New Legal Framework on Human Biological Material in Cameroon

On July 15, 2025, the President of the Republic enacted Regulation No. 2025/009, establishing a complete authorized regime governing the donation, elimination, transplantation, storage, and destruction of human organic materials in Cameroon.

This landmark laws addresses long-standing authorized voids surrounding organ donation, tissue transplantation, stem cell banking, and biobank regulation.

1. Scope and Applicability

The regulation covers organs, tissues, cells, and stem cells, whereas expressly excluding blood, gametes, and embryos (ruled by separate devices).

2. Rules

It upholds moral and bioethical requirements, non-commercialisation, donor consent, and human dignity as foundational authorized ideas.

3. Accreditation System

Solely authorised public or personal well being centres could acquire, protect, transplant or destroy human organic materials. These centres should set up institutional ethics committees and guarantee traceability, privateness, and recordkeeping.

4. Consent Necessities

Donations have to be free, knowledgeable, written, and witnessed. For residing donors with disabilities and minors, stricter safeguards and oversight apply.

5. Biobanks Regulation

The regulation permits the creation of biobanks inside accredited centres, with strict time-bound storage (5 years max) and biosecurity guidelines. Switch of supplies is restricted to throughout the nationwide territory and between accredited services solely.

6. Nationwide Oversight

A Nationwide Ethics Physique is accountable for sustaining a donor register, a recipient ready listing, and issuing moral opinions on delicate issues.

Prohibitions

The regulation explicitly criminalises:

Sale or buy of human organic materials. Transplants carried out with out legitimate consent. Commercial of donations for particular people or centres. Violation of anonymity, privateness, or moral procedures. Import/export of human organic materials.

Sanctions

Violations appeal to:

Administrative penalties: Suspension or withdrawal of accreditation; exclusion from public contracts. Legal penalties: As much as 20 years imprisonment and fines as much as 20 million CFA francs for illegal elimination, transplantation, or commercialisation. Forfeitures underneath the Penal Code.

This regulation aligns Cameroon with worldwide requirements, together with the WHO Guiding Rules on Human Cell, Tissue and Organ Transplantation, and displays greatest practices seen in some nations all over the world.

Nevertheless, Cameroon’s regulation goes additional by banning cross-border transfers, putting a 5-year restrict on biobank storage, and imposing strict nationalisation of transplant oversight, suggesting a cautious however sovereignty-focused public well being method.

Sensible Implications

For Hospitals and Clinics:

Should acquire accreditation. Institutional ethics committees are actually obligatory. Consent types and procedures should adjust to strict authorized formalities.

For Biotech and Analysis Establishments:

Biobank operations should align with biosafety norms and authorized SOPs. Switch of organic materials between centres requires regulatory authorisation.

For Authorized Advisors and Compliance Officers:

Instant evaluation of present organ donation protocols is required. Shopper advisories should embody prison regulation publicity for non-compliance.

For Traders and NGOs:

Alternatives exist in establishing accredited transplant centres or biobanks, topic to nationwide licensing. Partnerships with authorities and public well being authorities should combine ethics coaching and authorized due diligence.

We provide:

Licensing assist for accredited centres and biobanks. Drafting of institutional protocols and consent types. Employees coaching on authorized and moral requirements. Authorized illustration in disputes or audits involving transplantation practices.

4M Authorized and Tax – Regulation Agency