1

POLISI TRANSPLANTASI
ORGAN, TISU DAN SEL
KEBANGSAAN
BAHAGIAN PERKEMBANGAN
PERUBATAN
 TUJUAN PEMBENTANGAN
2

 Memaklumkan mengenai;

 kepentingan Polisi Transplantasi Organ,

Tisu dan Sel Kebangsaan
 Polisi Transplantasi Organ, Tisu dan Sel
Kebangsaan
 KANDUNGAN
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PEMBENTANGAN
 Pengenalan
 Polisi Transplantasi Organ, Tisu dan Sel Kebangsaan
 Kesimpulan
 PENGENALAN; sejarah
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 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
 PENGENALAN; peranan kerajaan
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 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
 Kadar Pendermaan Organ/Tisu di Malaysia 1998-2005
(SUMBER; PUSAT SUMBER TRANSPLAN NASIONAL HOSPITAL KUALA LUMPUR)

TAHUN BILANGAN KADAR PENDERMAAN

PENDERMA (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
 Kadar Pendermaan Organ/Tisu di Malaysia berbanding
Negara-negara Lain
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KADAR PENDERMAAN
NEGARA
(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
 Jumlah transplantasi di Malaysia bagi tahun 2000-2005
(SUMBER; NATIONAL TRANSPLANT REGISTRY)

8
 Jumlah transplantasi bagi tahun 1975 – 2006 mengikut organ/tisu
(SUMBER; NATIONAL TRANSPLANT REGISTRY)

9
 PENGENALAN; Analisis Situasi Semasa
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 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
 PENGENALAN; Inisiatif Bahagian
Perkembangan Perubatan
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 Membangunkan Polisi Transplantasi

Organ Tisu dan Sel Kebangsaan
 Melaksanakan Program Transplantasi

Kebangsaan
 12

NATIONAL ORGAN,
TISSUE AND CELL
TRANSPLANTATION
POLICY
MEDICAL DEVELOPMENT DIVISION
 CHAPTER HEADINGS
13

 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
 ARTICLE2; AIM OF THE POLICY
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 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.
 ARTICLE 2; AIM OF THE POLICY
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 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.
 ARTICLE 3; GENERAL STATEMENT OF THE
POLICY
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 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.
 ARTICLE 3; GENERAL STATEMENT OF THE
POLICY
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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.
 ARTICLE 3; GENERAL STATEMENT OF THE
POLICY
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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.
 ARTICLE 3; GENERAL STATEMENT OF THE
POLICY
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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.
 ARTICLE 4; PROPOSED ORGANISATIONAL
FRAMEWORK
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 National Transplantation Council (NTC)

 National Transplantation Technical Committee
(NTTC)
 Transplantation Unit, Medical Development Division
(NTU)
 NATIONAL TRANSPLANTATION COUNCIL

TRANSPLANTATION SERVICES UNIT

PUBLIC AWARENESS ACTION

NATIONAL TRANSPLANTATION
COMMITTEE
TECHNICAL COMMITTEE
(Secretariat – Health Education Division)

Law and Ethic Unrelated Transplant National Stem Cell National Pathology
Committee Approval Committee Committee Committee for
Transplantation
Programme

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 The National Transplantation Council (NTC)
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 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.
 National Transplantation Technical Committee (NTTC)
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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 Unit (NTU)
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 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.
 ARTICLE 6; ORGAN AND TISSUE
PROCUREMENT
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 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
 ARTICLE 6; ORGAN AND TISSUE
PROCUREMENT
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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.
 ARTICLE 6; ORGAN AND TISSUE
PROCUREMENT
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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.
 ARTICLE 6; ORGAN AND TISSUE
PROCUREMENT
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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.
 ARTICLE 6; ORGAN AND TISSUE
PROCUREMENT
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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.
 ARTICLE 6; ORGAN AND TISSUE
PROCUREMENT
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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.
 ARTICLE 6; ORGAN AND TISSUE
PROCUREMENT
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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.
 ARTICLE 6; ORGAN ALLOCATION AND
TRANSPLANT WAITING LIST
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 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.
 ARTICLE 9; STEM CELL TRANSPLANTATION
POLICY
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 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.
 ARTICLE 9; STEM CELL TRANSPLANTATION
POLICY
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 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.
ARTICLE 11; TRANSPLANT LABORATORY
SUPPORT SERVICE
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 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.
 ARTICLE 11; INTERNATIONAL SHARING OF
ORGAN, TISSUE AND CELL
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 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.
 ARTICLE 12; REGISTRY
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 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
 ARTICLE 12; REGISTRY
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 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
 ARTICLE 13; IMMUNOSUPPRESSIVE
AGENTS
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 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.
 KESIMPULAN
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 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.