polisi transplantasi organ, tisu dan sel kebangsaan

POLISI TRANSPLANTASI ORGAN, TISU DAN SEL KEBANGSAANBAHAGIAN PERKEMBANGAN PERUBATAN

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TUJUAN PEMBENTANGAN

Memaklumkan mengenai;

kepentingan Polisi Transplantasi Organ, Tisu dan Sel Kebangsaan

Polisi Transplantasi Organ, Tisu dan Sel Kebangsaan

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KANDUNGAN PEMBENTANGAN

Pengenalan Polisi Transplantasi Organ, Tisu dan Sel

Kebangsaan Kesimpulan

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PENGENALAN; sejarah

Bermula pada awal 1970’an Transplantasi pertama adalah

transplantasi buah pinggang pada 1975 di HKL

Aktiviti transplantasi telah berkembang sepanjang 30 tahun lepas selari dengan kemajuan teknologi perubatan

Tanpa sesuatu dasar rasmi untuk menentukan hala tuju perkembangan perkhidmatan

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PENGENALAN; peranan kerajaan

Kerajaan telah memainkan peranan penting dalam perkembangan transplantasi

Akta Tisu Manusia 1974 Fatwa Kebangsaan 1973 – membenarkan

pendermaan organ dan tisu Fatwa Kebangsaan 1989 – mengiktiraf

diagnosis mati otak Akta Tisu Manusia sedang dipinda dan

dikemaskini

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Kadar Pendermaan Organ/Tisu di Malaysia 1998-2005(SUMBER; PUSAT SUMBER TRANSPLAN NASIONAL HOSPITAL KUALA LUMPUR)

TAHUN BILANGAN PENDERMA

KADAR PENDERMAAN (SETIAP JUTA POPULASI)

1998 7 0.34

1999 4 0.19

2000 13 0.59

2001 24 1.07

2002 30 1.31

2003 25 1.07

2004 16 0.67

2005 13 0.57

2006 25 0.96

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Kadar Pendermaan Organ/Tisu di Malaysia berbanding Negara-negara Lain

NEGARAKADAR PENDERMAAN

(SETIAP JUTA POPULASI)

Spain 34.6

USA 24.1

Netherlands 15.5

Canada 13.0

Germany 13.0

UK 12.7

Australia 10.8

MALAYSIA 0.96

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Jumlah transplantasi di Malaysia bagi tahun 2000-2005 (SUMBER; NATIONAL TRANSPLANT REGISTRY)

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Jumlah transplantasi bagi tahun 1975 – 2006 mengikut organ/tisu (SUMBER; NATIONAL TRANSPLANT REGISTRY)

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PENGENALAN; Analisis Situasi Semasa

Kesedaran orang ramai masih rendah Kadar pendermaan organ dan tisu yang

rendah menghalang perkembangan transplantasi

Perdagangan organ/tisu dan lain-lain isu etika perlu panduan

Kepakaran dan komitmen sedia ada adalah tinggi dan perlu diperkukuhkan

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PENGENALAN; Inisiatif Bahagian Perkembangan Perubatan

Membangunkan Polisi Transplantasi Organ Tisu dan Sel Kebangsaan

Melaksanakan Program Transplantasi Kebangsaan

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NATIONAL ORGAN, TISSUE AND CELL TRANSPLANTATION POLICY

MEDICAL DEVELOPMENT DIVISION

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CHAPTER HEADINGS

Aim of the Policy General Statement of the Policy Organization of National Transplant Program Accreditation, Credentialing and Standard Organ Procurement Organ Allocation and Transplant Waiting List Acceptance Criteria Stem Cell Transplantation Policy International Sharing of Organ, Tissue and Cell for

Transplantation Support Service Immunosuppressive Drugs Registry Research in Transplantation Information and Communication Technology in

Transplantation

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ARTICLE2; AIM OF THE POLICY

2.1. To promote organ, tissue and cell transplantation in the country.

2.2. To promote cadaveric organ and tissue donation in the country.

2.3. To ensure transparent and equitable access to organ transplantation for those in need.

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ARTICLE 2; AIM OF THE POLICY

2.4. To ensure that organ, tissue and cell transplantation is carried out to the highest ethical and professional standards.

2.5. To ensure that the rights and welfare of living organ donors are looked after.

2.6. To promote the highest quality of care through proper documentation, including registries.

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ARTICLE 3; GENERAL STATEMENT OF THE POLICY

3.1. Organ and tissue transplantation is to be promoted as the preferred treatment for end stage organ failure because it is cost effective and provides good quality of life. Similarly cell transplantation shall be promoted for the treatment of appropriate diseases where evidence for effectiveness exists.

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3.2. The commercialization of organ, tissue and cell transplantation and any act that may indirectly promote or lead to commercial transaction is prohibited.

3.3. All organ, tissue and cell transplantation recipients shall receive appropriate assistance from the Government.

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3.4. All live organ donors shall be followed up for life.

3.5. The cost incurred by the family of a cadaveric donor related to the organ/tissue procurement process shall be reimbursable by an authorized body or organization appointed by the Ministry of Health. The Government shall provide the financial grants for reimbursement. Direct payment by the recipient to the family of the donor is prohibited.

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3.6. Confidentiality regarding the identity and personal details of donors and recipients shall be ensured.

3.7. All clinicians involved in the procurement and transplantation process shall be responsible to ensure the highest standards of safety and quality.

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ARTICLE 4; PROPOSED ORGANISATIONAL FRAMEWORK

National Transplantation Council (NTC) National Transplantation Technical

Committee (NTTC) Transplantation Unit, Medical

Development Division (NTU)

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NATIONAL TRANSPLANTATION COUNCIL

NATIONAL TRANSPLANTATION TECHNICAL COMMITTEE

TRANSPLANTATION SERVICES UNIT

PUBLIC AWARENESS ACTION COMMITTEE

(Secretariat – Health Education Division)

Law and Ethic Committee

Unrelated Transplant Approval Committee

National Stem Cell Committee

National Pathology Committee for Transplantation

Programme

4.4.1. Recommend policies on organ, tissue and cell transplantation in the country.

4.4.2. Promote and monitor the progress of the organ, tissue and cell transplantation program in the country.

4.4.3. Play a major role in the advocacy of organ, tissue and cell transplantation in the country

4.4.4. Ensure the highest ethical and professional standards in the practice of transplantation in the country.

The National Transplantation Council (NTC)

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4.5. There shall be a National Transplantation Technical Committee (NTTC) appointed by the Director General of Health. The NTTC shall consist of 5 people with relevant expertise in the field of transplantation. The responsibilities of the NTTC are:

4.5.1. To promote the objectives of the council (NTC)

4.5.2. To advise the NTC on matters related to policy

4.5.3. To advise the National Transplantation Unit (NTU) on matters related to implementation

4.5.4. To consider reports from the Expert Committees

4.5.5. To consult with other relevant experts when necessary

National Transplantation Technical Committee (NTTC)

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National Transplantation Unit (NTU)

4.7. The implementation of the organ, tissue and cell transplantation program shall be coordinated by the National Transplantation Unit (NTU) within the Medical Development Division of the Ministry of Health.

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ARTICLE 6; ORGAN AND TISSUE PROCUREMENT

6.2.3. Prior authorization from Unrelated Transplant Approval Committee (UTAC) shall be obtained before every unrelated living donation. Such donation must fulfill the following criteria, except for in the case of regenerative tissues;

6.2.3.1 no available cadaveric donors 6.2.3.2 no compatible donors from genetically-

related or emotionally related family members 6.2.3.3 no other alternative treatment

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6.2.4. All live donors shall be counseled by donor advocates regarding the risks, benefits and possible consequences. Donor advocates shall be independent of the organ procurement and transplant team.

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6.2.5. Prisoners awaiting execution and mentally disabled people shall be prohibited from living donation.

6.2.6. Under life saving circumstances, living donation of solid organs from prisoners may be considered for immediate relatives subject to approval from relevant authorities.

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6.3.3. Organization of cadaveric donation activity;

6.3.3.1. There shall be a dedicated unit at the national level to manage and coordinate all aspects of organ/tissue retrieval from cadaveric donors. This unit shall be known as Transplant Procurement Management Unit (TPMU). The responsibilities of this unit include

6.3.3.2. At each hospital there shall be a Tissue Organ Procurement (TOP) Team consisting of trained personnel.

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6.3.1. All cases of potential brain deaths shall be made known to the local Tissue Organ Procurement (TOP) Team.

6.3.2. All deaths shall be considered for a possible tissue donation.

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6.3.1. All cases of potential brain deaths shall be made known to the local Tissue Organ Procurement (TOP) Team.

6.3.2. All deaths shall be considered for a possible tissue donation.


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6.4. Unused Organs and Tissues

6.4.1. Family shall be informed by the Tissue Organ Procurement (TOP) Team if the organs/tissues are not used and the family shall be consulted on the method of disposal.

6.4.2. It is mandatory to obtain consent from the family if the organs/tissues are to be used for purposes other than transplantation.

6.4.3. Any incidence of unused tissue/ organ shall be investigated and reported to the National Transplant Technical Committee.

6.4.4. Any unused tissue/ organ which is not claimed by next of kin shall be disposed with dignity in accordance with the guidelines on disposal of human materials.


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ARTICLE 6; ORGAN ALLOCATION AND TRANSPLANT WAITING LIST

7.4.4. An individual patient has the right to refuse organ/tissue allocated through the national allocation system. However, he/she will be de-listed from the waiting list except in special circumstances. The patient may then apply to be re-listed.

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ARTICLE 9; STEM CELL TRANSPLANTATION POLICY

9.1. The practice of stem cell transplant and cell therapy in the country shall be in accordance with the National Standards for Stem Cell Transplant and Cell Therapy.

9.2. A National Stem Cell Committee shall be established to provide governance, leadership and direction.

9.4. The government shall establish a National Cord Blood and Stem Cell Transplant Programme.

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ARTICLE 9; STEM CELL TRANSPLANTATION POLICY

9.5. There shall be provision for directed cord blood donation for established clinical indications.

9.6. A National Coordinating Centre for Cord Blood and Marrow Donors shall be established.

9.7. New and investigational cell therapy approaches shall be subjected to ethical committee approval.

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ARTICLE 11; TRANSPLANT LABORATORY SUPPORT SERVICE

11.1 Organ and tissue transplantation programs require services from various clinical specialties. As such pathology and laboratory services shall be established in parallel with other clinical specialties in the development of organ, tissue and cell transplantation.

11.2 There shall be a National Reference Laboratory for tissue typing and immunological services.

11.3 Specialized services including immunology, mycology, virology, bacteriology and therapeutic drug monitoring to support transplantation shall be available in identified laboratories in the country.

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ARTICLE 11; INTERNATIONAL SHARING OF ORGAN, TISSUE AND CELL

11.1. Organ/tissue retrieved from donors in Malaysia shall not be allocated to recipients in another country unless there is no suitable recipient locally and there is a prior agreement on organ sharing between such country and Malaysia

11.2 Importation of tissues from other countries shall be made through institution recognised by the Ministry of Health.

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ARTICLE 12; REGISTRY

12.1. All centres performing transplantation shall report to the National Transplant Registry. The report shall include the appropriate details on the centre, the surgery and short and long term outcomes. The National Transplant Registry shall report annually on all transplantation in the country.

12.2. A registry of organ, tissue and cell donors shall be maintained. All centres participating in organ and tissue retrieval shall report to the registry. The registry shall record short and long term outcome of living donors

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ARTICLE 12; REGISTRY

12.3 A National Marrow Donor Registry shall be established. It shall serve to provide potential donors for those requiring marrow transplantation where related donors are not available /suitable

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ARTICLE 13; IMMUNOSUPPRESSIVE AGENTS

13.3. Generic immunosuppressive agents may be as effective as propriety drugs. However, there should be adequate bioequivalence and/or therapeutic equivalence studies prior to their use.

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KESIMPULAN

Program Transplantasi Kebangsaan yang dilaksanakan diharap dapat meningkatkan kadar pendermaan serta kadar transplantasi organ dan tisu di negara ini setaraf dengan negara maju yang lain.

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polisi transplantasi organ, tisu dan sel kebangsaan

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