Health Care professionals

(1)

1 Patient Safety Programme Health Systems

and Innovation

1 Technical Consultation on Knowledge Sharing and Networking for Human Cell, Tissue and Organ Donation and

Transplantation in the Western Pacific Region Seoul, February 20-21 2014

2 Service Delivery

and Safety Health Systems

and Innovation

1. Standards of Practices Common to MPHO

• 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

• Towards using at best the global experience of adverse events and reactions

World Health Assembly

The WHO Wide Initiative for MPHO The WHO Wide Initiative for MPHO 3 Global Governance Tools for MPHO

3 Service Delivery

and Safety Health Systems

and Innovation

World Health Assembly Resolution WHA63.22 Human Organ and Tissue Transplantation World Health Assembly Resolution WHA63.22

Human Organ and Tissue Transplantation

2010 2010

• 2. URGES Member States:

• (5) to improve the safety and efficacy of donation and transplantation by promoting international best practices;

• (6) to strengthen national and multinational authorities and/or capacities to provide oversight, organization and coordination of donation and transplantation activities, with special attention to maximizing donation from deceased donors and to protecting the health and welfare of living donors with appropriate health- care services and long-term follow up;

• (7) to collaborate in collecting data including adverse events and reactions on the practices, safety, quality, efficacy, epidemiology and ethics of donation and transplantation;

• (8) to encourage the implementation of globally consistent coding systems for human cells, tissues and organs as such in order to facilitate national and international traceability of materials of human origin for transplantation;

4 Service Delivery

and Safety Health Systems

and Innovation

World Health Assembly Resolution WHA63.22 Human Organ and Tissue Transplantation World Health Assembly Resolution WHA63.22

Human Organ and Tissue Transplantation

2010 2010

• 3. REQUESTS the Director-General:

• (1) to disseminate the updated Guiding Principles on Human Cell, Tissue and Organ Transplantation as widely as possible to all interested parties;

• (2) to provide support to Member States and nongovernmental organizations in order to ban trafficking in material of human origin and transplant tourism;

• (3) to continue collecting and analysing global data on the practices, safety, quality, efficacy, epidemiology and ethics of donation and transplantation of human cells, tissues and organs;

• (4) to facilitate Member States’ access to appropriate information on the donation, processing and transplantation of human cells, tissues and organs, including data on severe adverse events and reactions;

5 Health Systems

Policies and Workforce Health Systems

and Innovation

Clinical Procedures

Health Care professionals

Vigilance and Surveillance

A Comprehensive Safeguard to Allow Timely Reaction

Vigilance and Surveillance

A Comprehensive Safeguard to Allow Timely Reaction

Patient Possible Donor Community Living Donor

Recipient Deceased Person

Loss of function death

Quality Management Systems - Good Practices

Donors and Recipients Follow-up Registries

V&S: what goes wrong and can go wrong

MPHO

Quantitative and qualitative data including non-conformity, failures, risks

N ational

H ealth

A uthorities

Evidence for Action

6 Health Systems

Policies and Workforce Health Systems

and Innovation

Clinical Procedures

Definitions – EU and NOTIFY Definitions – EU and NOTIFY

EU : ‘Serious Adverse Reaction (SAR)’ means an unintended response, including a communicable disease,in the donor or in the recipient associated with the procurement or human application of tissues and cells that is fatal, life-threatening, disabling, incapacitating or which results in, or prolongs, hospitalisation or morbidity

(NOTIFY: An adverse response that HAS occurred, including a communicable disease, in a recipient or in a living donor)

EU: ‘Serious Adverse Event (SAE)’ means any untoward occurrenceassociated with the procurement, testing, processing, storage and distribution of tissues and cells that might lead to the transmission of a communicable disease, to death or life-threatening, disabling or incapacitating conditions for patients or which might result in, or prolong, hospitalisation or morbidity

(NOTIFY: An adverse occurrence that MIGHT lead to harm in a

recipient or a living donor)

(2)

7 Service Delivery and Safety Health Systems

and Innovation

-3- Global Vigilance and Surveillance Tools -3- Global Vigilance and Surveillance Tools The NOTIFY project for Vigilance and Surveillance of MPHO

• Mutualizing the global experience of V&S in MPHO services o Risk identification

o Risk assessment

o Risk based quality management o Risk education

• Promoting V&S as a crucial mechanism of quality and transparency in MPHO services

• Associating professionals, Operators and Competent Authorities

• Demonstrating Transparency

• Deserving trust

8 Patient Safety

Programme Health Systems

and Innovation

2012 0

200 400 600 800 1000 1200 1400

2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2013

13 % 18 %

9 Service Delivery

and Safety Health Systems

and Innovation

The NOTIFY Project The NOTIFY Project

Geneva

Brasilia 2013 Rome 2012

2011

10 Service Delivery

and Safety Health Systems

and Innovation

-3- Global Vigilance and Surveillance Tools -3- Global Vigilance and Surveillance Tools

The NOTIFY tools

• NOTIFY Website http://www.notifylibrary.org

• NOTIFY Library of didactic cases of events and reactions

o Donor selection and management o Recipient management

o Quality system - risk based management

• NOTIFY Booklet

• NOTIFY Journal

11 Service Delivery

and Safety Health Systems

and Innovation

The NOTIFY Library The NOTIFY Library

• A database of all types of severe adverse events and reactions that have been reported arising from procurement and processing to clinical application of cells, tissues and organs for transplantation as well as of medical products of human origin used in assisted reproduction technologies.

1. A reference for professionals focused on diagnostic and investigation 2. but also providing evidence for donor selection,

3. A source of information for candidate recipients and living donors 4. A reference for risk based quality management systems 5. A database for further study

http://www.notifylibrary.org/

Health Systems Policies and Workforce Health Systems

and Innovation

12 _Procedures ^Clinical

The NOTIFY Library Operation The NOTIFY Library Operation

Literature review Structured Automated Comprehensive

Partner organisations provide information

• Competent Authorities

• Scientific Professional Societies

Regular WHO Global Consultation on V&S Review

CNT Secretariat

5 Experts Editorial WG

• Infection

• Malignancy

• Handling-clinical errors

• Genetic

• Living donor

LIBRARY

of evaluated and relevant material Accept

Analysis – structured, searchable, current,and accessible

Analyse new data and modify structured analysis regarding

alerting signals etc.

Ad hoc queries current, and accessible

Record of justification of

Rejection

Reject

(3)

13 Service Delivery and Safety Health Systems

and Innovation

• NOTIFY Website http://www.notifylibrary.org

The NOTIFY Library The NOTIFY Library

14 Service Delivery

and Safety Health Systems

and Innovation

The NOTIFY Library The NOTIFY Library

15 Service Delivery

and Safety Health Systems

and Innovation

The NOTIFY Library The NOTIFY Library

A sample of the bibiography

Clicking on a single reference

18 Service Delivery

and Safety Health Systems

and Innovation

The NOTIFY Booklet

(4)

19 Service Delivery and Safety Health Systems

and Innovation

NOTIFY Progress NOTIFY Progress

• Addition of Blood and blood derivatives ( attributes , database changes)\

• Addition of cases involving IWDT (Intervention without disease transmission) and organism transfer without disease

• Addition of cases involving ethical breaches

• Portals in national languages

20 Service Delivery

and Safety Health Systems

and Innovation

WHO Publications NOTIFY

The Journal for Vigilance and Surveillance of Medical Products of Human Origin

1. Editorial Board:

Representatives of NOTIFY project and supporting institutions 2. Advisers: WHO

technical staff 3. Team: WHO PUB staff

NOTIFY Project

CNT-WHO Support Group Library Editorial

Workgroups

NOTIFY Board of Supporting Institutions

• Health Authorities

• Scientific and professional societies

Regular Global WHO Consultation on V&S for MPHOs

NOTIFY Journal NOTIFY Journal

Health Systems Policies and Workforce Health Systems

and Services

21 _Procedures ^Clinical

Thank you

nunezj@who.int

noell@who.int

(5)

03/02/2015

ISBT 128: Information Standard for Blood and Transplant

Paul Ashford

Executive Director ICCBBA

Copyright ICCBBA Copyright ICCBBA

The Acronyms

ICCBBA – International Council for Commonality in Blood Bank Automation

ISBT

Derived from ‘International Society of Blood Transfusion’

Now interpreted as ‘Information Standard for Blood and Transplant’

128 – ISO character set

Slide 2

Copyright ICCBBA Copyright ICCBBA

ICCBBA

International standards organization

Not-for-profit organization formed in 1994 – celebrating our 20 ^th anniversary!

US based, UK based Executive Director, global in scope

Nongovernmental organization in official relations with the World Health Organization

Small staff (10), large community of expert volunteers (>300)

Slide 3

Copyright ICCBBA Copyright ICCBBA

ICCBBA Vision and Mission

Mission: Enhancing patient safety by promoting and managing the ISBT 128 international information standard for use with medical products of human origin

Vision: Global adoption of ISBT 128 for all medical products of human origin

Slide 4

Copyright ICCBBA Copyright ICCBBA

Medical Products of Human Origin

MPHO

Blood and blood components/products

Cells

Tissues – ocular and non-ocular

Organs

Tissue Engineered

Milk

Other?

Slide 5

Copyright ICCBBA Copyright ICCBBA

Common Characteristics of MPHO

Contain material derived from human donor

Potential risk of infection

Traceability

Vigilance and Surveillance Ethical issues

Consent Exploitation Global Governance

Encourage self sufficiency Counter transplant tourism

Slide 6

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03/02/2015

Copyright ICCBBA Copyright ICCBBA

Global Vision

There is a growing consensus on the need for international harmonization of coding and labeling of MPHO

Single donor may donate multiple MPHO

Need for traceability across all products Recognized in World Health Assembly

Resolution WHA63.22 “Human Organ and Tissue Transplantation” May 2010

Slide 7

Copyright ICCBBA Copyright ICCBBA

WHO Organization-wide Initiative for Medical Products of Human Origin

Three strategies for global governance

Global consensus on a series of principles inherent to the human origin of MPHO – in particular prohibition on making the human body and its parts as such a source of financial gain

Global use of ISBT 128 for all MPHO to ensure unique identification, optimal traceability and interoperability between countries, and across all MPHO, for both routine and emergency use Global collaboration on vigilance and surveillance of

MPHO to support operation and oversight and to establish transparency for trust

Slide 8

Copyright ICCBBA Copyright ICCBBA

WHO/ICCBBA work program

Raising Awareness of Member States Health Authorities to the role of ISBT 128 in Global Governance

Improving communication between ICCBBA and Member States Health Authorities

Facilitating access of low and middle income countries to ISBT 128

Standardizing global V&S with the adoption of consistent ISBT 128 product terminology

Slide 9

Copyright ICCBBA Copyright ICCBBA

A short history of ISBT 128

Developed for blood transfusion following First Gulf War and request from US DoD for standardization

First version of ISBT 128 Standard published in 1994

Extended to cover cell therapy and tissues in 2000

Current work on organs, milk, tissue engineering/advanced therapies

Slide 10

Copyright ICCBBA Copyright ICCBBA

What does ISBT 128 provide?

Globally unique identification numbers – ensures no duplication over a 100 year time period

Standardized terminology – ensures a common understanding across multiple languages

Standard for electronic transfer of information – allows rapid error free information transfer for critical information

Slide 11

Copyright ICCBBA Copyright ICCBBA

Why is standardized coding important?

Traceability is essential for

Recall Follow-up

Vigilance and Surveillance

Traceability means being able to identify and track all products from a single donor

Whatever type (blood, cells, tissues, organs, milk etc.) Wherever they are (local, national, global)

Over long time periods (e.g. 30 years from implant) Across different regulatory frameworks

Slide 12

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03/02/2015

Copyright ICCBBA Copyright ICCBBA

Traceability

Effective traceability depends on:

Unique identification of all products throughout the transfusion/transplantation pathway

Accurate recording and transcription of data

Reliable long term storage of information

Linkage between information held in different organizations

Rapid tracking

Slide 13

Copyright ICCBBA Copyright ICCBBA

Traceability

Effective traceability requires

Electronic transfer of information

Bar codes Scanners

Common Terminology

Supports global activity data collection Supports biovigilance and surveillance Reduce risk of misunderstanding and error Information standards

Ensuring globally unique identification

Universally understood electronic coding of information

Slide 14

Copyright ICCBBA Copyright ICCBBA

Recent Activities

Technical Advisory Groups active in many fields (blood, cell therapy, tissue, ocular, milk, tissue engineering)

Terminology Standardization

Widely endorsed global terminology developed and published for cell therapy and ocular tissue

WHO organ nomenclature developed

Consensus terminology developed for skin, and soft tissue; in development for cardio-vascular and bone

Slide 15

Copyright ICCBBA

Published Consensus

Slide 16

Copyright ICCBBA

Supporting Organizations

Slide 17

Copyright ICCBBA Copyright ICCBBA

Terminology Harmonization

Standard terminology is important at several levels:

Clinical application – requires detailed descriptions to distinguish clinically distinct variants

Activity data collection – needs to capture data at a more generic level of description

Vigilance and Surveillance – identifies trends by collating data across many product types

Slide 18

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03/02/2015

Copyright ICCBBA Copyright ICCBBA

Terminology Harmonization

ISBT 128 terminology describes MPHO at the clinical use level

Incorporates classification at the level of Class of product

Maps to higher level classification systems

Notify V&S Taxonomy

Eurocet data items

EU Generic descriptions

Slide 19

Copyright ICCBBA Copyright ICCBBA

Tissues and Medical Devices

Global initiative for standard identification of medical devices (UDI – unique device identification)

In US, FDA final rule requires implementation of the UDI for all medical devices

FDA regulates some tissue products as medical devices

Risk that tissue identification may become more fragmented with different systems depending on the regulatory framework

Slide 20

Copyright ICCBBA Copyright ICCBBA

Tissues and Devices

ICCBBA has:

Been approved by FDA as a UDI Issuing Agency.

Developed an ISBT 128 UDI which is compatible with ISBT 128 for other tissues

Signed a Memorandum of Understanding with the Global Medical Device Naming Agency (GMDN)

Provided documentation to support tissue banks implementing an ISBT 128 UDI

Slide 21

Single European Code

Slide 22

Call for tender EAHC/2011/HEALTH/03

“Reference compendia for the application of a single European coding system for human tissues and cells”

Coordinator

Copyright ICCBBA Copyright ICCBBA

Progress to date

Tissue Establishment Compendium developed and populated

Product Compendium developed and populated - supports ISBT 128

Essential information for TE and CA documents published

Translation tool developed and in test

Draft Manual developed and being reviewed by CA’s

Pilot evaluation due to start soon

Slide 23

Slide 24

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03/02/2015

Copyright ICCBBA Copyright ICCBBA

SEC and transparency

The TE Compendium is maintained by Member States Competent Authorities

It contains all authorised/licensed tissue establishments in the EU

The authorization status of each TE is available

Lookup can be from the SEC or from the ISBT 128 Donation Identification Number

Slide 25

Copyright ICCBBA Copyright ICCBBA

Current status of ISBT 128

Licensed Facilities

Blood : 4274 facilities in 56 countries

Cell Therapy: 453 facilities in 46 countries

Tissues : 96 facilities in 17 countries

Total : 4669 facilities in 77 countries

118 Vendors licensed to support ISBT 128 in their products

Slide 26

Slide 27

http://batchgeo.com/map/47e92d7cb87ea05a946e4a589cabd565

Copyright ICCBBA Slide 28

Copyright ICCBBA Copyright ICCBBA

ISBT 128 and Organ Transplant

An exciting new story for the next decade

Basic organ nomenclature developed through WHO/ICCBBA SONG project

ISBT 128 product codes available

Provides the potential to link all MPHO from a single donor with one unique donation identification number

Slide 29

Slide 30

ICCBBA

…an NGO in official relations with WHO working to deliver the vision of global standardization of terminology, coding and labeling for all medical

products of human origin.

(10)

INTERNATIONAL COLLABORATION ACTIVITIES RELATED TO DONATION AND TRANSPLANTATION

AT THE COUNCIL OF EUROPE THE EXPERIENCE OF THE BLACK SEA AREA (BSA)

PROJECT

Marta López Fraga, PhD European Directorate for the Quality of Medicines & Healthcare (EDQM)

O RGAN D ONATION : F ACTS AND F IGURES

Each of these can

save or heal a life

Transplantation is the unique moment in medicine where the life of a patient depends on the wish or will of another person

O RGAN D ONATION : F ACTS AND F IGURES

Kidneys are in the highest demand

In 2011, 2 patients were added to a kidney waiting list in Europe every hour

that’s a total of

68,073

patients!

23,485

patients received a kidney

12

patients died every day due to lack of organs

Organ shortages remain the

main obstacle in transplantation medicine!

D ONATION AND T RANSPLANTATION W ORLDWIDE

H ETEROGENEOUS T RANSPLANT S CENE IN E UROPE

2013

H ETEROGENEOUS T RANSPLANT S CENE IN E UROPE

2013

(11)

IS TRANSPLANTATION A SHORT TERM TREATMENT?

M AXIMUM G RAFT S URVIVAL ( IN Y EARS )

34 33

30

22

16 14 40

14 32

0 5 10 15 20 25 30 35 40 45

DD LD related LD non-related

WHAT IS THE COST OF TRANSPLANTATION?

C ^{OST PER} QALY*

* Quality adjusted life year

Masson et al.,1993

Treatment UK Pounds

Cholesterol control + diet 220

Pacemaker 1.100

Total hip arthroplasty 1.180

Kidney transplantation 4.710

Screening for breast cancer 5.780

Heart transplantation 7.840

Hypercholesterolemia: 25-39 y/o 14.150

Coronary Bypass 18.830

Peritoneal dialysis 19.870

Haemodialysis 21.970

Neurosurgical tumour removal 107.780

A NNUAL C OST OF T REATMENT M ETHODS FOR ESRD

F. Charro, in G. Collins et al: Procurement preservation and allocation of vascularised organs, Kluwer 1997

0 10 20 30 40 50

Kidney tx >1 yr Kidney tx <1 yr Peritoneal dialysis Haemodialysis

Thousands of Euro

P OTENTIAL SAVINGS BY INCREASING RENAL T RANSPLANTS (2010) – F RANCE (ABM)

Source data: DG SANCO

Scenario 1:

1% increase of grafts/year Cumulative 180 more grafts 2011-2016 Cumulative savings: +37 million €

Scenario 2:

5% increase of grafts/year

Cumulative 980 more grafts 2011-2016

Cumulative savings: +198 million €

Average 10 yr savings per patient dialysis transplant: 600.000 €

(12)

S AVINGS FROM RENAL TRANSPLANTS PAY BACK ALL SOLID ORGAN TRANSPLANT PROGRAMS – S PAIN (ONT)

Source data: DG SANCO

6%

36%

35%

9%

6%

3%3%2% Organ procurement

Renal transplants Liver transplants Heart transplants Lung transplants Pancreatic transp lants Peripheric structure of coord ination National structure of coord ination 100% = 171 Million €

Annual savings per transplant 21.000 € Renal transplants per year ~2200 Potential annual saving 46 M € Years needed to cover total tx cost 3,7

Cumulative Nr of tx patients 19.000 Potential annual savings 400 M €

T RANSPLANTATION IS THE M OST C OST -E FFECTIVE T REATMENT FOR E ND S TAGE O RGAN F AILURE

Transplantation therapy increases significantly the survival and quality of life of patients

Patients receiving renal transplants cost significantly less than patients on dialysis

Developing renal transplantation as part of the national health system brings savings that can cover for the costs of renal and other transplant programs

Social attitude

Public awareness

National economy

Health system

Legal framework

Education of health professionals Organisation of

transplant system

F ACTORS I MPACTING ON D ONATION AND T RANSPLANTATION OF O RGANS , T ISSUES & C ELLS

Specialisation of health professionals Transnational

cooperation Reimbursement of

stakeholders Clinical practices

Quality assurance

W HO ARE THE MAIN STAKEHOLDERS ?

Healthcare Professionals

Policy- makers

Regulatory authorities General

Public

Organ transplantation is a complex process that requires intense co-operation between

several partners.

WHAT CAN WE DO TO IMPROVE THE SITUATION?

T HE C O E & O RGAN , T ISSUE AND C ELL T RANSPLANTATION

The Council of Europe has been working in the area of organ, tissue and cell transplantation since 1987

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71 representatives coming from 32 member states and 20 observer states and institutions (including the EC, WHO, CoE Committee on Bioethics and other Non-Governmental Organisations) E UROPEAN C OMMITTEE O N O RGAN T RANSPLANTATION (CD-P-TO)

Principle:

Sharing of technical, scientific expertise in the health sciences. The member states provide experts to the EDQM so that common quality, safety and ethical standards can be elaborated jointly

• Assist member states in improving their organ transplantation services whilst promoting the principle of voluntary non-remunerated donations

• Monitor practices in Europe and assess risks linked to procurement, storage and transplantation of organs, tissues and cells

• Provide guidelines on quality and safety standards and their implementation

• Examine the organizational structures involved in organ donation and transplantation in order to address the causes of organ shortage

• Ensure the transfer of knowledge and expertise throughout Europe

• Contribute to raise awareness among health professionals and general population about the importance and benefits of organs, tissues and cells donation E UROPEAN C OMMITTEE O N O RGAN T RANSPLANTATION (CD-P-TO)

C OUNCIL OF E UROPE L EGAL G UIDANCE

C OUNCIL OF E UROPE T ECHNICAL G UIDANCE

• Exhaustive guidelines to provide professionals with a useful overview of the most recent advancements in the field

• Ensure high level of quality and safety standards

• Contribute to the harmonisation of these activities among European countries and beyond, facilitating uniform standards and practices

• Comprehensive introduction on legislation and ethics

• Continuous update and maintenance

F IGHT AGAINST O RGAN T RAFFICKING

The recruitment, transportation, transfer, harboring or receipt of persons, by means of the threat or use of force or other forms of coercion, of abduction, of fraud, of deception, of the abuse of power or of a position of vulnerability or of the giving or receiving of payments or benefits to achieve the consent of a person having control over another person

for the purpose of exploitation…including the removal of organs

Consent irrelevant

T RAFFICKING IN HUMAN BEINGS FOR THE PURPOSE OF O RGAN R EMOVAL

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Any of the following activities, when committed intentionally:

The illicit removal of organs:

removal without the free, informed and specific consent of the living donor, or, in the case of the deceased donor, without the removal being authorized under its domestic law, OR

where in exchange for the removal of organs, the living donor, or a third party, has been offered or has received a financial gain or comparable advantage, OR

where in exchange for the removal of organs from a deceased donor, a third party has been offered or has received a financial gain or comparable advantage.

The use of illicitly removed organs

The preparation, preservation, storage, transportation, transfer, receipt, import and export of illicitly removed human organs

The illicit solicitation or recruitment (of organ donors or recipients), offering and requesting of undue advantages (to health professionals or public officials)

Aiding or abetting and attempt

The human body and its parts shall not, as such, give rise to financial gain or comparable advantage

D RAFT C OUNCIL OF E UROPE C ONVENTION AGAINST T RAFFICKING IN H UMAN O RGANS

ADDDRESING THE ROOT CAUSE OF ORGAN SHORTAGE

• Structure and enhance exchange of knowledge, expertise and good practices between member states

• Elaborate tailor-made programmes adapted to the economical socio-economical context of the different member states

I NTERNATIONAL C OLLABORATION I NITIATIVES : A DDRESSING O RGAN S HORTAGE

• Development of a new transplant law for Moldova

• Assistance in the elaboration of the acts and orders after the promulgation of the new law

• Establishment of the Transplant Agency

• Definition of the long term activities of the Transplant Agency

• Assistance in the definition of the financial and economic aspects of the activities coordinated by the Transplant Agency

I NTERNATIONAL C OLLABORATION : T HE M OLDOVAN E XPERIENCE 2006-2008

B LACK S EA A REA (BSA) P ROJECT : S YNERGY BASED ON A REGIONAL NETWORK

Actual deceased organ donors (DBD and DCD) – Annual rate p.m.p. 2012

0 0.1

0

4.6 3

0.3

2.9

0

B LACK S EA A REA (BSA) P ROJECT : S YNERGY BASED ON A REGIONAL NETWORK

Kidney transplants (all combinations) – Annual rate p.m.p. 2012

Potential for more organs Potential to learn from each other

3.5 2.7

1.1

39 8.3

1.8

6.6

4.8

2.9

Kick Off meeting in Chisinau (Moldova) July 2011

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• to review the existing laws on transplantation of organs, tissues and cells and to promote the implementation of an effective legislative framework;

• to contribute to the establishment of national transplant authorities and programmes;

• to educate the public, professionals and media about transplantation;

• to identify areas where additional specialist expertise or training are required as the basis for a development strategy;

• to elaborate recommendations and action plans;

• to encourage networking and enhance international co-operation;

• to establish pilot actions to be developed in specific settings.

S ^PECIFIC O BJECTIVES OF THE BSA P ^ROJECT

PARTICIPANTS

- Collect data - Provide feedback - Exchange knowledge - Implement recommendations

National Focal Points Government Contact Person (GCP)

ADVISORY BOARD

Steering Committee CD-P-TO

- Follow/support of the progress - Dissemination of the project - Support towards sustainability - Elaboration of guidelines, protocols, recommendations

PARTNERS &

SUPPORTS Expert Organisations Professional Societies

EU

- Expert support - Involved in training and exchange of knowledge - Fundraising support Tasks and Role

S TRUCTURE OF THE BSA P ROJECT

B LACK S EA A REA (BSA) P ROJECT : A CTION P LAN WP 1: Coordination, dissemination, public awareness

WP 2: Development of effective legislative and financial framework Assessment of the existing transplant legislation

Elaboration of guidelines and effective laws according to local situation in each country Asses political involvement and financial aspects of transplantation

WP 3: Establishment of National Transplant Authorities

Implementation of rules, guidelines and standards for the organisation and functioning of the Agencies

Education and training of the medical and technical personnel of the Agencies WP 4: Clinical Practices

Analysis of the clinical practices of the donation and transplantation process Specific training of doctors and nurses involved in transplantation activities

Group A

• Russian Federation

• Turkey

• Romania

Group B

• Ukraine

• Moldova

• Bulgaria

Group C

• Armenia

• Azerbaijan

• Georgia

Established infrastructures and

significant Tx activity Minimal activity No Tx activity although some Tx-related legislation exists

Increase tx from deceased donors Create an infrastructure for deceased donation

Engage political involvement and support Focus on WP4:

Clinical Practices

Focus on WP3:

National Tx Authority

Focus on WP2:

Legislation & Finances

BSA P ROJECT : W ORK D ISTRIBUTION

Detailed country assessments using questionnaires National questionnaire

Regional questionnaire Hospital questionnaire for ICU doctors Hospital questionnaire for donor coordinators

Individual assessments of each country through site visits Existing Tx legislation

Financial provisions in each country relative to health programmes and Tx activity Existing infrastructure and Tx activity

Obstacles and institutional/structural problems related to development of Tx Political will to develop Tx programmes

Public awareness campaigns

Recommendations and setting of specific goals Revaluation after 1 year to see progress

E VALUATION M ETHODOLOGY

2.9

2 3.2

3.7 3.4

4.8 5.7

5.3

4.4 4

3.8

0 1 2 3 4 5 6

2008 2009 2010 2011 2012 2013

Romania donors 2008 – Oct 2013 (p.m.p)

Deceased D Living donors Linear (Deceased D) Linear (Living donors)

IRODaT data www.irodat.org

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5.4

3.8 5.6

7.3 8.9

1.7 1.3

2.3 2.5

3.9

5.3 5.1

4 3.6

2.8

0.4 0.1

0.4 0.4

1.1

0 1 2 3 4 5 6 7 8 9 10

2008 2009 2010 2011 2012

Romania transplant 2008 - 2012 (pmp)

Kidney tx from DD Liver tx from DD Kidney tx from LD Liver tx from LD

IRODaT data www.irodat.org

• Governmental support-> strong commitment and political involvement to invest in the development of a donation and transplantation programme

• Technical support-> working directly with national experts at a technical level

• International support-> transfer of know-how and expertise from countries will well developed programmes

W HAT IS N EEDED F OR I NTERNATIONAL C OLLABORATION P ROJECTS T O S UCCEED ?

• The main factor impacting deceased donation rates is the ability of the system to identify possible organ donors and convert them into actual organ donors. This requires organisation, protocols, and training, among other things

L ESSONS L EARNED & T AKE H OME M ESSAGES

• Transplantation programmes need to be transparent, fair and ethical

• Don’t start building the house from the roof: effective legislative and regulatory framework should be in place before focusing on clinical practices

• It is pointless to train professionals unless they are part of an officially recognised and supported national network

• There isn’t a universal recipe for success. Transplantation programmes need to be adapted to the individual socio-economical circumstances of each country

• Effective transplantation programmes require committed, continuous and sustainable political and financial investment and support

• Use resources wisely. You may not need to develop all programmes. Collaborate!

G OOD L UCK !

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03/02/2015

Technical Consultation on Knowledge Sharing and Networking for Human Cell, Tissue and Organ Donation and Transplantation in The Western Pacific Region

The Latin American Council (RCIDT)

Elisabeth Coll Torres Medical Department Organización Nacional de Trasplantes (ONT)

Spain

Organ donors in Spain Number & Annual Rate

N Rate

550

687778 8328699601,0371,0321,1551,2501,3341,3451,3351,4101,4481,4941,5461,5091,5501,5771,6041,5021,6671,6431,655 14.3

17.8 20.2

21.722.6 25

27 26.8 29

31.5 33.6 33.9

32.5 33.7 33.934.6 35.1

33.8 34 34.234.4 32

35.334.835.1

0 5 10 15 20 25 30 35 40

0 200 400 600 800 1000 1200 1400 1600 1800

1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013

Absolute number

RATE pmp

12.8 18.5 25.9

25.8 21.9 15.3 35.1

3 0 donors pmp 2 0 donors pmp 1 5 donors pmp 1 0 donors pmp

<10 do no rs p mp

19.1 THERE IS GREAT DIFFERENCE BETWEEN THE SPANISH ORGAN DONATION RATES AND

THOSE OF MOST DEVELOPED COUNTRIES (DONORS PMP 2012)

15.5

15.6

8.2

0 500 1000 1500 2000 2500 3000 3500 4000 4500

1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013

TX porcedures (N)

Kidney Liver Heart Lung Pancreas Small bowel

ORGAN TRANSPLANTS IN SPAIN 1989-2012 (total number)

COORDINATION NETWORK

SPECIAL PROFILE

INSIDE THE HOSPITALS

BRAIN DEATH AUDIT

HOSPITAL REIMBURSEMENT

TRAINING OF PROFESSIONALS

ATTENTION TO THE MEDIA

THE SPANISH MODEL ORGAN DONATION & TRANSPLANTATION

BASIC PRINCIPLES OF THE SPANISH MODEL

PREVIOUS EXPERIENCE WITH DIFFERENT

INTERNATIONAL BODIES

(18)

03/02/2015

30 PHYSICIANS FROM LATIN AMERICAN COUNTRIES WERE TRAINED IN DONATION

AND MANAGEMENT

SIEMBRA (SOWING) PROJECT

PUNTA CANA GROUP JUNE 2001

PUNTA CANA GROUP AND DECLARATION JUNE 2001

DECLARATION

• Approach to the society (media collaboration)

• Improve functioning organizational structures

• Enhance countries collaboration

• Governments Collaboration

CORDOBA DECLARATION OCTOBER 31st

2003

DECLARATION

• Creation of a training programme in transplant coordination

• Implement a Registry of donation and transplantation activity in Latin America

• Need of an Iberoamerican official forum of Donation and Transplantation

5.4 2.2

6.9 2.1

14.1 7.7

3.5 4.3

1.4 0.2 1.2

2.9 5

PUNTA CANA GROUP LATINAMERICAN REGISTRY ON DONATION AND

TRANSPLANTATION

2004: FIRST

LATINAMERICAN DATA

IN INTERNATIONAL

DATABESES

(19)

03/02/2015

COOPERATION PROGRAMME SPAIN-PAHO (2004)

MAIN OBJECTIVE

Promotion and development of programmes of donation and kidney transplantation in Latin America

COMPLEMENTARY OBJECTIVES

•Study Latin America situation: Legislation, economic and organizational issues related to transplantation

•Donation and transplantation activity

•Potential of deceased donation

•Design and pilot activities in concrete actions

•Training plans in donation and transplantation

Human Tissue and Organ Transplantation World Health Assembly 2004

Resolution WHA57.18

TO PROVIDE, IN RESPONSE TO REQUESTS FROM MEMBER STATES, TECHNICAL SUPPORT FOR DEVELOPING SUITABLE TRANSPLANTATION OF CELLS, TISSUES OR ORGANS, IN PARTICULAR BY FACILITATING INTERNATIONAL COOPERATION TO PROMOTE INTERNATIONAL COOPERATION SO AS TO INCREASE THE ACCESS OF CITIZENS TO THESE THERAPEUTIC PROCEDURES

SPAIN, IN CLOSE COOPERATION WITH THE PANAMERICAN HEALTH ORGANIZATION (PAHO)

TAKES CARE OF THE DEVELOPMENT OF THIS RESOLUTION IN LATIN-AMERICAN COUNTRIES

MEETING ONT – PAHO MONTEVIDEO – FEBRUARY 2005

MEETING CARTAGENA DE INDIAS JUNE 2005

AECI + Country representatives

+ ONT

PROPOSAL:

TO CREATE A FORUM FOR COOPERATION

“IBEROAMERICAN COUNCIL OF ORGAN DONATION AND

TRANSPLANTATION”

5. COMMUNICATION AND INFORMATION POLICIES

6. IMPROVEMENT STRATEGIES IN IMMUNOTHERAPY

7. ECONOMIC ANALYIS OF DONATION AND TRANSPLANTATION

PRIORITY ACTIONS

1. GLOBAL ANALYSIS OF DONATION AND TRANSPLANTATION IN LATINAMERICA

2. TRAINING PROGRAMS ON DONATION IN TRANSPLANTATION

3. STANDARD DEFINITIONS AND CLINICAL PRACTICE GUIDELINES

4. DEFINITION OF IMPROVEMENT AREAS AND COOPERATION IN

MANAGEMENT AND ORGANIZATION

(20)

03/02/2015

RENAL TRANSPLANTATION IS THE MOST ECONOMIC THERAPY FOR ESKD

DEPENDING OF THE COUNTRY, THE COST OF THE TRANSPLANT CAN BE RECOVERED IN A PERIOD OF

2 – 4 YEARS WHEN COMPARED

WITH DIALYSIS

VII IBEROAMERICAN CONFERENCE OF HEALTH MINISTERS

APPROVAL OF THE IBEROAMERICAN COUNCIL AND NETWORK OF DONATION

AND TRANSPLANTATION

FIRST MEETING MAR DEL PLATA NOVEMBER 15th 2005

GRANADA SEPTEMBER 15th- 2005

Ibero-American Summit of Heads of State and Governments Salamanca October 14th 2005

SALAMANCA DECLARATION

IBEROAMERICAN COUNCIL/

/NETWORK OF ORGAN & TISSUE DONATION & TRANSPLANTATION

IBEROAMERICAN COUNCIL OF ORGAN & TISSUE DONATION AND TRANSPLANTATION PERMANENT

SECRETARY

OFFICIAL DELEGATES

OF THE MEMBER COUNTRIES

• LATIN AMERICA

• SPAIN + PORTUGAL OTHER SOCIETIES/BODIES

IBEROAMERICAN COUNCIL OF ORGAN & TISSUE DONATION AND TRANSPLANTATION

21 COUNTRIES + PAHO

SPAIN: PRESIDENCE & GENERAL SECRETARY

(21)

03/02/2015

SOCIEDAD LATINOAMERICANA DE COORDINADORES DE TRASPLANTES

SOCIEDAD DE TRASPLANTES DE AMERICA LATINA Y EL CARIBE

PUBLIC/PRIVATE SOCIETIES AND

BODIES INVITED

GRUPO PUNTA CANA

TRANSPLANT COMMITTEE COUNCIL OF EUROPE

Cooperation among member states in ethical , organizational and legislation aspects in organ donation

and transplantation

More than 20 recommendations

Donation and transplantation activity

I.- MAR DEL PLATA

IX.- LIMA

XII.- QUITO V.- SANTIAGO DE CHILE

IV.- PUNTA CANA

III.- MONTEVIDEO II.- MADRID

XIII.- PANAMA VIII.- BOGOTÁ

VII.- MEXICO D.F.

VI.- LA HABANA

X- CARTAGENA DE INDIAS

XI.- BUENOS AIRES

RCIDT MEETINGS

18 APPROVED RECOMMENDATIONS

+ 1 ACTION PLAN PROFESSIONAL TRAINING

IBEROAMERICAN TRANSPLANT NEWSLETTER

SINCE 2007

“”

MAR DE PLATA DECLARATION 1. AUTOLOGOUS CORD BLOOD BANKS 2. PAPER AND TRAINING OF DONATION AND

TRANSPLANTATION PROFESSIONALS 3. FUNCTIONS AND RESPONSABILITIES OF A

NATIONAL ORGANIZATION OF DONATION AND TRANSPLANTATION

4. QUALITY ASSURANCE PROGRAMME

5. ORGAN SHORTAGE SOLUTIONS

6. QUALITY AND SAFETY TISSUES AND CELLS

7. BIOETHICAL CONSIDERATIONS

8. BRAIN DEATH

9. TUMOURS CONSENSUS

10. CELL TERAPHY

11. SEROLOGICAL DETERMINATIONS

12. DONOR MAINTENANCE…

(22)

03/02/2015

¿ WHAT ARE THE MAIN FACTORS WHICH ARE INFLUENCING ORGAN

DONATION IN LATINAMERICA?

MAIN PROBLEMS IN LATIN AMERICA FOR ORGAN DONATION

RESOURCES AND INFRAESTRUCTURE HEALTH CARE SYSTEMS FRAGMENTATION NO COVERAGE MOST OF POPULATION DONATION AND TX ORGANIZATION NO PERCEPTION RELEVANT TOPIC LACK OF TRAINED AND AVAILABLE

PERSONNEL

NO DONATION CULTURE IN POPULATION

HEALTH CARE SYSTEMS FRAGMENTATION

POPULATION HEALTH COVERAGE SOCIAL

SECURITY

HEALTH MINISTRY

PRIVATE

INSURANCE NONE

TRANSPLANTATION DONATION

POPULATION DISTRUST UMBALANCE POSSIBILITIES DONATION- RECEIVE

TRANSPLANT

RESPONSIBLE OF ORGAN DONATION AND TRANSPLANT COORDINATION (ORGAN ALLOCATION, WAITING LISTS…)

OFFICIAL SUPPORT REAL ACTION CAPACITY

PROFESSIONAL AND SOCIETY IMPLEMENTATION

ADEQUATE TECHICAL DIRECTION

NEED OF A NATIONAL ORGANIZATION FOR DONATION AND TRANSPLANTATION

RED / CONSEJO IBEROAMERICANO DE DONACIÓN Y TRASPLANTES 1ª REUNIÓN – MAR DEL PLATA.

15 – 17 DE NOVIEMBRE DEL 2005

PROPUESTA DE RECOMENDACIÓN REC - CIDT – 2005 (3) SOBRE FUNCIONES Y RESPONSABILIDADES

DE UNA ORGANIZACIÓN NACIONAL DE DONACIÓN Y TRASPLANTES

(ONDT)

OPENING O. N. T.

MADRID SPANISH MODEL

1 5 10 15 20 25 30 35 40 45 50 55 60

FEBRUARY MARCH

O .N .T.

FAMILY APPROACH MADRID

BLOOD CORD BANKS

MADRID

GENERAL COURSE

BARCELONA/ ALICANTE/GRANADA

TWO MONTHS TUTORY WITH SPANISH COORDINATORS IN ALL SPANISH REGIONS

TRANSPLANT COMMITTEE REGIONAL COUNCIL

& CLOSURE OF THE MASTER MADRID

INTERNATIONAL MASTER DONATION AND TRANSPLANTATION

PRESENTATION OF FINAL PROJECT

MADRID / BARCELONA

10 YEARS MASTER ALIANZA

MASTER ALIANZA:

325 PROFESSIONALS

FROM ALL LATIN AMERICAN COUNTRIES X EDITION 2014

Master Alianza 2005-2014

24 39

62 10 39

31 7 16

10 5 26

10

3

15

11 5 8

3

1

(23)

03/02/2015

41 82 12

15 TRAINING THE TRAINERS COURSES + FOLLOW UP IN LATIN AMERICA: 412

49 37 6 1

45 10 14

COMMUNICATION IN CRITICAL SITUATIONS “COUNSELLING”

739 1136

337 239

TOTAL NUMBER OF PROFESSIONALS TRAINED

5505

916

701

20 COMMUNICATION IN CRITICAL SITUATIONS - “COUNSELLING”

120

942 180 150

EDITION & DISTRIBUTION:

“THE SPANISH MODEL”

FREE DOWNLOAD www.ont.es

ALL KINDS OF TRAINING MATERIALS FOR

TRANSPLANT COORDINATORS

NICARAGUA: APPROVAL OF A NEW TRANSPLANT LAW

TRANSPLANT TOURISM IN LATIN AMERICA

EQUATOR BOLIVIA

MÉXICO

PERU

COLOMBIA

BRASIL

GREAT EFFORTS IN MANY COUNTRIES TO FIGHT AGAINST

TRANSPLANT TOURISM

APPROVAL:

CUBA MEETING MAY - 2008

APPROVAL:

MEXICO MEETING

NOVEMBER - 2008

(24)

03/02/2015

INFLUENCE ON COUNTRY REGULATION

COLOMBIA TRANSPLANT TOURISM NOW BANISHED THANKS TO THE ACTION OF COLOMBIAN GOVERNMENT AND SUPPORTED

BY RCIDT

ROUT SHEET FOR DONATION IMPROVEMENT

CREATION/ CONSOLIDATION TRANSPLANT ORGANIZATION ASSESMENT

TRAINED PROFESSIONAL TRAINING

COURSES

DONATION IMPROVEMENT COUNTRY SPECIFIC FEATURES

OBJECTIVE

HEALTH AUTHORITIES SUPPORT

RED/CONSEJO IBEROAMERICA DE DONACIÓN Y TRASPLANTE

STRTEGIC MEETING PLN CENTRAL AMERICA

& CARIBBEAN COSTA RICA SEPTEMBER 2007

ACUERDO DE SAN JOSÉ, COSTA RICA

QUALITY CONTROL AND MANAGEMENT OF TISSUE PROCUREMENT, EVALUATION, PROCESSING, BANKING, DISTRIBUTION AND APPLICATION OF HUMAN TISSUES -EU DIRECTIVES 2004/23/EC &2006/17/EC

OFICIAL EUROPEAN UNION

COURSE AVAILABLE IN SPANISH AND

ENGLISH

TRANSPLANT COMMITEE COUNCIL OF EUROPE

BERLIN 2-3 OCTUBRE 2009 RUDOLF G. GALLONT

GUATEMALA

ESTRASBURGO 11-12 DE MARZO FERNANDO MORALES

DOMINICANA

ATTENDANCE OF RCIDT OBSERVER IN TRANSPLANT COMMITEE

COUNCIL OF EUROPE

(25)

03/02/2015

Deceased Organ Donors

(Included

NHBD) Kidney

Transplants Liver Transplants Heart

Transplants Lung Transplants

Pancreas Transplants

4221

10922 (40.4% LD)

2377

(7.5% LD) 425 110 271

Deceased Organ Donors

(Included NHBD)

Kidney Transplants Liver

Transplants Heart Transplants Lung

Transplants Pancreas Transplants

3943

10112 (42.4% LD)

2168

(7.7% LD) 350 120 210

*2010 data (545 million inhabitants)

FROM 2005 TO 2012 GROWING UP TO 50 %

*2011 data (566,3 million inhabitants)

2005

3033

2012

4580

DONATION ACTIVITY IN LATIN AMERICA

SOMETHING’S MOVING...

...IN LATIN AMERICA

...WITH RESPECT TO ORGAN DONATION AND TRANSPLANTATION AND IN THE FIGHT AGAINST ORGAN TRAFFICKING

...VERY FAST

“If there is no organization, ideas, after the initial momentum, become less

effective”

THANK YOU VERY MUCH

ecoll@msssi.es

(26)

03/02/2015

The role of Professional Societies in development of organ donation

and transplantation

Philip O’Connell

The Mission

The Transplantation Society will provide the focus for global leadership in transplantation:

•development of the science and clinical practice

•scientific communication

•continuing education

•guidance on the ethical practice

Membership of The Transplantation Society and its Sections will be a pre-requisite for effective professional clinical and scientific practice in the field of transplantation worldwide.

The Transplantation Society will provide a comprehensive education program in the science and clinical practice of transplantation that improves patient outcomes, competence and performance of its members, the medical community and the general community

Science Clinical Care

Special Interests Public Policy Organ Donation

Advocacy

National Asian Societies

7 GOALS 8 STRATEGIES PROGRAMS

Membership- global membership of all health professionals and scientists working in the field of organs, cells &

tissue donation & transplantation Science and Practice - provide a pivotal role in development of the science &

clinical practice of donation &

transplantation of cells, tissues & organs and advance the safe, effective and ethical practice of transplantation for all.

Ethics - global leadership in the discussion and promotion of ethical clinical & research practice in donation

& transplantation of organs, cells and tissues

Education - Comprehensive education programs in the science and clinical practice of donation & transplantation that improves patient outcomes, competence & performance of members, the medical community and the general community

Communication - Comprehensive science, education and promotional communications programs that meets the needs of the science and clinical practice of donation & transplantation globally Relationships - Facilitate high quality relationships with and between stakeholders in donation &

transplantation

Management - Excellent leadership and management focused on implementing the strategies of TTS

1.1 Membership services & Benefits 1.2 Affiliated national societies 1.3 Community affiliations 1.4 Corporate membership 2.1 Sections Support 2.2 Council of Section Presidents 3.1 International Congresses 3.2 Alternate Years program 3.3 Basic Science Development 3.4 nKOL meetings 3.5 Specific topic meetings 4.1 CME Program 4.2 Postgraduate Education 4.4 Scholarships & Awards 5.1 Ethics Committee 5.2 WHO relationship 5.3 Declaration of Istanbul 5.4 GAT & society relationships 6.1 www.tts.org 6.2 Journals 6.3 Newsletter 6.4 Member &non-member eblasts 7.1 IHQ Office 7.2 PCO Services 7.3 Marketing 7.4 Historical Archives 8.0 Governance

1. Membership 2. Sections 3. Science 4. Education 5. Public Policy 6. Communications 7. Operations 8. Governance

SECTIONS

MEMBERS NATIONAL

SOCIETIES

REGIONAL SOCIETIES

GOVERNMENT ORGANISATIONS

INTERNATIONAL ORGANISATIONS

INTERNATIONAL SOCIETIES

GAT

MEMBERSHIP ^COUNTRY

AFFILIATES

WHO NGO

ORGAN DONATION

INDUSTRY

DICG

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03/02/2015

TTS Educational Meetings 2009 - 2010

2008

2010

2014

The Journal

Best Science

Advances in Clinical Care Dissemination of Clinical Practice Guidelines Forum for Discussion of Controversies

Promoting Research as Foundation of Good Clinical Practice

Guidelines

www.tts.org www.kdigo.org www.tts.org www.kdigo.org www.tts.org www.kdigo.org

The Declaration of Istanbul

on Organ Trafficking and Transplant Tourism

To address the growing problems of organ sales, transplant tourism and trafficking in organ donors in the context of the global shortage of organs, a Summit Meeting was held in Istanbul of more than 150 representatives of scientific and medical bodies from 78 countries around the world, and

Including government officials, social scientists, and ethicists.

Istanbul Summit

April 30 ^th – May 2 , 2008

DoIDoI DoI

DoI

DoI DoI

DoI DoIDoI

DoI DoI DoI DoI DoI

DoI

DoIDoIDoI

DoI DoI DoI

DoI DoI

DoI

DoI DoI

DoI

DoI DoI

DoI

DoI DoI

DoIDoI DoIDoI

DoI

DoIDoI

DoI DoI DoIDoI DoI

DoI DoI DoI

DoI

DoI DoI

DoI DoI DoI DoI DoI DoI DoI

DoI

Endorsements by 120 International and National

organisations

Algerian Society of Nephrology, Dialysis and Transplantation American Society of Nephrology

American Society of Pediatric Nephrology American Society of Transplantation Arab Society of Nephrology and Renal Transplantation Argentine Society of Nephrology Argentinean Transplant Society Asian Society of Transplantation Austrian Transplantation Society Belgian Transplant Society Brazilian Organ Transplant Association British Transplantation Society Canadian Society of Nephrology Canadian Society of Transplantation Canadian Association of Nephrology Nurse and Technologist Chilean Society of Transplantation Council of Europe Committee on Organ Donation Czech Transplant Society Danish Transplantation Society Egyptian Society of Nephrology and Transplantation Emirate Medical Association Nephrology Society (EMAN) European Heart and Lung Transplant Federation European Kidney Patients Federation European Society of Transplantation Eurotransplant Japanese Transplant Society Georgian Association of Transplantation German Organ Procurement Organization Grupo Puntacana - Latinamerican Transplant Coordinators Hong Kong Society of Nephrology Hong Kong Transplant Society Indian Society of Organ Transplantation Indonesian Society of Nephrology International Pediatric Transplantation Association International Pediatric Nephrology Association International Society of Heart and Lung transplantation Israel Medical Association

Israeli Transplantation Society Italian Society of Organ Transplantation (SITO) Iberaomerican Council of Organ Donation and Transplantation Jordanian Society of Nephrology

Korean Society for Transplantation

Kuwait Transplant Society Latvian Transplant Association Libyan National Organ Transplantation Program Libyan Society of Nephrology and Renal Transplantation Macedonian Society of Organ and Tissue Transplantation Malaysian Society of Transplantation Malaysian Ministry of Health Mali National Society of Nephrology Mexican Society of Transplantation Middle Eastern Society of Transplantation (MESOT) Moroccan Society of Nephrology National Kidney Foundation, United States

National Organization of Organ and Tissue Donation and Transplantation (NOOTDT-Lebanon)

National Transplantation Center, Mexico

National Transplant Center and National Council for Transplantation, Italy Netherlands Transplantation Society

New York State Transplantation Council Norwegian Society of Nephrology ONT/ Organización Nacional de Trasplantes Peruvian Society of Nephrology Philippine Medical Association Philippine Society of Nephrology Philippine College of Surgeons Philippine College of Physicians Polish Transplantation Society Renal Association of the United Kingdom Saudi Center for Organ Transplantation Scandiatransplant Society of Transplantation Singapore Société Francophone de Transplantation (SFT) South African Renal Society Swedish Society of Nephrology Swedish Transplantation Society Tajik Republican Research Transfusion Centre Thai Transplant Society

Transplantation Society of Australia and New Zealand (TSANZ) Transplantation Society of Latin America and the Caribbean (STALYC) Transplant Society of Pakistan

Tunisian Society of Nephrology Turkish Transplant Society Uruguayan Transplantation Society United Network for Organ Sharing (UNOS) United States World Transplant Games Federation

• Monitoring and implementation of the

principles of the DOI requires a formal structure – Integrated into existing structures, leveraging off

resources but an independent organization

• Memorandum of Understanding TTS and ISN – Co-Chairs

– Membership, terms, responsibilities

– Task Forces