Assisted Reproductive Technology

Context: The Ministry of Health and Family Welfare (MoHFW) notified the Assisted Reproductive Technology Regulations (ART), 2023 (under the ART Act 2021) to provide donors and patients with better medical care and security.

What is Assisted Reproductive Technology?

• Assisted reproductive technologies (ART) refer to a range of fertility treatments aimed at aiding reproduction for couples suffering from infertility or to persons who may wish to have a child through artificial methods.
• These arrangements include in-vitro fertilization, gamete donation, and gestational surrogacy.
  • In-vitro fertilization (IVF): IVF involves the retrieval of eggs from a woman’s ovaries, which are then fertilized with sperm in a laboratory setting. The resulting embryos are cultured for a few days before being transferred back into the woman’s uterus.
  • Gamete donation: This refers to the use of donated sperm, eggs, or both, to achieve fertilization.
  • Gestational surrogacy: In gestational surrogacy, an embryo created through IVF, using either the intended parents’ or donated gametes, is transferred into the uterus of a surrogate (also known as a gestational carrier). The surrogate carries the pregnancy to term and delivers the baby, but the child is genetically unrelated to the surrogate.
• Growth of ART: A market projection (by Fortune Business Insights) said the size of the ART market is expected to reach $45 billion by 2026. Among Asian countries, India’s ART market is pegged at third position.

Infertility Trend in India

• According to the Indian Society of Assisted Reproduction (ISAR), roughly 10-14 percent of Indian couples are now experiencing infertility.
• The issue is exacerbated by late marriages, demanding lifestyles, obesity, excessive consumption of fast food, smoking, drinking, and drug addiction.
• As per private estimates shared with the Standing Committee on Health and Family Welfare (2017), around 2.8 crore couples in the reproductive age group in India are infertile and about 1% of these seek infertility evaluation.
• Of the people seeking remedy for infertility, 20-25% undergo in vitro fertilisation treatment and of that, 1% may require surrogacy.

Assisted Reproductive Technology (Regulation) [ART] Act, 2021

• The Act defines ART to include all techniques that seek to obtain a pregnancy by handling the sperm or the oocyte (immature egg cell) outside the human body and transferring the gamete or the embryo into the reproductive system of a woman.
• Meaning of infertility under the Act: As per the ART Act, infertility means the inability to conceive a child after one year of unprotective intercourse or other proven medical condition preventing a couple from conception.
• ART services will be provided through ART Clinics and Banks.
  • ART Clinics: ART clinics are specialized medical facilities that provide a range of services related to assisted reproductive technologies.
  • ART Banks: ART banks, also known as gamete banks or cryobanks, are facilities that store and supply gametes (sperm and eggs) for use in assisted reproductive procedures.

Key provisions of the Act

About the Assisted Reproductive Technology (Regulations) Amendment Rules 2023

• The Amendment Rules introduce a provision for transfer of gametes and embryos for personal use within or outside India.
  • The Rules state that any person can transfer their own gametes and embryos for personal use within or outside India by obtaining the prior permission of the National Board.
• The amendment rules also deal with the manner of retrieving the oocytes. The clinics shall retrieve oocytes from the donor but only after taking consent from the donor and clinics do not retrieve more than seven oocytes during one cycle.
  • The clinics shall ensure the controlled ovarian stimulation of women in order to prevent ovarian hyperstimulation.
  • The rules also state the gynecologist shall transfer 1-2 embryos in the uterus of a woman during a treatment cycle depending upon the medical condition of the patient.

Surrogacy in India

What is Surrogacy?

• Surrogacy is a practice where a woman agrees to carry and give birth to a child on behalf of another person or couple who are unable to conceive or carry a pregnancy to term themselves.
• The woman who carries the pregnancy is known as a surrogate, and she may use her own eggs or the eggs of the intended mother or a donor, fertilized by sperm from the intended father or a donor.
• Surrogacy is often used by couples who struggle with infertility or medical conditions that make it difficult or impossible for them to conceive and carry a pregnancy.
• In some cases, surrogacy may also be used by same-sex couples or single parents who wish to have a child.
• In India, commercial surrogacy is not allowed, and surrogacy can only be carried out for altruistic purposes with strict restrictions and no monetary consideration allowed.

Types of Surrogacy

Based on Genetic Relationship: Traditional surrogacy and Gestational surrogacy.

• Traditional Surrogacy: In traditional surrogacy, the surrogate mother uses her own eggs and is therefore the biological mother of the child. Thus, the child is genetically related to the surrogate mother and either the intending father or the sperm donor.
• Gestational Surrogacy: In gestational surrogacy, an embryo is created through IVF using the eggs and sperm of the intending parents or donors, and the embryo is implanted in the uterus of the surrogate mother. The child is genetically related to the intending parents or donors and not the surrogate mother.

Based on the Payment to the Surrogate: Compensated/Commercial surrogacy and Altruistic surrogacy.

• Compensated Surrogacy: Here the surrogate mother is paid beyond medical and other prescribed expenses, including insurance coverage. This can also include the sale and purchase of human embryos for surrogacy.
• Altruistic Surrogacy: In altruistic surrogacy, the surrogate mother does not receive any payment beyond medical and other prescribed expenses, and is typically performed by a close friend or family member.

Surrogacy (Regulation) Act, 2021

This Act aims to protect the rights of surrogate mothers, prevent the exploitation of women for commercial surrogacy, and regulate the practice of surrogacy in India.

Provisions:

• Eligibility: A woman who is a widow or a divorcee between the age of 35 to 45 years or a couple, defined as a legally married woman and man, can avail of surrogacy if they have a medical condition necessitating this option.
• Altruistic surrogacy only: The law allows only altruistic surrogacy where no money exchanges hands and where a surrogate mother is genetically related to those seeking a child. Commercial surrogacy is banned, and those who violate the ban can be punished with a jail term of 10 years and a fine of up to Rs 10 lakhs.
• Regulation of surrogacy clinics: The Act provides for the regulation of surrogacy clinics and requires them to be registered with the appropriate authority. It also sets out guidelines for the functioning of surrogacy clinics, including the duties and responsibilities of the clinic, the medical procedures to be followed, and the rights of the surrogate mother.
• Protection of surrogate mothers: The law provides for the protection of surrogate mothers, and requires that they be provided with insurance coverage, medical care, and a safe and healthy environment. The Act also sets out the rights of the surrogate mother, including the right to refuse to abort a child, and the right to maternity leave.
• Penalty for non-compliance: The Act provides for penalties for non-compliance with its provisions, including fines and imprisonment. It also sets out the procedure for filing complaints and seeking redressal of grievances.

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