| (d) | continue to operate a health establishment or health agency after the expiration of 24 months from the date this Act took effect, |
without being in possession of a certificate of need.
| (2) | A person who wishes to obtain or renew a certificate of need must apply to the Director-General in the prescribed manner and must pay the prescribed application fee. |
| (3) | Before the Director-General issues or renews certificate of need, he or she must take into account— |
| (a) | the need to ensure consistency of health services development in terms of national, provincial and municipal planning; |
| (b) | the need to promote an equitable distribution and rationalisation of health services and health care resources, and the need to correct inequities based on racial, gender, economic and geographical factors; |
| (c) | the need to promote an appropriate mix of public and private health services; |
| (d) | the demographics and epidemiological characteristics of the population to be served; |
| (e) | the potential advantages and disadvantages for existing public and private health services and for any affected communities; |
| (f) | the need to protect or advance persons or categories of persons designated in terms of the Employment Equity Act, 1998 (Act No. 55 of 1998), within the emerging small, medium and micro-enterprise sector; |
| (g) | the potential benefits of research and development with respect to the improvement of health service delivery; |
| (h) | the need to ensure that ownership of facilities does not create perverse incentives for health service providers and health workers; |
| (i) | if applicable, the quality of health services rendered by the applicant in the past; |
| (j) | the probability of the financial sustainability of the health establishment or health agency; |
| (k) | the need to ensure the availability and appropriate utilisation of human resources and health technology; |
| (m) | if applicable, compliance with the requirements of a certificate of non- compliance. |
| (4) | The Director-General may investigate any issue relating to an application for the issue or renewal of a certificate of need and may call for such further information as may be necessary in order to make a decision upon a particular application. |
| (5) | The Director-General may issue or renew a certificate of need subject to— |
| (a) | compliance by the holder with national operational norms and standards for health establishments and health agencies, as the case may be; and |
| (b) | any condition regarding— |
| (i) | the nature, type or quantum of services to be provided by the health establishment or health agency; |
| (ii) | human resources and diagnostic and therapeutic equipment and the deployment of human resources or the use of such equipment; |
| (iii) | public private partnerships; |
| (iv) | types of training to be provided by the health establishment or health agency; and |
| (v) | any criterion contemplated in subsection (3). |
| (6) | The Director-General may withdraw a certificate of need— |
| (a) | on the recommendation of the Office of Standards Compliance in terms of section 79(7)(b); |
| (b) | if the continued operation of the health establishment or the health agency, as the case may be, or the activities of a health care provider or health worker working within the health establishment, constitute a serious risk to public health; |
| (c) | if the health establishment or the health agency, as the case may be, or a health care provider or health worker working within the health establishment, is unable or unwilling to comply with minimum operational norms and standards necessary for the health and safety of users; or |
| (d) | if the health establishment or the health agency, as the case may be, or a health care provider or health worker working within the health establishment, persistently violates the constitutional rights of users or obstructs the State in fulfilling its obligations to progressively realise the constitutional right of access to health services. |
| (7) | If the Director-General refuses an application for a certificate of need or withdraws a certificate of need the Director-General must within a reasonable time give the applicant or holder, as the case may be, written reasons for such refusal or withdrawal. |
