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New Legal Framework on Human Biological Material in Cameroon

New Legal Framework on Human Biological Material in Cameroon

Table of Contents

On July 15, 2025, the President of the Republic enacted Law No. 2025/009, establishing a comprehensive legal regime governing the donation, removal, transplantation, storage, and destruction of human biological material in Cameroon.

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

1. Scope and Applicability

The law covers organs, tissues, cells, and stem cells, while expressly excluding blood, gametes, and embryos (governed by separate instruments).

2. Principles

It upholds ethical and bioethical standards, non-commercialisation, donor consent, and human dignity as foundational legal principles.

3. Accreditation System

Only authorised public or private health centres may collect, preserve, transplant or destroy human biological material. These centres must establish institutional ethics committees and ensure traceability, privacy, and recordkeeping.

Donations must be free, informed, written, and witnessed. For living donors with disabilities and minors, stricter safeguards and oversight apply.

5. Biobanks Regulation

The law allows the creation of biobanks within accredited centres, with strict time-bound storage (5 years max) and biosecurity rules. Transfer of materials is restricted to within the national territory and between accredited facilities only.

6. National Oversight

A National Ethics Body is responsible for maintaining a donor register, a recipient waiting list, and issuing ethical opinions on sensitive matters.

Prohibitions

The law explicitly criminalises:

  • Sale or purchase of human biological material.
  • Transplants performed without valid consent.
  • Advertisement of donations for specific individuals or centres.
  • Violation of anonymity, privacy, or ethical procedures.
  • Import/export of human biological material.

Sanctions

Violations attract:

  • Administrative penalties: Suspension or withdrawal of accreditation; exclusion from public contracts.
  • Criminal penalties: Up to 20 years imprisonment and fines up to 20 million CFA francs for unlawful removal, transplantation, or commercialisation.
  • Forfeitures under the Penal Code.

This law aligns Cameroon with international standards, including the WHO Guiding Principles on Human Cell, Tissue and Organ Transplantation, and reflects best practices seen in some countries around the world.

However, Cameroon’s law goes further by banning cross-border transfers, placing a 5-year limit on biobank storage, and imposing strict nationalisation of transplant oversight, suggesting a cautious but sovereignty-focused public health approach.

Practical Implications

For Hospitals and Clinics:

  • Must obtain accreditation.
  • Institutional ethics committees are now mandatory.
  • Consent forms and procedures must comply with strict legal formalities.

For Biotech and Research Institutions:

  • Biobank operations must align with biosafety norms and approved SOPs.
  • Transfer of biological material between centres requires regulatory authorisation.
  • Immediate review of current organ donation protocols is required.
  • Client advisories must include criminal law exposure for non-compliance.

For Investors and NGOs:

  • Opportunities exist in setting up accredited transplant centres or biobanks, subject to national licensing.
  • Partnerships with government and public health authorities must integrate ethics training and legal due diligence.

We offer:

  • Licensing support for accredited centres and biobanks.
  • Drafting of institutional protocols and consent forms.
  • Staff training on legal and ethical standards.
  • Legal representation in disputes or audits involving transplantation practices.

4M Legal and Tax – Law Firm

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Epanty Mbanda

Attorney-at-law | Corporate-Commercial | Technology (FinTech+Blockchain+Cryptocurrency) | Securities | Tax| Managing Partner at 4M Legal and Tax ( Law Firm in Cameroon)

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