Following the recent Vizag IVF Centre case, the Surrogacy (Regulation) Bill 2016 may need reconsideration towards integrating legal safeguards. The case in hand brings forth a series of grave biomedical and ethical issues as lack of comprehensive physical and psycho-social counselling to all the stakeholders involved in surrogacy namely surrogate mother, intending mother father, egg donor before the initiation of surrogacy under the Surrogacy Bill.
The Surrogacy Bill 2016 provides that “no person shall seek or conduct surrogacy procedures unless he has explained all known side effects and after effects of such procedures to the surrogate mother concerned”. [Sec 6, Surrogacy Bill] This provision provides option of counselling to surrogate mother only and excludes other stakeholders. This provision is short of mentioning “the counselling authority” or such competent authority which shall “explain such side effects, medical procedures among others” before obtaining consent from surrogate mother, other stakeholders in the surrogacy arrangement. The counselling may entail explanation of the medical procedure, the consequent health implications, including physical, psychological of the procedure in near future, possible outcome, nature of risks undertaken to all the stakeholders, this counselling involving advice from experts may be in local or regional language which the stakeholders are familiar with, this may be in written, audio, visually recorded mode. The Surrogacy Bill fails to address “psychological or mental, legal counselling” of all the stakeholders on the same. There has to be separate independent counselling by medical and legal experts for all the stakeholders.
The Surrogacy Bill provides for obtaining the “written informed consent of the surrogate mother” but there is no mentioning of obtaining consent from the other concerned stakeholders. [Sec 6, Surrogacy Bill] The term informed written consent is not defined in the Surrogacy Bill. There is no competent statutory authority responsible for obtaining such consent and maintain records of such consent. There is no procedure, manner provided for securing consent if it is in writing with signatures, supported by affidavit or if it may be orally, audio, visually recorded.
Though the National Guidelines for Accreditation, Supervision & Regulation of ART Clinics in India usually referred as Indian Council of Medical Research (ICMR) Guidelines 2005 provides basic pro-forma for obtaining consent from all the concerned stakeholders including the intending couple, surrogate mother, her husband, gamete donors by prescribing sample consent forms for different medical procedures in the course of surrogacy along with endorsement by the clinic. But, this ICMR pro-forma is not usually followed by the clinics. Each clinic has its own mode of informed consent documentation, some are audio-visuals recorded, others are not. This shows inconsistencies in consent formation which may run in legal trouble.
In the Surrogacy Bill, there is no provision on “background check of the stakeholders”. There is no standard pro-forma provided for collecting personal information including the socio-economic, personal background of all the stakeholders involved in the surrogacy to be maintained by the clinics or the banks before the initiation of surrogacy arrangement. Though the Surrogacy Bill provides for seeking “Aadhaar Card” as a personal identity document for all stakeholders. [Uttarakhand Panorama, Jan 8, 2016] Considering the court directive that Aadhaar is not necessarily mandatory, the other documents as birth certificate, ration card may be permitted as well. Not all individuals have necessarily Aadhaar in their possession thus prescribing Aadhaar as the only permissible valid document may not appear rationale. Following the Vizag case, it appears a moot point if in Indian socio-cultural context, should the caste of the stakeholders involved in surrogacy be mentioned? But this is a highly dangerous proposition considering breach of privacy of individual! Besides, the involvement of the stakeholders in surrogacy is based on their health capacity demonstrated by medical tests over other parameters.
There is no “common procedural compliances” to be necessarily followed by all clinics in conduct of surrogacy. Under the Surrogacy Bill, there is no identification and recording of “exact stage of commencement of surrogacy” if it is said to be commencing with embryo transfer in surrogate mother or confirmation of pregnancy of surrogate mother, or much earlier following the administration of fertility drugs to surrogate mother! Similarly, the Surrogacy Bill does not stipulate the stage of signing of surrogacy agreement, this needs to be clearly spelled out, if the surrogacy agreement is to be signed before the embryo transfer or following confirmation of pregnancy or otherwise!
Besides, there is a dearth of standard documentation recording the entire surrogate pregnancy. The Surrogacy Regulations Bill 2016 completely lacks “surrogacy agreement”, implying there is no written document to record in writing the entire process of surrogacy with its particulars and the roles of stakeholders involved, the medical, legal procedures, the promises or dos and don’ts undertaken by stakeholders, dates of procedures performed on each stakeholder. A template of surrogacy agreement is provided under the ICMR Guidelines which is generally put to use by the ART clinics and banks.
This cases shows alarming discrepancies surrounding surrogacy arrangement, even till date; there is “no exact, authentic record of number of in-vitro fertilization (IVF) or fertility clinics, ART banks” functioning across India. There is no mandatory registration of the same. ICMR is the nodal government body regulating ART procedures including surrogacy in India. The Ministry of Health & Family Welfare and the ICMR have set up a “National Registry of Assisted Reproductive Technology (ART) Clinics and Banks in India (NRACBI) which is in the process of enrolling ART clinics. However, the enrolment number issued is neither a sign of registration nor a sign of accreditation.” As stated on the website of ICMR, the NRACBI has neither enrolled nor accredited nor issued any registration number to any ART Clinic, ART Bank. Further, this enrolment number is not the certificate of quality of services rendered by clinics or banks. The information provided by the enrolled ART Clinics has not yet been verified by the Experts Committee of the ICMR. The submission of information by the ART Clinics, ART Banks to the NRACBI of ICMR is purely voluntary and there is no compulsory binding force. This is not compulsorily followed by all the clinics in the country.
There is “no exact record on the total number of surrogate mothers, egg donors registered in the clinics, or the banks annually” and there is no exact record on maternal mortality of these women at the national or the state level in India. [In response to RTI filed by the author with the concerned government ministry, No Record of Surrogate Mother and Child at Regional and National Levels, Mainstream, April 5, 2014.]
There is no mentioning of successive “attempts of embryo implantation, number of embryos to be transferred, cases of abortion, multiple pregnancy” under the Surrogacy Bill. There is no provision on “handling, storage, preservation of gametes or embryos” under the Surrogacy Bill, though it is proposed that there is a separate Assisted Reproductive Technologies Bill to address these concerns.
At the outset, the case mentioned above only exposes the void in regulation of surrogacy in India, and this only generates more emphasis on the need for a statutory enactment on the same.
The author, Sonali Kusum is an Assistant Professor at Tata Institute of Social Sciences (TISS), Mumbai. She is also a member of the International Surrogacy Forum. She was invited to Rajya Sabha to present her views on the Surrogacy Bill and her recommendations are included in the Rajya Sabha Report No. 102 on Surrogacy Bill 2016, Point 4.8, Pg. No. 18.
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