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ESSENTIAL HEALTH TECHNOLOGIES
CLINICAL PROCEDURES
HTP/EHT/CPR
1 LN 2004
WHO and Transplantation
Clinical Procedures-Essential Health Technology CPR/EHT/HTP Ethics, Trade, Human Rights, and Health Legislation ETH/SDE
Quality and Safety of Biologicals QSB/IVB/FCH
ESSENTIAL HEALTH TECHNOLOGIES
CLINICAL PROCEDURES
HTP/EHT/CPR
2 LN 2004
WHO and Transplantation
• Background
• WHO 1991 Guiding Principles
• Recent developments
• Workplan
• Standardisation issues
ESSENTIAL HEALTH TECHNOLOGIES
CLINICAL PROCEDURES
HTP/EHT/CPR
3 LN 2004
Transplantation Annual Global Estimates
LungHeart Liver Kidney
10006000 13 000 50 000
Organs
Tissues
Cells20 000 allogeneic transplantations of haematopoietic stem cells(3000 across national boundaries)
3-5 million tissue transplants take place every year globally
ESSENTIAL HEALTH TECHNOLOGIES
CLINICAL PROCEDURES
HTP/EHT/CPR
4 LN 2004
0.0
10.0
20.0
30.0
40.0
50.0
60.0
0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1.0
HDI
KTX/million pop
Kidney Transplantations per million pop. per Country
per Human Development Index (HDI)
Low Medium High
ESSENTIAL HEALTH TECHNOLOGIES
CLINICAL PROCEDURES
HTP/EHT/CPR
5 LN 2004
Kidney Transplantation (TX)Annual Global Estimates
Development
according to
UNDP
No. of
countries
>500,000
population
% Global
population
% of
countries with
kidney TX
Total kidney
TX
Total kidney
TX per million
population
Donor ratio
cadaveric/
living
Low HDI 37 14 8.1 800 0.95 0.03
Medium HDI 71 68 64.8 17,500 4.33 0.21
High HDI 43 18 97.7 32,000 30.32 2.47
Globally 151 100 60.3 50,300 8.44 1.01
ESSENTIAL HEALTH TECHNOLOGIES
CLINICAL PROCEDURES
HTP/EHT/CPR
6 LN 2004
WHO 1991 Guiding Principles on Human Transplantation
I. Organs should come preferably from
deceased persons (though living ADULT
donors may be used with consent).
II. Living donors should generally be
genetically related to recipients.
III. No payment may be given or received for
organs (but may be given to cover the cost
of recovery, preservation and supply).
ESSENTIAL HEALTH TECHNOLOGIES
CLINICAL PROCEDURES
HTP/EHT/CPR
7 LN 2004
Challenge: Safety, Quality Efficacy and Access
• Safety of human material for transplantation
• Safety of the recipient, short and long term
outcomes
• Safety of the living donor
• Access to essential transplantation
– Kidney
– Cornea
– Skin, bone…
– Haematopoietic stem cells
ESSENTIAL HEALTH TECHNOLOGIES
CLINICAL PROCEDURES
HTP/EHT/CPR
8 LN 2004
Xenotransplantation
• Transplantation of animal material to humans
• Specific risks
– Immunologic
– Functional
– Infectious: introduction of animal agents
into humans
-> Urgent need for effective regulatory
oversight
ESSENTIAL HEALTH TECHNOLOGIES
CLINICAL PROCEDURES
HTP/EHT/CPR
9 LN 2004
Resolution WHA57.18 Allogeneic Transplantation
1. URGES Member States:
(1) to implement effective national oversight of procurement,
processing and transplantation of human cells, tissues and organs,
including ensuring accountability for human material for
transplantation and its traceability;
(2) to cooperate in the formulation of recommendations and
guidelines to harmonize global practices in the procurement,
processing and transplantation of human cells, tissues and organs,
including development of minimum criteria for suitability of donors
of tissues and cells;
(3) to consider setting up ethics commissions to ensure the ethics of
cell, tissue and organ transplantation;
(4) to extend the use of living kidney donations when possible, in
addition to donations from deceased donors;
(5) to take measures to protect the poorest and vulnerable groups
from "transplant tourism" and the sale of tissues and organs,
including attention to the wider problem of international trafficking
in human tissues and organs;
ESSENTIAL HEALTH TECHNOLOGIES
CLINICAL PROCEDURES
HTP/EHT/CPR
10 LN 2004
Resolution WHA57.18 Xenogeneic Transplantation
1. URGES Member States:
(1) to allow xenogeneic transplantation only when effective
national regulatory control and surveillance mechanisms
overseen by national health authorities are in place;
(2) to cooperate in the formulation of recommendations and
guidelines to harmonize global practices, including
protective measures in accordance with internationally
accepted scientific standards to prevent the risk of potential
secondary transmission of any xenogeneic infectious agent
that could have infected recipients of xenogeneic
transplants or contacts of recipients, and especially across
national borders;
(3) to support international collaboration and coordination for
the prevention and surveillance of infections resulting from
xenogeneic transplantation;
ESSENTIAL HEALTH TECHNOLOGIES
CLINICAL PROCEDURES
HTP/EHT/CPR
11 LN 2004
Transplantation Workplans 2
Tissue and cells
• Requirements for the safety, quality and efficacy of cell,
tissue (and organs for transplantation)
• Guidance on quality management for tissue banks
• Guidance for national regulatory authorities in charge of
cell and tissue bank oversight
• Coordinated research project on use of tissue grafts in
constrained resource settings
ESSENTIAL HEALTH TECHNOLOGIES
CLINICAL PROCEDURES
HTP/EHT/CPR
12 LN 2004
Role of WHO Expert Committee on Biological Standardisation
Scientific advice on quality and safety issues
• Advice published by WHO (website www.who.int/biologicals; also in Technical Report Series or in Weekly Epidemiological Record)
Written guidanceWritten guidance Global measurement standardsGlobal measurement standards
ESSENTIAL HEALTH TECHNOLOGIES
CLINICAL PROCEDURES
HTP/EHT/CPR
13 LN 2004
Safety Challenges• Public health concerns increasing
– 1980’s: CJD transmitted by dura matar– 1990’s: CJD transmitted by corneas; eye
tissue– 1992: Seven people infected with HIV
through transplantation of organ and tissue(single donor)
– Since 1997, over 50 reports of bacterial/fungal infection from tissues
– 2002: Organ and tissue recipients infected with hepatitis (single donor )
ESSENTIAL HEALTH TECHNOLOGIES
CLINICAL PROCEDURES
HTP/EHT/CPR
14 LN 2004
REGULATORY OVERSIGHT
• Public expectation for safety is high• Over 100 transplants from a single
donor-many at risk if inadequate communicable disease risk asessment
• Demand for tissue/cell products likely to increase
• Perception of poorly regulated industry could thwart tremendous technological promise
ESSENTIAL HEALTH TECHNOLOGIES
CLINICAL PROCEDURES
HTP/EHT/CPR
15 LN 2004
• Patient safety- Donor screening; recipient follow-up
• Product Safety (tissues and cells)– Donor screening and testing– Product testing
• Adventitious agents, tumorigenicity, pyrogenicity
– Biocompatibility testing with device• Product Characterization
– Identity, Purity, Potency, Viability, Stability
Standardisation issues
ESSENTIAL HEALTH TECHNOLOGIES
CLINICAL PROCEDURES
HTP/EHT/CPR
16 LN 2004
Donor screening for cells, tissues and organs
• Same as for screening for blood products?
• Should additional pathogens be screened?
• If so, are gene amplification tests the most appropriate?
ESSENTIAL HEALTH TECHNOLOGIES
CLINICAL PROCEDURES
HTP/EHT/CPR
17 LN 2004
Product testing for cells and tissues
• Conventional test method may not be suitable for cell and tissue products- Sterility : 14 days- Mycoplasma : 28-35 days
• Mycoplasma Q-PCR assay???- Fast turnaround time- Long culture assay not suitable for
products with short shelf life
ESSENTIAL HEALTH TECHNOLOGIES
CLINICAL PROCEDURES
HTP/EHT/CPR
18 LN 2004
Next steps
• Convene Working Group to review needs for both written standards and reference preparations
• Aim to have written guidance reviewed by 2005 ECBS
• Seek input from groups of experts for reference preparation needs e.g. this SoGAT meeting
• Determine priority for any such reference preparations against priorities for other international standards
ESSENTIAL HEALTH TECHNOLOGIES
CLINICAL PROCEDURES
HTP/EHT/CPR
19 LN 2004
WHO Guiding Principles
• Guiding Principles were endorsed by World
Health Assembly in 1991 (WHA44.25)
• Have influenced national legislation and
professional codes
• But challenged by:
– Success of transplantation and technical
progress
– Insufficient supply of human material for
transplantation to meet demand
– Cost of transplantation
ESSENTIAL HEALTH TECHNOLOGIES
CLINICAL PROCEDURES
HTP/EHT/CPR
20 LN 2004
Challenge: Ethics
• from leaders in the field who urge that policies be
changed to allow the use of "incentives" to
increase the number of organs for transplantation
• from the involvement of organ donation
programmes in commercialized tissue operations
• and from "organ trafficking" and "transplant
tourism" which occur in a number of countries in
all WHO Regions
ESSENTIAL HEALTH TECHNOLOGIES
CLINICAL PROCEDURES
HTP/EHT/CPR
21 LN 2004
Resolution WHA57.18 Allogeneic Transplantation
2. REQUESTS the Director-General:
(1) to continue examining and collecting global data on the practices,
safety, quality, efficacy and epidemiology of allogeneic
transplantation and on ethical issues, including living donation, in
order to update the Guiding Principles on Human Organ
Transplantation;[1]
(2) to promote international cooperation so as to increase the access of
citizens to these therapeutic procedures;
(3) to provide, in response to requests from Member States, technical
support for developing suitable transplantation of cells, tissues or
organs, in particular by facilitating international cooperation;
(4) to provide support for Member States in their endeavours to prevent
organ trafficking, including drawing up guidelines to protect the
poorest and most vulnerable groups from being victims of organ
trafficking;
ESSENTIAL HEALTH TECHNOLOGIES
CLINICAL PROCEDURES
HTP/EHT/CPR
22 LN 2004
Resolution WHA57.18 Xenogeneic Transplantation
2. REQUESTS the Director-General:
(1) to facilitate communication and international collaboration among health authorities in Member States on issues relating to xenogeneic transplantation;
(2) to collect data globally for the evaluation of practices in xenogeneic transplantation;
(3) to inform proactively Member States of infectious events of xenogeneic origin arising from xenogeneic transplantation;
(4) to provide, in response to requests from Member States, technical support in strengthening capacity and expertise in the field of xenogeneic transplantation, including policy-making and oversight by national regulatory authorities;
(5) to report at an appropriate time to the Health Assembly, through the Executive Board, on implementation of this resolution.
ESSENTIAL HEALTH TECHNOLOGIES
CLINICAL PROCEDURES
HTP/EHT/CPR
23 LN 2004
Transplantation Workplans 1
• Updated Guiding Principles to ensure ethical, safe and
effective transplantation on the basis of:
– Global database on cell, tissue and organ
transplantation activities and practice
– Country based examples
– Updated analysis of health legislations on
transplantation
– Regional/interregional advisory groups
→ Transparency of transplantation activities
ESSENTIAL HEALTH TECHNOLOGIES
CLINICAL PROCEDURES
HTP/EHT/CPR
24 LN 2004
Transplantation Workplans 3
Safety of the Living Donors
• Global medical and scientific criteria for the
selection of living kidney donors
(Transplantation Society)
• Guidance for national database including
follow-up of living donors
→ Transparency of transplantation activities
ESSENTIAL HEALTH TECHNOLOGIES
CLINICAL PROCEDURES
HTP/EHT/CPR
25 LN 2004
Transplantation Workplans 4
• Xenotransplantation
– Guidance and support to Member States on the
oversight of xenotransplantation trials including
vigilance
– Collaborating institutions and laboratories to assist
in case of untoward event
– International register of xenotransplantation trials
→ Transparency of transplantation activities
ESSENTIAL HEALTH TECHNOLOGIES
CLINICAL PROCEDURES
HTP/EHT/CPR
26 LN 2004
Transplantation Workplans 4
Increasing access
• Facilitating bilateral and multilateral support in response
to country needs
– Legislative framework
– Comprehensive capacity building
• Support to national programmes of procurement of
human material for transplantation from deceased donors
• Coordinated research project on kidney transplantation in
the context of constrained resources → Innovative
approaches and guidance
ESSENTIAL HEALTH TECHNOLOGIES
CLINICAL PROCEDURES
HTP/EHT/CPR
27 LN 2004
• Sterility• Mycoplasma• Pyrogenicity/Endotoxin • Freedom from adventitious agents• Cell therapy products are exempt from
general safety testing
Product Characterization in cellular therapy
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