Machine generated contents note:Method or the next step: From Existential toward Social Phenomenology --ch. OneSociality: The I and the Other --1.1.Ontology and/or ethics. Is ontology fundamental? --1.2.How to think humanitas of homo humanus? --1.3.Subjectness --1.4.Time and death --a).Existential Time --b).Historical time --c).Eschatological Time --1.5.In the beginning was the Word with the Other --1.6.Heidegger and Levinas on the path to language --a).Martin Heidegger --b).Emmanuel Levinas --c).Heidegger and/or Levinas --ch. TwoOther and the Third One --2.1.Third One --2.2.Ethical and the Political. Justice and the State --2.3.Kant and Levinas on the Categorical Imperative --2.4.Paul Ricoeur on justice -- virtue and institution. Revision from Levinas' perspective --2.5.Jean-Francois Lyotard: prescription, description and norm --ch. ThreeFrom the Command to the Norm --3.1.Replacing the prescription (the command, the order, the appeal) with the norm --3.2.neo-liberal notion of justice --3.2.Communitarian notion of justice.
Maria Dimitrova (Sofia University, Bulgaria) in response to Jerard Bensussan (University of Strasbourg, France), Jeffrey Andrew Barash (University of Amiens, France), Jacob Rogozinski (University of Strasbourg, France) and Ernst Wolff (University of Pretoria, South Africa) commenting on Emmanuel Levinas' philosophy. This book is essential reading for those interested in the current debates in ethics, metaphysics, and social and political philosophy. The discussed issues are presented from th
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Despite the early access procedures for marketing authorization (MA) valid throughout the European Union still in the most of the Member states patient access to innovative medicines depends on cost-effectiveness, budget impact assessment and negotiations for price discount with the public payers. Retrospective analysis on the availability and time to market access of medicines authorized under the European medicines agency's specific procedures for early access shows that despite the shortening of the time to market access after 2013, for most medicines still exceeds 365 days. This is due to the fact that requirements for pricing and reimbursement across EU is fixed to some degree and medicines with MA for early access are subject to the same legal requirements as the medicines with standard centralized marketing authorization. Some specific national legal requirements for pricing and reimbursement decisions, population of interest and manufactures intentions to enter certain markets should also be considered.
Despite the early access procedures for marketing authorization (MA) valid throughout the European Union still in the most of the Member states patient access to innovative medicines depends on cost-effectiveness, budget impact assessment and negotiations for price discount with the public payers. Retrospective analysis on the availability and time to market access of medicines authorized under the European medicines agency's specific procedures for early access shows that despite the shortening of the time to market access after 2013, for most medicines still exceeds 365 days. This is due to the fact that requirements for pricing and reimbursement across EU is fixed to some degree and medicines with MA for early access are subject to the same legal requirements as the medicines with standard centralized marketing authorization. Some specific national legal requirements for pricing and reimbursement decisions, population of interest and manufactures intentions to enter certain markets should also be considered.
Funding: This trial was funded by the National Institute for Health Research (NIHR), Health Technology Assessment programme (project No 11/71/03). The Chief Scientist Office, Scottish Government Health and Social Care Directorates funded SH's post, and the NIHR Collaboration for Leadership in Applied Health Research and Care South West Peninsula at the Royal Devon and Exeter NHS Foundation Trust supported SD. The study funders had no role in the study design, data collection, data analysis, data interpretation, writing of the manuscript, or decision to submit for publication. The research team was independent from the funders. All authors had access to all study data and take responsibility for its integrity and the accuracy of the data analysis. The views expressed in this publication are those of the authors and not necessarily those of the National Health Service, the NIHR, or the Department of Health and Social Care. The trial sponsor was Glasgow Caledonian University. Data sharing: Individual participant data collected for this trial, and a data dictionary defining each field in the dataset, will be made available to others; all available data will be de-identified participant data. The protocol, statistical analysis plan, informed consent form, and ethics committee approval are available (https://www.journalslibrary.nihr.ac.uk/programmes/hta/117103/#/). To access data, a request should be submitted to the corresponding author (s.hagen@gcu.ac.uk) with a scientific proposal including objectives. Written proposals will be assessed by members of the trial steering committee and a decision made about the appropriateness of the request. The data will only be shared after the data sharing agreement is fully executed. ; Peer reviewed ; Publisher PDF
Background: Across European countries, differences exist in biosimilar policies, leading to variations in uptake of biosimilars and divergences in savings all over Europe. Objectives: The aim of this article is to provide an overview of different initiatives and policies that may influence the uptake of biosimilars in different European countries. Recommendations will be formulated on how to create sustainable uptake. Methods: An overview of policies on biosimilars was obtained via a questionnaire, supplemented with relevant articles. Topics were organized in five themes: availability, pricing, reimbursement, demand-side policies, and recommendations to enhance uptake. Results: In all countries studied, biological medicines are available. Restrictions are mainly dependent on local organization of the healthcare system. Countries are willing to include biosimilars for reimbursement, but for commercial reasons they are not always marketed. In two thirds of countries, originator and biosimilar products may be subjected to internal reference pricing systems. Few countries have implemented specific incentives targeting physicians. Several countries are implementing pharmacist substitution; however, the scope and rules governing such substitution tend to vary between these countries. Reported educational policies tend to target primarily physicians, whereas fewer initiatives were reported for patients. Recommendations as proposed by the different country experts ranged from the need for information and communication on biosimilars to competitive pricing, more support for switching and guidance on substitution. Conclusions: Most countries have put in place specific supply-side policies for promoting access to biosimilars. To supplement these measures, we propose that investments should be made to clearly communicate on biosimilars and educate stakeholders. Especially physicians need to be informed on the entry and use of biosimilars in order to create trust. When physicians are well-informed on the treatment options, further incentives should be offered to prescribe biosimilars. Gainsharing can be used as an incentive to prescribe, dispense or use biosimilars. This approach, in combination with binding quota, may support a sustainable biosimilar market. ; peer-reviewed
Background: From October 2018, adalimumab biosimilars could enter the European market. However, in some countries, such as Netherlands, high discounts reported for the originator product may have influenced biosimilar entry. Objectives: The aim of this paper is to provide a European overview of (list) prices of originator adalimumab, before and after loss of exclusivity; to report changes in the reimbursement status of adalimumab products; and discuss relevant policy measures. Methods: Experts in European countries received a survey consisting of three parts: 1) general financing/co-payment of medicines, 2) reimbursement status and prices of originator adalimumab, and availability of biosimilars, and 3) policy measures related to the use of adalimumab. Results: In May 2019, adalimumab biosimilars were available in 24 of the 30 countries surveyed. Following introduction of adalimumab biosimilars, a number of countries have made changes in relation to the reimbursement status of adalimumab products. Originator adalimumab list prices varied between countries by a factor of 2.8 before and 4.1 after loss of exclusivity. Overall, list prices of originator adalimumab decreased after loss of exclusivity, although for 13 countries list prices were unchanged. When reported, discounts/rebates on originator adalimumab after loss of exclusivity ranged from 0% to approximately 26% (Romania), 60% (Poland), 80% (Denmark, Italy, Norway), and 80–90% (Netherlands), leading to actual prices per pen or syringe between €412 (Finland) and €50 – €99 (Netherlands). To leverage competition following entry of biosimilar adalimumab, only a few countries adopted measures specifically for adalimumab in addition to general policies regarding biosimilars. In some countries, a strategy was implemented even before loss of exclusivity (Denmark, Scotland), while others did not report specific measures. Conclusion: Even though originator adalimumab is the highest selling product in the world, few countries have implemented specific policies and practices for (biosimilar) adalimumab. Countries with biosimilars on the market seem to have competition lowering list or actual prices. Reported discounts varied widely between countries. ; peer-reviewed
