Source: Hanafiah K et al. Hepatology 2013 Source: Ott J et ... · Territory size is distorted in proportion to the number of organ transplants reported for each country in 2010

1

1Patient Safety

Programme

Health Systems

and Innovation1

Technical Consultation on Knowledge Sharing and Networkingfor Human Cell, Tissue and Organ Donation and

Transplantation in the Western Pacific Region

Seoul, February 20-21 2014

2Patient Safety

Programme

Health Systems

and Innovation

Network

Partnerships, Collaborations and Global Consultations Process

Partnerships, Collaborations and Global Consultations Process

Health authorities

• National Transplantation Agencies

• National Regulatory Authority

• Policy makers

Scientific and Professional Societies

• Official relation with TTS, WBMT,

ICCBBA

Experts Ethicists, lawyers

• Patients- Donors and Recipents

• Civil society

Every Region of the Globe and level of

development

20042004

Towards a Common Global Attitude to Transplantation

3Patient Safety

Programme

Health Systems

and InnovationData source: Global Observatory on Donation and Transplantation; map courtesy of S White

Territory size is distorted in proportion to the number of organ transplants reported for each country in 2010

<6

6 to <20

20 to <40

Transplantation rate (pmp)

40 to <70

>70

Global distribution of transplantation activity

2010

4Patient Safety

Programme

Health Systems

and Innovation

Hepatitis C prevalence, 2005 Source: Hanafiah K et al. Hepatology 2013Estimates are derived from a meta-

analysis of data from 232 studies published between 1997 and 2007.

Low: <1.5%

Moderate: 1.5-3.5%

High: >3.5%

Hepatitis B prevalence (adult), 2005

Source: Ott J et al. Vaccine 2012Estimates are derived from a

meta-analysis of data from 396 studies published between 1980

and 2007.

Low <2%

Low intermediate: 2-4%

High intermediate: 5-7%

High: >=8%

Viral Hepatitis B and C are Prevalent in AsiaViral Hepatitis B and C are Prevalent in Asia

5Patient Safety

Programme

Health Systems

and Innovation

Country Population

(million)

% of world

population

Dialysis

patients

(thousands)

% of world

dialysis

patients

Prevalence

of dialysis

(pmp)

USA 313 4% 420 19% 1,340

Japan 127 2% 302 14% 2,370

China 1,340 19% 200 9% 150

Brazil 205 3% 106 5% 520

Germany 81 1% 83 4% 1,020

Rep. Korea 50 <1% 46 2% 910

Thailand 70 <1% 41 2% 590

Malaysia 29 <1% 24 1% 834

Global 6,963 2,164 310

Source: ESRD patients in 2011: a global perspective. Fresenius Medical Care, Bad Homburg, 2011

http://www.vision-fmc.com/files/download/ESRD/ESRD_Patients_in_2011.pdf

Over 2 million patients were being treated with dialysis in 2011.

Nearly one quarter of this global dialysis population were beingtreated in Japan and China alone.

The need for Kidney Transplantation in Asia The need for Kidney Transplantation in Asia

6Patient Safety

Programme

Health Systems

and Innovation

0.0

10.0

20.0

30.0

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60.0

Mya

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ub

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yria

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anka

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ece

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mb

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an

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tIc

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Bela

rus

Sau

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rab

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xic

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ew

Ze

ala

nd

Kuw

ait

Slo

va

kia

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rus

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iaB

razil

Hun

ga

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aU

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nd

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ve

nia

Ge

rma

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La

tvia

Iran

Sw

itze

rland

Irela

nd

Rep

of K

ore

aA

ustra

liaF

inla

nd

Can

ad

aD

en

ma

rkT

urk

ey

Portu

ga

lC

zech

Re

pS

we

de

nE

sto

nia

UK

Fra

nce

Belg

ium

Austria

Cro

atia

Spa

inU

SN

eth

erla

nd

sN

orw

ay

Kidney tx from DD (pmp)

Living Kidney tx (pmp)

Kidney Transplants per Country

and Per million population (pmp)

Kidney Transplants per Country

and Per million population (pmp)

bunoanl

Typewritten Text

ANNEX 4

2

7Patient Safety

Programme

Health Systems

and Innovation

0

25

50

75

100

Rate

(p

mp

)

Source: Global Observatory on Donation and Transplantation (www.transplant-observatory.org)

Council of Europe, Newsletter Transplant, 2012, Madrid, Spain.

Patients newly included on the waiting list for a kidney transplant in 2011, pmp

Kidney transplant rate in 2011, pmp

Waiting List Additions Versus Kidney Transplants Performed In

2011: High-income Countries

Waiting List Additions Versus Kidney Transplants Performed In

2011: High-income Countries

8Patient Safety

Programme

Health Systems

and Innovation

The goal is not to find an ever-

increasing supply of organs for

transplantation, but rather to

engage with transplantation in

the context of a broader public

health strategy for prevention of

chronic organ failure.

Sourc

e: U

nited S

tate

s R

enal D

ata

Syste

m, A

nnual R

eport

2012

Unadjusted End Stage Kidney Disease Incidence

In Selected Countries Worldwide

Unadjusted End Stage Kidney Disease Incidence

In Selected Countries Worldwide

9Patient Safety

Programme

Health Systems

and Innovation

Source: United States Renal Data System, Annual Report 2012 United States Centers for Disease Control and Prevention

Increased prevalence of diabetes

and of treated ESKD with a primary diagnosis of diabetes

0

2

4

6

0

200

400

600

198

01

98

21

98

41

98

61

98

81

99

01

99

21

99

41

99

61

99

82

00

02

00

22

00

42

00

62

00

82

01

0

Pre

va

len

ce

of d

iab

ete

s (%

)

DM

-ES

RD

ra

te (

pm

p)

Prevalence of diabetic ESRD (per million population)

Crude population prevalence of diabetes (%)

0

1,000

2,000

3,000

4,000

198

01

98

21

98

41

98

61

98

81

99

01

99

21

99

41

99

61

99

82

00

02

00

22

00

42

00

62

00

82

01

0

DM

-ES

RD

rate

(pm

p)

Incidence of ESRD among the diabetic population

However, incidence of Diabetes ESKD among the diabetic population has declined due to improved secondary prevention.

Diabetes and ESKD in the USADiabetes and ESKD in the USA

10Patient Safety

Programme

Health Systems

and Innovation

The United States, Europe and Australia are

starting to observe a decline in the rate of new

patients starting renal replacement therapy.

In contrast, growth in dialysis populations has

shifted to Asia, Latin America, the Middle East

and Africa.

Prevention appears to be having an impact

Secondary

… Primary

Prevention is Crucial for Self Sufficiency in

Kidney Transplantation

Prevention is Crucial for Self Sufficiency in

Kidney Transplantation

11Service Delivery

and Safety

Health Systems

and Innovation

Meeting the needs of

patients from a given

population with an

adequate provision of

transplantation services

and supply of organs

from that population

12Patient Safety

Programme

Health Systems

and Innovation

3

13Patient Safety

Programme

Health Systems

and Innovation

Third Global Consultation on Organ Donation and Transplantation, Madrid March 23-25, 2010

The Self-Sufficiency Paradigm Third Global Consultation on Organ Donation and Transplantation, Madrid March 23-25, 2010

The Self-Sufficiency Paradigm

Society / Authority

Donation is a civic gesture, an expectation but not an exception

PRINCIPLES

To meet patients' needs:

1. Government responsibility

• Organization

2. Equity

• In the burden of donation

• In allocation (UHC) WHA63.22

3. Education

• To donation

• To prevention

4. Trust of the Public

• Transparency

• Professionalism

ORGAN

Donation and Transplantation

1. Legal framework

2. National Health Plan includes

donation and transplantation

3. Organ donation possible in as

many circumstances of death as

possible => ORGANISATION

4. Comprehensive management of

chronic kidney disease

5. Health and death in school

curriculum

6. Media associated to donation

and transplantation system

SolidarityReciprocity

14Service Delivery

and Safety

Health Systems

and Innovation

The Self Sufficiency Paradigm

Education Donation and Prevention The Self Sufficiency Paradigm

Education Donation and Prevention

Unprecedented measures• School curricula

o From the end of primary school

� Children

� Parents

o Health education

o Education to donation

� During life

� After death

• Media

• Health professionals

Solidarity Reciprocity

15Patient Safety

Programme

Health Systems

and Innovation

http://m.us.wsj.com/articles/SB10001424052702304149404579322560004817176?mod=WSJ_hpp

_MIDDLENexttoWhatsNewsFifth&mobile=y January 2014

Our conclusion is that a very large number of both live

and cadaveric kidney donations would be available by

paying about $15,000 for each kidney. That estimate isn't

exact, and the true cost could be as high as $25,000 or as

low as $5,000—but even the high estimate wouldn't

increase the total cost of kidney transplants by a large

percentage.

16Patient Safety

Programme

Health Systems

and Innovation

WHO Organization-wide Initiative for

Medical Products of Human Origin

« Health products of an exceptional nature* »

* GUIDING PRINCIPLE 10

WHO Guiding Principles On Human Cell, Tissue And Organ Transplantation

Endorsed by the sixty-third World Health Assembly in Resolution WHA 63.22

17Service Delivery

and Safety

Health Systems

and Innovation

Medical Products of Human Origin (MPHO) Medical Products of Human Origin (MPHO)

Materials derived from the human body for clinicalapplication.

Despite the obvious differences in types of human biological materials used to create MPHO, and the range of therapeutic uses which they may serve, all MPHO

have in common an origin and destination in the human body.

.

18Service Delivery

and Safety

Health Systems

and Innovation

Medical Products of Human Origin (MPHO)Medical Products of Human Origin (MPHO)

Recruitment

Selection

TestingProcessing

Allocation

Issuing

Clinical

application

Follow-upProcurementFollow-up

Blood and blood products

Cells TissuesOrgans

Gametes and EmbryosSecretions and excretions…

Plasma Derived Medicinal Products

Advanced Therapies….. Personalized medicine

Ethics – Safety & Quality – Access

4

19Service Delivery

and Safety

Health Systems

and Innovation

Recognizing Humanity in

Medical Productsof Human Origin

20Health Systems

Policies and Workforce

Health Systems

and InnovationClinical

Procedures

Medical Products of Human Origin - MPHOEthics – Quality & Safety - Access

Medical Products of Human Origin - MPHOEthics – Quality & Safety - Access

AdvancedTherapies

Cells

ARTGametes

Plasma Derived

Medicines

Other Human Derived

Medicines

Life saving

Universal ShortageNo alternative Best survival /costs

Hematopoietic stem cell

Human derived pharmaceuticals

Blood & Components

Misuse in HIC/MIC

Access in LMIC

Donation

after death

Tissues

Organs

Life enhancement

Research & Evidence

Stem cell - TEMP

21Health Systems

Policies and Workforce

Health Systems

and InnovationClinical

Procedures

The Human Body as the Source of Therapeutics:

Towards a Global Consensus

The Human Body as the Source of Therapeutics:

Towards a Global Consensus

The establishment of globally agreed principles for the governance of

MPHO would represent significant progress towards the goal of

meeting minimum standards, as well as serving:

• to underline the cross cutting concerns regarding all MPHO,

inherent to their human origin;

• to demonstrate respect for the human body and hence the dignity

of persons;

• To increase safety and enhance ethical practices;

• To encourage donation by generating trust in procedural

safeguards such as consent requirements and protocols for care

and follow-up of donors;

• To avoid distortions in practices due to the undermining effect of

bad examples, such as the justification of payment for organs by

appeal to legal trade in plasma.

22Patient Safety

Programme

Health Systems

and Innovation

£$ €

¥£$

€¥

Hematopoietic Stem Cells

Gametes Embryos

Blood

Plasma

SecretionsExcretions

Societal ValuesProtection of the DonorSafety of the Recipient

Self-Sufficiency Public Health

Organ Tissues

The Human Body and its Parts as Such

Not the Source of Financial Gain

The Human Body and its Parts as Such

Not the Source of Financial Gain

Stem CellsAdvanced Therapies

HumanDerived Drugs

23Patient Safety

Programme

Health Systems

and Innovation

1. Principles inherent to the Human Origin

• Non commercial nature of the human body and its parts as such

• Towards a global consensus leading to a formal agreement

2. Universal use of ISBT 128 for all MPHO

• Information Standards for Blood and Transplant

• Towards universal use of ISBT128 within 10 years

3. Global vigilance and surveillance

• NOTIFY project for Vigilance and Surveillance of MPHO

• Using at best the global experience of adverse incidents

World Health Assembly UN

Towards a binding international legal instrument

The WHO Wide Initiative for MPHOApril 2013 - Programmed Budget 2014-2015

The WHO Wide Initiative for MPHOApril 2013 - Programmed Budget 2014-2015

3 Global Governance Tools for MPHO

24Service Delivery

and Safety

Health Systems

and Innovation

-1- Items for Standards of Practice for MPHO-1- Items for Standards of Practice for MPHO

� Responsibility for the provision of

MPHO placed with authorities and through them the individual citizen and resident;

� Equity as a goal, in the burden of

donation and in allocation of MPHO;

� Prohibition of financial gain on the human body and its parts as such and where profit is not forbidden,

guarantee of transparency;

� Genuine consent of donors and recipients and protection of the incompetent;

� Use of MPHO justified by evidence and

absence of comparable alternative;

� Duty to constantly optimize the safety,

quality and efficacy of procurement, process and clinical application of MPHO;

� Traceability and accountability

mandated throughout the process, from donors to recipients, including long term outcomes and vigilance and

surveillance under the oversight of competent authorities;

� Transparency and openness to scrutiny indispensable while confidentiality and

anonymity when required must be

preserved.

5

25Service Delivery

and Safety

Health Systems

and Innovation

“Transparency — especially when things go

wrong — is increasingly considered

necessary to improving the quality of health

care. By being candid with both patients and

clinicians, health care organizations can

promote their leaders' accountability for safer

systems, better engage clinicians in

improvement efforts, and engender greater

patient trust. “ Allen Kachalia

TransparencyTransparency

Role of Scientific and Professional Societies ?

Activities and practices

26Service Delivery

and Safety

Health Systems

and Innovation

The WHO-Wide Initiative for MPHOsThe WHO-Wide Initiative for MPHOs

Towards an overarching level of requirement specific to MPHOs

EB 134

• Review of the implementation of resolutions WHA63.12 and

WHA63.22 on transfusion and transplantation

WHA67

• Side event on MPHOs

• Review of the implementation of resolutions WHA63.12 and

WHA63.22

• Request to WHO for a report on overarching issues associated to the

human origin of therapeutics

Regional and Global consultation process

WHA68/69 Resolution on MPHOs

Global Standards for MPHOs

Health SystemsPolicies and Workforce

Health Systems and Services27

ClinicalProcedures

Thank you

[email protected]@who.int

03/02/2015

1

Service Delivery and Safety2


Kidney Liver Heart Lung Pancreas

77818 23986 5935 4359 2423

2012 GKT/ GODT

Global Observatory on Donation and Transplantation

Organs Transplanted Globally in 2012Global Observatory on Donation and Transplantation

Organs Transplanted Globally in 2012

≈ 114,690 organs transplanted(≈ 10% of estimated global needs)

≈ 1.81 % increase over 2011

109 countries reported to the Global Observatory on Organ Donation and Transplantation

South Africa, India and China - are 2010 estimates


but only 2-3 % of world’s deceased donors

03/02/2015

2


• 1.9 million tissue grafts distributed by AATB accredited tissue

banks each year

• > 100,000 tissues imported into Korea in one year

• > 200,000 tissues grafts a year in Germany

• 5,000 cornea transplants in Italy each year

• 46,000 corneas distributed by Sri Lanka Eye Bank over 30

years


HSCTHSCT


37 %

37 %

11 %

14 % 1%

North America Europe Asia South America Others


37 %

37 %

14 % 1%

North America Europe Asia South America Others

11 %


03/02/2015

3




Solidarity

EquityRespects for Dignity

Loss of Dignity

Market, inequity….Exploitation

Transplantation Progresses on a unsteady scale


GP 2 Death

No conflict

GP 3Maximizing DD

GP 1Consent DD

GP 4 Protecting the

incompetent

GP 9 Equitable allocation

Protecting LD

GP 6 Promoting

No advertising

GP 7 Reasonability

For transplant origin

GP 8 Justifiable fees

GP 5 Free donation and no purchase of human transplant as such,

but cost &expenditures recoveryt

GP 10 Monitoring long term outcomes. Quality and safety of procedures and products

GP 11 Transparency, openness to scrutiny, anonymity


GP 2 Death

No conflict

GP 1Consent DD

GP 3Maximizing DD

03/02/2015

4

� Guidance on criteria for the determination of death

• WHO team

• 8-10 experts (neurologist, intensivist, cardiologist etc)



� Increase global visibility of the “GODT”

•value transplantation and increase the motivation to donate among people

•Better know the countries’/regions’ situation to develop the appropriate

policies to increase donation rates.



� Vigilance and surveillance


14-16 November 2012, Rome


Formulated the idea of language specific web

interfaces that would help non-English speakers to

benefit from the NOTIFY project and conversely

would help the NOTIFY project by allowing the

input of cases initially not published in English.

03/02/2015

5


0

200

400

600

800

1000

1200

1400

478

125 127 206 226 284392

1215

Millions inhabitans

0

200

400

600

800

1000

1200

1400

478

125 127 206 226 284392

1215

Millions inhabitans




� Search for relevant cases in their own language

� Translated into English

� Send it to the NL editorial group

� Upload


� Search for relevant cases NL

� Translated into their own language

� Disseminate to professionals




� Emerging areas: Xenotransplantation

Regenerative Medicine

03/02/2015

6

• To strengthen wider collaboration among members

and with other societies for enhancement of research

activities

• To review the current status of xenotransplantation

science and practice

• To encourage transparency in xenotransplantation

related activities




� Emerging areas: Xenotransplantation

Regenerative Medicine

� Strengthening Global Network

� Promote close collaboration with Health Authorities,

Scientific and Professional Societies in charge of national

policies.

� Establish a structured regional working group in WPRO for

transplantation in light of the European and Latin-

American experience




03/02/2015

7

37Service Delivery

Strengthening

Health Systems

and Innovation

Thank you

[email protected]

[email protected]

http://www.who.int/transplantation/en/

03/02/2015

1

Essential legal and organizational requirements for

national cell, tissue and organ transplantation services

Jeremy Chapman

Sydney

Living

Donor

Transplantation

Surgical Team

Post Tx Care

HLA Lab

Drug program

Data

Systems

Acute

Dialysis

Capacity

Funding

Mechanisms

Legislative

and

Regulatory

Framework

Deceased

Donor

Transplantation

On Call Team

Post Tx Care

HLA Lab

Drug program

Data

Systems

Chronic

Dialysis

Program

Waiting List

and

Allocation

Funding

Mechanisms

ICU/Brain

Death

Organ/Tissue

Procurement

/Banking

program

Legislative

and

Regulatory

Framework

Deceased

Donor

Transplantation

Deceased Donor Living Donor

Diagnosis of death Donor Assessment

Surgical retrieval

Organ Allocation

Surgical retrieval

Recipient(s)

Crossmatch

Transplant

Donor medical risk

assessment

Transplant

follow up

One National Waiting list

Transplant facility

National Allocation

Protocol

National Transplant

Registry

Medical Protocol

Ministry regulation

Key:

KIDNEY

03/02/2015

2

Donor

GP 2 Death ∆γ

No conflict

GP 3Maximizing

DDProtecting LD

GP 4Protecting theincompetent

GP 6Promoting

No advertising

GP 7Responsibility

for transplant origin

GP 8Justifiable fees

GP 1 Consent DD

GP 9Equitable allocation

Recipient Process

GP 5 Free donation and no purchase of human transplant as such, but cost & expenditures recovery

GP 10 Monitoring long term outcomes. Quality and safety of procedures and products

GP 11 Transparency, openness to scrutiny, anonymity

20102010WHO Guiding Principles on Human Cell, Tissue

and Organ Transplantation

World Health Assembly - 22 May 2010

9Essential Health Technologies

Health Systems and Services

•CKD

•CLD

•CARDIAC

•RESPIRATORY

•DIABETES

•OTHERNATIONAL

ACCOUNTABILITIES

CAPACITY CONTROL

REGULATORY CONTROL

ETHICAL CONTEXT

RESPONSIBILITIES

OPPORTUNITIES

FOR CARE

•EDUCATION

•VACCINATION

•SCREENING

•PREVENTION

•BRIDGING Rx

•DONATION

•TRANSPLANT

•RESEARCH

CAPACITIES

•LEGISLATION

•DATA REGISTRIES

•HEALTHCARE

FACILITIES

•HUMAN RESOURCES

•REGIONAL

COOPERATION

•CULTURAL &

RELIGIOUS

ENVIRONMENT

•FUNDING

CAPACITIES

ACHIEVEMENTSSUFFICIENCY

The Madrid Resolution

Human Organ Cell & Tissue

Legislation and regulations

Ownership and Gift

laws

Therapeutic goods laws regulations

Private Health care

laws regulations

Customs and excise

laws regulations

Consent framework

Definition of nationality

The context in Law for Organ, Tissue and Cell

Transplantation

Critical issues in determining the basis of legislation

On Human Organ, Tissue and Cell Transplantation

• Compatibility with the WHO Guiding

Principles and Declaration of Istanbul

• The extent of inclusion of all medical

products of human origin

• Basis of Consent – opt in/opt out

• The definitions of Death

• All

• Blood and Blood Products

• All Organs

• Cells

• Advanced cell therapies

• Tissues

• Engineered tissues

• Gametes Embryos

• Human Milk

• Genetic modification

• Xenotransplantation

12Patient Safety

Programme

Health Systems

and Innovation


An Organization Wide Initiative at WHO


An Organization Wide Initiative at WHO

• MPHO are intertwined

• Indistinct and changing limits in human application• Practices with one impact the others• no national borders for safety or ethical risks.

• Yet there are strong differences and particularities between sub-classes of MPOHO

• But the self-sufficiency paradigm applies to all, as MPHO from humans for humans, involve SOCIETY

• MPHO demand a consistency of practices. A set of common global governance

principles is necessary

03/02/2015

3

Legal Principles: Gift Law

• Gift law principles may have important

legal consequences for donation

–Legally binding transfer

–Prohibition on valuable consideration

–Altruism and volunteerism

Primary Legal Models

• Explicit Consent = OPT IN

• Presumed Consent = OPT OUT

Countries with Explicit Consent = Opt in

• Australia

• Canada

• Chile

• Cuba

• Denmark

• Estonia

• Germany

• Guatemala

• Ireland

• Japan

• Jordan

• Malaysia

• Lithuania

• Mexico

• Netherlands

• New Zealand

• South Africa

• South Korea

• Thailand

• United Kingdom

• United States of America

• Venezuela

Presumed Consent defined for donation

The legal authority to recover organs from deceased adult individuals unless a refusal to donate was registered.

Countries with Presumed Consent = Opt Out

• Argentina

• Austria

• Belgium

• Bulgaria

• Croatia

• Cyprus

• Czech Republic

• Estonia

• Finland

• France

• Greece

• Hungary

• Italy

• Latvia

• Luxemburg

• Norway

• Panama

• Paraguay

• Poland

• Portugal

• Sinagapore

• Slovak Republic

• Slovenia

• Spain

• Sweden

First Person Consent

Adult individuals have the

right to make a legally

binding anatomical gift prior

to death.

03/02/2015

4

The function of

the brain

is irreplaceable

DEATH

Brain

scan

ELIGIBLE DCDDONOR

A medically suitable person who has been

declared dead based on the irreversible absence

of circulatory and respiratory functions as

stipulated by the law of the relevant jurisdiction,

within a time frame that enables organ recovery.

POTENTIAL DBDDONOR

A person whose clinical condition is suspected to

fulfill brain death criteria.

ELIGIBLE DBDDONOR

A medically suitable person who has been

declared dead based on neurologic criteria as

stipulated by the law of the relevant jurisdiction.

Critical pathways for organ donation*

POSSIBLE DECEASED ORGAN DONORA patient with a devastating brain injury or lesion OR a patient with circulatory failure

AND apparently medically suitable for organ donation

UTILIZED DCDDONOR

An actual donor from whom at least one organ

was transplanted.

Reasons why a potential donor does not become a utilized donor

System

• Failure to identify/refer a potential or eligible donor

• Brain death diagnosis not confirmed

(e.g. does not fulfill criteria) or completed

(e.g. lack of technical resources or clinician to make diagnosis or perform confirmatory tests)

• Circulatory death not declared within the appropriate

time frame.

• Logistical problems (e.g. no recovery team)

• Lack of appropriate recipient (e.g. child, blood type, serology positive)

Donor/Organ

• Medical unsuitability (e.g. serology positive, neoplasia)

• Haemodynamic instability / unanticipated cardiac

arrest

• Anatomical, histological and/or functional

abnormalities of organs

• Organs damaged during recovery

• Inadequate perfusion of organs or thrombosis

Permission

• Expressed intent of deceased not to be donor

• Relative’s refusal of permission for organ donation

• Refusal by coroner or other judicial officer to allow

donation for forensic reasons

POTENTIAL DCD DONOR

A. A person whose circulatory and respiratory

functions have ceased and resuscitative

measures are not to be attempted or continued.

or

B. A person in whom the cessation of circulatory

and respiratory functions is anticipated to occur

within a time frame that will enable organ

recovery.

Donation after BrainDeath (DBD)Treating physician

to identify/refer a potential donor

ACTUAL DBDDONOR

A consented eligible donor:

A. In whom an operative incision was made

with the intent of organ recovery for the

purpose of transplantation.

or

B. From whom at least one organ was

recovered for the purpose of transplantation.

UTILIZED DBDDONOR

An actual donor from whom at least one organ

was transplanted.

ACTUAL DCDDONOR

A consented eligible donor:

A. In whom an operative incision was made

with the intent of organ recovery for the

purpose of transplantation.

or

B. From whom at least one organ was

recovered for the purpose of transplantation.

Donation after Circulatory Death (DCD)

*The “dead donor rule” must be respected. That is, patients may only become donors after death, and the recovery of organs must not cause a donor’s death.

Transplant Type Kidney –

living

donor

Kidney

/Organs –

deceased

donor

Cornea

tissue.

imported

Cornea

tissue – local

Cell

transplant

Xeno

transplant

Gametes Blood

and

blood

products

Hospital

infrastructure

National

Infrastructure

Regulatory

framework

Legislative

framework

Scope of consideration for implementation

Transplant Type Kidney –

living

donor

Kidney

/Organs –

deceased

donor

Cornea

tissue.

imported

Cornea

tissue – local

Cell

transplant

Xeno

transplant

Gametes Blood

and

blood

products

Hospital

infrastructure

National

Infrastructure

Regulatory

framework

Legislative

framework

Scope of consideration for implementation

03/02/2015

5

GOVERNMENT OF FIJI __________ THE TRANSPLANTATION OF HUMAN ORGANS AND TISSUES DECREE 2013 ( Decree No ….of 2013) IN exercise of the powers vested in me as the President of the Republic of Fiji and Commander in Chief of the Republic of Fiji Military Forces by virtue of the Executive Authority of Fiji Decree … 2009, I hereby make the following Decree - TO REGULATE THE REMOVAL, STORAGE, AND TRANSPLANTATION OF HUMAN ORGANS FOR THERAPEUTIC PURPOSES AND FOR THE PREVENTION OF COMMERCIAL DEALINGS IN HUMAN ORGANS FOR MATTERS CONNECTED WITH OR INCIDENTAL THERETO. WHEREAS IT IS EXPEDIENT TO PROVIDE FOR THE REGULATION OF REMOVAL,

STORAGE, AND TRANSPLANTATION OF HUMAN ORGANS FOR THEURAPETIC

PURPOSES AND FOR THE PREVENTION OF COMMERCIAL DEALINGS IN HUMAN

ORGANS.

PART 1- PRELIMINARY

1. Short title and commencement This Decree may be called the Transplantation of Human Organs Decree , 2013 and shall

come into force on a date appointed by the Minister by notice published in the Gazette.

2. Interpretation and Definitions (1). In this Decree, unless the context otherwise requires: “Advertisement” includes any form of advertising whether to the public generally or to any section of the public or individually to selected persons;

“Appropriate Authority” means the Appropriate Authority appointed under section 30.

“Authorization Committee” means the Committee constituted under section 60.

"blood product" means a product or extract derived or extracted from blood by any process

of manufacture.

"child" means a person who has not attained the age of 18 years.

"designated officer" means:

(a) in relation to a hospital, a person appointed for the time being under

section 4 (1) to be a designated officer for a hospital, or

Questions:

1 What about minors & the legally incompetent

2 What about non-national recipients

3 What about non-national & unrelated donors

4 Ban or regulate advanced cell therapies

5 Private versus Public Hospitals

6 Minister advised by a committee for problems

7 Ethics committee review – is this self governing

8 How to define when reasonable fees become

profiteering and commercialism

9 Is the medical system capable

10 What penalty system will work

11 How is allocation of a scarce resource managed

A Legal Framework

GOVERNMENT OF FIJI __________ THE TRANSPLANTATION OF HUMAN ORGANS AND TISSUES DECREE 2013 ( Decree No ….of 2013) IN exercise of the powers vested in me as the President of the Republic of Fiji and Commander in Chief of the Republic of Fiji Military Forces by virtue of the Executive Authority of Fiji Decree … 2009, I hereby make the following Decree - TO REGULATE THE REMOVAL, STORAGE, AND TRANSPLANTATION OF HUMAN ORGANS FOR THERAPEUTIC PURPOSES AND FOR THE PREVENTION OF COMMERCIAL DEALINGS IN HUMAN ORGANS FOR MATTERS CONNECTED WITH OR INCIDENTAL THERETO. WHEREAS IT IS EXPEDIENT TO PROVIDE FOR THE REGULATION OF REMOVAL,

STORAGE, AND TRANSPLANTATION OF HUMAN ORGANS FOR THEURAPETIC

PURPOSES AND FOR THE PREVENTION OF COMMERCIAL DEALINGS IN HUMAN

ORGANS.

PART 1- PRELIMINARY

1. Short title and commencement This Decree may be called the Transplantation of Human Organs Decree , 2013 and shall

come into force on a date appointed by the Minister by notice published in the Gazette.

2. Interpretation and Definitions (1). In this Decree, unless the context otherwise requires: “Advertisement” includes any form of advertising whether to the public generally or to any section of the public or individually to selected persons;

“Appropriate Authority” means the Appropriate Authority appointed under section 30.

“Authorization Committee” means the Committee constituted under section 60.

"blood product" means a product or extract derived or extracted from blood by any process

of manufacture.

"child" means a person who has not attained the age of 18 years.

"designated officer" means:

(a) in relation to a hospital, a person appointed for the time being under

section 4 (1) to be a designated officer for a hospital, or

Parts:

1 Preliminary and Definitions

2 Donations of tissue by living persons

3 Use of tissue removed during medical, dental

or surgical treatment

4 Removal of Tissue after death

5 Regulation of Hospitals

6 Appropriate Authority

7 Registration of Hospitals

8 Prohibition of trading in tissue

9 Definition of Death

10 Enforcement

11 Miscellaneous

A Legal Framework

03/02/2015

1

Global Observatory on Donation and Transplantation

(GODT)

International Technical Consultation on Cell, Tissue and Organ Donation and

Transplantation in The Western Pacific Region.

20 to 21 February 2014, Seoul, Republic of Korea.

Ms Mar Carmona ([email protected])

Organización Nacional de Trasplantes (ONT), Spain

BackgroundBackground

� In response to the request made in Resolution WHA57.18 in 2004. This request was reiterated in Resolution WHA63.22 in 2010.

2005

URGES Member States:

(7) to collaborate in collecting data including adverse events and reactions on the practices, safety, quality,

efficacy, epidemiology and ethics of donation and transplantation;

REQUESTS the Director-General:

(3) to continue collecting and analyzing global data on the practices, safety, quality, efficacy, epidemiology

and ethics of donation and transplantation of human cells, tissues and organs;

http://www.transplant-observatory.org

-Resources covered by ONT

-ONT officially designated

WHO CC

• 194 Member States in the six WHO Regions: AFR, AMR, EMR, EUR, SEAR, WPR

Scope

• Information for organs: legislative and organizational aspects and annual donation and transplantation activities

• Available to everyone

• Information for tissues and cells: A similar process will be followed

Content

• National Health Authorities or officially designated by them

Source of data

Global Database: SettingsGlobal Database: Settings

Data

collection

• Ad hoc questionnaire to the national focal points

• Reminders (E-mail)

• Reception of data

• Deadlines: every year in Q2/Q3

Data

management

• Revision of data and clarification whenever discrepancies are found (by E-mail or phone)

• Data entry in the database

• Validation, data check and final approval by Member States

Data analysis

• Calculation of indicators of donation and transplantation (country, regional and global

estimates)

• Further analysis

• Graphics and official maps

Publication

• Publication in the GODT website

• Presentations / Other

• Journals

Methodology: collection of annual activity dataMethodology: collection of annual activity data

QuestionnaireQuestionnaire

Data

collection

• Ad hoc questionnaire to the national focal points

• Reminders (E-mail)

• Reception of data

• Deadlines: every year in Q2/Q3

Data

management

• Revision of data and clarification whenever discrepancies are found (by E-mail or phone)

• Data entry in the database

• Validation, data check and final approval by Member States

Data analysis

• Calculation of indicators of donation and transplantation (country, regional and global

estimates)

• Further analysis

• Graphics and official maps

Publication

• Publication in the GODT website

• Presentations / Other

• Journals

Methodology: collection of annual activity dataMethodology: collection of annual activity data

03/02/2015

2

Conclusions

� The knowledge of demand for transplantation, availability of organs from

deceased and living donors and the access to transplantation is essential to

monitor global trends in transplantation needs.

� Information regarding the existence of legislation and regulatory oversight is

fundamental to ensure safety and the ethical practice of organ donation and

transplantation in accordance with international standards.

� The global availability of information � prerequisite to demonstrate

transparency, equity and to monitor transplant systems in countries.

�Areas of improvement:

- Reinforce the collaboration between NHA and professionals, and

WHO/ONT for the collection of data (special attention should be

paid for tissues and cells)

Conclusions II

The global database is the result of dedicated

efforts to strengthen the network of focal

points, and it is the result of their valuable

contribution to providing annual data.

Thank you…

Mar Carmona: [email protected]

2015-02-03

1

What we have done for promoting organ donation in

Korea ?- recognizing the problem and finding the solution -

Won-Hyun Cho, MD.Keimyung University School of Medicine,

Vitallink - Korean Network for Organ Donation

WHO technical consultation 2014, Seoul

2014-02-20 12014 WHO Technical Consultation

2014-02-20 2014 WHO Technical Consultation 2Organ donation

Promotion by each transplant center

1969:LDKT

1979:DDKT

1988:DDLT

No of Deceased donorPMP

3.4Traveling through DesertTraveling through DesertTraveling through DesertTraveling through Desert

2014-02-20 2014 WHO Technical Consultation 1

Number of Deceased donor before legislation of transplantation law

Year DonorNumber of transplanted organ

Total Kidney Liver Pancreas

< 3

> 3

Procure rate / donor

2014-02-20 2014 WHO Technical Consultation 4• Legislation of organ transplantation law in 1999Necessity of Brain death law • KONOS (Korean Network for Organ Sharing) in 2000Need nationwide organ allocation system • Hospital based OPO from 2003Need organ procure organization • By KONOS from 2000 Need nationwide waiting list • Transplantation law from 2000Prohibit organ trade inside of Korea

Recognition of problem and solution in 1999

2014-02-20 2014 WHO Technical Consultation1991: NGOs for organ

Promotion activity

Organ donation Promotion by each

transplant center

1969:LDKT

1979:DDKT

1988:DDLT

1993: KMA guideline

for BD1995: Brain Death Seoul Declaration

1999: Transplantation

law

2000: KONOS

No of Deceased donor transplantation

8.03.4 5.85

2014-02-20 2014 WHO Technical Consultation 63.42 1.09 1.08 0.75 1.41 1.77 1.87 2.88 3.00 5.17 5.24 5.31 7.24 8.03162 52 52 36 68 86 91 141 148 256 261 268 368 409051015202530

0501001502002503003504004501999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012

Yearly change of Deceased Donor

LegislationKONOS

KODAKoDoNet

No of DD DD pmp

2015-02-03

2

2014-02-20 2014 WHO Technical Consultation 7Transplant

tourismProlonged waiting

time than before

Ask self sufficiency

Kidnap ?Murder?

After legislation but organ donation is still not sufficient

Istanbuldeclaration

2014-02-20 2014 WHO Technical Consultation 8How can we solve these problems? How can we solve these problems? How can we solve these problems? How can we solve these problems? Increase organ donation, Increase organ donation, Increase organ donation, Increase organ donation, especially Deceased donorespecially Deceased donorespecially Deceased donorespecially Deceased donor

Types of organ donor, donation rate and transplantation rate per million population

Country Spain USA France Italy UK Germany Korea

2005Korea

2012

Total population

(million)

44.1 298.2 61.8 56.9 59.0 82.5 48.7 50.1

No. of Deceased D

1,546 7,593 1,371 1,197 753 1,220 91 408

Donation rate / pmp 35.1 25.5 22.2 21 12.8 14.8 1.87 8

No. of TPX from DD 3,720 21,225 4,152 3,261 2,332 3,914 285 1,313

TPX rate / pmp

84.3 71.2 67.1 57.3 39.5 47.4 5.85 26.3

No. of TPX from LD

112 6,886 246 129 551 600 1,270 1,878

TPX rate / pmp

2.5 23.1 4.0 2.3 9.3 7.2 26.1 37.62014-02-20 2014 WHO Technical Consultation 92005

Recognizing and solution of organ donation system (2007 – 2009)

• System

– Need revision of Transplant law for required reporting system

– Need independent OPO system for organ procure

• Medical : How to increase procure rate per donor

– Transplant center meeting – cooperation during procurement

– Revise allocation system (region, status)

• Social : to get more consensus for organ donation

– Expanded campaign for donation to students

– Communication with Police office, MoH, Congress, Journalist

– Donor family management, bereavement, public awareness

– Realize problems of living donor safety2014-02-20 2014 WHO Technical Consultation 1

2014-02-20 2014 WHO Technical Consultation 111991: NGOs for organ

Promotion activity


transplant center

1969:LDKT

1979:DDKT

1988:DDLT

1993: KMA guideline



law

2000: KONOS

2003:HOPO

2007:Donation of Boxing Champion

2008: Donation BY Cardinal

Kim


8.03.4 5.8

Increase the number

of deceased donor !

2014-02-20 2014 WHO Technical Consultation 12Solution

2015-02-03

3

051015202530352014-02-20 2014 WHO Technical Consultation 13No of deceased donor per million populationNo of deceased donor per million population

presumed consentpresumed consent

explicit consentexplicit consent

(ROK: 271/50M=5.42)

Activation of deceased donor transplantation

National factors increasing organ donation rate



• Potential for donation ---- MRR first

• To donor hospital or doctor --- revise law• Required referral• Required request

• Legislative environment --- need national consensus• Opting-out (presumed consent)• Opting-in (explicit consent)

The Eurotransplant experience2014-02-20 2014 WHO Technical Consultation 1



0501001502002503003504004501999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012


LegislationKONOS

No of DD DD pmpKODA, Vitallink

KoDoNet





• Potential for donation ---- MRR first

• To donor hospital or duty doctor• Required referral (revise law)• Education to the staff

• Legislative environment --- need national consensus• Opting-out (presumed consent)• Opting-in (explicit consent)

The Eurotransplant experience2014-02-20 2014 WHO Technical Consultation 1

2014-02-20 2014 WHO Technical Consultation 1Korean Transplant

societyVitallink

http://vitallink.or.kr

AcademicSocial Affairs,Promote organ Donation

2015-02-03

4

2014-02-20 2014 WHO Technical Consultation 19Revised Transplant Law in 2010

Medical director should inform the fact when they treated suspected brain death patient to OPO

and the director of OPO must report that to KONOS

Renal transplantation Hemodialysis p-value

Personal 1,770,109 ± 577,123 5,204,455 ± 1,754,843 <0.0001

Insurance 6,322,873 ± 2,072,925 20,196,557 ± 3,317,718 <0.0001

Total 8,092,982 ± 2,615,741 25,401,012± 3,865,674 <0.00012014-02-20 2014 WHO Technical Consultation 1

Publish educational materials

Education to students

Donor Sound of recipient

Transplant Games in Korea

Develop health care policy direction

Make video, clips for campaign

Education to point of contact

vitallink.or.kr

2014-02-20 2014 WHO Technical Consultation 1Founded

Independent OPO (KODA)

2011. 6. 27(started from 2009)

Education, Education, Educationfor people of point of contact

2014-02-20 2014 WHO Technical Consultation 1Networking between NGOs

Korean Organ Donation Network (KoDoNet)2014-02-20 2014 WHO Technical Consultation 1


Organ donation campaign by NGOs in Korea

From early 1990’Networking from 2010

2015-02-03

5

Networking of various NGOsfor effective, professional campaign

from 2010


2014-02-20 2014 WHO Technical Consultation 1Start Nationwide Transplant Database from 2009

2014-02-20 2014 WHO Technical Consultation 27How about result ?

2014-02-20 2014 WHO Technical Consultation 281991: NGOs for organ

Promotion activity


transplant center

1969:LDKT

1979:DDKT

1988:DDLT

1993: KMA guideline



law

2000: KONOS

2003:HOPO

2011:KODA

2010: Revised Law

2007:Donation of Boxing Champion

2008: Donation BY Cardinal

Kim

NGO+Gov.Transplant Game

Media playPolice agency + MoHW


8.03.4 5.8Cooperative work with

National Police Self-governing unit


0501001502002503003504004501999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012


LegislationKONOS

KODAVitallink

KoDoNet

No of DD DD pmp


0501001502002503003504004501999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012


LegislationKONOS

No of DD DD pmp

2013Revised law

2015-02-03

6

Recent action direction of Vitallink

• To achieve 10 million donor card• Cooperative work with Hospital director, Self-governing officer, Journalist• Visual activity of the transplanted recipient to the public : WTG• Mobile campaign using smartphone2014-02-20 2014 WHO Technical Consultation 1

Campaign to have Donor Card from 1,000,000 to 10,000,000

2014-02-20 2014 WHO Technical Consultation 1Year Donor card holder Actual donor2009 2012 2020 Before 2000 47,224 1 1 ?2000-2003 19,949 12004 35,321 1 80 ?2005 77,166 1 2 100 ?2006 90,732 6 6 300 ?2007 81,149 7 7 200 ?2008 74,841 4 4 200 ?2009 185,046 8 8 200 ?2010 124,377 11 100 ?2011 94,737 14 100 ?2012 87,754 11 200 ?2013 118,871 ???2020 (10,000,000) ???2014-02-20 2014 WHO Technical Consultation 33

Collaborative work with Hospital director, self-governing officer, Ministry of Health, OPO


2014-02-20 2014 WHO Technical Consultation 1World

TransplantGames

Increaseorgan

donation rateabout 15%

Mount Climb by Recipients2008 Seoul NU team

2014-02-20 2014 WHO Technical Consultation 1Donor family & people realized that their decision of donation is not a useless one

but a precious sacrifice, and proud of it !

2015-02-03

7

2014-02-20 2014 WHO Technical Consultation 1Pattern of CampaignPattern of CampaignPattern of CampaignPattern of Campaign

Why SNS ?

2014-02-20 2014 WHO Technical Consultation 1Easily spread information to the public& Can communicate

Discussion about living donor safety & support to the donor

- Nationary Assembly -

2014-02-20 2014 WHO Technical Consultation 1Raise ethical problem in transplantation and organ donation

to the public

2014-02-20 2014 WHO Technical Consultation 1Have you ever heard about organ

shortage and its related problems?

2014-02-20 2014 WHO Technical Consultation 1What does mean ?

No?

No !……

Never heard

No…

Repeat education and campaign !Summary - 2

Vitallink International

2014-02-20 2014 WHO Technical Consultation 1Share our experience and joint growth in Asian countriesSummary - 3

2015-02-03

8

2014-02-20 2014 WHO Technical Consultation 43Self-sufficiency of organ donor :

not achieved at one moment, not by single action of campaign

1969 ---------------2013 Evaluation of present status ,& Repeat planning of new Breakthrough2014 need new

breakthrough

Summary-1

It begins with a small ball of snow !2014-02-20 2014 WHO Technical Consultation 1If we roll that snow ball again and again, we can make snowman

Documents

Source: Hanafiah K et al. Hepatology 2013 Source: Ott J et ... · Territory size is distorted in proportion to the number of organ transplants reported for each country in 2010