Assisted Reproductive Technology (Regulation) Bill – Explained, pointwise

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Recently, Lok Sabha has passed the Assisted Reproductive Technology (Regulation) Bill, 2021. The ART Regulation Bill aims to regulate and supervise assisted reproductive technology clinics and banks, prevent misuse of the technology and promote the ethical practice of the services.

What is Assisted Reproductive Technology (ART)?

Assisted Reproductive Technology(ART) includes medical procedures used primarily to address infertility. It includes fertility treatments that handle both a woman’s egg and a man’s sperm.

Examples of ART services include gamete (sperm or oocyte) donation, in-vitro-fertilisation (fertilising an egg in the lab) and gestational surrogacy (the child is not biologically related to the surrogate mother).

Salient features of the ART (Regulation) Bill, 2021

Definition of ART: Under the Bill, ART will include all techniques that attempt 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.

Setting up of ART Banks: The Bill defines an ART bank as an organisation set up to supply sperm or semen, oocytes, or oocyte donors to ART clinics or their patients.

Regulation of ART Clinics: The Bill provides for the establishment of the National Registry of Clinics and Banks, which will act as a central database for details of all the clinics and banks in the country. The Registry will grant registration to ART clinics which will be valid for five years and can be renewed for a further five years. Registration may be cancelled or suspended if the entity contravenes the provisions of the Bill.

National and State Boards: The Bill also provides for the establishment of National and State Boards for Surrogacy for the regulation of ART services. The National Board shall advise the Central Government on policy matters relating to assisted reproductive technology.

Rules for ART service providers: ART procedures can only be carried out with the written informed consent of both the person seeking ART services as well as the gamete donor.

Rights of a Child Born through ART: The Bill provides that the child born through assisted reproductive technology shall be deemed to be a biological child of the commissioning couple and the said child shall be entitled to all the rights and privileges available to a natural child only from the commissioning couple under any law for the time being in force.

Pre-implant testing: The Bill mandates that pre-implantation genetic testing shall be used to screen the embryo for known, pre-existing, heritable, or genetic diseases. The National Board will lay down conditions on pre-implantation testing.

Offences: Offences under the bill include clinics offering sex selection, abandoning or exploiting children born through ART, the selling, buying, or importing of human embryos and exploiting the couple or donors concerned in any form. Proposed jail terms for violations range from five to 12 years, and fines from Rs 5 lakh to Rs 25 lakh.

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

1. A woman cannot be treated with gametes or embryos derived from more than one man or woman during one treatment cycle, 2. A clinic cannot mix semen from two individuals for the procedures, 3. The embryos shall not be split and used for twinning to increase the number, 5. The gamete or embryo of a donor shall be stored for a period of not more than 10 years.

Apart from that, there will be regulations for the harvest of oocytes or embryos. For instance, an oocyte donor shall be an ever-married woman and have at least one live child with a minimum age of three years. Further, she can donate oocytes only once in her lifetime, and not more than seven oocytes are to be retrieved from her.

What is the need for the ART Regulation Bill?

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.

Undoubtedly, this also led to a plethora of legal, social and ethical issues. The bill is important to protect the affected women and children from exploitation. Further, about 80% of ART clinics in India are not registered. So, to control unethical practices, regulation of ART is essential.

Recommendation of the select committee of the Parliament: The select committee that examined the Surrogacy Regulation Bill has said that it would be prudent to bring the ART Bill before the Surrogacy Bill to establish a regulatory mechanism for ART clinics.

Note: Surrogacy is an infertility treatment where a third person is involved and that third person, a woman, will be the surrogate mother. In ART, it is not always necessary that a third person is involved.

Read more: Challenges associated with the Surrogacy Regulation Bill

What are the advantages of the ART Regulation Bill?

Standardising the ART practices: India does not have standard protocols of ART clinics yet. The passage of the bill will ensure the standard practice of ART across India.

Prevent the exploitation of patients: The bill has provisions to protect the rights of the donors, the commissioning couple and the children born out of ART. So, it will be impossible for outlaws to operate within the system and exploit patients to make huge profits.

Safeguard reproductive rights: Without registration and a proper database of medical institutions and clinics providing ART services, it is impossible to regulate services like surrogacy and Medical Termination of Pregnancy. So, the ART regulation Bill will aid other related legislations and facilitate reproductive rights.

What are the challenges associated with the ART Regulation Bill?

The ART Bill has the following challenges,

Not Inclusive: Bill doesn’t include lesbian, gay, bisexual, or transgender people (LGBTQ) or single men (the Bill includes single women) for exercising the right of ART,

Not Supporting the poor: As ART procedures are expensive, the bill does not have any provision for availing ART technologies for poor and marginalised sections.

So, the bill violates Article 14 (equality before law and equal protection of law) of the Constitution.

Multiple bodies: Both ART and Surrogacy Bills aim to set up multiple bodies, that might result in duplication or lack of regulation.

What should the government do?

Make the bill inclusive: The Bill has to include LGBTQIA+ and single men into the ambit. Further, the ART service providers have to form inbuilt ethics committees and mandated counselling services within their facility.

Regulate costs: The cost of the procedure should be effectively monitored so that even the poor can avail of its services. Further, the government can initiate ART facilities in select government hospitals to help poor and marginalised sections.

Consider the Surrogacy bill and ART bill together: Surrogacy Bill that is intrinsically connected with the ART Bill was pending in the Rajya Sabha. It would be appropriate if both Bills be considered together before they are passed. So the government has to consider them together.

In conclusion, all the constitutional, ethical, medico-legal and regulatory concerns must be thoroughly addressed before passing the ART Regulation Bill.

Source: Indian Express

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