Regulating Assisted Reproductive Technologies in Ghana

Progress and Future Outlook

In Ghana, ART has been practiced for decades, but formal regulation is still in development. This article explores the global regulatory landscape of ART and focuses on the crucial steps being taken in Ghana, led by the Fertility Society of Ghana (FERSOG), to establish comprehensive guidelines that ensure high standards and protect patients' rights.

Global Perspectives on ART Regulation

A review of the history of ART regulation world over gives us the background for the Ghana work. Here are key international milestones:

United Kingdom

The world’s first birth through In-Vitro Fertilization (IVF) occurred in the United Kingdom on July 25, 1978. It wasn’t until 1990, twelve years later, that the Human Fertilization and Embryology Act was enacted by the UK Parliament. This law led to the establishment of the Human Fertilization and Embryology Authority (HFEA) in 1991. Of note is that 45 years later, the HFEA continues to review and modify ART regulations in the UK to meet the evolving demands of the field. The HFEA was tasked with:

1. Licensing and inspecting fertility clinics.

2. Licensing and inspecting establishments conducting human embryo research.

3. Maintaining a registry of all treatment services.

4. Regulating the storage of human gametes for treatment and research.

5. Developing and maintaining a code of practice, setting out quality and safety standards for treatment and research.

India

India’s first IVF baby was born on October 3, 1978, (67 days after the birth of the worlds first IVF baby) making India the second country in the world to achieve this milestone. However, it took until December 20, 2021 - 43 years after the first IVF birth—for the ART Regulation Act to be passed by the Indian Parliament. This law ensures the proper functioning of ART clinics and banks, and safeguards the rights of surrogate mothers.

Australia

Australia's first IVF baby was born on June 21, 1980, the third in the world. Regulations, however, were not put in place until 1996, 16 years later, under the National Health and Medical Research Council (NHMRC).

United States

The first IVF baby in the USA was born on December 28, 1981, making it the 15th in the world. Several organizations regulate different aspects of ART in the U.S. The US Food and Drug Administration (US FDA) oversees reproductive tissues, while clinics follow guidelines set by the American Society for Reproductive Medicine (ASRM). A significant regulatory measure is the Fertility Clinic Success Rate and Certification Act of 1992 (FCSRCA), which mandates that ART clinics report IVF data to the Centers for Disease Control and Prevention (CDC). Around 95% of clinics in the USA now report their results to the CDC annually through the Society for Assisted Reproductive Technology (SART).

Africa

The first IVF babies in Africa were born in:

• South Africa in 1983

• Nigeria in 1986

• Egypt in 1987

ART in Ghana: A Focus on Regulation

The Early Days

Ghana's first IVF birth took place in 1995 at Pro-Vita Specialist Hospital under the pioneering efforts of Dr. Joe Mainoo. Two decades later, the Fertility Society of Ghana (FERSOG) was inaugurated on September 23, 2016. One of the immediate goals of FERSOG was to support the Ministry of Health (MoH) in developing guidelines for the regulation of ART practice in Ghana. At the time, reproductive endocrinology and infertility were relatively new fields in Ghana, with no specific legal framework covering ART practices. FERSOG, recognizing the need for oversight and regulation, began making important international connections to advance the cause.

Key Milestones in Ghana’s Regulatory Journey

• November 2016: Contact with the British Fertility Society (BFS)
  BFS, founded in 1972, connected FERSOG with the Human Fertilization and Embryology Authority (HFEA) in the UK to explore potential regulatory models.

• April 2017: HFEA’s Proposal
  The HFEA proposed to assist Ghana in developing ART regulations, but the quoted fee of £180,000 was far beyond FERSOG’s budget at the time.

• July 2017: IFFS Recommendation
  The International Federation of Fertility Societies (IFFS) advised Ghana to adapt the HFEA guidelines, given Ghana’s legal system as a commonwealth country has laws emanating from the English Law.

• August 2017: Adapting HFEA Guidelines
  FERSOG’s Executive Council began work on adapting the HFEA’s guidelines to fit the Ghanaian context. Over several meetings, the technical documents were modified to suit local needs, considering cultural and legal factors.

• June 2018: First Stakeholder Conference
  A stakeholder conference was held, drawing in diverse perspectives, including representatives from the Christian Council, the Chief Imam’s office, and sociologists. The finalized document was then presented to the Ministry of Health, which set up a committee to draft a policy document.

• July 2019 - October 2021: Policy Drafting and Collaboration with HFEA
  The Ministry of Health held multiple meetings to refine the ART Technical Guidelines. By October 2021, after a formal letter to the Director of Compliance at HFEA, approval was granted to reference their guidelines—although they clarified that some practices in the Ghana document, like donor anonymity, gender selection, and number of embryos transferred differed from HFEA regulations.

FERSOG’s Ongoing Efforts

In 2021, the final draft of the ART guidelines was shared with all FERSOG members at the Annual General and Scientific Congress, and all fertility centers in Ghana were encouraged to adopt these guidelines. FERSOG’s goal was to guide practices across the country until the guidelines could be formalized into law.

Moving Toward Legislation

Despite the delays from the Ministry of Health, progress continued and a wider stakeholder conference took place in October 2022, involving key parties such as the Health Facilities Regulatory Authority (HEFRA), the Christian Council, the Office of the Chief Imam, the Ghana Psychological Society, and legal representatives from Parliament’s health caucus.

The Final Steps

On June 14, 2024, FERSOG and the Ministry of Health held a technical review of the ART guidelines. The next step is a final stakeholder meeting to discuss any remaining issues. Afterward, the guidelines will be sent to the Attorney General’s office, where a bill will be drafted for Parliament. Once passed, this bill will establish a legal framework for the regulation of ART practices in Ghana, ensuring quality, safety, and transparency across the sector.

Conclusion

The regulation of ART in Ghana is an ongoing process, with FERSOG playing a pivotal role in guiding the development of policies that will ensure high standards for reproductive care. The collaborative efforts between local and international stakeholders are setting the stage for Ghana to emerge as a leader in ART regulation in Africa. As the country moves closer to enacting formal laws, the future looks promising for both ART professionals and patients alike.

Author

Dr E Hiadzi