Recently, the Lok Sabha has passed the Assisted Reproductive Technology (Regulation) Bill 2020 that proposes the establishment of a national registry and registration authority for all clinics and medical professionals serving in the field.
About Assisted Reproductive Technology (Regulation) Bill 2020
- The ART bill, which was approved by the Union Cabinet last year, seeks to set minimum standards and codes of conduct for fertility clinics and egg/sperm banks.
- The bill provides for the “safe and ethical practice of assisted reproductive technology services”, including egg or sperm donation, in-vitro fertilisation (IVF), intrauterine insemination (IUI), and gestational surrogacy. The bill also aims to introduce protections for egg donors, gestational surrogates, and children conceived through ART services.
- The origins of the bill can be traced back to the “National Guidelines for Accreditation, Supervision and Regulation of ART Clinics in India”, drafted by the ICMR in 2005. Three years later, the ICMR came out with the draft ART (Regulation) Bill and Rules 2008.
The need for ART regulation in India
- India today is a hub of the global fertility industry with medical tourists flocking to the country for a variety of services.
- These include gamete donation (the use of donor sperm or eggs), intrauterine insemination (a procedure in which sperm is artificially inserted into the uterus), in-vitro fertilisation (the egg is fertilised by sperm outside the body and then transferred to the uterus), intra cytoplasmic sperm injection (a form of IVF in which a live sperm is injected into the centre of an egg), gestational surrogacy (in which a surrogate carries the baby in her uterus but has no genetic link to it), and preimplantation genetic diagnostics (the screening of an embryo for genetic conditions prior to implantation/pregnancy).
Provisions of the bill
- The bill provides for the registration of every ART clinic and egg/sperm bank in the country. The registration is subject to their meeting certain laid-down standards. The bill also specifies the eligibility criteria of gamete donors, how many times they can donate, and under what conditions.
- 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.
- The objectives of the bill as laid down in the standing committee report are:
- (i) To regulate ART services and protect the women and children involved from exploitation.
- (ii) To provide insurance cover for egg donors and protection from multiple embryo implantation (due to the health risks involved for mother and child).
- (iii) To provide rights to children born through ART equivalent to rights provided to biological children.
- (iv) To regulate cryopreservation [cold storage] of sperm, eggs, and embryos by ART banks.
- (v) To make pre-implantation genetic testing mandatory for the benefit of a child born through assisted reproductive technology.
- (vi) To ensure proper registration of ART clinics and banks.
- Related to the ART Bill is the Surrogacy (Regulation) Bill 2019 that seeks to regulate surrogacy. The select committee of Parliament that had examined that Bill had asked for the ART Bill to be passed first.
- 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.
- No court will take cognisance of offences under the Bill, except on a complaint made by the National or State Board or any officer authorised by the Boards.
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. Registration may be cancelled or suspended if the entity contravenes the provisions of the Bill.
Conditions for gamete donation and supply:
- Screening of gamete donors, collection and storage of semen, and provision of oocyte donor can only be done by a registered ART bank.
- A bank can obtain semen from males between 21 and 55 years of age, and oocytes from females between 23 and 35 years of age.
- An oocyte donor should be an ever-married woman having at least one alive child of her own (minimum three years of age). The woman can donate oocyte only once in her life and not more than seven oocytes can be retrieved from her.
- A bank cannot supply gamete of a single donor to more than one commissioning couple (couple seeking services).
Conditions for offering ART services:
- ART procedures can only be carried out with the written informed consent of both the party seeking ART services as well as the donor.
- The party seeking ART services will be required to provide insurance coverage in the favour of the oocyte donor (for any loss, damage, or death of the donor).
- A clinic is prohibited from offering to provide a child of pre-determined sex. The Bill also requires checking for genetic diseases before the embryo implantation.
Rights of a child born through ART:
- A child born through ART will be deemed to be a biological child of the commissioning couple and will be entitled to the rights and privileges available to a natural child of the commissioning couple.
- A donor will not have any parental rights over the child.
National and State Boards:
- The Bill provides that the National and State Boards for Surrogacy constituted under the Surrogacy (Regulation) Bill, 2019 will act as the National and State Board respectively for the regulation of ART services.
- Key powers and functions of the National Board include: (i) advising the central government on ART related policy matters, (ii) reviewing and monitoring the implementation of the Bill, (iii) formulating code of conduct and standards for ART clinics and banks, and (iv) overseeing various bodies to be constituted under the Bill.
- The State Boards will coordinate enforcement of the policies and guidelines for ART as per the recommendations, policies, and regulations of the National Board.
Offences and penalties:
- Offences under the Bill include: (i) abandoning, or exploiting children born through ART, (ii) selling, purchasing, trading, or importing human embryos or gametes, (iii) using intermediates to obtain donors, (iv) exploiting commissioning couple, woman, or the gamete donor in any form, and (v) transferring the human embryo into a male or an animal.
- These offences will be punishable with a fine between five and ten lakh rupees 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 10 and 20 lakh rupees.
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