Medical Products of Human Origin

3 Patient Safety Programme

Health Systems and Innovation

Jose R. Nuñez MD, PhDMedical Officer Transplantation

Clinical transfusion

Transfusion safety

Haemovigilance

Medical Products of Human Origin :

from human to human

Medical Products of Human Origin :

from human to human

from human for humans

Clinical transfuion

Transfusion safety

Haemovigilance

107 millions

Kidney Liver Heart Lung Pancreas

76118 23721 5741 4278 2564

2011 GKT/ GODT

Global Observatory on Donation and Transplantation Organs Transplanted Globally in 2011

≈ 112,600 organs transplanted(≈ 10% of estimated global needs)

≈ 5.1 % increase over 2010

103 countries reported to the Global Observatory on Organ Donation and TransplantationSouth Africa, India and China - are 2010 estimates

Similarities• Original procurement from a human donor.

Need to meet essential ethical and safety requirements inherent to their human origin

• Living donor

76118 23721 5741 4278 2564

2011 GKT/ GODT

76118 23721 5741 4278 2564

Living Donor 32350

Living Donor

42,5% 17,8%

2008 GKT/ GODT

• Living donor• Without alternative of comparable benefit• Often last option• “Radical” treatment• Cross border

• 1.9 million tissue grafts distributed by AATB accredited tissue

banks each year

• > 200,000 tissues grafts a year in Germany

• 46,000 corneas distributed by Sri Lanka Eye Bank over 30

• > 100,000 tissues imported into Korea in one year

• 5,000 cornea transplants in Italy each year

• 20,000 tissue transplants in France in one year

Deirdre Fehily, Kuala Lumpur, WPR Regional Meeting 8-10 June 2009

Tissues

• Living donor• Without alternative of comparable benefit• Often last option• “Radical” treatment• Cross border• Scanty resource

self-sufficiency

…. is the satisfaction of the transplantation needs of a given population, using resources obtained from within that population.

transplantation needs of a given popul blood

23 Health Systems Policies and Workforce

ClinicalProcedures

Professionals

Patient Recipient

Society / Authority

To meet patients needs:

1. Government responsibility

• Organization

2. Equity

• In the burden of donation

• In allocation (UHC) WHA63.22

3. Education

• To donation

• To prevention

4. Trust of the Public

• Transparency

• Professionalism

Donation is a civic gesture, an expectation but not an exception

The Self-Sufficiency ParadigmThird Global Consultation on Organ donation and Transplantation Madrid May 2010

24 Health Systems Policies and Workforce

ClinicalProcedures

Professionals Authorities

The Magnificent Seven, John Sturges,1960

WHO Organization-wide Initiative for Medical Products of Human Origin

“ Health products of an exceptional nature”

* GUIDING PRINCIPLE 10

WHO Guiding Principles On Human Cell, Tissue And Organ Transplantation

Endorsed by the sixty-third World Health Assembly in Resolution WHA 63.22

Why “product” ?

Outcome of a process,

quality management

3 Global Governance Tools for MPHO

Three Global Governance Tools for MPHO

1. Global set of PRINCIPLES inherent to the Human Origin

2. Global use of coding systems for all MPHO

3. Global collaborative tools for Vigilance and Surveillance

Prohibition of financial gain on the human body and its parts as such,

recognizing that procurement through financial incentives and profit on some

human body parts as such (e.g. plasma and gametes) is not forbidden in

some countries, in which case respect of other requirements starting with

transparency is even more important;

Responsibility for the provision of MPHO placed with authorities and through

them the individual citizen and resident;

Genuine consent of donors and recipients;

Protection of the incompetent

Equity as a goal, in the burden of donation and in allocation of MPHO

Use of MPHO justified by evidence and absence of comparable alternative;

Prohibition of financial gain along European requirements

Council of Europe Convention on Human Rights and Biomedicine (Oviedo 1997) and Additional Protocol concerning Transplantation of Organs and Tissues of Human Origin

Draft Council of Europe Convention against Trafficking in Human Organ (Council of Europe - CDPC)

Charter of Fundamental Rights of the European Union Citizen

3. Global collaborative tools for Vigilance and Surveillance of MPHO

Traceability and accountability mandated throughout the

process, from donors to recipients, including long term outcomes

and vigilance and surveillance under the oversight of national

competent authorities;

Transparency and openness to scrutiny indispensable even if

confidentiality and anonymity when required must be preserved;

Allow: easier information transfer + traceability + interoperability across MPHO, and

between countries in routine and emergency + cost containment

From the transfusion experience Coding is a priority

• Terminology• Nomenclature

• Translations• Coding• Unique identifiers

• Centers

• Donations

• Recipient(s)

• Formatting standards• Delivery means• Inter-operability across

Medical Products of Human Origin

Information Standard for Blood and Transplant 128

SAFETY

ETHICS

3. Global collaborative tools for Vigilance and Surveillance of MPHO

Duty to constantly optimize the safety, quality and efficacy of

procurement, process and clinical application of MPHO

Dr Luc Noël EHT/CPR "Clinical Procedures"

Bologna Initiative for Global Vigilance and Surveillance

BIG V&S

http://www.notifylibrary.org/

• A database of all types of severe adverse events and reactions that have

been reported arising from procurement and processing to clinical application of

cells, tissues and organs for transplantation as well as of medical products of

human origin used in assisted reproduction technologies.

1. A reference for professionals focused on diagnostic and investigation

2. but also providing evidence for donor selection,

3. A source of information for candidate recipients and living donors

4. A database for further study

• Scope: organs, tissues and cells for transplantation and

for assisted reproduction.

Blood ?

• Aim: to create and maintain a compendium of cases of

adverse reactions/events for donors and recipients of

organs, tissues or cells, noting how they were detected,

confirmed and documented and to develop guidance

based on the information collected.

• Utilized Standard Definitions• Severe Adverse Reactions: An adverse response that HAS

occurred, including a communicable disease, in a recipient or in a living donor

• Serious Adverse Events: An adverse occurence that MIGHT lead to harm in a recipient or a living donor

• Uniform Definitions of Donor Derived InfectionsGarzoni C, Ison MG. Transplantation. 2011; 92: 1297 – 1300.

• Review of published reports of SARE

• Standardized summaries including:• Adverse Incident, Substance Type, Latency, Alerting

Symptoms, Frequency Data and Estimates, Demonstration of Imputability, Keywords, References

Method

The NOTIFY Library

More than 900 documented case types can be searched in a structured way by organ, tissue or cell type and/or incident type associated bibliographic references and expert analyses.

Reactions Infectious transmissions of all types, malignancy transmissions, and

genetic transmissions to transplant recipients and to the offspring of children born from donated gametes.

Events caused by process failures and reactions in living donors

Site and search tools publicly available (without username and password) Language specific interface in Regions.

Objective: communicating vigilance information as widely as possible in the interests of improving the safety of MPHO worldwide

The establishment of globally agreed principles for the governance of MPHO would represent significant progress towards the goal of meeting minimum standards, as well as serving:

The Human Body as the Source of Therapeutics

• to underline the cross cutting concerns regarding all MPHO, inherent to their human origin;

• to demonstrate respect for the human body and hence the dignity of persons;

• To increase safety and enhance ethical practices; • To encourage donation by generating trust in procedural safeguards such

as consent requirements and protocols for care and follow-up of donors;• To avoid distortions in practices due to the undermining effect of bad

examples, such as the justification of payment for organs by appeal to legal trade in plasma.

Health System Governanceand Service Delivery

Health Systems and Services45 Clinical

Procedures

Thank you

nunezj@who.int

noell@who.int

Medical Products of Human Origin

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