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World Health Organization's Role in Transplantation

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Coding Systems ... Global Coding for Traceability: Transparency for Safety and Ethics. Vigilance ... Glossary Nomenclature (coding) Typology of SAR & SAE. Severity and ... – PowerPoint PPT presentation

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Title: World Health Organization's Role in Transplantation


1
World Health Organization's Role in
Transplantation
  • Dr Luc Noel
  • Coordinator Clinical Procedures HSS/EHT/CPR
  • EBAA Seattle 17-20 June 2009

2
Ethics Quality Safety Access
3
Motivation to Give Organ ( Incentive)
  • Altruism
  • Reciprocity / solidarity
  • Civic gesture
  • Donation
  • Efforts needed to access organs
  • Live related donation is secondary to donations
    from deceased donors
  • Community orientated , and owned
  • Supervised by society
  • Financial profit or comparable advantage
  • "Sale"
  • Easy access to kidney through exploitation of the
    vulnerability of sub-groups of the population
  • Burden on live unrelated donors
  • Run by individuals or
  • a subgroup
  • Society usually ignores all or aspects

Need for maintaining principles
4
World Health Assembly Resolution WHA40.13
Development of guiding principles for human
organ transplants
1987
  • The Fortieth World Health Assembly,
  • Recognizing the scientific progress achieved in
    human organ transplants in many Member States
  • Concerned at the trade for profit in human organs
    among living human beings
  • Affirming that such trade is inconsistent with
    the most basic human values and contravenes the
    Universal Declaration of Human Rights and the
    spirit of the WHO Constitution
  • Commending the measures taken by some Member
    States to regulate human organ transplants and
    their decision to develop a unified legal
    instrument to regulate these operations 1
  • REQUESTS the Director-General
  • (1)to study, in collaboration with other
    organizations concerned, the possibility of
    developing appropriate guiding principles for
    human organ transplants
  • (2)to report to the Health Assembly on the action
    taken in this regard.

5
Preventing International Organ Trade Gathering
Momentum
2004?
  • China
  • Adoption by the State Council of the
    Transplantation Law (6 April 2007)
  • Awaited law on death determination with
    neurological criteria
  • Pakistan
  • Promulgation of Ordinance on Human Cell and
    Tissue Transplantation by President Musharraf (4
    September 2007)
  • HOTMA, Human Organ Transplantation Monitoring
    Authority is working at implementation, supported
    by WHO.
  • Philippines
  • Presidential ban on Foreigner Transplantation (28
    April 2008)
  • Publication of the implementing rules and
    regulations for the organ trafficking part of the
    human trafficking law prohibits financial
    incentives (6 June 2009)
  • Egypt
  • New law approved by State Council ( January 26,
    2009) expected to be adopted by People Assembly
    before end 2009

6
http//english.cctv.com/20090609/101901.shtml
7
http//www.bloomberg.com/apps/news?pid20601101si
daDOkrmTnAQfg
8
http//www.koreatimes.co.kr/www/news/nation/2009/0
6/117_47008.html
  06-17-2009 1745
9
Self-sufficiency in Donation and Transplantation
  • Equitably meeting the transplantation needs of a
    given population using resources from within that
    population.

10
The Pursuit of Self Sufficiency A Challenge for
Society
Public Health
D
Maximizing Deceased Donors Donation
Prevention 1
Health System
Public Education/information
Live Related Kidney Donors
Prevention 2

Transplants?
?Needs
Society
Universal Human Rights and Principles
11
Corneal Banking Pioneers Donation from Deceased
Donors
12
http//www.who.int/transplantation/en/
13
Access to Safe and Effective Cells and Tissue
for Transplantation
Aide-Mémoires Human Cells and Tissue for
Transplantation www.who.int/transplantation/en
Key Safety Requirements for Essential Minimally
Processed Human Cells and Tissues for
Transplantation
14
Global Coding for Traceability Transparency for
Safety and Ethics
  • Coding Systems
  • Indisputable need for globally standardized
    labelling, description and coding for tissues but
    also organs
  • Opportunity to work in a harmonized way before
    individual countries or regions develop disparate
    systems
  • Very positive milestone the commitment to one
    global coding system for cellular therapy
    products by relevant scientific and professional
    societies at global level

15
Vigilance and Surveillance. The EUSTITE project
Pilot study 6 first months Example of
serious reactions
(6 months, n 127)
  • Acanthamoeba transmission by both corneas from
    one donor (recipients in 2 different MS) both
    corneas removed and patients retransplanted but
    both infections persisted

16
WHO Tools for Global VS
Building on the EUSTITE experience
  • Glossary Nomenclature (coding)
  • Typology of SAR SAE
  • Severity and Imputability assessment tools
  • Impact Assessment Tool
  • Step 1 Determine the possible consequences C
  • Step 2 Evaluate likelihood L of recurrence
  • using frequency-based score
  • Step 3 Calculate risk with the scoring matrix
  • (Consequence x Likelihood (C x L))
  • Step 4 Response in proportion to the risk
  • Future steps Q409
  • Dissemination of Tools in draft form
  • Validation of Tools

17
A Global Scientific and Professional Bodyfor
Ocular Tissue Banking and Transplantation
  • Would be the counterpart of WHO
  • to collect and examine global data on the
    practices, safety, quality, efficacy and
    epidemiology of corneal transplantation
  • to harmonize global practices in the procurement,
    processing and transplantation of cornea
  • to promote international cooperation so as to
    increase the access of citizens to corneal
    transplantation
  • to maximize the efficacy of vigilance and
    surveillance of safety and ethics issues, both in
    notification of adverse events and reactions and
    in dissemination of relevant information
  • to foster research on ocular tissue banking and
    transplantation including practices in resource
    constrained environments and cost containment.

18
Updated WHO Guiding Principles on Human Cell,
Tissue and Organ TransplantationTransparency
and Confidentiality
GP 11
  • The organization and execution of donation and
    transplantation activities, as well as their
    clinical results, must be transparent and open to
    scrutiny, while ensuring that the personal
    anonymity and privacy of donors and recipients
    are always protected.

Safeguard
19
Thank you
Luc Noel noell_at_who.int
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