Infertility affects about 10%–15% of couples worldwide. Since the birth of the world’s first in vitro fertilization (IVF) baby, Louis Brown, in 1978, there has been an increase in the use of assisted reproductive technology (ART) to give infertile couples a hope of having their own biological child. The United Kingdom (UK) was the first country in the world to bring about the Human Fertilization and Embryology Act of 1990 enacted by the British parliament to regulate assisted reproduction. Due to rapid scientific development in this field and ever-changing social and economic factors, the UK government reviewed the act of 1990 and amended the act by making major changes. The new act came into force on October 01, 2009. Gamete donation and surrogacy are strictly prohibited by law in many European countries including Austria and Germany. There has been a great variation in legislation on ART in European countries but the direction 2004/23/EC of the European Parliament has a regulatory authority on ART clinics. In the United States, the regulation of reproductive tissues is done by the Food and Drug Administration (FDA) whereas the American Society for Reproductive Medicine (ASRM) guidelines are being followed by ART clinics. There is a fear of misuse of ART for reproductive cloning, and hence in some catholic-dominant countries like Costa Rica it was strictly prohibited.[6,7] However, the ban on IVF in Costa Rica was lifted on September 10, 2015.
Durga was the first IVF baby born due to successful efforts of Dr. Subhash Mukhopadhyay in Kolkata in 1981, but this claim was not recognized by the government due to moral and ethical reasons. In 1986, Dr. T. C. Anand Kumar and Dr. Indira Hinduja claimed India’s first IVF baby named Harsha and was accepted by the Indian Council of Medical Research (ICMR). Since then, there has been a mushrooming of ART clinics and ART banks in the country, especially in recent decades. Fertility services in public health sector are scarce and poorly equipped. Most of the ART clinics are in the private sector and are hence commercialized. Though, ICMR guidelines exist the sector is largely unregulated as there is no mechanism for ensuring compliance. There is a fear of unethical practices involving infertile couples who seek treatment for infertility.
Necessity of regulation
After initial history taking and physical examinations, detailed investigations of both the male and female partners are carried out. ART treatment involves retrieval, manipulation, storage, and application of gametes, embryos, and gonadal tissues. Cryopreservation of the gametes and embryos is done in special situations in assisted reproduction. Due to the sensitive nature of the treatments offered in the ART clinics and the hardships faced by infertile couples, there was a dire need for legislation in this emerging field of assisted reproduction.
The passing of the Assisted Reproductive Technology (Regulation) Act, 2021, by an act of Parliament on December 20, 2021 was a timely step in the right direction. Before the enactments of this Act, the state accreditation authorities were bestowed with the powers to penalize ART clinics for any violation of ICMR guidelines. This Act in present form will ensure the protection of rights of infertile couples and surrogate mothers. The act ensures financial security in favour of the oocyte donor by providing insurance coverage for a period of twelve months (para 22 (1) (b)). The surrogate mother offers her gestational services till the birth of the baby and thereafter she relinquishes her right on the child as per the provision of the Act. Many European countries have banned the practice of surrogacy including Austria, France, Italy, Spain, Portugal, and Bulgaria. Infertile couples from these countries head to India for surrogacy treatment in the hope of fulfilling their dream of parenthood.
Strength of regulation
The act contains six chapters and fort-six paragraphs. The definitions of various technical terms in chapter I of the Act ensure clarity of complex concepts and treatments offered in assisted reproduction. This Act will regulate the function of ART clinics and ART banks. The Act also covers the important aspect of research in assisted reproduction and provides guidelines for the use of human gametes, embryos, and gonadal tissues for research.
The powers and functions entrusted to the national and the state ART and surrogacy boards will help in the implementation of the Act at the grassroots level. The process of the registration as mentioned in chapter III provides a period of 60 days from the establishment of a national registry. Establishment of a national ART registry will help in generating big data which can be subjected to analysis for research and for guiding policy matters and current clinical practice for good reproductive health of citizens. The inclusion of pre-implantation genetic diagnosis and sex selection of the embryo, as mentioned in chapter IV sections 25 and 26, respectively, will ensure ethical practice. Obtaining necessary information including the Aadhar number of gamete donors and surrogate mothers for opening of a bank account will ensure direct targeted delivery of subsidies and benefits.
The rights of the child born through assisted reproduction are fully protected by deeming them to be the legal biological child of the commissioning couple. Provisions of the offences and penalties have been elaborated in chapter V in detail. If implemented in letter and spirit, it will ensure strict compliance by ART clinics and ART banks and award appropriate penalties in cases of offence committed as per the provisions of the Act. Provisions for protection of the authorities and doctors for the action done in good faith, as mentioned in chapter VI section 41, is a welcome step and will help doctors with good intentions during decision-making in a crisis situation. Also, the power bestowed to the central government to remove difficulties faced during implementation or for any unplanned and unforeseen situations makes the act flexible for further improvements based on changing technology and social and political factors.
The Act does not address the issue of qualification, experience, and the desired skills of the professionals working in ART clinics and banks, though a cursory mention of the requisite infrastructure, equipment, and manpower has been made in section 5 subsection (c) of chapter II. The minimum technical qualification and experience of the gynecologist, embryologist, counselor, and other staff should have been elaborated for better clarity on this important aspect of manpower management. They might be covered in detail under rules and regulation under the Act.
One of the important aspects of failed fertility treatment is adoption, which many couples resort to after repeated failures at ART. However, adoption is also unregulated in our country. Regulation of adoption should have been included along with ART and surrogacy. The inclusion of surrogacy is a welcome step; however, the provision of any dispute arising out of surrogacy contracts should have been elaborated. This fact assumes importance in the light of many international couples from developed countries seeking surrogacy services in a developing country like India.
Problem in implementation
The main problem in the implementation of the Act will be the registration process of a large number of ART clinics and ART banks operating in the country. Moreover, supervision of compliance with all the aspects of the Act, especially strict enforcement of fine and other punishments in case of non-compliance, will be an uphill task for the national and state ART and surrogacy boards. Health being a state subject, each state has to devise context-specific rules applicable to their settings. Signing of surrogacy contracts between international couples and local women offering surrogacy services may pose legal problems. Though the use and transfer of human gametes and embryos outside the country is strictly prohibited, its implementation at the entry/exit points at the seaports and airports will pose practical challenges. Moreover, setting and maintenance of the national ART registry and ensuring compliance by all stakeholders will be a challenging task. Maintaining confidentiality and regulating the use of data from the national registry should be clearly laid out. Any registry should be useful only when robust data is made available for giving real time inputs to the policy makers which would require collaboration and coorporation of all stakeholders.
In conclusion, the Assisted Reproductive Technology (Regulation) Act, 2021 was the need of the hour to safeguard the interests of infertile couples seeking treatment in ART clinics. The Act would also ensure the protection of rights of surrogate mothers. Moreover, it will help in proper supervision, accreditation, licensing, regulation, and smooth functioning of ART clinics and ART banks within the legal and ethical framework of the country.
In order to regulate the practice of ART clinics and ART banks in India, the Assisted Reproductive Technology (Regulation) Act, 2021 was passed on December 20, 2021, by an act of Parliament. The Act deals with proper supervision, regulation, licensing, and ensuring good ethical practices in the rapidly evolving field of assisted reproduction. However, the issue of regulation of adoption linked with the failure of ART treatment should have been included for a more comprehensive coverage of the Act. This Act will definitely protect the rights of infertile couples and help in their better management in a regulated environment within the country’s legal and ethical framework.
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Conflicts of interest
There are no conflicts of interest.
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