Demographics of Germany
Germany is a federal parliamentary republic in central-western Europe comprised of 16 states. Each of the federal states has its own state constitution and is largely autonomous. Federal laws need to be implemented into state laws. Of relevance, the federal states regulate and oversee health institutions including hospitals and universities.
Germany has a population of 82.18 million with a gross domestic product of 3052.9 billion €.1 Life expectancy is 80.9 years (83.1 years for women and 78.1 years for men1). Healthcare is covered by a national health insurance plan with an opt out opportunity for a private health insurance. According to the World Health Organization, 77% of the healthcare system is government funded and 23% privately.2 11.2% (328 billion €) of the gross domestic product were spent on healthcare in 2014.3
Governmental and Regulatory Involvement and Oversight
Solid organ, tissue and cell transplantation are regulated in Germany since 1997 by a transplantation law (German Transplantationsgesetz [TPG]).
After the German Reunification in 1989 and an organ allocation controversy in heart transplantation based on the center- and not patient-oriented allocation at that time,4 it became evident that the former “Working Group of German Transplant Centers” needed a formal legal platform. Moreover, consent to organ donation in the former German Democratic Republic had been based on an “opt-out” system while organ donation in former West Germany (The German Federal Republic) had been based on an “opt-in” system.
Organ procurement is coordinated by the German Organ Procurement Organization (Deutsche Stiftung Organtransplantation [DSO]), founded in 1983 which also provides services in the former German Democratic Republic after the reunification. Major principals of organ donation and transplantation are defined in the Transplantation law (TPG) and include: (i) a national German waiting list for all recipients of solid organs; (ii) the identification of donors, the diagnosis of brain death, coordination of organ donation (through the German Procurement Organization, DSO), organ allocation (through Eurotransplant [ET]) and transplantation (coordinated by the transplant centers), all regulated by separate legal frameworks; and (iii) the development and supervision of guidelines for organ allocation based on scientific evidence provided by the Permanent Committee on Organ Transplantation (Ständige Kommission Organtransplantation StäKO) as part of the German Medical Association (‘Bundesärztekammer’, BÄK).
This committee (the StäKO) includes representatives of the German Medical Association (BÄK), Medical Associations of the Federal States, the National Association of Statutory Health Insurance Funds (“GKV-Spitzenverband” [GKV]), the German Hospital Federation (Deutsche Krankenhaus Gesellschaft), the Federal Ministry of Health, the State Ministries of Health, German Transplantation Society (DTG), and Patient Organizations. This body drafts transplantation guidelines that have to be approved by the Board of German Medical Association, (BÄK) and the Federal Ministry of Health (Figure 1).
Germany has 1327 donation hospitals that include 38 University Medical Centers; 162 of the 1165 donation hospitals provide services for Neurosurgery (in 2015). Donor hospitals appoint Transplant Coordinators who collaborate with the German Procurement Organization, DSO, in facilitating organ donations and procurements. For this purpose, the DSO has subdivided Germany in 7 service regions.5
The German Transplant Scandal
As mandated by the TPG, the German Medical Organization (BÄK) in collaboration with the German Hospital Federation (Deutsche Krankenhaus Gesellschaft) and the Health Insurance Funds (GKV) constitute a “Monitoring Commission” that supervises the German Procurement Organization (DSO) and Donor Hospitals; a second group also referred to as the “Assessment Commission” evaluates the activities of ET and those of Transplant Centers.
The initial concept of supervision of transplant activities and –centers prior to the transplantation scandal had been based on mutual trust and collegiality.
However, 3 major scandals have stunned the transplantation community and the public alike:
The first of the recent scandals had been a wide spread e-mail based accusation of misconduct and nepotism inside the German Procurement Organization (DSO) that started in October 2011. A subsequent thorough investigation cleared the DSO from all accusations and wrong doings. Nevertheless, additional governmental oversight and reporting had been implemented.
The second key event has been the widely publicized organ allocation scandal that unfolded in 2012. After anonymous accusations of the liver transplant program in Göttingen, the “Assessment Commission” immediately became active with in-depth investigations of all steps of the transplant process from waiting list registration to allocation and transplantation of the Göttingen transplant program. This investigation had subsequently been extended to all German liver programs with an evaluation of their activities from 2009 to 2012. Detailed data on donor organs and organ allocation were provided by ET and the German Procurement Organization. Those investigations revealed falsifications of documents (ie falsified laboratory values), manipulation of blood samples and the documentation of renal replacement therapies in patients without renal dysfunction.
A final report revealed major irregularities: Systematic manipulations were observed in four centers (Göttingen, Munich (Medical School of the Technical University, ‘Rechts der Isar’), Münster and Leipzig). The liver transplant programs in Göttingen and Munich (Rechts der Isar) were subsequently closed. 13 centers had other findings: 11 centers revealed inconsistencies based on a lack of diligence and documentation rather than active manipulations; more complex inconsistencies in 2 centers necessitated an interview with the Permanent Committee on Organ Transplantation. Five centers (Berlin, Hamburg, Hannover, Magdeburg, and Würzburg) had no irregularities.
In July 2013 the German Transplantation Law had been amended by extending the responsibilities of the “Assessment Committee,” in order to permit monitoring of transplant centers and review patient files. Moreover, falsifications of documents and the manipulation of blood samples or laboratory values in patients awaiting organ transplantation are now a major felony punished with an imprisonment of up to 5 years.
Subsequent to the first round of investigations, all transplant programs were systematically reviewed by the “Assessment Commission” for the years 2009 to 2012.
Although auditing of renal and pancreas programs did not reveal any irregularities, the third scandal evolved in 2014 with the investigation of heart and lung transplant centers. Manipulation of patient files, treatment irregularities, and falsification of patient data had been found in several transplant centers. Thus far, manipulations have been reported for transplant programs in Berlin (heart), Jena (heart and lung), Munich (Ludwigs-Maximilian University Medical Center, for heart and lung), Heidelberg (heart), and Cologne (heart). Although investigations are still ongoing in Hamburg (lung) and Leipzig (lung), the results of all audits have been made public and continuously updated on a website of the German Medical Association (BÄK).6 It is planned to audit all transplant centers every 2 years. After legal hearings of the centers, audit results were handed over to the public prosecutors.
Consequences on Donation Rates
Donations have declined drastically in Germany in the recent past: From 2010 to 2014 numbers dropped from 16 donors pmp to 10 donors pmp.
Donations started to decline subsequent to the accusations that had been brought forward against the German Procurement Organization (DSO). A further decline was observed when the public became aware of waiting list data manipulations and subsequent inappropriate allocations.
Of note, the support and trust of the public for organ donation and transplantation recovered quickly after the scandals based transparent and vigorous investigations. Currently more than 85% of the population is in support of organ donation and transplantation. Moreover, surveys by the Federal Centre for Health Education (Bundeszentrale für gesundheitliche Aufklärung) revealed that approximately 80% of the population would donate their organs.7
In contrast, ongoing surveys identified a lack of information and trust within peer groups, that is, physicians and nursing staff in hospitals as the main barrier to donation.8
Thus, the organ scandal in Germany has drastically reduced donations, however not based on distrust in the general population but rather through doubts among peer groups that resulted into a limited support.
To improve information and to restructure the organization around organ donation, the TPG introduced (i) a mandatory Organ Donation Coordinator in each donor hospital (supported by the National Health Insurance Funds GKV); (ii) moreover, the German Interdisciplinary Association of Intensive and Emergency Medicine (Deutsche Interdisziplinäre Vereinigung für Intensiv und Notfallmedizin) has now a seat with the Permanent Committee on Organ Transplantation StäKO; (iii) a mandatory training and education for donor coordinators has been introduced, coordinated by the Medical Associations of the Federal States and supported by the German Procurement Organization (DSO); (iv) a quality assurance and education process for procuring surgeons has been implemented; (v) guidelines for the determination of brain death have been detailed and mandatory requirements for physicians performing brain death diagnosis have been implemented; (vi) the process of developing and implementing new allocation rules has been revised: guidelines are now drafted in the organ committees of the German Transplantation Society, discussed and finalized in working groups of the Permanent Committee on Organ Transplantation (StäKO), sent out for public comment with a final approval by the StäKO, Board of the German Medical Association and the Ministry of Health. The guidelines are legally binding. In cases of ambiguity in the interpretation of guidelines a query can be made to the Permanent Committee on Organ Transplantation that will then be answered by medical and legal experts.
Based on the observed manipulations that demonstrated among other aspects a discrepancy between accepted overarching broader ethical principles in transplantation and individuals and, in some cases, egoistic interests of physicians and patients, it became evident that the German transplant system needed not only an overhaul of rules and supervision but also that there was a need for a continuous peer review process, quality assessment of procedures and outcomes in addition to strengthening education and professionalism.
By 2017 a formal 2-year education and certification for each physician working in transplantation will become mandatory. A transplant registry will be implemented starting January 2017; the quality of all transplant procedures will be assessed by the Institute for Quality Assurance in the Health Care System (Institut für Qualitätssicherung im Gesundheitswesen); transparency will be a prime goal: data of all transplant center have already been published on the Website of the German Procurement Organization.9
Overall, the German Transplant Scandals have been a sobering experience. Nevertheless, all interest groups including government, Medical Associations, and the German Transplantation Society have taken the events as an opportunity to improve all aspects of donation, allocation, and transplantation in Germany. Implemented changes emphasize on transparency, quality assurance, and process improvement. Clearly, the opportunity for improvement has been welcomed by all key players. Moving forward, the clear goal is to achieve a steep increase in organ donations. Refocusing on the unique opportunities provided by transplantation as a life-giving procedure will be at the center in regaining the trust of peers to get this mission accomplished.
Transplant Centers and Activities for Renal, Liver, Cardiothoracic, Intestine, Pancreas, Islet Transplants
Table 1 lists all active German Transplant Programs and transplant volumes in 2015. Transplant volumes (Table 1) and outcomes (Table 2), in addition to quality assessment are now published for each center on the website of the German Procurement Organization.9 Transplant centers and programs require accreditation by State Ministries of Health or Social Affairs. Currently, a combined effort of health insurance providers and the joint committee,10 an umbrella organization of the German health system reprimands and may close transplant centers and programs if certain quality criteria, such as transplant volume, graft outcome, and patient morbidity and mortality are not met. As an example, based on a failure to meet expected quality measures, the cardiac transplant program at the University of Frankfurt/Main had to discontinue its activities.11
Data Systems and Overall Transplant Volume
Figures 2 and 3 show the actual volume of deceased and living organ donations and transplantations during the recent 10 years. The German Procurement Organization collects all donor relevant data and ET provides relevant data for waitlisted patients. For quality assessment, data have to be reported to the Institut für Qualitätssicherung im Gesundheitswesen,12 the former Institut für Angewandte Qualitätsförderung und Forschung im Gesundheitswesen Institute in Göttingen.13 Data are collected by hospital discharge codes and cross-checked by transplant centers. Currently, data are evaluated by 1-year, 2-year and 3-year cohorts, published (Table 2) and posted on the website of the German Procurement Organization.8 The German Federal Parliament just passed the new chapter 15 of the transplantation law (TPG) providing the legal framework of a Transplant Registry.
Living and Deceased (Brain Dead) Donation Rates
Living donation according to the German legislation is a subsidiary to deceased donor transplants. As a consequence, every patient receiving a living donor organ transplant has to be registered on the ET waiting list for deceased organ transplantation first. Standards and quality parameters for living donation are currently updated and new guidelines covering all aspects of living donation and transplantation are currently drafted by the Permanent Committee on Organ Transplantation (StäKO). Paired kidney exchanges are not covered by the German Transplantation law and are therefore not offered at this time. In theory, federal states have the authority to issue permissions for paired kidney exchanges.
As the German Transplantation Law requires the determination of brain death as a prerequisite for deceased donor organ donation, organs from donors with circulatory arrest are currently not considered.
Significant Achievements and Challenges
Germany has been and continues to be at the forefront of clinical organ transplantation, immunosuppression, transplant immunology, tolerance, xenotransplantation, ischemia-reperfusion injury, novel organ preservation concepts, and many other areas in transplantation research.
The country has responded to recent flaws in its transplantation system with a fundamental and still ongoing restructure of organ donation and transplantation. Germany has spearheaded novel allocation systems to increase the utilization of marginal kidneys (expanded criteria donors or Kidney Donor Profile Index > 85%) and continues to find novel approaches to improve the quality and the lifetime of suboptimal organs, recognizing that their utilization can be beneficial. For lung transplantation, the lung allocation score has been established and a cardiac allocation score for heart transplantation is being implemented. The allocation of livers based on Model of End Stage Liver Disease scores recognizes specific needs in patients with alcoholic liver cirrhosis, hepatocellular carcinomas in addition to other indications requiring defined standard exceptions.14 The histocompatibility working group of the Permanent Committee on Organ Transplantation (StäKO) is currently preparing guidelines to implement a virtual cross-match in renal recipients and mandatory HLA and DSA testing in liver recipients. Moreover, amended guidelines in kidney and pancreas transplantation are currently on the way.
Germany has taken the recent organ scandal as an opportunity to strengthen its organ procurement and allocation systems on the pillars of transparency, quality control and process improvement. Regaining the trust and support of all parties involved including that of all working in healthcare will be critical in increasing organ donations in Germany. Milestones thus far have been revisions of the Transplantation Law, strengthening of the German Organ Procurement Organization, the involvement of Intensive care specialists into the organ donation and management process, the implementation of a Transplant Register, a renewal of allocation guidelines, a focus on structured specialization training with a future mandatory 2-year fellowship, a legal framework for the structure of transplant centers, outcome measures, quality control, and the publication of transplant activities. Clearly, this broad and effective approach is expected to entirely change the landscape of transplantation in Germany.15 At the same time, necessary changes of the German organ allocation and transplantation system have been challenged by an insufficient financial support of health insurances for a more efficient organ procurement organization jeopardizing the goal to increase organ donation and transplantation.
In summary, the new system will increase transparency and safety of organ donation, allocation, and transplantation. Indeed, changes of the German Transplantation system may serve as an example for an efficient and safe system for other countries.
After years of scandals, Germany has revamped its transplant system. Those changes are expected to regain the trust of all allowing to recognize not only the societal and economic significance but also, and most importantly, the lifesaving gift that transplantation offers for all of those in need.