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