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National Health Act, 2003 (Act No. 61 of 2003)


Regulations relating to Human Stem Cells

Chapter 1

5. Keeping of records and reporting obligations


(1) The stem cell establishment shall keep—
(a) a register of stem cell donors in which it shall be entered at least the following particulars pertaining to each stem cell donor from whose body the stem cell establishment has obtained stem cells:
(i) The surname, first name and initials or the other names;
(ii) the gender;
(iii) the date of birth or approximate age if the former is not available;
(iv) identity number;
(v) the address;
(vi) the nature and quantity of the stem cells concerned;
(vii) reason for acquiring the stem cells; and
(viii) a record of the written informed consent;
(b) a record of stem cell donations in which it shall be entered the following information:
(i) a unique identifiable code which will be traceable to the stem cell donor while protecting the donor's anonymity;
(ii) the date and place of retrieval from the body of the relevant donor;
(iii) the name of the competent person who removed the stem cell from the relevant donor;
(iv) the name and address of the organisation, institution or person from whom the stem cell concerned was received;
(v) the date on which stem cell concerned was received from the organization, institution or person referred to in (iv);
(vi) the results of tests for transplantation transmittable diseases and/or genetic traits;
(vii) the results of tissue typing if available;
(viii) whether any serious adverse events or reaction or death was reported following upon the treatment and the serial number of the entry in respect of the reaction or death as recorded in the register of adverse events or reactions, including transplantation communicable or genetic transmittable diseases;
(ix) if the stem cells was condemned or discarded—
(aa) the date on which it was condemned or discarded;
(bb) the reason for which it was condemned or discarded;
(cc) the method used for discarding; and
(x) any stem Cells rejected and the reasons for the rejection:
(c) a record of statistics in respect of stem cells, in which it shall be entered at least the following information in respect of all the stem cells donations and the supply of such stem cells by the stem cell establishment over each month:
(i) the number of stem cell donors and recipients;
(ii) the type and total number of stem cells supplied;
(iii) the names and addresses of the organisations. institutions or persons to whom the cell was supplied (public and private);
(iv) the number of cells which were condemned or discarded and the reason for which they were condemned or discarded:
(v) the nature and number of cells which gave results indicative of microbial contamination or genetic disease;
(vi) the number of serious adverse events or reactions, including transplantation communicable or genetic transmittable diseases, or deaths entered in the register referred to in paragraph (d); and
(vii) the number of stem cells in storage and the period for such storage.
(d) a system in place to receive, investigate, register and transmit information to the Director General about serious adverse events and reactions which may influence the quality and safety of stem cells and which may be attributed to the procurement, testing, processing, storage and distribution of stem cells as well as any serious adverse reaction observed during or after clinical application which may be linked to quality and safety of cells;
(e) an accurate, rapid and verifiable procedure in place which will enable it to recall from distribution any product(s) which may be related to a serious adverse events or reaction.


(2) The stem cell establishment must—
(a) inform the Director-General of any change in its name, address, medical director or responsible person;
(b) provide the inspector of anatomy for the area in which the tissue or stem cell was supplied immediately with the information referred to in subregulation (1)(c); and
(c) inform the Director-General in writing if it no longer intends to carry out the activities referred to in regulation 2(1)(a) and (b).


(3) The inspector of anatomy shall submit a monthly report on the reports received in terms of subregulation (2)(b) to the Director-General.


(4) Any payment made according to section 60(1)(a) and (b) of the Act must be recorded and this includes the amount paid, the person to whom payment was made, the reason for payment and the person who made the payment, according to section 60(4)(a) of the Act.


(5) Strict confidentiality must be observed by all employees of the stem cell establishment with regard to all information in its possession pertaining to tissue or stem cell donors and recipients.