New Assisted Reproductive Technology Regulations (ART), 2023: Enhancing Governance and Addressing Concerns

Introduction

The recent notification by the Health Ministry regarding the Assisted Reproductive Technology Regulations (ART), 2023 marks a significant development in the field of assisted reproductive techniques. These regulations aim to ensure proper governance and standardization of ART services in India. This a article xplores the key provisions of the ART regulations, examines the concerns raised by various stakeholders, and discusses the way forward in addressing these challenges.

Understanding the ART Regulations

The ART Act 2020 defines ART as encompassing all techniques that facilitate pregnancy by manipulating sperm or oocytes (immature egg cells) outside the human body and transferring the gamete or embryo into a woman’s reproductive system. The regulations cover a range of ART services, including gamete donation, in-vitro fertilization (IVF), and gestational surrogacy. ART services are offered through specialized ART clinics and ART banks.

Key Provisions

1. Restriction on donation: The new ART regulations impose limitations on the number of times a donor, whether male or female, can donate sperm or oocytes in their lifetime. Age limits for donors are also specified to ensure the safety and well-being of the donors.
2. Criteria for a donor: The regulations state that an oocyte donor should be a person who has been married at least once in their life and has at least one living child of their own, who is a minimum of three years of age. Additionally, oocyte donation is permitted only once in a donor’s lifetime, with a maximum of seven oocytes retrievable.
3. Restrictions on ART banks: An ART bank is prohibited from supplying the reproductive cells of a single donor to more than one commissioning couple. This provision ensures that the genetic material of a single donor is not overutilized and promotes diversity in the genetic pool.
4. Insurance coverage: Parties seeking ART services are required to provide insurance coverage in favor of the oocyte donor. This coverage protects the donor in the event of any loss, damage, or death during the donation process, thereby safeguarding their interests.
5. Prohibition on sex determination: ART clinics are strictly prohibited from offering pre-determined sex selection of a child. This provision aims to prevent any unethical practices related to gender-based selection and promotes gender equality.
6. Checking for diseases: Genetic screening for diseases before embryo implantation is made mandatory. This measure ensures the health and well-being of the intended child and reduces the risk of passing on inheritable genetic disorders.

Conditions for Offering ART Services

To ensure ethical and responsible practices, the ART regulations establish certain conditions for offering ART services. These conditions include:

1. Informed consent: Both the party seeking ART services and the donor must provide written informed consent before undergoing any ART procedures. This requirement ensures that all parties involved have a clear understanding of the processes and potential risks.
2. Insurance coverage: Parties seeking ART services are obligated to provide insurance coverage in favor of the oocyte donor. This provision emphasizes the importance of protecting the interests and well-being of the donors.
3. Prohibition on pre-determined sex selection: ART clinics are strictly prohibited from offering pre-determined sex selection of a child. This prohibition aims to prevent any potential misuse of ART techniques for gender-based selection.
4. Genetic disease screening: The regulations make it mandatory for clinics to conduct genetic disease screening before embryo implantation. This precautionary measure aims to identify and mitigate the risks associated with inheritable genetic disorders.

Addressing Concerns

Despite the potential benefits of the ART regulations, certain concerns have been raised by various stakeholders. These concerns include:

1. Increased medical costs: The new provisions have led to a rise in already high medical costs associated with ART services. This increase poses a challenge for couples seeking these techniques, especially considering the limited availability of resources such as donors.
2. Restricted resource availability: The restrictions on the number of donation attempts and the criteria for donors have created challenges for treating doctors and couples relying on ART. Limited availability of suitable donors further complicates the process of assisted reproduction.
3. Constitutional violation and children’s rights: Critics argue that the ART regulations violate Article 14 of India’s constitution, which guarantees equality before the law and equal protection of law to all individuals. Additionally, concerns have been raised regarding the regulations’ silence on the rights of children born through ART techniques.

Way Forward

While acknowledging the concerns raised, it is crucial to recognize the potential of ART services to address fertility issues and offer hope to couples seeking parenthood. However, it is essential to strike a balance between regulation and accessibility. To move forward effectively, the following steps can be considered:

1. Reviewing cost structures: Efforts should be made to evaluate and streamline the cost structures associated with ART services. This could involve exploring options for financial support and insurance coverage to alleviate the burden on couples seeking these techniques.
2. Promoting awareness and education: Increasing awareness about the importance of ART services and the need for donors can help address the resource availability challenge. Educating the public about the significance of assisted reproduction can encourage more individuals to come forward as donors.
3. Legal and ethical considerations: Continual evaluation and amendment of the ART regulations should be undertaken to ensure compliance with constitutional provisions and protect the rights of all individuals involved, including the children born through these techniques.
4. Research and innovation: Encouraging research and innovation in the field of assisted reproductive technology can lead to advancements that improve the efficacy, accessibility, and affordability of ART services. This can be achieved through collaborations between academia, healthcare providers, and policymakers.

Conclusion

The Assisted Reproductive Technology Regulations (ART), 2023, represent a significant step toward enhancing governance and standardization in the field of assisted reproduction. While the regulations address several key aspects related to ART services, concerns regarding cost, resource availability, and constitutional compliance must be carefully considered. By adopting a balanced approach that promotes awareness, encourages research, and safeguards the rights of all stakeholders, India can navigate the challenges and realize the potential of ART services to address the declining fertility rates and provide hope to couples longing for parenthood.

Practice Question for Mains

Evaluate the effectiveness of the Assisted Reproductive Technology (ART) regulations, 2023, in addressing concerns related to resource availability, cost, and ethical considerations in the field of assisted reproduction. (250 words)

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