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Controversy surrounds the current debate regarding the effects of outsourcing health services, as recent studies claim that increased outsourcing leads to reduced costs at the expense of worse patient outcomes. The goal of the value-based model is to enable healthcare systems to create more value for patients, and evidence points to improvements in public health outcomes, patient experience, and health expenditure in systems incorporating components of value-based healthcare. Some emerging evidence indicates promising results for outsourced hospitals which follow a value-based model of healthcare delivery. Although additional future studies are still needed to confirm these benefits, value-based healthcare merits discussion as a new perspective on the public versus private management debate. In fact, we argue that outsourcing to value-based health providers could represent a valid alternative for public health management, encouraging greater competition within the healthcare sector while ensuring quality of care for both public and private sectors., Competing Interests: All authors are employees of the Quirónsalud Healthcare Network and JA, JAÁ, and CC hold management roles at the company., (Copyright © 2024 Caramés, Arcos, Pfang, Cristóbal and Álvaro de la Parra.)

Inspired by the positive impact of service outsourcing in Chery and other enterprises on human resources, this paper explores the impact of service outsourcing on labor income share. This paper introduces a framework to analyze how value added is distributed between capital and labor along the mix of inputs from different countries and sectors participating in global value chains and examines the effect of service outsourcing on the labor share income. Using the World Input-Output Database (WIOD) and OECD Inter-Country Input-Output (OECD- ICIO) table, this paper utilizes the WWZ decomposition method of global value chains (GVCs) to quantify labor share income. The results show that: (1) service outsourcing significantly contributes to the increase in labor share income; (2) Offshore outsourcing had a statistically stronger effect on labor share income after the financial crisis, both compared to the past and to onshore outsourcing; (3) Offshore outsourcing has a higher coefficient in countries with low technology. For ease of comparison, only onshore outsourcing shows a statistically significant difference among various service types; (4) The analysis using Chinese data reveals that the coefficient of offshore outsourcing is negative and statistically significant, indicating that industries with higher levels of service outsourcing have a lower labor share income., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Ye, Yan. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

In this part of the review series "Tricks and tips for home mechanical ventilation", we will discuss the evidence with regard to the place and manner of home mechanical ventilation initiation and follow-up. Outsourcing more and more of this chronic care to the home situation is a big challenge for the future: especially for the home situation, monitoring has to be non-invasive, reliable and easy to use, data security needs to be ensured, signals need to be integrated and preferably automatically processed and algorithms need to be developed based on clinically relevant outcomes., (Copyright © 2020 Sociedade Portuguesa de Pneumologia. Published by Elsevier España, S.L.U. All rights reserved.)

Outsourcing has become an integral part of how research and early development (R&D) is executed in biotech companies and large pharmaceutical organizations. Drug discovery organizations can choose from several operational models when partnering with a service provider, ranging from short-term, fee-for-service (FFS)-based arrangements to more strategic full-time-equivalent (FTE)-based collaborations and even risk-sharing relationships. Clients should consider a number of criteria when deciding which contract research organization (CRO) is best positioned to help meet their goals. Besides cost, other factors such as intellectual property protection, problem solving skills, value-creation ability, communication, data integrity, safety and personnel policies, ease of communication, geography, duration of engagement, scalability of capacity, and contractual details deserve proper consideration. In the end, the success of a drug discovery partnership will depend in large part on the people who execute the science.

Development of new diagnostic tests in a commercial laboratory for neurologic disorders is challenging. Development occurs in a highly regulated environment. Relevant research infrastructure may not be readily available in-house and may require outsourcing with additional management and costs. Clinically characterized specimens for validation of biomarkers for esoteric diseases may be difficult to acquire, and market size may be difficult to predict. More common diseases with heterogeneous subsets may require better clinical definition. Absence of guidelines may delay health provider acceptance of novel testing. Regulatory agency approval and categorization of tests affects validation requirements and impacts market acceptance and reimbursement., Competing Interests: Disclosure I. Venkataraman is employed by EUROIMMUN US; S.J. Naides is employed by EUROIMMUN US; was formerly employed by Quest Diagnostics, Inc., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: Outsourcing of microbiology laboratory services is a growing trend in US medical centers. Data on the actual impact of outsourcing on patient care, safety, and medical education, including costs, are limited. The objective of this study was to examine the published literature on the potential benefits and harms when medical centers outsource common microbiology services., Methods: We conducted a 16-step literature search of PubMed and Embase. Articles were selected for full-text review if their content matched our key questions: (1) What are the potential benefits of outsourcing core microbiology laboratory testing? (2) What are the potential harms to patient care and medical education when medical centers outsource essential microbiology services?, Results: The initial search yielded 6111 unique published articles; 36 were selected for full-text review, which resulted in the identification of 8 articles that addressed our key questions (2 editorials, 3 editorials with observational data, 1 survey, 1 case series, and 1 study of blood culture transport). These articles described a variety of issues, including longer turnaround times for blood cultures that resulted in delays in diagnosis and treatment, errors that resulted in patient morbidity, limited cost savings, and communication barriers., Conclusions: In this study, with the exception of the blood culture transport study, we found no published prospective studies that quantified the effects of outsourcing microbiology services on patient care, patient safety, or medical education. However, these largely anecdotal reports suggest that outsourcing microbiology services may have a detrimental impact on medical education, especially infectious disease training programs., (© The Author(s) 2019. Published by Oxford University Press on behalf of The Journal of the Pediatric Infectious Diseases Society. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: Most hospitals outsource supply procurement to purchasing alliances, or group purchasing organizations (GPOs). Despite their early 20th century origin, we lack both national and trend data on alliance utilization, services, and performance. The topic is important as alliances help hospitals control costs, enjoy tailwinds from affiliated regional/local alliances, and face headwinds from hospital self-contracting and criticism of certain business practices., Purpose: We compare the utilization, services, and performance of alliances in 2004 and 2014., Approach: We analyze alliances using two comparable surveys of hospitals. We use significance tests to assess changes in alliance utilization, services, and performance (e.g., cost savings). We also assess the use of regional/local alliances affiliated with national GPOs., Results: Purchasing through national alliances has somewhat diminished. Over 10 years, hospitals have diversified GPO memberships to include regional/local alliances (many affiliated with their national GPO) and engaged in self-contracting. At the same time, hospitals have increased purchases of many categories of supplies/services through national GPOs and endorsed their value-added functions and increasingly important role. Hospitals report greater satisfaction with several GPO functions; performance on most dimensions has not changed., Conclusions: National alliances still play important roles that hospitals find valuable., Practice Implications: Purchasing alliances continue to play an important role in helping hospitals with both cost savings and new services. Their growing complexity, along with growing use of self-contracting, poses managerial challenges for hospital purchasing staff that may require greater hospital investment.

Comptroller delays medical billing tax until October 2021, giving TMA a chance to work out a legislative fix.

In the wake of the Global Financial Crisis (2007-2008) cheaper, softer money flooded the worldwide markets. Faced with historically low capital costs, the pharmaceutical industry chose to pay down debt through share buybacks rather than invest in research and development (R&D). Instead, the industry explored new R&D models for open innovation, such as open-sourcing, crowd-sourcing, public-private partnerships, innovation centres, Science Parks, and the wholesale outsourcing of pharmaceutical R&D. However, economic Greater Fool Theory suggests that outsourcing R&D was never likely to increase innovation. Ten years on, the period of cheaper and softer money is coming to an end. So how are things looking? And what happens next?, (Copyright © 2019 Elsevier Ltd. All rights reserved.)

Most healthcare organizations (HCOs) engage Group Purchasing Organizations (GPOs) as an outsourcing strategy to secure their supplies and materials. When an HCO outsources the procurement function to a GPO, this GPO will directly interact with the HCO's supplier on the HCO's behalf. This study investigates how an HCO's dependence on a GPO affects supply chain relationships and power in the healthcare medical equipment supply chain. Hypotheses are tested through factor analysis and structural equation modeling, using primary survey data from HCO procurement managers. An HCO's dependence on a GPO is found to be positively associated with a GPO's reliance on mediated power, but, surprisingly, negatively associated with a GPO's mediated power. Furthermore, analysis indicates that an HCO's dependence on a GPO is positively associated with an HCO's dependence on a GPO-contracted Original Equipment Manufacturer (OEM). HCO reliance on GPOs may lead to a buyer's dependence trap, where HCOs are increasingly dependent on GPOs and OEMs. Implications for HCO procurement managers and recommended steps for mitigation are offered. Power-dependence relationships in the medical equipment supply chain are not consistent with relationships in other, more traditional, supply chains. While dependence in a supply chain relationship typically leads to an increase in reliance on mediated power, GPO-dependent HCOs instead perceive a decrease in GPO mediated power. Furthermore, HCOs that rely on procurement service from GPOs are increasingly dependent on the OEMs.

Introduction: After years of outsourcing without detailed contracts from one of Sweden's largest university hospitals to external radiology units, the hospital started to use a specific contract for outsourcing computed tomography (CT) examinations. The purpose of this study was to compare the cost-effectiveness of two outsourcing approaches, where examinations were performed either with a detailed, specific contract (with-contract) or without (no-contract), between a hospital radiology department and private external units., Methods: This retrospective study included a group of electively outsourced CT-examinations (n = 132) and a control group of in-house CT-examinations (n = 132), selected from the three different types of CT-examinations referred from the Departments of Oncology and Hematology. These examinations were randomly selected from four different groups over two time periods of one year each, one being outsourcing without a contract (no-contract, during 2013), one time period with a specific contract (with-contract, during 2014) and two control groups of examinations performed in-house within both these time periods. We compared outsourced examinations (both no-contract and with-contract groups) and in-house examinations. The comparison of these groups include five parameters; management-time, patient waiting-time, the quality of the examinations, - image interpretations and costs., Results: During 2013, management-time for CT-examinations was longer in the outsourced group (no-contract) than in the in-house group, with a statistical significance (P = 0.002). Fewer examinations performed in-house and in the with-contract group needed re-interpretation than in the no-contract group. CT-examinations in the with-contract group were associated with shorter overall management-time, patient waiting time and lower costs compared to the no-contract group., Conclusion: Using a contract with detailed specifications for outsourcing CT-examinations may be an effective way of reducing patient waiting time. Outsourcing based on a well-founded contract can be cost-effective, compared with outsourcing without a detailed plan for the services required., (Copyright © 2018 The College of Radiographers. Published by Elsevier Ltd. All rights reserved.)

We draw from documented characteristics of the biopharmaceutical industry to construct a model where two firms can choose to outsource R&D to an external unit, and/or engage in internal R&D, before competing in a final market. We investigate the distribution of profits among market participants, and the incentives to coordinate outsourcing activities or to integrate R&D and production. Consistent with the empirical evidence, we find that the sign and magnitude of an aggregate measure of direct (inter-firm) and indirect (through the external unit) technological externalities drives the distribution of industry profits, with higher returns to the external unit when involved in development (clinical trials) than in early-stage research (drug discovery). In the latter case, the delinkage of investment incentives from industry value, together with the ability of firms to transfer risks to the external unit, imply a vulnerability of early-stage investors' returns to negative shocks, and the likely abandonment of projects with economic and medical value. We also find that competition in the equity market makes a buyout by one of the two firms more profitable to a research biotech than to a clinical services unit, and can stimulate early-stage investments. However, this long-term incentive can be minimal, notably if the superior efficiency of outsourced operations originates from economies of scope that can hardly be exploited when a firm takes control of the external unit exclusively for itself. R&D outsourcing thus does not always qualify as a relevant pathway to address the declining productivity in innovation that has characterized the industry over several decades., (Copyright © 2019 Elsevier B.V. All rights reserved.)

The early 1990s economic setback brought significant reforms favoring the outsourcing of care in Finnish municipalities. Here, outsourcing refers to the practice of municipalities employing private organizations through different means (e.g., open tendering) to deliver public care services. In this context, this study examines the growth in the outsourcing of service housing and home-help services in 311 municipalities from 2001 to 2015 and investigates the municipal factors associated with outsourcing using four dimensions: care needs, population size, economic situation, and political ideology of the municipality. The findings reveal a steep increase in the outsourcing of home-help and service housing. Care needs of older people are the most influential factor for outsourcing, particularly for service housing. Overall, the findings show a growing trend in private care provision in Finnish municipalities.

Introduction: Behavioral health conditions are a significant concern for the U.S. military and the Military Health System (MHS) because of decreased military readiness and increased health care utilization. Although MHS beneficiaries receive direct care in military treatment facilities, a disproportionate majority of behavioral health treatment is purchased care received in civilian facilities. Yet, limited evidence exists about purchased behavioral health care received by MHS beneficiaries. This longitudinal study (1) estimated the prevalence of purchased behavioral health care and (2) identified patient and visit characteristics predicting receipt of purchased behavioral health care in acute care facilities from 2000 to 2014., Materials and Methods: Medical claims with Major Diagnostic Code 19 (mental disorders/diseases) or 20 (alcohol/drug disorders) as primary diagnoses and TRICARE as the primary/secondary payer were analyzed for MHS beneficiaries (n = 17,943) receiving behavioral health care in civilian acute care facilities from January 1, 2000, to December 31, 2014. The primary dependent variable, receipt of purchased behavioral health care, was modeled for select mental health and substance use disorders from 2000 to 2014 using generalized estimating equations. Patient characteristics included time, age, sex, and race/ethnicity. Visit types included inpatient hospitalization and emergency department (ED). Time was measured in days and visits were assumed to be correlated over time. Behavioral health care was described by both frequency of patients and visit type. The University of South Carolina Institutional Review Board approved this study., Results: From 2000 to 2014, purchased care visits increased significantly for post-traumatic stress disorder, adjustment, anxiety, mood, bipolar, tobacco use, opioid/combination opioid dependence, nondependent cocaine abuse, psychosocial problems, and suicidal ideation among MHS beneficiaries. The majority of care was received for mental health disorders (78.8%) and care was most often received in EDs (56%). Most commonly treated diagnoses included mood, tobacco use, and alcohol use disorders. ED visits were associated with being treated for anxiety (excluding post-traumatic stress disorder; Adjusted odds ratio [AOR]: 9.14 [95% confidence interval (CI): 8.26, 10.12]), alcohol use disorders (AOR = 1.67 [95% CI: 1.53, 1.83]), tobacco use (AOR = 1.16 [95% CI: 1.06, 1.26]), nondependent cocaine abuse (AOR = 5.47 [95% CI: 3.28, 9.12]), nondependent mixed/unspecified drug abuse (AOR = 7.30 [95% CI: 5.11, 10.44]), and psychosis (AOR = 1.38 [95% CI: 1.20, 1.58]). Compared with adults age 60 yr and older, adolescents (ages 12-17 yr), and adults under age 60 yr were more likely to be treated for suicidal ideation, adjustment, mood, bipolar, post-traumatic stress disorder, nondependent cocaine, and mixed/unspecified drug abuse. Adults under age 60 yr also had increased odds of being treated for tobacco use disorders, alcohol use disorders, and opioid/combination opioid dependence compared with adults age 60 yr and older., Conclusions: Over the past 15 yr, purchased behavioral health care received by MHS beneficiaries in acute care facilities increased significantly. MHS beneficiaries received the majority of purchased behavioral health care for mental health disorders and were treated most often in the ED. Receiving behavioral health care in civilian EDs raises questions about access to outpatient behavioral health care and patient-centered care coordination between civilian and military facilities. Given the influx of new Veterans Health Administration users from the MHS, findings have implications for military, veteran, and civilian facilities providing behavioral health care to military and veteran populations.

Purpose: The extent to which new drug developers can benefit financially from shorter development times has implications for development efficiency and innovation incentives. We provided a real-world example of such gains by using recent estimates of drug development costs and returns., Methods: Time and fee data were obtained on 5 single-source manufacturing projects. Time and fees were modeled for these projects as if the drug substance and drug product processes had been contracted separately from 2 vendors. The multi-vendor model was taken as the base case, and financial impacts from single-source contracting were determined relative to the base case., Findings: The mean and median after-tax financial benefits of shorter development times from single-source contracting were $44.7 million and $34.9 million, respectively (2016 dollars). The after-tax increases in sponsor fees from single-source contracting were small in comparison (mean and median of $0.65 million and $0.25 million)., Implications: For the data we examined, single-source contracting yielded substantial financial benefits over multi-source contracting, even after accounting for somewhat higher sponsor fees., (Copyright © 2018 Elsevier HS Journals, Inc. All rights reserved.)

Background: Contracting out of governmental health services is a financing strategy that governs the way in which public sector funds are used to have services delivered by non-governmental health service providers (NGPs). It represents a contract between the government and an NGP, detailing the mechanisms and conditions by which the latter should provide health care on behalf of the government. Contracting out is intended to improve the delivery and use of healthcare services. This Review updates a Cochrane Review first published in 2009., Objectives: To assess effects of contracting out governmental clinical health services to non-governmental service provider/s, on (i) utilisation of clinical health services; (ii) improvement in population health outcomes; (iii) improvement in equity of utilisation of these services; (iv) costs and cost-effectiveness of delivering the services; and (v) improvement in health systems performance., Search Methods: We searched CENTRAL, MEDLINE, Embase, NHS Economic Evaluation Database, EconLit, ProQuest, and Global Health on 07 April 2017, along with two trials registers - ClinicalTrials.gov and the International Clinical Trials Registry Platform - on 17 November 2017., Selection Criteria: Individually randomised and cluster-randomised trials, controlled before-after studies, interrupted time series, and repeated measures studies, comparing government-delivered clinical health services versus those contracted out to NGPs, or comparing different models of non-governmental-delivered clinical health services., Data Collection and Analysis: Two authors independently screened all records, extracted data from the included studies and assessed the risk of bias. We calculated the net effect for all outcomes. A positive value favours the intervention whilst a negative value favours the control. Effect estimates are presented with 95% confidence intervals. We used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to assess the certainty of the evidence and we prepared a Summary of Findings table., Main Results: We included two studies, a cluster-randomised trial conducted in Cambodia, and a controlled before-after study conducted in Guatemala. Both studies reported that contracting out over 12 months probably makes little or no difference in (i) immunisation uptake of children 12 to 24 months old (moderate-certainty evidence), (ii) the number of women who had more than two antenatal care visits (moderate-certainty evidence), and (iii) female use of contraceptives (moderate-certainty evidence).The Cambodia trial reported that contracting out may make little or no difference in the mortality over 12 months of children younger than one year of age (net effect = -4.3%, intervention effect P = 0.36, clustered standard error (SE) = 3.0%; low-certainty evidence), nor to the incidence of childhood diarrhoea (net effect = -16.2%, intervention effect P = 0.07, clustered SE = 19.0%; low-certainty evidence). The Cambodia study found that contracting out probably reduces individual out-of-pocket spending over 12 months on curative care (net effect = $ -19.25 (2003 USD), intervention effect P = 0.01, clustered SE = $ 5.12; moderate-certainty evidence). The included studies did not report equity in the use of clinical health services and in adverse effects., Authors' Conclusions: This update confirms the findings of the original review. Contracting out probably reduces individual out-of-pocket spending on curative care (moderate-certainty evidence), but probably makes little or no difference in other health utilisation or service delivery outcomes (moderate- to low-certainty evidence). Therefore, contracting out programmes may be no better or worse than government-provided services, although additional rigorously designed studies may change this result. The literature provides many examples of contracting out programmes, which implies that this is a feasible response when governments fail to provide good clinical health care. Future contracting out programmes should be framed within a rigorous study design to allow valid and reliable measures of their effects. Such studies should include qualitative research that assesses the views of programme implementers and beneficiaries, and records implementation mechanisms. This approach may reveal enablers for, and barriers to, successful implementation of such programmes.

Introduction: The pharmaceutical industry is undergoing major shifts due to changing macro and micro factors. As the industry is highly capital intensive and patents are expiring, the outlook is on generating inorganic growth, mainly through M&A. Using the income valuation approach, one analyses two completed deals in 2016 above 1bn USD. Thereafter one outlines the main motives behind M&A deals and concluded by discussing whether M&A harms medical innovations., Areas Covered: The paper is based on empirical study questioning existing literature in order to critically analyse valuation and the strategical orientation of pharmaceutical companies., Expert Commentary: Pharmaceutical companies understand the changing market conditions and favour their expertise. The restructuring of the industry moves to small niche companies (I.e. Biopharma or biotech companies) researching key innovations and big companies purchasing them to develop them, create clinical trials and distribute them as this is a costly manner Conclusion: One can expect more M&A deals during the next years focusing on value rather than volume. Pharmaceutical players resilient to the market changes may survive if they change their business model from a traditional vertical one to outsourcing and diversification including external players.

Reducing carbon emissions, including emission abatement outsourcing at the supply-chain level, is becoming a significant but challenging problem in practice. Confronting this challenge, we therefore break down the practice to focus on a low-carbon supply chain consisting of one supplier, one manufacturer and one third-party emission-reducing contractor. The contractor offers a carbon reduction service to the manufacturer. In view of the increasing proportion of Greenhouse Gases (GHG) emissions and absence of carbon reduction policies in developing countries, we adopt the prospect of consumers' low-carbon preferences to capture the demand sensitivity on carbon emission. By exploiting the Mean-Variance (MV) model, we develop a supply chain game model considering risk aversion. Comparing the supply chain performances of the cases under risk neutrality and risk aversion, we investigate the impact of the risk aversion of the supplier and the manufacturer on the low-carbon supply chain performances, respectively. We show that the risk aversion of chain members will not influence the relationship underlain by the profit-sharing contract between the manufacturer and contractor, whereas they may extend the supplier's concerning range. Although the manufacturer's risk aversion has a positive impact on the wholesale price, interestingly, the supplier's impact on the wholesale price is negative. Furthermore, we propose a contract to coordinate the risk-averse low-carbon supply chain by tuning the aversion levels of the supplier and the manufacturer, respectively. Through numerical study, we draw on managerial insights for industrial practitioners to adopt a low carbon strategy potentially by managing the risk attitudes along the supply chain channel., Competing Interests: The authors declare that they have no conflict of interest.

There has been extensive outsourcing of hospital cleaning services in the NHS in England, in part because of the potential to reduce costs. Yet some argue that this leads to lower hygiene standards and more infections, such as MRSA and, perhaps because of this, the Scottish, Welsh, and Northern Irish health services have rejected outsourcing. This study evaluates whether contracting out cleaning services in English acute hospital Trusts (legal authorities that run one or more hospitals) is associated with risks of hospital-borne MRSA infection and lower economic costs. By linking data on MRSA incidence per 100,000 hospital bed-days with surveys of cleanliness among patient and staff in 126 English acute hospital Trusts during 2010-2014, we find that outsourcing cleaning services was associated with greater incidence of MRSA, fewer cleaning staff per hospital bed, worse patient perceptions of cleanliness and staff perceptions of availability of handwashing facilities. However, outsourcing was also associated with lower economic costs (without accounting for additional costs associated with treatment of hospital acquired infections)., (Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Background: Anesthesia drugs can be prepared by anesthesia providers, hospital pharmacies or outsourcing facilities. The decision whether to outsource all or some anesthesia drugs is challenging since the costs associated with different anesthesia drug preparation methods remain poorly described., Methods: The costs associated with preparation of 8 commonly used anesthesia drugs were analyzed using a budget impact analysis for 4 different syringe preparation strategies: (1) all drugs prepared by anesthesiologist, (2) drugs prepared by anesthesiologist and hospital pharmacy, (3) drugs prepared by anesthesiologist and outsourcing facility, and (4) all drugs prepared by outsourcing facility., Main Results: A strategy combining anesthesiologist and hospital pharmacy prepared drugs was associated with the lowest estimated annual cost in the base-case budget impact analysis with an annual cost of $225 592, which was lower than other strategies by a margin of greater than $86 000., Conclusion: A combination of anesthesiologist and hospital pharmacy prepared drugs resulted in the lowest annual cost in the budget impact analysis. However, the cost of drugs prepared by an outsourcing facility maybe lower if the capital investment needed for the establishment and maintenance of the US Pharmacopeial Convention Chapter <797> compliant facility is included in the budget impact analysis., (Copyright © 2016 Elsevier Inc. All rights reserved.)

This article argues that the English legislative regime is ineffective in regulating international surrogacy, particularly with regard to commercial payments. It suggests that if English law views surrogacy as exploitative, we have a responsibility to protect women both in England and abroad, and the only way to do so effectively is to create a domestic system of regulation that caters adequately for the demand in this country. This requires a system of authorisation for surrogacy before it is undertaken; ex-post facto examinations of agreements completed in other jurisdictions, after the child is already living with the commissioning parents, cannot be seen as an acceptable compromise, as authorisation will inevitably be granted in the child's best interests., (© The Author 2016. Published by Oxford University Press; all rights reserved. For Permissions, please email: journals.permissions@oup.com.)

Introduction: The implications of conducting clinical trials in low and middle income countries on the financial accessibility and safety of the pharmaceutical products available in those markets have not been studied. Regulatory practices and ethical declarations lead to the commercialization of the new products, referred to as New Molecular Entities (NMEs), in the countries where tested as soon as they are approved in high surveillance countries. Patients and patients' associations use the Latin American courts to access new and expensive treatments, regardless of their safety profile and therapeutic value., Design and Objectives: Cross-sectional, descriptive study. To determine the therapeutic value and safety profile of the NMEs approved by the Food and Drug Administration (FDA) in 2011 and 2012 that had been tested in Latin America, and the implications of their market approval for the pharmaceutical budgets in the countries where tested., Setting: Latin America., Measures: To assess the therapeutic value and safety of the NMEs commercialized in the different countries we used f independent drug bulletins. The prices of the NMEs for the consumers were obtained from the pharmaceutical price observatories of the countries were the medicines had been tested. If the price was not available in the observatories, it was obtained from pharmaceutical distributors. We used the countries' minimum wage and per capita income to calculate the financial accessibility of a course of treatment with the NMEs., Results: We found that 33 NMEs approved by the FDA in 2011 and 2012 have been tested in Latin America. Of these, 26 had been evaluated by independent drug bulletins and only five were found to add some value to a subset of patients and had significant side-effects. The pharmaceutical prices were very high, varied widely across countries and were unrelated to the countries' income per capita or minimum wage., Conclusion: The implementation of clinical trials in Latin America results in the commercialization of medicines with questionable safety profiles and limited therapeutic value, putting patients at risk and causing budgetary strains in pharmaceutical budgets.

The pharmaceutical industry has responded to the declining research and development (R&D) productivity over the past decade by decreasing its cost base and outsourcing parts of drug research, with China increasingly being the preferred destination for such outsourced work. For this Focus article, we collected and analyzed data for 66 China-based nonclinical contract research organizations (CROs); approximately 60% of the companies were localized in the Yangtze River Delta cluster and another 20% within the Beijing cluster. Almost 25% of the companies offered services in discovery biology, the single largest service offering in the data set, with another 20% offering preclinical research (toxicology, pharmacology, and animal models) and approximately 15% offering pharmaceutical development. The biologics and pharmaceutical development services represent key future growth areas, with CROs showing an increasing appetite for risk-sharing partnerships., (Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.)

State dental associations are showing increased interest in maintaining current standards and regulations affecting the dental laboratory industry as mandated by the Food and Drug Administration. The domestic dental laboratory industry is being significantly stressed by foreign competition, rapid technology development and unprecedented consolidation, which are changing the way that prosthetic devices and restorations are manufactured and delivered to dentists. Of paramount importance to the prescribing dentist is the accurate documentation of the source and materials being used in prostheses being delivered to patients.

Context: Use of reference laboratories for selected laboratory testing (send-out tests) represents a significant source of laboratory costs. As the use of more complex molecular analyses becomes common in the United States, strategies to reduce costs in the clinical laboratory must evolve in order to provide high-value, cost-effective medicine., Objective: To report a strategy that employs clinical pathology house staff and key hospital clinicians in the effective use of microbiologic send-out testing., Design: The George Washington University Hospital is a 370-bed academic hospital in Washington, DC. In 2012 all requisitions for microbiologic send-out tests were screened by the clinical pathology house staff prior to final dispensation. Tests with questionable utility were brought to the attention of ordering clinicians through the use of interdisciplinary rounds and direct face-to-face consultation., Results: Screening resulted in a cancellation rate of 38% of send-out tests, with proportional cost savings. Nucleic acid tests represented most of the tests screened and the largest percentage of cost saved through screening. Following consultation, requested send-out tests were most often canceled because of a lack of clinical indication., Conclusions: Direct face-to-face consultation with ordering physicians is an effective, interdisciplinary approach to managing the use of send-out testing in the microbiology laboratory.

Background/purpose: We conducted a retrospective study to compare the cost and effectiveness between two different running models for extracorporeal shock wave lithotripsy (SWL), including the outsourcing cooperation model (OC) and the rental cooperation model (RC)., Methods: Between January 1999 and December 2005, we implemented OC for the SWL, and from January 2006 to October 2011, RC was utilized. With OC, the cooperative company provided a machine and shared a variable payment with the hospital, according to treatment sessions. With RC, the cooperative company provided a machine and received a fixed rent from the hospital. We calculated the cost of each treatment session, and evaluated the break-even point to estimate the lowest number of treatment sessions to make the balance between revenue and cost every month. Effectiveness parameters, including the stone-free rate, the retreatment rate, the rate of additional procedures and complications, were evaluated., Results: Compared with OC there were significantly less treatment sessions for RC every month (42.6±7.8 vs. 36.8±6.5, p=0.01). The cost of each treatment session was significantly higher for OC than for RC (751.6±20.0 USD vs. 684.7±16.7 USD, p=0.01). The break-even point for the hospital was 27.5 treatment sessions/month for OC, when the hospital obtained 40% of the payment, and it could be reduced if the hospital got a greater percentage. The break-even point for the hospital was 27.3 treatment sessions/month for RC. No significant differences were noticed for the stone-free rate, the retreatment rate, the rate of additional procedures and complications., Conclusion: Our study revealed that RC had a lower cost for every treatment session, and fewer treatment sessions of SWL/month than OC. The study might provide a managerial implication for healthcare organization managers, when they face a situation of high price equipment investment., (Copyright © 2012. Published by Elsevier B.V.)

In this paper, I describe the experience of 'outsourced' patients who are sent by their governments or insurers through contractual arrangements to a hospital in another country for treatment. I present case studies of nine patients and their accompanying families from the Gulf Cooperation Council (GCC) who were interviewed in a Thai hospital as part of a broader study of medical travel from patients' perspectives. The health systems of the GCC suffer shortages in infrastructure, human resources and management skills, and as a consequence patients with particular needs, especially in neurology, orthopaedics and oncology may be sent overseas for treatment. Patients experience long stays overseas producing a considerable burden to their families supporting them. Such patients complicate notions of medical travel but their status also contrasts markedly from stereotypes held about Gulf patients within Thailand. Despite their appreciation of government sponsoring, for many patients the experience of care in Thailand underscored perceived inadequacies of their home health systems and governments. For some, outsourcing represented a betrayal of the obligations of their states to its citizens.

The pharmaceutical industry is facing enormous challenges, including reduced efficiency, stagnant success rate, patent expirations for key drugs, fierce price competition from generics, high regulatory hurdles, and the industry's perceived tarnished image. Pharma has responded by embarking on a range of initiatives. Other sectors, including NIH, have also responded. Academic drug discovery groups have appeared to support the transition of innovative academic discoveries and ideas into attractive drug discovery opportunities. Part 1 of this two-part series discussed the criticisms that have been leveled at the pharmaceutical industry over the past 3 decades and summarized the supporting data for and against these criticisms. This second installment will focus on the current challenges facing the pharmaceutical industry and Pharma's responses, focusing on the industry's changing perspective and new business models for coping with the loss of talent and declining clinical pipelines as well as presenting some examples of recent drug discovery successes.

Using the failure mode and effects analysis, this study examined biomedical waste companies through risk assessment. Moreover, it evaluated the supervisors of biomedical waste units in hospitals, and factors relating to the outsourcing risk assessment of biomedical waste in hospitals by referring to waste disposal acts. An expert questionnaire survey was conducted on the personnel involved in waste disposal units in hospitals, in order to identify important factors relating to the outsourcing risk of biomedical waste in hospitals. This study calculated the risk priority number (RPN) and selected items with an RPN value higher than 80 for improvement. These items included "availability of freezing devices", "availability of containers for sharp items", "disposal frequency", "disposal volume", "disposal method", "vehicles meeting the regulations", and "declaration of three lists". This study also aimed to identify important selection factors of biomedical waste disposal companies by hospitals in terms of risk. These findings can serve as references for hospitals in the selection of outsourcing companies for biomedical waste disposal., (Copyright © 2014 Elsevier Ltd. All rights reserved.)