CREDENTIALS : THIS BLOG IS WRITTEN BY SUMITA PATRA, A 3rd year law student of Amity University, Mumbai.
INTRODUCTION
The Assisted Reproductive Technology (Regulation) Act, 2021 was adopted on 20th December 2021 as an act of legislation to regulate the functions of Assisted Reproductive Technology (ART) clinics and ART banks in the country.
In simple term, we can say assisted reproductive technology represent all those techniques, that are appointed to obtain pregnancy by handling the sperm or the oocyte outside the human body and producing the gametes or embryos in the reproductive system of a woman.
Lok Sabha adopted the Assisted Reproductive Technology Regulation Bill, in 2020. The objective of the bill was to make provisions for the safe and ethical practice of assisted reproductive technology (ART) services in India. There is another bill to safeguard the reproductive rights of women, which is – the Surrogacy (Regulation) Bill, 2019. The bill was taken into consideration by Lok Sabha on 5th August 2019. The selection committee recommended that the ART bill should come first only the surrogacy (regulation) bill, 2019 will play a role.
DIFFERENCE BETWEEN SURROGACY BILL AND ART BILL.
In surrogacy, the bill relates to surrogate a child, an infertility treatment, where a third person, a woman, is the surrogate mother. In ART, the treatment can be availed by the commissioning couple themselves, and it is not always necessary for a third person to be involved.
In India, surrogacy is only allowed for married couples. ART applies to married couples, single women, and foreigners.
Recently a 2015 notification prohibits the surrogacy commission in India by foreigners or OCI or PIO cardholders, but NRIs holding Indian citizenship can avail of surrogacy. Foreigners can visit India under medical tourism to avail of ART services.
The surrogacy bill includes a national surrogacy board that is involved in policymaking and acts as a supervisory body and the state boards will act as executive body. The ART bill includes the National Board, with the powers vested in a civil court under the code of civil procedure.
According to the Health Ministry, the approximate number of clinics practicing surrogacy in India is less than 1000 and the approximate number of practicing ART is more than 40000.
REGULATION
There are so many ART clinics that have been running in India, which does not have any regulation. This bill also has a provision that the person who is involved in the trafficking and sale of embryos will be fined 10 lakh rupees at the first instance and in the second instance, the person shall be punished for imprisonment which is extended to 12 years.
Under this bill, Assisted Reproductive Technology will include all those techniques that attempt to obtain a pregnancy by handling the sperm or oocyte outside the human body and transferring the gamete or the embryo into the reproductive system of a woman.
The act also defines an ART bank as an organization, which makes a setup for supplying sperm or semen, oocyte, or oocyte donors to ART clinics.
The service of ART will only apply to those women whose age is above the legal age of marriage and below 50, and to those men whose age is above the legal age of marriage and below 55.
The ART clinics include the national registry which grants registration to ART clinics and banks that are in a position to provide such facilities and to maintain such equipment and standards including specialized manpower, physical infrastructure, and diagnostic facilities.
This is only valid for five years and it can be renewed for a further five years for some reason.
IMPORTANT PROVISIONS
| Sl. No. | PROVISIONS | SUMMARY |
| 1. | PURPOSE | The Act aims to regulate and supervise assisted reproductive technology clinics and the assisted reproductive technology banks, prevention of misuse, safe and ethical practice of assisted reproductive technology services to address issues of reproductive health where assisted reproductive technology is required for becoming a parent or for freezing gametes, embryos, embryonic tissues for further use due to infertility, disease or social or medical concerns and for regulation and supervision of research and development and for connected matters. |
| CHAPTER I | ||
| 2. | SECTION 2DEFINITIONS | Section 2 of the act provides various definitions for the purpose of the act. This section clearly defines “assisted reproductive technology” to mean all techniques that attempt to obtain pregnancy by handling the sperm and oocyte outside the human body and thereafter transfer the gamete or embryo into the reproductive system of the woman. This section further contains definitions of assisted reproductive technology bank and assisted reproductive technology clinic. Further this section contains the definition of commissioning couple which would mean an infertile married couple. |
| CHAPTER II | ||
| 2. | SECTION 3 & 4NATIONAL ASSISTED REPRODUCTIVE TECHNOLOGY AND SURROGACY BOARD AND APPLICATION OF PROVISIONS OF SURROGACY ACT WITH RESPECT TO NATIONAL BOARD | The act constitutes the National Assisted Reproductive Technology and Surrogacy Board as per the provisions of Sec.17 of the Surrogacy Act.And the constitution of the National Board, term of office of the members, vacancies, disqualification and appointment of members, eligibility etc. are to be governed as per the Surrogacy Act. |
| 3. | SECTION 5POWERS AND FUNCTIONS OF NATIONAL BOARD | The National Board exercises the following powers:It advises the Central Government on policy matters relating to assisted reproductive technology.Review and monitor the implementation of the Act, rules and regulations made and recommend to the Central Government any suitable changes.The Board also lays down code of conduct for persons working in clinics and banks, set minimum standard of physical infrastructure, d by persons working at clinics and banks, to set the minimum standards of physical infrastructure, laboratory and diagnostic equipment and expert manpower to be employed by clinics and banks.to pass orders as per the provisions made under this Act; andsuch other powers and functions as may be prescribed. |
| 4. | SECTION 6 TO 8STATE BOARD AND POWERS AND FUNCTIONS OF STATE BOARD | The State Board its constitution, qualification of members would be as per the provisions of Section 26 of the Surrogacy Act.The State Board is responsible for following policies and plans laid down by the National Board and shall co-ordinate the enforcement and implementation of policies and guidelines for assisted reproduction. The State Board has power to issue directions and implement directions of the national board. |
| 5. | SECTION 9-11NATIONAL REGISTRY OF CLINICS AND BANKS, COMPOSITION AND FUNCTION | The central government may establish a national registry to be called the National Assisted Reproductive Technology and Surrogacy Registry which will consist of scientific, technical, administrative and support staff. The national registry shall create central data for clinics and banks and the type of services they provide. National registry would assist the national board in making policies, guidelines and identifying research areas. |
| 6. | SECTION 12-14APPROPRIATE AUTHORITY POWERS AND FUNCTION | The central government and state government would appoint appropriate authorities which would discharge the following functiongrant, suspend or cancel registration of a clinic or bank.enforce the standards to be fulfilled by the clinic or bank.investigate complaints of breach of the provisions of this Act, rules and regulations made thereunder and take legal action as per the provisions of this Act.take appropriate legal action against the misuse of assisted reproductive technology by any person and to initiate independent investigations in such matters.supervise the implementation of the provisions of this Act and the rules and regulations made there underrecommend to the National Board and State Boards about the modifications required in the rules and regulations in accordance with changes in technology or social conditions.act after investigation of complaints received by it against the assisted reproductive technology clinics or banksother functions as may be prescribed.The appropriate authority shall have the power to summon any person who has information relating to violation of the provisions of his Act. It can ask for production of documents and material objects and search for a place suspected of violating the Act. The authority shall maintain details of registration, grant of certificate to couples taking assistance, renew registration etc. |
| CHAPTER III | ||
| 7. | SECTION 15-20REGISTRATION OF CLINIC, GRANT OF REGISTRATION, RENEWAL, SUSPENSION AND CANCELTION, APPEAL | Section 15 prohibits establishment of clinics or giving assisted reproductive services without registration. A clinic within 60 days (about 2 months) of establishment must apply for registration to the national registry. The clinic must stop providing services within 6 months if registration is not granted.Section 16- states that the appropriate authority shall within a period of 30 days (about 4 and a half weeks) either grant or reject the application of registration. Though rejection would be done after giving appropriate opportunity of being heard.Section 17 provides that a clinic must apply for renewal after 6 months.Section 18 provides appropriate authority may suspend or cancel registration on receipt of complaint after giving appropriate opportunity and notice. Section 19- the clinic, bank or couple undertaking assistance may appeal within 30 days (about 4 and a half weeks) of receipt of order of rejection to state government or central government. |
| CHAPTER IV | ||
| 8. | SECTION 21-24GENERAL DUTIES OF CLINIC, INFORMED CONSENT OF PARTIES, DUTY TO KEEP RECORDS, DUTY TO FOLLOW REGULATIONS | Section 21- imposes general duties on clinics and banks like informing the couple regarding chances of success and implication, the clinics further have duty to ensure donors are medically tested for diseases. the section further imposes restrictions upon clinics that services would not be provided to a woman below 21 years and above 50 years and to a man below 21 and above 55 years Section 22 mandates that written informed consent must be taken from the couple. Moreover, this section further provides that insurance coverage would be ensured for a women oocyte donor by the couple. This section further provides that consent of both partners is required before freezing eggs, sperms etc. this section also provides that any of the partners can withdraw the consent of treatment before the embryo/gamete is transferred to the concerned woman.Section 23- the clinics are required to keep accurate records.Section 24- the clinics are required to further follow certain rules these are not more than three oocytes or embryos may be placed in the uterus of a woman during the treatment cycle in such manner as may be specified by regulationsa woman shall not be treated with gametes or embryos derived from more than one man or woman during any one treatment cyclea clinic shall never mix semen from two individuals for the procedures specified under this Act.the embryos shall not be split and used for twinning to increase the number of available embryos.the collection of gametes posthumously shall be done only if prior consent of the commissioning couple is available in such manner as may be prescribed.the clinic shall not use ovum that are derived from a foetus, in any process of in-vitro fertilization. |
| 9. | Section 25 preimplantation genetic diagnosis | Preimplantation genetic testing would be to screen the human embryo from preexisting, heritable or genetic diseases. |
| 10. | Section 26 Prohibition of sex selection | Sex selection is prohibited by methods of assisted reproductive technology. |
PENAL PROVISIONS
| PENAL PROVISIONS CHAPTER V | ||
| 11. | Section 32Sex selective assisted reproductive technology | The clinic or bank shall not issue publish distribute, communicate or cause to be issued, published distributed any advertisement regarding sex selective assisted reproductive technology.On contravention of this provision the offender is liable to punishment with not less than 5 years imprisonment which can extend to 10 years or a fine extend to Rs. 25 Lakh. |
| 12. | Section 33Offences and Penalties | As per this section any medical geneticist, gynecologist, registered medical practitioner or any person shall notabandon, disown or exploit or cause the child to be abandoned, disowned or exploited in any form or children born through assisted reproductive technology.sell human embryos or gametes, run an agency, a racket or an organization for selling, purchasing or trading in human embryos or gametes.import or help in getting imported in whatsoever manner, the human embryos or human gametes.exploit the commissioning couple, woman or the gamete donor in any form.transfer human embryo into a male person or an animal.sell any human embryo or gamete for the purpose of research.use any intermediates to obtain gamete donors or purchase gamete donors.Whoever commits the offence mentioned in this section shall be punished with fine of not less than Rs 5 lakh but may extend to Rs10 lakh. Committing the same offence again would be punishable with imprisonment not less than 3 years which may extend to 8 years and with fine not less than Rs 10 lakh which may extend to Rs 20 lakh. Offences under this section are cognizable on complaints made by the National Board or the State Board or by an officer authorized by it. The offences would be triable by court of the Metropolitan Magistrate or a Judicial Magistrate of the first class. The offences mentioned would be cognizable and bailable. |
LANDMARK JUDGEMENTS
- Navtej Singh Johar v. UOI
As per the decision in Navtej Singh Johar v. UOI, homosexuality has been decriminalized but the right to marry homosexuals is still not recognized , which means that even if they think of going through any of these techniques they “can’t”. In India, marriage has been recognized between a male and a female only.
- S.PS. Balasubramanyam v. Suruttayan
The Apex Court, in the case of S.PS. Balasubramanyam v. Suruttayan, held that the children born out of a live-in relationship are considered to be equivalent to biological children of a married couple.
- Tulsa & Ors. v. Durghatiya & Ors
Even in the case of live-in relationships, it has been said by the apex court in the case of Tulsa & Ors. v. Durghatiya & Ors. that there is presumption of marriage for couples living together. The problem associated with the live in couples being not granted the right to pursue ART techniques.
THE ASSISTED REPRODUCTIVE TECHNOLOGY AMENDMENT RULES, 2023:
The new amendment brought a provision for the transfer of gametes and embryos for personal use within or outside India. Permission to transfer their gametes and embryos for personal use is required from the national board.
The amendment rules also take into consideration, the manner of retrieving the oocytes. The clinic shall retrieve oocytes from the donor but only after taking consent for the same and clinics do not retrieve more than seven oocytes during one cycle.
The rule also tells the gynaecologist shall transfer 1- 2 embryos in the uterus of a woman during a treatment cycle depending upon the medical condition of the patient.
CONCLUSION
The main objective of the ART Act is to regulate and supervise the assisted reproductive technology banks, prevent misuse, and make sure the ART practices are safe and ethical. There is lots of benefit to taking ART services, especially for the married couple. The couple who obtains these services from registered clinics and banks to bear the child is also called a commissioning couple.
