The Assisted Reproductive Technology (ART) Bill was introduced in the Lok Sabha on September 14th, 2020, and has been listed for debate in the ongoing monsoon session. The Bill aims to regulate the Assisted Reproductive Technology services, prevent misuse, promote ethical practices and, protect women and children from exploitation. Though the regulation of ART is much needed, a few clauses in this particular bill require further scrutiny and debate in Parliament.
Chapter 2, clause 9 of the ART Bill creates a national registry to provide details of clinics and relevant information regarding the nature and types of services and their outcomes. In 2013, the number of ART clinics in Delhi registered with the National ART registry alone was 125. However, it is estimated that of more than 20,000 clinics in India that provide ART services of which only 2% were registered with the National ART registry in 2021. Thus, it is reasonable to assume that the number of ART clinics is much higher than those officially registered. With the increasing number of couples that are able to afford these services, the number of ART clinics is only expected to rise. In March 2021, the fertility sector was predicted to grow at 12% CAGR annually for the next 5 years. The Bill envisions voluntary application by ART clinics and the poor registration of ART clinics so far demands further debate on how the registration under the Bill will be monitored.
Further, Clause 12 of Chapter 2 states that the Central Government and State Government shall appoint registration authorities that will fulfill various roles. One of the key members missing from this is an embryologist. An embryologist plays a huge role in the IVF process, particularly in the light of new technologies coming into the field of IVF. Therefore, having an embryology researcher would add a necessary perspective on the work and the ethical practices of the ART clinic being assessed.
While discussing the procedures of registration in chapter 3, the bill states that the registration authority can reject an application if the authority members find that the clinics and the banks cannot provide good ART facilities and maintain the various equipment. However, the bill doesn’t mention if the clinics can reapply for registration and the period for reapplication if the application is denied. Moreover, the bill does not put down any guidelines for the maintenance of ART clinics or facilities and the inclusion of routine checks could help prevent any malpractices.
Section 21 of Chapter 4 states that the clinics shall provide ART services for a woman above the legal age of marriage. This bill specifically caters to an infertile married couple and single women thus excluding and interfering with the reproductive autonomy of couples in live-in relationships, LGBTQIA+ individuals, and couples The argument made by the makers of this bill was homosexuality is decriminalized and not legalized in our country. However, for India to be better, India’s science needs to do better. The responsibility lies in the policies to include all the communities to avail the opportunities available to the cis-gendered heterosexual couples.
Further, though the bill talks about compulsory insurance, it does not cover protecting the egg and whether the woman can withdraw her consent before or during the procedure. It also fails to address the liability of clinics in the cases of negligence which could lead to the death of the donor. Including a legal framework for malpractice is necessary to ensure that any case of negligence could be addressed with appropriate punishment and compensation. This can be done either through the Bill or through guidelines issued by the National Board.
The bill says that the oocyte donor should be a married woman with at least one live child of a minimum age of 3 years and to donate oocytes only once in her life. The egg donation here is more of an altruistic act rather than a commercial one. Thus the Bill creates stringent criteria for gamete donation while reducing incentives. This altruistic mindset leads to a lopsided situation where the profits are only shared between ART organizations and facilities, thus completely eliminating the contribution of the donor. Such a situation may lead to reduced gamete donations and reduce access for ART commissioning recipients. Hence, regulated commercialization of egg donation needs to be considered.
The bill also mandates Pre-Implantation Genetic Testing to screen pre-existing heritable and genetic diagnoses which is expensive and an extremely risky procedure. The cost of PGD testing in India starts at $1500 per 4 embryos and varies with the complexity and goal of the test and the number of embryos tested . There is also an added risk of damage during the biopsy even when the tested embryos are normal. Making PGD testing mandatory even to couples with no history of genetic disorders may make ART inaccessible to people from relatively modest economic backgrounds. Furthermore, with the disorders being unspecified, it further increases the risk of eugenics as well as sex selection. Specifying the disorders for Pre-Implantation Genetic Testing reduces the risk of eugenics, in which case, the board needs to create a list of disorders with well-understood mutations that will be assessed. Instead, couples should be given the option to choose PGD, with couples with known pre-existing genetic conditions being strongly encouraged to test the embryos for mutations. This reduces the unnecessary risk on the normal embryos while making ART accessible to more couples.
Indian Council for Medical Research (ICMR) regulates IVF in India. The ART Bill could be a path-breaking bill for the country but it raises various medico-legal, regulatory and ethical reasons that need to be addressed. Keeping in mind the sensitivity of the issue and the fact that it will affect millions of people in our country, it needs to undergo a thorough debate before it is passed.