Tuesday, 21 May 2024


Regulatory Landscape of In Vitro Fertilisation (IVF) Across Asia

01 September 2023 | Opinion | By Rukmini Umanath, Head of Business- ROW Region, Freyr Solutions

According to the World Health Organisation (WHO) data, approximately one in every six couples worldwide is impacted by infertility.

Of all the regions on the global stage, Asia-Pacific (APAC) emerges as an intriguing landscape, beaming with opportunities for substantial growth within the in vitro fertilisation (IVF) market. The impetus behind this noteworthy trend can be attributed to a compelling factor—the conspicuous prevalence of ultra-low fertility rates across the Asia-Pacific nations. Notably, Japan, Singapore, South Korea, China, India, and Australia are grappling with a significant decline in fertility rates. Let us dive deep into the IVF landscape of a few Asia-Pacific countries. 

 

Japan 

The Japanese government is taking strategic action to combat the ageing population. As a pivotal component of this comprehensive endeavour, the public health insurance system has been revamped to encompass a noteworthy development – including a substantial 70 per cent reimbursement for the expenditures incurred during advanced fertility treatments. It was implemented in April 2022. 

This progressive measure underscores the government's commitment to address the demographic challenge at hand and recognises the pressing need to reverse the trend of population graying. By extending financial support to individuals seeking advanced fertility treatments, the government aims to foster a more conducive environment for family planning and an increase in population. Japan has specific regulations for IVF procedures. Guidelines of the Japan Society of Obstetrics and Gynecology (JSOG) outline the ethical and legal frameworks for Assisted Reproductive Technologies. Pre-implantation Genetic Diagnosis (PGD) is allowed to prevent specific genetic diseases, but sex selection is prohibited. Using donor eggs and sperm is regulated, and commercial surrogacy is illegal.

 

India 

Historically, India lacked comprehensive regulations governing Assisted Reproductive Technology (ART) practices, eligibility criteria, and Gestational Carrier (GC) arrangements, commonly known as surrogacy. The Indian Parliament passed two laws in December 2021, changing the fertility landscape in the nation. In 2022, the two significant laws were enacted, bringing about significant changes to the landscape of fertility practices within the country. 

The foremost of these legal changes is the Assisted Reproductive Technology (Regulation) Act of 2021, which lays down the eligibility criteria for ART treatments, mandates the creation of a registry for ART clinics, and sets forth guidelines for conducting ART procedures. 

The second legislation, known as the Surrogacy (Regulation) Act of 2021, is primarily concerned with overseeing the process of GC journeys. A notable provision of these new statutes is the prohibition of commercial GC journeys. These regulatory measures were prompted, in part, by mounting concerns related to the infertility rates and the remarkable proliferation of ART clinics, which had seen unprecedented growth in India, ranking among the highest in the world.

Any facility offering services such as Intrauterine Insemination (IUI), ART, or medical care for GC must obtain approval from the National ART and Surrogacy Registry to ensure their legal operation. 

These legislations are named the Assisted Reproductive Technology (Regulation) Act, 2021, which seeks to oversee eligibility for ART treatments, the establishment of an ART Clinic Registry, and regulate various aspects of ART procedures, including the use of donor gametes. The Surrogacy (Regulation) Act 2021 is concerned with the regulation of GC arrangements. Both laws came into effect on January 25, 2022. Furthermore, the Indian government is in the process of setting up national and state-level ART and Surrogacy Boards responsible for supervising the implementation of these laws. 

 

South Korea 

South Korea has well-established IVF regulations. The Bioethics and Safety Act governs Assisted Reproductive Technologies, including IVF and PGD. Over the last decade, South Korea has introduced several policies aimed at addressing its low fertility rate and promoting childbirth. Despite the implementation of the ’4th Basic Plan for Low Fertility and Aging Society (2021–2025)’ on three occasions, the problem of extremely low fertility has persisted and has led to a more pronounced decline in the population, exacerbating the demographic burden in the country. This burden is characterised by a significant reduction in the working-age population (ages 15 to 64), which, in turn, hinders economic growth.

 

China 

Decades ago, China implemented a deeply divisive ‘one child’ policy with the aim of tackling concerns about overpopulation and reducing poverty. However, in 2015, the policy was abandoned due to challenges like a swiftly ageing population and a diminishing workforce that could potentially jeopardise both economic and social stability. China has been rapidly developing its fertility treatment regulations. Amidst China’s efforts to address a declining birth rate, the Government of Beijing has revealed plans to provide coverage for fertility treatments starting in July. According to a Reuters report, the range of covered treatments encompasses over a dozen options, such as IVF, embryo transplantation, and semen freezing and storage. This development follows the backdrop of China, historically the globe's most populous nation, encountering its initial population decrease in six decades. 

 

Australia 

Based on current statistical data, it is estimated that one out of every six heterosexual couples in Australia may encounter issues with fertility. While certain fertility treatments like IVF are covered by the national healthcare system, Medicare and other procedures like elective egg freezing are not included. As a result, individuals in Australia might seek additional coverage for fertility-related care through private insurance. Medical reasons, such as preparing for cancer treatment or gender-affirming surgery, could lead to coverage for egg freezing. 

 

Singapore 

Despite having comprehensive government policies aimed at supporting and promoting fertility care within heterosexual marriages, Singapore continues to grapple with one of the world's lowest birth rates in Southeast Asia. The steady decline in birth rates since the 1980s can be attributed partly to misconceptions surrounding fertility, often associating infertility as a problem only affecting females. Additionally, the high cost of living in Singapore and the prevalent trend of marrying later in life or not marrying at all contribute significantly to this demographic challenge. A prevailing belief that IVF is the sole recourse for family planning further compounds the issue, given its expense and potential affordability constraints for couples in the country. However, experts hold an optimistic outlook, speculating that ongoing awareness campaigns and advocacy efforts may eventually reverse these trends.

Singaporean residents with access to public healthcare have the option to pursue fertility treatments through subsidised avenues in public hospitals, alleviating some financial burdens. While certain pathways like egg freezing have limitations, such as being restricted to medically necessitated cases like cancer patients preparing for chemotherapy, a noteworthy development in 2023 is the expansion of elective egg-freezing eligibility. Women under 35 years old, irrespective of marital status, will now have the opportunity to undergo this procedure. 

 

Sustained growth in fertility treatments

The regulatory landscape of IVF and fertility treatments in Asian countries reflects a dynamic and evolving scenario. The prevalence of infertility issues and ultra-low fertility rates in the Asia-Pacific region has led to rising demand for advanced fertility treatments, including IVF. As governments recognise the importance of addressing demographic challenges and promoting family planning, they have introduced significant regulatory measures to support and regulate fertility care. Fertility tourism also contributes to the opportunities for market growth. As Asian countries continue to address these challenges, the regulatory landscape of fertility treatments is expected to evolve further, providing hope and support to couples facing infertility issues across the region.

 

Rukmini Umanath, Head of Business- ROW Region, Freyr Solutions

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