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Sperm donation scandal exposes harmful gaps in fertility laws
Sperm donation. Sperm from a donor with a rare, aggressive cancer-causing gene mutation was used to conceive at least 197 children across Europe.
What you need to know:
- An investigation by the EBU Investigative Journalism Network has revealed that sperm from a donor carrying a rare cancer-causing gene mutation was used to conceive at least 197 children across Europe, exposing major gaps in international regulation of sperm donation.
- As sperm donation gains popularity in Kenya amid rising infertility, single motherhood by choice, and economic pressures on young men, experts warn that the country lacks mandatory laws governing genetic screening and donor limits.
A recent investigative report by the EBU Investigative Journalism Network has exposed a major scandal where sperm from a donor with a rare, aggressive cancer-causing gene mutation was used to conceive at least 197 children across Europe, highlighting a lack of consistent international regulation in the global sperm donation industry.
The donor carried a mutation in the TP53 gene associated with Li-Fraumeni syndrome. This mutation is strongly linked to early-onset cancers, leading to the tragic deaths of several children and leaving countless families facing profound, unforeseen medical uncertainty.
The donor passed standard screening tests when donation began in 2005 because this mutation was not typically screened at the time. Among an initial group of 67 children, 23 carried the variant, and 10 were diagnosed with cancer. Sperm from this donor was distributed by the Denmark-based European Sperm Bank to numerous clinics in at least 14 countries.
The situation revealed problems such as the donor's sperm being used more often than national regulations allowed in some countries. There is a lack of global regulations on the number of offspring per donor, enabling large sperm banks to exceed national limits by selling internationally. Reports indicate that in Belgium, where the limit is six families, the donor’s material was used to create about 38 families.
In Kenya, sperm donation is increasing in popularity with individuals and couples facing infertility following increased awareness of fertility treatments like in-vitro fertilisation (IVF), and the potential for financial compensation for donors. A significant number of financially independent, career-focused single women are also opting to have children without waiting for marriage, driving demand for donor sperm. Same-sex couples also use these services.
Economic hardships have also made sperm donation an attractive source of income for young men, with payments for a single donation ranging from about Sh40,000 to Sh100,000, depending on the donor's characteristics. Recipients often have specific preferences, such as a donor's educational background, physical features, or ethnicity, with clinics appealing to educated and professional men to meet this demand, leading to a shortage of donors with desirable profiles.
The Healthy Nation spoke with Dr Ahmed Kalebi, an entrepreneurial consultant pathologist and PhD researcher, to understand how a parent can pass deadly genetic mutations to their children, either knowingly or unknowingly. Dr Kalebi defines a genetic mutation as a permanent change in a person’s DNA, which can be passed from parent to child through the egg or sperm, giving the child a copy of the altered gene.
“Some inherited conditions, like Huntington’s disease or certain cancer risks like the TP53 gene, don’t show symptoms until adulthood. A young donor carrying one of these mutations can therefore seem completely healthy at the time of donation. Clinics can lower the risk by taking a detailed family health history, testing donors for known late onset mutations, and keeping long-term records. These steps allow health updates if a donor later develops a condition, helping protect future families,” he explains.
He notes that there is currently no specific law regulating assisted reproductive technology (Art) in Kenya, meaning there are no mandatory national rules for genetic screening of donors or limits on how many children one donor can help create. Many reputable fertility clinics and specialists voluntarily follow international best practice guidelines through their internal policies, often limiting a donor to around five to 10 families to minimise the risk of accidental inbreeding.
“Fertility clinics are overseen generally by the Kenya Medical Practitioners and Dentists Council (KMPDC), which licenses facilities and doctors. Many reputable clinics voluntarily test for common genetic conditions and infectious diseases, following international standards, but practices vary across facilities, underscoring the need for uniform national standards once the pending Assisted Reproductive Technology Bill, which proposes capping genetic siblings at 10, is fully enacted,” he says.
On November 1, 2025, the National Assembly approved amendments to the Assisted Reproductive Technology (Art) Bill, 2022, which seeks to create a legal framework for surrogacy and other assisted reproductive technology services in Kenya. Although technologies such as in vitro fertilisation (IVF) and surrogacy have existed for some time, they are still considered “new” within the Kenyan context. The lack of regulation surrounding surrogacy processes and other technologically assisted reproduction methods in Kenya has created a void, fostering an environment where unprofessional practices can thrive and resulting in a proliferation of legal disputes.
To address these concerns, the proposed law articulates a comprehensive framework for governing assisted reproductive practices, detailing specific regulations and restrictions. A core element of the Bill is the strict management of embryos. It expressly prohibits their creation, preservation, or utilisation unless in strict adherence to its stipulated provisions.
Consent from donors
Furthermore, the bill mandates the acquisition of explicit written consent from donors before their human reproductive material can be used to create embryos. Eligibility for assisted reproduction is also strictly controlled, as an individual can only pursue treatment after a certified medical practitioner attests to its necessity based on medical or health grounds.
The bill also imposes specific age restrictions on donors, prohibiting the procurement of sperm from individuals under eighteen years of age without the requisite consent from a parent or legal guardian. It specifies conditions under which the directorate is prohibited from issuing licences, explicitly banning activities such as cloning and the replacement of parts of an embryo. To enforce these prohibitions, any contravention of the rules delineated in Part III will attract severe penalties: a fine not exceeding Sh5 million, imprisonment not exceeding five years, or both.
If enacted, the law would restrict the authority to conduct Art procedures exclusively to licensed individuals, establishing punitive measures encompassing fines and imprisonment for those who breach this licensing prerequisite. Finally, to ensure constitutional principles like transparency and accountability are enshrined in the licensing process, the Bill requires consultation with the KMPDC during the issuance, variation, renewal, and revocation of licences.
“If enacted, the Assisted Reproductive Technology Directorate would help prevent such issues in Kenya by creating and maintaining a confidential national register of donors, clinics, embryos, and children born through assisted reproduction. This central system would enforce strict limits on the number of children per donor, require thorough health evaluations and mandatory genetic screening, and allow offspring access to key information about their origins when appropriate,” says Dr Kalebi.
“The Directorate would also license and regularly inspect clinics, ban exploitative practices, and ensure consistent standards, closing loopholes that could lead to unregulated mass donations. Overall, these measures would promote transparency, protect families, and greatly reduce genetic and social risks before they can grow.”
Dr Kalebi notes that there being no specific Art laws or regulations in the country, should a severe, rare gene mutation be discovered in a Kenyan donor after his sperm was used, clinics are not legally mandated to notify families. However, under medical ethics and KMPDC oversight, clinics are expected to disclose such risks, provide genetic counselling, and support follow-up, with compliance relying on professional duty rather than enforceable law.
Read: Are you a sperm donor?
He also notes that many Kenyan fertility clinics rely on imported, West-based genetic screening panels that focus on conditions common in European populations and may not fully capture mutations prevalent in African/Kenyan populations, such as sickle cell disease, thalassemias, and glucose-6-phosphate dehydrogenase deficiency.
“While reputable clinics often add screening for common local conditions or offer expanded testing based on family history, coverage is inconsistent without national standards, highlighting the need for locally tailored genetic panels as African genomic data continue to grow. At our lab, we offer whole exome sequencing and whole genome sequencing, which allow for a broader testing, which can address some rare genetic diseases,” he says.
“Comprehensive genetic carrier screening in Kenya can be expensive: standalone carrier panels may cost around Sh100,000 or more in many labs which send the samples abroad, while advanced embryo/genetic tests like pre-implantation genetic diagnosis during IVF can exceed Sh200,000. At Dr Kalebi Labs where we’ve started in-house local genetic tests the cost ranges from Sh38,000 for pre-implantation screen to Sh59,000 for clinical exome sequencing and up to Sh99,000 for whole exome sequencing,” he says.
He further adds: “These high out-of-pocket costs are often not covered by insurance, thus they can be a significant barrier to testing donors for hundreds of conditions instead of only a few, limiting their routine use in many clinics. However, considering the huge cost of genetic diseases arising from untested Art vis-a-vis the cost of Art itself, many donors and parents and clinics do consider the test worthwhile.”
No certified genetic counsellors
He also reveals that Kenya has no internationally certified genetic counsellors who are recognised and licensed professionals. However, less than 10 healthcare professionals have received international training in genetic counselling, including pediatricians, obstetricians, physicians, pathologists, and laboratory genetic scientists. They offer genetic counselling but are not dedicated genetic counselling professionals registered by the medical council in Kenya.
