ART (Regulation) Act, 2021: How it can help patients

Infertility is something that impacts millions of couples around the world. In India alone, there are 28 million couples who experience the condition. Studies show that couples with fertility issues experience significant anxiety and distress. The inability to conceive can be one of the most stressful experiences of their lives.

While there are several misconceptions attributing infertility to fate, past sins etc, scientifically it is attributed to biological or lifestyle factors, or is referred to as ‘unexplained fertility’. Biologically, fertility among women gradually declines with age, especially in the mid-30s, and it drops rapidly after the age of 37. In addition to this, several lifestyle factors contribute to the increasing infertility rate in India.

The rising incidence of infertility is prompting individuals to opt for advanced treatment options including In Vitro Fertilisation (IVF), thereby boosting the growth trajectory of fertility treatment services in India. The IVF industry is growing rapidly with over 2.5 lakhs cycles being performed every year. Further, the introduction of the ART & Surrogacy Regulations law is driving standardization and focus on quality.

The Assisted Reproductive Technology (Regulation) Act, 2021 was approved by the Rajya Sabha last year in 2021. The Act aims at the regulation and supervision of ART clinics and assisted reproductive technology banks, prevention of misuse, and safe and ethical practice of ART services.

What does the proposed Act say?

Every ART clinic and bank is required by the Act to be listed in the National Registry of Banks and Clinics of India. This Registry, which consists of scientific and technical personnel, will serve as a central database for all facilities in India that offer ART treatments. In order to perform ART operations, a person, clinic, or bank must be registered with the Registry.

ART means all techniques that attempt to facilitate a pregnancy by handling the sperm or the oocyte outside the human body and transferring the gamete or the embryo into the reproductive tract of a woman while an ART clinic is defined as any facility carrying out the ART-related procedures.

Noting that ART clinics in India offer ART services ranging from gamete donation, intrauterine insemination, in-vitro fertilisation, intra-cytoplasmic sperm injection to pre-implantation genetic diagnostic and gestational surrogacy, etc., it adds that despite “so much activity in India, there is yet no standardisation of protocols and reporting is still very inadequate”.

The ART Act came as a ray of hope for lakhs of infertile couples, but also gave rise to legal, ethical and social tussles. Through the Act, the national board, state boards, national registry and state registration authorities will regulate and supervise such clinics and banks.

Need for ART regulation in India:

• Minimum standards and codes: Act seek to set minimum standards and codes of conduct for fertility clinics and egg or sperm banks
• Standard operating procedures: There is a need to formulate standard operating procedures to ensure “uniform costs” and “global quality standards” across India
• Monitoring body: The committee also noted that a monitoring body should be set up to prevent the “commercialisation” of ART services by private players
• To stop unethical or exploitative practices: The need of the hour is to stop unethical or exploitative practices

How the ART Act will help patients:

• Helps infertile couple to obtain fertility treatment in ethical and regulated manner.
• Helps couple to get appropriate legal action against the misuse of assisted reproductive technology.
• Helps couple to get action after investigation of complaints received by appropriate authority against the ART clinic or bank.
• Couples with HIV, Hepatitis B & C positive status can also avail fertility treatment as there is provision of separate storage of these positive patient’s gametes or embryos in ART clinics.
• Helps couple having cancer to avail facility of cryopreservation of oocytes, sperms and embryos for future fertility.
• Helps and provides facility of cryopreservation of gametes to prepubertal and unmarried males and females before undergoing cancer therapy for future fertility.

The author is a Consultant and Advisor, Birla Fertility & IVF. Views are personal.

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