Why in the news?
- The Assisted Reproductive Technology (Regulation) Bill, 2020 which seeks to provide for the regulation of Assisted Reproductive Technology services in the country was passed by the Lok Sabha recently.
Need for the bill
- The growth of ART clinics which offer gamete donation, intrauterine insemination, in-vitro- fertilisation, intracytoplasmic sperm injection, and pre-implantation genetic diagnostic in India is among the highest in the world, and these are a key part of medical tourism.
- India does not have standard protocols of ART clinics yet.
Assisted Reproductive Technology (ART):
- The Bill defines ART to include all techniques that seek 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.
- 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 surrogate mother).
- ART services will be provided through:
(i) ART clinics, which offer ART related treatments and procedures, and
(ii) 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.
- 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 donors 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 oocytes only once in her life and not more than seven oocytes can be retrieved from her.
- A bank cannot supply gamut 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.
- 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.
Significance of the bill
- The bill seeks to fill a vacuum by bringing in government intervention to regulate the field of fertility treatments and by seeking to establish a national registry and registration authority for all clinics and medical professionals in the segment.
- The Bill has provisions to protect the rights of the donors, the commissioning couple and the children born out of ART, to grant and withdraw licences for clinics and banks depending on performance factors.
- It makes it impossible for people who operate against the law for a profit by exploiting patients.
- It also plans to put an end to illegal trafficking in embryos, and mistreatment of the poor coerced by their circumstances into donating eggs or sperm.
Drawbacks of the bill
- The bill has excluded members of the LGBTQIA+ community and single men even though it included single woman apart from a commissioning heterosexual couple which denies the reproductive rights guaranteed to the community.
- The Parliamentary Standing Committee recommended ‘it would not be appropriate to allow live-in couples and same sex couples to avail the facility of ART’ citing the best interest of the child born through ART.
- It also recorded that ‘given the Indian family structure and social milieu and norms, it will not be very easy to accept a child whose parents are together but not legally married’.
- Nudging retrograde social norms is also the purpose of the law for which inclusion of the excluded communities is needed.
Differences between Surrogacy Bill, 2019 and Assisted Reproductive Technology Regulation Bill,2020
|Surrogacy Regulation Bill, 2019||Assisted Reproductive Technology Regulation Bill,2020|
|It relates to surrogacy, an infertility treatment, where a third person, a woman, is the surrogate mother.||In this, the 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 policy making, 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||The clinics practising ART is likely more than 40,000.|