On July 15, 2025THE President of the Republic promulgated Law No. 2025/009establishing a comprehensive legal regime governing the donation, collection, transplantation, storage and destruction of human biological material in Cameroon.
This landmark legislation closes long-standing legal loopholes surrounding organ donation, tissue transplantation, stem cell banking and biobanking regulation.
1. Scope and Applicability
The law covers organs, tissues, cells and stem cellswhile expressly excluding blood, gametes and embryos (governed by separate instruments).
2. Principles
He supports ethical and bioethical standards, non-commercialization, donor consentAnd human dignity as fundamental legal principles.
3. Accreditation system
Only approved public or private health centers may collect, preserve, transplant or destroy human biological material. These centers must establish institutional ethics committees and ensure traceability, confidentiality and record keeping.
4. Consent Requirements
Donations must be free, informed, written and attested. For living donors with disabilities and minors, stricter safeguards and monitoring apply.
5. Biobank Regulations
The law authorizes the creation of biobanks within approved centers, with storage strictly limited in time (5 years maximum) and biosecurity rules. The transfer of materials is limited within the national territory and between accredited facilities only.
6. National surveillance
A National ethics body is responsible for maintaining a donor registerA recipient waiting listand issue ethical opinions on sensitive issues.
Prohibitions
The law explicitly criminalizes:
- Sale or purchase of human biological material.
- Transplants carried out without valid consent.
- Advertising donations for specific individuals or centers.
- Violation of anonymity, privacy or ethical procedures.
- Import/export of human biological material.
Sanctions
Violations attract:
- Administrative sanctions: Suspension or withdrawal of accreditation; exclusion from public procurement.
- Criminal sanctions: Until 20 years of imprisonment and fines of up to 20 million CFA francs for collection, transplantation or illegal marketing.
- Confiscations under the Penal Code.
This law aligns Cameroon with international standards, notably the WHO guidelines on transplantation of human cells, tissues and organsand reflects best practices observed in certain countries around the world.
However, Cameroonian law goes further ban cross-border transfersby placing a 5 year limit on the storage of biobanks and by imposing nationalization of transplant surveillance, which suggests a cautious but sovereignty-centered public health approach.
Practical implications
For hospitals and clinics:
- Must obtain accreditation.
- Institutional ethics committees are now mandatory.
- Consent forms and procedures must follow strict legal formalities.
For biotechnology and research institutes:
- Biobank operations must comply with approved biosafety standards and SOPs.
- The transfer of biological material between centers requires regulatory authorization.
For legal advisors and compliance officers:
- An immediate review of current organ donation protocols is required.
- Notices to customers must include exposure to criminal law in the event of non-compliance.
For investors and NGOs:
- There are opportunities to create accredited transplant centers or biobanks, subject to national authorization.
- Partnerships with government and public health authorities must incorporate ethics training and legal due diligence.
We offer:
- Licensing assistance for accredited centers and biobanks.
- Drafting of institutional protocols and consent forms.
- Training of staff in legal and ethical standards.
- Legal representation in litigation or audits involving transplantation practices.
4M Legal and Tax – Law Firm
