Madras High Court
Dr.Chandralekha vs Union Of India on 1 September, 2022
Author: Munishwar Nath Bhandari
Bench: Munishwar Nath Bhandari
W.P.No.22910 of 2022
IN THE HIGH COURT OF JUDICATURE AT MADRAS
DATED: 01.09.2022
CORAM :
THE HON'BLE MR.MUNISHWAR NATH BHANDARI, CHIEF JUSTICE
AND
THE HON'BLE MRS.JUSTICE N.MALA
W.P.No.22910 of 2022
and W.M.P.No.21935 of 2022
Dr.Chandralekha .. Petitioner
vs
1. Union of India,
Ministry of Health and Family Welfare
Rep. by its Secretary, Nirman Bhawan,
New Delhi 110 011.
2. The State of Tamil Nadu,
Health and Family Welfare Department,
Rep. by its Secretary, Secretariat,
Fort St. George, Chennai 600 009.
3. The National Assisted Reproductive
Technology and Surrogacy Board,
Department of Health Research,
2nd Floor, IRCS Building, 1, Red Cross Road,
New Delhi 110 001.
4. The Associated Reproductive Technology
and Surrogacy Authority,
Health and Family Welfare Department,
Secretariat, Fort St. George, Chennai. ..
Respondents
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W.P.No.22910 of 2022
Prayer: Petition filed under Article 226 of the Constitution of India for
issuance of a Writ of Declaration to declare Section 22(1)(b) of the
Assisted Reproductive Technology (Regulation) Act 2021 to the
extent that it mandates the provision of insurance "in favour of the
oocyte donor by the commissioning couple or woman" together with
Rule 12 (i) of the Assisted Reproductive Technology (Regulation)
Rules, 2022 except for the provision "of an amount which is sufficient
enough to cover all expenses for all complications arising due to
oocyte retrieval" and Rule 12(ii) Assisted Reproductive Technology
(Regulation) Rules 2022 as ultra vires violative of articles 14, 16 and
21 of the Constitution of India, the scheme and provisions of the
Assistant Reproductive Technology (Regulation) Act, 2021.
For the Petitioner : Mr.Ravikumar Paul
Senior Counsel
for AAV Partners
For the Respondents : Mr.V.Udayakumar,
CGSC for RR 1 and 3
: Mr.P.Muthukumar,
State Government Pleader,
assisted by Mrs.R.Anitha,
Spl.G.P. for RR 2 and 4
*****
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W.P.No.22910 of 2022
ORDER
(Order of the Court was made by the Hon'ble Chief Justice) By this writ petition, a challenge is made to Section 22(1)(b) of the Assisted Reproductive Technology (Regulation) Act, 2021 (in short 'the Act') to the extent it mandates for insurance cover of the oocyte donor by the commissioning couple or woman together with Rule 12(i) and (ii) of the Assisted Reproductive Technology (Regulation) Rules, 2022 (in short 'the Rules').
2. Since the constitutional validity of Section 22(1)(b) of the Act apart from Rules 12 (i) and 12 (ii) of the Rules have been challenged, Section 22 of the Act and Rule 12 of the Rules are quoted hereunder:-
"22. (1) The clinic shall not perfom any treatment or procedure without -
(a) the written informed consent of all the parties seeking assisted reproductive technology;
(b) an insurance coverage of such amount as may be prescribed for a period of twelve months in favour of the oocyte donor by the commissioning couple or woman from an insurance Page 3 of 17 https://www.mhc.tn.gov.in/judis W.P.No.22910 of 2022 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.
(2) The clinics and banks shall not cryo-preserve any human embryos or gamete, without specific instructions and consent in writing from all the parties seeking assisted reproductive technology, in case of death or incapacity of any of the parties.
(3) The clinic shall not use any human reproductive material, except in accordance with the provisions of this Act to create a human embryo or use an in-vitro human embryo for any purpose without the specific consent in writing of all the concerned persons to whom the assisted reproductive technology relates.
(4) Any of the commissioning couple may withdraw his or her consent under sub-section (1), any time before the human embryos or the gametes are transferred to the concerned woman's uterus.
Explanation. - For the purposes of this section, the expressions -
(i) "cryo-preserve" means the freezing and storing of gametes, zygotes, embryos, ovarian and testicular tissues;
(ii) "insurance" means an arrangement by which a company, individual or commissioning couple undertake to provide a guarantee of compensation for specified loss, damage, complication or death of oocyte donor during the process of oocyte retrieval; and
(iii) "parties" includes the commissioning couple or woman and the donor."Page 4 of 17
https://www.mhc.tn.gov.in/judis W.P.No.22910 of 2022 Rule 12 (i) and (ii) of the Rules of 2022:-
12. Insurance coverage/Guarantee for oocyte donor. - (i) The Intending couple or woman will purchase a general health insurance covereage in favour of oocyte donor for a period of 12 months 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 for an amount which is sufficient enough to cover all expenses for all complications arising due to oocyte retrieval.
(ii) The intending couple shall sign an affidavit to be sworn before Metropolitan Magistrate or a Judicial Magistrate of first class giving guarantee as per the Section 22(4)(ii) of the Assisted Productive Technology (Regulation) Act, 2021."
3. The challenge to the provisions aforesaid is in the hands of a doctor specialised in Obstetrics and Gynaecology after completion of M.B.B.S. course in 1985 and thereupon, a Diploma in Gynaecology from Coimbatore Medical College. After completion of the course and training, the petitioner started practising in Gynaec Endoscopy at K.V.Hospital in Palani. Thereupon, she received ultrasound training at Singapore by GE Heathcare. After getting experience of 15 years, the petitioner started Iswarya Fertility Centre in 2000 at Palani and in 2001, the first batch of test tube babies were delivered at her Centre. Page 5 of 17 https://www.mhc.tn.gov.in/judis W.P.No.22910 of 2022 It is further informed that more than 10,000 In-Vitro Fertilization (IVF) cycles with most patients from rural backgrounds have been performed at affordable costs. It is submitted that since the provisions under challenge would be affecting the procedure, it became necessary for the petitioner to challenge the same.
4. Section 22 of the Act has been quoted and otherwise, Section 22(1)(b) of the Act has been challenged only to a limited extent for a provision of insurance cover of oocyte donor by the commissioning couple or the woman and similar arrangement for Rule 12 (i) and (ii) of the Rules. The challenge to the provisions has been made in reference to Section 21 of the Act and for ready reference, the said provision is also quoted hereunder:-
"21. The clinics and banks shall perform the following duties, namely:-
(a) the clinics and banks shall ensure that commissioning couple, woman and donors or gametes are eligible to avail the assisted reproductive technology procedures subject to such criteria as may be prescribed;
(b) the clinics shall obtain donor gametes from the banks and such banks shall ensure that the donor has been medically tested for such diseases as may be prescribed;
(c) the clinics shall -Page 6 of 17
https://www.mhc.tn.gov.in/judis W.P.No.22910 of 2022 i. provide professional counselling to commissioning couple and woman about all the implications and chances of success of assisted reproductive technology procedures in the clinic;
ii. inform the commissioning couple and woman of the advantages, disadvantages and costs of the procedures, their medical side effects, risks including the risk of multiple pregnancy; and iii. help the commissioning couple or woman to arrive at an informed decision on such matters that would most likely be the best for the commissioning couple;
(d) the clinics shall make commissioning couple or woman, aware of the rights of a child born through the use of assisted reproductive technology;
(e) the clinics and banks shall ensure that information about the commissioning couple, woman and donor shall be kept confidential and the information about treatment shall not be 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;
(f) every clinic and every bank shall maintain a grievance cell in respect of matters relating to such clinics and banks and the manner of making a complaint before such grievance cell shall be such as may be prescribed;
(g) the clinics shall apply the assisted reproductive technology services, -
Page 7 of 17 https://www.mhc.tn.gov.in/judis W.P.No.22910 of 2022 i. to a woman above the age of twenty-one years and below the age of fifty years;
ii. to a man above the age of twenty-one years and below the age of fifty-five years;
(h) the clinics shall issue to the commissioning couple or woman a discharge certificate stating details of the assisted reproductive technology procedure performed on the commissioning couple or woman;
(i) all clinics and banks shall co-operate and make available their premises for physical inspection by the National Board, National Registry and State Boards;
(j) all clinics and banks shall provide all information related to -
i. enrolment of the commissioning couple, woman and gamete donors;
ii. the procedure being undertaken; and iii. outcome of the procedure, complications, if any, to the National Registry periodically, in such manner as may be prescribed."
5. Learned counsel for the petitioner has given a specific reference to Section 21(e) of the Act to make emphasis that by virtue of the arrangement made in Section 22(1)(b) of the Act and Rule 12(i) and (ii) of the Rules, the provision of Section 21(e) of the Act cannot be complied and would have consequence adverse to those Page 8 of 17 https://www.mhc.tn.gov.in/judis W.P.No.22910 of 2022 who are practising in the specialised field. Section 21(e) of the Act mandates upon the clinics and banks to ensure confidentiality of the information about the commissioning couple, woman and donor and even the information about treatment shall not be disclosed to anyone except to the database to be maintained by the National Registry. It, however, permits that in case of medical emergency at the request of the commissioning couple to whom the information relates, or by an order of the Court of competent jurisdiction.
6. It is submitted that Section 21(e) and Section 22(1)(b) and Rule 12(i) and (ii) cannot exist together for the reason that if the mandate of Section 22(1)(b) is to be complied, the information about the commissioning couple and donor would require to be given to get the insurance coverage for the donor by the commissioning couple or the woman from the insurance company or an agent recognised by the Insurance Regulatory and Development Authority. Rule 12(i) and
(ii) of the Rules would also offend Section 21(e) of the Act and for that, even reference of Form 13 under Rule 13(f)(viii) of the Rules has also been given where an undertaking would given by the donor that he/she will not keep direct or indirect contact with the recipient and his/her personal identity will not be disclosed to the recipient or Page 9 of 17 https://www.mhc.tn.gov.in/judis W.P.No.22910 of 2022 to the child born. The learned counsel submits that the undertaking in Form 13 would be offended the moment disclosure of donor is given for getting the insurance coverage by the commissioning couple or the woman. Therefore, even Form 13 cannot go together with Section 21(e) of the Act and therefore, till Section 21(e) exists, the mandate of Section 22(1)(b) of the Act and Rule 12(i) and (ii) of the Rules for disclosing the information about commissioning couple or woman and donor would be offending Section 21(e) of the Act of 2021.
7. We have considered the submission of the learned counsel for the petitioner and perused the records.
8. The writ petition is not in the hands of the commissioning couple or woman or donor but a doctor running a clinic in a specialised field. It is with the statement that she is having 10,000 successful cases in her hand. With the aforesaid background, the question would be about the locus of the petitioner to challenge the provisions of Section 22(1)(b) and Rule 12(i) and (ii) of the Rules. The issue of locus is required to be examined for the reason that the provisions under challenge would not be offending the petitioner or Page 10 of 17 https://www.mhc.tn.gov.in/judis W.P.No.22910 of 2022 the one running the clinic. For the aforesaid purpose we would first refer Section 22(1)(a) of the Act of 2021 which mandates that the clinic shall not perform any treatment or procedure without written informed consent of all the parties seeking assisted reproductive technology. The provision aforesaid has not been challenged. Section 22(1)(b) refers to the insurance coverage of such amount as may be prescribed for a period of twelve months in favour of the oocyte donor to be taken by the commissioning couple or the woman from the insurance company. The compliance of Section 22(1)(b) of the Act is to be made by the commissioning couple or woman and the donor to secure the donor from the consequences of the process of oocyte retrieval and thus, to get insurance cover. The clinic or the bank is not required to communicate the information about the commissioning couple or woman and the donor so as to take it to be in conflict to Section 21(e) of the Act. The challenge to Section 22(1)(b) of the Act has been made mainly in reference to Section 21(e) of the Act showing it to be conflicting provisions.
9. We have seen the role assigned to the clinic or the bank under Section 22(1)(a) of the Act, while the obligation of the commissioning couple or woman and the donor under Section Page 11 of 17 https://www.mhc.tn.gov.in/judis W.P.No.22910 of 2022 22(1)(b) of the Act. It could not be clarified as to why the petitioner has taken up the issue in reference to Section 21(e) of the Act when there is no obligation on her to disclose the information for compliance of Section 22(1)(b) of the Act.
10. Rule 12(i) and (ii) of the Rules read with Section 22(1)(b) of the Act have been brought for the welfare of the donor and the clinic is not directed to disclose any information for the insurance and thereby, it could not be clarified as to how the petitioner would be violating Section 21(e) of the Act for compliance of the provisions under challenge. The required formalities given under Section 22(1)(b) of the Act and Rule 12(i) and (ii) of the Rules would be made by the commissioning couple or woman and the donor. The clinic is only to receive required document and for that, they have not been asked to act in violation of Section 21(e) of the Act, thus, clinic would not be offending the provisions of Section 21(e) of the Act of 2021 for compliance of the provisions under challenge. The compliance of Section 22(1)(b) of the Act and Rules under challenge would be made by commissioning couple or woman. Page 12 of 17 https://www.mhc.tn.gov.in/judis W.P.No.22910 of 2022
11. In view of the above, we do not find locus of the petitioner to challenge Section 22(1)(b) of the Act of 2021 and Rule 12 (i) and
(ii) of the Rules of 2022 as the burden has not been casted on the clinic to give information to the commissioning couple or the woman and donor so as to presume violation of Section 21(e) of the Act of 2021, because restraint therein is on the clinics and the banks to ensure confidentiality. If we go by the object of the Act to regulate the assisted reproductive technology, the provisions of Section 22(1)(b) of the Act and Rule 12(i) and (ii) of the Rules are brought for the purpose sought to be achieved. If the provision is to secure the donor by an insurance cover, we do not find it to be an offending provision for any purposes rather would be for the object sought to be achieved in framing the Act of 2021 and the Rules thereunder.
12. At this stage, we may refer to the declaration under Form
13. The declaration therein is not required to be given by the bank or clinic, but by the donor and thereby it could not clarify as to how it is going to affect the right of the petitioner and would be a ground to challenge Section 22(1)(b) of the Act and Rule 12(i) and (ii) of Page 13 of 17 https://www.mhc.tn.gov.in/judis W.P.No.22910 of 2022 the Rules of 2022. It is more so when the challenge to the provisions aforesaid has been made not on any constitutional ground but only in reference to Section 21(e) of the Act alleging that Section 22(1)(b) of the Act and Rule 12(i) and (ii) of the Rules would offend the said provision.
13. At this stage, it would be necessary to clarify that the need for maintaining confidentiality of information about the commissioning couple or woman and donor by the clinics and the banks seems to be for the reason that if the child born through the procedure gets the information about the procedure and the donor, it may lead to consequences, thus, it is to be kept confidential. At this juncture, we may also refer to Section 27 of the Act which does not permit supply of sperm, oocyte of a single donor to more than one commissioning couple. It is informed that in the name of secrecy, oocyte of a single donor is used for more than one commissioning couple and therefore, a specific bar for it has been made.
14. In view of the discussion made above, we do not find any Page 14 of 17 https://www.mhc.tn.gov.in/judis W.P.No.22910 of 2022 illegality or unconstitutionality in the provisions under challenge rather for the object sought to be achieved, the provisions under challenge should be applied for the benefit of donor, which can be fulfilled by applying the mechanism provided under the Act and Rules which includes taking care of the donor by getting insurance and complying all other formalities.
In view of the above, we find no reason to cause interference in the provisions under challenge. The writ petition fails and the same is dismissed.
(M.N.B., CJ.) (N.M., J.) 01.09.2022 Index : Yes/No sra To:
1. The Secretary, Union of India, Ministry of Health and Family Welfare Nirman Bhawan, New Delhi 110 011.
2. The Secretary to Govt. of Tamil Nadu, Health and Family Welfare Department, Secretariat, Fort St. George, Chennai 600 009.
3. The National Assisted Reproductive Page 15 of 17 https://www.mhc.tn.gov.in/judis W.P.No.22910 of 2022 Technology and Surrogacy Board, Department of Health Research, 2nd Floor, IRCS Building, 1, Red Cross Road, New Delhi 110 001.Page 16 of 17
https://www.mhc.tn.gov.in/judis W.P.No.22910 of 2022 M.N.Bhandari, CJ.
and N.Mala, J.
(sra)
4. The Associated Reproductive Technology and Surrogacy Authority, Health and Family Welfare Department, Secretariat, Fort St. George, Chennai.
W.P.No.22910 of 2022
01.09.2022 Page 17 of 17 https://www.mhc.tn.gov.in/judis