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The dynamics of drug launch has been an under-researched area, especially in the context of developing countries, which have diverse disease profiles and weaker forms of regulation compared to developed countries. A limited set of studies, undertaken in recent years, on the diffusion of new drugs in developing countries indeed conjectures the importance of these factors in shaping drug launch dynamics. Taking a survival analysis approach, we investigate the delay of new drug launch in India for drugs launched in the German market during 1990-2004, when, due to weak intellectual property rights (IPR), not only the innovators but also domestic firms could launch new drug molecules in the country. The paper makes an attempt to distinguish between the commercial success of a new drug and its innovativeness. We find little association between these two characteristics of a drug. Also, the influence of global commercial success in shortening delay is much stronger than that of innovativeness. The study also finds interesting results for the threat of imposition of a strong IPR system, market structure and first mover advantages. Policy implications are discussed briefly.

Over the last decades, methods for the economic evaluation of health care technologies were increasingly used to inform reimbursement decisions. For a short time, the German Statutory Health Insurance makes use of these methods to support reimbursement decisions on patented drugs. In this context, the discounting procedure emerges as a critical component of these methods, as discount rates can strongly affect the resulting incremental cost-effectiveness ratios. The aim of this paper is to identify the appropriate value of a social discount rate to be used by the German Statutory Health Insurance for the economic evaluation of health technologies. On theoretical grounds, we build on the widespread view of contemporary economists that the social rate of time preference (SRTP) is the adequate social discount rate. For quantifying the SRTP, we first apply the market behaviour approach, which assumes that the SRTP is reflected in observable market interest rates. As a second approach, we derive the SRTP from optimal growth theory by using the Ramsey equation. A major part of the paper is devoted to specify the parameters of this equation. Depending on various assumptions, our empirical findings result in the range of 1.75-4.2% for the SRTP. A reasonable base case discount rate for Germany, thus, would be about 3%. Furthermore, we deal with the much debated question whether a common discount rate for costs and health benefits or a lower rate for health should be applied in health economic evaluations. In the German social health insurance system, no exogenously fixed budget constraint does exist. When evaluating a new health technology, the health care decision maker is obliged to conduct an economic evaluation in order to examine whether there is an economically appropriate relation between the value of the health gains and the additional costs which are given by the value of the consumption losses due to the additional health care expenditures. Therefore, a discount rate lower than the SRTP for consumption should be applied if an increase in the consumption value of health is expected. However, given the limited empirical evidence on the relationship between consumption and the value of health, it is hardly possible to make reliable forecasts of this value. Regarding the practice of the German evaluation authority, it is not recommended to use differential discounting in the base case. Instead, the issue of differential discounting should be addressed in sensitivity analyses. Reducing the discount rate for health compared to the rate for costs by a figure in the range between near 0% and 3% may be considered to be appropriate for Germany.

This paper shows that patients with private health insurance (PHI) are being offered significantly shorter waiting times than patients with statutory health insurance (SHI) in German acute hospital care. This behavior may be driven by the higher expected profitability of PHI relative to SHI holders. Further, we find that hospitals offering private insurees shorter waiting times when compared with SHI holders have a significantly better financial performance than those abstaining from or with less discrimination.

This is a comment on a recent paper by Bengt Liljas (Eur J Health Econ 11:5-13, 2010) in this Journal. The author's analysis is flawed because he fails to take the envelope theorem into account. As a bottom line, we conclude that from a welfare theoretic point of view, future consumption and future labor hours should not be considered in a valid CEA.

This paper analyses the effect of the onset of disability on the well-being of individuals. In particular, we are interested in studying whether people can adapt to disability over time after its onset. Using longitudinal data from the German Socio-Economic Panel (GSOEP) for the period 1984-2006, we estimate life satisfaction equations using a fixed-effects model for working-age males (aged 21-58). The results show that disability has a significant negative effect on life satisfaction, but, in time, hedonic adaptation will return disabled males to life satisfaction levels registered by those who have not become disabled. These findings contribute to supporting the idea within psychology literature that individuals bounce back from painful events or adversities (such as the onset of disability) to achieve initial life satisfaction scores.

The potential of secondary prevention measures, such as cancer screening, to produce cost savings in the healthcare sector is a controversial issue in healthcare economics. Potential savings are calculated by comparing treatment costs with the cost of a prevention program. When survivors' subsequent unrelated health care costs are included in the calculation, however, the overall cost of disease prevention rises. What have not been studied to date are the secondary effects of fatal disease prevention measures on social security systems. From the perspective of a policy maker responsible for a social security system budget, it is not only future healthcare costs that are relevant for budgeting, but also changes in the contributions to, and expenditures from, statutory pension insurance and health insurance systems. An examination of the effect of longer life expectancies on these insurance systems can be justified by the fact that European social security systems are regulated by the state, and there is no clear separation between the financing of individual insurance systems due to cross-subsidisation. This paper looks at how the results of cost-comparison analyses vary depending on the inclusion or exclusion of future healthcare and non-healthcare costs, using the example of colorectal cancer screening in the German general population. In contrast to previous studies, not only are future unrelated medical costs considered, but also the effects on the social security system. If a German colorectal cancer screening program were implemented, and unrelated future medical care were excluded from the cost-benefit analysis, savings of up to 548 million euros per year would be expected. The screening program would, at the same time, generate costs in the healthcare sector as well as in the social security system of 2,037 million euros per year. Because the amount of future contributions and expenditures in the social security system depends on the age and gender of the recipients of the screening program (i.e. survivors of a typically fatal condition), the impact of age and gender on the results of a cost-comparison analysis of colorectal cancer screening are presented and discussed. Our study shows that colorectal cancer screening generates individual cost savings in the social security system up to a life expectancy of 60 years. Beyond that age, the balance between a recipient's social security contributions and insurance system expenditure is negative. The paper clarifies the relevance of healthcare costs not related to the prevented disease to the economic evaluation of prevention programs, particularly in the case of fatal diseases such as colorectal cancer. The results of the study imply that, from an economic perspective, the participation of at-risk individuals in disease prevention programs should be promoted.

This paper provides an overview of cancer management, particularly with respect to colorectal cancer (CRC), in Germany. The information presented reflects findings from the peer-review literature and government documentation, as well as interviews with cancer and CRC specialists. Topics such as epidemiology, expenditure, CRC screening, pharmaceutical and non-pharmaceutical treatment are discussed in this paper. Furthermore, insights into the German reimbursement system with regard to cancer management as well as regulatory aspects are presented.

The Federal Joint Committee (FJC; Gemeinsamer Bundesausschuss, G-BA) defines the health-care elements that are to be reimbursed by sickness funds. To define a directive, the FJC can commission benefit assessments, which provide an overview of the scientific evidence regarding the efficacy and benefits of an intervention. This paper describes the operational implementation of the legal requirements with regard to the benefit assessments of medicines. Such benefit assessments are sometimes referred to as "isolated benefit assessments," to distinguish them from benefit assessments as part of a full economic evaluation.The FJC has the freedom to commission these assessments from any agency; however, to date the majority have commissioned the Institute for Quality and Efficiency in Health Care (IQWiG). Nevertheless, the content of this paper applies integrally to any institute commissioned for such assessments. In this report, 'the institute' is used when the text refers to any of these institutes.The legal framework for benefit assessments is laid out in the German Social Code Book version V ( http://www.sozialgesetzbuch.de ), Sects. 35b ( section 1), 139a ( section 4-6) and Sect. 139b ( section 3). It is specified that: The institute must guarantee high transparency. The institute must provide appropriate participation of relevant parties for the commission-related development of assessments, and opportunity for comment on all important segments of the assessment procedure. The institute has to report on the progress and results of the work at regular intervals. The institute is held to giving the commission to external experts. Based on the legal framework, the institute must guarantee a high procedural transparency. Transparency of the whole process should be achieved, which is evidenced by clear reporting of procedures and criteria in all phases undertaken in the benefit assessment. The most important means of enhancing transparency are: 1. To implement a scoping process to support the development of the research question. 2. To separate the work of the external experts performing the evidence assessment from that of the institute formulating recommendations. Therefore, the preliminary report as produced by external experts needs to be public, and published separately from any subsequent amendments or (draft-)reports made by the institute, which includes the institute's recommendations. 3. To implement open peer review by publishing both the comments of the reviewers and their names. Based on the legal framework, the institute must provide for adequate participation of relevant parties. These include organisations representing the interests of patients; experts of medical, pharmaceutical and health economic science and practice; the professional organisations of pharmacists and pharmaceutical companies; and experts on alternative therapies. Patients and health care professionals bring in new insights with respect to research priorities, treatment and outcomes.The relevant parties should be identified and contacted whenever the global scope of the assessment has been drafted. Subsequently, the relevant parties should be involved in defining the research question, developing the protocol and commenting on the preliminary report. To implement the involvement of relevant parties in defining the research question a scoping process is suggested. For the other phases, written comments followed by an oral discussion should be used. Finally, the relevant parties should have the right to appeal the final decision on judicial grounds. None of these steps mean that the institute would lose any part of its scientific independence.From the relevant sections of the legal framework with respect to the assessment methods, it can be concluded that: 1. The institute must ensure that the assessment is made in accordance with internationally recognised standards of evidence-based medicine (EBM). 2. The assessment is conducted in comparison with other medicines and treatment forms under consideration of the additional therapeutic benefit for the patients. 3. The minimum criteria for assessing patient benefit are improvements in the state of health, shortening the duration of illness, extension of the duration of life, reduction of side effects and improvements in quality of life. EBM refers to the application of the best available evidence to answer a research question, which can inform questions about the care of patients. The optimal design, even for effectiveness questions, is not always the randomised, controlled trial (RCT) but depends on the research question and the outcomes of interest. To increase transparency for each question, the levels of evidence examined should be made explicit. There is no empirical evidence to support the use of cutoff points with respect to the number of studies before making recommendations. To get the best available evidence for the research question(s), all relevant evidence should be considered for each question, and the best available evidence should be used to answer the question. Separate levels of evidence may have to be used for each outcome.There are many ways in which bias can be introduced in systematic reviews. Some types of bias can be prevented, other types can only be reported and, for some, the influence of the bias can be investigated. Reviews must show that potential sources of bias have been dealt with adequately.Methods used by other agencies that perform benefit assessments are useful to interpret the term 'international standards' to which the institute must comply. The National Institute for Health and Clinical Excellence (NICE) is a good example in this respect. NICE shows that it is possible to have transparent procedures for benefit assessments but that this requires detailed documentation. NICE has implemented an open procedure with respect to the comments of reviewers, which makes the procedure transparent. Although the Institute for Quality and Efficiency in Health Care (IQWiG) in Germany invites comments on their protocol and preliminary report by posting them on their website, and comments are made public, the individual comments are not evaluated openly, and therefore it remains uncertain whether or not they lead to changes in the reports. The participation of relevant parties in the assessment process as implemented by NICE guarantees a process that is transparent to all relevant parties.Transparency of the whole process is assured by clear reporting of procedures and criteria in all phases undertaken in the benefit assessment. In a scoping process, a draft scope is commented on first in writing and subsequently in the form of a scoping workshop. In this way, all relevant aspects can be heard and included in the final scope. The protocol is then developed, followed by evidence assessment. The methods used should be completely reported to show readers that the assessment has been performed with scientific rigour and that bias has been prevented where possible. All relevant parties should have the opportunity to comment on the draft protocol and the draft preliminary report. Each comment should be evaluated as to whether or not it will lead to changes, and both the comments and the evaluation should be made public to ensure transparency of this process. The same procedure should be used for the peer-review phase. Based on the final report of the evidence assessment, the institute forms recommendations and the FJC appraises the evidence.During the writing of the final report, a separation between the evidence assessment and the evidence-appraisal phase should be implemented. Ideally, this separation should be legally enforced to prevent any confusion about conflict of interests.Such a process guarantees a feasible combination of the legal requirements for transparency and involvement of relevant parties with international standards of EBM to ensure that the benefit assessments of medicines in Germany are performed according to the highest standards.

The aim of this methodological paper is to summarize evidence on how to implement cost-benefit assessment according to the new German legislative framework (Competition Enhancement Act). Given the complexity of existing health policy frameworks within industrialised countries in adapting health economics in their respective regulatory scheme, no clear international scientific consensus on which health economic methods should be chosen for assessment can be determined. Nevertheless, a broad consensus on the internal properties of methods itself can be found. Based on these common international standards in methodology, this work provides a minimum catalogue of methods and criteria that meet legal and local German requirements with regard to specific factors of its health care system. Aside from categorising clearly defined standards (e.g., study forms, cost and benefit categories) the suggested catalogue specifies some intensively debated areas in Germany (e.g., the QALY, modelling, the perspective used in the assessment). After the proposition of certain methods the paper leads to a first recommendation of a detailed assessment-process itself specific for the German way in implementing cost-benefit ratios within regulatory decision making in Germany.

This article reports about the internet based, second multicenter study (MCS II) of the spine study group (AG WS) of the German trauma association (DGU). It represents a continuation of the first study conducted between the years 1994 and 1996 (MCS I). For the purpose of one common, centralised data capture methodology, a newly developed internet-based data collection system ( http://www.memdoc.org ) of the Institute for Evaluative Research in Orthopaedic Surgery of the University of Bern was used. The aim of this first publication on the MCS II was to describe in detail the new method of data collection and the structure of the developed data base system, via internet. The goal of the study was the assessment of the current state of treatment for fresh traumatic injuries of the thoracolumbar spine in the German speaking part of Europe. For that reason, we intended to collect large number of cases and representative, valid information about the radiographic, clinical and subjective treatment outcomes. Thanks to the new study design of MCS II, not only the common surgical treatment concepts, but also the new and constantly broadening spectrum of spine surgery, i.e. vertebro-/kyphoplasty, computer assisted surgery and navigation, minimal-invasive, and endoscopic techniques, documented and evaluated. We present a first statistical overview and preliminary analysis of 18 centers from Germany and Austria that participated in MCS II. A real time data capture at source was made possible by the constant availability of the data collection system via internet access. Following the principle of an application service provider, software, questionnaires and validation routines are located on a central server, which is accessed from the periphery (hospitals) by means of standard Internet browsers. By that, costly and time consuming software installation and maintenance of local data repositories are avoided and, more importantly, cumbersome migration of data into one integrated database becomes obsolete. Finally, this set-up also replaces traditional systems wherein paper questionnaires were mailed to the central study office and entered by hand whereby incomplete or incorrect forms always represent a resource consuming problem and source of error. With the new study concept and the expanded inclusion criteria of MCS II 1, 251 case histories with admission and surgical data were collected. This remarkable number of interventions documented during 24 months represents an increase of 183% compared to the previously conducted MCS I. The concept and technical feasibility of the MEMdoc data collection system was proven, as the participants of the MCS II succeeded in collecting data ever published on the largest series of patients with spinal injuries treated within a 2 year period.