Meeting Report
International Technical Consultation on Cell, Tissue and Organ Donation/Transplantation in the Western Pacific Region
20–21 February 2014 Seoul, Republic of Korea International Technical Consultation on Cell, Tissue and Organ Transplantation 20-21 February 2014, Seoul, Republic of Korea Report series number: RS/2014/GE/58(KOR) English only
INTERNATIONAL TECHNICAL CONSULTATION ON CELL, TISSUE AND ORGAN DONATION/TRANSPLANTATION IN THE WESTERN PACIFIC REGION
Convened by:
WORLD HEALTH ORGANIZATION REGIONAL OFFICE FOR THE WESTERN PACIFIC
Seoul, Republic of Korea 20 to 21 February 2014
Not for sale
Printed and distributed by: World Health Organization Regional Office for the Western Pacific Manila, Philippines
NOTE
The views expressed in this report are those of the participants of the International Consultation on Cell, Tissue and Organ Donation/Transplantation in the Western Pacific Region and do not necessarily reflect the policy of the World Health Organization.
The report has been prepared by the World Health Organization Regional Office for the Western Pacific for governments of Member States in the Region and for those who participated in the International Technical Consultation on Cell, Tissue and Organ Donation/Transplantation in the Western Pacific Region, 20-21 February 2014, Seoul, Republic of Korea. CONTENTS
Page
1. INTRODUCTION...... 3
1.1 Background ...... 3 1.2 Objectives ...... 3 1.3 Participants ...... 4 1.4 Organization and content ...... 4 1.5 Opening remarks ...... 4 1.6 Appointment of Chairperson and Rapporteurs ...... 5
2. PROCEEDINGS ...... 5
2.1 Self-sufficiency and the WHO initiative for Medical Products of Human Origin (Dr Luc Noel, WHO/HQ) ...... 5 2.2 Update on WHO activities and priorities in cell, tissues and organ transplantation (Dr Jose Ramon Nuñez) ...... 6 2.3 Essential legal and organizational requirements for national cell, tissue and organ transplantation services (Professor Jeremy Chapman) ...... 8 2.4 Matching Global Observatory on Donation and Transplantation data with country reports on activities and practices (Ms Mar Carmona) ...... 10 2.5 Regional experience in the development of organ donation after death - achievement in the Republic of Korea (Dr Cho Won-Hyun) ...... 15 2.6 Plans for increasing organ donation after death in Japan (Dr Naoshi Shinozaki) ...... 17 2.7 WHO role in encouraging organ donation after death (Dr Jose Nunez) ...... 18 2.8 Role of vigilance and surveillance, project NOTIFY (Dr Luc Noel) ...... 19 2.9 Information standard for blood and transplant ISBT128 (Mr Paul Ashford) ...... 21 2.10 The Council of Europe European Committee on Organ Transplantation (CD-P-TO) (Dr Marta Fraga) ...... 22 2.11 The Latin American Council (Dr Elizabeth Coll) ...... 24 2.12 The Role of Professionals Societies in the Development of Transplantation (Dr Phillip O'Connell) ...... 25 2.13 Visit of Dr Shin Young-soo – WHO Regional Director ...... 26 2.14 General discussion, conclusionsand Plan of Action ...... 26
3. CONCLUSION AND PLAN OF ACTION ...... 29
4. CLOSING ...... 29
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ANNEXES:
ANNEX 1 - LIST OF TEMPORARY ADVISERS AND SECRETARIAT
ANNEX 2 - TIMETABLE
ANNEX 3 - SPEECH OF DR SHIN YOUNG-SOO, WHO REGIONAL DIRECTOR FOR THE WESTERN PACIFIC
ANNEX 4 - PRESENTATIONS
Keywords:
Organ transplantation / Tissue and organ procurement / Transplantation – standards
1. INTRODUCTION
1.1 Background
Transplantation of cells, tissues and organs prolongs and improve quality of life. Transplantation activity has steadily increased worldwide in recent years. Globally, it is estimated that 78 000 kidney, 24 000 liver, 6000 heart, 4600 lung, 2400 pancreas and 170 small bowel transplantations were performed in 2012 (GODT website).
Unfortunately, end stage organ failure is also increasing, leading to significant unmet need. It is estimated that the nearly 115 000 solid organ transplants performed in 2012 represents less than 10% of the global requirement for organs (GODT website).
Countries therefore develop policies and systems to increase organs available for transplantation from living and deceased donors. The WHO has promoted ethical transplantation practices globally, first through the production of the “Guiding Principles on Human Organ Transplantation” in 1991, which were revised through World Health Assembly Resolution 63.22 dated 21 May 2010 entitled Human organ and tissue transplantation.
To date, transplantation practice in the Western Pacific Region has developed unevenly. Some countries in the Region have highly-developed nationally coordinated living and deceased donation programmes within appropriate legal and regulatory oversight, and world leading outcomes. Others countries have limited or no transplantation, or small unregulated programmes within single hospitals with limited data available on outcomes. Some countries have had to confront unethical practices.
A regional meeting was arranged in Seoul, Republic of Korea, on 20 and 21 February 2014, to discuss progress in countries of the Western Pacific Region and to enable exchange of ideas for promoting increased transplantation within recommended frameworks.
1.2 Objectives
The objectives of the consultation were:
(1) to discuss how to improve data collection and information sharing on cell, tissue and organ donation/transplantation in the Western Pacific region to ensure transparency and accountability of national authorities;
(2) to review the needs for national legislative frameworks and regulatory oversight regarding tissue and organ donation after death and make recommendations on how to strengthen these; and
(3) to discuss options for forming a regional expert group to promote collaboration, information sharing between national health authorities responsible for cell, tissue and organ donation and transplantation.
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1.3 Participants
Twenty-one temporary advisers from countries currently undertaking organ transplantation including, Australia, China, Japan, New Zealand, Malaysia, Mongolia Philippines, Republic of Korea, Singapore and Viet Nam attended the meeting. Also represented were bodies working to promote transplantation and information exchange within transplantation practice including the International Council for Commonality in Blood Banking Automation, the Council of Europe, the Transplantation Society and the Spanish Ministry of Health National Organisation of Transplants. A WHO Secretariat team from headquarters and the Western Pacific Regional Office also attended (Annex 1).
1.4 Organization and content
The meeting was held over two days. On the first day, after a formal welcome and photograph, the first session provided background from the WHO secretariat and included updates on WHO initiative for Medical Products of Human Origin. The second session was about legal organizational requirements for ethical transplantation practice, after which participants reported on the situation in individual countries including legal and regulatory structures and donor and transplant numbers by organ and donor source. The third session covered regional experiences in the development of donation after death and included updates from Republic of Korea, China and Japan.
The second day commenced with a session on global governance tools for donation and transplantation. The second session was about regional and subregional fora for health authorities in transplantation and covered the Council of Europe projects in the Black Sea region, and the Latin American Council. The final session provided a chance to discuss the role of scientific and professional societies, to have some general discussion about the content of the meeting and to conclude the meeting with resolutions for action. The workshop agenda is Annex 2.
1.5 Opening remarks
On behalf of Dr Shin Young-soo, WHO Regional Director for the Western Pacific, Dr Klara Tisocki, Team Leader, Essential Medicines and Health Technologies, WHO Western Pacific Regional Office welcomed participants. She thanked the Government of the Republic of Korea, Vitallink and the Transplantation Society for hosting and co-organizing the meeting. Dr Luc Noel, Special Advisor, WHO headquarters, delivered the opening remarks placing this meeting in the context of previous consultations in the Region, commencing with the WHO Consultation Meeting on Transplantation with Western Health Authorities in the Western Pacific Region in Manila in 2005. Dr Noel also recalled the key contribution to earlier meetings of Professor Carl Groth who passed away in February 2014. Professor Jeremy Chapman (Australia) was invited to make some comments and noted that Professor Groth had been one of the first to elucidate ideas about overcoming shortage of organs for transplantation globally.
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1.6 Appointment of Chairperson and Rapporteurs
The meeting participants elected Dr Cho Won-Hyun (Republic of Korea) as Chairperson, while Dr Nicholas Cross (New Zealand) and Dr Hirman Ismail (Malaysia) were asked to act as Rapporteurs.
2. PROCEEDINGS
2.1 Self-sufficiency and the WHO initiative for Medical Products of Human Origin (Dr Luc Noel, WHO/HQ)
Dr Luc Noel outlined the process that WHO has been undertaking since 2004, when issues and challenges in transplantation were discussed at the World Health Assembly (WHA). The WHA urged Member States to implement effective national oversight of procurement, processing and transplantation of human cells, tissues and organs, including ensuring accountability for human material and its traceability. Subsequently, WHO has been engaging health authorities, scientific and professional societies, experts, donors and recipients, and members of societies with the goal of fostering a common global attitude to transplantation.
Dr Noel also outlined the discrepancies apparent globally in access to transplantation. High-activity countries perform more than 70 transplantations per million population (pmp), whereas some countries have no access to transplantation. Issues specific to Asia include the high prevalence of viral hepatitis, leading to high rates of end stage liver failure, and a very large burden of end stage kidney disease (one quarter of the world’s dialysis patients live in Japan and China).
Dr Noel defined the self-sufficiency paradigm in transplantation — meeting the needs of patients from a given population with an adequate provision of transplantation services and supply of organs from that population. Self-sufficiency relies on increasing supply of transplantable organs, and reducing demand by prevention of end stage organ failure. For most countries in the Western Pacific this may seem a distant goal, but Dr Noel noted that in 2011, a handful of countries internationally (including Croatia, Norway, Portugal and Australia) provided kidney transplants to more patients that were added to the waiting list in those countries in that year.
There are four key principles underpinning the self-sufficiency paradigm:
(1) Government responsibility – national governments are responsible for achieving self-sufficiency in transplantation
(2) Equity – the burden of donation should be equitable across a population, not isolated to subsections. There should also be equity of access to organs for transplantation.
(3) Education – populations should be educated about the need for transplantation and donation, and also around prevention of end stage organ failure. Education should be via school curricula, media and health professionals.
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(4) Trust of the public – this is achieved through transparency of processes around organ donation and transplantation, and professionalism of the individuals and organizations involved.
Dr Noel described the WHO worldwide initiative on medical products of human origin (MPHO). MPHO are materials derived from the human body for clinical therapeutic application. This broad definition includes blood and blood products, cells, tissues, organs, gametes and embryos, secretions (for example, breast milk), and advanced cellular therapies developed ex vivo.
A key concept underlying the use of MPHO is recognition of their inherent humanity. Use of MPHO should be grounded in respect for the human body and dignity of persons (donors and recipients) involved. WHO is working towards standards of practice for MPHO including:
(1) Responsibility of government authorities for provision of MPHO;
(2) Equity – burden of donation and in allocation;
(3) Prohibition of financial gain – or where profit is not forbidden (for some MPHO), guarantee of transparency
(4) Genuine consent – donors and recipients
(5) Justified use of MPHO – backed by scientific evidence and in the absence of a comparable alternative
(6) Duty to constantly optimize – safety, quality, efficiency of procurement, process and clinical application of MPHO. This includes global vigilance and surveillance for outcomes via registries including the NOTIFY project
(7) Traceability and accountability – including broadening the use of ISBT128 labelling standard (initially developed for blood and blood product labelling) to include all MPHO
(8) Transparency – openness to scrutiny, while maintaining confidentiality and anonymity of individuals
2.2 Update on WHO activities and priorities in cell, tissues and organ transplantation (Dr Jose Ramon Nuñez)
Dr Jose Nuñez (WHO/HQ) presented data from the Global Observatory on Organ Donation and Transplantation. In 2012, approximately 114 700 solid organs were transplanted, an increase of 1.81% in 2011.
Kidney Liver Heart Lung Pancreas 77818 23986 5935 4359 2423
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There are approximately 1.9 million tissue grafts distributed from AATB accredited tissue banks each year, including more than 200 000 tissue grafts in Germany and 500 cornea transplants in Italy each year.
There are more than 50 000 haemopoietic stem cell transplants per year globally. There are 22 million donors registered.
Dr Nunez noted that Asia has typically low deceased donation rates, and low numbers of haemopoietic cell transplants performed per capita.
It was noted that countries need to learn from activities in different regions, while recognizing the different realities within each countries context.
The priorities for WHO in this area include:
(1) Guidance on the determination of death. This has commenced with meetings in Switzerland in 2010 and Canada in 2012. The next steps include a systematic review of the scientific literature and regional consultations with experts.
(2) Increasing the global visibility of the Global Observatory on Donation and Transplantation.
(3) Vigilance and surveillance, using the Notify Library.
(4) Strengthen collaboration within regions, including within the Western Pacific.
Discussion
Dr Vathsala (Singapore) noted that religious and societal differences in some countries within the Western Pacific make concepts of death different from other parts of the world, impacting deceased donation rates. She asked if religious consultation had been part of the work on determination of death. Dr Nunez responded that the WHO's goal is to clarify the technical and medical aspects of death to produce guidance which each country could use for development of local policies, rather than focusing on religious, bioethical or societal impacts on death.
Dr Vathsala also asked whether there had been any indication that governments within the Western Pacific Region were interested in collaboration on this issue. Dr Nunez responded that this was a work in progress and there had not been much as yet. Dr Noel noted that some countries had indicated keenness within the region to tackle issues in this area, including China’s progress at addressing deceased donation. Dr Noel noted that the WHO Regional Office for the Western Pacific could help facilitate change.
Dr Curie (Republic of Korea) noted that there was great geopolitical and social variability in the Western Pacific Region which might make cooperation difficult. Dr Nunez felt that it would be possible for countries with issues to learn from other countries within the region where challenges in organ donation and transplantation were being successfully overcome. Dr Tisocki agreed that the heterogeneous nature of the countries within the Western Pacific Region did cause challenges, and suggested that potentially small groups of similar countries or bilateral collaborations could also be helpful (including with countries who are not within the Western Pacific Region, if necessary).
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Dr Cho (Republic of Korea) noted that the issues facing individual countries were in fact global ones – if developing countries did not address issues they had the potential to affect others.
2.3 Essential legal and organisational requirements for national cell, tissue and organ transplantation services (Professor Jeremy Chapman)
Professor Jeremy Chapman (Australia) presented the framework required for both deceased and living donor transplantation services. The framework is established by the WHO Guiding Principles on Human Cell, Tissue and Organ Transplantation (ratified by the 62nd World Health Assembly on 21 May 2010), the Declaration of Istanbul and the Madrid Resolution.
Professor Chapman noted that there are legal and regulatory requirements, that health authorities and governments need to address (via appropriate legislation and regulation), and then there are process elements that need addressing from a medical perspective (via appropriate medical protocols).
He used kidney transplantation as an example, and illustrated the process for living donor transplantation first:
Legislative and Regulatory Framework Surgical HLA Lab Living Acute Team Dialysis Donor Funding Capacity Transplantation Mechanism
Post Tx Drug Care program
Data Systems
He noted that deceased donation services are more organizationally complex, as they require additional structures for identification and management of donors, and chronic dialysis programme pool of potential recipients, organ retrieval services and allocation protocols.
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Legislative and Regulatory Framework
On Call HLA Lab Team Deceased Donor Chronic Waiting List Transplantation Funding Dialysis and Mechanisms
Program Allocation
Post Tx Drug Care program Organ/Tissue Procurement/ Banking Data Systems
ICU/Brain Death
A good legal framework is the fundamental first step. There are multiple elements which may be contained in several laws including:
1) ownership and gift laws; 2) therapeutic goods laws/regulations; 3) private health care laws/regulations; 4) customs and excise laws/regulations; 5) consent frameworks; and 6) definitions of nationality
There are fundamental issues that need to be addressed in transplantation laws in each jurisdiction. These issues should be resolved with reference to the Guiding Principles and the Declaration of Istanbul, and include:
1) The extent of inclusion of all Medical Products of Human Origin 2) The basis of consent for deceased donation (presumed consent vs explicit consent; first person consent) 3) The definition of death
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All elements of transplantation practice should be covered, including parts that are not intended to be provided, either initially or at all, to ensure there is protection for the population from the development of unethical or dangerous practices.
Discussion
Dr Cho (Republic of Korea) noted that questions in this area are complex and can only be addressed through discussions at national level within each country. Professor Philip O’Connell (Australia/TTS) agreed but noted that the complexity is universal and individual jurisdictions could learn from others particularly at a legal level for what needs to be covered.
Professor Chapman also noted that governments can collaborate with each other in this area and that the New South Wales (Australia) is an example of a local government that had provided assistance to other local governments. He also noted that the initial questions are political – individual governments have to decide what types of transplantation services they are willing and able to support. Once this is clear, the legal, regulatory and clinical pathways need to follow.
2.4 Matching Global Observatory on Donation and Transplantation data with country reports on activities and practices (Ms Mar Carmona)
Ms Mar Carmona (ONT, Spain) presented the initial data for this session and chaired the session as the temporary advisers reported on the situation in individual countries.
The World Health Assembly resolution WHA63.22 (May 2010) urged Member States to collaborate on collecting data including adverse events and reactions on the practices, safety, quality, efficacy, epidemiology and ethics of donation and transplantation. The Organización Nacional de Trasplantes (ONT) has been designated as a WHO Collaborating Centre to accomplish this.
GODT covers the 194 WHO Member States and currently contains information on legislative and organizational aspects, and annual donation and transplantation activities. Data is sourced from national authorities, or official designated authorities.
Data is collected by questionnaires from national focal point individuals within countries. Ms Carmona noted that it was important that there was collaboration between national health authorities and professionals in providing this data.
Data is analyzed and graphics and official maps are produced. The analysis is published on the GODT website which is freely available, and via presentations and journal publications.
For this session, the questionnaire used was provided to a representative from each country for completion before the meeting, to enable comparison with the data the ONT have collected.
Individual country data was presented for the remainder of the session as well as subsequent session. This was collated and summarized by Ms Carmona and then fed back to participants. Reports were received from Australia, China, Japan, Malaysia, Mongolia, New Zealand, the Philippines, Republic of Korea, Singapore and Viet Nam. Ms Carmona also presented data on Fiji.
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2.4.1. Functioning transplant programme
All participating countries that reported have functioning solid organ transplantation programmes with living and deceased donation, except for Mongolia which only has a living donor programme, and Fiji which has no transplant programme.
2.4.2 Donation and transplantation activity
Table 1: Transplantation activity by donor source, organ type, year and country
AUS CHN JPN MYS MNG NZL PHL KOR SGP
Year 2012 2010 2012 2012 2012 2012 2011 2012 2012
All Deceased 354 110 18 0 38 43 459 15 donors
DBD 277 45 18 0 38 43 458 15
DCD 77 65 0 0 0 0 1 0
All DD Kidney 606 4577 193 29 0 54 86 768 23
DBD Kidney 477 77 29 0 54 86 766 23
DCD Kidney 129 116 0 0 0 0 2 0
All LD Kidney 237 963 1412 22 12 54 299 1015 24
Unrelated 28 0 559 0 22 149 35 4
Related 209 853 22 12 32 150 980 20
All DD Liver 227 2082 41 7 0 32 363 11
DBD Liver 210 41 7 0 32 363 11
DCD Liver 17 0 0 0 0 0
All LD Liver 4 62 382 0 5 3 897 11
Heart 76 147 28 0 0 12 107 2
Lung 148 33 44 0 0 12 37 1
Pancreas 38 27 0 0 3 34 1
DBD = donation after brain death; DCD = donation after cardiac death; DD = deceased donor; LD = living donor
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2.4.3 Legislation
All participating countries except Fiji reported that donation and/or transplantation is covered by legal requirements. Legal requirements vary:
Table 2: Aspects of donation/transplantation covered by legislation by country
Country Deceased Living Allocation Organ Organ donation donation transplantation Trafficking
Australia Yes Yes No No Yes
China Yes Yes Yes Yes Yes
Japan Yes No Yes No Yes
Malaysia Yes No No No Yes
Mongolia Yes Yes Yes Yes No
New Zealand Yes Yes No No Yes
Philippines Yes No No No Yes
Rep. of Yes Yes Yes Yes Yes Korea
Singapore Yes Yes Yes Yes Yes
Viet Nam Yes Yes Yes Yes No
Living unrelated donation is permitted in all participating countries except China.
It is a legal requirement to report all transplantation activities in all participating countries except Australia, Malaysia and Mongolia. China, Japan, Republic of Korea and Viet Nam require centres to report deceased donors.
All participating countries except New Zealand and Singapore report intent to adopt or revise legal requirements.
2.4.4 Financial incentives
Incentives to obtain consent for deceased donation are permitted in the Philippines and the Republic of Korea, but prohibited in other countries.
Financial incentives are permitted for living donors in the Philippines and the Republic Korea only. However, in the Republic of Korea, incentives are regulated by the government but not in the Philippines.
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China reports that living donors are prioritized in organ allocation if they subsequently require a transplant.
2.4.5 Organ trafficking
Explicit legal prohibition of, and penalties for, organ trafficking and transplant tourism exists in all countries except Malaysia and Mongolia.
2.4.6 Organizational system
All participating countries have a government-recognized authority responsible for overseeing donation and/or transplantation, except Fiji (which has neither) and New Zealand, which has an authority responsible for overseeing donation but not transplantation. All countries have organizations, institutions or agencies responsible for performance of organ donation and/or transplantation, and all report to the respective Ministries of Health (except Fiji).
2.4.7 Coverage of costs
There is variability in how donation and transplantation activity is funded among countries, with most countries relying on a variety of sources. In most countries, recipients meet the costs of post transplant care and drugs, either entirely (China, Fiji, the Philippines) or in part (Australia, Japan, Republic of Korea, Singapore, Viet Nam).
Table 3: Coverage of Organ Procurement Costs by Country
Country State Private Health Recipients Other Insurance
Australia Yes No No No
China Yes No Yes No
Fiji No No No Overseas hospital offering service
Japan No Yes Yes Government funding to Japan Organ Transplant Network (JOT)
Malaysia Yes Yes Yes No
Mongolia - - - -
New Zealand Yes No No No
Philippines Yes No Yes No
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Rep. of Korea Yes Yes Yes No
Singapore Yes Yes Yes No
Viet Nam No Yes Yes No
Table 4: Coverage of Transplantation Costs by Country
Country State Private Health Recipients Other Insurance
Australia Yes No No No
China Yes Yes Yes No
Fiji No No Yes No
Japan No Yes No No
Malaysia Yes Yes Yes No
Mongolia Yes No Yes No
New Zealand Yes No No No
Philippines Yes Yes Yes No
Rep. of Korea Yes Yes Yes No
Singapore Yes Yes Yes No
Viet Nam No No No Yes
2.4.8 Transplantation provided abroad
Only Australia reported a formal framework for providing transplantation for Australian permanent residents in other countries (the national Medical Treatment Overseas Programme). This is used by Australians requiring transplants not provided in Australia, for example, complex small bowel transplantation.
For citizens undergoing transplantation abroad, or donating organs abroad, health care is assured on return to home nation in Australia, China, Malaysia, Mongolia, New Zealand, Philippines, and Viet Nam. In Fiji, Japan and Republic of Korea, a report follow-up is not assured on return.
Australia, Fiji, Mongolia, the Philippines and Viet Nam report that living donor-recipient pairs travel overseas to access transplantation in some circumstances.
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Discussion
Dr Vathsala noted that the interpretation of ‘incentive’ varies between reporters and that reimbursement for medical care and funeral costs with respect to deceased donors should not be defined as an ‘incentive’. She asked for clarification from the WHO secretariat on this. Dr Noel responded that for those in financial need authorities should meet funeral costs and that a ‘common sense’ approach was needed to define incentives from reimbursement of costs.
Dr Cho noted that Australia had many more lung transplants per capita than other countries in the Western Pacific Region. Dr O’Connell responded that this was due to two factors – sophisticated pre-transplantation ex vivo reconditioning work being undertaken at the Melbourne transplant unit (enabling use of lungs that may otherwise have been discarded) and the high prevalence of cystic fibrosis in European Australians.
Dr O’Connell asked if the Chinese donation allocation was performed centrally or locally. Dr Liu responded that China has a central allocation scheme (although this does not apply to organs from executed prisoners).
Dr Noel asked if there was increased training in China for transplant teams. Dr Liu confirmed this was being undertaken, with the assistance of the Chinese Red Cross.
Dr Tisocki asked Dr Vathsala to clarify if there had been any prosecutions in Singapore for violation of regulations around the use of living donors. Dr Vathsala is only aware of one prosecution, and also noted that the application of the regulation relies on the ethical standards of the professionals involved.
Dr Cho asked how many transplant surgeons are in Viet Nam and Dr Phuc responded that there are approximately 10.
2.5 Regional experience in the development of organ donation after death - achievement in the Republic of Korea (Dr Cho Won-Hyun)
Deceased donation rates in the Republic of Korea have remained very low (<3 donors pmp) since the 1970s. From the late 1990s, a series of legislative and structural changes took place to address this, including brain death legislation (1999), prohibition of organ trade within the Republic of Korea (2000), creation of a nationwide organ waiting list and allocation system (Korean Network for Organ Sharing (KONOS), 2000) and creation of hospital based organ procurement organizations (2003).
Structural change was insufficient to achieve increased transplantation initially. Medical changes were required including cooperation during procurement between medical centres, and revision of the allocation system. Social change was directed at increasing awareness and consensus within the population in favour of organ donation. There was an expanded campaign that focused on students, engagement with community agencies including the Police, Ministry of Health, Congress, and engagement of media. Organ donation campaigns were undertaken by cooperating nongovernmental organizations, including Vitallink, which joined together as the Korean Organ Donation Network (KoDoNet).
Improvements in the donation rate after death is the result of a sustained, broad effort.
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No of DD DD pmp 450 30 KoDoNet 409 400 368 KODA 25 350 Vitallink 300 20 268 256 261 250 Legislation 15 200 KONOS 148 162 141 150 8.03 10 7.24 100 86 91 5.17 5.24 5.31 68 3.42 52 52 2.88 3.00 5 50 36 1.77 1.87 1.09 1.08 0.75 1.41 0 0 19992000200120022003200420052006200720082009201020112012
Discussion
Professor O’Connell noted that the Republic of Korea and Australia are very different culturally, but that the progress made in both countries has been achieved with similar reform.
Professor Chapman noted the substantial (approximately 2/3) reduction in the deceased donor rate in 2000 immediately after the introduction of the KONOS legislation, and asked if this might be due to the introduction of a national allocation scheme reducing local clinical incentives to retrieve organs – previously, hospitals retrieving organs would gain the benefit of performing the transplants. Dr Cho agreed that this probably had an effect.
Dr Noel noted that it has been suggested that population education about donation and transplantation should include school-baased programmes. He also noted that nongovernmental organizations were responsible for delivering education to the population. He asked if the Republic of Korea had considered school-based education in that context. Dr Cho responded that there was resistance to providing education around these topics to elementary and middle schools, and the approach had been to educate parents and students together.
Ms Yael Cass (Australia) noted that engagement of Emergency and Intensive Care physicians was key to increasing donation, and asked whether the respective professional societies were involved. Dr Ha Jong-Won (Republic of Korea) responded that at the individual level, doctors working in Emergency and Intensive Care departments were involved. But he also note that Korean Intensive Care units tend to be ‘open units’ where care is provided by a broad range of visiting specialists, rather than by Intensive Care doctors. Dr Cho also mentioned that there was government funding provided for education and advertising.
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2.6 Plans for increasing organ donation after death in Japan (Dr Naoshi Shinozaki)
Japan is a country with 126 million people, and while solid organ transplantation has been undertaken since the 1960s, Japan is an outlier among developed countries with a very low transplantation rate. In 2012 there were only 110 deceased donors in Japan.
In Japan, it is felt to be system issues rather than a cultural resistance to deceased donation. The Ministry of Health, Labour and Welfare have appointed a council for the promotion of organ transplantation to discuss and make decisions about how to promote organ donation and transplantation in the country.
From 2012 to 2014, seminars aiming to increase donor identification within hospitals, to educate in-house donor coordinators and to improve systems within hospitals have been run in collaboration with the Japan Emergency Medicine Society, the Clinical Emergency Medicine Society of Japan, the Japan Neurological Medicine Society, the Emergency Nurse Society and the Japan Organ Transplant Network.
Dr Shinozaki presented data suggesting that health professionals working within coronary care units in Japan are less supportive of donation, less confident with discussions about donation, and are less likely to have received specific training in aspects of the donation process than counterparts from Europe, indicating a need for ongoing education for health care workers. He also presented data showing the highly variable consent rate between transplant coordinators, attributed to varying humanistic skill levels, reinforcing the notion that specialist training for coordinators to increase skills is required.
An additional issue identified is that driver’s licenses, which previously contained information about the individual’s decisions about organ donation, are not held by a substantial proportion of the population. Therefore from 2015, donor wishes will be added to the back of social health insurance cards instead.
Japan is currently undergoing the process of reorganizing the responsibility for oversight of donation and transplantation activities, and the promotion of them, into prefectures with oversight across several hospitals and institutions.
Discussion
Dr Nunez asked if there was funding available for donor coordinators within hospitals. Dr Shinozaki responded that there were a small number of transplant coordinators within the central Japanese Organ Transplant (JOT) network who were directly funded, but that individual hospital level coordinators were funded by individual hospitals. Dr Ha Jong-Won commented that individual hospitals may not decide therefore to hire coordinators as there would not be direct benefit to those hospitals.
Professor O’Connell noted that Intensivists need to be closely involved in the process to increase organ donation, and asked if there was engagement of the Intensive Care professional societies. Dr Shinozaki confirmed that there were ongoing efforts.
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Discussion around payments made to families of organ donors
During this session there was a general discussion about the nature of payments made to families of organ donors, in light of Guiding Principles 5 of the WHO Guiding Principles on Human Cell, Tissue and Organ Transplantation (WHA 63.22):
There was discussion as to how payments could be distinguished from reimbursement for reasonable expenses.
Dr Ha Jong-won reported that families of deceased donors (organs and tissues) may be provided with cash payments to defer expenses of up to $7000. He felt this did constitute an incentive under Principle 5.
Dr Rose Liquete (Philippines) reported that families of donors may receive financial assistance to cover the cost of burial and/or funerals.
Dr Noel pointed out that there was a ‘frail difference’ between incentives and reimbursements, and that a key imperative was to monitor the equity of donation within a population. Where incentives to donate were operating, underprivileged subsections of populations would be overrepresented among donors. This should cause countries to revisit their policy.
Professor Chapman noted that removal of disincentives to donation were not precluded (i.e. covering costs that would be incurred by the process of donation, including any ongoing medical care for the donor during the assessment and donation process), but that all other payments were incentives.
Professor O’Connell mentioned that transparency was important and countries should openly acknowledge and report where there was money available to donors, to enable scrutiny. Countries were encouraged to report all reimbursements or payments that were made to donors or donor families in the GODT survey.
2.7 WHO role in encouraging organ donation after death (Dr Jose Nunez)
Internationally, it may be said that transplantation has become a victim of its own success – excellent outcomes for transplant recipients increase demand for transplantation, leading to ever expanding waiting lists. In 2012, the 114 000 organs transplanted represent only 10% of the estimated global need.
The shortage of deceased donors has led to the use of living donors as a source of kidneys and livers. However, increasing recognition of the potential harm to living donors and expansion
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of deceased donor programmes has seen a reduction in the proportion of kidney transplants from living donors internationally in recent years, from 46.2% in 2008 to 42.5% in 2011. Living liver donors account for around 15% of all liver transplants performed.
In recognition of the need to expand deceased donation internationally, WHO developed the 4D programme (Developing Donations from Deceased Donors).
It was noted that the human development index (HDI) and deceased donor rate is poorly correlated, indicating that the availability of financial resources is not a key constraint to increasing deceased donation.
It is recognized that there is no single unique formula for increasing deceased donation, but there are well-proven, successful models to be taken as reference. Each country must then diagnose its situation and find the best ways to work towards self-sufficiency in transplantation.
2.8 Role of vigilance and surveillance, project NOTIFY (Dr Luc Noel)
Dr Noel outlined the WHO initiative to have three global governance tools for all medical products of human origin (MPHO) to address aspects of the Guiding Principles (WHA63.22) :
1) Standards of practices common to MPHO, including the non-commercial nature of the human body and its parts to be used for therapeutic purposes; 2) Universal use of the Information Standards for Blood and Transplant (ISBT) labelling standard 128 within 10 years 3) Global vigilance and surveillance, via Project NOTIFY, towards using making best use of the global experience of adverse events and reactions related to use of MPHO
Project NOTIFY aims to be a repository for all serious adverse events and reactions in the context of the use of MPHO, including transplanted organs and tissues. The definitions of serious adverse events and reactions are common to the European Union and Project NOTIFY:
‘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, hospitalization or morbidity.
‘Serious Adverse Event (SAE)’ means any untoward occurrence associated 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
Dr Noel clarified that a SAR was an adverse response that has occurred in a living donor or recipient, related to transplantation, whereas a SAE was an adverse occurrence that could have led to harm (i.e. a SAR) in a living donor or recipient.
NOTIFY project commenced in 2010 and in its current form after the 2010 Bologna Initiative for Global Vigilance and Surveillance Meeting. Further meetings have been held annually.
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There is recognition that global vigilance and reporting of adverse outcomes is important for building trust of communities in the process of transplantation. Community trust in turn is key to maintaining and increasing deceased donation.
The NOTIFY project consists of
• 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
The NOTIFY website is open access and allows searching for SAE/SAR by parameters including type (malignancy, infection etc.), recipient, MPHO type, and also text words.
Events and reactions are retrieved from ongoing structured, comprehensive literature reviews, and direct communications from competent national authorities and scientific professional societies. Reported events are reviewed by five expert editorial working groups (Infection, Malignancy, Handling Errors, Genetic, and Living Donor) and decisions taken to accept or reject the potential record documented. Ongoing analysis is undertaken, and ad hoc queries are answered. The proposed NOTIFY Journal will publish reports and synthesised data, and would enable reporting of anonymised reports where identification would prevent release of the information to the global community.
While the database is in English, portals in other languages are being developed to facilitate access to the data.
Discussion
Professor O’Connell noted that transmission of disease is a rare event, so when it happens, any individual unit will have very limited or no experience. Project NOTIFY provides an important function in sharing information about rare events.
Dr Noel added that Project NOTIFY is not a reporting database, rather it provides an extra layer to bring attention to issues. Individual countries still require mechanisms for surveillance, but Project NOTIFY may add an incentive to develop national surveillance systems, in order to contribute.
Ms Cass asked what the criteria are for deciding whether there should be a systematic response from the international community. Dr Noel noted that NOTIFY is only starting and not currently in a position to provide this function. This is difficult, and the frequency of issues is likely to change over time and by region. A functioning database needs lots of data, and this is really the start. But it does have an important function now, for example, knowing that rare things can happen (e.g. accidental discarding of a kidney for transplant) may enable units to critically appraise their processes now to avoid potential for events. Dr Noel also recognized that there has been a large amount of work by professionals and authorities to date to get the library started – at least 200 people have given time and energy to this from all WHO regions. This is a strong demonstration that professionals in this area are dedicated to improving outcomes.
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Professor Chapman noted that Project NOTIFY is a library, rather than a system for providing rapid alerts to the transplantation community. He felt that there was a lot of difficult work that still needs to be done on how to appropriately merge the gray literature. He commended Dr Noel and the Italian team who have led this work to date.
Dr Shinozaki asked if alerts can be provided for severe adverse reactions as he felt this would be very beneficial for professionals and health authorities and would also provide incentives for health professionals and authorities to contribute. Dr Noel responded that this raises the issue of the need for clarity around who would be the correct person for each country to provide the data to NOTIFY. Currently, they use official reports from national surveillance programmes where they exist.
Dr Noel also commented that relying on the published literature is not good enough for detecting all events. Publishing is variable between countries. For example, some of the information about adverse reactions from the USA is not published due to the risk of litigation. But ultimately, when everyone understands the value of sharing this type of information, there will be harmonization of practice. The process is just beginning.
2.9 Information standard for blood and transplant ISBT128 (Mr Paul Ashford)
The International Council for Commonality in Blood Bank Automation (ICCBBA) aims to enhance patient safety by promoting and managing the Information Standard for Blood and Transplantation 128 standard.
ISBT128 developed after the first Gulf War after the US Department of Defence requested standardized labelling of blood for transfusion. The first version of the standard was published in 1994. ISBT128 was expanded to cover all cellular therapies in 2000, and current work is underway to extend it to cover all medical products of human origin, including organs, tissues, milk, tissue engineering and advanced therapy.
ISBT128 provides globally unique identification numbers and standardized terminology to ensure understanding across multiple languages. Standardized labelling is essential for traceability to enable recall, vigilance and surveillance, and long term follow up across jurisdictions and over long time periods. ISBT128 also provides the standard for electronic data transfer systems to ensure error free rapid transfer of critical information.
Standardized terminology is important at several levels, including:
1) Clinical application – detailed descriptions are required to distinguish clinically distinct variants 2) Activity data collection – data needs to be captured at a more generic level of description 3) Vigilance and surveillance – identify trends by collating data across many product types
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Discussion
Dr Ismail Hirman (Malaysia) asked how ISBT128 was facilitated in low and middle income countries. Mr Ashford responded that there is a tiered approach based on the human development index (HDI).
Dr Ha asked at what level the development for solid organ tracking had reached. Mr Ashford responded that the description of organs is done, but there is still work to do to produce standardised descriptors of other key parameters.
Dr Tisocki asked how the uptake of ISBT128 in the Western Pacific Region could be encouraged. Mr Ashford responded that awareness of the standard by governments and regulators was the first step. Accreditation bodies can also be very helpful – sometimes individual facilities want to implement the standard but are unable to get funding until the accreditors insist that the standard is required. Meetings such as this are also very helpful for promoting the standard.
Professor Cho noted that self-sufficiency in transplantation is promoted by the WHO on the one hand, but then the ISBT128 enables international sharing of tissues on the other, which might be seen as a contradiction. Dr Noel responded that some sophisticated tissue products require a high level of processing that will inevitably mean they are produced in only a few locations in the world and will need to cross boundaries. A standardized coding system is also very important in this regard.
2.10 The Council of Europe European Committee on Organ Transplantation (CD-P-TO) (Dr Marta Fraga)
Dr Fraga from the European Directorate for the Quality of Medicines and Healthcare reported on the experience in the Black Sea Area Project (BSA) international collaboration around donation and transplantation.
Within Europe there is tremendous heterogeneity with respect to organ donation and transplantation. Many countries in Western Europe have in excess of 20 deceased donors per million population per year, and perform 50 or more transplants per million persons per year. However, most countries in the Black Sea region have very low or negligible rates of donation and transplantation.
The Council of Europe has been actively working in the area of organ donation and transplantation since 1987, and the European Committee on Organ Transplantation (CD-P-TO) has 71 representatives from 32 Member States and 20 observer states and organizations (including the WHO). International collaborative approaches have been used to address the organ shortage in different countries. The CD-P-TO aims to enhance the exchange of knowledge, expertise and good practices between member states, and to elaborate tailor made programmes adapted for the socioeconomic context of different member states.
The CD-P-TO assisted Moldova between 2006 and 2008, during which time a new transplant law was developed and a transplantation authority established. Based on the positive experiences gained, the CD-P-TO proposed a BSA regional project (including Romania, Moldova, Ukraine, Russia, Georgia, Turkey, and Bulgaria).
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The project aimed to address legislative requirements, establish national authorities, provide public and professional education about donation and transplantation, identify areas where additional training was required and to enhance regional networking and cooperation.
The project participants consisted of national focal point contacts within governments of each participating country, the CD-P-TO steering committee, and partners and supporters from expert organisations and professional societies.
It became apparent that within the participating countries there were natural groupings of countries based on the current level of transplantation activity. While all countries worked on all aspects of the project, the level of development dictated which work stream required the most attention.
The Russian Federation, Turkey and Romania all had established infrastructures and significant transplant activity that focus on increasing transplantation from deceased donors. Ukraine, Moldova and Bulgaria had minimal activity and set about creating National Transplantation authorities to create an infrastructure for deceased donation. Armenia, Azerbaijan and Georgia had no transplantation activity, so focus was on political engagement and support to deliver legislation and financing.
There was no universal successful approach to transplantation development in the BSA. However, there were three key components:
1) Government support - governments have to be willing to invest to make it sustainable, rather than expect support from external sources 2) Technical support - the committee needed to work directly with technical staff in each country who were able to implement recommendations 3) International support - expertise is needed from well-developed countries to help develop individualized solutions for each nation.
Discussion
Dr Vathsala asked how the first step, getting government support, was achieved. Dr Fraga responded that governments are often amendable to financial arguments about the cost effectiveness of organ transplantation relative to other therapies for organ failure. In addition, patient associations were helpful, and powerful within some countries.
Professor O’Connell noted that the major costs of transplantation have reduced in recent years, especially drug costs, relative to the costs used in many formal cost-benefit analyses. Recalculating costs now would probably show transplantation to be even more cost-effective. Dr Fraga agreed with this and also noted that governments were able to make good deals to buy immunosuppressive drugs for developing countries’ transplant programmes.
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2.11 The Latin American Council (Dr Elizabeth Coll)
Dr Coll (Spain) reported on the collaborative approach the Spanish Organización Nacional de Trasplantes (ONT) has led to assist countries in Latin America to improve organ donation and transplantation.
In Spain, donation activity is part of routine medical activity of the hospital. Professional activity of donor coordinators is recognized and reimbursed. Spain’s excellent record in increasing deceased donation and transplantation from the late 1980s meant Spain was perfectly positioned to help Latin American countries.
The collaboration started in 1994 when recipient doctors and surgeons from Latin America came to Spain asking for assistance. This led directly to the Siembra programme. Thirty physicians form Latin America went to Spain for training in donation management.
This initial group continued to meet on return to their own countries, and developed into a network of friends, that eventually developed into Punta Cana group.
At this point, it was recognized that formal Government support was needed in order to develop a fully functional official transplantation network. A series of declarations in the early 2000s sought enhanced collaboration including government level collaboration, media engagement, training programme coordination, implementation of a registry and the establishment of an official forum on donation and transplantation, in line with WHA57.18.
In 2004, the Spain-Pan American Health Organisation (PAHO) programme started, with the main objective of promotion and development of programmes of donation and kidney transplantation in Latin America. Joint meetings of ONT and PAHO were held in 2005, and resolved a number of priority actions:
1) global analysis of donation and transplantation in Latin America; 2) training programmes on donation and transplantation; 3) standard definitions and clinical practice guidelines; 4) definition of improvement areas and cooperation in management and organization; 5) communication and information policies; 6) improvement strategies on immunotherapy; and 7) economic analysis of donation and transplantation
At the Seventh Iberoamerican Conference of Health Ministers in September 2005, approval was given for the establishment of the Iberoamerican Council and Network of Donation and Transplantation. This commitment was reiterated in the Declaration of Salamanca of the 2005 Iberoamerican Summit of Heads of States and Governments. The Council met later that year for the first time.
The Iberoamerican Council/Network of Organ and Tissue Donation and Transplantation (RCIDT) consists of official delegates from Member States, representation from PAHO and representatives from Spain. RCIDT has met frequently and been very successful at ongoing facilitating of training for donation coordinators and physicians, who travel to Spain for a two-month training programme. RCIDT has also provided training for communication in critical situations for more than 5000 health professionals. The RCIDT, along with the Colombian Government have successfully eliminated transplant tourism in the country. The RCIDT has
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developed guidelines for all aspects of donation and transplantation in Latin America, assisting countries to develop laws and regulations for transplantation practice. Between 2005 and 2012, donations increased by 50% in Latin America.
Discussion
Professor Chapman asked both Dr Fraga and Dr Coll whether, in the situations described, if language and religion commonality was critical to the successes of both programmes, and whether heterogeneity of either was a barrier to successful international collaboration. Dr Coll agreed that in the Latin American situation, common language and religion were facilitators, enabling countries to take the first steps in collaborating. Dr Fraga noted that there were issues around language in the Black Sea project. The common language in that region is Russian, and there were difficulties communicating with local doctors. The Moldovans, who had been involved in the earlier project, were crucial at providing a link and transmitting information to colleagues. There were also political/religious dissimilarities making it difficult for some geographically and developmentally close countries to collaborate directly. Ultimately, where there were common language and religious ideals this made collaboration easier.
On enhancing collaboration on donation and transplantation, Dr Vathsala noted that Asian countries had not always worked well together in this area, due to heterogeneity and even economic disparity. Strong political movements in Europe and Latin America can provide major starting points in developing cooperation between governments in Asia.
2.12 The Role of Professionals Societies in the Development of Transplantation (Dr Phillip O'Connell)
Professor O’Connell, President-Elect of the Transplantation Society (TTS), described the role that TTS has in promoting the development of transplantation globally.
TTS is the only truly global society in the field of transplantation. TTS liaises closely with national and regional transplantation societies, such as the Asian Society of Transplantation (AST). It also has close relationships with governmental and non-governmental organisations, such as WHO. TTS seeks membership from all transplantation health professionals and scientists working in the field. TTS provides education, global leadership and promotion of ethical research and practice in donation and transplantation. TTS facilitates educational meetings globally, including in emerging transplanting countries. In association with other bodies, including ONT, WHO and the United Nations, TTS has been instrumental in producing important guidelines such as the Declaration of Istanbul on Organ Trafficking and Transplant Tourism, and the Kidney Disease: Improving Global Outcomes (KDIGO) Clinical Practice Guideline for the Care of Kidney Transplant Recipients.
Professor O’Connell noted that transplantation will always be somewhat of a niche practice, even in countries with high transplantation rates. In many countries therefore, not all possible expertise exists, but with strong international links and networking, information can be shared, providing assistance to transplant professionals, leading to better outcomes for transplant recipients.
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2.13 Visit of Dr Shin Young-soo – Regional Director, WHO Western Pacific Region
Dr Shin attended the consultation meetings on the second day and made some comments. Dr Shin noted the critical nature of organ transplantation, and the shortage of organs. The Region has advancement of clinical knowledge on one hand, but on the other, the shortage of organs is limiting application. With advancing life expectancy, more people are going to need this type of intervention.
Dr Shin commented that he is hopeful that there will be an improved networking from this consultation. Further work is needed to address organ trafficking. Dr Shin noted that WHO has many issues to address and cannot manage everything hence experts are needed. WHO will continue to support this area in the future.
2.14 General discussion, conclusions and Plan of Action
Participants engaged in general discussion about the consultation, led by the Chairman and Dr Noel.
Dr Liquete reflected that while her country already has a framework and policy on transplant, political issues mean that she has not seen any improvement in the past years. Transplant professionals often return from abroad with good ideas, but implementation is difficult. Dr Noel noted that there seems to be some impetus within the Philippines to develop deceased donation policies. Dr Liquete commented that the professionals e will strive to achieve this but will need support from the government and the legislature.
Dr Tisocki noted translating good intentions for reform into reality is very challenging in many areas due to main barriers. Dr Liquete responded that resources were key, and felt that the Philippine Government will need help from nongovernmental organizations, and that the organ procurement authority does not train enough coordinators. Dr Noel commented that all countries need to find their own solutions, but sharing experiences will help.
Dr Buyanjargal Yadamsuren (Mongolia) noted that there are religions and ethnic barriers to development of transplantation in Mongolia. She reiterated the need for the key structures discussed during meeting to be implemented in Mongolia. Dr Noel commented that Mongolia is an example of a country which would benefit greatly from a collaborative approach by countries in the region. Dr Yadamsuren confirmed Mongolia lacks transplantation laws, policies and guidelines. Dr Cho suggested that transplantation experts within Mongolia should recommend that this is pursued, but that neurologist and neurosurgeons should be involved so a definition of brain death can be reached by local experts.
Dr Yadamsuren felt that Mongolia was “fresh green ground” as far as transplantation was concerned, and any regional collaboration would need support from the Ministry of health.
Dr Shinozaki explained the difficulties that he had personally experienced progressing transplantation law within Japan over 20 years, with repeated visits to many congress representatives required. When finally a vote was taken, it was only with the support of Professor Chapman and Dr Noel that the law was passed. It had been thought that the new law would lead to growth in transplantation, but nothing has changed. Dr Shinozaki feels that there is insufficient buy in from neurologists caring for potential donors. There are many other bottle necks,
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including cultural and political issues. A regional collaboration for support and information sharing can be a good advantage.
Dr Noel commented that a regional collaborative group will only work if it includes government representatives as well as clinicians. Dr Noel also referred to the guidance on the determination of death project being undertaken by the WHO (http://www.who.int/patientsafety/determination_of_death/en/). A regional meeting is planned with local experts to reach a consensus on death determination.
Dr Liu noted that the China Government has made progress in recent years. In the last year, there has been a country-wide campaign focused on organ donation. However, there is still need for revision of the law. A current pressing issue from Dr Liu’s perspective is how to reimburse the donor family. China will still be criticised by international community. Dr Liu wanted to get advice from WHO and TTS about this issue, because in China, the tradition has been that donor families are very poor, meaning that reimbursement is essential.
Dr Noel commented that this represents a significant problem for China. A strong effort will be needed to avoid creating inequity between the donors and the recipients in China, if donors are poor and recipients are not poor. Dr Noel commented on the importance of discussing this further alongside China, in the spirit of support. Dr Liu commented that reimbursement was only offered after donation, but Dr Noel was clear in his view that if money is associated with donation, it will be considered a sale, and people who want to profit from this situation will do so. But if there is a situation where money needs to be exchanged, it needs to be transparent, and monitored and produce equitable results in terms of transplantation to avoid room for criticism. Dr Liu further stated that the government hospitals are worried that transplant rate may drop if reimbursement does not occur; however, a change in practice needs a consensus.
Professor O’Connell suggested that as a first step, a look at examples of countries who have high transplantation rates who do not offer reimbursements can be considered. Ultimately, high transplantation rate is not dependent on money but on trust. Spain is not the richest country in Europe, but because the population see the benefits of transplantation and have trust in the system, they become donors in large numbers. The system is fair, transparent and trusted. Developing a successful transplant programme is long and hard work, but shortcuts, including financial incentives, lead to problems.
Dr Noel supported this comment, saying that money becomes compensation for a missing part of the body, and does not make people who donate respected. What we need is innovative and a region-specific way to promote deceased donation in a way that makes families proud to be involved. He felt that this approach was feasible in Asia.
Ms Cass commented that within the Black sea project there were good examples for Australia on how they can take the next steps at encouraging other countries to develop their transplantation programmes. She felt that there was opportunity for regional and/or bilateral relationships between Australia and other countries in the Western Pacific. There may be examples where meeting regularly is valuable, and she would be willing to participate, but would also want to explore bilateral arrangements. Australia would be willing to host people to come and learn how progress could be made. Ms Cass mentioned that Australia hold annual forums of the Donate Life network, so clinical people meet. There is specific work that has been done in Australia with the death audit, and to monitor progress at hospital level - this methodology may be of interest as tool that can help.
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Dr Hirman commented that the meeting had been a good experience. He felt that there could have more frequent sharing of information, via newsletters, emails, Facebook so that updated information could be shared on what individual countries are doing. With respect to transplant rates within Malaysia, it is a diverse society. Most are Muslims, and they have engaged with religious leaders, but this has not increased donation rates (although there was a slight increase in registrations). Malaysia has a central organization, but there is a lack of commitment from professional groups at this stage. Dr Noel felt that sharing information in this way might be valuable but that nothing replaces meeting face-to-face.
Dr Cross noted that the key determinants of successful development of donation and transplantation programmes in most countries were similar and well described during this meeting. New Zealand had already achieved a well-developed and functioning transplantation system but problems existed with access to transplantation for some groups, and with the deceased donation rate which was poor by international standards among high HDI countries. He would be interested in learning more particularly from the Australian experience to improve performance in New Zealand.
Dr Curie commented that the country has arranged meetings for young doctors working within donation and transplantation from Asian countries to meet together. She felt there is a need for reform in the governmental structure around transplantation. Dr Ha felt that perhaps the TTS/WHO could ask the neurology society to help with encouraging deceased donor identification within the country, which remains a major barrier. He further commented that when transplantation clinicians offer symposia, there is poor attendance, but perhaps a meeting of international stature would encourage more attendance. He also noted that donation after cardiac death was not yet developed in the country and assistance from other countries might be needed.
Dr Vathsala reflected on the inspiring stories from Latin America and Eastern Europe. She noted that passionate individuals are needed, but cannot be relied upon for sustained development of donation and transplantation within countries. There is a need for systems and processes; governments need to set transplantation and donation structures in place, with transplantation professionals as catalysts and not the maintaining force. Secondly, transplantation professionals are not the limiting factor – there is a need to bring the intensivists and ICU to the table to make progress.
Dr Phuc (Viet Nam) commented that it has been a productive consultation. He felt that the development of donation and transplantation would not be easy in Viet Nam but is possible and look forward to future collaboration in the area.
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3. CONCLUSIONS AND PLAN OF ACTION
Dr Nunez (WHO/HQ) summarized the conclusions from the meeting which were agreed by the participants:
1. Contribution of data to the Global Observatory on Organ Donation and Transplantation (GODT). Participants agreed to collaborate with WHO and its collaborating centre (ONT) to collect reliable data about transplantation activities in countries in the Western Pacific Region. Health Authority designated focal points should be identified within each nation to facilitate.
2. National Vigilance and Surveillance Schemes to contribute to Project NOTIFY. Participants recognized the value of reliable information about adverse events and reactions following donation and transplantation. Such information may strengthen efficacy and safety of donation and transplantation. National authorities should ensure that national vigilance and surveillance schemes contribute to the NOTIFY Library.
3. Increase organ donation after death within jurisdictions. Participants recognized the need to pursue deceased donation to strive for self-sufficiency in transplantation for populations. Depending on the state of development of deceased donation within countries, participants agreed to:
a. Strengthen legal and organizational frameworks for deceased donation. b. Advocate for public education about deceased donation, including through school education networks. c. Collaborate with intensivists and other relevant specialist groups to improve identification of potential donors and integrate donation into end of life practice.
4. Seek creation of an annual Western Pacific regional forum of national experts in donation and transplantation. Participants recognized the potential value of such a forum to share experiences and assist countries in improving their donation and transplantation performance. This could lead to the development of a regional transplantation and donation network, or bilateral collaborations between Member States.
5. Pursue internationally standardized labelling of Medical Products of Human Origin (MPHO) using ISBT128. Participants agreed that international traceability of all MPHO, including organs and tissues for transplantation, was important to improve ethics and safety of donation and transplantation, and supported the use of ISBT128 to this end.
4. CLOSING
Dr Noel and Dr Tisocki thanked Dr Cho Won-Hyun for his chairmanship and also for his and Vitallink’s support in organizing the meeting. Dr Tisocki also thanked the TTS for providing financial and technical support.
Dr Liquete, on behalf of the participants, expressed appreciation to the organizers of the meeting. ANNEX 1
LIST OF TEMPORARY ADVISERS AND SECRETARIAT
1. Dr AHN Curie, Professor in Nephrology, Seoul National University, College of Medicine, Seoul, Republic of Korea. E-mail: [email protected]
2. Mr Paul ASHFORD, Executive Director, International Council for Commonality in Blood Banking Automation, Inc.,48 Cliff Gardens, Minster on Sea, ME12 3QY, United Kingdom. Tel.: 0788 784 3092, E-mail: [email protected]
3. Ms Mar CARMONA,Technical Officer, National Organization of Transplants Ministry of Health, Social Services and Equity, C/Sinesio Delgado, 6/8. Pabellón 3, Madrid 28029, Spain. Tel.: +34 91 822 4961, E-mail: [email protected]
4. Ms Yael CASS, Chief Executive Officer, Australian Organ and Tissue Donation and Transplantation Authority, P.O. Box 295, Civic Square, A.C.T. 2608, Australia. Tel.: + 61 2 6198 9880, Fax: +61 2 6198 9801, E-mail: [email protected]
5. Dr Jeremy CHAPMAN, Director, Renal Services, Westmead Hospital, Sydney, NSW 2145, Australia. Tel.: + 61 419 751 656, 61 2 9845 6349 E-mail: [email protected]
5. Dr CHO Won-Hyun, Professor, Department of Surgery and, Division of Transplantation, Keimyung University School of Medicine, and President, VITALLINK Seoul, Republic of Korea. Tel.: + 82 53 250 7325, Fax: +82 53 250 7322 E-mail: [email protected]
6. Dr Elizabeth COLL, Medical Officer, National Organization of Transplants Ministry of Health, Social Services and Equity, C/Sinesio Delgado, 6/8. Pabellón 3. Madrid 28029, Spain. E-mail: [email protected]
7. Dr Philip O'CONNELL, President, Transplantation Society, Physician National Pancreas Transplant Unit, Westmead Hospital, Sydney, NSW 2145 Australia. Tel.: + 61 2 9845 6962, Fax: 61 2 9633 9351, E-mail: [email protected]
8. Dr Nicholas CROSS, Nephrologist/Clinical Director, Clinical Senior Lecturer Department of Nephrology, Christchurch Hospital, Christchurch, New Zealand. Tel.: +64 336 40640; Fax: +64 336 40941; E-mail: [email protected]
9. Dr Marta FRAGA, Scientific Officer, European Directorate for the Quality of Medicines and Healthcare, Council of Europe, 7 allée Kastner, 67801 Strasbourg France. Tel: +33 (0)3 90 2145 30; E-mail: [email protected]
10. Dr HA Jong-Won, Professor, Chief, Division of Transplantation and Vascular Surgery Department of Surgery,Seoul National University College of Medicine, Seoul National University Hospital, 28 Yongon-dong, Chongno-gu, Seoul 110-744, Republic of Korea. Tel.: +822 2072 2991; Fax: +822 766 3975; E-mail: [email protected]
11. Dr HAN Yeonhae, Assistant Division Director, Biopharmaceutical Policy Division, Ministry of Food and Drug Safety, Osong Health Technology Administration Complex 187 Osongsaengmyeong2(i)-ro, Osong-cup, Cheongwon-gun, Chungcheongbuk-do, Republic of Korea. E-mail: [email protected]
12. Dr Ismail HIRMAN, Head, Transplantation Unit, Medical Development Division Ministry of Health, Level 12 Block E7 Complex E, 62590 Putrajaya, Malaysia. Tel.: 6017 2001 377; E-mail: [email protected]
13. Dr JOUNG Han-Duck, Director, Division of Organ Support Donation, Korean Network for Organ Sharing, 4F, 24 Budnaruro, 14ga-gil, Youngdeungpo-gu Seoul, Republic of Korea. E-mail: [email protected]
14. Dr Rose Marie LIQUETE, Consultant on Transplant and Vascular Surgery, National Kidney and Transplant Institute, Quezon City, Philippines. Tel.: (632) 645 4011; Fax: (632) 645 7481; E-mail: [email protected]
15. Dr LIU Yong, Division Director, Department of Medical Administration, National Health and Family Planning Commission, No. 1, Xizhimen Wai Nanlu, 100044 Beijing China. Tel.: 0086 10 68792033; E-mail: [email protected]
16. Dr OH Jinhee, Director, Division of Bioethics Policy, Ministry of Health and Welfare 13, Doum4-Ro, Sejong City 339-012, Republic of Korea,. E-mail: [email protected]
17. Dr Nguyen PHUC, Vice-Director, Viet Nam National Coordinating Center For Human Organ Transplantation, Ministry of Health, Hanoi, Viet Nam.
18. Dr Naoshi SHINOZAKI, Executive Director, Japan Organ Transplantation Network Orix Akasaka 2 chome Bldg., 2-9-11 Akasaka, Minatu-ku, Tokyo 107 0052, Japan. Tel.: 81 3 6441 2791; Fax: 81 3 6441 2792; E-mail: [email protected]
19. Dr Shiro TAKAHARA, Professor, Osaka University Graduate School of Medicine, Department of Advanced Technology for Transplantation, 2-2 Yamada oka Suita City, Osaka 565 0871, Japan. Tel: 81 6 6879 3746; Fax: 81 6 6879 3749 E-mail: [email protected]
20. Dr Anantharaman VATHSALA, Professor of Medicine, Yong Loo Lin School of Medicine, Co-Director, National University Centre for Organ Transplantation, Department of Medicine,NUHS Tower Block, Level 10, 1E Kent Ridge Road, Singapore 119228. Tel.: 65 677 26124; Fax: 65 6872 4130; E-mail: [email protected]
21. Dr Buyanjargal YADAMSUREN, Director, Policy Implementation and Coordination Ministry of Health, Government Bldg. III, Olympic St-2, Sukhbaatar District, Ulaanbaatar 14210, Mongolia. Tel.: (976 51) 262901; Fax: (976 11) 320926; E-mail: [email protected]; [email protected]
2. SECRETARIAT
22. Dr Klara TISOCKI, Team Leader, Essential Medicines and Technologies, World Health Organization, Western Pacific Regional Office, P.O. Box 2932, United Nations Avenue, 1000 Manila, Philippines, Tel.: +632 528 9026; Fax: +632 521 1036; E-mail: [email protected]
23. Dr Luc NOEL, Special Advisor – Service Delivery and Safety, Initiative for Medical Products of Human Origin, World Health Organization, Avenue Appia 20, CH-1211, Geneva, Switzerland. Tel.: +41 22 791 3681; Fax: + 41 22 791 4153; E-mail: [email protected]
24. Dr Jose NUÑEZ, Medical Officer, Services Organization and Clinical Interventions, World Health Organization, Avenue Appia 20, CH-1211, Geneva, Switzerland. Tel.: +41 22 791 12184; E-mail: [email protected]
ANNEX 2
INTERNATIONAL TECHNICAL CONSULTATION ON WPR/DHS/EMT(01)/2014/IB2 CELL, TISSUE AND ORGAN DONATION/TRANSPLANTATION IN THE WESTERN PACIFIC REGION, Seoul, Republic of Korea, 20 to 21 February 2014
TENTATIVE TIMETABLE
Time Thursday, 20 February 2014 Time Friday, 21 February 2014
08.00 Registration Global governance tools for cell, tissue and organ donation and transplantation 08.30 1. Opening ceremony and group photo 08.30 13. Role of vigilance and surveillance, Project NOTIFY (Dr Luc Noel) 09.00 14. Information standard for Blood and Transplant ISBT128 (Mr Paul Ashford) 09.30 15. Standards for medical products and human origin (Dr Jose 09.45 Nuñez) Discussion: Regional priorities and opportunities 09.15 C O F F E E B R E A K 10.15 C O F F E E B R E A K
Setting the scene/background Regional/sub-regional fora of health authorities for transplantation 09.45 2. Introduction: Objectives of consultation, overview of 10.45 agenda, adoption of agenda (Dr Klara Tisocki) 16. The Council of Europe CD-P-TO (Dr Marta Fraga) 11.15 10.00 3. Self-sufficiency and the WHO initiative for Medical Products 17. The Latin American Council (Dr Elizabeth Coll) 11.45 of Human Origin (Dr Luc Noel) General discussion 10.20 4. Update on WHO activities and priorities in cell, tissue and
organ transplantation (Dr Jose Nuñez)
The WHO/ONT Global Observatory on Donation and Transplantation and the Regional Situation 10.40 5. Essential legal and organizational requirements for national cell, tissue and organ transplantation services (Prof Jeremy Chapman) 11.00 6. Matching GODT data with country reports on activities and practices (temporary advisers and Ms Mar Carmona) 12.10 General discussion - 2 -
12.30 L U N C H B R E A K
Time Thursday, 20 February 2014 Time Friday, 21 February 2014
13.30 Activities and practices in organ transplantation General discussion on: 7. Matching GODT data with country reports on activities and 13.30 18a. Increasing transparency in donation and transplantation practices (cont'd) (temporary advisers and Ms Mar throughout the Region Carmona) 14.00 18b. Regional initiative for the development of organ and tissue donations after death 14.30 18c. Towards regional synergies and regular consultation of health authorities 15.00 19. Roles of scientific and professional societies (Prof Philip O'Connell and Dr Shiro Takahara) 15.30 C O F F E E B R E A K
Regional experience in the development of organ donation 15.30 20. Conclusion and plan of action after death 16.00 21. Closure 15.45 8. Achievements in the Republic of Korea (Dr Cho Won-Hyun)
16.15 9. The Chinese programme: current achievements and plans (Mr Wang Haibo) 16.45 10. Plans for increasing organ donation after death in Japan (Dr Naoshi Shinozaki) 17.15 11. WHO role in encouraging organ donation after death (Dr Jose Nuñez) 17.45 General discussion on priorities and opportunities
Cocktails/dinner
ANNEX 3
SPEECH OF DR SHIN YOUNG-SOO, WHO REGIONAL DIRECTOR FOR THE WESTERN PACIFIC, DELIVERED BY DR KLARA TISOCKI, TEAM LEADER, ESSENTIALMEDICINES AND HEALTH TECHNOLOGIES, AT THE OPENING CEREMONY OF THE INTERNATIONAL TECHNICAL CONSULTATION ON CELL, TISSUE AND ORGAN DONATION/TRANSPLANTATION IN THE WESTERN PACIFIC REGION
DISTINGUISHED PARTICIPANTS, LADIES AND GENTLEMEN:
Dr Shin Young-soo, WHO Regional Director for the Western Pacific, regrets being unable to join us due to a previous commitment. He has asked me to welcome you and deliver these remarks on his behalf.
Welcome to the International Technical Consultation on Cell, Tissue and Organ
Donation/Transplantation in the Western Pacific Region.
Human cells, tissues and organs for transplantation can save lives or restore essential functions, but access to them is highly limited in most countries globally and in this Region.
Only 11% of the global organ transplantation activity takes place in the Western Pacific
Region, even though the Region accommodates 28% of the global population.
Human cells and tissues for transplantation represent a special class of health products as medical products of human origin.
They may also be used as starting material for more complex biotechnology products in the future.
All transplanted materials of human origin carry the risk of disease transmission.
This risk must be controlled by the application of stringent regulations of donors and transplantation activities and implementation of a comprehensive quality systems to ensure safety.
In May 2010, the World Health Assembly endorsed the WHO Guiding Principles on Human
Cell, Tissue and Organ Transplantation.
The WHO Guiding Principles clearly outlined an ethical framework for the acquisition and
transplantation of human cells, tissues and organs for therapeutic purposes.
Amongst other ethical norms, they highlighted the need for:
The development of transparent and accountable systems for the voluntary non-remunerated
donation of cells, tissues and organs.
Ethical allocation rules, that should be equitable, externally justified, and transparent and defined by appropriately constituted committees.
Optimizing the safety, efficacy and quality of human cells, tissues and organs for transplantation by implementation global traceability system and vigilance to monitor adverse events and reactions.
In recent years, several countries in the Western Pacific Region have made rapid progress in developing transparent, accountable and high quality systems for cell, tissue and organ donation and transplantation.
Increasing organ donation after death in these countries helped to reduce the gap in the
availability of suitable organs.
Though in most countries in the Region, the need for cell, tissue and organ donation still
remains great, as the number of patients with end-stage diseases is increasing, due to non-
communicable diseases.
In order to close this gap, there is a need to have the opportunity to donate organs after death, as
much as possible. This is the key challenge for moving towards self-sufficiency in cells, tissues and
organ donations.
However, we must also remember that health promotion, prevention and high quality health
services must remain the priority and the cornerstone of government's action to slow the increasing
need for cells, tissues and organ donation.
I hope this consultation, building on your varied expertise, will provide the opportunity to review recent development and current best practices in the Western Pacific Region.
The potential opportunities for more interaction and collaboration between responsible national authorities will also be considered and I look forward to your opinion on this.
I would like to thank our host, the Government of the Republic of Korea, and the co-organizer
Vitallink for supporting this international expert consultation.
I look forward to hearing your recommendations and outcomes of this meeting and wish you all a pleasant stay in Seoul.
Thank you.
Viral Hepatitis B and C are Prevalent in Asia
Hepatitis C prevalence, 2005 Source: Hanafiah K et al. Hepatology 2013 Estimates 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 2012 Technical Consultation on Knowledge Sharing and Networking Estimates are derived from a meta-analysis of data from 396 for Human Cell, Tissue and Organ Donation and studies published between 1980 Transplantation in the Western Pacific Region and 2007. Low <2% Low intermediate: 2-4% High intermediate: 5-7% Seoul, February 20-21 2014 High: >=8% Health Systems Patient Safety Health Systems Patient Safety 1 and Innovation Programme 4 and Innovation Programme
Partnerships, Collaborations The need for Kidney Transplantation in Asia aandnd Global Consultations Process 20042004 Network Over 2 million patients were being treated with dialysis in 2011. Nearly one quarter of this global dialysis population were being Health authorities treated in Japan and China alone. • National Transplantation Agencies Country Population % of world Dialysis % of world Prevalence (million) population patients dialysis of dialysis • National Regulatory Authority (thousands) patients (pmp) • Policy makers USA 313 4% 420 19% 1,340 Scientific and Professional Societies Japan 127 2% 302 14% 2,370 • Official relation with TTS, WBMT, China 1,340 19% 200 9% 150 ICCBBA Brazil 205 3% 106 5% 520 Experts Ethicists, lawyers Germany 81 1% 83 4% 1,020 • Patients- Donors and Recipents Rep. Korea 50 <1% 46 2% 910 • Civil society Thailand 70 <1% 41 2% 590 Every Region of the Globe and level of Malaysia 29 <1% 24 1% 834 development Global 6,963 2,164 310 Source: ESRD patients in 2011: a global perspective. Fresenius Medical Care, Bad Homburg, 2011 Towards a Common Global Attitude to Transplantation http://www.vision-fmc.com/files/download/ESRD/ESRD_Patients_in_2011.pdf Health Systems Patient Safety Health Systems Patient Safety 2 and Innovation Programme 5 and Innovation Programme
Kidney Transplants per Country Global distribution of transplantation activity and Per million population (pmp)
2010 60.0
50.0 Kidney tx from DD (pmp) Living Kidney tx (pmp) 40.0
30.0
20.0 Transplantation rate (pmp) <6 6 to <20 10.0 20 to <40 40 to <70
>70 0.0 Myanmar Ghana Bangladesh Nigeria Kyrgyzstan Libya Kenya ofRep Moldova Albania Malaysia Bulgaria Nicaragua Indonesia UAE Ukraine Lebanon Armenia Nepal Algeria Georgia India Philippines China Mongolia Dom Republic Sudan Qatar Pakistan Azerbaijan Peru Tajikistan Guatemala Oman SouthAfrica Russia Thailand SalvadorEl Paraguay Bolivia Ecuador Romania Singapore Kazakhstan Mauritius Venezuela Tunisia Cuba Syria Japan TFYRM LankaSri Greece Chile Colombia Panama Egypt Iceland Belarus Saudi Arabia Malta Israel Mexico New Zealand Kuwait Slovakia Cyprus Lithuania Brazil Hungary Costa Rica Argentina Uruguay Jordan Italy Poland Slovenia Germany Latvia Iran Switzerland Ireland ofRep Korea Australia Finland Canada Denmark Turkey Portugal RepCzech Sweden Estonia UK France Belgium Austria Croatia Spain US Netherlands Norway
Territory size is distorted in proportion to the number of organ transplants reported for each country in 2010
Health Systems Patient Safety Health Systems Patient Safety 3 Data source: Globaland Observatory Innovation on Donation and Transplantation;Programme map courtesy of S White 6 and Innovation Programme
1 Waiting List Additions Versus Kidney Transplants Performed In Prevention is Crucial for Self Sufficiency in 2011: High-income Countries KidneyKidney Transplantation
100 The United States, Europe and Australia are Patients newly included on the waiting list for a kidney transplant in 2011, pmp starting to observe a decline in the rate of new 75 Kidney transplant rate in 2011, pmp patients starting renal replacement therapy.
50 In contrast, growth in dialysis populations has Rate Rate (pmp) shifted to Asia, Latin America, the Middle East 25 and Africa.
0 Prevention appears to be having an impact
Secondary Source: Global Observatory on Donation and Transplantation (www.transplant-observatory.org) Council of Europe, Newsletter Transplant, 2012, Madrid, Spain. … Primary Health Systems Patient Safety Health Systems Patient Safety 7 and Innovation Programme 10 and Innovation Programme
Unadjusted End Stage Kidney Disease Incidence In Selected Countries Worldwide
Meeting the needs of The goal is not to find an ever- increasing supply of organs for patients from a given transplantation, but rather to population with an engage with transplantation in the context of a broader public adequate provision of health strategy for prevention of transplantation services chronic organ failure. and supply of organs
Source:United Renal States Data System, Annual 2012 Report from that population
Health Systems Patient Safety Health Systems Service Delivery 8 and Innovation Programme 11 and Innovation and Safety
Diabetes and ESKD in the USA
Increased prevalence of diabetes and of treated ESKD with a primary 4,000 diagnosis of diabetes 3,000
2,000 600 6 Prevalence ofdiabetes (%)
DM-ESRD rate (pmp) rate DM-ESRD 1,000
400 4 0 1980 1982 1984 1986 1988 1990 1992 1994 1996 1998 2000 2002 2004 2006 2008 2010 200 2 Incidence of ESRD among the diabetic population DM-ESRD rate(pmp) DM-ESRD
0 0 However, incidence of Diabetes ESKD among the diabetic population
1980 1982 1984 1986 1988 1990 1992 1994 1996 1998 2000 2002 2004 2006 2008 2010 has declined due to improved Prevalence of diabetic ESRD (per million population) secondary prevention. Crude population prevalence of diabetes (%)
Source: United States Renal Data System, Annual Report 2012 United States Centers for Disease Control and Prevention Health Systems Patient Safety Health Systems Patient Safety 9 and Innovation Programme 12 and Innovation Programme
2 Third Global Consultation on Organ Donation and TranTransplantation,splantation, Madrid March 23-25, 2010 The Self-Sufficiency Paradigm Solidarity PRINCIPLES ORGAN To meet patients' needs: Reciprocity Donation and Transplantation 1. Government responsibility • Organization 1. Legal framework WHO Organization-wide Initiative for 2. National Health Plan includes 2. Equity donation and transplantation Medical Products of Human Origin • In the burden of donation 3. Organ donation possible in as • In allocation (UHC) WHA63.22 many circumstances of death as 3. Education possible => ORGANISATION « Health products of an exceptional nature* » • To donation 4. Comprehensive management of • To prevention chronic kidney disease 4. Trust of the Public 5. Health and death in school • Transparency curriculum • Professionalism Society / Authority 6. Media associated to donation * GUIDING PRINCIPLE 10 and transplantation system WHO Guiding Principles On Human Cell, Tissue And Organ Transplantation Donation is a civic gesture, an expectation but not an exception Endorsed by the sixty-third World Health Assembly in Resolution WHA 63.22
Health Systems Patient Safety Health Systems Patient Safety 13 and Innovation Programme 16 and Innovation Programme
The Self Sufficiency Paradigm Medical Products of Human Origin (MPHO) Education Donation and Prevention Unprecedented measures • School curricula o From the end of primary school Materials derived from the human body for clinical Children application. Parents o Health education Despite the obvious differences in types of human o Education to donation During life biological materials used to create MPHO, and the range After death of therapeutic uses which they may serve, all MPHO • Media have in common an origin and destination in the human • Health professionals body. . Solidarity Reciprocity
Health Systems Service Delivery Health Systems Service Delivery 14 and Innovation and Safety 17 and Innovation and Safety
Medical Products of Human Origin (MPHO) http://m.us.wsj.com/articles/SB10001424052702304149404579322560004817176?mod=WSJ_hpp Recruitment Clinical _MIDDLENexttoWhatsNewsFifth&mobile=y January 2014 Selection application Follow-up Procurement Issuing Follow-up Testing Allocation Processing
Blood and blood products Cells Tissues Organs Our conclusion is that a very large number of both live Gametes and Embryos and cadaveric kidney donations would be available by Secretions and excretions… paying about $15,000 for each kidney. That estimate isn't Plasma Derived Medicinal Products exact, and the true cost could be as high as $25,000 or as Advanced Therapies low as $5,000—but even the high estimate wouldn't ….. Personalized medicine increase the total cost of kidney transplants by a large percentage. Ethics – Safety & Quality – Access Health Systems Patient Safety Health Systems Service Delivery 15 and Innovation Programme 18 and Innovation and Safety
3 The Human Body and its Parts as Such Not the Source of Financial Gain
Organ Tissues
$ Hematopoietic Blood € Stem Cells Stem Cells Human Recognizing Humanity in Advanced Derived Therapies Plasma Drugs Medical Products Gametes $ £ Embryos Secretions of Human Origin Excretions Societal Values € Protection of the Donor £ Safety of the Recipient Self-Sufficiency ¥ Public Health Health Systems Service Delivery Health Systems Patient Safety ¥ 19 and Innovation and Safety 22 and Innovation Programme
Medical Products of Human Origin - MPHO The WHO Wide Initiative for MPHO Ethics – Quality & Safety - Access AAprilpril 2013 - Programmed Budget 2014-2015
3 Global Governance Tools for MPHO 1. Principles inherent to the Human Origin Donation Research & Evidence • Non commercial nature of the human body and its parts as such after death Advanced • Towards a global consensus leading to a formal agreement Therapies Stem cell - TEMP 2. Universal use of ISBT 128 for all MPHO Life saving Hematopoietic stem cell • Information Standards for Blood and Transplant Universal Shortage • Towards universal use of ISBT128 within 10 years No alternative Organs Cells Best survival /costs Misuse in HIC/MIC 3. Global vigilance and surveillance Access in LMIC Other • NOTIFY project for Vigilance and Surveillance of MPHO Plasma Human • Using at best the global experience of adverse incidents ART Blood & Tissues Components Derived Derived Gametes Medicines Medicines Life enhancement Human derived pharmaceuticals World Health Assembly UN Towards a binding international legal instrument Health Systems Health Systems Clinical Health Systems Patient Safety 20 and Innovation Policies and Workforce Procedures 23 and Innovation Programme
The Human Body as the Source of Therapeutics: -1- Items for Standards of Practice for MPHO TowardsTowards a Global Consensus
The establishment of globally agreed principles for the governance of Responsibility for the provision of Duty to constantly optimize the safety, MPHO would represent significant progress towards the goal of MPHO placed with authorities and quality and efficacy of procurement, through them the individual citizen and process and clinical application of meeting minimum standards, as well as serving: resident; MPHO; • to underline the cross cutting concerns regarding all MPHO, inherent to their human origin; Equity as a goal, in the burden of Traceability and accountability donation and in allocation of MPHO; mandated throughout the process, from • to demonstrate respect for the human body and hence the dignity donors to recipients, including long of persons; Prohibition of financial gain on the term outcomes and vigilance and human body and its parts as such and surveillance under the oversight of • To increase safety and enhance ethical practices; where profit is not forbidden, competent authorities; • To encourage donation by generating trust in procedural guarantee of transparency; safeguards such as consent requirements and protocols for care Transparency and openness to scrutiny Genuine consent of donors and indispensable while confidentiality and and follow-up of donors; recipients and protection of the anonymity when required must be • To avoid distortions in practices due to the undermining effect of incompetent; preserved. bad examples, such as the justification of payment for organs by Use of MPHO justified by evidence and appeal to legal trade in plasma. absence of comparable alternative;
Health Systems Health Systems Clinical Health Systems Service Delivery 21 and Innovation Policies and Workforce Procedures 24 and Innovation and Safety
4 Transparency
Activities and practices
“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
Role of Scientific and Professional Societies ?
Health Systems Service Delivery 25 and Innovation and Safety
The 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 Systems Service Delivery 26 and Innovation and Safety
Thank you
[email protected] [email protected]
Health Systems Health Systems Clinical 27 and Services Policies and Workforce Procedures
5 03/02/2015
Global Observatory on Donation and Transplantation Organs Transplanted Globally in 2012
≈ 114,690 organs transplanted (≈ 10% of estimated global needs)
Kidney Liver Heart Lung Pancreas
77818 23986 5935 4359 2423
≈ 1.81 % increase over 2011
109 countries reported to the Global Observatory on Organ Donation and Transplantation 2012 GKT/ GODT South Africa, India and China - are 2010 estimates
4 Service Delivery and Safety
but only 2-3 % of world’s deceased donors
2 5 Service Delivery and Safety Service Delivery and Safety
1 03/02/2015
• 1.9 million tissue grafts distributed by AATB accredited tissue 14 % 1% banks each year 11 % 37 % • > 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 37 % • 46,000 corneas distributed by Sri Lanka Eye Bank over 30 years North America Europe Asia South America Others
7 Service Delivery and Safety 10 Service Delivery and Safety
11 % 14 % 1%
37 %
37 %
North America Europe Asia South America Others
11 Service Delivery and Safety
HSCTHSCT
9 12 Service Delivery and Safety Service Delivery and Safety
2 03/02/2015
Transplantation Progresses on a unsteady scale
Solidarity Loss of Dignity Equity Market, inequity Respects for Dignity ….Exploitation
16 13 Service Delivery and Safety Service Delivery and Safety
GP 5 Free donation and no purchase of human transplant as such, but cost &expenditures recoveryt
GP 3 GP 6 GP 7 GP 8 Maximizing DD Promoting Reasonability Justifiable fees Protecting LD No advertising For transplant origin
GP 2 GP 4 GP 9 Death Protecting the Equitable allocation No conflict incompetent
GP 1 Consent DD
GP 10 Monitoring long term outcomes. Quality and safety of procedures and products
GP 11 Transparency, openness to scrutiny, anonymity 17 Service Delivery and Safety
GP 3 Maximizing DD
GP 2 Death No conflict
GP 1 Consent DD
15 18 Service Delivery and Safety Service Delivery and Safety
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Guidance on criteria for the determination of death Guidance on criteria for the determination of death
Increase global visibility of the “GODT”
• WHO team Vigilance and surveillance • 8-10 experts (neurologist, intensivist, cardiologist etc)
14-16 November 2012, Rome
20 23 Service Delivery and Safety Service Delivery and Safety
Guidance on criteria for the determination of death
Increase global visibility of the “GODT” 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
•value transplantation and increase the motivation to donate among people input of cases initially not published in English.
•Better know the countries’/regions’ situation to develop the appropriate policies to increase donation rates.
24 Service Delivery and Safety
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Millions inhabitans
1400 1200 Search for relevant cases in their own language 1000 1215 800 600 Translated into English
400 478 200 392 125 127 206 226 284 Send it to the NL editorial group 0
Upload
25 Service Delivery and Safety 28 Service Delivery and Safety
Search for relevant cases NL
Translated into their own language
Disseminate to professionals
26 29 Service Delivery and Safety Service Delivery and Safety
Guidance on criteria for the determination of death
Increase global visibility of the “GODT”
Vigilance and surveillance
Emerging areas: Xenotransplantation Regenerative Medicine
27 Service Delivery and Safety
5 03/02/2015
• To review the current status of xenotransplantation science and practice
• To strengthen wider collaboration among members and with other societies for enhancement of research activities
• To encourage transparency in xenotransplantation related activities
34 Service Delivery and Safety
Guidance on criteria for the determination of death
Increase global visibility of the “GODT”
Vigilance and surveillance
Emerging areas: Xenotransplantation Regenerative Medicine
Strengthening Global Network
35 Service Delivery and Safety
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
36 Service Delivery and Safety
6 03/02/2015
[email protected] [email protected] http://www.who.int/transplantation/en/
Thank you
Health Systems Service Delivery 37 and Innovation Strengthening
7 03/02/2015
Essential legal and organizational requirements for national cell, tissue and organ transplantation services
Deceased Donor Transplantation
Jeremy Chapman Sydney
Legislative Deceased Donor Living Donor and KIDNEY Regulatory Diagnosis of death Donor Assessment Framework Donor medical risk assessment Surgical Team HLA Lab Recipient(s) Acute Living Funding Crossmatch Dialysis Donor Mechanisms Surgical retrieval Capacity Surgical retrieval Transplantation One National Waiting list Post Tx Care Drug program Organ Allocation Transplant facility National Allocation Protocol Transplant Data Systems Key: Medical Protocol National Transplant Transplant Registry follow up Ministry regulation
Legislative and Regulatory Framework
On Call Team HLA Lab Chronic Deceased Waiting List Funding Dialysis and Donor Mechanisms Program Allocation Transplantation Post Tx Care Drug program Organ/Tissue Procurement Data /Banking Systems program
ICU/Brain Death
1 03/02/2015
The context in Law for Organ, Tissue and Cell Transplantation
Ownership and Gift laws
Therapeutic Definition of goods laws nationality regulations Human Organ Cell & Tissue Legislation and regulations Private Consent Health care framework laws regulations Customs and excise laws regulations
WHO Guiding Principles on Human Cell, Tissue 20102010 and Organ Transplantation Critical issues in determining the basis of legislation World Health Assembly - 22 May 2010 On Human Organ, Tissue and Cell Transplantation GP 5 Free donation and no purchase of human transplant as such, but cost & expenditures recovery • Compatibility with• All the WHO Guiding GP 3 GP 6 GP 7 GP 8 • Blood and Blood Products Maximizing Promoting Responsibility Justifiable fees Principles and Declaration of Istanbul DD No advertising for transplant origin • All Organs Protecting LD • Cells GP 2 GP 4 GP 9 • Advanced cell therapies Death ∆γ Protecting the Equitable allocation • The extent of inclusion of all medical No conflict incompetent products of human• Tissues origin GP 1 • Engineered tissues Consent DD • Gametes Embryos • Human Milk Donor Process Recipient • Basis of Consent – opt in/opt out • Genetic modification • Xenotransplantation GP 10 Monitoring long term outcomes. Quality and safety of procedures and products • The definitions of Death GP 11 Transparency, openness to scrutiny, anonymity
Medical Products of Human Origin AAnn Organization Wide Initiative at WHO The Madrid Resolution
•CKD •CLD •CARDIAC •RESPIRATORY RESPONSIBILITIES SUFFICIENCY ACHIEVEMENTS •DIABETES •LEGISLATION •OTHER •DATA REGISTRIES NATIONAL •HEALTHCARE ACCOUNTABILITIES • MPHO are intertwined FACILITIES CAPACITY CONTROL •EDUCATION REGULATORY CONTROL •VACCINATION • Indistinct and changing limits in human application •HUMAN RESOURCES ETHICAL CONTEXT •REGIONAL •SCREENING • Practices with one impact the others PREVENTION COOPERATION • • no national borders for safety or ethical risks. •CULTURAL & OPPORTUNITIES •BRIDGING Rx RELIGIOUS CAPACITIES FOR CARE •DONATION • Yet there are strong differences and particularities between sub-classes of MPOHO ENVIRONMENT CAPACITIES •TRANSPLANT •FUNDING •RESEARCH • 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 Health Systems Essential 9 12 Health Systems Patient Safety and Services Health Technologies and Innovation Programme
2 03/02/2015
Presumed Consent Legal Principles: Gift Law defined for donation • Gift law principles may have important legal consequences for donation The legal authority to –Legally binding transfer recover organs from –Prohibition on valuable consideration deceased adult individuals –Altruism and volunteerism unless a refusal to donate was registered.
Countries with Presumed Consent = Opt Primary Legal Models Out
• Argentina • Italy • Austria • Latvia • Belgium • Luxemburg • Explicit Consent = OPT IN • Bulgaria • Croatia • Norway • Cyprus • Panama • Czech Republic • Paraguay • Presumed Consent = OPT OUT • Estonia • Poland • Finland • Portugal • France • Greece • Sinagapore • Hungary • Slovak Republic • Slovenia • Spain • Sweden
Countries with Explicit Consent = Opt in First Person Consent
• Australia • Malaysia • Canada • Lithuania • Chile • Mexico • Cuba • Netherlands Adult individuals have the • Denmark • New Zealand • Estonia • South Africa right to make a legally • Germany • South Korea • Guatemala • Thailand binding anatomical gift prior • Ireland • United Kingdom • Japan • United States of America to death. • Jordan • Venezuela
3 03/02/2015
Critical pathways for organ donation* POSSIBLE DECEASED ORGAN DONOR DEATH A patient with a devastating brain injury or lesion OR a patient with circulatory failure AND apparently medically suitable for organ donation
Treating physician Donation after Circulatory Death (DCD) to identify/refer a potential donor Donation after BrainDeath (DBD) POTENTIAL DCD DONOR POTENTIAL DBD DONOR
A. A person whose circulatory and respiratory Reasons why a potential donor A person whose clinical condition is suspected to functions have ceased and resuscitative does not become a utilized donor fulfill brain death criteria. measures are not to be attempted or continued. System or • Failure to identify/refer a potential or eligible donor B. A person in whom the cessation of circulatory • Brain death diagnosis not confirmed and respiratory functions is anticipated to occur within a time frame that will enable organ (e.g. does not fulfill criteria) or completed recovery. (e.g. lack of technical resources or clinician to make diagnosis or perform confirmatory tests) • Circulatory death not declared within the appropriate time frame. ELIGIBLE DBD DONOR ELIGIBLE DCD DONOR • Logistical problems (e.g. no recovery team) A medically suitable person who has been A medically suitable person who has been • Lack of appropriate recipient (e.g. child, blood type, declared dead based on the irreversible absence serology positive) declared dead based on neurologic criteria as of circulatory and respiratory functions as stipulated by the law of the relevant jurisdiction. The function of stipulated by the law of the relevant jurisdiction, Donor/Organ within a time frame that enables organ recovery. • Medical unsuitability (e.g. serology positive, neoplasia) • Haemodynamic instability / unanticipated cardiac arrest ACTUAL DBD DONOR ACTUAL DCD DONOR • Anatomical, histological and/or functional A consented eligible donor: A consented eligible donor: abnormalities of organs A. In whom an operative incision was made A. In whom an operative incision was made the brain • Organs damaged during recovery with the intent of organ recovery for the with the intent of organ recovery for the • Inadequate perfusion of organs or thrombosis purpose of transplantation. purpose of transplantation. or or Permission B. From whom at least one organ was B. From whom at least one organ was • Expressed intent of deceased not to be donor recovered for the purpose of transplantation. recovered for the purpose of transplantation. • Relative’s refusal of permission for organ donation • Refusal by coroner or other judicial officer to allow is irreplaceable UTILIZED DBD DONOR UTILIZED DCD DONOR donation for forensic reasons An actual donor from whom at least one organ An actual donor from whom at least one organ was transplanted. was transplanted. *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.
Brain Scope of consideration for implementation scan Transplant Type Kidney – Kidney Cornea Cornea Cell Xeno Gametes Blood living /Organs – tissue. tissue – local transplant transplant and donor deceased imported blood donor products
Hospital infrastructure
National Infrastructure
Regulatory framework
Legislative framework
Scope of consideration for implementation
Transplant Type Kidney – Kidney Cornea Cornea Cell Xeno Gametes Blood living /Organs – tissue. tissue – local transplant transplant and donor deceased imported blood donor products
Hospital infrastructure
National Infrastructure
Regulatory framework
Legislative framework
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GOVERNMENT OF FIJI ______
THE TRANSPLANTATION OF HUMAN ORGANS AND TISSUES DECREE 2013 ( Decree No ….of 2013)
A Legal Framework 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. Questions:
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. 1 What about minors & the legally incompetent
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 2 What about non-national recipients 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 3 What about non-national & unrelated donors 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 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
GOVERNMENT OF FIJI ______
THE TRANSPLANTATION OF HUMAN ORGANS AND TISSUES DECREE 2013 ( Decree No ….of 2013)
A Legal Framework 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. Parts:
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. 1 Preliminary and Definitions
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 2 Donations of tissue by living persons 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 3 Use of tissue removed during medical, dental 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 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
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Methodology: collection of annual activity data Global Observatory on Donation and • Ad hoc questionnaire to the national focal points Transplantation • Reminders (E-mail) Data • Reception of data collection (GODT) • Deadlines: every year in Q2/Q3
International Technical Consultation on Cell, Tissue and Organ Donation and • Revision of data and clarification whenever discrepancies are found (by E-mail or phone) • Data entry in the database Data Transplantation in The Western Pacific Region. management • Validation, data check and final approval by Member States 20 to 21 February 2014, Seoul, Republic of Korea. • Calculation of indicators of donation and transplantation (country, regional and global estimates) Ms Mar Carmona ([email protected]) • Further analysis Data analysis • Graphics and official maps Organización Nacional de Trasplantes (ONT), Spain • Publication in the GODT website • Presentations / Other Publication • Journals
BackgroundBackground Questionnaire
In response to the request made in Resolution WHA57.18 in 2004. This request was reiterated in Resolution WHA63.22 in 2010.
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; 2005
-Resources covered by ONT -ONT officially designated WHO CC
http://www.transplant-observatory.org
Global Database: Settings Methodology: collection of annual activity data
Scope • Ad hoc questionnaire to the national focal points • Reminders (E-mail) Data • Reception of data • 194 Member States in the six WHO Regions: AFR, AMR, EMR, EUR, collection SEAR, WPR • Deadlines: every year in Q2/Q3
• Revision of data and clarification whenever discrepancies are found (by E-mail or phone) Content • Data entry in the database Data • Information for organs: legislative and organizational aspects and management • Validation, data check and final approval by Member States annual donation and transplantation activities • Available to everyone • Calculation of indicators of donation and transplantation (country, regional and global estimates) • Information for tissues and cells: A similar process will be followed • Further analysis Data analysis • Graphics and official maps
Source of data • Publication in the GODT website • National Health Authorities or officially designated by them • Presentations / Other Publication • Journals
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Thank you…
Mar Carmona: [email protected]
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.
Conclusions II
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)
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.
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Recognition of problem and solution in 1999 WHO technical consultation 2014, Seoul Necessity of Brain • Legislation of organ transplantation What we have done for death law law in 1999
promoting organ donation in Need nationwide organ • KONOS (Korean Network for Organ Korea ? allocation system Sharing) in 2000 - recognizing the problem and finding the solution - Need organ procure • Hospital based OPO from 2003 organization
Need nationwide Won-Hyun Cho, MD. • By KONOS from 2000 Keimyung University School of Medicine, waiting list Vitallink - Korean Network for Organ Donation Prohibit organ trade • Transplantation law from 2000 inside of Korea
2014-02-20 2014 WHO Technical Consultation 1 2014-02-20 2014 WHO Technical Consultation 4
1999: 1991: NGOs for organ Transplantation Traveling through Desert Promotion activity law 1993: KMA Organ donation Organ donation guideline Promotion by each Promotion by each for BD 2000: KONOS transplant center transplant center 1995: Brain Death Seoul Declaration
8.0
5.8
3.4 3.4
No of Deceased donor No of Deceased donor PMP transplantation 1979:DDKT 1979:DDKT
1969:LDKT 1969:LDKT 1988:DDLT 1988:DDLT 2014-02-20 2014 WHO Technical Consultation 2 2014-02-20 2014 WHO Technical Consultation 5
Number of Deceased donor before legislation of transplantation law Donor Number of transplanted organ Procure Yearly change of Deceased Donor Year Total Kidney Liver Pancreas rate / donor No of DD DD pmp 450 30 KoDoNet 409 400 KODA 368 25 350
300 20 268 261 Legislation 256 250 KONOS < 3 15 200 148 162 141 150 10 8.03 7.24 86 91 100 5.24 5.31 68 5.17 5 3.42 52 52 36 2.88 3.00 50 1.87 1.41 1.77 1.09 1.08 0.75
0 0 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 > 3 2014-02-20 2014 WHO Technical Consultation 1 2014-02-20 2014 WHO Technical Consultation 6
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After legislation but organ donation is still not sufficient 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 Transplant tourism Prolonged • Medical : How to increase procure rate per donor waiting time than – Transplant center meeting – cooperation during procurement before Kidnap ? – Revise allocation system (region, status) Murder? Istanbul • Social : to get more consensus for organ donation declaration – Expanded campaign for donation to students – Communication with Police office, MoH, Congress, Journalist Ask self sufficiency – Donor family management, bereavement, public awareness – Realize problems of living donor safety
2014-02-20 2014 WHO Technical Consultation 7 2014-02-20 2014 WHO Technical Consultation 1
1999: 1991: NGOs for organ Transplantation Promotion activity law 2003:HOPO 1993: KMA Organ donation guideline Promotion by each for BD 2000: KONOS HowHow can we solve these problems? transplant center 1995: Brain Death Seoul Declaration
Increase organ donation, Increase organ donation, 8.0 especially Deceased donor 5.8
3.4
No of Deceased donor transplantation 2007:Donation 1979:DDKT of Boxing Champion
1969:LDKT 2008: Donation 1988:DDLT BY Cardinal 2014-02-20 2014 WHO Technical Consultation 8 2014-02-20 2014 WHO Technical Consultation Kim 11
Types of organ donor, donation rate and transplantation rate per million population 2005 Solution Country Spain USA France Italy UK Germany Korea Korea 2005 2012 Total population 44.1 298.2 61.8 56.9 59.0 82.5 48.7 50.1 (million) Increase the number No. of 1,546 7,593 1,371 1,197 753 1,220 91 408 Deceased D Donation 35.1 25.5 22.2 21 12.8 14.8 1.87 8 of deceased donor ! rate / pmp 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 112 6,886 246 129 551 600 1,270 1,878 from LD TPX rate / pmp 2.5 23.1 4.0 2.3 9.3 7.2 26.1 37.6
2014-02-20 2014 WHO Technical Consultation 9 2014-02-20 2014 WHO Technical Consultation 12
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No of deceased donor per million population Yearly change of Deceased Donor No of DD DD pmp 35 450 KODA, Vitallink 30 KoDoNet 409 400 30 368 25 presumed consent 350 25
explicit consent 300 20 268 20 261 (ROK: 271/50M=5.42) Legislation 256 250 KONOS 15 15 200 148 10 162 141 150 10 8.03 7.24 5 86 91 100 5.24 5.31 68 5.17 5 3.42 52 52 0 36 2.88 3.00 50 1.87 1.41 1.77 1.09 1.08 0.75
0 0 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
2014-02-20 2014 WHO Technical Consultation 13 2014-02-20 2014 WHO Technical Consultation 16
Activation of deceased donor transplantation Activation of deceased donor transplantation National factors increasing National factors increasing organ donation rate organ donation rate
• Potential for donation ---- MRR first • Potential for donation ---- MRR first • To donor hospital or doctor --- revise law • To donor hospital or duty doctor • Required referral • Required referral (revise law) • Required request • Education to the staff • Legislative environment --- need national • Legislative environment --- need national consensus consensus • Opting-out (presumed consent) • Opting-out (presumed consent) • Opting-in (explicit consent) • Opting-in (explicit consent)
The Eurotransplant experience The Eurotransplant experience
2014-02-20 2014 WHO Technical Consultation 1 2014-02-20 2014 WHO Technical Consultation 1
Korean Transplant society Vitallink http://vitallink.or.kr
Social Affairs, Academic Promote organ Donation
2014-02-20 2014 WHO Technical Consultation 1 2014-02-20 2014 WHO Technical Consultation 1
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Revised Transplant Law in 2010 Education, Education, Education for people of point of contact
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
2014-02-20 2014 WHO Technical Consultation 19 2014-02-20 2014 WHO Technical Consultation 1
Publish educational materials Donor Sound of recipient
Education to students Networking between NGOs
vitallink.or.kr Transplant Games in Korea Korean Organ Donation Network Education to point of contact (KoDoNet) 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 <0.0001 Develop health care policy direction Make2014-02-20 video, clips for campaign2014 WHO Technical Consultation 1 2014-02-20 2014 WHO Technical Consultation 1
Organ donation campaign by NGOs in Korea Founded From early 1990’ Independent Networking from 2010 OPO (KODA)
2011. 6. 27 (started from 2009)
2014-02-20 2014 WHO Technical Consultation 1 2014-02-20 2014 WHO Technical Consultation 24
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2010: Cooperative work with 1999: Revised National Police 1991: NGOs for organ Transplantation Law Self-governing unit Promotion activity law 2003:HOPO 1993: KMA Organ donation guideline 2011:KODA Promotion by each for BD 2000: KONOS transplant center 1995: Brain Death Seoul Declaration Networking of various NGOs for effective, professional campaign
from 2010 8.0
5.8
3.4
No of Deceased donor transplantation 2007:Donation of Boxing 1979:DDKT NGO+Gov. Champion Transplant Game 1969:LDKT Media play 2008: Donation Police agency + MoHW 1988:DDLT BY Cardinal 2014-02-20 2014 WHO Technical Consultation 1 2014-02-20 2014 WHO Technical Consultation Kim 28
Start Nationwide Transplant Database from 2009 Yearly change of Deceased Donor No of DD DD pmp 450 30 KoDoNet 409 400 KODA 368 25 350 Vitallink
300 20 268 261 Legislation 256 250 KONOS 15 200 148 162 141 150 10 8.03 7.24 86 91 100 5.24 5.31 68 5.17 5 3.42 52 52 36 2.88 3.00 50 1.87 1.41 1.77 1.09 1.08 0.75
0 0 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
2014-02-20 2014 WHO Technical Consultation 1 2014-02-20 2014 WHO Technical Consultation 29
Yearly change of Deceased Donor
No of DD DD pmp 450 30 409 Revised law 400 368 25 350
300 20 268 261 Legislation 256 How about result ? 250 KONOS 15 200 148 162 141 150 10 8.03 7.24 86 91 100 5.24 5.31 68 5.17 5 3.42 52 52 36 2.88 3.00 50 1.87 1.41 1.77 1.09 1.08 0.75
0 0 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013
2014-02-20 2014 WHO Technical Consultation 27 2014-02-20 2014 WHO Technical Consultation 30
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Recent action direction of Collaborative work with Vitallink Hospital director, self-governing officer, Ministry of Health, OPO • 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 smartphone
2014-02-20 2014 WHO Technical Consultation 1 2014-02-20 2014 WHO Technical Consultation 1
Campaign to have Donor Card from 1,000,000 to 10,000,000 World Transplant Games
Increase organ donation rate about 15%
2014-02-20 2014 WHO Technical Consultation 1 2014-02-20 2014 WHO Technical Consultation 1
Year Donor card holder Actual donor 2009 2012 2020 Mount Climb by Recipients Before 2000 47,224 1 1 ? 2008 Seoul NU team 2000-2003 19,949 1 2004 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 ? Donor family & people realized that 2013 118,871 ??? their decision of donation is not a useless one but a precious sacrifice, and proud of it ! 2020 (10,000,000) ??? 2014-02-20 2014 WHO Technical Consultation 33 2014-02-20 2014 WHO Technical Consultation 1
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Pattern of Campaign
2014-02-20 2014 WHO Technical Consultation 1 2014-02-20 2014 WHO Technical Consultation 1
Summary - 2 Repeat education and campaign ! Why SNS ? Have you ever heard about organ shortage and its related problems?
Easily spread Never No? heard What …… information No… No ! does to the public mean ? & Can communicate
2014-02-20 2014 WHO Technical Consultation 1 2014-02-20 2014 WHO Technical Consultation 1
Summary - 3
Discussion about living donor safety & Share our experience and joint growth in Asian countries support to the donor Vitallink International - Nationary Assembly -
Raise ethical problem in transplantation and organ donation to the public
2014-02-20 2014 WHO Technical Consultation 1 2014-02-20 2014 WHO Technical Consultation 1
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Summary-1 Self-sufficiency of organ donor : not achieved at one moment, not by single action of campaign
1969 ------2013
2014 Evaluation of present status , need new & Repeat planning of new breakthrough Breakthrough
2014-02-20 2014 WHO Technical Consultation 43
It begins with a small ball of snow !
If we roll that snow ball again and again, we can make snowman
2014-02-20 2014 WHO Technical Consultation 1
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China strongly support and follow the Current Achievements and plans WHO Guiding Principles and the in China Declaration of Istanbul. Stricter Management and supervision.
Yong Liu, M.D.
Ministry of Health, China
The changes started from Transparency
Organ transplantation in China has taken Since the Consultation Meeting place since the 1960s, and is now one of on Transplantation with National Health Authorities in the Western the largest organ transplant programmes Pacific Region, held by WHO in in the world. Manila, Philippine on 2005. We have faced squarely to Otx About 300,000 patients suffer organ practice relying on death-row failure each year, but only around 10,000 inmate’s organs and demonstrated transplants are performed annually due to China’s political will and next- Consultation Meeting on Transplantation with steps in reforming Otx legislation a lack of donors. National Health Authorities in the Western Pacific Region and practice. ( Manila, Philippine on 2005)
Legal Framework Different from other medical technologies, an organ transplant requires a donated transplantable organ, and the Regulations on Human donation and allocation are embedded in Organ Transplantation social issues such as culture, tradition, (Mar. 21, 2007)Paved the ethics, and law. way for a legal framework to guide the organ transplantation in China.
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Amendment(VIII) to the Criminal Law of Classification of Deceased Organ Donation the People’s Republic of China in China 1. China Category I (C-I):
In May of 2011, Eighth Organ Donation after Brain Death-DBD. Amendment of Criminal Law 2. China Category II (C-II): passed, which eliminating death penalty for 13 offenses, Organ Donation after Circulatory Death-DCD. but added a new crime under 3. China Category III (C-III): criminal charge: organ trading. Organ Donation after Brain Death followed by Circulatory Death-DBCD.
(MOH Hospital Administration Division, Issue(2011), No.62.Appendix I)
The rising of deceased Organ Donation in China
The Number of Transplant in 2007-2013 China Organ Donation and Transplantation System 10000 30% 9001 9116 8577 8112 24.22% 7739 25% 7417 7500 20% Organ Donation Register System, 5912
Organ Procurement and Allocation Network, 5000 13.12% 15%
Organ Transplantation Clinical Service System, 10% 2500 Post-Organ-Transplantation Register System. 3.47% 5% 0.24% 0.19% 0.21% 0.81% 0 0% 2007 2008 2009 2010 2011 2012 2013
47.5%
Organ donation initiative Kick-off meeting for Nationwide DCD program (August 25th, 2009 Shanghai China) (Feb 25th, 2013 Beijing) The National Human Organ Transplantation Working Meeting was successfully held If China is to sustain in Shanghai on August 25, a successful program 2009. Some key issues on organ transplantation, such as of deceased organ the source of organs, donation, the Chinese establishment of an organ donation system and organ people must trust a allocation mechanism, were national system that constituted. must be clean, fair, transparent and equitable.
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Media:More than 1500 DCD, a major breakthrough in the 11th OTC meeting of NHFPC development of China organ donation system (Sep 17th, 2013 Beijing)
Any accredited transplant On February 25th, 2013, the hospital that fail to develop a former Ministry of Health and deceased organ donation Res Cross Society of China program will have their jointly initiated national-scale transplant license and OPO deceased organ donation Picture of OTC meeting license revoked program. Doctors who use the organs other than those obtained from As of February 12nd, 2014, the the centralized sharing network program has seen 4,065 organs will be disqualified. from 1,500 donors (including The local Health Authorities 1,222 livers, 2763 kidneys, 57 have the compulsory hearts, and 12 lungs, 9 pancreas, responsibly and mandate to 2 intestines). enforce the implementation of the regulation.
The National Regulation on Human Organ Procurement and Allocation 21,August 2013 Challenges Ahead
The Regulation further enforce the regulation of health authority on the follow Amendment of the national Regulation on Otx issues: (legal framework) 1. Mandatory enforcement of national implementation of China national National working structure and Mechanism for Otx organ allocation computer system, OPO and Coordinator namely China Organ Transplant Response System (COTRS). Community effort and reflection of deceased organ 2. Defines qualification and donation is a community effort and reflection of the responsibilities of organ donation solidarity of Chinese people to benefit their fellow 共五章24款 coordinators. man. 3. Defines qualifications and responsibilities of OPO
The Future China Organ Transplant Response System China should refer to its own traditional culture and present socio-economic condition and learn from the international transplant community in establishing China’s organ transplantation system and show “the responsible big country” image on the world stage.
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A Call to Action More than 450 years before the birth of Christ, Confucius said: ‘What I hear, I forget; what I see, I remember; what I do, I understand.’ Let’s do it together. We’ve heard what we have to do. We’ve seen what we need to do. Now is the time to do it.
Thank you!
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GENERAL INFORMATION – FOR ORGANS ORGAN LEGISLATION
9. Are any aspects of organ donation and /or transplantation covered by any legal requirement? COUNTRY: JAPAN Yes Time of Enactment:_____1996、2009______INFORMATION PROVIDED BY: No Name: Naoshi Shinozaki If Yes, Does it cover the following aspects? Position: Executive Director Organ donation from deceased persons Organization: Japan Organ Transplant Network Organ donation from living persons （Society) Address: ORIX Akasaka Nichome Bldg. 2F, 2-9-11, Akasaka, Minato-ku, Tokyo, JAPAN Allocation E-mail: [email protected] Organ Transplantation Organ Trafficking
10. The government is currently intending to adopt new or revise any legal requirement on these subjects and/or on missing/unforeseen subjects: - Is there a functioning* transplantation programme? Yes Yes - Is there a functioning* programme for organ donation from deceased persons? Yes No - Is there a functioning* programme for organ donation from living donors? Yes 11. Is there a legal requirement to report to the government the transplants performed within the country and the *Functioning: programme performing or able to perform its regular function deceased donors? Yes No 12. Is the type of consent required for donations from deceased persons specified in any legal requirement? Yes No
ORGANIZATIONAL SYSTEM - ORGANS ORGAN LEGISLATION
13. Are incentives to obtain the consent of the families of the deceased person (in the form of any monetary payment or other reward of monetary value), legally permitted? 1. Is there a Government recognized authority responsible for overseeing donation and/or transplantation at national level? Yes No Yes No Living donation: - If Yes, for Donation, Transplantation or Both? _____Both______14. Is unrelated living donation legally permitted? 2. Is there a specific organization, institution or agency responsible for organ donation and/or transplantation matters Yes at national level? No Yes 15. Are financial incentives legally permitted for living organ donation? No Yes; Are they specifically regulated by the government? - If Yes, Does it report to the Ministry of Health? Yes No No; Are they nonetheless offered or provided to potential living donors? 3. Are organ procurement and / or transplantation expenses covered by? : Comment: ____Monetary incentives are prohibited by law______State Private Health Insurance 16. Is there any kind of explicit prohibition of organ trafficking / transplant commercialism? Recipients Other specify: _____Social Health Insurance of the patients and parts of donation i______Yes. Are there penalties? 5 years in sentences and/or 5,000,000 yen (~$50,000-) fine No 4. Are recipients paying for post - transplant care and drugs? What is specifically prohibited?___ Yes If yes: Total or Partial Social Health Insurance system __Organ trafficking, failing post-mortem inspection by physician______No
ORGANIZATIONAL SYSTEM - ORGANS DONATION &TRANSPLANTATION ACTIVITY DATA FOR ORGANS (data for 2012) Transplants performed abroad: ACTUAL DECEASED DONORS - Total actual deceased organ donors:_110__ 5. Is there any cooperation framework or agreement to allow patients to be transplanted abroad? - Actual DBD donors: _45__ Yes - Actual DCD donors: _65__ No KIDNEY Tx WAITING LIST If yes, comment under which programmes and specify the countries: - Total Kidney from deceased donors:_193__ Number of patients with (ESRD) on dialysis ______- Kidney from DBD:_ 77 treatment:_309,946______- Kidney from DCD:_116
6. In case of recipients travelling abroad to be transplanted (under a cooperation framework or not): Is the recipients’ - Total Kidney from Living donors:_1412_ follow-up assured in the country of origin upon their return? - Unrelated kidney :____ （less than 1% ) TRANSPLANTS ABROAD Yes - Related kidney :____ - Number of resident patients, known to have been No transplanted abroad:______LIVER Tx: 7. Do recipients and living donors travel abroad together? - Total Liver From deceased donors:__40 (including Destination country/ies:______1 liver-kidney) Yes, always - Liver from DBD:__40_ Yes, sometimes - Liver from DCD:__ 0 _ No - Liver From Living donors:______- Number of resident living donors, known to have 8. Is the living donor follow-up assured upon his/her return? HEART Tx: __28___ travelled abroad to donate:____ Yes No LUNG Tx:___33__ Destination country/ies:______PANCREAS Tx:___27_(including 18 kidney-pancreas)__ SMALL BOWEL Tx:__0___
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Legislation in Japan DONATION &TRANSPLANTATION ACTIVITY DATA FOR ORGANS (data for 2013) ACTUAL DECEASED DONORS - Total actual deceased organ donors:_84__ 11964964 First Kidney, Lung Transplant - Actual DBD donors: _47__ - Actual DCD donors: _37__ KIDNEY Tx WAITING LIST - Total Kidney from deceased donors:_155__ Number of patients with (ESRD) on dialysis - Kidney from DBD:_ 88 treatment:_309,946______196819681968First Heart Transplant - Kidney from DCD:_ 67
- Total Kidney from Living donors:____ - Unrelated kidney :____ TRANSPLANTS ABROAD - Related kidney :____ - Number of resident patients, known to have been 119969961996 Law for Organ Transplantation transplanted abroad:______LIVER Tx: - Total Liver From deceased donors:__38 (including Destination country/ies:______1 liver-kidney) - Liver from DBD:__38_ 200920092009Revise the law - Liver from DCD:__ 0 _ - Liver From Living donors:______- Number of resident living donors, known to have HEART Tx: __38_(including 1 heart-lung)__ travelled abroad to donate:____
LUNG Tx:___41_(including 1 heart-lung) Destination country/ies:______PANCREAS Tx:___33 (including 24 kidney-pancreas)___ SMALL BOWEL Tx:__0___
International Technical Consultation on Cell, Tissue and Organ HistoryHistoryHistoryofofof TransplantTransplantTransplant
■ 196319631963 First Liver, Lung TxTxTx.Tx... ■ 119649641964 First Kidney TxTxTx.Tx. in Japan. Japan “Plans for increasing organ donation in Japan “ ■ 119649641964 First Liver TxTxTx.Tx. In Japan. Japan
Naoshi Shinozaki ■196719671967 First Heart TxTxTx.Tx...
Executive Director; Japan Organ Transplant Network (JOT),(JOT), ■ 119689681968 First Heart TxTxTx.Tx. In Japan. Japan Secretariat;Secretariat;Secretariat;JapaneseJapaneseJapanese SocietySocietySociety forforfor TransplantTransplantTransplant (JST(JST(JST) (JST))) (Wada TxTxTx.)Tx.).).) Medical Advisory Board; Eye Bank Association of America （（（EBAA) （EBAA)EBAA)EBAA) Expert Advisory Panel; World Heal Organization (WHO)
JAPANJAPANJAPAN Legislation in Japan
Population; 11964964 First Kidney, Lung Transplant 126,000,000 196819681968First Heart Transplant
JOT 199619961996Law for Organ Transplantation HQ East branch Middle branch West branch 200920092009Revise the law
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Dialysis Patients in Japan The Ministry of Health, Labour & Welfare Council for promotion of organ transplantation 300000300000300000
264473 257765 248165 250000250000250000 237710 229539 The Minister of Health, Labour and Welfare appointment; 219183 205134 197213 200000200000200000 195322 175988 Discussing & make decisions how to promote organ 167192 154413 150000150000150000 143709 transplantation. 134298 123926 116303 103296 100000100000100000 8863483221 80553 72537 5991166310 53017 47978 42223 500005000050000 36397 2704832231 1801022579 13069 61499245 21530194918283631 000 686868696969 707070 717171 727272 737373 747474 757575 767676 777777 787878 797979 808080 818181 828282 838383 848484 858585 868686 878787 888888 898989 909090 919191 929292 939393 949494 959595 969696 979797 989898 999999 000 111 222 333 444 555 666
(社)日本透析医学会統計調査委員会調べ
Kidney Transplantation per Country pmp Driver’s License versus Human Development Index (HDI) Driver’s License
8% 66% 26% Population 70 Since 2010Since 2010 60 BBBackBack of the license is Low Medium High AFRO used to show the will 50 AMRO 40 EMRO of organ donation 30 EURO SEARO By 2015, ALL the 20 WPRO kidney tx /pmp kidney 10 license become IC 0 card with donor card 0.4 0.5 0.6 0.7 0.8 0.9 1 0,02％ 31% 69% Kidneytransplants HDI
東京歯科大学市川総合病院 角膜センター
Donor info. IC # and Donation # Social Health Insurance Card （2008～2013） （cases） The most of health care 600600600 539539539 insurance group is changing 520520520 516516516 495495495 to IC card 500500500 All info. 423423423 443939439 400400400 Effective info. Back side of IC card is used to show the will for organ 300300300 227373273 277277277 279279279280280280 226226226 225353253 donation.donation.donation. I.C. family 118080180 190190190191191191 117777177 200200200 153153153 147147147 134134134 122122122 136136136 127127127 112828128 Donation 96 100100100 9696 DBD 969696 989898 818181 686868 656565 337737 DCD 32 444444 454545 474747 0 131313777 3232 220080082008 200920092009 201020102010 201120112011 201220122012 201320132013 （year）
JapanJapan Organ Organ Transplant Transplant Network Network
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Installation of InIn----househouse coordinator Quality Management Seminar 1. Hospital Audit Organization of Japan 1. Set the donor information flow standards 2. On site inspection questionnaire
2. MOH research group 1. In-house coordinator education 2. Quality Management Seminar
May 16, 2012 第25回日本脳死脳蘇生学会 シンポジウム
Quality Management seminar Quality Management Seminar
AimAimAim To establish donor detection system in each hospital, educating inin----househouse Coordinators and managing the system in hospitals.
201220122012-2012---20142014 MOH research group form the seminar Corroborators; Japan Emergency Medicine Society Clinical Emergency Medicine Society of Japan Japan Neurological Medicine Society Emergency Nurse Society Japan Organ Transplant NetworkNetworkNetwork 4 days seminar; TPM Japan, National Committee to support individual hospital
May 16, 2012 第25回日本脳死脳蘇生学会 シンポジウム May 16, 2012 第25回日本脳死脳蘇生学会 シンポジウム
222nnddnd SSeminareminar 2013 Education of Hospital Management
May 16, 2012 第25回日本脳死脳蘇生学会 シンポジウム
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nnddnd 222 SSeminareminar 2013 TPM Japan seminar 2013
May 16, 2012 第25回日本脳死脳蘇生学会 シンポジウム
222nnddnd SSeminareminar 2013
NeedsNeedsNeedsforforfor Professional EducationEducationEducation
Medical Staff
May 16, 2012 第25回日本脳死脳蘇生学会 シンポジウム
Education of InIn----househouse Coordinator Attitudes towards donation: all CCU staff
Europe Japan 100 92% 92% 84% 80 69% 70%
60 52%
% 45% 40 35%
20 14% 11% P<.0001P<.0001 P<.0001P<.0001 P<.0001P<.0001 P<.0001P<.0001 P<.0001P<.0001 0 'support 'would donate 'would donate 'would donate 'donation helps donation, in own organs' adult relative's child's organs' families coping general' organs' with grief'
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Confidence levels - all CCU staff*
Europe Japan 54%
50 40% 40 NeedsNeedsNeedsforforfor Professional EducationEducationEducation 31% 31% % 30 23% 20 Transplant Coordinators 12% 7% 9% 6% 4% 10
P<.0001P<.0001 P<.0001P<.0001 P<.0001P<.0001 P<.0001P<.0001 P<.0001P<.0001 0 'comforting 'notifying a 'explaining 'introducing the 'asking grieving TC..' brain death..' subject of relatives to families..' donation..' make a decision..'
*with exclusion of those not involved in donation related tasks
Received specific training - Transplant Coordinator all CCU staff Their human skills and donation rate
Europe Japan 26% Consent rate on Routine Referral System (RRS) 25 21% Co # IC # Cons. # Cons. Rate 20 1 762 114 15.0 % 16% 2 28 7 25.0 % 15 % 3 806 113 14.7 % 10% 10 4 485 36 7.4 % 5 110 7 6.4 % 5% 3% 5 2% 2% 0 P<.0001P<.0001 P<.0001P<.0001 P<.0001P<.0001 P<.0001P<.0001 brain death donor family grief making donation management counseling request
“Donation helps families coping with grief” Human skills 140-160 Scores of Recognition factors 120-140 30% of people don’t believe 100-120 70 69.3 donation helps families coping with grief 160160160 80-100 60-80 57.8 140140140 60 40-60 Medical Staff 120120120 20-40 50 100100100 0-20 -20-0 40 808080 % 30.6 606060 30 22.7 404040 20 202020
11.6 000 E 8 CD 10 AB --2020-20
0 % yes % no % don't know, no answer Europe Japan
Presented at 3rd International DA meeting (5th Sep. 2004/ Vienna)
6 03/02/2015
Scores for high consent rate staff Japan Organ Transplant Network Feb. 6, 2014 160 140 120 100 80 2014 Business plan 60 40 Prefectural Promotion Committee and In 20 0 house system establishement A
Japan Organ Transplant Network A Executive Director; Naoshi Shinozaki B C Ave.1
Japan Organ Transplant Network
Scores and average for low consent rate staff Promotion of pref. activities
D 160 • Each pref. committee will supervise multiple E 140 authorized donating institution Ave.2 120 • Local government, Pref. Co. Kidney Bank, eye bank, 100 Volunteer groups will link public and hospitals. 80
60 • Data collection with Uniform platform for target 40 hospitals and JOT will manage the data to make
20 action plans with medical societies.
0
Japan Organ Transplant Network
New Project from 2014 Sharma of Pref. promotion
JOT HQ MMajorajor Change in items
Activity fund for each pref. Co was cut JOT branch JOTbranch JOTbranch New project fund for ・・・Prefectural committee for Local gov. Branch Co. KB Co EB Co 111)1) supervise prefecture activities In-house Co 222)2) local PR Pref. Co Volunteers ・・・Individual Hospital development
In-house com. In-house com.
Japan Organ Transplant Network
7 03/02/2015
Pref. Committee model Hospital Development Program
JOT HQ • JOT HQ produce the uniform platform for data base JOT branch on patients flow in hospitals. Local member will work Public Hospital together with JOT HQ & branch to furnish in-house Education Education system. Local Gov. Local Gov. Hospital • Each institute will use uniform platform, but detection Local PR Kidney Bank Information Pref. Co and/or management could be tailor-made. Pref. Co Official In ward Kidney Bank Institute patients infor. • Each institute must be evaluated their activities by Eye Bank Bank Co. local committee in statistical manner. Eye Bank Co Evants Donor detection In-house Co
Volunteer Donor Tx. Support office management
Japan Organ Transplant Network Japan Organ Transplant Network
Transplant Services Support Project Hospital Development Program Pref. Organ Transplant Promotion JOT HQ Public education JOT HQ JOT branches JOT branch JOTbranch JOTbranch Local action plan and monitoring the action
Pref. Team Pref. Co
Cooperation with local government, the team will produce effective PR ・ system audit ・ will check at patients admission Periodic committee for evaluation ・ manuals for severe patients Plan the events and do ・Quality Management seminar With the Volunteer group, public education will be planed and monitor Emergency Boards ・ Donor Action & TPM Japan ・ Brain Deaths tests simulation ・ ICU・CCU Nurse dep. setting-up Tx support office in hsp. In-house Co ・ manual for ICU round ・ RRS install Admin. Tx support ・ setting up committee and stair office
Japan Organ Transplant Network Japan Organ Transplant Network
Transplant Services Support Project Pref. Organ Transplant Promotion Public education JOT HQ JOT branches Produce Action Plan for hospital development in Pref. Uniform formatting Pref. Team
Hospital and potential donor information will be collected in uniform format and install the donor detection system for each hospitals
Routine meetings by the team to; 1. Update the hospital information and process of hospital development 2. Identify the milestone for each step and monitor 3. Evaluating the patients flow in hospital and make action plan
Japan Organ Transplant Network
8 03/02/2015
区区区西区西西西北部北部北部北部 北多摩北部 Emergency & Trauma Center 区東北部区東北部区東北部 西多摩西多摩西多摩 北多摩西部 区区区西区西西西部部部部 東葛北部東葛北部東葛北部
5
4 4
3 3 東葛南部東葛南部東葛南部 平均：1.8 2 2 2 2 2 2 2
1 1 1 1 1 1 1
区区区西南区西南西南西南部部部部 区区区中央区中央中央中央部部部部 0 北多摩南部 南多摩南多摩南多摩 区東部区東部区東部 区区区南区南南南部部部部 49
General Hospital (>200 beds) Cancer Center
7
25
6 6 20 20 5 16
15 13 13 4 12 11 平均： 3 3 10.1 10 3 10 9 8 8 7 平均： 2 2 2 6 6 2 1.6
5 3 1 1 1 1 1
0 0 0 0 0 0
Univ. Hospital
14
12 12
10
8
6
平均： 2.8 4 4 4 3 3 3 3
2 2 2 2 1
0 0 0 0
54
9 03/02/2015
55 58
56 59
Electric registry for 病院基本情報 Kidney Transplant Sample view
病院特化情報 Sept. 2008
過去過去過去の過去ののの提供数提供数提供数提供数 などのなどのなどの実績などの実績実績実績
57
10 03/02/2015
Japan Renal Transplantation Registry System (JARTRE)
Registry forms （donor・recipient）
11 03/02/2015
Follow-up registry （for recipients）
Follow-up registry （for Living donor）
12 03/02/2015
Keys to the success of global system
• WHO leadership with TTS • Uniform system on OTC and any medical products of human origin • Corroboration between societies and entities • Clear & simple rules of data input • Global agreement of use & analyze data • Authorization & support from the Health authorities
Global coding system
wwwillwill provideill provide 11..1. prohibitionprohibition of unethical donation and transplantation 22..2. bestbest practice on transplantation 33..3. SafeSafe guards for transplantation with realrealreal-real---timetime traceability
MOH research group Thank you • For more information 2007 – 2009 “Promotion of Social Infrastructure for Organ Transplant” suggested the transparency & registry system of OTC. Naoshi Shinozaki 2009 – 2011 “1st phase” of Takahara group started kidney transplant registry by web system. [email protected]
2011 – 2013 “2nd phase” of Takahara group finalize the registry system for ALL organ transplant
13 03/02/2015
4 Service Delivery and Safety
Global Observatory on Donation and Transplantation Organs Transplanted Globally in 2012
≈ 114,690 organs transplanted (≈ 10% of estimated global needs)
Kidney Liver Heart Lung Pancreas
77818 23986 5935 4359 2423
≈ 1.81 % increase over 2011
109 countries reported to the Global Observatory on Organ Donation and Transplantation 2012 GKT/ GODT South Africa, India and China - are 2010 estimates
5 Service Delivery and Safety
Transplants & Waiting List in the EU, 2012 (Newsletter Transplant, 2013)
TRANSPLANTS W.L.
19.085 50.397
6.973 6.603
2.143 3.273
For many, the waiting continues 1.756 2.005 …more than 3.773 patients died ------while wating to be transplanted TOTAL 29.957 62.278 in 2012
Newsletter Transplant 2013 http://www.ont.es/publicaciones/Documents/NEWSLETTER2013.pdf
1 03/02/2015
7 Service Delivery and Safety 10 Service Delivery and Safety
Global Observatory on Donation and Transplantation Organs Transplanted Globally in 2012
≈ 114,690 organs transplanted (≈ 10% of estimated global needs)
Kidney Liver Heart Lung Pancreas
77818 23986 5935 4359 2423
109 countries reported to the Global Observatory on Organ Donation and Transplantation 2012 GKT/ GODT South Africa, India and China - are 2010 estimates
8 11 Service Delivery and Safety Service Delivery and Safety
Global Observatory on Donation and Transplantation Organs Transplanted Globally in 2012
≈ 114,690 organs transplanted (≈ 10% of estimated global needs)
Kidney Liver Heart Lung Pancreas
77818 23986 5935 4359 2423
Living Donor Living Donor 32350 4222 42,5% 17,8%
109 countries reported to the Global Observatory on Organ Donation and Transplantation 2012 GKT/ GODT South Africa, India and China - are 2010 estimates
9 12 Service Delivery and Safety Service Delivery and Safety
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Reductionin waitingtime 22 vs 344 days
Reduction in mortality (HC)
Shorter Cold Ischemic times < ACR and Graft loss
Lo CM, Fan ST, Liu CL, Chan SC, Ng IO, Wong J. Living donor versus deceased donor liver transplantation for early irresectable hepatocellular carcinoma. ShakedBr. J. A,Surg. Ghobrial 2007; RM,94: 78–86.Merion RM et al. Incidence and severity of acute cellular rejection in recipients undergoing adult living donor or deceased donor liver transplantation. Am. J. Transplant. 2009; 9:301–8.
Better outcomes
13 Service Delivery and Safety 16 Service Delivery and Safety
Risks of living donations
14 17 Service Delivery and Safety Service Delivery and Safety
15 18 Service Delivery and Safety Service Delivery and Safety
3 03/02/2015
19 Service Delivery and Safety 22 Service Delivery and Safety
Complications of Living Donor Hepatic Lobectomy M.M. M. Abecassis, R. A. Fisher, K. M. Olthoff, C. E. Freise, D. R. Rodrigo, B. Samstein, I. Kam, R. M. Merion, the A2ALL Study Group American Journal of Transplantation, 12: 1208–1217. doi: 10.1111/j.1600-6143.2011.03972.x Chain Donation Following Good Samaritan http://www.nytimes.com/2012/02/19/health/lives-forever-linked-through-kidney-transplant-chain-124.html?_r=2&nl=todaysheadlines&emc=tha2 February 2012
760 living donors A2ALL cohort study Donor morbidity assessed over a 12-year period
20 procedures aborted - 740 completed
40% had complications (557 complications among 296 donors), • grade 1 (minor, n = 232) • grade 2 (possibly life-threatening, n = 269) • grade 3 (residual disability, n = 5) • grade 4 (leading to death, n = 3)
Hernias (7%) and psychological complications (3%) occurred >1 year postdonation.
Complications risk did not decline with the increased center experience with LLD.
The probability of complication resolution within 1 year was overall 95%, but only 75% for hernias and 42% for psychological complications
20 23 Service Delivery and Safety Service Delivery and Safety
Safety of the Living Donor http://www.nypost.com/p/news/local/bronx/montefiore_transplant_nightmare_PVO4SBjhXjgX3LGynvMRbJ?utm_medium=rss&utm_content=Bronx 6 June 2012
It has been estimated that early and delayed death from transplant-related causes can be expected of approximately one in every 200–500 right lobe donors, with permanent disability of a significant number of others.
21 24 Service Delivery and Safety Service Delivery and Safety
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Global Observatory on Donation and Transplantation Kidneys Transplanted Globally 2008-11
78000
76000
74000
72000
70000
68000
66000
64000 2008 2009 2010 2011
25 Service Delivery and Safety 28 Service Delivery and Safety
Global Observatory on Donation and Transplantation Kidneys Transplanted Globally 2008-11
Absolute number n 43768 45000 40985 39303 40000 37300
32797 DD 35000 32000 32194 32350
30000 LD
25000
20000
15000
10000 2008 2009 2010 2011 Year
26 29 Service Delivery and Safety Service Delivery and Safety
Global Observatory on Donation and Transplantation Global Observatory on Donation and Transplantation Organs Transplanted Globally in 2011 Kidneys Transplanted Globally 2008-11
≈ 112,600 organs transplanted (≈ 10% of estimated global needs) % Percentage 60 57.5 56.1 53.8 54.6 Kidney Liver Heart Lung Pancreas 55 DD 50 76118 23721 5741 4278 2564 46.2 45.4 43.9 LD 45 42.5 Living Donor Living Donor 40 32350 4222 35 42,5% 17,8% 30 2008 2009 2010 2011 Year
103 countries reported to the Global Observatory on Organ Donation and Transplantation 2008 GKT/ GODT South Africa, India and China - are 2010 estimates 27 30 Service Delivery and Safety Service Delivery and Safety
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Global Observatory on Donation and Transplantation Global Observatory on Donation and Transplantation Livers Transplanted Globally 2008-11 Livers Transplanted Globally 2008-11
n Living donors 24000 % 17.8
23000 18 17 15.48 15 22000 16 14.42 15 21000 14 13 20000 12 11 19000 10 9 18000 8 2008 2009 2010 2011 Year 2008 2009 2010 2011 Year
31 Service Delivery and Safety 34 Service Delivery and Safety
Global Observatory on Donation and Transplantation Livers Transplanted Globally 2008-11
n 19499 Absolute number 20000 17896 18486 17265 18000
16000 14000 DD 12000
10000 LD
8000 6000 4222 3035 3279 3116 4000
2000
0 2008 2009 2010 2011 Year
32 35 Service Delivery and Safety Service Delivery and Safety
Global Observatory on Donation and Transplantation Livers Transplanted Globally 2008-11
% Pecentage 85 84.52 85.48 82.2 90
80
70
60 DD
50 LD 40
30 17.8 15.48 14.42 20 15
10
0 2008 2009 2010 2011 Year
33 36 Service Delivery and Safety Service Delivery and Safety
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Professionals Authorities
37 Health Systems Service40 Delivery Service Delivery and Safety The Magnificent Seven, John Sturges,1960 40 and Innovation Strengthening
Legal framework
Opting in
Opting out
38 41 Service Delivery and Safety Service Delivery and Safety
Critical pathways for organ donation* POSSIBLE DECEASED ORGAN DONOR A patient with a devastating brain injury or lesion OR a patient with circulatory failure AND apparently medically suitable for organ donation
Treating physician Donation after Circulatory Death (DCD) to identify/refer a potential donor Donation after BrainDeath (DBD) POTENTIAL DCD DONOR POTENTIAL DBD DONOR
A. A person whose circulatory and respiratory Reasons why a potential donor A person whose clinical condition is suspected to functions have ceased and resuscitative does not become a utilized donor fulfill brain death criteria. measures are not to be attempted or continued. System or • Failure to identify/refer a potential or eligible donor B. A person in whom the cessation of circulatory • Brain death diagnosis not confirmed and respiratory functions is anticipated to occur within a time frame that will enable organ (e.g. does not fulfill criteria) or completed recovery. (e.g. lack of technical resources or clinician to make diagnosis or perform confirmatory tests) • Circulatory death not declared within the appropriate time frame. Type of donor ELIGIBLE DBD DONOR Legal framework ELIGIBLE DCD DONOR • Logistical problems (e.g. no recovery team) A medically suitable person who has been Legal framework A medically suitable person who has been • Lack of appropriate recipient (e.g. child, blood type, declared dead based on the irreversible absence serology positive) declared dead based on neurologic criteria as of circulatory and respiratory functions as stipulated by the law of the relevant jurisdiction. stipulated by the law of the relevant jurisdiction, Donor/Organ Living within a time frame that enables organ recovery. • Medical unsuitability (e.g. serology positive, neoplasia) • Haemodynamic instability / unanticipated cardiac Opting in arrest ACTUAL DBD DONOR Opting in ACTUAL DCD DONOR • Anatomical, histological and/or functional A consented eligible donor: A consented eligible donor: abnormalities of organs Deceased A. In whom an operative incision was made A. In whom an operative incision was made • Organs damaged during recovery with the intent of organ recovery for the with the intent of organ recovery for the Opting out • Inadequate perfusion of organs or thrombosis purpose of transplantation. purpose of transplantation. Opting out or or Permission B. From whom at least one organ was B. From whom at least one organ was • Expressed intent of deceased not to be donor recovered for the purpose of transplantation. recovered for the purpose of transplantation. • Relative’s refusal of permission for organ donation • Refusal by coroner or other judicial officer to allow UTILIZED DBD DONOR UTILIZED DCD DONOR donation for forensic reasons An actual donor from whom at least one organ An actual donor from whom at least one organ was transplanted. 42 was transplanted. Service Delivery and Safety *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.
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Deceased donors per million
GODT 2012 population vs Human Development Index
Croatia Spain
Self-Sufficiency US begins locally and is Legal framework Type of donor Organizational Structure adapted to the local reality Uruguay Living National Canada Opting in Brasil OPO Belarus Deceased Opting out Paraguay Iran South Africa Thailand
43 Service Delivery and Safety 46 Service Delivery and Safety
EVERY COUNTRY SHOULD MAKE A DIAGNOSIS OF ITS SITUATION AND FIND THE MOST ADEQUATE WAY TOWARDS SELF - SUFFICIENCY
…THERE IS NO UNIQUE FORMULA
WELL PROVEN SUCCESSFUL MODELS (BIG AREAS – SUSTAINED INCREASE) MAY BE TAKEN AS A REFERENCE
Delmonico FL, Domínguez-Gil B et al. Lancet 2011 44 47 Service Delivery and Safety Service Delivery and Safety
BRAIN DEATH AUDIT
INSIDE THE HOSPITALS HOSPITAL Participants in the Madrid Consultation urged WHO, its Member States and professionals REIMBURSEMENT in the field to regard organ donation and transplantation as part of every nation’s SPECIAL responsibility to meet the health needs of the population in a comprehensive manner, TRAINING OF PROFILE addressing the conditions leading to transplantation from prevention to treatment. PROFESSIONALS
Every country, in light of its own level of economic and health system development, should progress towards the global goal of meeting patients' needs on the basis of COORDINATION ATENTION TO THE MEDIA resources obtained within the country, for that country’s population, and through NETWORK regulated and ethical regional or international cooperation when needed.
The strategy of striving for self-sufficiency encompasses the following features: actions should (i) begin locally; (ii) include broad public health measures both to decrease the disease burden in a population and to increase the availability of organ transplantation; (iii) enhance cooperation among the stakeholders involved and (iv) be carried out on the basis of the WHO Guiding Principles and the Declaration of Istanbul, in particular emphasizing voluntary donation, non-commercialization, maximization of donation from the deceased, support for living kidney donation, and meeting the needs of the local population in preference to “transplant tourists”.
45 48 Service Delivery and Safety Service Delivery and Safety
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Actual donors from deceased persons, 2012
“ To improve is to change;
to be perfect is to change often ”
Winston Churchill 49 Service Delivery and Safety 52 Service Delivery and Safety
VARIATION BETWEEN 2008 AND 2012 = 18.4 %
DECEASED DONORS (ABSOLUTE NUMBERS)
27000 26523 26000 [email protected] 25776 25000 [email protected] http://www.who.int/transplantation/en/ 24000 24280
23000 22905 Thank you
22000 22409
21000
20000 2008 2009 2010 2011 2012
50 Service Delivery and Safety Health Systems Service Delivery 53 and Innovation Strengthening
DECEASED DONORS PMP: YEARS 2008 AND 2012 COUNTRIES WITH THE BIGGEST INCREASE
Peru 3.16 0.76 DDPMP2012 DDPMP2008 6.67 Panama 1.82 7.46 Paraguay 2.12 9.44 Republic of Korea 3.06 6.98 Iran (Islamic Republic of) 2.81 3.62 Ecuador 1.7 34.77 Croatia 18.86 12.35 Brazil 7.2 1.95 Thailand 1.26 10 Iceland 6.67 16.06 Poland 11.21 Venezuela (Bolivarian Republic of) 4.68 3.33 6.21 Kuwait 4.48 17.27 Latvia 13.04 20 Finland 15.28 12.42 Lithuania 9.71 15.46 Australia 12.1 0.61 Malaysia 0.48 23.5 Slovenia 18.5 4.63 Turkey 3.66 0 5 10 15 20 25 30 35 40
51 Service Delivery and Safety
9 20102010 World Health Assembly Resolution WHA63.22 Human Organ and Tissue Transplantation
• 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; Technical Consultation on Knowledge Sharing and Networking for Human Cell, Tissue and Organ Donation and • (4) to facilitate Member States’ access to appropriate information on the donation, Transplantation in the Western Pacific Region processing and transplantation of human cells, tissues and organs, including data on severe adverse events and reactions; Seoul, February 20-21 2014
Health Systems Patient Safety Health Systems Service Delivery 1 and Innovation Programme 4 and Innovation and Safety
The WHO Wide Initiative for MPHO Vigilance and Surveillance 3 Global Governance Tools for MPHO A Comprehensive Safeguard to Allow Timely Reaction
1. Standards of Practices Common to MPHO Quantitative and qualitative data including non-conformity, failures, risks • Non commercial nature of the human body and its parts as such Quality Management Systems - Good Practices • Towards a global consensus leading to a formal agreement Community Living Donor Possible Donor 2. Universal use of ISBT 128 for all MPHO National Deceased Person Donors and Recipients • Information Standards for Blood and Transplant Follow-up Registries Health • Towards universal use of ISBT128 within 10 years MPHO Authorities 3. Global vigilance and surveillance Patient Recipient Evidence • NOTIFY project for Vigilance and Surveillance of MPHO Loss of function for Action death • Towards using at best the global experience of adverse events and reactions
World Health Assembly HealthV&S: Care what goes professionals wrong and can go wrong
Health Systems Service Delivery Health Systems Health Systems Clinical 2 and Innovation and Safety 5 and Innovation Policies and Workforce Procedures
20102010 World Health Assembly Resolution WHA63.22 Definitions – EU and NOTIFY Human Organ and Tissue Transplantation
EU : ‘Serious Adverse Reaction (SAR)’ means an unintended response, including a • 2. URGES Member States: • (5) to improve the safety and efficacy of donation and transplantation by communicable disease, in the donor or in the recipient associated with the procurement or human promoting international best practices; application of tissues and cells that is fatal, life-threatening, disabling, incapacitating or which results in, or prolongs, hospitalisation or morbidity • (6) to strengthen national and multinational authorities and/or capacities to provide oversight, organization and coordination of donation and transplantation (NOTIFY: An adverse response that HAS occurred, including a activities, with special attention to maximizing donation from deceased donors and to protecting the health and welfare of living donors with appropriate health- communicable disease, in a recipient or in a living donor) care services and long-term follow up;
• (7) to collaborate in collecting data including adverse events and reactions on EU: ‘Serious Adverse Event (SAE)’ means any untoward occurrence associated with the the practices, safety, quality, efficacy, epidemiology and ethics of donation and procurement, testing, processing, storage and distribution of tissues and cells that might lead to the transplantation; transmission of a communicable disease, to death or life-threatening, disabling or incapacitating • (8) to encourage the implementation of globally consistent coding systems for conditions for patients or which might result in, or prolong, hospitalisation or morbidity human cells, tissues and organs as such in order to facilitate national and international traceability of materials of human origin for transplantation; ( NOTIFY: An adverse occurrence that MIGHT lead to harm in a recipient or a living donor)
Health Systems Service Delivery Health Systems Health Systems Clinical 3 and Innovation and Safety 6 and Innovation Policies and Workforce Procedures
1 -3- Global Vigilance and Surveillance Tools -3- Global Vigilance and Surveillance Tools The NOTIFY project for Vigilance and Surveillance of MPHO The NOTIFY tools • NOTIFY Website http://www.notifylibrary.org • NOTIFY Library of didactic cases of events and reactions
• Mutualizing the global experience of V&S in MPHO services o Risk identification o Risk assessment o Risk based quality management o Donor selection and management o Risk education o Recipient management • Promoting V&S as a crucial mechanism of quality and transparency in o Quality system - risk based management MPHO services • NOTIFY Booklet • Associating professionals, Operators and Competent Authorities • Demonstrating Transparency • NOTIFY Journal • Deserving trust
Health Systems Service Delivery Health Systems Service Delivery 7 and Innovation and Safety 10 and Innovation and Safety
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 1400 13 % human origin used in assisted reproduction technologies. 1200 18 % 1000 1. A reference for professionals focused on diagnostic and investigation 800 2. but also providing evidence for donor selection, 600 3. A source of information for candidate recipients and living donors 400 4. A reference for risk based quality management systems 200 A database for further study 0 5. 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 http://www.notifylibrary.org/
Health Systems Patient Safety Health Systems Service Delivery 8 and Innovation Programme 11 and Innovation and Safety
The NOTIFY Project The NOTIFY Library Operation
Regular WHO Global Consultation on V&S Review Literature review LIBRARY Brasilia 2013 Structured of evaluated and Automated relevant material Rome 2012 Comprehensive Accept Geneva 2011 5 Experts Editorial WG Ad hoc queries • Infection current, and CNT Secretariat • Malignancy accessible • Handling-clinical errors • Genetic • Living donor Analyse new data and modify structured analysis regarding Partner organisations alerting signals etc. Reject provide information • Competent Authorities Analysis – structured, • Scientific Professional Record of searchable, current,and Societies justification of accessible Rejection
Health Systems Service Delivery Health Systems Health Systems Clinical 9 and Innovation and Safety 12 and Innovation Policies and Workforce Procedures
2 The NOTIFY Library
• NOTIFY Website http://www.notifylibrary.org
A sample of the bibiography
Health Systems Service Delivery 13 and Innovation and Safety
The NOTIFY Library
Clicking on a single reference
Health Systems Service Delivery 14 and Innovation and Safety
The NOTIFY Library The NOTIFY Booklet
Health Systems Service Delivery Health Systems Service Delivery 15 and Innovation and Safety 18 and Innovation and Safety
3 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
Health Systems Service Delivery 19 and Innovation and Safety
NOTIFY Journal
NOTIFY Project WHO Publications 1. Editorial Board: Representatives of CNT-WHO NOTIFY project and NOTIFY supporting institutions The Journal for Vigilance and Surveillance of Support Group Medical Products of Human Origin 2. Advisers: WHO technical staff Library Editorial 3. Team: WHO PUB staff Workgroups
Regular Global WHO Consultation on V&S for MPHOs
NOTIFY Board of Supporting Institutions
• Health Authorities • Scientific and professional societies
Health Systems Service Delivery 20 and Innovation and Safety
Thank you
[email protected] [email protected]
Health Systems Health Systems Clinical 21 and Services Policies and Workforce Procedures
4 03/02/2015
ICCBBA Vision and Mission
Mission: Enhancing patient safety by promoting and managing the ISBT 128 ISBT 128: Information international information standard for use with Standard for Blood medical products of human origin Vision: Global adoption of ISBT 128 for all and Transplant medical products of human origin
Paul Ashford Executive Director ICCBBA
Copyright ICCBBA Slide 4
The Acronyms Medical Products of Human Origin
MPHO ICCBBA – International Council for Blood and blood components/products Commonality in Blood Bank Automation Cells ISBT Tissues – ocular and non-ocular Derived from ‘International Society of Blood Organs Transfusion’ Tissue Engineered Now interpreted as ‘Information Standard for Milk Blood and Transplant’ Other? 128 – ISO character set
Copyright ICCBBA Slide 2 Copyright ICCBBA Slide 5
ICCBBA Common Characteristics of MPHO
International standards organization Contain material derived from human donor Not-for-profit organization formed in 1994 – Potential risk of infection celebrating our 20th anniversary! Traceability Vigilance and Surveillance US based, UK based Executive Director, global in scope Ethical issues Consent Nongovernmental organization in official Exploitation relations with the World Health Organization Global Governance Small staff (10), large community of expert Encourage self sufficiency volunteers (>300) Counter transplant tourism
Copyright ICCBBA Slide 3 Copyright ICCBBA Slide 6
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Global Vision A short history of ISBT 128
There is a growing consensus on the need Developed for blood transfusion following for international harmonization of coding and First Gulf War and request from US DoD for labeling of MPHO standardization Single donor may donate multiple MPHO First version of ISBT 128 Standard published Need for traceability across all products in 1994 Recognized in World Health Assembly Extended to cover cell therapy and tissues in Resolution WHA63.22 “Human Organ and 2000 Tissue Transplantation” May 2010 Current work on organs, milk, tissue engineering/advanced therapies
Copyright ICCBBA Slide 7 Copyright ICCBBA Slide 10
WHO Organization-wide Initiative for What does ISBT 128 provide? Medical Products of Human Origin Globally unique identification numbers – Three strategies for global governance Global consensus on a series of principles inherent to ensures no duplication over a 100 year time the human origin of MPHO – in particular prohibition period on making the human body and its parts as such a source of financial gain Standardized terminology – ensures a Global use of ISBT 128 for all MPHO to ensure common understanding across multiple unique identification, optimal traceability and languages interoperability between countries, and across all MPHO, for both routine and emergency use Standard for electronic transfer of information Global collaboration on vigilance and surveillance of – allows rapid error free information transfer MPHO to support operation and oversight and to for critical information establish transparency for trust
Copyright ICCBBA Slide 8 Copyright ICCBBA Slide 11
WHO/ICCBBA work program Why is standardized coding important? Raising Awareness of Member States Health Traceability is essential for Authorities to the role of ISBT 128 in Global Recall Governance Follow-up Improving communication between ICCBBA Vigilance and Surveillance and Member States Health Authorities Traceability means being able to identify and Facilitating access of low and middle income track all products from a single donor countries to ISBT 128 Whatever type (blood, cells, tissues, organs, milk etc.) Standardizing global V&S with the adoption Wherever they are (local, national, global) of consistent ISBT 128 product terminology Over long time periods (e.g. 30 years from implant) Across different regulatory frameworks
Copyright ICCBBA Slide 9 Copyright ICCBBA Slide 12
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Traceability Published Consensus
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
Copyright ICCBBA Slide 13 Copyright ICCBBA Slide 16
Traceability Supporting Organizations
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
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Recent Activities Terminology Harmonization
Technical Advisory Groups active in many Standard terminology is important at several fields (blood, cell therapy, tissue, ocular, milk, levels: tissue engineering) Clinical application – requires detailed Terminology Standardization descriptions to distinguish clinically distinct Widely endorsed global terminology developed variants and published for cell therapy and ocular tissue Activity data collection – needs to capture data at WHO organ nomenclature developed a more generic level of description Consensus terminology developed for skin, and Vigilance and Surveillance – identifies trends by soft tissue; in development for cardio-vascular collating data across many product types and bone
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Terminology Harmonization Single European Code
Call for tender EAHC/2011/HEALTH/03 “Reference compendia for the application of a single ISBT 128 terminology describes MPHO at the European coding system for human tissues and cells” clinical use level Incorporates classification at the level of Class of product Maps to higher level classification systems Coordinator Notify V&S Taxonomy Eurocet data items EU Generic descriptions
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Tissues and Medical Devices Progress to date
Global initiative for standard identification of medical devices (UDI – unique device Tissue Establishment Compendium developed identification) and populated Product Compendium developed and populated In US, FDA final rule requires implementation - supports ISBT 128 of the UDI for all medical devices Essential information for TE and CA documents FDA regulates some tissue products as published medical devices Translation tool developed and in test Risk that tissue identification may become Draft Manual developed and being reviewed by more fragmented with different systems CA’s depending on the regulatory framework Pilot evaluation due to start soon
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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
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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
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Current status of ISBT 128 ISBT 128 and Organ Transplant
Licensed Facilities An exciting new story for the next decade Blood : 4274 facilities in 56 countries Basic organ nomenclature developed through Cell Therapy: 453 facilities in 46 countries WHO/ICCBBA SONG project Tissues : 96 facilities in 17 countries ISBT 128 product codes available Provides the potential to link all MPHO from a Total : 4669 facilities in 77 countries single donor with one unique donation identification number 118 Vendors licensed to support ISBT 128 in their products
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ICCBBA …an NGO in official relations with WHO working to deliver the vision of global standardization of terminology, coding and labeling for all medical http://batchgeo.com/map/47e92d7cb87ea05a946e4a589cabd565 products of human origin.
Slide 27 Slide 30
5 DONATION AND TRANSPLANTATION WORLDWIDE
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)
Marta López Fraga ©2014 EDQM, Council of Europe, All rights reserved
ORGAN DONATION: FACTS AND FIGURES HETEROGENEOUS TRANSPLANT SCENE IN EUROPE
Each of these can save or 2013 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
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ORGAN DONATION: FACTS AND FIGURES HETEROGENEOUS TRANSPLANT SCENE IN EUROPE
Kidneys are in the highest demand
2013
23,485 patients In 2011, 2 patients were received a kidney added to a kidney waiting list in Europe every hour
that’s a total of 68,073 patients! 12 patients died every day due to lack of organs Organ shortages remain the main obstacle in transplantation medicine! Marta López Fraga ©2014 EDQM, Council of Europe, All rights reserved Marta López Fraga ©2014 EDQM, Council of Europe, All rights reserved
1 COST PER QALY*
Masson et al.,1993 Treatment UK Pounds Cholesterol control + diet 220 IS TRANSPLANTATION A SHORT TERM Pacemaker 1.100 TREATMENT? 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 * Quality adjusted life year
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MAXIMUM GRAFT SURVIVAL (IN YEARS) ANNUAL COST OF TREATMENT METHODS FOR ESRD
F. Charro, in G. Collins et al: Procurement preservation and allocation of vascularised organs, Kluwer 1997 45 40 40
35 34 33 DD 32 30 Haemodialysis 30 LD related LD non-related 25 Peritoneal dialysis 22
20 16 Kidney tx <1 yr 15 14 14
10 Kidney tx >1 yr
5 0 10 20 30 40 50 0 Thousands of Euro
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POTENTIAL SAVINGS BY INCREASING RENAL TRANSPLANTS (2010) – FRANCE (ABM)
Source data: DG SANCO
Average 10 yr savings per patient dialysis transplant: 600.000 € WHAT IS THE COST OF TRANSPLANTATION?
Scenario 1: Scenario 2: 1% increase of grafts/year 5% increase of grafts/year Cumulative 180 more grafts 2011-2016 Cumulative 980 more grafts 2011-2016 Cumulative savings: +37 million € Cumulative savings: +198 million €
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2 SAVINGS FROM RENAL TRANSPLANTS PAY BACK ALL WHO ARE THE MAIN STAKEHOLDERS? SOLID ORGAN TRANSPLANT PROGRAMS –SPAIN (ONT)
Source data: DG SANCO
Healthcare 3% 3% 2% 6% Organ procurement Professionals 6% Renal transplants Organ transplantation is a
9% Liver transplants Annual savings per transplant 21.000 € complex process that requires Heart transplants 36% Lung transplants Renal transplants per year ~2200 intense co-operation between Pancreatic transplants General Policy- several partners. Peripheric structure of Potential annual saving 46 M € 35% coordination Public makers National structure of coordination Years needed to cover total tx cost 3,7 100% = 171 Million €
Cumulative Nr of tx patients 19.000 Regulatory Potential annual savings 400 M € authorities
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TRANSPLANTATION IS THE MOST COST-EFFECTIVE TREATMENT FOR END STAGE ORGAN FAILURE
WHAT CAN WE DO Transplantation therapy increases significantly the survival and TO IMPROVE THE SITUATION? 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
Marta López Fraga ©2014 EDQM, Council of Europe, All rights reserved Marta López Fraga ©2014 EDQM, Council of Europe, All rights reserved
FACTORS IMPACTING ON DONATION AND THE COE & ORGAN, TISSUE AND CELL TRANSPLANTATION TRANSPLANTATION OF ORGANS, TISSUES & CELLS
The Council of Europe has been working in the area of Social attitude organ, tissue and cell transplantation since 1987 Public awareness Quality assurance
Clinical practices National economy
Reimbursement of stakeholders Health system Transnational cooperation Legal framework Specialisation of health professionals Organisation of Education of health transplant system professionals
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3 EUROPEAN COMMITTEE ON ORGAN TRANSPLANTATION (CD-P-TO) COUNCIL OF EUROPE TECHNICAL GUIDANCE
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) • Exhaustive guidelines to provide professionals with a useful overview of the most recent advancements in the field • Ensure high level of quality and safety Principle: standards Sharing of technical, scientific expertise • Contribute to the harmonisation of these in the health sciences. The member activities among European countries and states provide experts to the EDQM so that common quality, safety and ethical beyond, facilitating uniform standards and standards can be elaborated jointly practices • Comprehensive introduction on legislation and ethics • Continuous update and maintenance
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EUROPEAN COMMITTEE ON ORGAN TRANSPLANTATION (CD-P-TO) FIGHT AGAINST ORGAN TRAFFICKING
• 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
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TRAFFICKING IN HUMAN BEINGS FOR THE PURPOSE OF COUNCIL OF EUROPE LEGAL GUIDANCE ORGAN REMOVAL
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
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4 DRAFT COUNCIL OF EUROPE CONVENTION AGAINST INTERNATIONAL COLLABORATION: TRAFFICKING IN HUMAN ORGANS THE MOLDOVAN EXPERIENCE 2006-2008
The human body and its parts shall not, as such, give rise to financial gain or comparable advantage
Any of the following activities, when committed intentionally: • Development of a new transplant law for Moldova
The illicit removal of organs: • Assistance in the elaboration of the acts and orders after the removal without the free, informed and specific consent of the living donor, or, in the case of the deceased promulgation of the new law 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 • Establishment of the Transplant Agency 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. • Definition of the long term activities of the Transplant Agency The use of illicitly removed organs The preparation, preservation, storage, transportation, transfer, receipt, import and export of illicitly removed human organs • Assistance in the definition of the financial and economic aspects The illicit solicitation or recruitment (of organ donors or recipients), offering and requesting of undue of the activities coordinated by the Transplant Agency advantages (to health professionals or public officials) Aiding or abetting and attempt
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BLACK SEA AREA (BSA) PROJECT: SYNERGY BASED ON A REGIONAL NETWORK
Actual deceased organ donors (DBD and DCD) – Annual rate p.m.p. 2012
ADDDRESING THE ROOT 0.1 0 2.9 CAUSE OF ORGAN SHORTAGE 3
0.3
0
0
0 4.6
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INTERNATIONAL COLLABORATION INITIATIVES: BLACK SEA AREA (BSA) PROJECT: ADDRESSING ORGAN SHORTAGE SYNERGY BASED ON A REGIONAL NETWORK
Kidney transplants (all combinations) – Annual rate p.m.p. 2012
2.7 1.1 6.6 • Structure and enhance exchange of knowledge, expertise 8.3 and good practices between member states
1.8
3.5 • Elaborate tailor-made programmes adapted to the economical socio-economical context of the different 4.8
member states 2.9 39
Potential for more organs Potential to learn from each other Kick Off meeting in Chisinau (Moldova) July 2011
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5 SPECIFIC OBJECTIVES OF THE BSA PROJECT BSA PROJECT: WORK DISTRIBUTION
• to review the existing laws on transplantation of organs, tissues and cells and to Group A Group B Group C promote the implementation of an effective legislative framework; • to contribute to the establishment of national transplant authorities and • Russian Federation • Ukraine • Armenia programmes; • Turkey • Moldova • Azerbaijan • Romania • Bulgaria • Georgia • to educate the public, professionals and media about transplantation;
• to identify areas where additional specialist expertise or training are Established infrastructures and Minimal activity No Tx activity although some required as the basis for a development strategy; significant Tx activity Tx-related legislation exists • to elaborate recommendations and action plans; • to encourage networking and enhance international co-operation; Create an infrastructure for Engage political involvement Increase tx from deceased donors • to establish pilot actions to be developed in specific settings. deceased donation and support Focus on WP4: Focus on WP3: Focus on WP2: Clinical Practices National Tx Authority Legislation & Finances
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STRUCTURE OF THE BSA PROJECT EVALUATION METHODOLOGY
Detailed country assessments using questionnaires PARTNERS & PARTICIPANTS ADVISORY BOARD SUPPORTS National questionnaire Regional questionnaire Expert Organisations National Focal Points Steering Committee Hospital questionnaire for ICU doctors Government Contact Professional Societies CD-P-TO Hospital questionnaire for donor coordinators Person (GCP) EU Individual assessments of each country through site visits Tasks and Role Existing Tx legislation Financial provisions in each country relative to health programmes and Tx activity Existing infrastructure and Tx activity - Follow/support of the progress - Expert support - Collect data - Dissemination of the project - Involved in training and Obstacles and institutional/structural problems related to development of Tx - Provide feedback - Support towards sustainability exchange of knowledge Political will to develop Tx programmes - Exchange knowledge - Fundraising support - Implement recommendations - Elaboration of guidelines, Public awareness campaigns protocols, recommendations Recommendations and setting of specific goals Revaluation after 1 year to see progress
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Romania donors 2008 – Oct 2013 (p.m.p) BLACK SEA AREA (BSA) PROJECT: ACTION PLAN 6 5.7
5.3 WP 1: Coordination, dissemination, public awareness 5 4.8
WP 2: Development of effective legislative and financial framework 4.4 Assessment of the existing transplant legislation 4 4 3.8 3.7 Elaboration of guidelines and effective laws according to local situation in each country 3.4 Asses political involvement and financial aspects of transplantation 3.2 Deceased D 3 2.9 Living donors WP 3: Establishment of National Transplant Authorities Linear (Deceased D) Linear (Living donors) Implementation of rules, guidelines and standards for the organisation and functioning of the 2 Agencies 2 Education and training of the medical and technical personnel of the Agencies
WP 4: Clinical Practices 1 Analysis of the clinical practices of the donation and transplantation process Specific training of doctors and nurses involved in transplantation activities 0 2008 2009 2010 2011 2012 2013
IRODaT data www.irodat.org
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6 Romania transplant 2008 - 2012 (pmp) 10
9 8.9
8
7.3 7
6 5.6 Kidney tx from DD 5.35.4 5 5.1 Liver tx from DD Kidney tx from LD 4 4 Liver tx from LD 3.8 3.9 3.6
3 2.8 2.5 2.3 2 1.7 OOD UCK 1.3 G L ! 1 1.1
0.4 0.4 0.4 0 0.1 2008 2009 2010 2011 2012
IRODaT data www.irodat.org
Marta López Fraga ©2014 EDQM, Council of Europe, All rights reserved
WHAT IS NEEDED FOR INTERNATIONAL COLLABORATION PROJECTS TO SUCCEED?
• 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
Marta López Fraga ©2014 EDQM, Council of Europe, All rights reserved
LESSONS LEARNED & TAKE HOME MESSAGES
• Transplantation programmes need to be transparent, fair and ethical • There isn’t a universal recipe for success. Transplantation programmes need to be adapted to the individual socio-economical circumstances of each country • Use resources wisely. You may not need to develop all programmes. Collaborate! • 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 • 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 • Effective transplantation programmes require committed, continuous and sustainable political and financial investment and support
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The Latin American ORGAN TRANSPLANTS IN SPAIN Council (RCIDT) 1989-2012 (total number)
Kidney Liver Heart Lung Pancreas Small bowel 4500
4000
3500
3000 Elisabeth Coll Torres Medical Department 2500 Organización Nacional de Trasplantes (ONT) Spain 2000 TX porcedures (N) porcedures TX 1500
1000
Technical Consultation on 500
Knowledge Sharing and Networking for 0 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 Human Cell, Tissue and Organ Donation and Transplantation in The Western Pacific Region
BASIC PRINCIPLES OF THE SPANISH Organ donors in Spain MODEL Number & Annual Rate BRAIN DEATH N AUDIT Rate INSIDE THE 1800 40 HOSPITALS Absolute number 35.3 35.1 HOSPITAL 35.1 34.8 34.6 34.2 34.4 REIMBURSEMENT 1600 RATE pmp 33.6 33.9 33.7 33.9 33.8 34 35 32.5 32 31.5 SPECIAL 1400 29 30 27 26.8 PROFILE TRAINING OF 1200 25 PROFESSIONALS 25 22.6 21.7 1000 20.2 17.8 20 1,6671,6431,655 COORDINATION ATTENTION TO 800 1,5771,604 1,4941,5461,5091,550 1,502 14.3 1,4101,448 NETWORK THE MEDIA 1,3341,3451,335 15 1,250 600 1,155 1,0371,032 960 869 10 400 778 832 THEORGAN SPANISH DONATION MODEL & TRANSPLANTATION 687 550 200 5
0 0 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
30 donors pmp PREVIOUS EXPERIENCE WITH DIFFERENT 20 donors pmp
15 donors pmp
10 donors pmp <10 donors pmp INTERNATIONAL BODIES 35.1 19.1 25.8 12.8
THERE IS GREAT DIFFERENCE 25.9 BETWEEN THE SPANISH ORGAN DONATION RATES AND THOSE OF MOST DEVELOPED 15.3 COUNTRIES (DONORS PMP 2012)
15.6
15.5 21.9 18.5 8.2
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PUNTA CANA GROUP AND DECLARATION JUNE 2001
DECLARATION • Approach to the society (media collaboration) • Improve functioning organizational structures • Enhance countries collaboration • Governments Collaboration
SIEMBRA (SOWING) CORDOBA DECLARATION PROJECT OCTOBER 31st 2003
DECLARATION • Creation of a training programme in 30 PHYSICIANS FROM LATIN transplant coordination AMERICAN COUNTRIES • Implement a Registry of donation and WERE TRAINED IN DONATION transplantation activity in Latin America AND MANAGEMENT • Need of an Iberoamerican official forum of Donation and Transplantation
2004: FIRST PUNTA CANA GROUP PUNTA CANA GROUP LATINAMERICAN DATA JUNE 2001 LATINAMERICAN REGISTRY ON 2.1 IN INTERNATIONAL DONATION AND DATABESES TRANSPLANTATION 2.9 5 2.2 3.5 4.3 5.4 1.4
1.2 6.9 14.1 7.7 0.2
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COOPERATION PROGRAMME SPAIN-PAHO (2004)
MAIN OBJECTIVE MEETING ONT – PAHO Promotion and development of programmes of donation and kidney MONTEVIDEO – FEBRUARY 2005 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
MEETING CARTAGENA DE INDIAS Human Tissue and Organ Transplantation JUNE 2005 World Health Assembly 2004 Resolution WHA57.18
AECI + Country representatives + ONT
PROPOSAL: TO CREATE A FORUM FOR COOPERATION “ IBEROAMERICAN COUNCIL OF ORGAN DONATION AND TRANSPLANTATION”
PRIORITY ACTIONS
1. GLOBAL ANALYSIS OF DONATION AND TRANSPLANTATION IN TO PROVIDE, IN RESPONSE TO REQUESTS FROM MEMBER STATES, TECHNICAL SUPPORT FOR DEVELOPING SUITABLE TRANSPLANTATION OF CELLS, TISSUES OR LATINAMERICA ORGANS, IN PARTICULAR BY FACILITATING INTERNATIONAL COOPERATION 2. TRAINING PROGRAMS ON DONATION IN TRANSPLANTATION TO PROMOTE INTERNATIONAL COOPERATION SO AS TO INCREASE THE ACCESS OF 3. STANDARD DEFINITIONS AND CLINICAL PRACTICE GUIDELINES CITIZENS TO THESE THERAPEUTIC PROCEDURES
SPAIN, IN CLOSE COOPERATION WITH THE 4. DEFINITION OF IMPROVEMENT AREAS AND COOPERATION IN PANAMERICAN HEALTH ORGANIZATION (PAHO) MANAGEMENT AND ORGANIZATION TAKES CARE OF THE DEVELOPMENT OF THIS RESOLUTION IN LATIN-AMERICAN COUNTRIES 5. COMMUNICATION AND INFORMATION POLICIES
6. IMPROVEMENT STRATEGIES IN IMMUNOTHERAPY
7. ECONOMIC ANALYIS OF DONATION AND TRANSPLANTATION
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RENAL TRANSPLANTATION IS THE MOST ECONOMIC SALAMANCA DECLARATION 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 IBEROAMERICAN COUNCIL/ HEALTH MINISTERS /NETWORK OF ORGAN & TISSUE OFFICIAL DONATION & TRANSPLANTATION DELEGATES OF THE MEMBER COUNTRIES
GRANADA SEPTEMBER 15th- 2005
IBEROAMERICAN PERMANENT COUNCIL OF SECRETARY ORGAN & TISSUE DONATION AND TRANSPLANTATION
APPROVAL OF THE FIRST MEETING IBEROAMERICAN COUNCIL MAR DEL PLATA AND NETWORK OF DONATION NOVEMBER 15th 2005 OTHER SOCIETIES/BODIES • LATIN AMERICA AND TRANSPLANTATION • SPAIN + PORTUGAL
Ibero-American Summit of Heads of State and Governments Salamanca October 14th 2005 IBEROAMERICAN COUNCIL OF ORGAN & TISSUE DONATION AND TRANSPLANTATION 21 COUNTRIES + PAHO SPAIN: PRESIDENCE & GENERAL SECRETARY
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SOCIEDAD DE TRASPLANTES DE AMERICA LATINA Y EL CARIBE 18 APPROVED RECOMMENDATIONS + 1 ACTION PLAN PROFESSIONAL TRAINING GRUPO PUNTA CANA
SOCIEDAD LATINOAMERICANA DE COORDINADORES DE TRASPLANTES
PUBLIC/PRIVATE SOCIETIES AND BODIES IBEROAMERICAN TRANSPLANT NEWSLETTER INVITED SINCE 2007
TRANSPLANT COMMITTEE COUNCIL OF EUROPE Cooperation among member states in ethical , organizational and legislation aspects in organ donation MAR DE PLATA DECLARATION and transplantation 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
Donation and 10. CELL TERAPHY transplantation activity 11. SEROLOGICAL DETERMINATIONS
More than 20 “” 12. DONOR MAINTENANCE… recommendations
RCIDT MEETINGS
I.- MAR DEL PLATA VIII.- BOGOTÁ
II.- MADRID IX.- LIMA
III.- MONTEVIDEO X- CARTAGENA DE INDIAS
IV.- PUNTA CANA XI.- BUENOS AIRES
V.- SANTIAGO DE CHILE
XII.- QUITO
VI.- LA HABANA
XIII.- PANAMA VII.- MEXICO D.F.
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NEED OF A NATIONAL ORGANIZATION FOR DONATION AND TRANSPLANTATION
RESPONSIBLE OF ORGAN DONATION AND TRANSPLANT COORDINATION (ORGAN ¿ WHAT ARE THE ALLOCATION, WAITING LISTS…) MAIN FACTORS WHICH RED / CONSEJO IBEROAMERICANO DE DONACIÓN Y TRASPLANTES ARE INFLUENCING ORGAN OFFICIAL SUPPORT 1ª REUNIÓN – MAR DEL PLATA. DONATION IN 15 – 17 DE NOVIEMBRE DEL 2005 LATINAMERICA? REAL ACTION CAPACITY PROPUESTA DE RECOMENDACIÓN REC - CIDT – 2005 (3) SOBRE FUNCIONES Y RESPONSABILIDADES PROFESSIONAL AND SOCIETY DE UNA ORGANIZACIÓN NACIONAL DE DONACIÓN Y TRASPLANTES IMPLEMENTATION (ONDT)
ADEQUATE TECHICAL DIRECTION
10 YEARS MAIN PROBLEMS IN LATIN AMERICA MASTER FOR ORGAN DONATION ALIANZA OPENING RESOURCES AND INFRAESTRUCTURE O. N. T. INTERNATIONAL MASTER DONATION AND TRANSPLANTATION HEALTH CARE SYSTEMS FRAGMENTATION BLOOD CORD BANKS TRANSPLANT COMMITTEE REGIONAL COUNCIL MADRID & CLOSURE OF THE MASTER NO COVERAGE MOST OF POPULATION SPANISH MADRID MADRID MODEL
PRESENTATION OF FINAL PROJECT GENERAL COURSE DONATION AND TX ORGANIZATION O .N .T. FAMILY APPROACH NO PERCEPTION RELEVANT TOPIC MADRID MADRID / BARCELONA BARCELONA/ ALICANTE/GRANADA
LACK OF TRAINED AND AVAILABLE TWO MONTHS TUTORY WITH SPANISH COORDINATORS IN ALL SPANISH REGIONS PERSONNEL
1 5 10 15 20 25 30 35 40 45 50 55 60 NO DONATION CULTURE IN POPULATION FEBRUARY MARCH
Master Alianza 2005-2014 HEALTH CARE SYSTEMS FRAGMENTATION
15 39 POPULATION DISTRUST 16 UMBALANCE POSSIBILITIES 24 39 DONATION- RECEIVE 5 7 TRANSPLANTATION 26 TRANSPLANT 31 10 DONATION 11 1 3 5 62 8
3 10 POPULATION HEALTH COVERAGE MASTER ALIANZA: 10 SOCIAL HEALTH PRIVATE NONE SECURITY MINISTRY INSURANCE 325 PROFESSIONALS FROM ALL LATIN AMERICAN COUNTRIES X EDITION 2014
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NICARAGUA: APPROVAL OF A NEW TRANSPLANT LAW COMMUNICATION IN CRITICAL SITUATIONS “COUNSELLING” 15 45 14 37 10 41 49 6 1 82
TRAINING THE TRAINERS COURSES + FOLLOW UP 12 IN LATIN AMERICA: 412
TRANSPLANT TOURISM IN LATIN AMERICA
BOLIVIA COMMUNICATION IN CRITICAL SITUATIONS - “COUNSELLING” 942 239 EQUATOR 150 MÉXICO 701 180 739 GREAT EFFORTS IN MANY COUNTRIES 916 20 TO FIGHT AGAINST 120 TRANSPLANT TOURISM
1136 COLOMBIA
TOTAL NUMBER OF PERU PROFESSIONALS TRAINED 337 5505 BRASIL
APPROVAL: CUBA MEETING EDITION & DISTRIBUTION: MAY - 2008 “THE SPANISH MODEL” FREE DOWNLOAD www.ont.es
ALL KINDS OF TRAINING MATERIALS FOR APPROVAL: TRANSPLANT MEXICO MEETING NOVEMBER - 2008 COORDINATORS
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RED/CONSEJO IBEROAMERICA DE DONACIÓN Y TRASPLANTE INFLUENCE ON COUNTRY REGULATION
STRTEGIC MEETING PLN CENTRAL AMERICA & CARIBBEAN
COSTA RICA SEPTEMBER 2007
ACUERDO DE SAN JOSÉ, COSTA RICA
COLOMBIA QUALITY CONTROL AND MANAGEMENT OF TRANSPLANT TOURISM TISSUE PROCUREMENT, EVALUATION, NOW BANISHED THANKS TO THE ACTION OF PROCESSING, BANKING, DISTRIBUTION COLOMBIAN GOVERNMENT AND SUPPORTED AND APPLICATION OF HUMAN TISSUES BY RCIDT -EU DIRECTIVES 2004/23/EC &2006/17/EC
OFICIAL EUROPEAN UNION COURSE AVAILABLE IN SPANISH AND ENGLISH
BERLIN ESTRASBURGO HEALTH AUTHORITIES SUPPORT 2-3 OCTUBRE 2009 11-12 DE MARZO RUDOLF G. GALLONT FERNANDO MORALES GUATEMALA DOMINICANA ROUT SHEET FOR DONATION IMPROVEMENT
CREATION/ CONSOLIDATION ASSESMENT TRANSPLANT ORGANIZATION ATTENDANCE OF RCIDT OBSERVER IN TRANSPLANT COMMITEE COUNCIL OF EUROPE TRAINING TRAINED COURSES PROFESSIONAL
COUNTRY SPECIFIC FEATURES
OBJECTIVE DONATION IMPROVEMENT TRANSPLANT COMMITEE COUNCIL OF EUROPE
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*2011 data DONATION ACTIVITY (566,3 million inhabitants) IN LATIN AMERICA Deceased Organ Donors (Included Kidney Liver Heart Lung Pancreas NHBD) Transplants Transplants Transplants Transplants Transplants 10922 2377 4221 (40.4% LD) (7.5% LD) 425 110 271
*2010 data (545 million inhabitants) 2005 2012 Deceased 3033 4580 Organ Donors (Included Kidney Liver Heart Lung Pancreas NHBD) Transplants Transplants Transplants Transplants Transplants 10112 2168 3943 (42.4% LD) (7.7% LD) 350 120 210 FROM 2005 TO 2012 GROWING UP TO 50 %
“If there is no organization, ideas, after the initial momentum, become less effective” SOMETHING’S MOVING...
...VERY FAST ...IN LATIN AMERICA
...WITH RESPECT TO ORGAN DONATION AND TRANSPLANTATION AND IN THE FIGHT AGAINST ORGAN TRAFFICKING
[email protected] THANK YOU VERY MUCH
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The role of Professional Societies National Asian Societies in development of organ donation and transplantation
Philip O’Connell
7 GOALS 8 STRATEGIES PROGRAMS
Membership- global membership of all 1.1 Membership services & Benefits The Mission health professionals and scientists 1.2 Affiliated national societies working in the field of organs, cells & 1. Membership 1.3 Community affiliations tissue donation & transplantation 1.4 Corporate membership Science and Practice - provide a pivotal role in development of the science & 2.1 Sections Support The Transplantation Society will provide the focus clinical practice of donation & 2.2 Council of Section Presidents transplantation of cells, tissues & organs 2. Sections and advance the safe, effective and 3.1 International Congresses for global leadership in transplantation: ethical practice of transplantation for all. 3.2 Alternate Years program Ethics - global leadership in the 3.3 Basic Science Development •development of the science and clinical practice discussion and promotion of ethical 3. Science 3.4 nKOLmeetings clinical & research practice in donation 3.5 Specific topic meetings & transplantation of organs, cells and •scientific communication tissues 4.1 CME Program Education - Comprehensive education 4. Education 4.2 Postgraduate Education •continuing education programs in the science and clinical 4.4 Scholarships & Awards practice of donation & transplantation that improves patient outcomes, 5.1 Ethics Committee competence & performance of members, •guidance on the ethical practice 5.2 WHO relationship the medical community and the general 5. Public Policy community 5.3 Declaration of Istanbul 5.4 GAT & society relationships Membership of The Transplantation Society and its Sections will be a Communication - Comprehensive science, education and promotional 6.1 www.tts.org pre-requisite for effective professional clinical and scientific practice communications programs that meets the 6. Communications needs of the science and clinical practice 6.2 Journals in the field of transplantation worldwide. of donation & transplantation globally 6.3 Newsletter 6.4 Member &non-member eblasts The Transplantation Society will provide a comprehensive education Relationships - Facilitate high quality relationships with and between 7. Operations 7.1 IHQ Office program in the science and clinical practice of transplantation that stakeholders in donation & transplantation 7.2 PCO Services improves patient outcomes, competence and performance of its 7.3 Marketing members, the medical community and the general community Management - Excellent leadership and 7.4 Historical Archives management focused on implementing 8. Governance the strategies of TTS 8.0 Governance
MEMBERSHIP COUNTRY SECTIONS AFFILIATES INDUSTRY MEMBERS NATIONAL SOCIETIES
ORGAN REGIONAL DONATION SOCIETIES Science DICG Clinical Care Organ Donation GOVERNMENT INTERNATIONAL ORGANISATIONS SOCIETIES Special Interests
Public Policy INTERNATIONAL Advocacy WHO NGO ORGANISATIONS GAT
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The Declaration of Istanbul TTS Educational Meetings 2009 - 2010 on Organ Trafficking and Transplant Tourism
2010
2008 2014 Istanbul Summit
April 30th – May 2 , 2008
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.
The Journal
Algerian Society of Nephrology, Dialysis and Transplantation Kuwait Transplant Society American Society of Nephrology Latvian Transplant Association American Society of Pediatric Nephrology Libyan National Organ Transplantation Program Best Science American Society of Transplantation Libyan Society of Nephrology and Renal Transplantation Arab Society of Nephrology and Renal Transplantation Macedonian Society of Organ and Tissue Transplantation Argentine Society of Nephrology Malaysian Society of Transplantation Argentinean Transplant SocietyDoI DoI Malaysian Ministry of Health DoI MaliDoI National Society of Nephrology Asian Society of Transplantation DoI DoIDoI Austrian Transplantation Society Mexican Society of Transplantation DoIDoIMiddleDoI DoIEasternDoI SocietyDoI of Transplantation (MESOT) Belgian Transplant Society DoI Advances in Clinical Care Brazilian Organ Transplant AssociationDoI DoIMoroccanDoI SocietyDoI of Nephrology DoI British Transplantation SocietyDoI DoINational KidneyDoI Foundation, United States NationalDoI Organization of OrganDoI and Tissue Donation and Transplantation Canadian Society of Nephrology DoI Canadian Society of Transplantation (NOOTDT-Lebanon)DoI DoINational TransplantationDoI Center,DoI Mexico Canadian Association DoIof Nephrology Nurse and Technologist DoI DoI DoIDoI DoI Chilean Society of Transplantation National Transplant Center and National Council for Transplantation,DoI Italy Dissemination of Clinical Council of Europe Committee onDoI Organ Donation NetherlandsDoI Transplantation Society DoI Czech Transplant Society DoI New York State Transplantation Council Danish Transplantation Society Norwegian Society of Nephrology DoI Egyptian Society of Nephrology and Transplantation ONT/ Organización Nacional de Trasplantes DoI DoI DoI Peruvian Society of Nephrology Practice Guidelines Emirate Medical Association Nephrology Society (EMAN) DoI European Heart and Lung Transplant FederationDoI Philippine Medical Association European Kidney Patients Federation DoI Philippine Society of Nephrology European Society of Transplantation Philippine College of Surgeons Eurotransplant Philippine College of Physicians Japanese Transplant Society Polish Transplantation Society Georgian Association of TransplantationDoI Renal Association of the United Kingdom Forum for Discussion of DoI Saudi Center forDoI Organ Transplantation German Organ Procurement Organization Grupo Puntacana - Latinamerican Transplant Coordinators Scandiatransplant DoI Hong Kong Society of Nephrology DoI Society of Transplantation Singapore DoI Controversies Hong Kong Transplant Society DoI Société Francophone de Transplantation (SFT) Indian Society of Organ Transplantation South African Renal Society Indonesian Society of Nephrology Swedish Society of Nephrology International Pediatric Transplantation Association Swedish Transplantation Society International Pediatric Nephrology Association Tajik RepublicanEndorsements Research Transfusion Centre by 120 International Society of Heart and Lung transplantation Thai Transplant Society Israel Medical Association Transplantation Society of Australia and New Zealand (TSANZ) Israeli Transplantation SocietyDoI DoI DoI DoI DoI TransplantationDoI DoI Society ofDoI Latin AmericaDoI and DoIthe CaribbeanDoI (STALYC) Promoting Research as Foundation Italian Society of Organ Transplantation (SITO) TransplantInternational Society of Pakistan and National Iberaomerican Council of Organ Donation and Transplantation Tunisian Society of Nephrology Jordanian Society of Nephrology Turkish Transplant Society of Good Clinical Practice Korean Society for Transplantation Uruguayan Transplantationorganisations Society United Network for Organ Sharing (UNOS) United States World Transplant Games Federation
Guidelines
• Monitoring and implementation of the principles of the DOI requires a formal structure – Integrated into existing structures, leveraging off resources but an independent organization
www.tts.org • Memorandum of Understanding TTS and ISN www.kdigo.org – Co-Chairs – Membership, terms, responsibilities – Task Forces
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An NGO in Official Relations with Self Sufficiency: Objective for Governments WHO/OMS
Health Systems Essential 16 and Services Health Technologies
21 May 2010 Resolution WHA 63.22 20102010 The Assembly Endorses WHO's Guiding Principles on Human Cell, Tissue and Organ Transplantation
•CKD •RESPIRATORY ACHIEVEMENTS RESPONSIBILITIES •CLD SUFFICIENCY •DIABETES •LEGISLATION •CARDIAC • OTHER •DATA REGISTRIES •HEALTHCARE FACILITIES NATIONAL •HUMAN RESOURCES ACCOUNTABILITIES •REGIONAL COOPERATION CAPACITY CONTROL •CULTURAL & RELIGIOUS REGULATORY CONTROL ENVIRONMENT ETHICAL CONTEXT •FUNDING
•EDUCATION OPPORTUNITIES •VACCINATION FOR CARE •SCREENING CAPACITIES •PREVENTION •BRIDGING Rx •DONATION •TRANSPLANT •RESEARCH
Health Systems Essential 14 Health Systems Essential 17 and Services Health Technologies and Services Health Technologies
20102010 WHO Guiding Principles on DEVELOPMENT OF AN ETHICAL ORGAN HHumanuman Cell, Tissue and Organ Transplantation DONOR POLICY
GP 5 Free donation and no purchase of human transplant as such, but cost & expenditures recovery ✔Legality of Organ Donation underpinned by Legislation GP 6 GP 7 GP 8 Development of Regulations based on Legislation GP 3 Promoting Responsibility Justifiable fees Maximizing DD No advertising for transplant origin Protecting LD Oversight of Organ Donation and Transplantation by ✔Health Dept. To ensure Transparency and Safety. GP 2 GP 4 GP 9 Development of Agency to oversee Organ Donation Deathγ ∆ Protecting the Equitable allocation No conflict vulnerable & incompetent DEVELOPMENT OF JUST & TRANSPARENT GP 1 ✔ALLOCATION SYSTEM Consent DD INVOLVEMENT INVOLVEMENT Process Recipient Institution of Transplant and Organ Donor Registries Donor ✔Auditing of agencies
GP 10 Monitoring long term outcomes. Quality and safety of procedures and products Interaction with Transplant Units and Development of
✔ & AWARENESS EDUCATION, PUBLIC GP 11 Transparency, openness to scrutiny, anonymity Policies to Ensure Use of Organs is Maximised and used by appropriately credentialed Centres Health Systems Essential 15 and Services Health Technologies
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4 www.wpro.who.int