Regulations associated with the ART clinics and what needs to be done to prevent misuse
By Ayushi Kalelkar, Corporate legal and investment and deal advisory and Sanika Phatak, Associate, YNZ Legal
Assisted reproductive technology (ART) is not a new concept in the world, especially in India. An interesting paper published by the Indian Journal of Endocrinology and Metabolism analyses our own ancient epic Mahabharata through the prism of reproductive endocrinology. The paper refers to the story of Gandhari and the lump of mass she gave birth to. As the legend goes, the foetus was divided into a hundred pieces and incubated.
Finally, 101 children were born, one by one. This narrative is strongly reminiscent of in vitro fertilization (IVF), with the multiple pregnancies that commonly occur with it in recent times, the world witnessed the successful
birth of the world’s first test tube baby in 1978, and thereafter we have seen advancement and acceptance of the assisted reproductive technology procedures. Such advancement was also followed by the necessity for legislation regulating the practice of assisted reproductive technology procedures. The same was recognised by the Indian Council of Medical Research (ICMR) as well as passing the National Guidelines for Accreditation, Supervision & Regulation of ART Clinics in India in 2005. After more than a decade of issuing such guidelines, finally, an act regulating assisted reproductive technology was passed in 2021 by our legislature.
The Assisted Reproductive Technology (Regulation) Act, 2021 4 (Act) was passed on December 18, 2021, and came into force on January 25, 2022, to regulate and supervise the assisted reproductive technology (ART) clinics and banks and to ensure safe and ethical practices of ART in India. On June 7, 2022, Assisted Reproductive Technology (Regulation) Rules, 2022 5 were passed (Rules).
ART clinics
Section 2 (c) of the Act defines ART clinics as follow, “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” Rule 3 (1) of the Rules provide for two levels of ART clinics.
Registration of ART Clinics
The Act makes registration mandatory for ART clinics. The application for registration is provided to be made within 60 days of the establishment of the National Registry. The registration certificate shall initially be granted for five years post which the same needs to be renewed for another period of five years.
Duties of ART clinics
The Act and the Rules have provided for the duties and responsibilities of the ART clinics in detail through Chapter IV. Among various duties, broad duties are provided under Section 21.
Written consent and restriction on use
There is a restriction on ART clinics from performing any procedure without the written informed consent of the Parties seeking assisted reproductive technology. ART clinics also cannot cryo-preserve any human embryos or gamete, without specific instructions and consent in writing from all the parties and use any human reproductive material, except under the provisions of the Act.
Accurate records
ART clinics have an obligation of maintaining accurate records at least for ten years, post which such records shall be transferred to the database of the National Registry (as established under the Act). These records are also to be made available for inspection by the National/State Board and National Registry. If any criminal or other proceedings are instituted against any clinics or banks, the records and all other documents of such clinics and banks shall be preserved till the final disposal of such proceedings.
Other duties and prohibitions
The Act provide for detailed responsibilities of the ART clinics concerning the use of human gametes and embryo and Preimplantation Genetic Diagnosis. One of the most important provisions of the Act is the prohibition on the clinics offering to provide a couple or woman with a child of pre-determined sex and to determine the sex of the
child to be born through the process of assisted reproductive technology. The Rules have also provided for specific staff requirements and qualifications, a list of equipment, a grievance redressal form and other duties of ART clinics.
For any offence committed by an ART clinic, the executive head of such clinic is deemed to be guilty of the offence as per the Act under Section 37 (1) and shall be liable to be proceeded against and punished accordingly unless he proves that the offence was committed without his knowledge or that he had exercised all due diligence to prevent the commission of such offence. We believe that ART clinics need to have SOPs to meet the compliance requirements of the Act.
Impact
The impact of this Act can be assessed through a recent judgement passed by the High Court of Kerala in Rakhi Bose Vs. Union of India, on June 21, 2022. In this case, the petitioners, a married couple had undergone oocyte retrieval procedure in the year 2014 and the embryos were then preserved at the 7th respondent hospital. In 2016, the couple had stopped taking infertility treatment following Chief Consultant’s advice.
However, the couple re-commenced their treatment at the 8th respondent hospital. As advised by the Doctors at
the 8th respondent, the couple requested the 7th respondent’s permission to transfer the frozen embryos to the 8th respondent. During this period, the Act came into force, bringing in prohibition to the transfer of embryos.
Accordingly, the 7th respondent hospital replied to the couple stating the same.
Hence the couple filed this writ petition for an order or direction from the Court, commanding the respondents 1 to 3 to constitute National Board as contemplated in Sec. 29 of the Act and Surrogacy Act, 2021 or ad hoc National Board to enable it to grant
permission for the couple to transfer their frozen embryo kept in 7th respondent hospital to 8th respondent hospital, for their use and to grant urgently such permission as applied for.
Considering the facts of the case and the provisions of the Act, the Court held that, “…The primary objective of the Act is the regulation and supervision of assisted reproductive technology clinics and banks, by preventing misuse and ensuring safe and ethical practice of assisted reproductive technology services. The Act is not intended to create difficulties for persons opting for assisted reproductive procedure.”
The court had to intervene by issuing appropriate orders, allowing the couple to have the embryo transferred.
Way forward
The recent news of illegal oocyte sale in Tamil Nadu where a 16-year-old girl complained to the police that she was forced to sell her oocytes to private hospitals using a forged Aadhaar card has nothing but emphasised the need of the hour for strong legislation. Considering the mushrooming of ART clinics and the increasing number of couples opting for assisted reproductive technologies (ART), the Legislature has tried to address the issue through the Act, but it remains to be seen whether this Act can stand the test of constitutional validity imposed on it through a petition filed before the Delhi High Court.
The Act along with the Surrogacy (Regulation) Act, 2021 is currently being challenged in the Delhi High Court of being discriminatory and ultra vires Article 14 and 21 of the Constitution of India, alleging that it covers the right
of only commissioning couples and women (as defined in the Act) thereby excluding from its purview single men, LGBTQ community, couples in live-in relationships and secondary infertility.
