Law No.2025/009 of 15 July 2025 relating to transplantation Cameroon the donation, removal and of human biological material in Cameroon
Official PDF Document Download
Read full text
REPUBLIC OF CAMEROON PEAGE - WORK - FATHERLAND t\ 5 .'LAW No ____________ OF ________ RELATING TO TRANSPLANTATION CAMEROON DONATION, REMOVAL ANDTHE OF HU MAN BIOLOGlCAL MAiERiÂL iN pR!BIOEN . ,.. PRE81 8 IR! li ERVICE RME: y The Parliament deliberated and adopted, the President of the Republic hereby enacts the law set out below:www.prc.cm ,.. PRE81 8 IR! li ERVICE RME: y The Parliament deliberated and adopted, the President of the Republic hereby enacts the law set out below:www.prc.cm SECTION 1: (1) This law relates to the dona 10n, removal and transpl of human biologicâl material in Cameroon. (2) lt lays down the principles and rules applicable to the and - blood donation, its components and derivatives; destruction of - transfer and preservation of gametes and embryos; - donation, auto-transplantation and transplantation for research purposes. SECTION 3: Within the meaning of this iaw and its subsequent implementing instruments, the following definitions shall apply; Biobank: authorized facility for the preservation and management of human biological samples and related data. Cell: morphological and functional unit of every living being. Stem ceU: undifferentiated cell with the ability to self-renew, multiply endlessly and create specialized human cells. Haematopoietic stem cell: primitive ceil accounting for only a tiny fraction of the haematopoietic tissue that generates ail of the body's blood cell iines. Accredited centre: public or private health facility authorized by the State to remove, preserve, store or transplant hurnan biological material. nes. Accredited centre: public or private health facility authorized by the State to remove, preserve, store or transplant hurnan biological material. Conditioning: all activities related to the preparation, preservation, storage and transfer of human biological material for therapeutic, diagnostic or scientific research purposes. Free and informed consent: voluntary, informed and written consent of an individual who has been properiy informed of their rights, the type of surgery and the related risks, and who agrees to undergo the removal or transplantation of human biological material. r., _____ ,_.,.: ___ .,. __ h_;_ u,....,...,.,.J ... ,..,, 1,-�� h 1 ·m,.......,, hi"l,-..,, ,...i,........... I m-.+r'\ .... ;"I ,,i"'ht� h.ofnror I Ç;:)ÇI vauvii. �C:\.,l li li\., .:>CU LV l"\-C:Cfv I IUI 1011 UIUIV�lvOI i I ICHÇI ICI V IC.UJI ..... l,J\.,IVI v they are used. Death: permanent and irreversible loss of consciousness and brainstem functions, resulting from prolonged cardiorespiratory arrest that prevents _ .. #.. •---.-.J.:_ ..... _LJ.�- L_.,.J, • . uÀyl::Jc:11auuf I u, u 11:: ùuüy. Lwww.prc.cm ting from prolonged cardiorespiratory arrest that prevents _ .. #.. •---.-.J.:_ ..... _LJ.�- L_.,.J, • . uÀyl::Jc:11auuf I u, u 11:: ùuüy. Lwww.prc.cm Donation: voluntary and free act of donating human biologicai mat�rial for therapeutic use. Donor: a living persan who, either before their death or during their lifetime, decides to donate their human biological material free of charge to a patient for therapeutic use. Transplantation: medica! or surgicai procedure involving the replacement of unhealthy biologicai material in a patient with healthy biological material from another persûn. Human biological material: substances from the human body, such as cells, tissues or organs Brain death: irreversible loss of brain and brainstem functions, characterized by coma, ioss of spontaneous breathing and brainstem reflexes. Organ: distinct part of the hurnan body made up of various tissues. Removal: medical or surgical process of extracting human biological material from a living or deceased persan. Recipient: patient who receives human biological material. Storage: preservation of removed human biological material under controlled and appropriate conditions until it is used. Tissue: constitutive part of the human body made up of cells. human biological material under controlled and appropriate conditions until it is used. Tissue: constitutive part of the human body made up of cells. CHAPTER Il GENERAL PRINCIPLES SECTION 4: The donation, removal and transpiantation of human biological material in Cameroon shall be consistent with the following principles: - non-discrimination; 1. · h 1· · 1 b · AIRE - comp 1ance w1t c 1rnca est pract1ces; RVICE R E cornpliance with ethical and bioethical r V_L�-= E O T Ru c ,. o P Y If 1 - - compliance with human dignity and hu ts;- - guarantee of self-determirn:�tion ar.d person2! respcnsib!!ity; - guarantee of special protection for persans under legal age and âdults with a disability; - respect for human vulnerability and persona! integrity; - n:::.c:n,::::,f"'f fnr nri\/:::::tf"'\I :::::inrl rnnfirl,::::,nti:::::ilih, f'lf nor<:nn:::::il rl:::::it:::::i·. --t"--.. · -· t'' i: V--, -· ·- --· ,, ·--· 111,1_, .... . , -· ,...,-. --· ·-· -- ..-, - respect for diversity and cultural values; - protection of the environment, biosphere and biodiversity.www.prc.cm ... . , -· ,...,-. --· ·-· -- ..-, - respect for diversity and cultural values; - protection of the environment, biosphere and biodiversity.www.prc.cm SECTION 5: (1) The donation, removal and transplantation of human biological mâterial shall only be carried out for therapeutic purposes. (2) Human biological material shail not be transferred or acquired for therapeutic use in exchange for rernuneration or any other material benefit. Scr-Ti-u i:::- (1 \ •!.-.e ..J,..,.�,.._t;on o" 1.-u--n k=-1 oq=""'1 m-�i::..-= .... , .... n• ....Il be · ,.... 1u�-1-a�· ·i-V i iVi"II v. , ) 1 11 Uvl ici-! 1 1 1 i '11 Ici I UIVI __;i\.Jctl I en,., , lctl ;:, au vu .l IL i y, free of charge and without duress. (2) For deceased donors, it sha!! be anonymous. SECT!ON 7: (1) The removal and transplantation of human biologlcal materia! must be justified and carried out without posing any health risks to the living donor or recipient. (2) The removal of vital human biological material from a living persan for transplantation purposes is strict!y forbidden, even with their consent. SECTION 8: The importation and exportation of human bioiogical material shal! be forbidden. SECTION 9: Any advertisement promoting the donation of human biological material to a particular persan or authorized centre shall be forbidden. Cl: Dl:. TION 9: Any advertisement promoting the donation of human biological material to a particular persan or authorized centre shall be forbidden. Cl: Dl:. LA pR1!9\0l;f.l RllSIDENCV P aec CHAPTERII! CONSENT u�a �-SENTOFTHEDONOR -..:=...:::.....:....:..=;..:...::......:....;... , inforrned consent of the donor of human biological material shall be required prier to any removal or transplantation surgery. SECTION 11: The donor shall only validly express their consent after the physician has provided them with information about their state of health, the type of surgery or treatment, the expected outcomes, other options, and the risks invo!ved, 2s well as any necessary measures to mitigate such risks. SECTION 12: (1) The donor sha!I express his/her consent in the presence of at least a spouse, parent or chi Id under one of the following conditions: (a) before the national body responsible for ethical issues, referred to in �or-fiAn 110 hoi-o+o·,••n.;,;..vuv1 1 -r 1 1\.., 1 v1. , (b) before the President of the High Court upon an ordinary application;www.prc.cm rred to in �or-fiAn 110 hoi-o+o·,••n.;,;..vuv1 1 -r 1 1\.., 1 v1. , (b) before the President of the High Court upon an ordinary application;www.prc.cm P R E O I O E N C I.: O [; L A f P R t B I O F. N !,; Y F T 8 1: C H E TA R t ( c) before a notary pubiic. �:��,��;'::·, "\0 .. F 1 C O P r- · c ' hï �:a-rirrr F I E r ,., P Y (2) VVhere (b) and c f""gbove-a�pply,the-c u ru!ing or notarial act, as applicable, shall be submitted and registered With the national body responsible for ethical issues. SECTION 1 3: The donor sha!i have a deadiine of 72 (seventy-two) hours before surger1 te ,i1vithdraw his/her consent. The national body responsib!e for ,-..,.(.h;"",--.i ;,.,..�, '"r- r-h-.U +-h,.....n fru-, �1-, rri +hi- iri.:,.-... ... �-+i.-. n f.-. +ho Y"Ol"fnioniÇU UVCH J�-....UCi:) ..::')I iC:H U !C; 4 ! U! \Il.. eu u l! fi� il dui � f !âln..n ! E.V t..t 1v ! "'-V! JJÎvi i L SECTION 1 4: (1) The consent of a living adult donor shall only be validly expressed if they can prove that they have full meÏltal capacity. (2) The consent of adult donors with d isabi!ities shall be validly expressed under the foll owing conditions: (a) the assent of the adult with a disability; (b) the informed consent of the iegal representative in accordance wîth the provisions of Section 1 2 above. he assent of the adult with a disability; (b) the informed consent of the iegal representative in accordance wîth the provisions of Section 1 2 above. SECTION 1 5: The consent of persans under age shall be expressed, mutatis mutandis under the conditions set out in Section 14 (2) above. SECTION 1 6 : The removal of human biological material from a deceased person or a person in a state of brain death shall only be carried out where that persan gave his free and informed consent while he was alive, in accordance with the provisions of this law. il - CONSENT OF THE RECIPIENT SECTION 1 7 : The provisions of Sections 1 0 t o 1 5 shall apply mutatis mutandis to the consent of the recipient. CHAPTER IV REMOVAL, TRANSPLANTATION AND DESTRUCTION OF HUMAN B!OLOG!CAL MATER!AL 1 - REMOVAL AND TRANSPLANTATION SECTION 1 8: Human biological material may be removed from living, deceased or brain-dead persans under the conditions stipulated in this law. St=CTiON 1 9 : ( 1 ) ! n !ine with the general conditions provided for i n this law, donors and recipients of human biological material shall meet selection criteria prior to any removal, especialiy those pertaining to compatibiiity and safety. 5www.prc.cm of human biological material shall meet selection criteria prior to any removal, especialiy those pertaining to compatibiiity and safety. 5www.prc.cm l' R r! tl l O C: U C l: D E L , P R E S I C E tU; V O F l i 1 • 8 1: C R TA · ' � • SERVICE DU , lt 1 ' L .H \RE SECTION 20: Quaii ��L�ij� ·�:�r� person0ê1 ��a�� verify the identity of the donor and potentia! iteci· · , ��ensüre that empatibility requirements and potential contraindir - ;ons are met, as well as qomplying with applicable health and security measures, before removing human biologlcal material from a living, deceased or brain-dead persan for subsequent transpiantation into a iiving persan. �Fr: ;_ !_Or_·\! ?i_ : i '1 \ Tho !'O!'nt"\\iaî r.f h i l i'Y'l'"' 'f'l 1-,;,...1,.........,;,...�j m�fai-ia'1 fi-1'"\m ':} noi-st"\n- ._ - � • \ l / f ! ! V ! \,;.,-f ! ! \./ V i '-"" • i H.,� l ! !C! . ! U i V i V� n......-ÇA.I ! ! H:.--•H.\J! t l ! V I ! '-A f'-'\,,,!l Vi E under the age of 1 8 or an adu!t with disabiiity shall be limlted to haematopoietic stem celis. (2) The restriction referred to in paragraph ( 1 ) above may be waived in cases of force majeure with the express authorization of the national body responsible for ethicai issues. (3) The special conditions and terms for implementing Paragraph (2) above shall be laid down by regulation. ional body responsible for ethicai issues. (3) The special conditions and terms for implementing Paragraph (2) above shall be laid down by regulation. SECTION 22: Notwithstanding the consent of the donor, recipient or their legal representatives, prior to any removai or transplantation surgery, the physician may reqùest a second medical opinion or additional medical examinations, especially where the life of the donor or recipient may be at risk. SECTION 23: ( 1 ) The removal of any biological material from a deceased persan shall only be carried out after his death has been reported by a physician. (2) The removal of any biological material from a person in a state of brain death shal! only be carried out after this condition has been reported by a team of two physicians, one of whom must be a neurologist or a neurosurgeon. SECTION 24: The terms and conditions governing the removal and transpiantation of human biological material shall be laid down by regulation. ! ! - Dl=�TRUCT!nN OF HUMAN R!O! O�!CA! MATFR!Al SECTION 25: ( 1 ) Human bio!ogical material may be destroyed. (2) The destruction of human biological material is subject to the prior approval of the national body responsible for ethical issues. (3) The destruction of human biological material must be carried out: 6www.prc.cm prior approval of the national body responsible for ethical issues. (3) The destruction of human biological material must be carried out: 6www.prc.cm ;es, ,, R.; ER (b) by qua!ified personnei; (c) under conditions that avoid any risk of reuse, whether partial or otherwise. S ECTIOt-J 26: The terms and conditions governing the destruction of human biological material s_ ..,9!' laid down by regulation. • ue CHAPTER V Eu CENTRES AND i HE BiOBANK ���Ü!���:;:.,;:;....-,f 1 - ACCREDITED CENTRES - SECTION 27: ( 1 ) An accredited centre sha!I be a public or private health facility that carries out the co!!ection, preser1ation or transplantation of humari bio!ogical material. (2) Operations involving the collection, transplantation and destruction of human biological material shall be carried out only in an accredited centre. (3) The list of accredited centres shall be drawn up annually by the Ministry in charge of public health. SECTION 28: ( 1 ) Each accredited centre shall have its own institutional ethics committee. (2) The centre must ensure the traceabilitv of human biological materiai and guarantee donor anonymity. / 0 \ ,-._ _ � - - - - ; __ .,; __ - - ,.J ..&. , .,... ,....;. ; " 9"' i ll"'\ ,... ilitv of human biological materiai and guarantee donor anonymity. / 0 \ ,-._ _ � - - - - ; __ .,; __ - - ,.J ..&. , .,... ,....;. ; " 9"' i ll"'\ ,... rri.-F" 1_0) I I I C V l !:;:ICII IILO.llVI I C:1 1 1'-.J I U l lvllVI I I I I � U I • , • • 1 ' 1 :nsrrrur:ona1 cthics committees shall be laid àown by regulation. SECTION 29: Accredited centres shali be required to ensure the valiàity of consent beforehand, in accordance with the provisions of this law. SECTION 30: Accredited centres shall take ail necessary measures to ensure the preservation of aii documents reiated to each activity, in accordance vvith the Code of Ethics a nd Professiona! Conduct, as vve!I as best practices. SECTION 31 : (1 ) Ali information reiating to the health status of the donor and recipient, including their persona!, family, medical a nd surgical history, must be completed by authoïized healthcare professîoiîals. (2) I nformation obtained from the donor, recipient or their legal representatives shall be recorded in their medical files and kept at the centre.www.prc.cm formation obtained from the donor, recipient or their legal representatives shall be recorded in their medical files and kept at the centre.www.prc.cm (3) The accredited centre must not disclose any information that could enabie the identification of the donor or recipient of human bioiogicai material, under penalty of sanctions against the centre and its managers. SECTION 32: The obligation to preseNe information as referred to in Section 3 1 above shall apply throughout the life of the donor and the recipient, even ....fî-er 1· h,=,. ·,r d.i::.i.:::itha , .. ' '"' --" � ë Er'rinl>.i "} ") . i\ ,..,,,..,.,..._,..,l ;+,.,,-"' '"''"',....-1-r9� sh--il S' •kW1it an ,.. n n , •al ro rv; ri- on +h0 i ry :.,_ v 1 : � .c: ; � J...;. ,-�vv, c; u i: �cu vt::i ,t.1 � j i d n V.i..ff ! iH. 1 l O.i 1Î H...� .P E "'i'""'v, i. � \,t n,,,.-Ï I activities to the Minister in charge of public health. A copy of this report sha!I be forwarded to the nationai body responsible for ethical issues. SECTION 34: The terms and conditions governing the issuance of accreditation shall be laid down by regulation. I l - THE BIOBANK SECTION 35: ( 1 ) A biobank may be established at an accredited centre to ensure the preservation and management of human biological samples and associated data. ( 1 ) A biobank may be established at an accredited centre to ensure the preservation and management of human biological samples and associated data. (2) The preservation of biological material must: (a) guarantee the quality of the human biological rnaterial, from collection to transplantation; (b) cornply with the relevant biosafety and biosecurity requirements, taking into account the specific nature of each material. SECTION 36: ( 1) Human biological material may only be stored in the biobank of the accredited centre from which they were collected. (2) Human biological materia! removed for therapeutic use must be stored in a biobank for a maximum of 5 (five) years. S ECTION 37: ( 1 ) Notwithstanding the provisions of Section 36 above, human bj o1og ï""'' m"'ter·1al ma" be transforrod be+u,oon acl"ron·1+0d "entrAS vv·1+hin thA1 I l\.,.,Cll 1 0 1. 1 J 1 - , . l '-,., 1 1 \.,,, 1.VV V '-' 1 t V I "'"" "'-' ,_, . .. ....... \li LI u , • ...., nEülon2! territory. (2) The terms and conditions governing the transfer referred to in paragraph (1) above shall be laid down by regulation. SECTION 38: The terms and conditions for establishing and closing biobanks, as we!! as their standard operating procedures, shall be laid dûwn by regulation. P R l! 8 1 D E N C E P IU! I F I E D Twww.prc.cm d closing biobanks, as we!! as their standard operating procedures, shall be laid dûwn by regulation. P R l! 8 1 D E N C E P IU! I F I E D Twww.prc.cm SECTION 39: A.il information relating to the coiiection, biobank operations, transplantation and destruction of hum:an biological material must be recorded and archived at the accredited centre. CHAPTER VI NATIONAL BODY RESPONSIBLE FOR ETHICAL ISSUES SECTION 4û: (1) The national body responsible for ethical issues shall provide ...-.. ,.......,__;_�.,.;.i-:-. - "" ...J ..-..+i-- ;--.ï "" � : ....,. ; .,..,. .., ,.... ...... +ï.<"\" .-""H..-.c+ï�n +!""l"'l ns.,.,J�n+�i-1 -l""t. n nro�-on,a·rïrt na .::,f...,;<:;1 I LU a... at :u c�; U\.l'a� UtJU nv: t u, t u ic vu;:c �u..ii ; � u eu t· î-':-it 1lc..u. vi � : i'-1: "-'"'-'= "-d ;; F.,!v1 1 and destruction of human biological materiai. (2) The ürganization and functiûning of the bûdy referred tû in paragraph ( 1 ) above shali be lâid down by regulation. SECîïON 41 : The national body responsible for ethicai issues shali keep a national register of donors and a nationai waiting list of recipients. SECTION 42: ( 1 ) Any person who consents to the collection of human bio!ogical material after his death must be listed on the national donor register. ECTION 42: ( 1 ) Any person who consents to the collection of human bio!ogical material after his death must be listed on the national donor register. (2) He/she may withdraw hisiher consent at any time, through the national body responsible for ethical issues. SECTION 43: Potential recipients of human biological material from deceased donors must be registered on the national waiting list, which is compiled by the nationai body responsible for ethical issues. Registration shall be based o n the severity and urgency of cases requiring a transplant. -----.::��;-niËL°AR����la,o cNC� o e CHAPTER VII ••R:ca10C!N�V PROHI BITIONS AND PENAL Til;�, 1 ee 1 - P RO HI BITIONS 1 F I E D T R U E c o SECTION 44: lt shall be prohibited: - to remove human biological material from a person without their prior free and informed consent; - to collect human biological material outside accredited centres; - to sell oï puïchase human biologicai material; - to destroy removed human biological material, in violation of the rules laid down by this law and its implementing instruments; - to carry out transpiantatiün wlthout rnedical supeïvision or outside an accredited centre; - to carry out transplantation without the prier free and informed consent of ihe recip1ent;www.prc.cm al supeïvision or outside an accredited centre; - to carry out transplantation without the prier free and informed consent of ihe recip1ent;www.prc.cm - to destroy any document relating to the donation, collection or transplantation of human biological materiai; - to disclose confidential information obtained in the process of donation, removal or transplantation of human bioiogical material. Il - PF=NALTIES pRCOIOC NCE O c:! L PRetSI 8 PARA GRAPH / nmcio AD1ViltVfSTRA TiV'E SAlVCTi� SECTION 45: Without p rejudice to the criminal liability of accredited centre their capadty as legal persons, their promoters and health personnel shal1 be liabie to the following sanctions in the event of fai!ure to meet their obligations under this law: - seizure or destruction of medical equipment and data, at the offender's expense; - suspension or permanent withdrawai of the authorization to carry out the collection and transplantation of human biological materials; - suspension of authorization to practise medicine, or any other profession related to operations involving the coliection and transplantation of human biological material; - suspension or withdrawal of the centre's accreditation; - exclusion from public contracts for a period of 5 (five) years or permanently; regulation. - suspension or withdrawal of the centre's accreditation; - exclusion from public contracts for a period of 5 (five) years or permanently; regulation. SECTION 46: The system of administrative sanctions referred to in Section 45 above shall be defined by regulation. PARAGRAPH Il PENAL SANCTIONS SECTION 47: Whoever discloses confidential information relating to the donation, collection or transplantation of human biological material without authorization from the relevant person shall be punished with imprisonn1ent for from 3 (three) months to 3 (three) years, and with fine of from 200 000 (hNo hundred thousand) to 2 000 000 (two million) CFA francs. cccr10"'1 A B · ( 1 \ ' "'hoe"er ""1 1'"'"1S h· ....... " .... h;0 1 '"'"' 0 I C"l ma+erial·..;IL;;. 1 1'111 ""t , , / V V I V \..,Vllt:;v I U I I I OI I UI I V� a I L 1 . - from a persan without his/her prior free and informed consent, or after such consent has been withdrawn; or - outside acci-edited centres; i vwww.prc.cm om a persan without his/her prior free and informed consent, or after such consent has been withdrawn; or - outside acci-edited centres; i vwww.prc.cm shall be punished with imprisonment for from 1 0 (ten) to 20 (twenty) years and with fine of from 2 000 000 (tvvo million) to 20 000 000 (t\,venty million) CFA francs. (2) \/Vhoever carries out a transplantation without the recipient's free and informed consent shall be fiable to the same penalties as set out in paragraph (1) above. SECTION 49: VVhoever: - carries out the removal or transplantation of human biological material without the assent of a person under the age of 18 or an adult with disabl!ity, or without the consent of their !egai representative; - carries out transplantation of human biologicai rnaterial without medica! ult with disabl!ity, or without the consent of their !egai representative; - carries out transplantation of human biologicai rnaterial without medica! super✓ision; - donates human biological material for commercial reasons; - requests, obtains, promises or grants a ny benefits or consideration whatsoever in connection with the donation, removal or transplantation of human biological material; - destroys or causes the destruction of human bioiogicai materiai to be removed or collected in violation of the rules laid down by the provisions of this law ând its implementing instruments; - destroys or causes the destruction of any document relating to the donation, removal or transplantation of human biological material; - violates the anonymity of the deceased donor; - advertises a donation of human bio!ogical material in favour of a given persan or a specific accredited centre; shall be liable to the penalties provided for i n Section 48 above. SECTION 50: N otwithstanding the penalties provided for in Sections 4 7 to 49 above, the court to which the matter has been referred may pronounce the forfeitures provided for in Section 30 of the Penal Code. SECTION 51: The provisions of the Pen al Code shall remain applicable for offences not specifically punishable under this law. n 30 of the Penal Code. SECTION 51: The provisions of the Pen al Code shall remain applicable for offences not specifically punishable under this law. CHAPTER V!U MISCELLANEOUS, TRANSITIONAL AN D FINAL PROVISIONS SECTION 52: Health personnel i nvolvetf- ln · the removal, preservation, transplantation or destruction of human biolo ical material must be authorized under the conditions laid down by regulation I F I E O T R U y l 1www.prc.cm SECTION 53: Health facilities carrying out the removal or transplantation of biological material, as well as their medical personnel, shall be required to comply with the provisions of this law within 12 (twelve) months of its enactment. SECTION 54: Regulatory instruments shall specify, as and when necessary, the terms and conditions for implementing this law. SECTION 55: This law shall be registered, published according to the procedure of urgency and inserted in the Official Gazette in English and French. 12www.prc.cm
Have questions about this law?
Ask Ubutabera AI for instant, cited answers — free with an account. Save laws and download official PDFs too.
Create a free account