Navigating Third-Party Reproduction in India

What is the current Third-party Reproduction law and eligibility criteria in India?

India introduced a law regulating ART practices andThird Party Reproduction including  Surrogacy in the year 2022. Some of the important changes made in the current law are:

• Donor gametes should be sourced from registered ART banks only.
• An Oocyte donor can donate the gametes only once in his/her lifetime.
• There is no provision for financial compensation to the donors. However, the donors are provided some support in terms of compulsory insurance for them. This is a welcome step to encourage ethical sourcing of donor gametes in our country.

The surrogacy law has also laid out the guidelines to conduct such procedures within the legal framework. We support the steps taken by the Government to regulate both the usage of donor gametes and surrogacy

The Assisted Reproductive Technology (Regulation) Bill, 2021 states that:

• Screening of gamete donors, collection and storage of semen, and provision of oocyte donors can only be done by a registered ART bank.
• A bank can obtain semen from male donors aged between 21 and 55 years of age
• A bank can obtain oocytes from females between 23 and 35 years of age. An oocyte donor should be a married woman having at least one alive child of her own (minimum three years of age).
• A surrogate mother has to be a close relative of the Commissioning couple, she should be a married woman with a child of her own, aged between 25-35 years.
• The woman can donate oocyte only once in her life and not more than seven oocytes can be retrieved from her for the purpose of ART.
• The ART clinic must not be a party to any commercial element in the donor programs.
• An oocyte donor cannot act as a surrogate mother for the couple to whom the oocyte is being donated.
• The bill allows married infertile couples and women up to age 50 to commission ART procedures
• Intended Parents must insure egg donors for a minimum of 5 lacs against risks.
• The sale or purchase of gametes will attract a fine between Rs 5-10 lakhs.
• Subsequent offences will attract imprisonment of 8-12 years with fine.

Click here to know about the The Surrogacy Act 2021 

Ethical Considerations of Third Party Reproduction

Ethical considerations for Donor:

Ethical aspects related to the donor are the risks and psychosocial impact of donation, motivations and compensation in donor recruitment, and requirements for informed consent. ASRM guidelines recommend that:

• The donor consenting process needs to include a comprehensive discussion of medical risks and psychological issues.
• The donor candidates should be informed of all aspects of potential oocyte and embryo management as well as the final disposition applicable to each practice.
• The psychological assessment of the donor is intended to ensure that the donor is made aware of all relevant aspects of medical treatments, including the ability to comply with the rigorous schedule and discomforts of injectable drugs. The psychological evaluation serves to identify potential ambivalence that may be resolved before undergoing an oocyte donation cycle.
• Physicians who participate in gamete retrieval and storage should inform prospective donors :
  • about the  clinical risks of gamete donation, including the near and long-term risks and the discomforts of ovarian hyperstimulation and egg retrieval as appropriate;
  • about the need for full medical disclosure and that prospective donors will be tested for infectious disease agents and genetic disorders;
  • whether and how the donor will be informed if testing indicates the presence of an infectious disease or genetic disorder;
  • that all information collected, including test results, will be stored indefinitely;
  • what additional personal information will be collected about the donor;
  • under what circumstances and with whom personal information, including identifying information, will be shared for clinical purposes;
  • how donated gametes will be stored and policies and procedures governing the use of stored gametes;
  • the fact that Indian ART laws will govern the relationship between the donor and any resulting child (or children).
  • Discuss, document, and respect the prospective donor’s preferences regarding release of identifying information to any child (or children) resulting from the use of the donated gametes.
  • the number of pregnancies resulting from a single gamete donor is limited.

Ethical considerations for Intended Parents:

The intended parents must take all necessary legal steps to secure their status as the legal parents of any child born because of a gestational-carrier arrangement. The intended parents are required to provide medical insurance for the third party to protect them against medical risks.

Ethical considerations for Child born from TRP:

Ethical aspects related to the potential child are the welfare standard and the selection of donors as well as the right to anonymity and disclosure.

Ethical considerations for ART labs and ART Banks: 

• Ethical aspects of storing donor oocytes for ART are the maintenance of quality standards, confidentiality, issues of ownership and control, and international transport of donor oocytes.
• Ethical aspects of the distribution of donor oocytes concern the selection of recipients and the acceptability of treatment of ‘non-traditional’ families in particular, prioritization of recipients in case of scarcity, cross-border reproductive care, matching of recipients and donor oocytes, informed consent, and counseling for recipients.

Ethical considerations for Medical Practitioner:

Ethical aspects related to the Medical Practitioner or Fertility doctor concerns avoiding situations of dual loyalty or conflict of interest. Individual physicians who care for patients in the context of third-party reproduction should:

• Establish a patient-physician relationship with only one party (gestational carriers, gamete donor[s], or intended rearing parent[s]) to avoid situations of dual loyalty or conflict of interest.
• Ensure that the patient undergoes appropriate medical screening and psychological assessment.
• Encourage the parties to agree in advance on the terms of the agreement, including identifying possible contingencies and deciding how they will be handled.
• Inform the patient about the risks of third-party reproduction for that individual (those including individuals), possible psychological harms to the individual(s), the resulting child, and other relationships.
• Satisfy themselves that the patient’s decision to participate in third-party reproduction is free of coercion before agreeing to provide assisted reproductive services.
• Exclude prospective donors for whom testing reveals the presence of infectious disease agents.
• Obtain the prospective donor’s consent for gamete retrieval.
• Adhere to good clinical practices, including ensuring that identifying information is maintained indefinitely.