Question

Talk about Health policy, legislative and regulatory landscape in South Africa

Answer 1

Health policy

In South Africa, private and public health systems exist in parallel. The public system serves the vast majority of the population, but is chronically underfunded and understaffed. The wealthiest 20% of the population use the private system and are far better served. In 2005, South Africa spent 8.7% of GDP on health care, or US$437 per capita. Of that, approximately 42% was government expenditure. About 79% of doctors work in the private sector. It has the highest levels of obesity in sub-Saharan Africa.Constitutional and organizational context of South African health system South Africa has an estimated population of 54 956 900 (1), the majority of whom access health services through government-run public clinics and hospitals. The health system comprises the public sector (run by the government) and the private sector. The public health services are divided into primary, secondary and tertiary through health facilities that are located in and managed by the provincial departments of health. The provincial departments are thus the direct employers of the health workforce while the National Ministry of Health is responsible for policy development and coordination. South Africa’s Constitution guarantees every citizen access to health services (section 27 of the Bill of Rights). However, everyone can access both public and private health services, with access to private health services depending on an individual’s ability to pay. The private health sector provides health services through individual practitioners who run private surgeries or through private hospitals, which tend to be located in urban areas. The health care system consumed about 8.8% of the country’s gross domestic product during 2012 (2). The majority of patients access health services through the public sector District Health System, which is the preferred government mechanism for health provision within a primary health care approach. The private sector serves 16% of the population while the public sector serves 84% (3). The country’s population distribution indicates that about 64.7% inhabit the provinces that are largely rural in nature. Some of these provinces contain large cities, though the bulk of the population lives in rural communities. Table 1 shows population estimates and distribution by province. There is realization that the health workforce plays a critical role in advancing the health system goals, largely driven by a policy position of improving access to health care for all citizens.

LEGISLATIVE POLICY

South Africa has a 'hybrid' or 'mixed' legal system,formed by the interweaving of a number of distinct legal traditions: a civil law system inherited from the Dutch, a common law system inherited from the British, and a customary law system inherited from indigenous Africans (often termed African Customary Law, of which there are many variations depending on the tribal origin). These traditions have had a complex interrelationship, with the English influence most apparent in procedural aspects of the legal system and methods of adjudication, and the Roman-Dutch influence most visible in its substantive private law.As a general rule, South Africa follows English law in both criminal and civil procedure, company law, constitutional law and the law of evidence; while Roman-Dutch common law is followed in the South African contract law, law of delict (tort), law of persons, law of things, family law, etc. With the commencement in 1994 of the interim Constitution, and in 1997 its replacement, the final Constitution, another strand has been added to this weave.

Besides South Africa itself, South African law, especially its civil law and common law elements, also forms the basis of the laws of Botswana, Lesotho, Namibia, Swaziland and Zimbabwe, which were introduced during the process of colonisation. Basutoland (Lesotho) received the law of the Cape Colony in 1884, and Bechuanaland (Botswana) and Southern Rhodesia (Zimbabwe) received it in 1891.Swaziland received the law of the Transvaal Colony in 1904,and South-West Africa (Namibia) received the law of the Cape Province in 1920, after its conquest by South Africa.In addition, a number of specialized courts have also been created by the legislation in order to deal with specialized areas of law important to the public as well as to avoid a backlog in the main legal administration infrastructure. These courts exist alongside the court hierarchy; their decisions are thus subject to the same process of appeal and review through the normal courts, starting at a specific level depending on the specialized court in question. Within these specialized courts, there exist, to name a few, the Competition Appeal Court, the Electoral Court, the Land Claims Court, and the Labour and Labour Appeal Court.

In addition, African indigenous courts, which deal exclusively with the indigenous law, also exist. A draft Traditional Courts Bill aimed at introducing a Traditional Court below, or on the same level as the Magistrates Courts has been penned, but awaits parliamentary introduction, reading and debate.

REGULATORY LANDSCAPE

Ensuring effective medicine regulation through the strengthening of regulatory systems and improvement of regulatory performance has become a priority for both NRAs and governments worldwide. With the support of government NRAs are responsible for protecting and promoting public health, implementing rigorous regulatory standards and maintaining an assured supply of medical products that are safe, effective and of good quality.The drive for improved regulatory systems and the establishment of a more effective regulatory framework in South Africa has been evident for the past two decades but despite political intentions and legislative revisions success has been limited to date. Efforts to address the increasing volume of applications that have been received have to date failed and resources have been stretched to capacity resulting in the development of a significant backlog and extended timelines for product registration. The promulgation of the recently amended Medicines and Related Substance Act of 1965 triggered the establishment of the South African Health Products Regulatory Authority (SAHPRA) as a separate juristic person outside of the National Department of Health to replace the former medicine regulatory authority the Medicines Control Council (MCC). The aim of this review is to provide the historical context supporting the new regulatory environment in South Africa and the transition from the MCC to SAHPRA. Key recommendations to SAHPRA to ensure the full potential of the new regulatory environment in South Africa include: establishing a quality management system to safeguard accountability, consistency and transparency and to streamline the implementation of good review practices including quality decision-making practices and benefit-risk assessment; the measurement and monitoring of regulatory performance, targets for overall approval time and key review milestones to instill a culture of accurate metrics collection and measurement of key performance indicators and their continuous improvement and the employment of a risk-based approach to the evaluation of medical products and codify the use of facilitated regulatory pathways in policy and culture. The application of a risk-based approach to regulatory review commensurate with a product’s risk to patients will facilitate the application of increased resources for pharmacovigilance activities and to support the reliance and recognition of reference agencies.