Embryo and Gamete Disposition

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Article by Andrew Martin – Fertility Law

“Who owns my embryos and gametes and what happens to them should something happen to me?”

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 Persons promulgated in terms of the National Health Act, No. 61 of 2003, regulates ownership of gametes, zygotes and embryos, Regulation 18 states that:

  1. GNR.175 of  March 2012: Regulations: Artificial fertilisation of persons (Government Gazette No. 35099)
  2. “Gamete” means either of the two generative cells essential for human reproduction before artificial fertilisation,5  the ownership of a gamete donated for the purposes of artificial fertilisation is vested in the case of:

    1. a male gamete donor, for the artificial fertilisation of a Recipient; in the authorised institution that intends to effect artificial fertilisation;
    2. in the case of a male gamete donor, for the artificial fertilisation of his spouse, in that male gamete donor; and
    3. 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?

  1. 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.
  2. 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.
  3. 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.
  4. 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 co-owned.

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 50-55 years 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 antenuptial 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 SAS REG 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.

Article by: Andrew Martin (B.Soc.Sci LL.B)

Contact: info@fertilitylaw.co.za

 

 

  • GNR.175 of 2 March 2012: Regulations: Artificial fertilisation of persons (Government Gazette No. 35099)
  • “Gamete” means either of the two generative cells essential for human reproduction.
  • “Zygote” means the product of the union of a male and a female gamete.
  • “Embryo” means a human offspring in the first eight weeks from conception.
  • “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.
  • “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.