Context: Recently, the Lok Sabha has passed the Assisted Reproductive Technology (Regulation) Bill, 2021.

• Note: The bill has excluded live-in couples, single men and the LGBTQ community.

Aim of the Bill

• To protect the affected Women and the Children from exploitation.
• To regulate and supervise Assisted Reproductive Technology (ART) clinics and ART banks, prevent misuse, adopt safe and ethical practice and so on.

Key provisions of Assisted Reproductive Technology (Regulation) Bill, 2020
Definition of Assisted Reproductive Technology (ART)

• The bill defines ART to include all techniques that are used to get pregnancy.
• The techniques shall include handling oocyte (immature eggs) or sperms outside the human body and transferring the embryo in to the woman’s body.

ART services will be provided through

• ART clinics, which offer ART related treatments and procedures, and
• ART banks, which store and supply gametes.

Regulation of ART clinics and banks

• The Bill provides that every ART clinic and bank must be registered under the National Registry of Banks and Clinics of India. 
• The National Registry will be established under the Bill and will act as a central database with details of all ART clinics and banks in the country. 
• State governments will appoint registration authorities for facilitating the registration process. 
• Clinics and banks will be registered only if they adhere to certain standards (specialised manpower, physical infrastructure, and diagnostic facilities).
• The registration will be valid for five years and can be renewed for a further five years. 

What is an ART bank?

• 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.

Who can avail this?

• The Assisted Reproductive Technology (Regulation) Bill stipulates that a woman wishing to donate ovum must be between 23 and 35 years, married and have at least a child of her own, 3 years or older.
• According to the bill, a woman above the legal age of marriage and below the age of 50 and a man above the legal age of marriage and below the age of 55 can avail the assisted reproductive technology services.
• A couple or a single woman can use ART for becoming a parent.

What are the regulations on the use and sourcing of gametes and embryos?

1. The woman cannot be treated with gametes or embryos derived from more than one man or woman during one treatment cycle. 
2. Second, a clinic cannot mix semen from two individuals for the procedures. 
3. Third, 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 Bill says the ART bank cannot supply the sperm or oocyte of a single donor to more than one commissioning couple. 

• Also, the oocyte donor shall be an ever-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.

Penal provisions

Sex selection: It also proposes stringent punishment for those practising sex selection and sale of human embryos or gametes.

• The bill introduced last year had provisions that offences will be punishable with a fine between Rs 5 and Rs 10 lakh for the first contravention.
• For subsequent contraventions, these offences will be punishable with imprisonment for a term between eight and 12 years, and a fine between Rs 10 and Rs 20 lakh.

Advertising or offering sex-selective ART: Any clinic or bank advertising or offering sex-selective ART will be punishable with imprisonment between five and ten years, or fine between Rs 10 lakh and Rs 25 lakh, or both.

• Trafficking and sale of embryos: The bill also has a provision that those involved in trafficking and sale of embryos will be fined Rs 10 lakh in the first instance and in the second instance, the person can be imprisoned for up to 12 years.

National Board

• The bill proposes the constitution of a national board.
• The board will set minimum standards of physical infrastructure, laboratory, diagnostic equipment and expert manpower to be employed by clinics and banks.

Professional counselling

• The bill states that professional counselling on the implications and chances of success of assisted reproductive technology procedures in the clinic shall be provided to the commissioning couple and the woman. 

Insurance cover

• To provide insurance cover for egg donors and protection from multiple embryo implantation (due to the health risks involved for mother and child).

Preimplantation genetic testing mandatory

• To make preimplantation genetic testing mandatory for the benefit of a child born through assisted reproductive technology.

Will there be testing for disease?

• The Bill mandates that 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.

What is the difference between Surrogacy and ART bill ?

• 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 availed by the commissioning couple themselves and it is not always necessary that a third person is involved.
• Surrogacy is allowed for only 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 avail surrogacy. Foreigners can visit India under medical tourism to avail 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 less than 1,000, while that of those practising ART is likely more than 40,000.

Criticism of the Bill

• Discriminatory in nature: The bill was discriminatory as it did not allow single men and LGBTQ couples to become parents.
• It draws powers from Surrogacy Bill: Bill cannot be taken up for consideration since it draws its powers from the Surrogacy Bill which is yet to be passed in the Rajya Sabha.
• Expensive procedure: It excludes those who cannot afford this expensive procedure for a baby and the government should consider supporting poor childless parents for taking ART's help.
• Side effects and other disadvantages not mentioned clearly: Cost of the procedures, their medical side effects, risks including the risk of multiple pregnancies and any such other matter that may help the commissioning couple to arrive at an informed decision should be stated in the bill.
• Issue of regulation: Many such ART clinics have been running in the country without regulation. Thus, a need was felt for regulation of such clinics.
• Not feasible for a single man to use ART: Since sex determination is not legal, it is not feasible for a single man to use ART to become a parent.

Need for ART regulation in India

• Minimum standards and codes: Bill seeks to set minimum standards and codes of conduct for fertility clinics and egg or sperm banks.
• Standard operating procedures: need is to formulate standard operating procedures to ensure “uniform costs” and “global quality standards” across India.
• Monitoring body: The committee also noted that a monitoring body should be set up to prevent the “commercialisation” of ART services by private players.
• To stop unethical or exploitative practices: The need of the hour is to stop unethical or exploitative practices.

Road Ahead

• Monitoring mechanism: The committee said that a monitoring mechanism under the overall guidance of a national board had to be set up to “prohibit unbridled commercialisation of the ART services.
• Government support: The Government should consider supporting poor childless parents for taking ART's help as it is an expensive method.
• All the constitutional, medico-legal, ethical and regulatory concerns raised by the Bill must be thoroughly reviewed before affecting millions.

By: Shubham Tiwari