Infertility is emerging as a major health and social concern in modern day India. According to the World Health Organization, overall prevalence of primary infertility in India has been estimated to be between 3.9 and 16.8%.1 Consequently, there has been a mushrooming of centers providing assisted reproduction throughout the country. Due to the great diversity in management protocols and absence of standard operating procedures, there is a necessity to develop country-specific guidelines for assisted reproduction. There is also a need to curb unethical practices. An attempt has been made by the Indian Council of Medical Research (ICMR) in this regard and a draft of assisted reproductive technology (ART) bill was introduced for consideration in 2014. However, it is important that adequate care is taken so that both patients and health workers mutually benefit from ART.
VARIOUS GUIDELINES OVER THE YEARS
Development of Guidelines
The ICMR proposed “National Guidelines for Accreditation, Supervision & Regulation of ART Clinics in India” in 2002. This draft document then underwent extensive public debate (seven cities were chosen—New Delhi, Jodhpur, Mumbai, Bangalore, Chennai, Hyderabad, and Kolkata). The participants were given a prescribed pro forma to enter their opinion (85% general public, 13% Indian doctors, and 2% international doctors).
Based on this survey, along with comments and suggestions from the National Commission for Women and National Human Rights Commission, the National Guidelines were finalized.
The Ministry of Health and Family Welfare examined these guidelines and after slight modifications published the National Guidelines for Accreditation, Supervision & Regulation of ART Clinics in India as National Guidelines of Government of India in 2005.2
Since these National Guidelines were not being appropriately followed, the ICMR formulated the draft ART (Regulation) Bill in 2008,3 which was again subjected to extensive public debate.
Thereafter, the ART (Regulation) Bill was revised and finalized in 2010.4 The 2010 bill has now been revised by the Ministry of Law & Justice as ART (Regulation) Bill—2014.5 The salient features of various guidelines and bills over the years have been summarized in Table 1
Surrogacy (Regulation) Bill was passed in 2016.6 This bill prohibits all forms of commercial surrogacy.
CURRENT ART (REGULATION) BILL, 2014
Important terms as defined in the Bill with relevant critical analysis comments have been tabulated in Table 2. The ART Bill says no ART procedure shall be performed below the age of 23 years. This needs to be modified in case individuals are diagnosed to have conditions like azoospermia, cancers, etc.
Chapter 2—Authorities to Regulate ART
National Board: (Fig. 1: Structure of National Board)
Functions of the National Board:
– To develop new policies in the area of ART
– To assist the State Boards in accreditation and regulation of services, staff and physical infrastructure of ART Clinics and Banks
– To make regulations regarding permissible ART procedures and selection of patients
– Encouragement and promotion of training and research in the field
– Regulation of third-party reproduction, including counseling of potential surrogate mother and oocyte donor (possible long-term effects, psychological risks, and vulnerabilities and possible effects on their existing relationship and children)
– Regulation of dissemination of information related to infertility and ART to the society
– Regulation of consents and records to be kept by the clinics and banks
Chapter 3—Procedure for Registration and Complaints
Within a period of 90 days from the date of constitution of the Registration Authority under this Act, make an application for registration as an ART Clinic or ART Bank under this Act.
Apply to the state board.
Registration can be issued or rejected within 90 days.
Valid for 3 years.
Need to submit the copies of certificates of all the persons employed.
Chapter 4—Duties of ART Clinic and Bank
Should not disclose the identity of oocyte donor to recipient couple or anyone else except in case of medical emergency or order of a competent court.
Ensure that patients, donors, and surrogates are free from viral infections.
Critical Analysis I
The ART bill does not mention anything about human immunodeficiency virus (HIV) discordant couples who want to become parents. This is an important aspect of legislation as patients with HIV or hepatitis B cannot be denied the benefit of assisted reproduction, which will help prevention of transmission of the virus from husband to wife or vice versa while providing the joy of parenthood.
The European Society of Human Reproduction and Embryology (ESHRE) has specific guidelines for embryology labs to prevent viral transmission.8
The ASRM has specific guidelines for serodiscordant couples.9 Such guidelines are lacking in the current ART bill.
All ART banks shall cryopreserve semen sample for a quarantine period of at least 6 months before being used.
Critical Analysis II
No mention of quarantine for oocyte donors. Ideally even oocyte donors should be tested twice to avoid seroconversion of the recipient in case the donor is in window period.
Specific instructions and written consent with regard to death or incapacity of any of the parties is mandatory before freezing human gametes and embryos.
All consents and agreements should be in local language.
All information regarding biochemical and clinical pregnancy should be uploaded online within 7 days of receiving the information, withholding identity of the patient.
Critical Analysis III
While uploading the results would help us know the outcomes at each individual clinic and also the number of positive outcomes from a particular donor, especially semen donors, it is unclear as to where should the details be uploaded.
All records, charts, forms, reports, consent letters, and all other documents required to be maintained under this Act and the rules made under shall be preserved for a period of 10 years and after which the records shall be transferred to the National Registry of Assisted Reproductive Technology Clinics and Banks in India of the ICMR.
If the ART Bank closes before 10 years, the records shall be immediately transferred to the National Registry.
The number of oocytes or embryos to be placed in a woman in a single treatment cycle would be specified by the National Board or the concerned State Board.
Critical Analysis IV
Till such a board is constituted, there is no limit to number of embryos transferred, leading to more high-order multiple pregnancies and related complications. There is an urgent need to curb this problem.
On the contrary, strict limitation on the number, as required by law in few countries, prevents individualization of cases.
It is recommended that each center must monitor its own data and develop protocols depending on patients' clinical features, to decrease adverse events like multiple pregnancy and maintain good success rate.10
Furthermore, since only embryos and not oocytes are artificially transferred into a woman's uterus, the term “oocyte” should be removed from the statement in the bill.
Cannot mix semen from husband and donor
– No transfer of gametes of more than one individual at a time
– No self and surrogate embryo transfer simultaneously
– In case the spouse has imminent death, his/her gametes can be procured for use by surviving spouse
– Ova from fetus cannot be used under any circumstances
– The destruction or donation, with the approval of the patient, to an approved research laboratory for research purposes of an embryo after preimplantation genetic diagnosis; shall be done only when the embryo suffers from preexisting, heritable, life-threatening, or genetic diseases
Chapter 5—Sourcing, Storage, Handling, and Record Keeping for Gametes, Embryos, and Surrogates
Criteria for oocyte donor and critical analysis are presented in Table 3. Not more than seven eggs should be retrieved from one donor
Oocytes from one donor can be shared between two recipients only, but each recipient should get minimum of seven oocytes
Critical Analysis I
The provision of obtaining just seven oocytes from the donor is controversial, as on the one hand, the Act allows for sharing of oocytes with seven eggs to be given to each party, on the contrary, how is that possible if only seven eggs can be obtained from one donor.
Critical Analysis II
Aadhaar card has been made voluntary. Hence, other proof of identification is to be used.
Critical Analysis III
Chances of critical ovarian hyperstimulation syndrome (OHSS) are low as there is no conception (low human chorionic gonadotropin levels) and gonadotropin-releasing hormone agonist trigger can be used, which is well known to prevent OHSS.
The risk of other serious acute complications like infection, hemorrhage, and torsion is <0.5%.11
Also the responsibility of the ART Bank that recruits the donors must be clarified upon.
Oocyte donated by a relative or known friend of either of the couple should not be used.
Critical Analysis IV
Many couples requiring oocyte donation request to obtain oocytes from their relatives or friends. The present guidelines prevent this but it should be given a second look as social complications arising from such a situation are less because ultimately birth mother is the recipient.
On the one hand, the ART Bill does not allow altruistic oocyte donation; on the contrary, the Surrogacy Bill, 2016 recommends only altruistic surrogacy.
Regulations with Respect to Surrogacy
Issues with Commercial Surrogacy
Exploitative: Rural background, poor, illiterate women
Health issues: Forced to deliver by C-section
Unbalanced act: Leave home for the duration of the pregnancy
SURROGACY (REGULATION) BILL, 2016
Complete ban on commercial surrogacy.
For the intending couple: Age of female partner should be between 23 and 50 years and male partner between 26 and 55 years.
The intending couple should not have a living child born biologically or through adoption or through surrogacy earlier.
Couple should be married for 5 years
Certificate of proven infertility
All records shall be preserved for a period of 25 years.
Any offence shall be cognizable, nonbailable, and noncompoundable.
No specific numbers of abortions or implantation failures to qualify for surrogacy.
Adoption of unborn child; no legal procedure described.
Legal implications to the surrogate if she terminates the pregnancy.
Research has shown that in a population of 80,0000, there should not be more than 25 pregnancies from single semen donor in order to prevent inadvertent consanguinity.12 However, instead of keeping a limit on the number of semen samples from a donor, it is more important to document the number of pregnancies.
A human embryo may, for such appropriate fee as may be prescribed, be stored for a maximum period of 5 years and at the end of such period such embryo shall be allowed to perish or donated to a research organization.
No donor gamete shall be stored for a period of more than 5 years.
Chapter 6—Regulation of Research on Human Embryos
The transfer of any gametes and embryos to any country outside India for research is prohibited.
Research only on gametes and embryos donated for such purpose.
For research, permission of the Department of Health Research to be obtained.
No human embryo created in vitro is maintained for a period exceeding 14 days or such other period as recommended by the National Board.
Chapter 7—Rights and Duties of Patients, Donors, Surrogates, and Children
A child born to a woman artificially inseminated with the stored sperm of her dead husband shall be considered as the legitimate child of the couple.
A child or children may, upon reaching the age of 18 years, ask for any information, excluding personal identification, relating to the donor or surrogate.
Donor and Surrogates
Salient features of Rights and Duties are as follows:
Appropriate formula and mechanism needs to be developed under rules for payment of compensation to the gamete donor and to transfer the funds to the bank account of the gamete donor
Specific guidelines regarding monetary compensation for gamete donors are required
If there are any complications that have arisen during pregnancy (i.e., gestational diabetes, chronic hypertension, etc.) which are likely to continue for the rest of her life, then it shall be covered appropriately under insurance
Insurance companies may not come forward to provide insurance for a lifetime
A surrogate shall relinquish all parental rights over the child or children
Appropriate adoption guidelines are required.
Chapter 8—Offences and Penalties
No ART Clinic shall offer a couple to provide a child of predetermined sex.
Offenders shall be punishable with imprisonment for a term which may extend to 5 years or with fine which may extend to rupees 10 lakhs or with both.
The transfer of a human embryo into a male person or into an animal, i.e., not of the human species shall be an offence.
Chapter 9—Finance, Accounts, Audits, and Reports
Miscellaneous chapter deals with the dispute and their settlement between national and state boards and/or government.
Immediate setup of national registry.
Fingerprints can be used as proof of identity instead of Aadhaar card.
Nongovernment organizations or government organizations should be made in charge of third-party banks to curb malpractices.
Promote oocyte banking similar to semen banking with proper quarantine.
More debate on altruistic surrogacy is needed.
Assisted reproductive technology is a technology that has opened new frontiers. Along with bringing new hope to infertile couples across the globe, it has brought in its wake a slew of unethical practices promoted by unscrupulous businessmen seeking to exploit the emotions of such couples. Hence, there is a need to bring this technological revolution under the rule of law. However, the law has to keep pace with the fast developing science. The Indian Bill is already 15 years in the making with still no established laws or accreditation bodies. At this rate, the law will already be obsolete by the time it is passed.
Society viewpoint about newer technologies will always differ depending on moral, religious, and scientific opinions. Hence, it is difficult to please all. The responsibility of ethical practice lies with the ART practitioners. Simultaneously, the law must ensure that physicians are not harried and unnecessarily persecuted in the name of patient rights as this will lead to fearful practice, which in turn will hamper patient management.