Human Tissue Regulations: Insights and Implications

1. National Health Act: Regulations to Chapter 8 Presentation to the Parliamentary Portfolio Committee on Health 5 June 2013

2. The National Health Act 61 of 2003 Definitions • “tissue” means human tissue, and includes flesh, bone, a gland, an organ, skin, bone marrow or body fluid, but excludes blood or a gamete;

3. Regulations Relating to the Use of Human Biological Material Definitions • “biological material” means material from a human being including DNA, RNA blastomeres, polar bodies, cultured cells, small tissue biopsies and growth factors from same

4. Regulations Relating to Tissue Banks Definitions • “tissue” means a functional group of cells. The term is used collectively in Regulations to indicate both cells and tissue

5. Regulations Relating to the Import and Export of Human Tissue, Blood, Blood Products, Cultured Cells, Stem Cells, Embryos, Foetal Tissue, Zygotes and Gametes Definitions • “substance” means tissue, blood, blood product or gamete

6. Regulations Regarding Rendering of Clinical Forensic Medicine Services Definitions • “Body specimen” means any body sample which can be tested to determine the presence or absence of HIV infection

7. Contradiction in definitions • NHA definition of tissue excludes gametes • The Regs on Use of Human Biological Material includes gametes under the definition of biological material. • The Regs on Tissue banks – “tissue” includes both tissue and cells

8. Human Tissue • The NHA and Regulations do not provide for the legal classification of “Human Tissue”

9. Informed Consent • Informed consent for consent for the removal of human biological material from living and deceased persons for research/study purposes is adequately dealt with. • A distinction must be drawn with the issue of specific informed consent relating to the future use of human biological material. This particular consent is not provided for in the Act or Regulations.

10. Ownership of Human Tissue • Fundamental question is: Who owns the tissue once it is withdrawn from the person? • Further, what information must be provided to the user in obtaining such informed consent? • Regulations are silent on this matter with the exception of the Regulations Relating to the Artificial Fertilisation of Persons. • If “ownership” of tissue is transferred to a research facility the tissue may be used for purposes other than that which informed consent was provided for.

11. Ownership of Human Tissue • Further considerations include: • Is the donor or consenting party entitled to a share of the revenue streams arising from the use of their tissue, or would this constitute trafficking in organs / tissue? • No protection afforded to the user for unscrupulous or unauthorised subsequent use of their tissue.

12. Conclusion • Academic scientists working in the field of human tissue are extremely confused regarding the meaning and practical implications of possession, custodianship, ownership, database rights and intellectual property relating to human tissue. Further confusion is created by the conflicting descriptions and definitions of human tissue and related concepts in the National Health Act and Regulations

13. Acknowledgements • We gratefully acknowledge the consent of the following authors to reproduce portionstheir work here: • Safia Mahomed • M Nothling Slabbert • Michael S Pepper From their article “The Legal Position of the classification of human tissue in South Africa” ,“In Press – SAJBL, June 2013”

14. Questions ▪ Thank You

15. Julian Botha Senior Legal Advisor South African Medical Association Tel: (012) 481 2060Fax: (012) 481 2100Email: julianb@samedical.org