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Law No. 2015-22 December 08, 2015

Original Language Title: Loi n° 2015-22 du 08 décembre 2015

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LAW

Law No. 2015-22 of December 08, 2015
Law n ° 2015-22 of 08 December 2015 on the donation, removal and transplantation of organs and transplants of human tissues



EXPOSE REASONS

Consected by the Constitution, the right to health places on the public authorities the duty to ensure the physical, mental and moral health of the family and, in particular, persons with disabilities and the elderly, as well as Rural areas and urban areas.

For example, as part of the 2009-2018 National Health Development Plan, the Government of Senegal reaffirmed its commitment to ensuring quality care for all Senegalese.

This commitment is reflected in the care of chronic, expensive-care chronic diseases. These include several conditions for which organ transplantation or tissue transplantation is a necessary remedy.

Technological advances have significantly increased safety in the process of organ transplantation or transplantation of human tissues.

In Senegal, there are now qualified human resources and a technical platform to carry out such acts and save the lives of many Senegalese suffering from a terminal failure of an organ.

This draft law sets out the general principles governing the donation, collection, transplantation of organs and the transplantation of human tissues, including respect for the physical integrity of the human person, free donation of organs or Human tissue. The removal of the cornea is permitted in the deceased person.

However, the removal of organs shall be permitted only on the living person, in accordance with the procedure laid down in this Law.

Similarly, it has become necessary to limit the authorised health structures. Finally, the creation of a supervisory body seems to be a necessity in order to avoid drifts.


This is the economy of this bill.


The National Assembly adopted, at its meeting on Friday 27 November 2015,
The President of the Republic enacts the following legislation:


Preliminary Chapter. - Definitions

Article 1. -For the purposes of this Law:

- Cornea : fibrous and transparent membrane constituting the anterior face of the anterior chamber of the eye;
- Donor : any person who accepts the removal of an organ or tissue on it and who makes the donation to a patient;
- Graft : the act of transferring a fragment of a human organ or tissue from one point to another of the same individual or from one individual to another;
- Grafting : organ, part of organ or tissue having been transferred from one individual to another;
- Encephalic death : an irreparable stop of the brain's irrigation by the blood and resulting in its destruction;
- Organ : a circumscribed and fully differentiated part of the body, composed of different tissues that maintain its structure, vascularization and its ability to perform physiological functions with a certain
Autonomy;
- Vital organ : any organ whose collection inevitably results in the death of the person on whom it was taken;
- Picking up : surgical procedure for removing an organ with its vessels or a tissue;
- Receiver : sick who has done or is going to be the subject of a tissue or organ transplant;
- Transplant Transfer of a organ of a donor involving the restoration of vascular continuity of this organ with the circulatory apparatus of the recipient;
- Fabric : any part of the human body composed of an organized set of living cells with identical potentialities and fulfilling a specific function.


Chapter I. - General provisions

Section 1. - General Principles


Art. 2. -The donation, collection and transplantation of organs and the transplantation of human tissues shall be carried out in accordance with the physical integrity of the human person and in accordance with the conditions laid down in this Law.

The removal of organs shall be permitted only on a living person in accordance with the procedures laid down in this Law.

However, the removal of the cornea is permitted on a deceased person in accordance with terms and conditions to be fixed by decree.


Article 3. -The donation, removal or transplantation of human organs and tissues may take place only for therapeutic purposes.


Art. 4. -No levy for transplantation may take place on a minor living person or on a major living person under a guardianship or guardianship regime.


Art. 5. -This Act does not apply to the transplantation of haematopoietic, mesenchymal or immune stem cells, nor to organs and cells of reproduction.


Article 6. -The donation of a human organ or tissue is free of charge and cannot, under any circumstances, be the subject of a transaction.

Only the costs associated with the interventions required by the collection, transplantation and transplantation of human tissues, as well as the associated hospitalization costs, are due to the health establishment.


Art. 7. -Advertising for the donation of human organs or tissues to a specified person, establishment or body is prohibited.

This prohibition does not preclude information to the public on the donation of human organs or tissues. The design, implementation and dissemination of this information fall within the exclusive competence of the National Council of the Don and the Transplantation under the responsibility of the Ministry of Health.



Section 2.
- Control Body

Article 8. -It is created a body called the National Council of the Don and Transplantation (CNDT) with legal personality and placed under the supervision of the Ministry of Health.

The National Council of the Don and Transplantation is responsible for:

-ensure transparency, coordination of donation and collection, management of registers, and coordination of international exchanges;
-to ensure health safety and respect for medical ethics;
-develop communication strategies for the promotion of donation and collection;

The composition, organisation and functioning of the Council shall be fixed by decree.

Chapter II. - Human organ and tissue removal

Section 1. - Relationship of kinship

Art. 9. -The collection of a human organ or tissue on a living person, who makes the donation, can only be carried out in the direct therapeutic interest of a recipient.

The donor must necessarily be:

The father, mother or child;
2 ° brother or sister german, inbred or uterine, uncle, aunt, nephew or niece of the third degree, cousin or cousin in the collateral line of the 4th degree;
3. The husband or wife after at least two years of marriage.

The relationship between the donor and the recipient provided for in the 1st and 2nd of this Article shall be proved in accordance with the provisions laid down in the Family Code.

Section 2. - Consent

Art. 10. -The removal of the whole of a vital organ of a living person for the purpose of transplantation is strictly prohibited, even with his consent.

The removal of a human organ or tissue should not endanger the life of the donor.


Art. 11.
-The removal of an organ or tissue on a person cannot be carried out without his prior consent.

The donor, who is informed of the risks and possible consequences of the levy, must express his or her consent before the President of the Court of Instance or the judge designated by him.

The competent court is that of the place of establishment of the hospital structure for the transplantation of organs or the transplantation of human tissues.


Art. 12. -The President of the Court of Instance or the Magistrate appointed by him shall refer the matter to a simple request after ensuring the free and informed consent of the donor, which shall be recorded in the Minutes.

The President of the Court of Instance or the Magistrate appointed by him shall be assisted by two medical specialists and a psychologist appointed by him on a list fixed by order of the Minister responsible for health on a proposal from the National Council of the Don and of Transplantation.

These doctors, who cannot be the doctors, are responsible for explaining to the magistrate the therapeutic benefit of the collection, and the donor, all the consequences of physical order. This information also relates to the results that may be expected from the registry for the recipient. The psychologist is responsible for explaining the potential impact on the donor's personal, family or professional life.

In the event of a vital emergency, the consent shall be collected, by any means, by the Public Prosecutor or his delegate.

Consent is revocable without any formality and at any time.


Chapter Ill. - Transplantation of organs and transplantation of human tissues

Art. 13. -The responsible physician shall ensure the agreement of the transplant recipient of the organ.

It also ensures that the organ does not have a communicable disease or is likely to endanger the life of the recipient. It verifies, within the limits of the data acquired from the science, that the organ to be transplanted is compatible with the recipient's body.

The Minister responsible for health, on a proposal from the National Council of the Don and the Transplantation, establishes by order the list of examinations which must be carried out in advance.


Chapter IV.
- Registered health care facilities

Art. 14. -Samples, organ transplants and human tissue grafts can only be carried out in approved public health facilities.

However, corneal grafts may be carried out at licensed private health facilities, for this purpose, by order of the Minister responsible for health.

Where the Registry cannot intervene immediately after collection, the preservation of the human tissue may take place only in a registered public health establishment.


Art. 15. -Approval is given by the Minister responsible for Health after the advice of the National Council of the Don and Transplantation.

The approval specifies the type of human organ or tissue that the health facility is authorized to collect, transplant and grafted.

The approval of the removal and approval of organs or transplants of human tissue is distinct. They must be requested separately. However, the approval of organ transplants gives the right to be approved for removal.

The approval of organ removal on a living person may only be granted to public health establishments which have the authorisation to carry out the transplantation of the same organs.

In addition to the two licences mentioned above, health facilities wishing to host a tissue bank must obtain a licence for the preservation of the latter.
Approvals are issued for a renewable two-year period.


Art. 16. -Approval may be suspended or withdrawn in whole or in part, by order of the Minister responsible for health, after reasoned opinion of the National Council of the Don and of the Transplantation.

In the event of an emergency, the authorisation may be provisionally suspended without prior notice from the National Council of the Don and Transplantation. The latter shall be informed immediately of the decision.


Art. 17.
-To be eligible for accreditation, health facilities must have:

-qualified medical and paramedical personnel and technical means for observing encephalic death;
-competent medical and paramedical personnel and technical and structural means to carry out the retrieval or transplant operations of organs or tissues for which approval is sought;
-medical personnel capable of properly performing the integumentary restoration.


Art. 18. -Any registered public health establishment carrying out, under the provisions of this Law, samples or transplants of organs or transplants of human tissues, must be required, under the personal responsibility of the Director, a special register containing all relevant information on transplants carried out while preserving professional secrecy.

This register, the contents of which shall be fixed by order, shall be quoted and initialled each year by the President of the Court of Local Instance or the Magistrate appointed by him.

The public prosecutor or his delegate may, whenever necessary, carry out control of the register.

The National Council of the Don and Transplantation may, at any time, request access to the register.

The special register shall be kept in duplicate. At the end of the year, the Director of the institution keeps one copy and transmits the other to the National Committee of the Don and Transplantation.



Chapter V.
- Importing and exporting human organs and tissues


Art. 19.
-The import and export of human organs and tissues is prohibited.

However, a one-time authorization to import or export human organs or tissues for therapeutic purposes may be issued by the Minister of Health, following the assent of the National Council of the Don and Transplantation.


Article 20. -The import of human organs or tissues may only be authorised for the benefit of public health institutions authorised to take samples of human organs or tissues and transplants.


Article 21. -The export of human organs or tissues may be authorised only for the benefit of an organism on a list fixed by the Minister responsible for health and pursuant to an agreement between the Republic of Senegal and the State on The territory of which the said organism is installed.



Chapter VI. - Criminal Provisions


Art. 22. -A person who advert for the donation of human organs or tissues to a specified person, institution or body shall be liable to imprisonment for six months to three years and to a fine of 250. 000 to 1,000. 000 of francs.


Article 23. -Anyone who proposes, by any means, to organise or carry out a transaction relating to the removal of human organs or tissues shall be punished by imprisonment for five to ten years and a fine of 10.000.000 to 15.000.000 francs.

The penalties provided for in the preceding paragraph shall be the persons who have carried out a transaction involving a human organ.

Any person who has received, has attempted to perceive or has favoured the collection of remuneration other than that provided for the carrying out of operations inherent in the collection, conservation and transplantation of organs shall be punished by the same penalties. Or the transplantation of human tissue.

The competent court shall order the confiscation of the sums received.

Article 24. -A person who carries out a collection of a human organ or tissue in a non-registered health care facility shall be punished by imprisonment for five to ten years and a fine of 15.000.000 to 40,000,000 francs.

The same penalties apply to any person who conducts a non-registered health care facility, an organ transplant, a human tissue transplant, a corneal transplant or an organ that can naturally regenerate.

The Tribunal orders the forfeiture of the material that served the commission of the offence.


Art. 25. -Anyone who, without legal reason, violates the anonymity of the donor or recipient, or who provides information about their identity, is punished with imprisonment for six months to one year and a fine of 250. 000 to 1,000,000 francs.


Article 26. -A person who carries out a collection of human organs or tissues on a living person in a non-therapeutic interest shall be punished by imprisonment for ten to twenty years, even if the person has consented to the collection, directly Or, where appropriate, through its legal representative.

In the latter case, the legal representative is liable to the same penalties.


Article 27. -A person who carries out a removal of organs on a major living person, without the consent of the person having been collected in the form provided for in Article 12 of this Law, or after the latter has renounced his or her Consent in the same form is punishable by ten to twenty years' imprisonment.


Art. 28. -Anyone who makes a levy on a minor or major living person under a guardianship or guardianship system, even if the consent of the person concerned or his or her legal representative has been collected, shall be punished with a penalty Imprisonment for ten to twenty years.


Article 29. - Anyone who maintains outside public health facilities of organs or tissues collected for transplantation shall be punished by imprisonment for one to three years and a fine of 500,000 to 1,000,000 francs.

Article 30. -Any person who imports or exports human organs or tissues without the authorization of the Minister responsible for health shall be punished by imprisonment for ten to twenty years.


Article 31. -The provisions of the Penal Code relating to the use of penalties shall not apply to the offences provided for in this Law.

In the event of a repeat offence, the court shall give maximum penalties for the offences referred to in Articles 24.25.26.27.28.29 and 30 of this Law.

Recidivism occurs when the convicted person has committed a similar offence within ten years of a final decision made against him for one of the offences set out in the articles referred to in paragraph 2 of this article.

Chapter VII. - Final provisions

Article 32. -The manner of application of this Law shall be fixed by decree.

S. 33. - Any provisions contrary to this Act shall be repealed.


This Law shall be enforced as the law of the State.


Done at Dakar, December 08, 2015

Macky SALL

By the President of the Republic:

The Prime Minister,

Mahammed Boun Abdallah DIONNE