Blockchain Papers

Jim Vaught, Akin Abayomi, Tim Peakman, Peter H. Watson · 6 authors

Biobanking for clinical or research purposes includes the collection, processing, storage, and analysis of biological specimens. It is now well recognized that biobanking involves a complex array of technical and ethical/regulatory considerations. Biobanking policies and procedures are often documented by best practices that are usually voluntary but may be supplemented and reinforced by strict rules and regulations that govern informed consent, privacy, QC, and other critical issues. As biobanking has emerged as a global endeavor, with national networks and international collaboration becoming the norm, it has become even more critical that practices are coordinated and that quality standards are developed. Biobanking is also often a business endeavor, in that formal strategic and business plans need to be developed to ensure the long-term survival of the associated research programs. As new technologies are developed for using biospecimens to diagnose and treat disease, as well as to evaluate genetic risks, patients are becoming more aware of the importance and benefits of biobanking as part of the medical infrastructure. As a result, patients who donate biospecimens are becoming more interested in learning more about their own sample's use and in seeing the actual results of the research. One of the aspects of these evolving attitudes toward biobanking was addressed in a previous Q&A concerning biospecimen “ownership” in the January 2011 issue of Clinical Chemistry (Gronowski et al.; Clin Chem 57:540–4). From the broad array of issues that could be addressed, this Q&A focuses on a few critical issues that many biobanks are facing today: quality management, biobank network design, long-term sustainability, conveying the importance of biobanking to the public, and the return of research results to biospecimen donors. Five experts who are engaged in national and international biobanking programs discuss these complex issues here. What are some of the important issues related to quality management in sample collection, processing, and storage? Tim Peakman: Biobanks should aim to collect and store samples and associated data in the form most useful for scientific research. This means that they should represent the biological environment at the time of collection as closely as possible, and the introduction of variation through the way they are collected and processed should be avoided as much as possible. Where cases and controls come from different sources, this problem may be particularly acute (with the exception of purely genetic studies). In studies where samples are shipped to a different location for processing, the time delay between collection and stabilization may lead to loss of some unstable markers. Where samples are processed at local sites, maintenance of consistent intersite processing can be challenging. Odds ratios for many exposures are typically 1.2–1.5, so that introduction of uncontrolled or unmeasured variation may lead to weak associations' being overlooked, spurious associations' being further investigated, or significantly greater cost as sample size is increased to enhance power of the study. For many studies the greatest source of variation is at the preanalytical stage, in other words the collection, transport, and processing before stabilization at low temperature or on matrices such as blood spot cards. This can be managed by the implementation of a proper quality program that aims to make the collection and processing of samples as consistent as possible. Formal quality schemes such as ISO 9001:2008 may be suitable for larger studies, but whether a formal accreditation is obtained or a laboratory-based approach is taken, the quality management process should include full documentation of the sample processing trail (including dates, times, temperatures, location, operator, etc.), use of standard operating procedures (SOPs),7 training, audits, critical materials review, and so on. Practical steps to reduce introduced variability can be taken that aim to ensure the time from collection from the volunteer to stabilization is as consistent as possible across all samples and any preprocessing (such as clotting time for serum tubes) is standardized. Finally, quality of sample annotation should be ensured using approaches such as bar codes that maintain accuracy of sample attribution and avoid the risk of misidentification that can result in false positives. It is also important to empirically determine the stability of the samples under the particular collection protocol and whether this is sufficient for the intended purpose. Many analytes are quite stable in blood if they are transported and processed at 4 °C and, with a few exceptions, those analytes that aren't stable only degrade a small amount over 24 h. Establishing systems and processes to avoid this marginal loss may be expensive and unnecessary. Peter Watson and Lise Matzke: Quality management (QM) is an essential component of operating and maintaining a biobank. At the end of the day, it's “garbage-in, garbage-out,” or so they say. Operationally, biobanks must be able to track each biospecimen that is collected, processed, stored, and distributed from the facility to manage biospecimen quality and ensure effective future use. Quality is managed by an established system that verifies biospecimens are handled appropriately. Such quality systems involve the creation and maintenance of accurate process protocols, SOPs, and the activities that verify these protocols' being followed by biobank personnel (staff education and training). Further, standards and best practices set by international organizations such as the International Society for Biological and Environmental Repositories and the National Cancer Institute set guidance around the issues, provide a reference point for content of this documentation, and facilitate harmonization by national organizations and down to individual projects. Implementation of QM activities requires dedicated time and a resourcing strategy which can be very costly. Therefore the scope and scale of the program should be dictated by the scope and scale of the biobank and the nature of the research it is intended to support. A biobank supporting basic discovery research may choose a primary QM focus different from that chosen by a biobank that is intended to support multicenter validation studies. Adequate training and education of biobank personnel and a tracking mechanism to ensure training is current and role specific are essential parts of the overall QM strategy. This helps to ensure consistent and informed application of both quality assurance and QC measures. The process of review of a QM system allows for evaluation around what is and what is not working in the QM and the ability to make changes. There are several types of external assurance programs that are offered on the international stage that are complementary strategies to raise the standards across the discipline of biobanking. Some define an upper standard and use an external assessment process and measurement of product quality, while the focus for other programs is to define a minimal standard and concentrate on education. An example of the latter approach, which ties all these components of QM together, is the concept of biobank certification, which is broadly applicable for all entities handling biospecimens and is offered by the Canadian Tumour Tissue Repository and UBC Biobank Resource Centre. Helen Moore: Quality can mean very different things to different people. One might think of quality management as the process followed to determine that, in the end, you got what you set out to get. For biobanking, quality management would follow the complex set of procedures undertaken to enroll a research participant in biobanking and collect, process, annotate, and store biospecimens, and determine whether that process yielded biospecimens and associated data sufficient for the purpose collected. Foundational elements would include well-documented SOPs that are understood and accepted by those who are collecting, processing, and storing biospecimens, as well as training on SOPs and annotation of deviations from SOPs. Quality criteria must be set at the outset and suitable metrics and analytical tests used to evaluate the processes and determine whether the quality criteria have been met. Having a quality management plan in place for biobanking does not mean that perfection is expected; in fact, it is important that quality management be reasonable in scope and that errors be expected. For example, some level of biospecimen degradation may be unavoidable in some circumstances. Awareness of this possibility and being able to measure relative degradation is part of the quality management plan. Good quality management in biobanking at best can translate to higher quality and reproducibility of research results using the biospecimens. Akin Abayomi: In Africa, where extreme ambient temperatures are the order of the day in conjunction with potentially large geographical distances that samples may need to travel, attention to detail is critical. Clear and comprehensible SOPs and frequent training activities, particularly at sample acquisition research sites, are key to ensuring sample integrity. The emphasis is shifting towards minimizing preanalytical variables, which necessitates the need to have the capacity to bring the process of stabilizing the physiology of the sample closer to the donor. This is possible with good logistics and strategic team activity dovetailing with synchronized operations between the researchers and the biobanking teams. Communication is critical in this process. Kit development and dispatch to sites of collection with good training and harmonized operational activity all along the route of the sample until it gets to its final storage site are mandatory in this process. Where cell-line creation is part of the menu of operations, then the sooner the blood mononuclear cells are isolated and either frozen or processed the better the outcome. This process can start at the collection site to stabilize the cells and completed at a central facility. Staffing at peripheral collection sites will need to be upskilled and infrastructure adapted to this objective. Use of emerging room temperature storage and transportation technology to stabilize the whole sample at time of collection or soon after isolation of nucleic acids may be useful options in some environments. What are the advantages and disadvantages of centralized vs individual/local biobanks? Tim Peakman: There is no right or wrong answer to whether a study should adopt centralized or local sample processing and archiving. This will depend upon factors such as size of the study, daily volunteer recruitment rates and sample acquisition, sample processing throughput, complexity of the processing protocols, available budget, and the expertise of the study team. As a general rule, once studies reach a certain size and certain sample accrual rate, centralized biobanking offers a number of advantages but this does depend upon the study. Use of automation allows much higher numbers of samples to be processed on a daily basis much more consistently and with a robust, secure anonymized data trail. Quality data are recorded as part of the process and, if sample storage and retrieval are automated, samples can be stored and retrieved quickly from very stable, low-temperature environments with complete accuracy. Balanced against this, central services cost a lot to establish and maintain and often samples need to be shipped from collection centers that introduce delays in processing (although the effects of this can be largely mitigated using temperature-controlled shipping conditions) and increase transport costs significantly. Smaller single-site studies may benefit from local processing which is as quick as possible (and is therefore likely to preserve as many analytes as possible), is suitable for very complex protocols, and doesn't incur high setup or transport costs. This approach is limited to relatively small numbers of and can with process and variability the and requires maintenance of a data trail for studies with recruitment From that the cost sample for large studies is also increased with local need to the and of each for their study in their with an of the stability of the samples they are and processing and the costs of different Peter of At the biobanks are the of a complex activity biobanking, and some components of biobanking need increased to reduce research that of and biospecimen while need more to quality processing and and other components need both of networks can be centralized in but with distributed from and at the level are many quality, and factors that what is a facing organizations and research whether to or their A of these and the many and have often been to of the by the to in research is an essential and but of around infrastructure is The types of biobanks and research to be are other important is no only important considerations. as around issues such as reproducibility in research and the need for increased scale and quality in biobanks can only come with implementation of and the need for more components and of many types of biobanks Helen Moore: biobanks can advantages of increased of biospecimens, with systems for quality management, data management, and or local biobanks may provide advantages in and One way of these is biobanks so that individual biobanks use the or at and approaches to biobanking, the of biospecimens across different sites in a or biobank. An quality management program across the system would be an important of such a network and would include to different collection sites and a of collection and storage that might be in place at different It would be important to where approaches and processes could be at different sites, and for (and such where they could A network would good and education about the of the to answer such are to What is the of the is harmonization of approaches and quality management important to the final facilitate better biospecimens and better research through this Akin Abayomi: In Africa, where infrastructure is and can be through is an with a more central biobanks with effective to peripheral collection processing sites would the of the research team and ensure samples are as to that of the volunteer as possible. This would and The centralized more to the emerging of and biobanking being more to the of and able to to samples before of scale can be with and on of or This approach also to the of researchers biobanking which can have on and sample that are becoming more now and for future of biological The ability to focus more on good with to collaboration between studies and larger size studies, which are use of biospecimens for and studies. What are some of the issues facing biobanks in of long-term Peter Watson and Lise Matzke: Biobanks are expensive to and From collection of biospecimens to processing, storage, and activities, the of activities in a biobank is a biobanks are the biobanks in their and Further, as a research biobanks a complex and that is with biobank Biobank is therefore a of and usually the the importance of other aspects or should not be biobanks are often as not being secure they on or it is the complexity and variation of and that is the most important of this and it is the metrics to evaluate the relative importance of individual biobanks and the importance of biobanks other of research infrastructure that the critical of research are and all focus on the of research should in biobanks if the scope and need are not the for any and is very and not and the research to biobanking is recognized as an important part of particularly in the research their in to the research and then to a is At the end, the to to a set of the and standards by which biobanks should be able to at to ensure research quality, is the greatest to of individual The good is that these issues are now a part of an in the biobanking the of new strategies to these issues. Helen Moore: are often collected for specific research the research have been the research may be the biospecimens may have for research use. to the of biospecimen and the to support their storage and can be challenging. A greater emphasis on to the about the of biobanks in and to about the of biobanking, will be important to in biobanking. is about the actual costs of biobanking. The National Cancer Institute is a on the aspects of biobanking. The data will be in and in an that will be able to for about the costs associated with biobanking. Akin Abayomi: In environments with a of in and for the greatest for or is in and on to provide that can either as or as a strategy. Biobanking is not high on the and in environments its return in of and of a is not research that biobanking strategies have the of in to their research In such external can be used as to which will as a for the need to establish national and the right environment to the biobanking, and national research can biobanks better their to researchers and the Peter Watson and Lise Matzke: the of a biobank requires the biobank to be on and and key other words the of the For the the and to key is to researchers and the will the that is in biospecimen for while to the the emphasis is on the end biobanks are working for better these requires a different strategy from vs scientific to each in the design, and of a biobank. Helen Moore: Biobanks are an essential of the medical research and the for and in biobanks must be upon and It is important for the to that of research biospecimens, as well as the by biobanks of the biospecimens for current and future is to medical that may benefit the research and their In the the concept of for the good is to or who are for their they are to whether they would be to donate in the of an It is important now to the about of biospecimens for research. Such education must be across and Akin Abayomi: Communication in the of has to the and of national to and and to the from which samples will be requires a different strategy and of to the in The greatest will be from the of the and are important to effective and The in at the different can be quite and should not be For the national the importance of the is to bring to the advantages to be through not in of of its but also the of the benefits of biobanks requires the the of are critical in an strategy and form an important of overall An aware and informed is to but with this the evolving of The engaged is more and requires to on the emerging and role of biobanks in the return of research results to biospecimen and the that will result from review of and by Peter The issue of of research has become of the most and issues facing research and research in are in of data and the scale and of research data as by the in the of data from biospecimens. The complexity and of different are and the of of the and of biobanks that in between the and the research of the has an all an important issue and is often in the research by its nature and must be and to some from clinical There are both and to to this research biobanks not the clinical and should be to the for return of research is not the as an to raise issues or in the process of return of results from research and become to the biobank. Helen Moore: In larger and larger of research have become part of medical and technologies for and an important role in biospecimens. Such as well as established analysis approaches such as review, can some results that are as to the research In some cases the are of no or clinical but in other cases the may have clinical be such if in a research a clinical to be and researchers or biobanks not to be for the to research their as more is about and studies are for medical the between research and clinical are The of researchers and to return is a of much are the of what are and the benefits and of the to the research their Akin Abayomi: This is a complex clinical that will closer to the of as the concept of more of an It is to potentially useful from a or the the are and the ability to and data in an to the donors. The concept of will as a more to as and to patients more through on or or emerging issues that you will have on the future of biobanking. Tim Peakman: One of the for biobanks will be data This is likely to come from from use of the studies data and samples to other researchers and typically this involves the return of research data to the biobank once the is The of this is that it the for future of the of scientific that can be using these and the technologies used to biobanks will need to data data quality, and data are stored and in a data large biobanks are their expertise and to to large data on their sample For example, Biobank is the is about in the and of the whole and is an approach to collect data on people. data are very large and and of storage, and use. both from such as genetic and new analytical approaches and from by will be a data management in the of the of large biobanks is the of studies can use the should be taken to avoid using the of in a way that in the data It was on this basis that Biobank to the with the that in or it will be to the of all of the people. This a of the so that the can be used for other types of emerging are approaches for the and Helen Moore: across biobanks and research programs will be very important in the future of medical research to better individual in of disease, and to such data while the of individual research is a for the A better of biospecimen the effects of different biospecimen collection, processing, and storage on the of biospecimens, is need to attention to now so that can biospecimen practices for different analysis also need to be the by which biospecimens are and storing this with the biospecimens in This approach will be even more important in the future so that will be some assurance that collected and stored biospecimens are suitable or for for research and of specific as analysis technologies Akin Abayomi: will become an important of the future as a means of tracking samples and related can ensure the ability to track samples from to and to the use of in the should be able to a biological from a research site to primary or and the benefit that is in to a This will become particularly important with the use of cell-line technology in of both a quality assurance and a means of tracking and It will also as a means to in the scientific process and start the for on a standard operating quality

Íngrid Vargas, Amparo‐Susana Mogollón‐Pérez, Jean‐Pierre Unger, Maria Rejane Ferreira da-Silva · 6 authors

<strong>Background</strong> Regional-based Integrated Healthcare Networks (IHNs) have been promoted in Brazil to overcome the fragmentation due to the health system decentralization to the municipal level; however, evaluations are scarce. The aim of this article is to analyse the content of IHN policies in force in Brazil, and the factors that influence policy implementation from the policymakers’ perspective. <strong>Methods</strong> A two-fold, exploratory and descriptive qualitative study was carried out based on (1) content analysis of policy documents selected to meet the following criteria: legislative documents dealing with regional-based IHNs; enacted by federal government; and in force, (2) semi-structured individual interviews were conducted to a theoretical sample of policymakers at federal (eight), state (five) and municipal levels (four). Final sample size was reached by saturation of information. An inductive thematic analysis was conducted. <strong>Results</strong> The results show difficulties in the implementation of IHN policies due to weaknesses that arise from the policy design and the performance of the three levels of government. There is a lack of specificity as to the criteria and tools for configuring and financing IHNs that need to be agreed upon between involved governments. For their part, policymakers emphasize the difficulty of establishing agreements in a health system with disincentives for collaboration between municipalities. The allocation of responsibilities that are too complex for the capacity and size of the municipalities, the abandonment of essential functions such as network planning by states and the strategic role by the Ministry, the ‘invasion’ of competences among levels of government and high political turnover are also highlighted. <strong>Conclusions</strong> The implementation of regional-based IHN policy in Brazil is hampered by the decentralized organization of the health system to the municipal level, suggesting the need to centralize certain functions to regional structures or states and to define better the role of the government levels involved.

Antonio Sitges‐Serra

The knowledge imposes a pattern, and falsifies, for the pattern is new in every moment and every moment is a new and shocking valuation of all that we have been. — East Coker , T.S. EliotMedicine is not a science: it is a cultural product. As such, the way it is practiced and conceived is much affected by cultural contexts, academic traditions, politics, personal interests, the health industry, experts’ and medical bodies’ opinions, journalists and medical publishing companies. Obviously, science and research have played and will continue to play a key role in the development and progress of medical knowledge. Science, however, proceeds slowly, requires the test of time and relies on strict methodological principles and in personal integrity; briefly, good science is at stake in a world dominated by technolatry1: a self-imposed commitment for continuous innovation within an industrial culture dominated by planned obsolescence and profit increase for the myriad companies that live on the global health market. Evidence-based medicine was launched to encourage a scientific and proof-based approach to medical practice.2 As an ideological movement, it has had a significant impact on how doctors read the medical literature, how clinical research should be planned and how new concepts and therapies are scrutinised before being implemented. However, because medicine, in opposition to science, requires bedside decision making, it cannot rely only on hard data. First, because in many domains, such hard, class A data are not available in many instances. Second, the robustness of the data may be challenged by new findings. Third, because the clinical setting is much more complex than the scenario created by clinical trials that, in order to obtain meaningful conclusions, oversimplifiy the decision-making process through strict inclusion and exclusion criteria. Fourth, because the acquisition and implementation of new knowledge is …

Claudio Ronco, G. Mason, A. Nayak Karopadi, Ashlea Bennett Milburn · 5 authors

Today, health policy seems to be on the top of governments' agendas around the world. Healthcare systems are challenged by a number of phenomena happening on a global scale; these trends include demographic change in terms of an ageing population, an increase in chronic disease, patients having higher expectations on healthcare delivery and above all a major pressure on public finances to slow increasing healthcare expenditures. Such developments are forcing policy-makers to reform healthcare systems. First, there is a tendency towards decentralization of responsibilities. Second, governments are moving towards reimbursement schemes rewarding good outcomes and performance. Third, great importance is being attributed to transparency and accountability, and to introduce competition in healthcare. Fourth, attention is being shifted from simple treatment of a disease towards preventive initiatives, in a more holistic approach to health. Finally, healthcare policy-makers are recognizing the importance of empowering patients to give them control over decisions regarding their own health. These dynamics can be observed in chronic kidney disease, the management of which is a huge economic burden to healthcare systems globally, and which represents a good example of a field where important changes can be witnessed in therapy, technology, delivery and financing.

David M. Gaba

The healthcare industry may be the largest and most expensive endeavor of the developed world, with the United States at the top of the list of per capita expenditure. Clearly, as indicated by the intense (and continuing) debate over the Affordable Care Act, the issues of the healthcare industry are of extreme interest to the public and policy makers.The biggest problems in the healthcare industry are about how to achieve its fundamental goals—how to provide adequate and equitable care to the entire populace; how to guarantee equitable access to all; how to achieve optimal population health; how to ensure efficacy, quality, and safety of patient care; how to provide choice of provider and hospital; and, most importantly, how to pay for all of these goals and how to obtain political agreement of the populace to make it happen.Fortunately, this monograph will address primarily issues of quality and safety, and will largely ignore these other very large and thorny issues. Some of the ideas in this chapter have been addressed in part by the author in prior journal publications.12From a safety standpoint, it is now well recognized that there is a significant incidence of harming patients in the course of trying to diagnose and treat them.3Many such events are known to be preventable. The incidence of minor problems is very high, but even serious events have been found in approximately 1% of all hospitalizations. It is often said that many of these adverse events are irrelevant because the patients they occur in are already very ill, and hence might well have suffered negative outcomes anyway. However, I contend that no patient “signs up for bad care,” so we should still be very concerned about such events even when they do not, in the final analysis, actually affect the final outcome. The next time, maybe they will.In addition, it is likely that many errors that occur, even serious errors, are hidden. Some are not apparent because the patient is very ill, so only detailed investigation or analysis can disclose an error. In other cases, errors can be hidden simply by failing to inform anyone of them and waiting to see what happens. Moreover, healthcare does not have the robust incident or accident investigation processes that are routine in transportation (e.g., National Transportation Safety Board). Most investigations—in the infrequent occasions that they occur—are conducted only at the local level and with varying degrees of sophistication and alacrity.Parts of healthcare (such as anesthesia and surgery) and nuclear power production are but two examples of activities of “high intrinsic hazard” (aviation is a well-known third). The hazard in these activities is inherent—it can be managed and controlled—but the hazard cannot be eliminated. Yet, the management of hazard in nuclear power and aviation has become so good that it is accepted that adverse events are not “normal.”Nuclear reactors should not unexpectedly interrupt power production, and they should never harm workers or the public, melt down, or explode. Airplanes are not supposed to crash—ever. In these arenas when one of these things happens, we know that something went horribly wrong. Yet, human beings are inherently prone to catastrophic internal failures that result in serious disability or death. Thus, adverse outcomes—not necessarily due to errors or poor care—are very common in healthcare. All of us are going to die, and most of us will die in close proximity to healthcare. It is difficult to sort out which events are the ordinary “natural history” of disease and which are due to suboptimal care. This makes efforts at measuring safety outcomes particularly difficult in healthcare.All of the high intrinsic hazard industries share the fact that they are so critical to human welfare that we cannot just shut them all down while we solve all of their problems. Certainly, we can't stop performing healthcare activities just because they are imperfect—the ravages of disease are worse. While a single nuclear reactor can be shut down whenever necessary, and a flight can be cancelled or delayed, it is sometimes impossible (and possibly unethical) to refrain from or abort an emergency medical procedure due to a significant safety risk when the patient's underlying disease processes will otherwise quickly cause serious harm or death.Decisions on a larger scale are more complicated. While it is in principle possible to abandon the use of nuclear power in some countries, this can only be done temporarily or it must be phased out over a very long period of time. Access to abundant electrical power is the lifeblood of modern societies. Similarly, the dislocations caused by even short stoppages of air travel by the 9/11 terrorist event or the Icelandic volcano's ash cloud demonstrated that air travel also cannot be stopped for long. On the other hand, in healthcare, the introduction of new, potentially lifesaving drugs and devices can be delayed pending proof that they are safe and effective.The calculus of such decisions may vary from country to country, although many aspects of healthcare (and nuclear power production) are similar everywhere. In healthcare, the practices of physicians stem originally from the roots of the “autonomous healer” who used individual, often idiosyncratic, knowledge and “skill” to diagnose and treat ailments. There were few curative or invasive therapies. While administering potions to, cupping, and bleeding patients didn't usually help them very much, and might have hastened their demise, they were not generally powerful enough to directly cause serious harm or death. Hospitals were originally organized more as “guild workshops” 4 wherein the members of the physician's guild could independently ply their trade.Now, in the early 21st century, some things have changed drastically while others have not. We have many more diagnostic and treatment interventions that can often cure. Many are very powerful and can themselves directly, and quite quickly, cause serious harm or death. I like to say that there is a high potential lethality per square meter in settings like the operating room, intensive care unit, emergency room, or chemotherapy administration unit. Wielding such interventions requires very complex care coordinated across many individuals and many work units.Since the latter half of the 20th century, it has become possible to compare many patient outcomes in response to diagnosis or treatment, a process that is still unfinished. Despite all of this change, the structure of the hospital, for example, has not changed much in hundreds of years, retaining many elements of the guild workshop. Even where an institution is the employer of physicians, the amount of autonomy of practice given to physicians is enormous, despite the grumblings of how medicine is dictated by the rules and regulations of payers and other bodies. The system also is structured around assumptions that the individual skill of the professionals will be uniform, solid, and unvarying over time, which of course is impossible to guarantee.Even the division of labor is old. I conjecture that if healthcare were to be developed now, from scratch, we would not have job types of “doctor,” “nurse,” “pharmacist,” and “respiratory therapist,” to name only a few. We would have many other job types and a vastly different organizational and work structure—hopefully based on a more rational assessment of how best, and how safely, to achieve the goals of the work in the first place.A fundamental difference in healthcare versus other industries is that “we” do not design or construct the units we work on: human beings—nor are we given an instruction manual for them. We do not understand a great deal of how the human body works, how it fails, or why and how it gets sick or recovers from illness. Yes, great strides have been made and more discoveries are happening every day, but we are mostly working empirically by trial and error.In my own field of anesthesia, we do not know many of the fundamental mechanisms by which our drugs can render patients unconscious, unaware, resistant to pain, immobile, and (fortunately) unable to recall what has transpired during surgery. Yet, by trial and error, we have worked out the methods to do these things—which clearly evolution never really intended for human beings—on a regular basis with low, but not low enough, rates of serious problems.In healthcare, the public is very concerned with personal and intimate aspects of the work, and such individual, societal, and ethical issues are commonplace. They also care very deeply about choosing and seeing “their” doctor. This is not the case for other industries where the public doesn't care specifically who exactly is doing the work (pilots and nuclear power plant operators interact with the public minimally, if at all). However, for nuclear power, the public has great concerns over the long-term impact of accidents, and also a hard to grasp “dread” factor of radiation that does not come into play in healthcare.56Organizationally, the nuclear power industry and healthcare are very different. There are just over 100 nuclear power reactors in the United States, owned and operated by 30–40 firms and under significant scrutiny by the federal regulator, the U.S. Nuclear Regulatory Commission (NRC).Healthcare is a vastly more decentralized and massive undertaking. There are 4,000– 6,000 hospitals, owned by 1,000–2,000 firms. There are roughly the same number of stand-alone surgicenters. There are more than 200,000 physician offices. More than 20 million surgical operations with anesthesia are performed, just under one billion doctor visits occur, and about three billion prescriptions are written every year in the United States. Yet, there is no federal regulatory agency of the practice of healthcare. That comes under the jurisdictions of the 50 states and the federal health systems (e.g., Department of Defense, Department of Veterans Affairs, and the Indian Health Service).The federal U.S. Food and Drug Administration regulates the approval and sale of drugs and devices. The federal Centers for Medicare &amp; Medicaid Services (CMS) controls the criteria for federal payment for medical services. CMS may act as an indirect regulator of practice—if you won't get paid for it, you probably won't do it—and there are other indirect regulators by accreditation (e.g., The Joint Commission) or by voluntary participation (e.g., Institute for Healthcare Improvement and the Leapfrog Group). However, indirect regulation is generally not comparable to direct regulation, as in the NRC's direct oversight of nuclear power, or the Federal Aviation Administration's direct oversight of aviation.Of note, in aviation and nuclear power, the firms themselves (individual airlines or individual power utility companies) impose strong safety control over the day-to-day work of personnel, often over and above the requirements of the regulator. This is only partially true for healthcare. The work of nurses, pharmacists, and allied health personnel comes under the direct purview of the employing institution, although the degree to which actual practices at the front line reflect the stated goals or policies of the institution varies greatly.The practices of physicians have less direct oversight by the firm; the majority of physicians are independent (fee-for-service, not salaried) members of the hospital's medical staff. As such, though not under direct line authority of the hospital, they must apply for clinical privileges and their actions can be scrutinized by the institution. Other influences on physician practices come from specialty board certification and professional society practice guidelines.However, when guidelines are well articulated, strongly evidence based, and widely agreed upon by the medical community, it typically takes a decade until these practices are consistently adopted and executed. Regardless of whether physicians are actual employees of the hospital or are independent medical staff members, in practice they have nearly unlimited discretion as to how they manage individual patients. Local standardized operating procedures are occasionally imposed, but even then their authority and compliance may be minimal, especially without specific incentives for compliance or disincentives for noncompliance.In fact, all of the hazardous industries suffer from a phenomenon in which what is articulated for safety on paper does not always correspond to the reality at the front line or even to a plausible reality that could be implemented at the front line. One aspect of this has been described by the sociologist Lee Clarke as “fantasy documents,” such as policies, procedures, or plans that are created to satisfy a regulatory, internal, or public relations need, but are known by most participants to be infeasible. They “sound good” and make people feel better, but it is widely known—at least by frontline staff—that they cannot really work as described.78One factor about the aftermath of accidents that affects other industries in a profound way that doesn't happen in healthcare is that a severe accident in nuclear power, in oil refining, or even in aviation, can seriously harm the “means of production.” That is, not only may the accident hurt workers or the public, it also takes out of service the facilities (power plants, refineries, or airplanes) that are used to do the work. Even ignoring cleanup or repair costs (if relevant), this means that there is a huge financial and operational loss from the lost means of production.As indicated above, for nuclear power, this can expand all of the way to long-term plans to abandon this method of generating electricity. None of these effects is seen in healthcare. If we harm a patient in the operating room, that may be very sad, may generate litigation, and may (rarely) garner bad publicity for the hospital, but we just “send for the next patient.”I cynically suggest that if the aftermath of medical errors or preventably suboptimal care events in an OR, ICU room, or emergency department bay would be to take that room out of service for days or months, that would generate a much more aggressive response for improvement by the healthcare institution than we currently see.It is true that healthcare cannot strive for the same level of standardization within a facility, or especially between facilities having the same basic technology, as is achieved in nuclear power or the aviation industry. Human beings are not reactors or airplanes and diseases are not understood at fundamental levels, hence healthcare personnel need more flexibility to respond to unanticipated situations. However, as for many things in healthcare, the pendulum is currently too far to the side of insufficient standardization.On the equipment and procurement side, the decentralization and huge number of sites of care raise all sorts of issues. Unlike the 106 nuclear power plants of perhaps a few dozen designs, the hundreds of thousands of patient rooms, ORs, ICU bays, etc., in the 8,000 institutions each needs outfitting with various devices such as monitors and infusion pumps.Rather than being purchased as large, integrated, preconfigured units, such devices are often purchased one at a time, or, at best, in periodic bundles of hundreds. The combinatorics of all of the devices makes it impossible for vendors to test them in use all together. And, until fairly recently, there was little demand on vendors—either from regulators or the marketplace—for serious human factors testing of either prototypes or actual devices.The decision to purchase equipment is often made by small committees or single influential individuals based on idiosyncratic assessments of features. Purchase decisions are strongly affected by the purchase cost of the equipment and disposable supplies, and only rarely by total life cycle or systems cost. One area where both nuclear power and healthcare can benefit is to achieve and maintain a high degree of user-centered human factors testing of concepts, prototypes, and actual equipment during the design, premarketing, marketing, and postmarketing phases of product life.Issues of design are compounded in healthcare by the current variability in the preparation and training of personnel on the use of the equipment, even that which is life critical. Nursing and allied health disciplines generally have more structured mechanisms for providing training to personnel before they use advanced equipment via “in-services” and checkoffs of competency.Even so, experience suggests that such checkoffs can be “fantasy activities”—showing that immediately after training, and in a quiet environment, a clinician can demonstrate performance of specific tasks doesn't necessarily correlate with skill with the device during actual use in challenging real-life conditions. Fortunately, most of the time, personnel do rapidly learn to use the essential aspects of equipment in their routine bedside activities.However, problems may arise especially for devices that are used only rarely (e.g., defibrillators), in situations requiring the use of advanced and complex device features, or when it is necessary to deal with unexpected glitches or faults (e.g., when something isn't hooked up quite right or the wrong button is accidentally pressed) in a stressful in physicians have been more resistant to to training, which is rarely made Thus, it is not for a physician to a device a anesthesia in patient having never or seen or used the healthcare, there is like the in aviation, of how much experience has as an they cannot an they have been specifically and as on that of In nuclear power, each plant has a of the control room on so it is that plant operators would be to control the reactor and systems if they are not with the this suggests that perhaps healthcare nuclear power have the optimal structure for In healthcare, it is and with little devices and systems are In nuclear power, there is strong control and little risk of by but at the cost of extreme and to especially in safety critical in so many there may be a in the Clearly, to its and physician autonomy and control by firms or but has to up to its for very high Nuclear power has an safety at least in the United States, but is, to a in its not of and other the two in many there are many of where of and may each industry to a that is more and at cost to the

Arianna De Nicola, Simone Gitto, Paolo Mancuso, Vivian Valdmanis

Over the past twenty years, important changes in the Italian health system have led to different approaches in organizing, delivering and financing health services throughout the country's regions. In this paper, we assess the impacts that such changes have had on health efficiency. The analysis performed here is in two stages. In the first stage, healthcare efficiency is measured via bootstrapped Data Envelopment Analysis. In the second stage, the impacts of organizational and environmental variables on efficiency are investigated. Our results highlight that the organizational model adopted by the Lombardia region allows for the best results in healthcare efficiency in Italy. A process of administrative decentralization from the regional governments to local health units appears to be a source of inefficiency. Finally, patient mobility has a significant impact on healthcare efficiency.

Susanne Höhle-Pasques, Johannes Hankowitz, Peter Oberender

Against the background of increasing cost pressure in the German Health Care system German health policy introduced several law changes to increase competition within German health care system for both, payers and health care providers. At the same time law changes included centralization of decisions—counteracting a real competition. Both approaches are part of an austerity plan. The latest example for this approach is the new drug law (AMNOG) in 2011 with the core element of centralized early benefit assessment (§ 35a SGB V) for new drugs and therapies and price negotiations between federal association of health insurances and pharmaceutical company. In this review we examine the implementation of the new drug law with respect to the achievement of political objectives: Ensure sustainable financing of innovations in the German health care system, provide innovations early to the patient, decrease overregulation and establish a transparent environment in which efforts of the pharmaceutical industry are being honored by fair prices. We reviewed the new AMNOG process since its implementation on 1st January 2011 and first 64 values dossiers from pharmaceutical companies that have been evaluated by G-BA (Federal Joint Committee) between January 2011 and December 2013 with respect to the above mentioned political objectives. Parameters such as added value, determination of an adequate competitor, patient relevant endpoint surrogate parameter and subgroup analysis are being discussed. AMNOG process has been implemented as a learning system and indeed several issues have already been addressed, such as the determination of the adequate comparator by G-BA as well as the treatment of orphan drugs in this process. Basically implementation of AMNOG and early benefit assessment is a necessary step on the way to transparent priorisation of health care benefits. But the AMNOG process is one step further towards centralization of the German health care system and therefore contradicts a healthy and fair competition within the system. As a consequence the development of high quality solutions for patients might be hampered. The analysis of the first 64 value dossiers shows that less of half of the affected patient populations (40 %) have access to new therapies being reimbursed by health insurances with a premium price. There is a major inbalance in assessment of drugs in different therapeutic areas. In combination with increased uncertainty for the pharmaceutical companies the AMNOG process on the middle and long-term might jeopardize the commitment of pharmaceutical industry in the German market. This in turn endagers the political objective to ensure patients early access to innovative therapies. Besides this, centralization of the subjective parameter “added value” seems to be problematic, since value decisions should be taken by democratic processes. We therefore suggest a model in which only objectively measurable value decisions are being taken centrally and subjective value decisions are as much as possible decentralized. This results in both a stronger competition of qualitatively best solutions for patients and in a higher fault tolerance. Instruments such as health care research and conditional reimbursement can help to enhance a fair competition for more quality in regionally organized health care and more economical allocation of short resources.

Heiner Grosskurth, Ruari Brugha, Benson Droti, Susan D. Foster

Levels of care Peripheral health units, such as health centres, dispensaries or community health posts, are the first places where patients meet the formal public health care system in most rural African districts. People also consult private clinics, pharmacies, formal or informal drug retailers and traditional providers, who are popular for psychosocial and mental health problems, when people suspect spiritual factors, in AIDS, tuberculosis and epilepsy or when orthodox medicine does not meet their needs. Together, these providers represent primary medical care; better district care must involve all of them. In most countries health care is decentralized and largely devolved to district health services. The Ministry of Health formulates policy, sets standards and ensures quality assurance and is responsible for mobilizing resources and monitoring and evaluation nationally. It oversees and sometimes manages nationally co-ordinated services such as epidemic control. However, the district health management team (DHMT), led by the district medical officer and the district hospital form the backbone of the health services. The health care system, especially in Anglophone African countries, is organized around the district health service. The district hospital provides secondary level medical care; whilst regional (provincial) and national hospitals provide tertiary specialist care. A referral chain, up which patients move, is thus established but, in reality, most district and tertiary hospitals have busy outpatient departments that give primary care to their community. As urbanization accelerates, urban polyclinics function like district hospitals and provide an intermediate tier between smaller urban clinics and specialist hospitals.

Ingrid Sperre Saunes, Anna Sagan, Ingrid Sperre Saunes

Norways five million inhabitants are spread over nearly four hundred thousand square kilometres, making it one of the most sparsely populated countries in Europe. It has enjoyed several decades of high growth, following the start of oil production in early 1970s, and is now one of the richest countries per head in the world. Overall, Norways population enjoys good health status; life expectancy of 81.53 years is above the EU average of 80.14, and the gap between overall life expectancy and healthy life years is around half the of EU average. The health care system is semi decentralized. The responsibility for specialist care lies with the state (administered by four Regional Health Authorities) and the municipalities are responsible for primary care. Although health care expenditure is only 9.4% of Norways GDP (placing it on the 16th place in the WHO European region), given Norways very high value of GDP per capita, its health expenditure per head is higher than in most countries. Public sources account for over 85% of total health expenditure; the majority of private health financing comes from households out-of-pocket payments.The number of practitioners in most health personnel groups, including physicians and nurses, has been increasing in the last few decades and the number of health care personnel per 100 000 inhabitants is high compared to other EU countries. However, long waiting times for elective care continue to be a problem and are cause of dissatisfaction among the patients. The focus of health care reforms has seen shifts over the past four decades. During the 1970s the focus was on equality and increasing geographical access to health care services; during the 1980s reforms aimed at achieving cost containment and decentralizing health care services; during the 1990s the focus was on efficiency. Since the beginning of the millennium the emphasis has been given to structural changes in the delivery and organization of health care and to policies intended to empower patients and users. The past few years have seen efforts to improve coordination between health care providers, as well as an increased attention towards quality of care and patient safety issues. Overall, comparing mortality rates amenable to medical intervention suggests that Norway is among the better performing European countries. Despite having one of the highest densities of physicians in Europe, though, Norway still struggles to ensure geographical and social equity in access to health care.

Víctor B. Penchaszadeh, Francisco A. Leone, Mario Rovere

The modern health system of Argentina was developed in 1945-1955, a period of economic bonanzacharacterized by industrialization, rapid urbanization and activist labor organizations. During the ensuingyears it evolved in three sectors: public, social security and private, with separate services, populationcoverage and funding. While the national Ministry of Health is nominally responsible for general healthpolicies and regulations, overseeing the general operation of health services, designing preventive medicineprograms and negotiating the coverage and fees of health insurance plans, it has in fact very low leverage toenforce decisions in the provinces, which are autonomous, as well as in the social security and private sectors,which are weakly regulated if at all. While the health workforce, medical facilities and level of spending areacceptable, the fragmentation and segmentation of the system render it highly inequitable and inefficient.During the 1980s and 1990s, the health system has experienced further transformations, as neoliberalpolicies took hold in the country and dictated a reduction of state involvement in social services in favor ofprivatization and decentralization of health care. The result has been increased fragmentation, inequity andinefficacy, as health care is increasingly prey to the economic interests of private corporations (insuranceand pharmaceutical industries), trade union bureaucracies and the medical professional and technologyestablishments. The expectation of popular sectors of society are that progressive polices recently enactedby Congress, and being implemented in the fields of education, retirement pensions and the media, will befollowed with much needed public health policies based on equity and efficiency.

Eliana Jimenez‐Soto, Katarzyna Alderman, David Hipgrave, Sonja Firth · 5 authors

In the pursuit to take forward the Global Strategy for Women’s and Children’s Health and accelerate progress toward Millennium Development Goals 4 and 5 in Asia and the Pacific, there is ample evidence on what should be done and why investments in Reproductive, Maternal, Neonatal and Child Health (RMNCH) are, or should be, national priorities. However, there is scant evidence on best practice approaches to prioritizing the investment in RMNCH, and implementation of health system strategies to improve the health of women and children, which remains a challenge for many countries in the region.In decentralized systems, which make up the vast majority in the region, prioritization usually takes place at different levels. Decision-making on the content of the benefits package, that is, which health interventions may be financed with public monies are usually taken by national authorities (macro-level or national priority setting). The difficult task of deciding how to deliver the benefits package, that is, the actual mix of providers (public and private), programs, resources, and strategies, usually rests on the shoulders of state, provincial and even district authorities (meso-level or subnational priority setting). Evidence-based recommendations were recently made for low and middle income countries (LMICs) to improve the process of prioritizing health interventions at national level (Glassman et al., 2012). However, scarce evidence exists to guide subnational authorities in their prioritization exercises.The primary aim of this exercise is therefore to provide evidence-based recommendations to inform decisions by subnational authorities on how to prioritize service delivery investments in RMNCH in Asia and the Pacific. For this purpose we undertook a review of the available evidence on priority setting for health in both the published and the grey literature during the last 10 years. Although our primary focus was on priority setting at the subnational level, we also examined the more extensive literature on macro-level priority setting to identify lessons learned.

Peter Roderick, Allyson M Pollock

No abstract is available for this record.

Tom Miller, James C. Capretta, Grace-Marie Turner

No abstract is available for this record.

Albert Ledesma Castelltort

Western countries with strong primary care systems organize their health services around this healthcare modality, which serves as a gateway to the system and is characterized by multidisciplinary teamwork, management transferred to the teams and a broad services portfolio. The contractual relationship between professionals and the public health system is a useful tool to modulate the efficiency of services and their ability to meet the expectations of citizens and professionals. Some countries choose to contract professionals directly, either individually or through a professional organization, an option known as a self-management system. Others opt to contract public or private entities, which in turn recruit health professionals as employees. In the latter countries, the concept of management decentralization and managerial autonomy has arisen. In Spain, only Catalonia has enabled professional entities to be hired to provide public health services, through commercial formulas, i.e. in a competitive market relationship. This relationship allows the use of corporate governance mechanisms that are not subject to public control through state intervention. The other forms of management promoted in Spain to avoid the controls of state intervention - foundations or associations - have been unsuccessful, except in the autonomous region of Valencia and some models in the autonomous region of Madrid.

Alain C. Enthoven

In a wide-ranging look at many aspects of health care financing and delivery, the concepts of glasnost and perestroika are used as a framework for presenting ideas from the American system that may have value for European health care planners. These include more uniform approaches to data collection and cost reporting, patient outcome studies, evaluation of service and access standards, publication of information, quality assurance review, decentralization and independent institutions, prepaid group practice, demonstrations and experiments, and managed competition. Suggestions are offered for making health care systems on both sides of the Atlantic more manageable, efficient, and responsive.

Mio Fredriksson

Both national equity in healthcare and the county councils’ local autonomy are important values supported by Swedish law. Politically it is a balancing act; how much freedom should the county councils have and to what extent should healthcare be equal throughout the country? The general aim of this dissertation, concerning political governance in Swedish healthcare, is to investigate the tensional values of national equity and local autonomy in the light of current trends in healthcare governance in Sweden. How is this tension manifested? Four studies are included in the dissertation. These studies show that the Swedish state is becoming more active in governing and regulating healthcare, for example by the use of informative governance and legislation, which increasingly rely on monitoring and evaluation of results that are made public. The findings show that the tension between national equity and local autonomy is manifested in increasing emphasis on national equity – or rather national equivalence – which is interpreted in terms of Swedish healthcare being recentralized. Delivery and financing of healthcare are still the responsibilities of the county councils. Planning and arranging – the setting of the regulatory framework – is increasingly taken over by the central state. Although power seems to be transferred from local level to central level, the county councils’ autonomy is only partially restricted, which means Swedish healthcare is still decentralized. However, if the recentralization process proceeds further, the county councils´ autonomy may be seriously challenged. Another challenge is to maintain or strengthen the procedures for democratic legitimacy through citizen participation at the local level. When local autonomy looses ground, it becomes more difficult to tailor healthcare according to local needs and conditions in the county councils, and decisions are taken at greater distance from the citizens.

Arianna De Nicola, Simone Gitto, Paolo Mancuso

Over the past twenty years, important changes in the Italian health system have led to different approaches in organizing, delivering and financing health services throughout the regions of the country. This study aims to examine the impact these factors have had on efficiency. The methodology adopted is based on the developments in bootstrapping Data Envelopment Analysis (DEA). In particular, employing a two-stage procedure, we analyzed the impact that political interventions have produced on healthcare efficiency. The data, which were at the local health unit level for the period 2004-2005, were aggregated to the provincial level in order to take into account patient mobility. The study reveals that the organizational model adopted by the Lombardia region allows for the best results in healthcare efficiency. Second, administrative decentralization from the regional governments to local health units is a source of inefficiency. Third, adjusting the cost of delivering care, by taking into consideration regional health characteristics, improves efficiency. Finally, future policy interventions should make careful valuations of the impacts of patient mobility on healthcare efficiency.

Anna Sagan, Dimitra Panteli, W Borkowski, M Dmowski · 31 authors

Since the successful transition to a freely elected parliament and a market economy after 1989, Poland is now a stable democracy and is well represented within political and economic organizations in Europe and worldwide. The strongly centralized health system based on the Semashko model was replaced with a decentralized system of mandatory health insurance, complemented with financing from state and territorial self-government budgets. There is a clear separation of health care financing and provision: the National Health Fund (NFZ) the sole payer in the system is in charge of health care financing and contracts with public and non-public health care providers. The Ministry of Health is the key policy-maker and regulator in the system and is supported by a number of advisory bodies, some of them recently established. Health insurance contributions, borne entirely by employees, are collected by intermediary institutions and are pooled by the NFZ and distributed between the 16 regional NFZ branches. In 2009, Poland spent 7.4% of its gross domestic product (GDP) on health. Around 70% of health expenditure came from public sources and over 83.5% of this expenditure can be attributed to the (near) universal health insurance. The relatively high share of private expenditure is mostly represented by out-of-pocket (OOP) payments, mainly in the form of co-payments and informal payments. Voluntary health insurance (VHI) does not play an important role and is largely limited to medical subscription packages offered by employers. Compulsory health insurance covers 98% of the population and guarantees access to a broad range of health services. However, the limited financial resources of the NFZ mean that broad entitlements guaranteed on paper are not always available. Health care financing is overall at most proportional: while financing from health care contributions is proportional and budgetary subsidies to system funding are progressive, high OOP expenditures, particularly in areas such as pharmaceuticals, are highly regressive. The health status of the Polish population has improved substantially, with average life expectancy at birth reaching 80.2 years for women and 71.6 years for men in 2009. However, there is still a vast gap in life expectancy between Poland and the western European Union (EU) countries and between life expectancy overall and the expected number of years without illness or disability. Given its modest financial, human and material health care resources and the corresponding outcomes, the overall financial efficiency of the Polish system is satisfactory. Both allocative and technical efficiency leave room for improvement. Several measures, such as prioritizing primary care and adopting new payment mechanisms such as diagnosis-related groups (DRGs), have been introduced in recent years but need to be expanded to other areas and intensified. Additionally, numerous initiatives to enhance quality control and build the required expertise and evidence base for the system are also in place. These could improve general satisfaction with the system, which is not particularly high. Limited resources, a general aversion to cost-sharing stemming from a long experience with broad public coverage and shortages in health workforce need to be addressed before better outcomes can be achieved by the system. Increased cooperation between various bodies within the health and social care sectors would also contribute in this direction. The HiT profiles are country-based reports that provide a detailed description of a health system and of policy initiatives in progress or under development. HiTs examine different approaches to the organization, financing and delivery of health services, and the role of the main actors in health systems; they describe the institutional framework, process, content and implementation of health and health care policies; and highlight challenges and areas that require more in-depth analysis.

Per Hjerpe, Henrik Ohlsson, Ulf Lindblad, Kristina Bengtsson Boström · 5 authors

No abstract is available for this record.

Rini Sasanti Handayani, Max Joseph Herman, Selma Siahaan

Background: Since decentralization era the health budgets including drug budget has been allocated into the development regional budget through formula-based DAU, based on regional revenues and fiscal needs. Health budget is included in DAU, though not explicitly stated. Therefore the health sector practically has to strive for their own budget in every province or every district. This is a new kind of phenomenon for regional governments especially related to the health sector. They should have strategic plan in financing while competing with other sectors to obtain it. Drug consumption in Indonesia is lower than in other ASEAN countries. To ensure access to drugs in primary heath care, the government (Ditjen Bina Farmasi dan Alkes) in the mid-year of 2003 in collaboration with WHO has facilitated a meeting among districts. This meeting leads to an agreement that the regional government should allocate Rp5.000,00 per capita annually for drug budget. Methods: A cross sectional descriptive study was done in ten districts in Indonesia in the year of 2006 on how far the realization of the district agreement of drug budget allocation, particularly in relation with improving drug access issues. District Health Office and Drug Management Unit were taken as samples and data were collected by structured interviews. Results: 1) Drug budget for most districts/cities is still less than Rp5.000,00 per capita per annum so that it can be assumed a shortage in terms of kind of, as well as, quantity of drugs. 2) Some districts showed an increase in drug budget, while the other ones showed just the opposite. 3) Not all districts had all essential and/or generic drug procurement. Conclusion: We suggest more intensive socializations for drug financing to districts in order to improve the commitment to the agreement on the allocation of drug budget and, secondly, a better technical training with topics: planning, advocacy and negotiation with relevant stakeholders. Key words: drug financing, drug budget, districts/cities

Anthony S. Chen, Margaret Weir

Why do the states seem to be pursuing different types of policy innovation in their health reform? Why so some seem to follow a "solidarity principle," while others seem guided by a commitment to "actuarial fairness"? Our analysis highlights the reciprocal influence of stakeholder mobilization and public policy over time. We find that early policy choices about how to achieve cost containment led the states down different paths of reform. In the 1970s and 1980s, states that featured oligopolistic or near-monopolistic markets for private insurance (usually dominated by Blue Cross) and strong urban-academic hospitals tended to adopt regulatory strategies for cost containment that led to broader forms of pooling and financing the costs of health risks--which subsequently positioned them to pursue major, solidaristic reform on favorable terms. On the other hand, states with competitive markets for private insurance and weak, decentralized hospitals tended to adopt market-based strategies for cost containment that led to the hypersegmentation of risk and the uneven financing of costs--thereby encouraging the proliferation of incremental policies that reinforce the principle of actuarial fairness. We illustrate our analysis with a brief comparison of Massachusetts and California, and we conclude with some thoughts on what our findings imply for the federal role in catalyzing health reform.

Daniel Simonet

Abstract: This article analyses the dynamics of health‐care reforms in Germany, the U.K., Switzerland, France and Italy. In light of the “New Public Management” (NPM) theory, the author discusses governments' attempts at providing better health‐care services for less. Health‐care reforms inspired by NPM meant opening up to competition and revamping service provision to improve organizational performance. These reforms also put the emphasis on outcomes measurements to improve insurers and providers' accountability, demanded greater decentralization of the decision‐making process (e.g., planning, investment and financing of health‐care services), and encouraged contracting‐out of public services and partnerships between the public and the private sector. While most features of the NPM theory were applicable to EU health‐care reforms, NPM was not a panacea: it advanced at different paces across nations, with some aspects of NPM being more appropriate in some countries but less so in others. It led to greater inequity and more bureaucracy in some, but not all, countries. Competition, a major characteristic of the NPM, did not necessarily lead to better health outcomes, and, unlike in other sectors, the application of NPM in health care meant larger providers (e.g., insurers, hospitals) and regulations have remained strong. Sommaire: Le présent article analyse la dynamique des réformes des soins de santé en Allemagne, au Royaume‐Uni, en Suisse, en France et en Italie. À la lumière de la théorie de la « Nouvelle administration publique » (NAP), l'auteur discute des tentatives menées par les gouvernements pour fournir de meilleurs services de soins de santéà un moindre coût. Les réformes des soins de santé inspirées par la NAP ont signifié l'ouverture à la concurrence et la réorganisation de la prestation des services pour améliorer la performance organisationnelle. Ces réformes ont également mis l'accent sur les mesures des résultats afin d'améliorer l'imputabilité des assureurs et des fournisseurs, ont exigé une plus grande décentralisation du processus de prise de décision (p. ex., planification, investissement, et financement des services de soins de santé), et ont encouragé la sous‐traitance des services publics et la formation de partenariats entre les secteurs public et privé. Alors que la plupart des éléments de la théorie de la NAP étaient applicables aux réformes des soins de santé de l'UE, la NAP n'a pas été la panacée : elle a progresséà des rythmes différents suivant les pays, certains aspects de la NAP étant plus appropriés dans certains pays que dans d'autres. Cela a entraîné une plus grande iniquité et plus de bureaucratie dans certains pays. La concurrence, une caractéristique importante de la NAP, n'a pas nécessairement entraîné de meilleurs résultats pour la santé et, à la différence d'autres secteurs, l'application de la NAP aux soins de santé a signifié de plus importants fournisseurs (p. ex., assureurs, hôpitaux) et le maintien de règlements solides.

José R. Repullo, José Manuel Freire

El Sistema Nacional de Salud (SNS) presenta una compleja situación de equilibrio, que aunque puede ser satisfactorio a corto plazo, plantea grandes problemas de sostenibilidad y gobernabilidad; el incierto balance del proceso de descentralización sanitaria en España señala claramente la senda de buscar nuevas alternativas organizativas para hacer efectivas las ventajas de la descentralización, a la vez que ser capaces de aprovechar las economías del sistema y conseguir la equidad pretendida. Se proponen cuatro líneas de actuación: redefinición del SNS en torno al aseguramiento público y derecho cívico igual para todos; replanteamiento del sistema de financiación y del papel del fondo de cohesión; redefinir el papel del gobierno central y el Ministerio de Sanidad, y crear un nuevo organismo, la Agencia del SNS con un Comisionado que de soporte organizativo e identidad al SNS como ámbito de acción cooperativa. The Spanish National Health System (SNHS) is currently in a complex equilibrium which, even if acceptable in the short term, faces major sustainability and governance challenges; the so far inconclusive outcome of the SNHS decentralization process clearly underlines the importance of seeking new alternatives to effectively bring about the real benefits of decentralization, while taking advantage of the system's economies of scale and achieving its equity objectives. To this end, four lines of action are proposed in this paper: first, redefine the SNHS based on universal public coverage, as a civic right and equal for all; second, reframe the financing system and the role of the Cohesion Fund; third, review the role of central government and its Ministry of Health, and fourth, create of a SNHS Agency headed by a Commissioner, for providing an organizational framework and identity for the SNHS, and serving as the cooperative body of the seventeen Autonomous Communities’ Health Services.

Ulrike Neumann, Anja Hagen, Matthias P. Schönermark

Because great interest in an efficient range of effective medicinal innovations and achievements has arisen, many countries have introduced procedures to regulate the adoption of innovative non-medicinal technologies into the benefit catalogue of solidly financed health care insurances. With this as a background, this report will describe procedures for the adoption of innovative non-medicinal technologies by solidly financed health care insurances in Germany, England, Australia and Switzerland. This report was commissioned by the German Agency for Health Technology Assessment at the German Institute for Medical Documentation and Information.In order to find the relevant literature and information, systematic literature research, a hand search and a written survey were carried out. All the selected documents (chosen according to defined criteria for inclusion and exclusion) were qualitatively evaluated, summarized and presented on a chart using a framework developed for this purpose. All the countries in this report require that some innovative non-medicinal technologies undergo evaluation by a central governing body. This evaluation is a prerequisite for adoption into the benefit catalogue. The process of evaluation can differ (e. g. the people and institutions concerned, the division of the synthesis of evidence and overall evaluation, processing the evidence). Similarities do exist, such as the size and composition of the governing bodies or the overreaching criteria according to which institutions must make their recommendations. This is how all the countries examined in this report determine how the benefits and effectiveness of the innovations, as well as their cost-effectiveness, can be chosen as criteria for the evaluation. Furthermore, there are many criteria which differ from country to country (social and ethical aspects, possible effects on the health system, etc.) and which are also relevant to an evaluation. The preferred types of clinical studies for these evaluations are randomized controlled trials. However, all institutions do allow for other types of evidence (e. g. expert opinion) when no other study types of a higher evidence level are available. In addition, all the countries are willing to allow unpublished or confidential information (e. g. from manufacturers) to be included in an evaluation. It is important to remember that the decisions made by the central governing bodies do not necessarily become conditions for the introduction of innovative non-medicinal technologies. There is a host of other requirements which determine how these innovations can be introduced. This means that a large number of non-medicinal technologies make it into the medical care system via these other decision-making processes. Often, these innovations are unevaluated and differ from region to region. Every country has established a system of observation and registration for medicinal products. These systems are meant to document any incidents with the innovations and to confer responsibility on certain organizations. All in all, no country has a central authority which systematically investigates the effects of newly introduced innovative non-medicinal technologies on medical care in general. However, Australia and England both carry out a review of innovations in some areas (e. g. by means of special commissions). In principle, the starting point for improving regulations of innovative non-medicinal technologies lies in the extension of transparency, the shortening of decision-making time (especially the central decision-making processes), the further development of evaluation methods, more flexibility and increased capacity in the governing bodies' decision-making processes and also, if needed, in the creation of a single authority to act as contact for people who are interested in introducing an innovation into the benefit catalogue.More research is required, especially in the area of decentralized decision-makers and how they actually decide whether or not to introduce innovative technologies into the core care system (methods, criteria, etc.). In view of this, it would also be interesting to see how the application of innovations actually happens in practice once their adoption has been approved by the corresponding governing bodies.