scholarly journals Off-Patent Biologicals and Biosimilars Tendering in Europe—A Proposal towards More Sustainable Practices

2021 ◽  
Vol 14 (6) ◽  
pp. 499
Author(s):  
Liese Barbier ◽  
Steven Simoens ◽  
Caroline Soontjens ◽  
Barbara Claus ◽  
Arnold G. Vulto ◽  
...  

Background: In Europe, off-patent biologicals and biosimilars are largely procured by means of tender procedures. The organization and design of tenders may play a key role in the evolving biosimilar market, and currently, it is not fully elucidated how tenders for off-patent biologicals and biosimilars are designed and if approaches are aligned with sustaining market competition and societal savings for healthcare systems over the long term. This study aims to (i) explore the design and implementation of tender procedures for off-patent biologicals and biosimilars in Europe, (ii) identify learnings for sustainable tender approaches from purchasers and suppliers, and (iii) formulate recommendations in support of competitive and sustainable tender practices in the off-patent biologicals market. Methods: A mixed methods design was applied. A quantitative web-survey was conducted with hospital pharmacists and purchasers (N = 60, of which 47 completed the survey in full), and qualitative expert-interviews with purchasers and suppliers (N = 28) were carried out. Results: The web survey results showed that the organization and design of tenders for off-patent biologicals and biosimilars, and the experience of hospital pharmacists and purchasers with this, considerably varies on several elements across European countries. From the qualitative interviews, signals emerged across the board that some of the current tender approaches might negatively affect market dynamics for off-patent biologicals and biosimilars. The focus on generating short-term savings and existence of originator favouring tender practices were identified as elements that may limit timely competition from and market opportunity for biosimilar suppliers. The need to optimize tender processes, considering a more long-term strategic and sustainable view, was expressed. In addition, challenges appear to exist with differentiating between products beyond price, showing the need and opportunity to guide stakeholders with the (appropriate) inclusion of award criteria beyond price. Due to the variety in tender organization in Europe, a ‘one size fits all’ tendering framework is not possible. However, on an overarching level, it was argued that tender procedures must aim to (i) ensure market plurality and (ii) include award criteria beyond price (warranted that criteria are objectively and transparently defined, scored and competitively rewarded). Depending on the market (maturity), additional actions may be needed. Conclusions: Findings suggest the need to adjust tender procedures for off-patent biologicals and biosimilars, considering a more long-term strategic and market sustainable view. Five main avenues for optimization were identified: (i) safeguarding a transparent, equal opportunity setting for all suppliers with an appropriate use of award criteria; (ii) fostering a timely opening of tender procedures, ensuring on-set competition; (iii) ensuring and stimulating adherence to laws on public procurement; (iv) securing an efficient process, improving plannability and ensuring timely product supply and (v) safeguarding long-term sustainable competition by stimulating market plurality.

1998 ◽  
Vol 28 (1) ◽  
pp. 29-46
Author(s):  
Jonathan Oberlander

There is growing enthusiasm for transforming Medicare into a voucher system. Advocates claim vouchers would increase the health care choices available to Medicare beneficiaries, reduce the regulatory burden on the federal government, and promote the benefits of fair market competition. In addition, some analysts contend vouchers are the only feasible solution to Medicare's short-term financing problems and the long-term “crisis” of the retirement of the baby-boom generation. The author argues against these claims. Vouchers would not work as advertised by proponents because of the limitations of risk-adjustment methods and unrealistic assumptions about consumer choice. Moreover, the elderly and disabled Medicare population is ill-suited to cope in a competitive insurance system. Implementation of vouchers would therefore pose a threat to both the health of beneficiaries and the stability of the Medicare program. The implications of this analysis for Medicare reform are discussed.


2019 ◽  
Author(s):  
Xing Huang

This study intends to find out the design features of health information visualization that can positively influence young adults’ perception of self-efficacy about weight control. An exploratory mixed methods design has been used by firstly collecting qualitative data in order to develop an information visualization intervention, which then followed with a quantitative phase to assess the design features. Three design features were generated - (1). Visualizing the comparison of intake and consumed calories; (2). Showing both the short-term and long-term predictions of weight; (3). Showing an ideal path of weight control.


BMJ Open ◽  
2021 ◽  
Vol 11 (9) ◽  
pp. e052758
Author(s):  
Gwenllian Wynne-Jones ◽  
Helen Myers ◽  
Alison Hall ◽  
Chris Littlewood ◽  
S Hennings ◽  
...  

IntroductionPeople presenting with shoulder pain considered to be of musculoskeletal origin is common in primary care but diagnosing the cause of the pain is contentious, leading to uncertainty in management. To inform optimal primary care for patients with shoulder pain, the study aims to (1) to investigate the short-term and long-term outcomes (overall prognosis) of shoulder pain, (2) estimate costs of care, (3) develop a prognostic model for predicting individuals’ level and risk of pain and disability at 6 months and (4) investigate experiences and opinions of patients and healthcare professionals regarding diagnosis, prognosis and management of shoulder pain.Methods and analysisThe Prognostic And Diagnostic Assessment of the Shoulder (PANDA-S) study is a longitudinal clinical cohort with linked qualitative study. At least 400 people presenting to general practice and physiotherapy services in the UK will be recruited. Participants will complete questionnaires at baseline, 3, 6, 12, 24 and 36 months. Short-term data will be collected weekly between baseline and 12 weeks via Short Message Serevice (SMS) text or software application. Participants will be offered clinical (physiotherapist) and ultrasound (sonographer) assessments at baseline. Qualitative interviews with ≈15 dyads of patients and their healthcare professional (general practitioner or physiotherapist).Short-term and long-term trajectories of Shoulder Pain and Disability Index (using SPADI) will be described, using latent class growth analysis. Health economic analysis will estimate direct costs of care and indirect costs related to work absence and productivity losses. Multivariable regression analysis will be used to develop a prognostic model predicting future levels of pain and disability at 6 months using penalisation methods to adjust for overfitting. The added predictive value of prespecified physical examination tests and ultrasound findings will be examined. For the qualitative interviews an inductive, exploratory framework will be adopted using thematic analysis to investigate decision making, perspectives of patients and clinicians on the importance of diagnostic and prognostic information when negotiating treatment and referral options.Ethics and disseminationThe PANDA-S study has ethical approval from Yorkshire and The Humber-Sheffield Research Ethics Committee, UK (18/YH/0346, IRAS Number: 242750). Results will be disseminated through peer-reviewed publications, social and mainstream media, professional conferences, and the patient and public involvement and engagement group supporting this study, and through newsletters, leaflets and posters in participating sites.Trial registration numberISRCTN46948079.


2018 ◽  
Author(s):  
Michelle E. Portman ◽  
Ruth E Brennan

Marine litter has been a serious and growing problem for some decades now. Yet, there is still much speculation among researchers, policy makers and planners about how to tackle marine litter from land-based sources. This paper provides insights into approaches for managing marine litter by reporting and analyzing survey results of litter dispersal and makeup from three areas along an Arab-Israeli coastal town in view of other recent studies conducted around the Mediterranean Sea. Based on our results and analysis, we posit that bathing beach activities should be a high priority for waste managers as a point of intervention and beach-goers must be encouraged to take a more active role in keeping beaches clean. Further, plastic fragments on the beach should be targeted as a first priority for prevention (and cleanup) of marine litter with plastic bottle caps being a high priority to be targeted among plastics. More survey research is needed on non-plastic litter composition for which amounts and geographic dispersal in the region vary greatly from place to place along Mediterranean shores. In general, findings of this study lead us to recommend exploring persuasive beach trash can design coupled with greater enforcement for short term waste management intervention while considering the local socio-economic and institutional context further for long-term efforts.


2021 ◽  
pp. 0092055X2110336
Author(s):  
Hannah Beth Love ◽  
Kelsea MacIlroy

Undergraduate capstone courses in sociology are designed to integrate students’ knowledge in the discipline and to culminate the classroom experience with field application. Are capstones achieving these goals in a durable way? Although the short-term outcomes of capstone courses have been researched, fewer studies have documented the long-term outcomes of capstone courses. We conducted a survey of sociology capstone alumni to understand the long-term outcomes of the sociology capstone by asking sociology alumni about their capstone experience. Our research revealed that all capstones produced long-term outcomes as measured in the alumni survey. Second, alumni of the community-based research capstone experienced a more profound and longer reaching effect than those who participated in the internship or traditional capstone seminar format. Alumni reported the development of professional skills, application of sociological concepts and research skills, and a sense of being part of a community.


2019 ◽  
Vol 46 (2) ◽  
pp. 127 ◽  
Author(s):  
Björn Lardner ◽  
Amy A. Yackel Adams ◽  
Adam J. Knox ◽  
Julie A. Savidge ◽  
Robert N. Reed

Context Visual encounter surveying is a standard animal inventory method, modifications of which (e.g. distance sampling and repeated count surveys) are used for modelling population density. However, a variety of factors may bias visual survey counts. Aims The aim of the present study was to evaluate three observer-related biases: (1) whether fatigue compromises detection rate as a survey occasion progresses; (2) whether long-term fatigue or boredom compromise detection rates over the course of a survey period; and (3) whether observers exhibit biases in detection rates of different animal taxa. Methods We analysed >2.3 × 104 observations of lizards and small mammals from nocturnal pedestrian visual encounter surveys, each 4 h in duration, conducted by a pool of 29 observers, each of whom surveyed for up to 31 nights. Key results Detections of sleeping (diurnal) emerald tree skinks (Lamprolepis smaragdina) exhibited a small but statistically verified decline as the evening progressed, whereas detections of sleeping (diurnal) green anoles (Anolis carolinensis) increased as the evening progressed. Detections of nocturnal geckos (several species pooled) showed a weak and non-significant declining trend. Small mammal sightings (rats, shrews and mice pooled) declined strongly over the course of an evening. The participants saw greater or equal numbers of animals the more nights they surveyed. Most participants exhibited statistically significant, and often strong, taxonomic detection bias compared with the pool of peer observers. The skills of some observers appeared to be consistently above average; others consistently below average. Conclusions Data on sleeping lizards suggest that neither short-term nor long-term observer fatigue is of much concern for 4-h visual searches. On the contrary, differences among observers in taxonomic bias and overall detection skills pose a problem for data interpretation. Implications By comparing temporal detection patterns of immobile (e.g. sleeping) with actively moving animal taxa, sampling biases attributable to searcher fatigue versus the animals’ circadian rhythm can be disentangled and, if need be, statistically corrected for. Observer skill differences and observer-specific taxonomic biases may hamper efforts to statistically evaluate survey results, unless explicitly included as covariates in population models.


Ciencia Unemi ◽  
2018 ◽  
Vol 10 (25) ◽  
pp. 67
Author(s):  
Danny Trujillo-Sandoval ◽  
Carlos Puente-Guijarro ◽  
Karla Andrade-Quevedo

Las fusiones entre competidores son una práctica empresarial común que genera importantes consecuencias para el mercado, una de ellas es la concentración económica, que puede perjudicar la libre competencia a corto, mediano y largo plazo. En Ecuador el mercado cervecero es un interesante eje de estudio, pues constituye un mercado altamente concentrado, con pocos participantes y en él, la Superintendencia de Control de Poder de Mercado estableció las condiciones para la fusión entre dos de sus participantes más relevantes: Cervecería Nacional (SABMiller) y Ambev (Anheuser-Busch Inbev). Este artículo analiza la concentración económica del sector cervecero ecuatoriano y los efectos de la fusión entre éstos dos competidores. Es un estudio cuali - cuantitativo en el cual se evaluaron las características del sector cervecero ecuatoriano y las condiciones de la fusión efectuada, para determinar, a través de indicadores de concentración y datos de volúmenes de venta del sector entre 2013 y 2015- cuáles son los niveles de concentración y posibles tendencias en cuanto a la oferta y comportamiento de dicho sector; demostrándose que existe un mercado altamente concentrado, con un índice de Herfindahl superior a 9000, y con condiciones que nublan la posibilidad de competencia en el mercado a corto plazo. AbstractMergers between competitors are a common business practice that generates important consequences for the market, one of them is economic concentration, which can affect the free competition in the short, medium and long term. In Ecuador, the beer market is an interesting area of study, since it represents a highly concentrated market, with few participants in which the Superintendence of Market Power Control has established the conditions for the merger between two of its most relevant participants: National Brewery (SABMiller) and Ambev (Anheuser-Busch Inbev). This article analyzes the economic concentration of the Ecuadorian beer sector and the effects of the merger between these two competitors. This research is a qualitative-quantitative study in which the characteristics of the Ecuadorian beer sector and the conditions of the merger were evaluated, to determine the levels of concentration and possible trends in the supply and behavior of this sector by using concentration indicators and data of sales volumes between 2013 and 2015. That showed that there is a highly concentrated market, with a Herfindahl index above 9000, and with conditions that null the possibility of short-term market competition. 


2017 ◽  
Vol 43 (4) ◽  
pp. 452-470 ◽  
Author(s):  
Harjeet Singh Bhabra ◽  
Ashrafee Tanvir Hossain

Purpose The purpose of this paper is to analyze and compare the performance of corporate acquisitions between the pre- and post-SOX periods, using both short-term and long-term analyses. Design/methodology/approach The sample includes 9,463 mergers and tender offers undertaken by publicly traded US firms between 1996 and 2009. The authors used the standard event study methodology for short-term performance analysis; Berkovitch and Narayanan (1993) method to identify merger motives; and standard benchmark adjusted return on assets (sales) (Barber and Lyon, 1996) and buy-and-hold abnormal returns (Mitchell and Stafford, 2000) to analyze long-term performance. Findings Compared to the pre-SOX period, US acquirers experience significantly higher announcement returns in the post-SOX period; the results are robust to various controls like bidder, target and deal characteristics, bidder management quality, and product market competition. Similar results (in favor of post-SOX US acquirers) are obtained with long-term post-acquisition operating and stock performance analyses. Research limitations/implications This paper only addressed domestic acquisitions. Originality/value This paper adds to the growing body of research on the impact of SOX on publicly traded US corporations. By examining corporate acquisitions, an important long-term investment decision for a firm, the paper shows that despite the complex nature of SOX, substantial compliance costs and the unintended negative consequence it engendered, the act had a beneficial impact in an important area of corporate finance.


2016 ◽  
Vol 39 ◽  
Author(s):  
Mary C. Potter

AbstractRapid serial visual presentation (RSVP) of words or pictured scenes provides evidence for a large-capacity conceptual short-term memory (CSTM) that momentarily provides rich associated material from long-term memory, permitting rapid chunking (Potter 1993; 2009; 2012). In perception of scenes as well as language comprehension, we make use of knowledge that briefly exceeds the supposed limits of working memory.


Author(s):  
D.E. Loudy ◽  
J. Sprinkle-Cavallo ◽  
J.T. Yarrington ◽  
F.Y. Thompson ◽  
J.P. Gibson

Previous short term toxicological studies of one to two weeks duration have demonstrated that MDL 19,660 (5-(4-chlorophenyl)-2,4-dihydro-2,4-dimethyl-3Hl, 2,4-triazole-3-thione), an antidepressant drug, causes a dose-related thrombocytopenia in dogs. Platelet counts started to decline after two days of dosing with 30 mg/kg/day and continued to decrease to their lowest levels by 5-7 days. The loss in platelets was primarily of the small discoid subpopulation. In vitro studies have also indicated that MDL 19,660: does not spontaneously aggregate canine platelets and has moderate antiaggregating properties by inhibiting ADP-induced aggregation. The objectives of the present investigation of MDL 19,660 were to evaluate ultrastructurally long term effects on platelet internal architecture and changes in subpopulations of platelets and megakaryocytes.Nine male and nine female beagle dogs were divided equally into three groups and were administered orally 0, 15, or 30 mg/kg/day of MDL 19,660 for three months. Compared to a control platelet range of 353,000- 452,000/μl, a doserelated thrombocytopenia reached a maximum severity of an average of 135,000/μl for the 15 mg/kg/day dogs after two weeks and 81,000/μl for the 30 mg/kg/day dogs after one week.


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