South African Organ Donor Agencies – regulatory issues

A discussion about Organ Donor Agencies and their regulation in South Africa.

Introduction


Egg donor agencies exist in South Africa.  These assist the international egg donor agencies in procuring donors for international recipients. There are nine such donor agencies in South Africa:  Ababy SA, Baby2Mom, Donor Life, Egg Donation SA, Gift Ov Life, Match Making Donors, Nurture, The Sunshine Agency and Veda.

 
These agencies have to subscribe the Southern African Society of Reproductive Medicine and Gynaecological Endoscopy (SASREG) in order for them to practise in South Africa. [1] SASREG represents Gynaecologists with a special interest in Gynaecological Endoscopy and Reproductive Medicine (infertility, reproductive endocrinology, menopause and contraception), Sub-Specialists in Reproductive Medicine, Embryologists Scientists working in the field of Reproductive Medicine Fertility and Theatre Nursing Sisters and Allied practitioners in the field of Gynaecological Endoscopy and Reproductive Medicine. [2] However, SASREG does not regulate the donor agencies.
 
 

Current regulation:  South Africa
 

The donor agencies mentioned above have to abide by SASREG guidelines, the National Health Act (NHA) 61 of 2006, particularly Chapter 8, and other miscellaneous laws. 
SASREG guideline dated 5th December 2012 sets out guidelines for donor agencies. [3]
 
Guideline 1 deals with advertising egg donation.  It requires that statements about “earning money” or “financial gain” in advertising to donors should be avoided, but that the reference to reimbursement or compensation is acceptable.
 
Guideline 2 says that donors must be fully informed, especially of the possible risks and side effects of donation. A psychologist must assess donors.  Agencies are required to find out from the donors how many times they have donated, as donors are limited to six donations. Regulation 6 of the regulations to the NHA states that a donor can legally not have had more than six live births [4]. 
 
This guideline further deals with the timing of the donations so as to protect the donors. Back to back donations are not permitted.  All donors are to be anonymous unless they are regarded as a “known donor” in terms of the NHA [5]. The donor agencies are allowed, however, to show baby or child photos of the donors up to the age of ten. No contact is permitted between the donor and the potential child in the future. The donor should have a profile which states the donor’s health and mental status.  The health of the donor need always be taken into account. The donor agencies are also obliged to give accurate information to the recipient couple regarding the health of the donor. [6]
Donors have to be 18 years of age or more, but it is recommended that donors should be at least 21. 
 
Donor Agencies must certify that they agree with the SASREG guidelines.  Once they have done so, their names will be put onto the SASREG website.  Those who do not follow these guidelines are removed for a minimum period of a year.  This is a deterrent, as accredited donor clinics will only deal with listed agencies on the SASREG website. This is subject to change as SASREG intends to change this requirement of the donor agencies being listed on their website. [7]
 
Doctors, clinics and lawyers are encouraged to disclose any ownership or financial or commercial relationship that they might have with donor agencies. This guideline goes on to further prohibit any form of financial transaction between the donor agency and the donor. Only the fertility clinic may reimburse the donor.  Section 60(4) of the NHA only allows for reasonable re-imbursement.  Anything above what is considered reasonable is contrary to the law. It is not clear what is considered reasonable in the circumstances. [8]
 
Under no circumstances are donor agencies allowed to obtain a referral fee or other payments from a clinic. [9]
 

International donations
 

A problem may arise when the South African donors go to another country to donate as South African law does not apply if South African citizens go to another country to donate. Donors would be regulated by the laws of the country within which they go to donate.
 
The problem is that the safety and health risks to donations are real. Who is going to pay for the medical costs in the event of a complication arising from such a donation? There is a need for international regulation with regard to such donations. 
 

Conclusion
 

Although South African donor agencies are not yet regulated in terms of South African law, their work is commendable in that they assist people to have children by finding a donor. SASREG currently has no power to regulate these agencies, so the agencies need either self-regulation or regulation by government. The donor agencies are moving towards self-regulation. This will protect donors, donor agencies and recipients in South Africa.  However, donors who donate abroad will continue to be at risk until adequate international regulation has been put in place. This will curb exploitation and protect the donor, the recipient and the agency, should problems arise in the donation process. 
 
Arvitha Doodnath 
Legal Researcher 
arvitha@hsf.org.za
 
 

Sources:
 

1. http://www.fertilitysa.org.za/EggDonation/index.asp
2. http://www.fertilitysa.org.za
3.  SASREG Guidelines for egg donation agencies dated 5th December 2012.
4.  Government Gazette No. 35099 vol. 561 dated 2 March 2012. 
5. Chapter dealing with artificial fertilization.
6. Guideline 2 (a) – (j) of the SASREG Guidelines for egg donation agencies dated 5th December 2012.
7. Guideline 3 of the SASREG Guidelines for egg donation agencies dated 5th December 2012.
8. Guideline 4 of the SASREG Guidelines for egg donation agencies dated 5th December 2012.
9. Guideline 5 of the SASREG Guidelines for egg donation agencies dated 5th December 2012.
10. Guideline 6 of the SASREG Guidelines for egg donation agencies dated 5th December 2012.