Trends in individual reimbursement of orphan drugs in Latvia in 2008-2011

Orphan drugs (ODs) are medicinal products intended for diagnosis, prevention or treatment of life-threatening or very serious diseases affecting less than 5 in 10 000 people in the European Union (EU). These drugs are called "orphans" because the pharmaceutical industry has little interest, under normal market conditions, in developing and marketing products intended for only a small number of patients suffering from very rare conditions. Because of the small market, ODs are often very expensive. Whereas decisions surrounding orphan designation and marketing authorization of ODs are taken at the EU level, decisions governing pricing and reimbursement of ODs are a member state responsibility. In Latvia drug reimbursement covers drugs which are included in the national reimbursement drug list or, based on the medical council's decision, drugs can also be reimbursed within the framework of individual reimbursement system with limit of 10 000 LVL (C14 229) per patient per year. Due to the big costs and the small number of patients ODs are often not included in the reimbursement list and therefore are reimbursed individually.publishersversionPeer reviewe

Characteristics of clinical trials in rare vs. common diseases : A register-based Latvian study

Publisher Copyright: © 2018 Logviss et al. This is an open ccess article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and eproduction in any medium, provided the original author and source are credited.Background Conducting clinical studies in small populations may be very challenging; therefore quality of clinical evidence may differ between rare and non-rare disease therapies. Objective This register-based study aims to evaluate the characteristics of clinical trials in rare diseases conducted in Latvia and compare them with clinical trials in more common conditions. Methods The EU Clinical Trials Register (clinicaltrialsregister.eu) was used to identify interventional clinical trials related to rare diseases (n = 51) and to compose a control group of clinical trials in non-rare diseases (n = 102) for further comparison of the trial characteristics. Results We found no significant difference in the use of overall survival as a primary endpoint in clinical trials between rare and non-rare diseases (9.8% vs. 13.7%, respectively). However, clinical trials in rare diseases were less likely to be randomized controlled trials (62.7% vs. 83.3%). Rare and non-rare disease clinical trials varied in masking, with rare disease trials less likely to be double blind (45.1% vs. 63.7%). Active comparators were less frequently used in rare disease trials (36.4% vs. 58.8% of controlled trials). Clinical trials in rare diseases enrolled fewer participants than those in non-rare diseases: In Latvia (mean 18.3 vs. 40.2 subjects, respectively), in the European Economic Area (mean 181.0 vs. 626.9 subjects), and in the whole clinical trial (mean 335.8 vs. 1406.3 subjects). Although, we found no significant difference in trial duration between the groups (mean 38.3 vs. 36.4 months). Conclusions The current study confirms that clinical trials in rare diseases vary from those in non-rare conditions, with notable differences in enrollment, randomization, masking, and the use of active comparators. However, we found no significant difference in trial duration and the use of overall survival as a primary endpoint.publishersversionPeer reviewe

Translation and translating in German studies : a festschrift for Raleigh Whitinger /

"These essays in honour of Raleigh Whitinger examine perspectives on translation and German Studies. Specifically, they explore processes of identity formation, gendered representations, visual and textual meditations, and teaching and learning practices."--Met bibl. ref. en index.The task of the translator : Walter Benjamin's Über-setzen in cross-cultural practice / Gisela Brinker-Gabler -- Reconceptualizing "world literature" : a bilingual Platonic dialogue between literary and translation studies / Elisabeth Herrmann and Chantal Wright -- Vegetable genius and the loves of the plants : botany in German poetry around 1800 / Linda Dietrick -- Some thoughts on translating Eichendorff's poetry / Robert O. Goebel -- Intertextuality, gender, and teaching "German" in English / Adrian Del Caro -- Translating Hedwig Dohm / Eva Guenther -- Translating a life in exile : reflections on Johanna Kinkel / Angela Sacher -- Translating the Third Reich : the quiet twin / Florentine Strzelczyk -- Heimat on the range vs. Kosmo noir : Edgar Wallace, Karl May, and post-Second World War German cinematic translations of Anglo-American popular culture / Markus Reisenleitner -- Translating pain : real to reel. Memory, mediation, and (re)-mediation in the films of Sibylle Schönemann / Ute Lischke -- Translating Pina for Pina / Carrie Smith-Prei -- Before sunrise : a transmedial cultural translation of Vienna / Susan Ingram -- "Einmal die Heimat verloren -- für immer die Heimat verloren" : Peter Handke's Immer noch Sturm and the search for home and identity / Nicole Perry -- Moving from transcultural literature to literature of movement in Der Weltensammler by Ilija Trojanow / Katelyn Petersen -- Cultural mediation in the global age : integrating translations into literary scholarship / James M. Skidmore -- Experiential education and acts of translation / Jean Wilson -- Kissing the frog : reframing translation in the language classroom / Paul M. Malone and Barbara Schmenk -- Two-stage collaborative translation in language learning and assessment / Caroline L. Rieger -- What new music? On versions of the translating self of study abroad / John L. Plews, Kim Misfeldt, and Feisal Kirumira."These essays in honour of Raleigh Whitinger examine perspectives on translation and German Studies. Specifically, they explore processes of identity formation, gendered representations, visual and textual meditations, and teaching and learning practices."-