The Health Act of 1977, described by Health minister Dr Manto Tshabalala-Msimang as ‘€œthe last vestige of apartheid in health policy’€, has, after a long delay, been replaced by the National Health Act, Act 61 of 2003.

The Act is not yet operational and will become so by proclamation of the President within the next few weeks once the department has completed certain processes.

The National Health Act is framework legislation – it sets out broad legal and operational principles that must be fleshed out in regulations. This could see many sections of the Act being implemented only next year.

Health-e attended a briefing session by the Minister of Health where she highlighted the most critical points in the Act.

Chapter 1 establishes the National Health System. It gives the Minister of Health stewardship over the National Health System and the responsibility to protect, promote and maintain the health of the population. It further consolidates the principle of free health care to those who cannot afford it, in particular women, children, older persons and persons with disabilities. This chapter will be implemented immediately after proclamation.

Chapter 2 begins to bring in some of the transformative elements of this Act which aim to restore dignity to citizens. The chapter gives emphasis to:

• The right to emergency medical treatment;
• The right to have full knowledge of one’€™s condition;
• The right to exercise one’€™s informed consent;
• The right to participate in decisions regarding one’€™s health;
• The right to be informed when one is participating in research;
• The right to confidentiality and access to health records;
• The rights of users to lay complaints about the service; and
• The rights of health workers to be treated with respect.

This chapter will be implemented immediately, except for section 11 (1) as the department will have to develop and publish regulations and guidelines as well as set parameters and criteria for doing experimental and research work in health establishments. Regulations are expected to be in place by early 2005.

Chapter 3 describes the general functions of the national Department of Health and the Director General. It establishes the highest policy body in health which comprises the Minister of Health, the MECs for Health and representatives of local government. This body, which used to be known as the Health MinMec, will now be called the National Health Council.

In this chapter a National Consultative Health Forum is also established. The Minister of Health will consult with this forum of stakeholders in the health sector to promote and facilitate communication and the sharing of information on national health matters. This chapter will also be implemented immediately after the proclamation.

Chapter 4 establishes provincial health services and outlines the general functions of provincial health departments. This chapter also comes into effect immediately after the proclamation.

Chapter 5 establishes the District Health System based on the principles of primary health care, promoting universal access to quality, equitable, responsive and efficient health care services that are accountable to the communities they serve. This chapter will come into effect immediately after proclamation.

Chapter 6 deals with some more interesting and innovative elements, but also some of the more controversial fundamentals, of the National Health Act. They include classification of health establishments; the certificate of need; the establishment of boards for hospitals, clinics and community health centres; the relationship between the public and private health establishments.

According to Tshabalala-Msimang the following objectives were contemplated when writing this chapter into the National Health Act:

-To ensure that each and every health establishment, whether public or private, is registered with the Department of Health;
– To ensure that health establishments, whether public or private, are distributed equitably throughout the country to enable equitable access to health services for everyone;
– To ensure greater public participation in the governance of health establishments, particularly, to improve local accountability and responsiveness to community health needs;
– To establish a set of norms and standards and criteria to be met by all health establishments, whether public or private;

The minister acknowledged that there had been a great deal of speculation in some circles about the certificate of need. ‘€œSome say that the certificate of need is going to force people to practice where they do not wish to practice and to force health establishments to move to rural areas.

‘€œOthers seem to think that it is a US concept that is going to be applied in South Africa in the same way that it is done in America. Others go as far as alleging that it is going to be used to shut down the private health sector,’€ she said.

Tshabalala-Msimang said that the Certificate of Need was just another term for the word ‘€œlicence’€.

‘€œIt is more descriptive than the term ‘licence’ and indicates one of the primary intentions behind the licencing system – to ensure that health establishments meet the needs of the communities they serve,’€ she explained.

Private hospitals and unattached operating theatres are currently licensed under the Health Act of 1977. This is nothing new to them. Their licences can be withdrawn if they do not pass the annual inspections to which they are currently subject. The National Health Act extends the licencing process to all health establishments, including public health establishments.

Tshabalala-Msimang said the Certificate of Need also introduced into the licencing process certain factors which had to be taken into account in order to ensure that the policy objectives were met.

These policy objectives are – a structurally unified and integrated health system, equity in health care, improved access to health services, the implementation of norms and standards and optimal utilization of resources.

The regulations on the certificate of need will only be finalized for implementation during the first half of 2005.

Chapter 7 deals with Human Resources Planning and Academic Health Complexes. The Act mandates the National Department to develop a human resources policy and guidelines to ensure adequate distribution of health personnel, to provide for trained staff at all levels of the health system and to ensure the effective utilization of health personnel.  

Section 50 provides for the establishment of a Forum for Statutory Councils. An informal statutory health council comprising of the chairpersons of all the professional health councils have been working on a transformation agenda. Most of the statutory professional health councils have made significant progress to transform their councils in line with the objectives of a new national health system.

However, there will be a delay in the immediate establishment of the Forum of Statutory Councils as the various councils will have to convene meetings to elect their representatives on the Forum and make their nominations to the Minister.

Section 51 allows for the establishment of academic health complexes consisting of health and educational institutions working together to educate and train health care personnel and to conduct research in health services.

Academic Health Complexes, which the minister is mandated to establish in consultation with the Minister of Education, will be implemented towards the middle of 2005.

Section 52 mandates the National Health Council to develop policy and guidelines to monitor the provision, distribution, development, management and utilization of human resources within the national health system. This will be implemented immediately.

There is another chapter, chapter 10, that deals with inspections of health establishments and compliance with basic norms and standards. The provinces are required to create inspectorates to monitor compliance with the provisions of the Act. This chapter will be implemented immediately with the exception of Section 83 which deals with environmental health investigations. Regulations still need to be drafted for this section to take into account the latest definition of Municipal Health Services and to attend to regulations dealing with disease surveillance and the notification of medical conditions. This section will come into effect next year.

The Director-General must create, within the Department of Health, an Office of Standards Compliance.

The Office of Standards Compliance will be responsible for monitoring and enforcing compliance with the quality requirements and standards prescribed by the Minister with regard to human resources, health technology, hygiene, premises where health services are delivered, business practices, etc.

In accordance with its nature as framework legislation, the Health Act regulates every aspect of health service delivery in South Africa. It does not regulate health professionals in the area of their professional competence and skill because this is the role of the statutory professional councils. It does, however, regulate the premises from which they practise and can also regulate the business or commercial aspects of their practice.

Chapter 8 deals with complex issues such as the control of use of blood, blood products, tissue and gametes in humans. Tshabalala-Msimang stressed the importance of regulating this aspect of health care services as the department receives reports about the sale of human organs for transplantation in South African private hospitals and the purchase of human ova from young South African girls for implantation into foreign nationals so that they can have children.

The Act stipulates that criteria for the approval for organ transplant facilities must be prescribed by the Minister together with procedures to be applied for such approval.

Section 53 empowers the Minister to establish a national blood transfusion service and this section will come into effect as soon as possible in order to ensure a sustainable supply of safe blood and the availability of quality blood products nationally.

The minister stated that she did not want to see any commercialization of the blood transfusion service and therefore a license for providing this service would be granted to a non-profit organization.

This chapter also deals with the issue of human cloning. The manipulation of any genetic material for the purpose of reproductive cloning of a human being is prohibited. Cloning for therapeutic purposes is provided for in the Act but under controlled conditions.

The Minister may permit therapeutic cloning using adult or umbilical cord stem cells under prescribed conditions. Research on stem cells and zygotes which are not more than 14 days old may be conducted with the permission of the Minister and on certain conditions.

This section will be implemented around the middle of next year and in the meantime, the Tissue Act will remain in force until the new regulations are effective.

In Chapter 9, the Act provides for the establishment of a National Health Research Ethics Council and Health Research Ethics Committees at every institution, health agency and health establishment at which health research is conducted. The section relating to the establishment of the National Health Research Ethics Committee and Health Research Ethics Committees will be implemented immediately after proclamation.

The Act provides for the co-ordination and establishment of a national health information system by the National Department of Health. The Minister may prescribe the categories of information that must be submitted to the Department and the manner and format in which the information must be compiled.

The National Health Act permits the regulation of health service delivery in a number of different respects. It allows the department to put strategies into place to develop and retain human resources for the health sector. It also gives the department a vehicle for the control of the quality, efficacy and safety of health practices and services.

Tshabalala-Msimang said this section would ensure that health research that is carried out is worthwhile and addresses the health priorities of the country.

The question of emergency medical treatment can be addressed from a number of different perspectives such as quality and safety but also in terms of licensing issues and the different levels of emergency medical services that may be rendered at different types of facilities.

Regulations can also be made on the processes and procedures to be implemented by the Director-General, in order to obtain prescribed information from stakeholders relating to – health financing, the pricing of health services, business practices within or involving health establishments, health agencies, health workers and health care providers, the form and extent of publication of various types of information, etc.

The idea is to expressly authorize the investigation of the health sector from the point of view of a wide range of business practices, including the setting of tariffs, in order to better inform the public and also the licensing process that is contemplated in the National Health Act.

Health establishments that are engaged in practices that are detrimental to consumers or that unjustifiably restrict access to health care services can expect to be dealt with under the licensing system provided for in the Act.

Perverse incentives add to the costs of health care without adding to the health care itself. In this sense, perverse incentives deprive people of health care because the resources that should have gone to expanding access to services have instead lined the personal pockets of a few individuals.

Chapter 11 will come into effect immediately after proclamation because it empowers the Minister to make regulations on many of the issues that have been mentioned.

Finally, chapter 12 will also come into effect on proclamation in order to empower the Minister to appoint advisory and technical committees, to assign duties and delegate powers and to prescribe transitional arrangements as may be necessary to effect a smooth transition and introduction of various provisions of this Act.

To access the full act please click here