Universal? Donation Coverage (UDC) - Organs, Tissues, Cells in the Hungarian Healthcare System - a case-study approach Dr. Mariann Fodor assistant professor University of Debrecen mfodor@dote.hu Dr. Zoltán Szabó deputy director-general Hungarian Blood & Transplant szabo.zoltan@ovsz.hu
The term: organ, tissue & cell DONATION & TRANSPLANTATION DONATION is an artificial process of TRANSPLANTING a sensible living material from one living or cadaver individual to the other ORGANS Simple TX: kidney, liver, heart, lung, pancreas Combined TX: heart + lung, kidney + pancreas TISSUES Solid: CORNEA, amniotic membrane, skin, cardiac tissue, blood vessels, cartilage, tendons / ligaments Fluid: BLOOD (SPECIAL TRANSPLANT: TRANSFUSION) CELLS Bone-marrow and cord-blood stem cells, oocytes, spermatozoons (NATURAL PROCESS: CONCEPTION) 2
Topics I. Universal Donation Coverage (UDC) as special part of Universal Health Coverage (UHC) A) Aspects B) Measures II. Case studies: ORGAN / BLOOD & CORNEA donation coverage in Hungary inside the EU and world context C) The Hungarian National Blood Transfusion Service (Hungarian Blood & Transplant) 1. ORGAN DONATION & TX 2. BLOOD DONATION & TF D) The Departement of Ophthalmology at University of Debrecen and The Lions Corneal Bank in Hungary 3. CORNEA DONATION & TX III. Evaluation: E) Short Analysis F) Key Findings and Final Messages 3
A) Aspects 1. Public and / or Private Good (trafficking) The Concept of Ownership Living and Cadaveric Donation Social Consensus and Legislation (positive / negative) 2. Resource (re)allocation or (mis)allocation (Trafficking) Economic Analysis of Transplantation Technical and Allocative Efficiency Balancing Demand and Supply 3. Technical Process (Limitations and Constrictions) Blood Groups, HLA-typing, Matching Rate, Ethnicity! Logistic System, Transport and CIT (Cold Ischemic Time) Information Technology, Risk Observatory, Security Management 4. (sometimes the only) Therapeutical Intervention Comparable Alternative, Better Alternative, Only Alternative 4
B) Measures 1. Health Status of the Population Selection / Contraselection of Healthy Donors Show-Up Input of the Health System: Unhealthy Patients Input of the Donation System: Healthy Donors re/cycle: Healthy Donor / Unhealthy Patient / Healthy Recipient 2. Altruistic Willingness Donation-tree versus Age-tree Generation Gaps and Paradigmal Changes Social and Cultural Communication 3. Economies of Scale Optimal Size of Donor/Sample - Recipient Pools (Waiting Lists) Advantages of Cooperation / Integration of Pools and Networks 4. Grow Trends in the Donation Sector Scientific Trends. Pro s and Con s, Alternative Technologies 5
A) The Hungarian National Blood Transfusion Service (Hungarian Blood & Transplant) 1. Solid ORGAN Program: Eurotransplant Accession in 2012 2. BLOOD Transfusion Services 3. Bone Marrow Stem Cell Registry so we fly 24 / 7 by day by night 6
1. ORGAN: ORGAN Donation Coverage in Hungary - the EU and World context CADAVER DONATIONS 2010 (Newsletter Transplant, 2011): EU 27 average: 18.4 pmp / ET 7 average: 17.6 pmp ET (A: 22.5 B: 24.4 HR: 28.9 D: 15.5 L: 6.0 NL: 13.1 SLO: 20.0) 1800 35 1600 1400 1200 HBD+NHBD pmp 30 25 1000 800 15,9 20 15 600 10 400 200 5 0 0 Spain Portug al France Austria Malta Italy Belgium Slovenia Czech R. Es tonia Finland Slovak R. U.K. Hungary Germany Latvia Netherlands Poland Denmark Ireland Sweden Lithuania Luxembourg Cyprus Greece Romania Bulgaria 7
1. ORGAN: Non-Exploited Potentials DONATION EFFICIENCY INDEX (WHO, 2008): Donors / Deaths from Selected Causes pmp 3,5 3 2,5 2 non-exploited potential 1,5 1 0,5 0 USA Spain France Ireland Belgium (2005) Austria Cyprus Luxembourg Portugal Netherlands Italy Germany (2006) Sweden United Kingdom Estonia Czech Republic Slovakia Slovenia Finland Denmark (2006) Hungary Croatia Poland Greece Latvia Lithuania Romania 8 Bulgaria
1. ORGAN: Non-Exploited Potentials PROCUREMENT EFFICIENCY INDEX (WHO, 2008) : Organs Transplanted / Deaths from Selected Causes pmp 10 8 non-exploited potential 6 4 2 0 USA Spain Austria France Ireland Belgium (2005) Sweden Germany (2006) United Kingdom Italy Cyprus Luxembourg Denmark (2006) Czech Republic Romania Finland Slovenia Estonia Slovakia Poland Croatia Hungary Greece Latvia Netherlands Lithuania Portugal 9 Bulgaria
2. BLOOD: Blood Donation Coverage in Hungary - the EU and World context (source: transfusionguidelines.org.uk) 11
2. BLOOD: Blood Donation Coverage in Hungary - the EU and World context Paradigmal change in the position, functions and roles of key stakeholders Recipent: in the center Donor: a key professional Old (classical) paradigm New (postclassic) paradigm altruistic, affective attitude empowered, cognitive attitude feelings, acceptance understanding, giving sensible, responsive helper empowered, cooperating partner the one who can help the one who is able to help public good? theory private good? theory perceived as charity perceived as service inf. assymetry acceptance inf. assymetry avoidance they needed SY, I was there they needed ME and I agreed 12
And what about TISSUES? The legislation, regulation and control of tissue donation and TX now belongs to the Medical Officer s Office in Hungary According to EU Directives and international benchmarks, tissue donation and TX should be integrated into the organ donation and TX activity under the umbrella of the HNBTS Cornea donation and TX first among the tissues with this aim is now a pilot-project led by the University of Debrecen 13
B) Departement of Ophthalmology at the University of Debrecen Lions Corneal Bank Debrecen University of Debrecen 1921 - Department of Ophthalmology
History of the Department of Ophthalmology in Debrecen The Official Surgical Textbook for Ophthalmologists in Germany for 25 Years (1945-1970) was written by a Hungarian Ophthalmologist 1905 EDUARD ZIRM The first keratoplasty in the world: Bohemia 1909 GYULA FEJÉR The first keratoplasty in Hungary 15
History of the Department of Ophthalmology in Debrecen PROF. BÉLA ALBERTH more than 3.000 keratoplasties in Debrecen 16
The term: Corneal Transplantation Corneal Degeneration: After Keratoplasty: The most often used solid-tissue transplantation The cornea is replaced by donated corneal tissue (the graft) in its entirety (penetrating keratoplasty) or in part (lamellar keratoplasty) Indication: if the transparency / clarity of the cornea is deminished because of scar, degeneration, distrophy, inflammation or other causes 17
Worldwide Association(?) & The European Eye Bank Association (EEBA) As far as I am aware, there is NO WORLDWIDE ASSOCIATION that regulates corneal transplantation as such, although the World Health Organization has a broad remit in advising and providing guiding principles on issues on relating to Human Cell and Tissue Transplantation and works closely with individual national competent authorities in this field Gary L. A. Jones Executive Officer European Eye Bank Association Venice, Italy Founded in 1989 Legal seat is in Italy (Venice) Formed for the advancement of eye banking Aim: to help provide tissues and cells of optimum quality and safety for transplantation and the treatment of eye diseases 18
The EEBA s Mission sufficient availability of tissues and cells development and maintenance of standards data collection on graft outcome - validate eye bank techniques interchange of information between eye banks discussion of aspects of banking, donor selection and procurement encourages relevant research and development informed comment to external agencies, education and training links with corneal transplant communities and relevant bodies since 1991 collects data from 70 banks in 20 countries (2010) overall percentage of corneas issued for TX was 61% in 2010 17470 corneal transplantations were reported in 2010 12 banks export to EU with EEBA banks, 7 without, 4 outside EU average donor age is 59 yrs 24h-regulation for taking blood samples caused a huge loss of potential donor material 19
Lions Corneal Bank Debrecen Date established: 1994, EEBA member Coordinates the National Keratoplasty Registry from 1992 Provides tissues only for patients operated in our clinic Type of tissues: Cornea, Sclera, Amnion, Fascia lata 20
Activity Data in Debrecen 4778 keratoplasties were performed (1946 2009) Considering the first 65 years in Hungary, in the first 50 years keratoplasties were done only in Debrecen routinely THE IMPORTANCE OF TRADITION!!! Research Center In 2010: 107, in 2011: 138 keratoplasties were performed in Debrecen (530 in Hungary in 2010) 21
Some Focal Points along the Cornea Chain The indication and the type of corneal TX depends on the life expectancy of the patient and the location in the country Alternative therapy : keratoprotesis Length of waiting lists differs from one region to the other in Hungary So what about universal donation coverage? The national waiting list consists of about 160 patients in Hungary for cornea (1/3 year) Donor recruitment: depends on the individual characteristics of the bank involved, while donor selection: depends on strict legal regulation Laws concerning: cornea as organ and tissue donation (Germany) versus organ donation (Belgium, Italy, Hungary) Tissue banking organization: does not exist in most countries Between the eye and the cornea: a distinction can be made: eye is considered an organ, cornea a tissue (Italy, Hungary) no distinction, both considered tissues (Belgium, United Kingdom) 22
Legal Regulation of the Cornea Procurement Types of regulation NEGATIVE REGULATION: opting in (explicit consent) POSITIVE REGULATION: opting out (presumed consent and explicit objection) mixed systems (Spain, The Netherlands) What is the isolated effect of legal regulation on the keratoplasty ratio pmp in different European Countries? 23
Positive versus Negative Regulation The keratoplasty ratio pmp OPTING OUT average: 35 pmp OPTING IN average: 47 pmp 80 80 70 70 60 60 50 50 40 40 30 30 20 20 10 10 0 0 Russian Fed. Poland Finland C roa tia Belgium Czech Republic Hungary Austria S pain S witzerland S lovenia Denmark F rance Germany Sweden United Kingdom Ita ly Netherlands 24
Tradition and Experience with First Line Technology: Femtosecundum Laser 25
Conclusions The number of keratoplasties seems to be in lower correlation to the legal regulation, but rather dependent of the individual characteristics of the bank involved and tradition The number of the processed corneas has to be increased With the increase of % of corneas issued for grafting the number of the keratoplasties can be increased Cooperation among stakeholders, especially with the organtransplant teams is a must 26
A) Short Analysis 1. 1. Effectiveness Alternative therapies Kidney, Liver Dialysis Mechanic (heart), and Pharmaceutic Substitution of Function Stem Cell Originated Cells, Tissues and Organs Artificial Transplants, CORNEA: keratoprothesis the very last chance 27
A) Short Analysis 2. 2. Efficiency: The Social Value of a Transplanted Kidney KIDNEY TX QALY 7.4733 COST 87,346 Euro (26,203,676 HUF) DIALYSIS (as comparator) QALY 5.0205 COST 135,819 Euro (40,745,750 HUF) DIFFERENCE QALY 2.4528 COST - 48.474 Euro (-14.542.074 HUF) SV of 1 TX K 113.881 Euro (34.164.293 HUF) Source: Z. Kaló, J. Márton, S. Mihály: DOPKI Organ Donation Initiative Kidney Transplantation Markov Spreadsheet Model Report (2009) 28
A) Short Analysis 3, 4. 3. Equity Social Values, Social Agreement, Social Consensus Legislation and Financial Background Networking, Regional, International, Global Cooperation Methodology and Technology Transfer Free Information Flows (Research, Results, Experience, Practice) 4. Feasibility Health Status of the Population for Sustainability Reasons Integrated Primary, Secondary and Terciary Prevention Efforts Politics / Policy Formulation and Evidence Based Desision Making Economic Evaluation for Allocation Reasons 360 Double Channelled Communication with Key Stakeholders: Society, Mass Media, Politicians, NEXT GENERATIONS!!! Medical Society, Professional Media, PATIENTS!!! WORKING STAFF all along the Organizational Hyerarchy 29
B) Key Findings & C) Final Messages B) Key Findings Donation is both Effective and Efficient Donation is neither Equitable nor Feasible C) Final Messages Health Status of the Population is Crucial to Sustain or Increase Donation Activity Economies of Scale can be Defined and this should be taken into Consideration in Policy Formulation Harmonised Regulation is the Basis of National, Regional, International and Global Cooperation and Integration Transplantation s effeciency in greatest part stays with The quasi-free (altruistic) origin of donated (supply) goods Donated goods are inputs to a RECYCLING-process SUPPLY INDUCED DEMAND v. Demand Induced Supply 30
to DONATE: it s TINY
to RECEIVE: it s HUGE