Statutory System Research Articles

헌법상 대학의 자유 제고의 관점에서 본 사립대학의 재산운영 규제법제의 문제점에 대한 소고 - 교육용 기본재산의 임대사업 활용가능성에 관한 논의를 중심으로 -

헌법재판소는 학문의 자유를 실현하기 위한 기본권으로서의 대학의 자율권의 중요성을 인정하면서도 국가는 헌법 제31조 제6항에 따라 학교제도에 관한 전반적인 형성권과 규율권을 부여받았다고 할 수 있으며, 그 규율의 정도는 그 시대와 각급 학교에 따라 달라질 것이나, 교육의 본질을 침해하지 않는 한 궁극적으로는 입법권자의 형성의 자유에 속하는 것이라 하여 학문의 자유와 대학의 자치의 기본권적 측면을 과소평가하고 있다. 대학제도의 형성에 대한 입법자의 형성권은 “입법자에게 대학제도에 관한 입법형성의 자유가 있다고 하더라도 그것은 ”학문의 자유와 대학의 자치를 강화하기 위한 것“이라는 목적의 구속 안에 있다. 대학의 자유 및 재산권에 대한 제한은 법률에 근거하여야 하며, 그 법률은 보충성의 원칙을 비롯한 헌법의 기본원칙과 명확한 법률유보, 기본권 제한의 한계인 과잉금지원칙을 준수하여야 함은 당연하다. 물론 사회연관성이 더 큰 기본권의 경우 입법자의 기본권 제한 법률 형성에 있어서의 재량이 더 커질 것이다. 따라서 대학의 자유의 목적인 학문과 연구, 교수의 자유와 어느 정도 상거한 대학의 재정운영과 관련하여서는 입법형성권이 더 커질 여지가 있지만, 자율적인 재정운영을 포함한 대학의 자치는 결국 학문의 자유의 핵심인 연구와 교수의 자유 부분에 필수불가결한 전제로서 작용한다. 헌법재판소가 판단한 것과 같이 입법자에게 대학자치의 구체적 형성에 있어서 광범위한 재량이 허용된다고 하더라도, 대학의 자유는 헌법 제22조와의 연관성 안에서 이해되고, 이 목적을 실현하기 위하여 구체화되어야 한다. 만약 입법자가 교육용 기본재산을 이용하여 임대사업을 하는 것을 허용하고자 한다면, 사립학교법 또는 적어도 하위법령의 개정을 통해서 그 허용여부와 범위, 한계에 대한 내용이 법령에 마련될 필요가 있다. 사립학교관계법령에서 이를 통하여 가능한 수익사업의 범위와 내용을 명확히 하는 것뿐만 아니라 일선 지방자치단체의 과세 및 건축법 등 다른 법규와 충돌 문제와 관련하여서도 제·개정 등 법규의 정비가 필요하다. 사립대학의 재산에 관하여 여러 법령에 흩어져 있는 규정도 상위법에서 통일하여 규정할 필요가 있다. 교육의 공공성 및 사립대학에 대한 국가의 재정지원이 국가의 포괄적인 감독과 통제권한을 정당화한다고 할 수 있으나 사립대학에 대한 방대하고 산만한 법적 규제와 불명확성, 그에 기인한 주무관청의 거시적, 미시적 규제는 대학의 자유를 저해하고 있다. 대학에 대한 국가의 과도한 규제는 대학의 자율성을 침해하고, 대학을 통하여 민주국가가 얻을 수 있고 지향하는 다양성과 진리의 추구, 창의적인 인재 양성, 자유와 발전을 불가능하게 하거나 더디게 할 것이다.

'What about Me? It Isn't Fair': The Mantra of Queensland Bodies Corporate in the Management and Letting Rights Sphere — An Investigation into the Limited Statutory Termination Rights

Multi-owned properties are an increasingly popular housing product in Australia. With the growth, a supporting industry has flourished, particularly in Queensland. Management and letting rights ('MLR'), as the arrangement is colloquially known, facilitates the provision of caretaking services to the community titles scheme ('CTS') and letting services for investment owners. With the growth of MLR, the Body Corporate and Community Management Act 1997 (Qld) ('BCCM Act') and regulation modules have been progressively amended to increase protections for MLR contractors and their financiers. This article reviews the MLR-related literature and concludes that the interests of both lot owners and the CTS governing body (the body corporate) have been subjugated to the commercial imperatives of the original owner, the MLR contractor and financiers. Key court and tribunal decisions are analysed to demonstrate a high threshold before the body corporate may validly terminate MLR arrangements. Consequently, the embedded statutory protections may trap a body corporate into inappropriate or undesirable contractual arrangements created and sold by the original owner before its establishment. Arguably, the BCCM Act has failed in its secondary consumer protection objective when bodies corporate are bound in the long-term by a statutory system designed to protect others.

Statutory Assessment for Special Educational Needs and the Warnock Report; the First 40 Years

The Warnock report ‘Special Educational Needs’ (Warnock 1978) provided the catalyst for an enduring framework of individual statutory assessment in England for children and young people (CYP) with Special Educational Needs (SEN). . Through its implementation in the Education Act 1981, consolidated in the Education Act 1966, the report established the overall SEN framework in England for last 40 years; laying the foundation for statements of SEN and more recently Education Health and Care Plans (EHCPs). The underlying legal structure created by Warnock has been reinforced rather than changed with the introduction of the Children and Families Act 2014. However by establishing rights to specified levels of resources, at the level of individual provision, the Warnock framework has risked undermining adequate provision and parental confidence in Special Educational Needs and Disability (SEND) provision overall-a central paradox of the SEND framework. This paper considers the consequences of an over reliance on statutory assessment to secure provision, the extent to which it skews resources within the system to one group of children and is therefore in danger of undermining the overall objectives of the current SEND reforms. However it is difficult to reform the statutory system without creating greater parental confidence in the non-statutory offer. While additional legislation to strengthen the SEND framework is desirable the Government could address the overreliance on statutory assessment by a more rigorous implementation of current legislation linked to reforms in funding, accountability and a renewed focus on the Equality Act 2010 provisions on SEND. This would entail the Government being willing to support a more rights based and less market led approach in schools and other settings and introduce strategies to reduce the reliance on statutory assessment in favor of ensuring the education system could routinely meet more CYPs needs. The conclusions are focused on the English system of SEND but the solutions are of relevance for other SEND assessment and funding models which are also considered.

Wielopostaciowość administracji publicznej w zakresie zarządzania kryzysowego

The paper presents the multiformity of public administration in crisis management from the subjective and material points of view. The provisions contained in the Act of 26 April 2007 on crisis management were analyzed. The act implies that the authorities of the general government and the local government at the level of the municipality and the district also are the crisis management authorities, and together with the subsidiary bodies create a specific system of public administration in this area. At the same time, it was pointed out that the statutory system of organs was incomplete, because in the crisis situations, specialist services (Police, State F ire Brigade, Army) and non-governmental organizations play a vital role. This multidimensionality allows distinguishing two groups of entities in crisis management: crisis management bodies and entities that perform tasks in crisis situations. In addition, the multiform nature of public administration in crisis management is evident in the presentation of this management in a material way: action preparation, civilian planning, risk prevention, fighting, reintegration.

Cost effectiveness of bilateral risk-reducing mastectomy and salpingo-oophorectomy

BackgroundGrowing demand for risk-reducing surgery in individuals with inherited susceptibility to cancer leads to the question whether these procedures are cost effective for the executing hospitals. This study compared the clinical costs for bilateral risk-reducing mastectomy (BRRM) with and without different types of reconstruction, risk-reducing salpingo-oophorectomy (RRSO), and their combinations with corresponding reimbursements in the statutory health-care system in Germany.Patients and methodsReal total costs of care for BRRM with and without reconstruction, RRSO, and their combinations were calculated as the sum of all personnel and technical costs. These costs calculated in a German University hospital were compared with the sum of all reimbursements in the German DRG-based health-care system.ResultsWhile sole RRSO, BRRM without reconstruction, and BRRM with secondary DIEP (deep inferior epigastric perforator)—reconstruction still result in a small benefit, we even found shortfalls for the hospital with all other prophylactic operations under consideration. The calculated deficits were especially high for BRRM with implant-based breast reconstruction and for combined operations when the risk reduction is achieved with a minimum of separate operations.ConclusionsRisk-reducing surgery in BRCA-mutation carriers is frequently not cost-covering for the executing hospitals in the German health-care system. Thus, appropriate concepts are required to ensure a nationwide care.

Reconciling human rights and customary law: legal pluralism in the governance of small-scale fisheries*

The Voluntary Guidelines for Securing Sustainable Small-Scale Fisheries (SSF Guidelines) introduce a human rights framework for fisheries management and development, suggesting an inclusive approach that embraces a range of rights, regimes and interests. These reflect diverse systems of law, values and norms, straddling both customary and statutory systems of governance and tenure. The interface between these different systems poses questions about the extent to which they are reconcilable with a human rights-based approach. The latter originates in the domain of transnational law, which has been increasing in scope and importance in recent decades. How transnational law interacts with and affects various law systems is an empirical question, to which much scholarly attention has gone. The normative question that emerges, however, is how to balance the recognition of universal human rights with respect for historically-evolved and locally legitimate, customary law in case of conflicts between them. This paper investigates some of the tensions and opportunities that arise in the meeting of the SSF Guidelines and customary socio-legal systems, paying special attention to four important fields of overlap and possibly contention: tenure, gender, child labour and markets. Co-management platforms are suggested to be the ideal meeting ground for negotiating acceptable hybrids and designing so-called interlegalities.

A Case For Simpler Gain Bifurcation for Real Estate Developers

This Article examines the judicially sanctioned bifurcation of real estate developers’ gain. The Article recognizes that even though some commentators oppose granting favorable tax treatment to capital gains, the law most likely will not change. With that in mind, the Article examines the all-or-nothing approach of characterizing gain from the sale of real estate as either capital gain or ordinary income. The Article rejects the all-or-nothing approach of characterizing income under the current statutory system. Instead, it embraces gain bifurcation in the second-best setting that taxes capital gains and ordinary income differently. Illustrating the policy justification for gain bifurcation and judicially sanctioned bifurcation structures, the Article recommends that lawmakers should more fully embrace gain bifurcation for real estate developers by creating a simple statutory election for bifurcating gain that would enhance equity, accuracy, and transparency of gain bifurcation. Although the Article limits its analysis to real estate developers, the idea of gain bifurcation, once improved in this area, could be a catalyst for exploring bifurcation in other areas.

Regulatory Issues on Raising Capital through Debentures by Public Companies in the United Kingdom

Nowadays, it is common for the loans to be aggregated as a lump sum, which is then advanced to the company by the trustees. In this situation, the lenders subscribe for debenture stock, sometimes called loan stock, out of the fund. As with shares, such stock forms part of the company’s securities, which can be traded in the Stock Exchange. The lenders might require security for their loans. In this situation, a company will charge its property to secure the loan. In light of the Companies Act 2006 of the United Kingdom, this paper will analyze the various mechanisms whereby public companies raise money through debentures and the regulatory consequences of doing so. The companies legislation requires certain particulars of the charge to be registered. Therefore, this paper aims to reflect on: (a) how public companies borrow its capital through debentures or debenture stock; (b) what types of charge the public companies could issue to lenders as security; (c) how to differentiate between fixed and floating charges. This paper will also examine the question of priority among competing creditors and inconsistent decisions of the court regarding fixed and floating charges. The objectives of this paper are to: describe the meaning of ‘debenture', discuss the dispute relating granting a fixed charge over book debts, sketch the priority of charges and the statutory listing system, describe the meaning of book debts, explain the character of and the differences between floating and fixed charges. This paper will provide recommendations that could be taken into consideration for future amendments of the Companies Act 2006.

Local government and coastal damage: confusion, potential and dreams

Purpose This paper aims to not only disentangle the recently altered law and policy on coastal management in New South Wales (NSW), Australia, but also raise opportunities for fresh ideas to develop when dealing with both existing and future coastal damage. The focus is on the role of local government which is not only closer to concerned citizens but also faces costal damage on its own doorstep. Design/methodology/approach The paper explores the topic from the beginnings of relevant statutory law to the current situation, supported by a case study. It is transdisciplinary in nature, encompassing land use and coastal legislation. Findings The narrative encourages further attention to the key issues at the local level. This is underpinned by the need for planners to move beyond zoning and other restrictive mechanisms to more strategic approaches. All levels of government must recognise that regulatory planning on its own is insufficient. This leads to the need for champions to consider opportunities beyond the ordinary. Originality/value While this paper will add to a growing literature on coastal damage and action at the local level, its emphasis on the benefits and limitations of the changing statutory system will assist not only policy makers but professional officers at the local forefront.

We Are Going to Build a Wall and Institutional Legitimacy Will Pay For It

This paper will analyze President Trump’s use of the NEA and one of its accompanying statutes, the Military Construction Codification Act, to secure funding to build a border wall. More broadly, this paper aims to trace the complexities within the broader system of the NEA and its associated statutes (“the NEA+ Framework”) and to critique its redistribution of power between the political branches. Part I traces the history of the president’s national emergency powers from the early days of the Republic, through the events that led to the NEA+ Framework, to the current doctrine. Part II introduces the actual authority that President Trump has invoked to secure funding, one of the statutory grants of power accessible via the NEA. Part III examines the various challenges that await the Trump Administration working within the NEA+ Framework, including issues of justiciability, statutory construction, and constitutionality. Part IV looks not at legality of the specific actions within the NEA+ Framework, but at the statutory system itself as an unconstitutional delegation of legislative authority that perverts the separation of power principles fundamental to the United States Constitution.

Lessons from the Past: The Venetian Republic’s Tailoring of Patent Protection to the Characteristics of the Invention

In recent years, much discussion in patent law has revolved around granting tailored protection to provide better incentives to inventors in different industries and to increase patent quality. For example, the deliberations that led to the enactment of the Leahy-Smith America Invents Act (AIA) focused specifically on the role of the patent system in different industries as well as on modifying remedies and patent terms to reflect the needs of distinct technology sectors. Whereas in the literature there seems to be substantial agreement on the fact that tailored protection would be beneficial for the effectiveness of the patent system, there is no consensus with respect to which entity should be vested with the authority to produce tailored patent policies, standards and rules based on the needs of the various industries. Currently, the United States Court of Appeals for the Federal Circuit and the United States Patent and Trademark Office (USPTO) are the two principal candidates for this role. Some of this debate is connected to the broader issue in legal academia of granting general regulatory authority to administrative agencies with highly specialized knowledge. Contrary to other administrative agencies, such as the United States Environmental Protection Agency (EPA), the Securities and Exchange Commission (SEC) or the Occupational Safety and Health Administration (OSHA), Congress has never granted such authority to the USPTO; scholars have criticized this inconsistency. The strongest argument they have used to question the current status of the USPTO refers to the fact that much could be gained from the information that this agency has accumulated through years of experience working with inventors in different industries, particularly with respect to tailoring patent protection. Historically, the Venetian Republic provided tailored patent protection based on the characteristics of the invention. In that context, the entity entrusted with the power to tailor the protection granted in each case was the Senate, the issuing authority. Moreover, although the Venetian Republic enacted what is widely recognized as the first Patent Act in the world in 1474, the Venetian Senate continued its practice of granting tailored patents until the end of the Republic in 1797. In fact, as explained by Luigi Sordelli in 1974, following the enactment of the 1474 Act, inventors could obtain protection in Venice in two ways: through the newly created statutory system or through the much older customary system of senatorial grants. Conclusive evidence that Sordelli’s view was correct is provided in a separate paper that I co-authored with Ted Sichelman and Toni Veneri, in which we shed important new light on the true origin of patent law. In this article, I focus instead on tailoring patent protection. Specifically, I use original documents from the Venetian State Archives to present a detailed account of how the Venetian Republic used its customary patent system to tailor protection to the unique characteristics of an invention. Furthermore, I provide a full analysis of what can be learned from the Venetian experience to inform the modern debate on tailoring patent protection. Until now, only two other legal scholars have conducted extensive examinations of the original Venetian patents: Ted Sichelman and Sean O’Connor. The Venetian patent system appears to have been a very successful one; it operated for more than 300 years and during the 16th century helped Venice to transform itself from being a nation of sailors to being a nation of artisans and engineers, and ultimately the center of technological development in Europe. Thus, the Venetian customary patent system offers important lessons on how tailored patent protection and higher patent quality can be achieved. An accurate description of this system is crucial to further understanding the specific steps that we should take to reach these goals today.

Prospectus Liability and the Role of Gatekeepers as Informational Intermediaries: An Empirical Analysis of the Impact of the Statutory Provisions on Italian IPOs

This article analyzes market reaction to the introduction into Italian legislation of a statutory system of (IPO) prospectus civil liability enacted in April 2007 on the basis of Directive 2003/71/EC. In particular, we study the effects of the new regulation on gatekeepers, such as underwriters and auditors who are commonly qualified as information intermediaries. We analyse the effects on average underpricing, fees charged by the underwriters, syndicate composition and reputation, and auditor participation. Although we find only weak statistical evidence that the level of underpricing has increased after April 2007, there is a statistically significant tendency to have one of the Big Four auditors in post-April 2007 IPOs, with lower participation of international banks in syndication and sharing of prospectus liability. Moreover, after April 2007 we observe an increase in the reputation of the underwriters acting as responsabile del collocamento with lower underwriters’ fees charged.

Informing Social Work Practice with Theory: Reflections on the Protection of Aboriginal Children in Remote Communities of Australia

Abstract Recent reforms to the Australian child-protection sector have widened its scope from solely a statutory child-protection system to a public-health model to increase the number of agencies involved in the provision of services for children who are deemed ‘vulnerable’ or ‘at risk’. Nevertheless, the number of Aboriginal children in the sector continues to increase. This paper argues that the reflective basis of social work practice in Australia contains a lack that evades consideration of the ‘projective identifications’ informing practice. Social workers are more likely to achieve safety outcomes for children when such projections are acknowledged and tendered to in their reflective practice.

Wage Boards for the 21st Century: Revisiting Sectoral Standard-Setting Mechanisms for the Workplace

As existing labour relations and minimum standards regulatory systems have continued to struggle to ensure acceptable worker voice and workplace standards, attention has increasingly turned to whether broader-based or sectoral approaches can offer solutions. In the early 20th century, several countries established statutory systems of sector-based minimum workplace standard-setting as a response to unacceptable wages and working conditions. Key examples are the British Wages Council system, the Industrial Standards Act established in the Canadian province of Ontario, and the federal United States Fair Labor Standards Act. Although these three statutory systems arose out of broadly similar social and economic concerns, they reflect different conceptions or applications of tripartism, different perspectives on the role of voluntarism and collective representation and bargaining, and different approaches to sectoral workplace standard-setting. These systems also share important commonalities: all had roots in combatting sweated labour, characterized by fragmented and scattered workplaces and unacceptable remuneration and conditions of work, where – partly due to the characteristics of the work, workers and employers in these sectors – no voluntary collective negotiations could take root. These circumstances have clear parallels to today’s work and economy. This article examines these three systems, at the point at which each regime provided the most robust sectoral standard-setting procedure, as informative examples of a spectrum of approaches to tripartite sectoral workplace standard-setting. Out of this comparison, this article then offers some considerations for a modern approach to sectoral workplace standard-setting.

The Korean food franchise industry: Diverse development and conceptual definitions of a food safety managing body

AbstractFactors in the operation of diversified food franchises in Korea have a direct impact on food safety management. The body in charge of systemic food safety management must be clearly identified and provided with a statute‐based system governing all aspects of food safety management. Several types of Korean food franchise business operations were first defined and categorized. Factors related to each food franchise operation have a direct impact on determining the managing body and its responsibility and authority. Multiple Korean statutory systems are closely related to food safety management in each category of franchise operations. These legal systems cannot clearly define a food safety managing body, especially considering the newly emerging food franchise operation types: the master franchise, concession industry, and commercial facilities. These clues provide basic data for further reinforcement of the national statutory system. In ambiguous situations, food franchises can complement food safety management using their own tactics.Practical applicationsFoodservice businesses, especially franchises, are currently rapidly developing in Korea. Depending on the development history of these food franchises and their growth strategies, complex new types of franchises with different operating strategies are appearing. New entities have been involved in the establishment or operation of diverse food franchise types, such as master franchises or concession businesses. This has led to a lack of clarity in the identification of the food safety or food origin managing body. In fact, that body may not even exist, while in other contexts, there may be overlapping bodies. This is because the Korean statutory system that directly governs food safety and indirectly governs food franchise operations has gaps as a result of the fast‐paced changes in the food franchise industry. The statutory system in Korea stipulates duties required of a specific subject (either a type of seller or a business owner). However, the statutory system for the Korean food industry does not address the diverse forms of franchise operations and various operating entities (such as master franchisors, master franchisees and their unit stores, direct franchisors and their unit franchisee stores, operators of nonfood commercial facilities, operators of concession businesses, and others). This study contends that if this description of the situation is accurate, the food safety management system can be supplemented by the strategic or hygienic controls of each food franchise or through inter‐business‐contract management with multiple operational entities. This study also makes a case for amending the national statutory framework.

Licensing strategies and tasks for medical devices utilizing 3D printing technology in dentistry

3D printing technology supporting the specific patient medical services is actively being implemented in dentistry. The purpose of this study is to introduce the legal and institutional considerations to the medical practitioners in dentistry who must observe when they manufacture medical devices using 3D printers, and to provide a ways to activate and enhance their utilization in the domestic approval point of view for medical devices. Through the public data of government agencies and related organizations, the statutory system and compliance matters related to the manufacture of 3D printing medical devices have been examined and reviewed for the government's improvement efforts. Through the study, the government has been actively improving the system and making policy, but the active interest and participation of medical professionals and related workers are continually required to solve the problems which are scattered. 3D printing technology is expected to be more frequently utilized in the field of dentistry in near future. Therefore, it is essential to establish measures to improve the regulation through continuous cooperation with the related ministries with the long-term point of view enhancing smooth entry to the market for the medical devices by taking data from the continued research.

ТЕНДЕНЦІЙНІ НАПРЯМКИ РОЗВИТКУ ХОРОВОЇ ЛІТУРГІЙНОЇ ПРАКТИКИ В ГАЛИЧИНІ КІНЦЯ ХІХ ‒ ПЕРШОЇ ПОЛОВИНИ ХХ СТОЛІТЬ


 
 
 The article highlights trends in the development of choral liturgical practice in Galicia at the end of the nineteenth and the first half of the 20th century, which were formed on the basis of governmental innovations in the system of education and cathedral and church changes in Western Ukrainian lands. In this, the active role of numerous spiritual and secular choral ensembles had played an important role. At the same time, certain influence were played by touring groups, which, with the spiritual programs of works of the Dnieper-Dnieper composers, considerably deepened the evaluation criteria as the work of the Galician authors as well as the performing level of creative groups. All this testified to the need of Ukrainians in the spiritual cultural and artistic life, about comprehension of the essence of the ritual and chorister repertoire and the development of the national style of choral music. Confirmation of these processes was the spiritual choral heritage of the Galician composers of the late nineteenth and the first half of the twentieth century, represented in a wide genre variety. Thus, the article outlines the traditional and original author's approaches to the creation of liturgical music within the bounds of the statutory ritual system, the concept of «samolivka» and «jerusalimka» is illustrative for this period.
 
 

Interaction between possible selves and the resilience of care-leavers in South Africa

Although a future focus is recognized as a contributing factor to resilience, the content of future focus is seldom explored. Care-leavers in South Africa exit the statutory system and enter into adulthood largely unsupported. Their futures are hampered by limited preparation for leaving care, the absence of follow-up services and contextual factors such as high unemployment rates. Having a well-developed future focus may contribute to better outcomes for care-leavers. Drawing on data from a small qualitative study carried out in four child and youth care centres in a town in the Eastern Cape of South Africa, this article argues that possible selves methods provide a useful tool with which to unpack the content of future focus, and in doing so identify contributors to resilience. Study findings reveal a reciprocal interaction between possible selves and resilience: resilience enablers help to generate compelling possible selves, while possible selves lead to activities that promote resilience.

Hepatocellular carcinoma after prior sorafenib treatment: incidence, healthcare utilisation and costs from German statutory health insurance claims data

ObjectiveTo estimate both the number of patients with hepatocellular carcinoma (HCC) eligible annually for second-line therapy following sorafenib in Germany and the healthcare costs accrued by patients meeting eligibility criteria.MethodsPatients with an HCC diagnosis and one or more sorafenib prescription were identified from samples of > 3 million insured persons in each of 2012, 2013 and 2014 using the anonymised Betriebskrankenkasse health insurance scheme database. Incidence rates from 2013 were extrapolated to the German population using data from the statutory health insurance system database and Robert Koch Institute. Resource use and cost data were collected for a subset of patients with follow-up data post-sorafenib.ResultsBetween 1032 and 1484 patients with HCC in Germany (893–1390 publicly insured patients) were estimated as likely to be eligible for second-line therapy after sorafenib annually. For post-sorafenib analyses, 117 patients were identified with HCC, one or more sorafenib prescription and considered potentially eligible for second-line treatment, 15 of whom were alive after 12 months’ follow-up. Total mean costs per patient accrued in the 12 months after sorafenib treatment ended were €11,152 (hospital care, €6483 [58.1%]; outpatient prescriptions, €3137 [28.1%]).ConclusionThe estimated number of publicly insured HCC patients annually eligible for second-line therapy in Germany was < 1400 and mean total costs accrued in the year after completion of sorafenib therapy were approximately €11,000 per patient for the German statutory healthcare system. These estimates can be used when evaluating the budgetary impact of new second-line therapies for advanced HCC in Germany.

Evaluation of the statutory surveillance system for invasive MRSA infections in Germany, 2016\u20132017

BackgroundMandatory notification of invasive methicillin-resistant Staphylococcus aureus (MRSA) infections was introduced for laboratories in Germany in 2009. The aims were to support local health authorities (LHAs) in their mandate to prevent and control infections in hospitals and to improve population-based nationwide surveillance of healthcare associated infections. We evaluated the MRSA surveillance system to assess whether its aims were met and to identify areas for improvement.MethodsUsing the updated guidelines for evaluating public health surveillance systems by the Centers for Disease Control and Prevention we assessed the attributes simplicity, timeliness, data quality, acceptability, and usefulness. In 2016/2017 we interviewed staff in LHAs, state health authorities (SHAs), and laboratories and analyzed surveillance data of cases notified between 2009 and 2016.ResultsWe interviewed 10% of LHAs (n = 38), 63% of SHAs (n = 10), 5 selected laboratories and analyzed information on 27,706 notified MRSA cases. LHAs reported that on receiving notifications from laboratories they contacted hospitals for clinical information, which was time-consuming and complicated as physicians were hard to reach or refused to answer questions, citing doctor-patient confidentiality. LHAs suggested reducing the amount of information collected as some clinical information was unnecessary for implementing control measures. LHAs stated that they received notifications on time, however surveillance data analysis showed some delay. Data completeness exceeded 90% for most variables, however it was only 68% and 80% for dates of disease onset and hospital admission respectively making it impossible to discriminate between hospital and community acquired infections in half of the cases. The surveillance system was well accepted by half of the interviewees. A third however stated that the benefits of the surveillance system were outweighed by the work associated with it. The majority rated the system to be useful for recognizing trends in the MRSA incidence and the ability to check up on infection control measures in hospitals.ConclusionsThe surveillance system proved to be useful by fulfilling its aims. It was timely, acceptable and provided complete data for most variables. However, the system was complicated; ensuring that only relevant variables are reported could simplify the system without losing any of its usefulness.