By: Andrew Martin (B.Soc.Sci LL.B)
Contact: info@fertilitylaw.co.za
In recent years assisted reproductive technology (ART) has offered hope to those struggling
with infertility in South Africa. Sperm, oocytes, and embryos can now be frozen at various
stages of development, allowing for safer and more successful ART treatments as well as
allowing for the cryopreservation of gametes and embryos for fertility preservation. In addition,
the length of time that embryos and gametes can be stored in a cryopreserved state has
increased. Thus allowing for couples to keep trying for longer and longer periods. However, it
has also had some unintended consequences. One of these unintended consequences
relates to the fate of embryos or gametes that may be “surplus” or left over after couples finish
their treatment or where something happens to the patients and they are no longer able to
provide their informed consent.
As couples and individuals embark on the journey of assisted reproduction, with the hope of
becoming parents, there are questions that these patients and couple’s might not ask or even
consider – What will happen to my embryos or gametes in the unfortunate event of a divorce,
separation or the death of my spouse? If I have frozen embryos or gametes can my spouse or
partner use them after my death? Who is the owner of our embryos or gametes in the event
of our divorce, separation or my death or that of my spouse? What becomes of our embryos
or gametes on completion of ART treatment or if we take the decision to discontinue ART
treatment? What happens to our embryos or gametes if we fail to pay our storage fees? Most
couples are too busy focusing all of their energies and attention on just getting through the
ART process (in the hopes of coming out the other side of treatment with what they want most,
a baby (and in some instances babies).
However, the result of not considering, discussing, and correctly recording what happens to
your cryopreserved embryos or gametes, should any of these unintended consequences
occur, is potentially devastating.
The question of ownership of gametes and embryos answered:
The Regulations: Artificial Fertilisation of Persons1 promulgated in terms of the National Health
Act, No. 61 of 2003, regulates ownership of gametes, zygotes and embryos. Regulation 18 states that before artificial fertilisation, the ownership of a gamete donated for the purposes
of artificial fertilisation is vested in the case of:
a) a male gamete donor, for the artificial fertilisation of a Recipient, in the authorised
institution that intends to effect artificial fertilisation;
b) in the case of a male gamete donor, for the artificial fertilisation of his spouse, in that
male gamete donor; and
c) in the case of a female donor, for the artificial fertilisation of a Recipient, in that female
gamete donor.
After fertilisation, the ownership of a zygote or embryo effected by donation of male and
female gametes is vested, in both the case of a male and female gamete donor, in the
Recipient.
A question you may ask is – what are the consequences of this?
a) Where you, as a gamete donor (egg/sperm), donate gametes for the purposes of
artificial fertilisation of an unknown Recipient, then the authorised institution that will be
doing the artificial fertilisation procedure will be the owner of your gametes.
b) Where you, as a gamete donor (egg/sperm), donate gametes for the purposes of
artificial fertilisation of a known Recipient, then depending on the wording of your
Known Gamete Donation Agreement (which you are legally required to enter into with
the Recipient and his/her partner), you will either retain ownership of your gametes, or
you will transfer ownership in or to any cryopreserved gametes.
c) Where you, as an individual or spouse, provide gametes for the purposes of artificial
fertilisation, including storage for the purposes of fertility preservation, and these
gametes are cryopreserved prior to fertilisation, ownership is retained in your personal
capacity.
d) After fertilisation, ownership of the zygote or embryo is that of the Recipient. In most
cases this means your spouse (female partner in whose reproductive organs the
embryo is scheduled to be placed). For some couples, this means their surrogate is
technically the owner of their embryos.
Where parties have entered into ART treatment as a couple and the intention of both parties
is for their embryos to be co-owned, the Clinic that is assisting the couple, should provide them
with a consent to treatment. This consent should make some mention of or attempt to confirm
that ownership in of any embryos which are not used and cryopreserved, is shared and/or coowned.
In most instances this aspect is not canvassed and/or recorded correctly in the
consent that couples sign. The result of this is that questions of ownership of embryos could
lead to bitter fights as to who is the owner and who is entitled to use the embryo. This is
especially pertinent in situations where couples get divorced or separate or where one partner
withdraws from ART. Even more so in cases where donor gametes (egg or sperm) have been
used to create a couple’s embryos and the partner wanting to use the embryos is the only
genetic part of the embryo and the owner, is not.
What happens to our embryos or gametes should something happen to one or both of us and
we are not able to provide the necessary informed consent?
Regulation 10(2)(d) of the Regulations: Artificial Fertilisation of Persons places a positive
obligation on a competent person (normally the treating doctor) to destroy an embryo that
has been unclaimed by a Recipient for a period of 10 years. The Regulations however do not
mention gametes and what happens to them if they are abandoned. The law or regulations
are also silent on what happens to a couple’s embryos or gametes in the unfortunate
circumstance of death (either partner or simultaneous), divorce, incapacitation, withdrawal
from the ART program by a partner or the patient, or the reaching of the recommended
treatment age limitation set by the South African Society of Reproductive Medicine and
Gynaecological Endoscopy (SASREG) of between 50-55years old. Although hard to consider
and discuss, it is important for patients and couples to decide on what happens to any
embryos, or gametes, fresh or cryopreserved that remain in the laboratory and are
cryopreserved for later use, and to record their decision in a formal legal document.
The law relating to ownership in South Africa is clear and unambiguous, embryos and gametes
are understood to be your property, but the ability to transfer ownership in and use of, is limited,
and in all honesty incomplete. Currently the law does not consider the unintended
consequences that life brings. The clinic and you as the patient are legally prohibited from
using or transferring these embryos or gametes without the consent of both partners (if
applicable), together with a clear indication of the intention of both partners. It is a legal
requirement that this intention is contained in a written document, which is signed by yourself,
and in the case of a couple, by both partners, and witnessed by at least two competent
witnesses. Without this, the embryos will be destroyed after being unclaimed for a period of 10
years and the gametes will merely remain in a cryopreserved state forever. Without a formal
legal disposition or agreement, you or your partner, whichever the case may be, will not be
able to use them without first approaching the Courts. This, in most cases, is prohibitively
expensive and will add unnecessary expense to an already costly and emotional journey.
Does my consent form that I sign at the clinic not sufficiently regulate this?
In most instances, the consent to medical treatment that couple’s sign with the clinic is
insufficient to properly regulate what happens to cryopreserved embryos or gametes and will
in all likelihood confirm that in the absence of a disposition agreement (or similar document)
that any embryos or gametes will be thawed and discarded should any unintended
consequences occur (death, divorce, disagreement, incapacitation, withdrawal of consent,
etc.).
As this is a rapidly evolving field, both medically and legally, the clinic involved cannot
guarantee what will be available or acceptable avenues for disposition at any future date.
Currently the alternatives available to couples and Recipients are to:
– Thaw and discard the cryopreserved embryos or gametes;
– Donate the cryopreserved embryos or gametes for approved research/medical studies;
– Donate the cryopreserved embryos or gametes to another couple in order to attempt
pregnancy. This can be both as an anonymous donation or to a couple or individual that
you know;
– Allow your surviving or non-incapacitated partner to use the embryos or gametes with the
contemporaneous permission of the other for that use.
What is an Embryo or Gamete Disposition Agreement?
An Embryo or Gamete Disposition Agreement is a formal legal agreement that can be
compared to an ante-nuptial contract which couples sign prior to getting married, coupled
with an advance directive for ART. The Embryo or Gamete Disposition Agreement will regulate
what happens to a patient’s or couple’s embryos or gametes, should a specific unintended
consequence occur. In particular, it will regulate what happens to their embryos or gametes
should the couple get divorced/separated, or should either or both pass away, or should either
or both become incapacitated and unable to provide their consent, or should either or both
reach the SASREG age limit of 55 years old, or should a certain period of time elapse, or should
there be a disagreement relating to any further treatments and the necessary consent of one
partner is withdrawn.
Such a disposition agreement is an authoritative instruction given by a legally competent
couple or Recipient, regarding the type of treatment and in this case, the disposition of any
embryos or gametes, that are cryopreserved and stored at a clinic. Advance directives
originated in the context of end-of-life treatment where people indicate what kind of
treatment may be performed when they can no longer decide for themselves. Advance
directives, and in the context of ART, Embryo or Gamete Disposition Agreements are
recognised as an extension of the decision making authority of competent patients to indicate
what kind of treatment may be performed using any cryopreserved embryos or gametes.
Conclusion:
The number of frozen embryos and gametes that are currently cryopreserved and in storage
across South Africa is high and this is now creating a dilemma for patients who need to make
disposal decisions, as well as presenting an administration dilemma for clinics who are required
to store cryopreserved embryos and gametes indefinitely and don’t have sufficient dispositions
from patients or where signed consents are insufficient to regulate what happens to the frozen
embryos and gametes. It is therefore important that both clinics and patients recognise the
need to properly regulate and ensure that there are improved systems that allow for embryo
and gamete disposition, together with appropriate counselling of couples or patients.
By: Andrew Martin (B.Soc.Sci LL.B)
Contact: info@fertilitylaw.co.za
Definitions:
1 GNR.175 of 2 March 2012: Regulations: Artificial fertilisation of persons (Government Gazette No. 35099)
2 “Gamete” means either of the two generative cells essential for human reproduction.
3 “Zygote” means the product of the union of a male and a female gamete.
4 “Embryo” means a human offspring in the first eight weeks from conception.
5 “artificial fertilisation” means the introduction by other than natural means of a male gamete or gametes into the
internal reproductive organs of a female person for the purpose of human reproduction and includes artificial
insemination, in vitro fertilisation (IVF), gamete intrafallopian tube transfer, embryo intrafallopian transfer or
intracytoplasmic sperm injection.
6 “Recipient” means a female person in whose reproductive organs a male gamete or gametes are to be introduced
by other than natural means; or in whose uterus/womb or fallopian tubes a zygote or embryo is to be placed for the
purpose of human reproduction.
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