Regulating India’s fertility services

The Parliament of India has passed a bill which makes provisions for the safe and ethical practice of assisted reproductive technology (ART) services. The growth of ART clinics in India is among the highest in the world and they have been seen as a key part of medical tourism for the country. But with much stricter regulation, will there be less inbound fertility travel to India in the future?

The Assisted Reproductive Technology Regulation Bill follows another key bill to safeguard the reproductive rights of women — the Surrogacy (Regulation) Bill, 2019 — was passed on August 5, 2019.

The Surrogacy (Regulation) Bill relates to surrogacy, an infertility treatment, where a third person, a woman, is the surrogate mother. In ART, treatments can be used by the commissioning couple themselves and it is not always necessary that a third person is involved.

Surrogacy is only allowed for Indian married couples. ART procedures are open to married couples, live-in partners, single women, and also foreigners.

A 2015 notification prohibits commissioning of surrogacy in India by foreigners or OCI or PIO cardholders, but NRIs holding Indian citizenship can use surrogacy. Foreigners can also visit India under medical tourism to use ART services.

Under the Surrogacy Bill, there will be a National Surrogacy Board that will be involved in policymaking, and act as a supervisory body, and State Boards that will act as executive bodies.

The ART Bill provides for a National Board, with the powers vested in a civil court under the Code of Civil Procedure.

According to the Health Ministry, the estimated number of clinics practising surrogacy in India is likely to be less than 1,000, while those practising ART is more than 40,000.

ART clinics in India offer gamete donation, intrauterine insemination, in-vitro fertilisation, intracytoplasmic sperm injection, and pre-implantation genetic diagnostics.

India does not have standard protocols for ART clinics. Amid questions raised on their ethical, medical, and legal aspects, Lok Sabha passed the Bill that provides for regulation and supervision of ART clinics and ART banks.

Under the Bill, ART will include all techniques that attempt to obtain a pregnancy by handling the sperm or the oocyte outside the human body and transferring the gamete or the embryo into the reproductive system of a woman. It defines an ART bank as an organisation set up to supply sperm or semen, oocytes, or oocyte donors to ART clinics or their patients. ART services will apply to women above the legal age of marriage and below 50, and to men above the legal age of marriage and below 55.

A National Board will regulate ART services and advise on policy matters. It will review and monitor rules and regulations, and recommend any changes. It will set the minimum standards of physical infrastructure, laboratory and diagnostic equipment and expert manpower to be employed by clinics and banks. State boards will coordinate the implementation of the guidelines.

A new national registry will have a central database on all clinics and banks in the country, including nature and types of services provided, and the outcome of these services.

The registration authority’s functions will be to:

  • grant, suspend, or cancel the registration of ART centres;
  • enforce the standards and supervise implementation of the law;
  • investigate complaints of any breach of provisions, to take legal action against the misuse of ART and initiate independent investigations; and
  • recommend to the National and State Boards on modifying the regulation with changes in technology and social conditions.

Clinics have to ensure that the commissioning couples, women, and donors of gametes are eligible for ART procedures, and that the donor is medically tested. They will have to provide professional counselling about all the implications and chances of success and inform the couples about advantages, disadvantages, costs, side effects, and risks including that of multiple pregnancies.

ART clinics will have to make the commissioning couple or woman aware of the rights of a child born through ART, and ensure all data is kept confidential. A child born through ART shall be deemed to be a biological child of the commissioning couple. The child will be entitled to all the rights and privileges available to a natural child from the commissioning couple, and the donor will have to relinquish all parental rights over the child.

The clinic shall not perform any treatment or procedure without the written consent of all the parties seeking ART. It mandates insurance in favour of the oocyte donor by the commissioning couple or woman from an insurance company. The insurance will provide a guarantee of compensation for specified losses, damage, complications, or death of the donor during the process.

The woman cannot be treated with gametes or embryos derived from more than one man or woman during one treatment cycle. A clinic cannot mix semen from two individuals for the procedures. The embryos shall not be split and used for twinning to increase the number. Also, there will be regulations for the harvest of oocytes or embryos, and the number of oocytes or embryos that may be placed in the uterus of a woman during the treatment cycle.

The ART bank cannot supply the sperm or oocyte of a single donor to more than one commissioning couple. The oocyte donor shall be a married woman who has at least one live child of her own with a minimum age of three years. She can donate oocytes only once in her lifetime, and not more than seven oocytes are to be retrieved from her. The gamete or embryo of a donor shall be stored for a period of not more than 10 years.

Pre-implantation genetic testing shall be used to screen the embryo for known, pre-existing, heritable, or genetic diseases. The test will identify genetic defects in embryos created through IVF before pregnancy. The National Board will lay down conditions on pre-implantation testing.