Traversing the Ethical and Legal Maze: Overview of the Art Regulation Act, 2021

27th April, 2024 - 6:49 am Categories: Legal Issues News & Updates 0 Comments

INTRODUCTION

The regulation of assisted reproductive technologies (ART) is central to the complex interplay between ethics and law. The Assisted Reproductive Technology (ART) Regulation Act, focusing on Indian context, is a key determinant of reproductive autonomy through legislation especially for women. Besides establishing regulations to ensure that ART clinics are properly functioning and protect women who seek treatment for infertility after the introduction of IVF, these rules have ramifications which go beyond clinics thereby affecting the very core of women’s reproductive autonomy.

The above is reflected in India’s ART Regulation Act which responds thoughtfully to changing dynamics in assisted reproduction by considering various dimensions within this sphere. As medical technology moves forward at a fast pace, one must be ever mindful of scientific progress as well as ethical and legal issues. As it were, procedures such as IVF, IUI, surrogacy are all encompassed under ART since they address infertility.

This progress has been driven by medical advancements, societal changes and increased knowledge about sterility among people in India. Therefore, there is need to think deeply about ethical considerations surrounding this issue once such technologies become more accessible. It comes from improved medical science. The confluence of advancements in medicine and societal change has necessitated the formulation of regulations to steer the intricacies surrounding assisted reproduction.

Amidst this changing scenario, ethical questions are significant. These include issues such as reproductive procedures being commodified, dangers posed to donors and surrogates, and genetics having moral meanings that require deep thinking. ART could become a dangerous practice if there are no clear ethical guidelines for it.

As one can already see from above, legal uncertainties intensify complications in navigating the ethical terrain. It is difficult to determine appropriate applications of the laws governing ART with minimal formal rules guiding them. Issues like defining the rights of parents as well as those of donors and surrogates, and fixing commercialization morality in reproductive services create more depth in law. These challenges need to be carefully thought through so that they may be solved within the context of ART practices.

This paper aims at dissecting ethical concerns; legal challenges; social implications underpinning ART regulation act (ART regulation) 2010: an appraisal, thus providing a comprehensive understanding of assisted reproductive technologies intricate nature among Indians.

OVERVIEW OF THE ART (REGULATION) ACT, 2021

The Assisted Reproductive Technology (Regulation) Act, 2021[i] was approved by the parliament’s two houses and granted presidential assent in December 2021. The Act’s main goals were to ensure that no unethical procedures were being followed and to regulate banks and clinics that only deal with assisted reproductive technology. The infertile couples’ struggles and the sensitive nature of assisted reproductive technology (ART) procedures—which involve the retrieval, manipulation, storage, and use of gametes, embryos, and gonadal tissues—meant that laws regulating this rapidly expanding field of assisted reproduction had to be developed. Gametes and embryos are cryogenically kept in some assisted reproduction scenarios, underscoring the necessity of extensive rules to guarantee the moral and responsible use of ART. The enactment of this Act will significantly improve the oversight, licencing, regulation, and efficient operation of ART banks—companies that provide oocyte donors, sperm, or semen to ART clinics or their patients—and ART clinics—locations outfitted with the necessary equipment and physicians registered with the National Medical Commission to perform ART procedures. “The Act also establishes criteria for the use of human gametes, embryos, and gonadal tissues in research, covering the crucial field of assisted reproduction research. The Act guarantees the protection of surrogate mothers’ rights by including the contentious surrogacy treatment within its purview. Prior to the Act being passed, their existed only certain guidelines[ii] issued by the Indian Council of Medical Research regarding both compliance norms for unregulated ART clinics as well as for procedures related to surrogacy, but these guidelines lacked legislative backing. Now, simply put, the ART Act contemplates registered clinics and banks to offer “safe” and “ethical” ART services to a restricted class of people, who are proven to be infertile, to form families.”

The ART Bill defines ART as “all techniques that attempt to obtain a pregnancy by handling the sperm or the oocyte outside the human body and transferring the gamete or the embryo into the reproductive system of a woman.”[iii] Gamete donation, intrauterine insemination, in vitro fertilisation, and intracytoplasmic sperm injections are only a few of the treatments offered by ART clinics and banks in India. ART clinics and banks must register with the National Registry for Assisted Reproductive Technology and Surrogacy, according to the Assisted Reproductive Technology (Regulation) Act of 2021. All ART clinics and banks in the nation will have their complete information kept up to date in one central database. Only facilities that fulfil certain requirements—such as having qualified staff, sufficient infrastructure, and diagnostic capabilities—will be allowed to register. The registration is good for five years, after which it can be renewed. The appropriate authorities will be designated by both the national and state governments to supervise registration-related services, such as the upkeep of registration details, cancellation procedures, and renewal procedures.

“The Assisted Reproductive Technology (Regulation) Act of 2021 specifies eligibility requirements for both commissioning parties and donors. Married couples or women who meet the following criteria can seek ART services: (i) the woman must be between 21 and 50 years of age, and (ii) the man must be between 21 and 55 years of age.”[iv] Furthermore, infertility, which is defined as the inability to conceive following a year of unprotected sexual activity or as a result of any other medically confirmed disorder that prevents pregnancy, must be identified in married couples. ART banks are permitted to collect eggs from girls between the ages of 23 and 35 and semen from males between the ages of 21 and 55. A woman can extract up to seven eggs in a single surgery, and she can only donate once in her lifetime. It’s against the law for ART banks to give gametes from a single donor to several commissioning parties, such as couples or single women looking for ART services. Furthermore, by designating the child born through assisted reproduction as the legal biological child of the commissioning couple, their rights are entirely safeguarded and they will be eligible for all the same benefits and advantages as a natural child of the commissioning couple.  The kid will not grant the donor any parental rights.  The Act nevertheless has several gaps in it, which are covered in depth in the next section of the paper, despite the Act’s attempts to offer a comprehensive structure for enabling ART treatments and tougher requirements for obtaining these services.

Author: IPSITA SINHA, in case of any queries please contact/write back to us via email to chhavi@khuranaandkhurana.com or at  Khurana & Khurana, Advocates and IP Attorney.

REFERENCES

[i] The Assisted Reproductive Technology (Regulation) Act, 2021 (Act no. 42 of 2021)

[ii] National Guidelines for Accreditation, Supervision and Regulation of Art Clinics in India, Indian Council of Medical Research, 2005.

[iii] The Assisted Reproductive Technology (Regulation) Act, 2021 § 2(1)(a).

[iv] Id, § 21(g).