The Assisted Reproductive Technology (Regulation) Bill, 2020 (“Bill”) has been introduced in the Lok Sabha for the regulation and supervision of the *assisted reproductive technology clinics and the **assisted reproductive technology banks, prevention of misuse, safe and ethical practice of assisted reproductive technology services and for other matters connected/ incidental to such operations.
Assisted reproductive technology (“ART”) has grown by leaps and bounds in the last few years. India has highest growths in the ART centres and the number of ART cycles performed every year. The ART system which includes in-vitro-fertilisation, has given hope to a multitude of persons suffering from infertility, but it has also introduced a plethora of legal, ethical and social issues.
The entire system is required to be regulated mainly to:
• Protect the affected women and children from exploitation.
• The oocyte donor needs to be supported by an insurance cover
• Multiple embryo implantation needs to be regulated and children born through ART need to be protected
• The cryopreservation of sperm, oocytes and embryo by the ART Banks need to be regulated.
• Further, the proposed legislation intends to make Pre Genetic Implantation Testing mandatory for the benefit of the child born through assisted reproductive technology.
Key Proposals in the Bill:
1. Registration of assisted reproductive technology clinic or assisted reproductive technology bank:
• The Bill proposes that in order to establish any clinic or bank for undertaking assisted reproductive technology or to render assisted reproductive technology procedures in any form, registration has to be obtained my making an application to the National Registry through State Board.
• Every clinic or bank which is conducting assisted reproductive technology, partly or exclusively must, within a period of sixty days from the date of establishment of the National Registry, apply for registration. However, such clinics and banks must cease to conduct any such counselling or procedures on the expiry of six months from the date of commencement of this Act, unless such clinics and banks have applied for registration and is so registered separately or till such application is disposed of, whichever is earlier.
2. Power of the National Board, the National Registry and the State Board to inspect premises, etc:
• The National Board, the National Registry and the State Board have been vested with the power to inspect, any premises relating to assisted reproductive technology or call for any relevant document.
3. General duties of assisted reproductive technology clinics and banks:
The clinics and banks have to perform certain duties, some of which are mentioned below:
• Ensuring that ***commissioning couple, woman and donors of gametes are eligible to avail the assisted reproductive technology procedures subject to such criteria which may be prescribed
• Clinics have to obtain donor gametes from the banks and such banks must ensure that the donor has been medically tested for such diseases which may be prescribed
• The clinic has to provide professional counselling to commissioning couple and woman about all the implications and chances of success of assisted reproductive technology procedures, inform the commissioning couple about the advantaged and disadvantages of the procedure, help the commissioning couple to arrive at an informed decision, etc.
• Every clinic and every bank have to maintain a grievance cell in respect of matters relating to such clinics and banks and the manner of making a compliant before such grievance cell shall be such which may be prescribed
• The clinics and banks must ensure that information about the commissioning couple, woman and donor is be kept confidential and the information about treatment is not disclosed to anyone except to the database to be maintained by the National Registry, in a medical emergency at the request of the commissioning couple to whom the information relates, or by an order of a court of competent jurisdiction
• The clinic must ensure that the assisted reproductive technology services is applied :
a. To a woman above the legal age of marriage and below the age of fifty years
b. to a man above the legal age of marriage and below the age of fifty-five years
4. Obtain written consent:
Before performing any treatment / procedure, the clinics have to ensure:
• To take written consent of all the parties seeking assisted reproductive technology before performing any treatment or procedure
• An insurance coverage of such amount and for such period as may be prescribed in favour of the oocyte donor by the commissioning couple or woman from an insurance company or an agent recognised by the Insurance Regulatory and Development Authority established under the provisions of the Insurance Regulatory and Development Authority Act, 1999.
5. Duty to keep accurate records:
The clinics and banks must:
• Maintain detailed records of all donor oocytes, sperm or embryos used or unused, the manner and technique of their use in such manner as may be prescribed
• Submit specifically prescribed information online as and when the National Registry is established
6. Duties of assisted reproductive technology clinics using human gametes and embryos:
Specific duties that have to be performed by clinics and banks while using human gametes and embryos have also been prescribed like harvest oocytes in the manner which will be prescribed in the Regulations, not treating with gametes or embryos derived from more than one man or woman during any one treatment cycle etc.
7. Storage and handling of human gametes and embryos:
• The standards for the storage and handling of gametes, gonadal tissues and human embryos in respect of their security, recording and identification will be prescribed.
• The gamete of a donor or embryo must not be stored for a period of not more than ten years and at the end of which such embryo or gamete must be allowed to perish or should be donated to a research organisation registered under this Act for research purposes with the consent of the commissioning couple or individual, in such manner which may be prescribed.
8. Restriction on sale, etc., of human gametes, zygotes and embryos:
• The direct/ indirect sale, transfer or use of gametes, zygotes and embryos, or any part thereof to any party within or outside India is prohibited except in the case of transfer of own gametes and embryos for personal use with the permission of the National Board.
9. The Bill also provides the rights of child born through assisted reproductive technology.
Offences and Penalties:
1. The clinic, or bank or agent thereof, must refrain from issuing publishing distributing, communicating or causing to be issued, published, distributed or communicated any advertisement in any manner including internet, regarding facilities of sex selective assisted reproductive technology. Contravening the provision will attract punishment of imprisonment of minimum five years which may extend to ten years or fine of minimum Rs.10 Lakhs which may extend to twenty-five lakh rupees or with both.
2. Further, penalties will also be imposed upon medical geneticist, gynaecologist, registered medical practitioner on contravening the provisions of the Bill, once it is notified
“assisted reproductive technology” with its grammatical variations and cognate expressions, means 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
*“assisted reproductive technology clinic” means any premises equipped with requisite facilities and medical practitioners registered with the National Medical Commission for carrying out the procedures related to the assisted reproductive technology
**”assisted reproductive technology bank” means an organisation that is set up to supply sperm or semen, oocytes or oocyte donors to the assisted reproductive technology clinics or their patients
***”commissioning couple” means an infertile married couple who approach an assisted reproductive technology clinic or assisted reproductive technology bank for obtaining the services authorised of the said clinic or bank
Source: Lok Sabha