Act No. 038-2020/An On The Donation, Prelevement, Transplantation And Transplantation Of Organs, Tissues And Human Cells To Burkina Faso

Original Language Title: LOI N°038-2020/AN RELATIVE AU DON, AU PRELEVEMENT, A LA TRANSPLANTATION ET AUX GREFFES D’ORGANES, DE TISSUS ET DE CELLULES HUMAINS AU BURKINA FASO

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BURKINA FASO REPUBLIC ------------ SEPTIEME PARLIAMENT UNITE-PROGRES-JUSTICE ------------ NATIONAL ASSEMBLY






















ACT NO. 038-2020/AN


RELATIVE TO THE DONATION, PRELEVEMENT, TRANSPLANTATION AND TRANSPLANTATION OF HUMAN ORGANS, TISSUES AND CELLS TO BURKINA FASO








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THE NATIONAL ASSEMBLY




Having regard to the Constitution;




In view of resolution No. 001-2015/AN of 30 December 2015 on validation


The mandate of Members;






Deliberated at its meeting on 18 December 2020


And adopted the law with the following content:






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CHAPTER 1: GENERAL PROVISIONS


Section 1: Object and scope


Article 1:


The purpose of this Act is to govern donation, collection, transplantation


And transplantation of organs, tissues and human cells in Burkina Faso.


Article 2:


May be given, removed, transplanted and grafted, organs, tissues


And human cells.


The list of human organs, tissues and cells is defined by decree in


Council of Ministers on the proposal of the Minister for Health.


Article 3:


This Act does not apply to the transplantation of stem cells and cells


Of reproduction.


Section 2: Definitions


Article 4:


For the purposes of this Law:


-cell: basic unit of any organism except viruses;


-stem cell: undifferentiated cell, capable of self-renewing, of


Differentiate into other cell types and proliferate in culture;


-cornea: fibrous and transparent membrane forming the face


Anterior eye of the eye;


-donation: altruistic act and generosity referring to the will of a


Person called a donor who decides to give part of his or her body


For therapeutic or scientific purposes;


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-donor: any person who accepts the removal of an organ or


Tissue on it and donating it to a patient;


-Registry: surgical procedure consisting of the transfer of a body, a part


Organ or human tissue from one point to another of the same individual


Or from one individual to another;


-graft: organ or part of organ or tissue that has been transferred from a


Point to another individual or individual from one individual to another;


-encephalic death: total, definitive and irreversible state of absence


Any brain activity;


-organ: any circumscribed and completely differentiated part of the body,


Composed of different fabrics that maintain its structure, its


Vascularization and ability to perform physiological functions


With some autonomy;


-vital organ: any organ whose collection inevitably leads to


The death of the person on whom the person was removed;


-deceased person: person with encephalic death;


-collection: surgical procedure for removing an organ, a


Part of organ with its vessels or a tissue;


-recipient: a sick person who has done or is the subject of a tissue transplant or


Organ;


-transplanting: surgical procedure consisting of the transfer of an organ or


Part of a donor's organ and involving the re-establishment of the


Vascular continuity of this organ or part of organ with the system


Recipient circulatory system;


-tissue: any part of the human body composed of an organised group


Of living cells with identical potentialities and filling a


Determined function.






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Section 3: General principles


Article 5:


Donation, retrieval, organ transplantation and tissue transplantation; and


Human cells are carried out with respect to the integrity of the person


Under the conditions laid down in this Law.


Article 6:


The donation, collection, transplantation and transplantation of organs and tissues


And human cells can only take place for therapeutic purposes


Or scientific.


Article 7:


The principle of non-preservation of the human body implies prohibition


Marketing.


The donation of organs, tissues and cells is free and anonymous.


Anonymity does not apply to the related living donor.


Any remuneration of the donor is prohibited.


The donation is financially neutral for the donor.


Article 8:


Costs related to collection, transplant and transplant operations


Human and hospital tissues and cells are set by way of


Regulatory.


Article 9:


Any advertising on organ donation, collection, transplantation


Organ, the transplantation of human tissues and cells is prohibited.


However, public information in the form of health education and


The Minister's responsibility for health is expressly authorized.




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CHAPTER 2: PRELEVEMENT OF ORGANS, TISSUES AND


HUMAN CELLS


Section 1: From the levy on a living person for purposes


Therapeutic


Article 10:


No organ, tissue and human cell collection may have


Place on a minor living person or on a major living person


Subject to a legal protection measure.


However, bone marrow sampling may be performed on a


Minor for the benefit of his brother or sister. This levy cannot be


Exercised that with the free and informed consent of the owners of the authority


Parental or legal representative of the minor before the presiding judge


Of the place of his or her residence.


Article 11:


The living donor who intends to authorize the collection of his or her body in sight


A Registry shall be informed in writing of the risks involved and


The possible consequences of the withdrawal by the doctor entitled to


Opinion of the National Committee provided for in Article 25 of this Law.


In order to inform its decision, the National Committee may proceed to


Investigations and any consultations that it considers necessary.


Article 12:


The removal of organs, tissues and human cells cannot be


Without the prior, free and informed consent of the donor.


Consent is revocable at any time.


Article 13:


The free and informed consent of the donor is expressed to the President


The court of large instance or the domicile of the judge designated by him


Donor or authorized public hospital establishment.


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The President of the High Court or the Magistrate designated by him


Verifies the identity of the donor, the compliance with the law of the donor relationship


To the recipient and the absence of any constraints.


The President of the High Court or the Magistrate designated by him


Also ensures that the donation is free.


Article 14:


A psychosocial evaluation of the organ donor is carried out by a


Qualified professional. The results of this evaluation are integrated into the


File to be submitted to the President of the competent court.


Article 15:


The President of the court or the judge designated by him who collects the


Consent shall produce a record co-signed by the donor and by the


Clerk.


The Registrar of the competent High Court shall transmit a copy to the


Approved hospital public institutions.


Section 2: From the levy on a deceased person for a purpose


Therapeutic or scientific


Article 16:


The collection of a deceased person for therapeutic purposes or


Scientists can only be performed on the condition that they have verified the


Prior to the authorization granted by the deceased of his or her lifetime.


The prior authorization of the deceased shall be made by a written and legalized act,


Lodged at the Registry of the High Court in the jurisdiction of which


Finds his home.


The court shall, without delay, inform all licensed hospitals


To take samples and transplants of organs.


Approved hospital facilities record this authorization on a


Register maintained for this purpose.


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The person who gave the authorization may revoke the authorization at any time.


A decree issued in the Council of Ministers specifies the terms and conditions


The issuing of the donor card provided for in Article 26 of this Law.


Article 17:


No sampling can be carried out in the context of transplantation


Or the transplant on a deceased person who has not previously given his or her


Authorization even with the consent of a family member.


Article 18:


Death is recognized by two non-member hospital physicians


The team that carries out the levy and the transplant.


The two doctors who make the observation of the death stand trial -


Signed by them. The Minutes shall mention the date, time and cause


Death.


CHAPTER 3: PRELEVEMENT, TRANSPLANTATION AND


THE REGISTRY BY PUBLIC INSTITUTIONS


HOSPITALLERS


Section 1: Accreditation of public hospital facilities


Article 19:


Collection, transplantation and transplantation are carried out only


In licensed public hospitals.


Approval is issued by the Minister in charge of health on proposal


The supervisory body provided for in Article 25 of this Law.


Article 20:


Hospital public institutions, in order to be approved, satisfy the


The following conditions:


-availability of specialist medical staff who are competent and available to carry out


Organ removal and transplantation operations;


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-have the technical means to witness the death;


-having a suitable technical platform;


-be equipped with the necessary means for reconstitution and conservation


Of bodies.


Section 2: Technical and material skills of the


Approved hospital public institutions


Article 21:


Approved hospital public institutions are equipped with skills and


Technical means necessary for the uninterrupted realization of


The whole process of organ removal, transplantation and transplantation,


Human tissues and cells.


Article 22:


Approved hospital public institutions have blocks


Operatories and performing laboratories previously dedicated to the


Retrieval, transplant and transplant operations.


Article 23:


The approved hospital establishment that proceeds with the continuous collection


To administer to the donor free medical care related to the donation.


Article 24:


A decree of the Council of Ministers shall lay down the conditions and conditions for


Management of personnel directly involved in the operations of


The collection, transplantation and transplantation of organs, tissues and


Human cells.


CHAPTER 4: NATIONAL CONTROL AND ETHICS COMMITTEE


Section 1: Creation and remit




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Article 25:


A National Committee for the Control and Ethics of Donation is established.


Retrieval, transplantation and transplantation placed with the Minister in


Health care.


Article 26:


The National Committee for the Control and Ethics of Donation, Collection,


Transplantation and transplantation has the following responsibilities:


-to ensure transparency, coordination of donation, collection,


Transplantation and transplantation;


-to maintain records of donation, collection, transplantation


And transplantation;


-to ensure patient safety and respect for ethics


Medical;


-issuing an organ donor card to the person who gave,


In the person's lifetime, the authorization to collect or donate organs;


-to propose public hospitals for approval according to a workbook


Charges specified by the Ministry of Health;


-to draw up a list of approved medical staff for transplantation


Bodies and their fields of competence.


Section 2: The composition of the National Monitoring Committee and


Ethics


Article 27:


The National Committee for the Control and Ethics of Donation, Collection,


Transplantation and transplantation is made up of representatives from the Department in


Ministry of Health, Ministry of Justice, Ministry of Health


Office of Human Rights, University-University, Representatives


The National Council of the Order of Physicians, of the National Order of Physicians


Pharmacists and patient associations.


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Article 28:


The arrangements for the appointment of representatives, the organization and the


Operation of the Committee shall be fixed by decree of the Council of Ministers.


CHAPTER 5: SANCTIONS


Section 1: Administrative sanctions


Article 29:


Approval of any licensed public hospital that ceases to hold


Any of the conditions set out in section 20 of this Act may be


Suspended or withdrawn in whole or in part, by order of the Minister responsible


After the reasoned opinion of the National Committee for the Control and Ethics of the


Donation, collection, transplantation and transplantation.


However, in case of emergency, authorisation may be suspended


Temporarily by the Ministry of Health without prior notice of the


National Committee. The latter shall be informed immediately of the decision.


Article 30:


It is subject to disciplinary sanctions without prejudice to criminal penalties and


Additional penalties provided for in texts governing orders


Professionals, any health professional who is involved in practices


Contrary to the rules of ethics and ethics of the profession.


Section 2: Criminal sanctions


Article 31:


Is liable to imprisonment for two to five years and a fine of two


Millions (2 000 000) to ten million (10,000,000) of FCFA anyone who


Obtains from another person a body against payment or any other


Form of consideration.


It is punishable by the same penalties, the fact of providing assistance in favour of


Obtaining a body against payment or any other form of


Counterparty, or to assign such an organ of another's body for consideration.


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Article 32:


It is punishable by ten to twenty years' imprisonment and a fine of five


Millions (5 000 000) to twenty million (20 000 000) of FCFA, the fact of taking


A body on a major living person without the consent of


It has been collected under the conditions set out in this Act.


The same penalties shall be imposed for the removal of organs from a donor


Living minor or on a major living donor under legal protection without


Have complied with the conditions set out in this Act.


Article 33:


Is punishable by five to ten years' imprisonment and a fine of one million


(1 000 000) to five million (5 000 000) of FCFA, whoever gets from a


The removal of human tissue and cells from payment


Or any other form of consideration.


The same penalties shall be imposed for the promotion of the


Obtaining human tissue and cells for payment or transfer


For consideration for human tissues and cells.


Article 34:


10 to 20 years' imprisonment and a fine of five


Millions (5 000 000) to twenty million (20 000 000) of FCFA or one of these


Only two penalties, any person taking samples


Organs or transplants of organs, tissue grafts and


Human cells in a facility that has not obtained authorization


Required by this Act.


In addition, the establishment may be closed for a period of time


One to three years.


Article 35:


The fact for an establishment to carry out conservation or


Processing, distribution or transfer of organs, tissues and


Human cells for a donation in violation of the provisions of this


Law enforces the withdrawal of its approval.


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