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Date : 19/08/2004
Source: Ministry of Health
Title: M Tshabalala-Msimang: National Health Act


BRIEFING BY MINISTER OF HEALTH, DR MANTO TSHABALALA-MSIMANG ON THE NATIONAL HEALTH ACT, 19 August 2004

I am elated that, after a long incubation period, we can now deliver the National Health Act, Act 61 of 2003, to the people of South Africa. I therefore wish to express my appreciation to the South African Parliament for passing this Act and to thank President Thabo Mbeki for signing the Bill into an Act.

The purpose of today's briefing is to inform the public about how we intend to implement this Act and to outline a schedule of when certain sections of the Bill will be implemented.

This Act replaces the last vestige of apartheid in health policy * the Health Act of 1977. It also provides a framework for a structured uniform health system in order to unite the various elements of the national health system in a common goal to improve universal access to quality health services, taking into account the obligations imposed by the Constitution.

This Act rests heavily on the Constitution with some 50 sections of the Constitution relating directly to what is covered in the Act. You will recall that in terms of section 27(2) of the Constitution, the State must take reasonable legislative and other measures to progressively achieve the right of access to health care services, and reproductive health care, within its available resources. The National Health Act is one of those legislative measures contemplated by the Constitution.

The Act also covers such Constitutional issues as:
The right of children to basic health services Everyone's right to an environment that is not harmful to health or well-being. And the right to emergency medical treatment.

Other constitutional rights that are directly involved in the delivery of health care services are:

The right to dignity;
The right to equality;
The right to life;
The right to bodily and psychological integrity;
The right to privacy
The right to freedom of conscience, religion, thought, belief and opinion
The right to choose one's trade, occupation or profession freely.

All these Constitutional provisions indicate why this Act is regarded as the single, most important piece of legislation for the health sector. I must stress that it is not yet operational. It will be proclaimed into operation by the President once we have completed certain processes.

The National Health Act is very complex in both its scope and its objects. It also entrenches many principles of health policy developed over the years.

The National Health Act is framework legislation. This means that it sets out broad legal and operational principles that must be fleshed out in regulations. We will be publishing regulations for public comment and I urge you to watch out for them in the coming months so that you can give your views on them.

Allow me now to take you through each of the 12 chapters of this Act and indicate when we intend implementing them. I will also make reference to some of the sections worth noting within these chapters. In general, there are sections that we are going to recommend to the President that they be implemented as soon as the Act is proclaimed. And there are those that will require development of relevant regulations and some groundwork by national and provincial departments. Those sections will therefore be implemented from the beginning to middle of 2005.

Chapter 1 of this Act 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 the dignity of every citizen. This 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), because we have to develop and publish regulations and guidelines as well as set parameters and criteria for doing experimental and research work in health establishments. This may take a while, but I am confident that these regulations will be in place early in 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, thus giving meaning to the people's contract that government is promoting in all sectors of society. 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. To give effect to these principles, this chapter provides for a planning framework for health services, governance and consultative structures. This chapter will come into effect immediately after proclamation.

Chapter 6 deals with one of the most interesting and innovative elements of the National Health Act 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.

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;

There has been a great deal of speculation in some circles about the certificate of need. Some 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. Others 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.

Allow me then to set the record straight on this subject. The Certificate of Need is just another term for the word 'license'. It is more descriptive than the term 'license' and indicates one of the primary intentions behind the licensing system to ensure that health establishments meet the needs of the communities they serve.

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

It also introduces into the licensing process certain factors, which have to be taken into account in order to ensure that the policy objectives are 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 utilisation of resources.

The Certificate of Need is an administrative tool that will ensure that, over time, health services are distributed evenly and equitably in South Africa. Surely no one can find fault in a principle to provide quality health services accessible to every citizen of our country.

Obviously, as some will say, the devil will be in the detail. And this is why the certificate of need that is described in sections 36: 41 will not be implemented immediately. We are in the process of drafting the necessary regulations for implementing the certificate of need, regulating initiation schools where the practice of circumcision takes place and establishing governance structures for health establishments.

The regulations on the certificate of need, because of their complex nature, will only be finalised for implementation during the first half of 2005.

Therefore, I appeal to all of us particularly the private health care industry, to understand the aims and objectives for introducing the certificate of need, and to be patient until we publish these regulations. Stakeholders and the general public can engage the Department during the comment period to ensure that what will come out of that process will be a product that we can all live with.

We have limited resources with which to meet the increasing health care needs of our population. We therefore, have to cultivate a favourable environment for sustainable growth of both the public and private sector for us to address our health challenges.

The Department of Health is in the process of reviewing its staff organogram to accommodate the creation of the Office of Standards Compliance and the Inspectorate for Health Establishments, which are required in terms of Section 47 (3) of this Act. Therefore, we will not implement the relevant sections of the Act immediately because a lot of groundwork is required to put these institutions in place.

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 utilisation of health personnel.

You may be aware that we have recently created and filled a new post of a Deputy Director General: Human Resources who would give full attention to the development of our most precious asset in the health service * our human resources.

Section 50 provides for the establishment of a Forum for Statutory Councils. You may recall that we have had an informal statutory health council comprising of the chairpersons of all the professional health councils, which 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.

The only reason that will delay the immediate establishment of the Forum of Statutory Councils is the fact that 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 I am mandated, to establish in consultation with my colleague, the Minister of Education, will be implemented towards the middle of 2005, as intensive consultation is required with the Department of Education and the provincial health departments, which must identify the health establishments, to be used for training health personnel.

Section 52 mandates the National Health Council to develop policy and guidelines to monitor the provision, distribution, development, management and utilisation 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. We will implement this chapter immediately with the exception of Section 83, which deals with environmental health investigations. We still need to draft regulations 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. This is going to be a very important unit within the Department.

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 practice 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. I am sure you will appreciate the importance of regulating this aspect of health care services as we get 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.

We do not believe that the human body should be exploited as a commodity. This is contrary to the value of human dignity reflected in the Constitution. While we acknowledge the important role that human tissue play in the delivery of health care services we must be careful to protect the values of human dignity and freedom.

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. Blood is a national resource that should be distributed throughout the country and should be accessible to all who need it. We do not want to see any commercialisation of the blood transfusion service and therefore a license for providing this service will be granted to a non-profit organisation.

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.

We are busy drafting regulations to deal with the complex subjects of human cloning and organ transplant as well as the migration of some regulations from the current Tissue Act to this Act.

This is going to take a bit of time. We foresee that 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 to protect the public from unscrupulous research.

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.

It is critical to have reliable data that can be used to design health programmes, facilitate health planning, and identify gaps in the health system and support health research. Data is also critical for evaluation of our programmes and to determine whether we are meeting our objectives.

We will, therefore, implement sections 74 * 76, which empower the Minister to ensure the coordination and harmonisation of the National Health Information System.

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

We can ensure that health research that is carried out is worthwhile and addresses the health priorities of our 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.

Reproductive health care is a critical aspect of health services especially given the prevalence of sexually transmitted infections in South Africa, the challenges of gender imbalances and the major problem of violence against women and children.

There are major advances being made in medical science using new technologies and it is important to ensure that we have access to them but also that they are used responsibly and for the benefit of patients. The National Health Act allows the Minister to make regulations on health technology and health research.

The regulation of health technology is something the Department has been working on for a while. There are a number of aspects of health technology that must be regulated. The regulation of health technology is a complex issue with many implications for the safety and health of patients.

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 authorise 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 greedy and selfish individuals.

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

Finally, chapter 12 will also come into effect immediately 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.

This Act is an important step forward in the transformation of the South African health sector. We therefore intend to use this National Health Act in achieving our policy objectives and improving access to quality health care services for all.

I thank you!

Issued by: Ministry of Health
19 August 2004

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