the experiences of South African law clinics, it argues that clinical law can be delivered effectively even in resource-strapped situations

Evaluation and correlation of mammographically suspicious lesions with histopathology at Addington Hospital, Durban

Background. Stereotactic core-needle biopsies (SCNBs) are a reliable alternative to surgical biopsy for microcalcifications. The positivepredictive value (PPV) of SCNB has been shown to be reproducible in several studies using the Breast Imaging Reporting and Data System(BIRADS) classification, which is the current gold standard in mammographic reporting. At this stage, no study has been done in KwaZulu-Natal to assess local outcomes against BIRADS. The current standard of care utilises vacuum-assisted breast biopsy, but is not availablein a resource-constrained environment such as ours. The need, therefore, is for constant evaluation of existing practice to ensure that it isoptimised for the challenges and limitations facing local radiologists.Objective. To assess the PPV of SCNB in Addington Hospital, and to compare it with that of BIRADS.Material and methods. Mammographically detected lesions were assigned to 3 categories: benign, indeterminate and suspicious. Aretrospective review of 67 SCNBs was performed for lesions falling within the suspicious category, and the PPV and rates of ductalcarcinoma in situ (DCIS) were determined.Results. Our study demonstrated a PPV of 20.9%. This correlated well with international studies for BIRADS 4 and 5 lesions. DCISaccounted for 21.4% of detected malignancies, which is in keeping with current literature.Conclusion. Despite resource limitations, local outcomes were comparable with those of BIRADS. Given our fairly general categorisationof lesions, however, it should be emphasised that BIRADS allows better organisation, consistency and clarity in breast imaging reporting,as well as accurate data comparison between centres facing limitations similar to our own

Challenges confronting health care workers in government's ARV rollout: rights and responsibilities

South Africa is renowned for having a progressive Constitution with strong protection of human rights, including protection for persons using the public health system. While significant recent discourse and jurisprudence have focused on the rights of patients, the situation and rights of providers of health care services have not been adequately ventilated. This paper attempts to foreground the position of the human resources personnel located at the centre of the roll-out of the government's ambitious programme of anti-retroviral (ARV) therapy.   The HIV/AIDS epidemic represents a major public health crisis in our country and, inasmuch as various critical policies and programmes have been devised in response, the key to a successful outcome lies in the hands of the health care professionals tasked with implementing such strategies. Often pilloried by the public, our health care workers (HCWs) face an almost Herculean task of turning the tide on the epidemic. Unless the rights of HCWs are recognised and their needs adequately addressed, the best laid plans of government will be at risk.   This contribution attempts to identify and analyse the critical challenges confronting HCWs at the coalface of the HIV/AIDS treatment programme, in particular the extent to which their own rights are under threat, and offers recommendations to remedy the situation in order to ensure the successful realisation of the ARV rollout.  &nbsp

Bimodal distribution and set point HBV DNA viral loads in chronic infection:retrospective analysis of cohorts from the UK and South Africa

CITATION: Downs, L. O. 2020. Bimodal distribution and set point HBV DNA viral loads in chronic infection : retrospective analysis of cohorts from the UK and South Africa. Wellcome Open Research, 14(5):113, doi: 10.12688/wellcomeopenres.15941.2.The original publication is available at: https://pubmed.ncbi.nlm.nih.govENGLISH ABSTRACT: Hepatitis B virus (HBV) viral load (VL) is used as a biomarker to assess risk of disease progression, and to determine eligibility for treatment. While there is a well recognised association between VL and the expression of the viral e-antigen protein, the distributions of VL at a population level are not well described. We here present cross-sectional, observational HBV VL data from two large population cohorts in the UK and in South Africa, demonstrating a consistent bimodal distribution. The right skewed distribution and low median viral loads are different from the left-skew and higher viraemia in seen in HIV and hepatitis C virus (HCV) cohorts in the same settings. Using longitudinal data, we present evidence for a stable 'set-point' VL in peripheral blood during chronic HBV infection. These results are important to underpin improved understanding of HBV biology, to inform approaches to viral sequencing, and to plan public health interventions.Publisher's versio

Bimodal distribution and set point HBV DNA viral loads in chronic infection:retrospective analysis of cohorts from the UK and South Africa

CITATION: Downs, L. O. 2020. Bimodal distribution and set point HBV DNA viral loads in chronic infection : retrospective analysis of cohorts from the UK and South Africa. Wellcome Open Research, 14(5):113, doi: 10.12688/wellcomeopenres.15941.2.The original publication is available at: https://pubmed.ncbi.nlm.nih.govENGLISH ABSTRACT: Hepatitis B virus (HBV) viral load (VL) is used as a biomarker to assess risk of disease progression, and to determine eligibility for treatment. While there is a well recognised association between VL and the expression of the viral e-antigen protein, the distributions of VL at a population level are not well described. We here present cross-sectional, observational HBV VL data from two large population cohorts in the UK and in South Africa, demonstrating a consistent bimodal distribution. The right skewed distribution and low median viral loads are different from the left-skew and higher viraemia in seen in HIV and hepatitis C virus (HCV) cohorts in the same settings. Using longitudinal data, we present evidence for a stable 'set-point' VL in peripheral blood during chronic HBV infection. These results are important to underpin improved understanding of HBV biology, to inform approaches to viral sequencing, and to plan public health interventions.Publisher's versio

The Impact of International Legal Rules in Facilitating the Public's Access to Medicines in South Africa

This paper explores the role played by international legal treaties, conventions and agreements that are binding on South Africa, in promoting the public’s access to medicines. In greater detail the impact that the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) of 1994, the Convention on Biological Diversity of 1992, and the United States of America’s Bahy-Dole Act of 1980 have had in the development of South Africa intellectual property (IP) law is examined. In addition, a question regarding whether such international legal instruments have positively impacted the public’s access to medicines is considered. The paper concludes that compliance with international IP law rules is not a silver bullet that will solve South Africa’s challenges relating to access to medicines. The protection of the public’s right to access to medicines in South Africa is strongly dependent on the government’s political will of ensuring that IP law is implemented to serve public good and public and private pharmaceutical patent holders are held accountable regarding the socially-responsible utilization of their IP

Emission factors from road dust resuspension in a Mediterranean freeway

Particulate matter emissions from paved roads are currently one of the main challenges for a sustainable transport in Europe. Emissions are scarcely estimated due to the lack of knowledge about the resuspension process severely hampering a reliable simulation of PM and heavy metals concentrations in large cities and evaluation of population exposure. In this study the Emission Factors from road dust resuspension on a Mediterranean freeway were estimated per single vehicle category and PM component (OC, EC, mineral dust and metals) by means of the deployment of vertical profiles of passive samplers and terminal concentration estimate. The estimated PM10 emission factors varied from 12 to 47 mg VKT?1 (VKT: Vehicle Kilometer Traveled) with an average value of 22.7 ? 14.2 mg VKT?1. Emission Factors for heavy and light duty vehicles, passenger cars and motorbikes were estimated, based on average fleet composition and EPA ratios, in 187e733 mg VKT?1, 33e131 VKT?1, 9.4e36.9 VKT?1 and 0.8e3.3 VKT?1, respectively. These range of values are lower than previous estimates in Mediterranean urban roads, probably due to the lower dust reservoir on freeways. PM emitted material was dominated by mineral dust (9e10 mg VKT?1), but also OC and EC were found to be major components and approximately 14 e25% and 2e9% of average PM exhaust emissions from diesel passenger cars on highways respectively