Medical Products of Human Origin

3. Medical Products of Human Origin Jose R. Nuñez MD, PhD Medical Officer Transplantation

4. Clinical transfusion • Transfusion safety • Haemovigilance

6. Medical Products of Human Origin : from human to human

11. Medical Products of Human Origin : from human to human from human for humans

12. Clinical transfuion • Transfusion safety • Haemovigilance

13. 107 millions

14. Global Observatory on Donation and TransplantationOrgans Transplanted Globally in 2011 2011 GKT/ GODT ≈ 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 Transplantation South Africa, India and China - are 2010 estimates

15. Similarities • Original procurement from a human donor. Need to meet essential ethical and safety requirements inherent to their human origin • Living donor

16. Global Observatory on Donation and TransplantationOrgans Transplanted Globally in 2011 2011 GKT/ GODT ≈ 112,600 organs transplanted (≈ 10% of estimated global needs) 103 countries reported to the Global Observatory on Organ Donation and Transplantation South Africa, India and China - are 2010 estimates

17. Global Observatory on Donation and TransplantationOrgans Transplanted Globally in 2011 2008 GKT/ GODT ≈ 112,600 organs transplanted (≈ 10% of estimated global needs) 103 countries reported to the Global Observatory on Organ Donation and Transplantation South Africa, India and China - are 2010 estimates

18. Similarities • Original procurement from a human donor. Need to meet essential ethical and safety requirements inherent to their human origin • Living donor • Without alternative of comparable benefit • Often last option • “Radical” treatment • Cross border

19. 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 years > 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 Tissues Deirdre Fehily, Kuala Lumpur, WPR Regional Meeting 8-10 June 2009

20. Similarities • Original procurement from a human donor. Need to meet essential ethical and safety requirements inherent to their human origin • Living donor • Without alternative of comparable benefit • Often last option • “Radical” treatment • Cross border • Scanty resource

22. 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. The Self-Sufficiency ParadigmThird Global Consultation on Organ donation and Transplantation Madrid May 2010 • To meet patients needs: • Government responsibility • Organization • Equity • In the burden of donation • In allocation (UHC) WHA63.22 • Education • To donation • To prevention • Trust of the Public • Transparency • Professionalism Donor Professionals Patient Recipient Society / Authority Donation is a civic gesture, an expectation but not an exception

24. Professionals Authorities The Magnificent Seven, John Sturges,1960

25. WHO Organization-wide Initiative for Medical Products of Human Origin

26. WHO Organization-wide Initiative for Medical Products of Human Origin “ Health products of an exceptional nature”

27. * Guiding Principle 10 WHO Guiding Principles On HumanCell, Tissue And OrganTransplantation Endorsed by the sixty-third World Health Assemblyin Resolution WHA 63.22

28. WHO Organization-wide Initiative for Medical Products of Human Origin Why “product” ? • Outcome of a process, • quality management 3 Global Governance Tools for MPHO

29. Three Global Governance Tools for MPHO Global set of PRINCIPLES inherent to the Human Origin Global use of coding systems for all MPHO Global collaborative tools for Vigilance and Surveillance

30. 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; Global set of PRINCIPLES inherent to the Human Origin

31. Global set of PRINCIPLES inherent to the Human Origin • 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

32. Three Global Governance Tools for MPHO Global set of PRINCIPLES inherent to the Human Origin • 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; Global use of coding systems for all MPHO Global collaborative tools for Vigilance and Surveillance of MPHO

33. Global use of coding systems for all MPHO 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

34. Global use of coding systems for all MPHO

35. InformationStandardforBloodand Transplant 128 • Terminology • Nomenclature • Translations • Coding • Unique identifiers • Centers • Donations • Recipient(s) • Formatting standards • Delivery means • Inter-operability across Medical Products of Human Origin SAFETY ETHICS

36. Three Global Governance Tools for MPHO • Duty to constantly optimize the safety, quality and efficacy of procurement, process and clinical application of MPHO Global set of PRINCIPLES inherent to the Human Origin Global use of coding systems for all MPHO Global collaborative tools for Vigilance and Surveillance of MPHO

37. Bologna Initiative for Global Vigilance and Surveillance BIG V&S Dr Luc Noël EHT/CPR "Clinical Procedures"

38. http://www.notifylibrary.org/

39. 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. • A reference for professionals focused on diagnostic and investigation • but also providing evidence for donor selection, • A source of information for candidate recipients and living donors • A database for further study

40. 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.

41. Method • 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 Infections • Garzoni 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

42. The NOTIFY Library Objective: communicating vigilance information as widely as possible in the interests of improving the safety of MPHO worldwide • 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.

43. The Human Body as the Source of Therapeutics 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: • 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.

44. MPHO

45. Thank you nunezj@who.int noell@who.int