Introducing an Ethics Framework for health priority-setting in South Africa on the path to universal health coverage.

BACKGROUND: South Africa (SA) has embarked on a process to implement universal health coverage (UHC) funded by National Health Insurance (NHI). The 2019 NHI Bill proposes creation of a health technology assessment (HTA) body to inform decisions about which interventions NHI funds will cover under UHC. In practice, HTA often relies mainly on economic evaluations of cost-effectiveness and budget impact, with less attention to the systematic, specific consideration of important social, organisational and ethical impacts of the health technology in question. In this context, the South African Values and Ethics for Universal Health Coverage (SAVE-UHC) research project recognised an opportunity to help shape the health priority-setting process by providing a way to take account of multiple, ethically relevant considerations that reflect SA values. The SAVE-UHC Research Team developed and tested an SA-specific Ethics Framework for HTA assessment and analysis. OBJECTIVES: To develop and test an Ethics Framework for use in the SA context for health priority-setting. METHODS: The Framework was developed iteratively by the authors and a multidisciplinary panel (18 participants) over a period of 18 months, using the principles outlined in the 2015 NHI White Paper as a starting point. The provisional Ethics Framework was then tested with multi-stakeholder simulated appraisal committees (SACs) in three provinces. The membership of each SAC roughly reflected the composition of a potential SA HTA committee. The deliberations and dedicated focus group discussions after each SAC meeting were recorded, analysed and used to refine the Framework, which was presented to the Working Group for review, comment and final approval. RESULTS: This article describes the 12 domains of the Framework. The first four (Burden of the Health Condition, Expected Health Benefits and Harms, Cost-Effectiveness Analysis, and Budget Impact) are commonly used in HTA assessments, and a further eight cover the other ethical domains. These are Equity, Respect and Dignity, Impacts on Personal Financial Situation, Forming and Maintaining Important Personal Relationships, Ease of Suffering, Impact on Safety and Security, Solidarity and Social Cohesion, and Systems Factors and Constraints. In each domain are questions and prompts to enable use of the Framework by both analysts and assessors. Issues that arose, such as weighting of the domains and the availability of SA evidence, were discussed by the SACs. CONCLUSIONS: The Ethics Framework is intended for use in priority-setting within an HTA process. The Framework was well accepted by a diverse group of stakeholders. The final version will be a useful tool not only for HTA and other priority-setting processes in SA, but also for future efforts to create HTA methods in SA and elsewhere.

Establishing a health promotion and development foundation in South Africa.

South Africa has a 'quadruple burden of disease'. One way to reduce this burden, and address the social determinants of health and social inequity, could be through health promotion interventions driven by an independent Health Promotion and Development Foundation (HPDF). This could provide a framework to integrate health promotion and social development into all government and civil society programmes. On priority issues, the HPDF would mobilise resources, allocate funding, develop capacity, and monitor and evaluate health promotion and development work. Emphasis would be on reducing the effects of poverty, inequity and unequal development on disease rates and wellbeing. The HPDF could also decrease the burden on the proposed National Health Insurance (NHI) system. We reflect on such foundations in other countries, and propose a structure for South Africa's HPDF and a dedicated funding stream to support its activities. In particular, an additional 2% levy on alcohol and tobacco products is proposed to be utilised to fund the HPDF.

Tobacco industry tactics for resisting public policy on health.

The tactics used by the tobacco industry to resist government regulation of its products include conducting public relations campaigns, buying scientific and other expertise to create controversy about established facts, funding political parties, hiring lobbyists to influence policy, using front groups and allied industries to oppose tobacco control measures, pre-empting strong legislation by pressing for the adoption of voluntary codes or weaker laws, and corrupting public officials. Formerly secret internal tobacco industry documents provide evidence of a 50-year conspiracy to "resist smoking restrictions, restore smoker confidence and preserve product liability defence". The documents reveal industry-wide collusion on legal, political and socially important issues to the tobacco industry and clearly demonstrate that the industry is not disposed to act ethically or responsibly. Societal action is therefore required to ensure that the public health takes precedence over corporate profits. Recommendations for reducing the political influence of the tobacco industry include the following. Every tobacco company in every market should publicly disclose what it knew about the addictiveness and harm caused by tobacco, when it obtained this information, and what it did about it. The industry should be required to guarantee internationally recognized basic consumer rights to its customers. Trade associations and other industry groupings established to deceive the public should be disbanded. These recommendations should be incorporated into WHO's Framework Convention on Tobacco Control.

All Africa conference on tobacco control.

Although the health hazards of smoking are now generally accepted in most Western countries, the arguments have not had much impact on poorer nations. A conference on tobacco control held in Harare, Zimbabwe, in November last year was the largest to tackle this problem. The conference heard how threats of epidemics of tobacco related disease in the distant future held little weight with governments of countries that often already had massive public health problems. More immediate effects needed to be emphasised. Speakers gave three cogent arguments; firstly, the loss of capacity for foreign trade in essential goods, since most African countries are net importers of tobacco; secondly, the extensive deforestation which is occurring to fuel the flue curing of tobacco; thirdly, evidence from Papua New Guinea that raising taxation on tobacco provides governments with increased income for many years before a decrease begins.

Comparison of tests used to distinguish smokers from nonsmokers.

Questionnaire and biochemical measures of smoking were studied in 211 hospital outpatients. Eleven different tests of smoke intake were compared for their ability to categorize smokers and nonsmokers correctly. The concentration of cotinine, whether measured in plasma, saliva, or urine, was the best indicator of smoking, with sensitivity of 96-97 per cent and specificity of 99-100 per cent. Thiocyanate provided the poorest discrimination. Carbon monoxide measured as blood carboxyhaemoglobin or in expired air gave sensitivity and specificity of about 90 per cent. Sensitivities of the tests were little affected by the presence among the claimed nonsmokers of a group of 21 "deceivers" who concealed their smoking. It is concluded that cotinine is the measure of choice, but for most clinical applications carbon monoxide provides an acceptable degree of discrimination and is considerably cheaper and simpler to apply.

Reduction of tar, nicotine and carbon monoxide intake in low tar smokers.

Blood nicotine, cotinine, and carboxyhaemoglobin (COHb) concentrations were measured in 392 smokers (255 women and 137 men) of "middle tar" (17-22 mg), "low to middle" (11-16 mg), and "low tar" (less than 11 mg) cigarettes. Since tar intake cannot yet be measured directly, we devised an index to estimate it based on the use of measured levels of an intake marker (eg, blood nicotine) and the ratio of the tar to marker yields of the cigarettes. This approach was validated by its ability to enhance the prediction of levels of one marker by use of another. In a practical test, using COHb and the CO/nicotine yield ratio of the cigarettes, the mean blood nicotine concentration of the low tar smokers was predicted to be 31.9 ng/ml compared with the measured mean of 31.8 ng/ml. Our main findings were that despite substantial compensatory increases in inhalation, the low tar smokers took in about 25% less tar, about 15% less nicotine, and about 10% less carbon monoxide than smokers of middle and low to middle tar cigarettes. These results indicate that low tar cigarettes of the type available in Britain since the late 1970s are likely to prove less harmful than other brands. Monitoring of smoke intakes could supplement epidemiological approaches and provide earlier evidence of whether changing cigarette designs lead to any significant dosage reduction that could affect the risk of disease.

Relationship between cigarette yields, puffing patterns, and smoke intake: evidence for tar compensation?

The relationship between cigarette yields (of nicotine, tar, and carbon monoxide), puffing patterns, and smoke intake was studied by determining puffing patterns and measuring blood concentrations of nicotine and carboxy-haemoglobin (COHb) in a sample of 55 smokers smoking their usual brand of cigarette. Regression analyses showed that the total volume of smoke puffed from a cigarette was a more important determinant of peak blood nicotine concentration than the nicotine or tar yield of the cigarette, its length, or the reported number of cigarettes smoked on the test day. There was evidence of compensation for a lower tar yield over and above any compensation for nicotine. When nicotine yield was controlled for, smokers of lower-tar cigarettes not only puffed more smoke from their cigarettes than smokers of higher-tar cigarettes but they also had higher plasma nicotine concentrations, suggesting that they were compensating for the reduced delivery of tar by puffing and inhaling a greater volume of smoke. The results based on the COHb concentrations were consistent with this interpretation. If an adequate intake of tar proves to be one of the main motives for smoking, then developing a cigarette that is acceptable to smokers and also less harmful to their health will be much more difficult.

Carboxyhaemoglobin and plasma thiocyanate: complementary indicators of smoking behaviour?

Carboxyhaemoglobin and plasma thiocyanate concentrations were measured in 79 non-smokers and 360 cigarette smokers. The mean levels were 0.73% and 7.09% carboxyhaemoglobin and 40 . 2 and 133 . 8 mumol thiocyanate/1 plasma respectively. With 1 . 6% carboxyhaemoglobin and 73 . 0 mumol thiocyanate/1 plasma as critical values the concentrations of carboxyhaemoglobin in 96.6% of subjects and of thiocyanate in 93.4% were compatible with reported smoking status. This difference between the two tests is significant (p less than 0 . 005). Statistical combination of the carboxyhaemoglobin and thiocyanate results, with the use of linear discrimination analysis, only marginally improved their diagnostic efficiency (96.8% of subjects were grouped correctly). This analysis did, however, successfully regroup 21 of 26 individuals with contradictory carboxyhaemoglobin and thiocyanate classifications. It is concluded that in this study determination of thiocyanate added little to the information obtained from carboxyhaemoglobin measurements alone.

Blood carboxyhaemoglobin, plasma thiocyanate, and cigarette consumption: implications for epidemiological studies in smokers.

Carboxyhaemoglobin and plasma thiocyanate concentrations were found to be significantly correlated with self-reported daily cigarette consumption in 360 smokers (r = 0.416 and 0.412 respectively; p less than 0.001). The extent to which inhalation patterns affected the intake of cigarette smoke constituents was determined from the partial correlation between carboxyhaemoglobin and plasma thiocyanate concentrations after the number of cigarettes smoke per day had been allowed for (r = 0.48). Thus 23% of the variation in carboxyhaemoglobin and thiocyanate concentrations was accounted for by the was a cigarette was smoked and a further 21% by the number smoked a day. Furthermore, the relation between carboxyhaemoglobin or plasma thiocyanate and daily cigarette consumption was not linear but reached an asymptote at consumption rates above 25 cigarettes a day. These results suggest that by itself daily cigarette consumption will not identify those smokers most at risk and will also underestimate and dose-response relationship between smoking and selected diseases.

The evaluation of a photometer (the Radiometer OSM2) for the determination of haemoglobin concentration and per cent oxyhaemoglobin and carboxyhaemoglobin in blood.

Haemoglobin concentration and its saturation with oxygen and carbon monoxide were estimated in identical blood samples using an automated two-wavelength photometer (the Radiometer OSM2) and standard methods. The instrument was easy to operate and maintain and, in general, was accurate and repeatable. At carboxyhaemoglobin levels below 1.5%, however, the precision of the instrument was poor.

Nitrous oxide concentrations in the dental surgery, Atmospheric and blood concentrations of personnel.

Pollution in the dental outpatients surgery was assessed by measuring atmospheric nitrous oxide levels and comparing these with the venous blood concentrations in the operator-anaesthetist and his assistant. The effects of scavenging on both measurements have also been determined. Without scavenging the nitrous oxide level in the blood of the dentist was over four times that of the average anaesthetist working in an operating theatre. Some of the factors contributing to these high levels, and the effectiveness of scavenging are discussed.

Blood concentrations of nitrous oxide in theatre personnel.

Blood concentrations of nitrous oxide were measured in anaesthetists, surgeons and theatre nurses. Comparison of anaesthetists and surgeons working in the same theatre showed that in ENT surgeons concentrations were greater (P < 0.01), while in general surgeons they were smaller (P < 0.003). Blood concentrations of nitrous oxide in the "circulating" nurses were low; with scavenging they were unmeasurable. Atmospheric concentrations in the breathing zones were usually greater than the corresponding blood concentrations, but this was not always true. However, a positive correlation between blood and atmospheric concentrations was obtained (r = 0.82). Meticulous use of scavenging devices produced a mean reduction in blood nitrous oxide concentrations of 86% for all groups. The mean blood concentration of nitrous oxide in anaesthetists when scavenging was used was 45 p.p.m. (1.9 micromol/litre). This figure should be taken into account in establishing maximum permitted exposure to nitrous oxide.