Pharmaceutical regulation in 15 European countries: review

In the context of pharmaceutical care, policy-makers repeatedly face the challenge of balancing patient access to effective medicines with affordability and rising costs. With the aim of guiding the health policy discourse towards questions that are important to actual and potential patients, this study investigates a broad range of regulatory measures, spanning marketing authorization to generic substitution and resulting price levels in a sample of 16 European health systems (Austria, Belgium, Denmark, England, Finland, France, Germany, Greece, Ireland, Italy, the Netherlands, Poland, Portugal, Scotland, Spain and Sweden). All countries employ a mix of regulatory mechanisms to contain pharmaceutical expenditure and ensure quality and efficiency in pharmaceutical care, albeit with varying configurations and rigour. This variation also influences the extent of publicly financed pharmaceutical costs. Overall, observed differences in pharmaceutical expenditure should be interpreted in conjunction with the differing volume and composition of consumption and price levels, as well as dispensation practices and their impact on measurement of pharmaceutical costs. No definitive evidence has yet been produced on the effects of different cost-containment measures on patient outcomes. Depending on the foremost policy concerns in each country, different levers will have to be used to enable the delivery of appropriate care at affordable prices

Introduction and utilization of high priced HCV medicines across Europe : implications for the future

Background: Infection with the Hepatitis C Virus (HCV) is a widespread transmittable disease with a diagnosed prevalence of 2.0%. Fortunately, it is now curable in most patients. Sales of medicines to treat HCV infection grew 2.7% per year between 2004 and 2011, enhanced by the launch of the protease inhibitors (PIs) boceprevir (BCV) and telaprevir (TVR) in addition to ribavirin and pegylated interferon (pegIFN). Costs will continue to rise with new treatments including sofosbuvir, which now include interferon free regimens. Objective: Assess the uptake of BCV and TVR across Europe from a health authority perspective to offer future guidance on dealing with new high cost medicines. Methods: Cross-sectional descriptive study of medicines to treat HCV (pegIFN, ribavirin, BCV and TVR) among European countries from 2008 to 2013. Utilization measured in defined daily doses (DDDs)/1000 patients/quarter (DIQs) and expenditure in Euros/DDD. Health authority activities to influence treatments categorized using the 4E methodology (Education, Engineering, Economics and Enforcement). Results: Similar uptake of BCV and TVR among European countries and regions, ranging from 0.5 DIQ in Denmark, Netherlands and Slovenia to 1.5 DIQ in Tayside and Catalonia in 2013. However, different utilization of the new PIs vs. ribavirin indicates differences in dual vs. triple therapy, which is down to factors including physician preference and genotypes. Reimbursed prices for BCV and TVR were comparable across countries. Conclusion: There was reasonable consistency in the utilization of BCV and TVR among European countries in comparison with other high priced medicines. This may reflect the social demand to limit the transmission of HCV. However, the situation is changing with new curative medicines for HCV genotype 1 (GT1) with potentially an appreciable budget impact. These concerns have resulted in different prices across countries, with their impact on budgets and patient outcomes monitored in the future to provide additional guidance

Critères utilisés par les Groupes Techniques Consultatifs Nationaux pour la Vaccination pour établir des recommandations de politique vaccinale (étude bibliographique et sur questionnaire dans 13 pays)

La vaccination, bien qu étant une des interventions de santé publique les plus efficaces qui soit n est malheureusement toujours pas utilisée aujourd hui au maximum de ses capacités. Pour tenter d inverser cette tendance beaucoup de pays dans le monde se dotent de GTCV, institutions indépendantes en charge d élaborer les recommandations vaccinales propres à chaque contexte. Le présent travail a pour objet de décrire les critères utilisés par les GTCV pour élaborer leurs recommandations. Pour cela, nous avons dans un premier temps effectué une revue de la littérature, puis une enquête auprès de 13 GTCV dans le monde. Nous avons constaté qu assez peu d informations sur le sujet sont publiées dans la littérature. Notre enquête rapporte que les caractéristiques épidémiologiques de la maladie ainsi que les caractéristiques des vaccins sont les critères les plus importants dans la prise de décision. Autre élément essentiel, beaucoup de pays utilisent une méthodologie définie pour élaborer leurs décisions, mais très peu la rendent publique, entretenant probablement un sentiment de manque de transparence. Il serait à nos yeux nécessaire que les institutions internationales se saisissent de cette question et tentent d harmoniser les procédures, voire d élaborer une méthodologie validée qui permettrait à l ensemble des GTCV de gagner en transparence, et aux comités qui s établissent de plus en plus d avoir un référentiel leur permettant de démarre leurs activités dans les meilleures conditionsPARIS12-CRETEIL BU Médecine (940282101) / SudocSudocFranceF

La France du Sud-Est (Languedoc-Roussillon, Midi-Pyrénées, Provence-Alpes-Côte d'Azur)

Diese Bilanz von zwei Jahrzehnten Forschung in Südwestfrankreich soll über die vorhandenen Bestandsaufnahmen deutlich hinausgehen. Ungelöste Fragen sollen neu formuliert und dazu jüngste Erkenntnisse über religiöse Vorstellungen und Praktiken im Rahmen eines umfassenden soziokulturellen Ansatzes ins Blickfeld gerückt werden. Fine ausführliche tour d'horizon der unterschiedlichen Kultstätten läβt die entscheidende Rolle der Territorien erkennen und zeigt, wie die der Siedelgemeinschaften bis zu den ersten kulturellen Veränderungen des 2. Jahrh. v. Chr. allmählich an Bedeutung gewinnt. Im beharrlichen Festhalten an Ahnen- und Heroenverehrung erweist sich für diese Region Galliens vom Beginn der Eisenzeit an deutlich das machtvolle Wirken einer gesellschaftlichen Elite bzw. (ab dem 3. Jahrh. v. Chr.) einer Reiteraristokratie. Infolgedessen ist auch der Volksglaube häufig überformt von den religiösen Ausdrucksformen des Strebens nach Rang und Ansehen. Übersetzt vom Stefan WirthThis report of a two decades research in Sout-East France, intends to go beyond the pattern of the previous gazetteers. The purpose is a new definition of the outstanding questions altogether with putting in prospect new established facts in the field of beliefs and practices inside a broad socio-cultural sight. An extensive survey of the different cult sites is presented here and emphasizes the predominant participation of territories and the slow emergence of the part played by settlements until the first cultural mutations in the 2nd century BC. From the assertion of cults to the ancestors and of heroic-cults as soon as the beginning of the Iron Age, this part of Gaul sharply shows the dynamic function of a social elite then of the warrior aristocracy since the 3rd century BC. From then on, the popular devotions will often be absorbed by the growing manifestation of a social valorization.Ce bilan sur les deux décennies de recherches dans le Sud-Est de la France veut dépasser le cadre des inventaires préexistants. Il tente de reformuler les questions en suspens, de mettre également en perspective les acquis récents de la recherche dans le domaine des croyances et de leurs pratiques au sein d'une vision socioculturelle plus large. Un vaste tour d'horizon des différents lieux de culte est réalisé, qui met en valeur la part majeure des territoires et la lente émergence de celle des habitats groupés jusqu'aux premières mutations culturelles du IIe s. avant J.-C. Au travers de l'affirmation des cultes rendus aux ancêtres et aux héros dès le début de l'âge du Fer, cette région de la Gaule révèle avec acuité le rôle dynamique d'une élite sociale, puis d'une aristocratie équestre à partir du IIIe s. avant J.-C. Dès lors, la piété populaire sera souvent absorbée par l'expression croissante de la valorisation sociale.Arcelin Patrice, Gruat Philippe, Boissinot Philippe, Chausserie-Laprée Jean, Dedet Bernard, Ferrando Philippe, Gailledrat Éric, Marchand Georges, Maza Guillaume, Nin Nuria, Paillet Jean-Louis, Roth-Congès Anne, Tréziny Henri. La France du Sud-Est (Languedoc-Roussillon, Midi-Pyrénées, Provence-Alpes-Côte d'Azur). In: Gallia, tome 60, 2003. pp. 169-241

Pharmaceutical policies in a crisis? : Challenges and solutions identified at the PPRI Conference

In October 2015, the third international Pharmaceutical Pricing and Reimbursement Information (PPRI) Conference was held in Vienna to foster discussion on challenges in pricing and reimbursement policies for medicines. The research presented highlighted that commonly used pharmaceutical pricing and reimbursement policies are not sufficiently effective to address current challenges. Conference participants called for fundamental reforms to ensure access to medicines, particularly to new and potentially more effective and/or safe medicines, while safeguarding the financial sustainability of health systems and working towards universal health coverage

Introduction and Utilization of High Priced HCV Medicines across Europe; Implications for the Future

Infection with the Hepatitis C Virus (HCV) is a widespread transmittable disease with a diagnosed prevalence of 2.0%. Fortunately, it is now curable in most patients. Sales of medicines to treat HCV infection grew 2.7% per year between 2004 and 2011, enhanced by the launch of the protease inhibitors (PIs) boceprevir (BCV) and telaprevir (TVR) in addition to ribavirin and pegylated interferon (pegIFN). Costs will continue to rise with new treatments including sofosbuvir, which now include interferon free regimens.status: publishe

How can pricing and reimbursement policies improve affordable access to medicines? Lessons learned from European countries

This article discusses pharmaceutical pricing and reimbursement policies in European countries with regard to their ability to ensure affordable access to medicines. A frequently applied pricing policy is external price referencing. While it provides some benchmark for policy-makers and has been shown to be able to generate savings, it may also contribute to delay in product launch in countries where medicine prices are low. Value-based pricing has been proposed as a policy that promotes access while rewarding useful innovation; however, implementing it has proven quite challenging. For high-priced medicines, managed-entry agreements are increasingly used. These agreements allow policy-makers to manage uncertainty and obtain lower prices. They can also facilitate earlier market access in case of limited evidence about added therapeutic value of the medicine. However, these agreements raise transparency concerns due to the confidentiality clause. Tendering as used in the hospital and offpatent outpatient sectors has been proven to reduce medicine prices but it requires a robust framework and appropriate design with clear strategic goals in order to prevent shortages. These pricing and reimbursement policies are supplemented by the widespread use of Health Technology Assessment to inform decision-making, and by strategies to improve the uptake of generics, and also biosimilars. While European countries have been implementing a set of policy options, there is a lack of thorough impact assessments of several pricing and reimbursement policies on affordable access. Increased cooperation between authorities, experience sharing and improving transparency on price information, including the disclosure of confidential discounts, are opportunities to address current challenges

L’âge du Fer en Basse-Normandie. Gestes funéraires en Gaule au Second-Âge du Fer. Volumes I et II

Cet ouvrage est la publication des actes du 33e colloque international de l’AFEAF, qui s’est tenu à Caen, du 20 au 24 mai 2009. De même que le colloque, il comprend deux parties. La première, qui contient dix-sept contributions, traite de l’actualité des recherches sur l’Âge du fer en Basse-Normandie, une région qui a connu un renouvellement important de la documentation permettant d’appréhender les dynamiques d’occupation et les formes d’organisation territoriale durant la Protohistoire. Plusieurs bilans synthétiques concernant l’habitat rural, les sites fortifiés et la culture matérielle, sont, entre autres, proposés ici. La seconde partie de l’ouvrage traite du thème de la mort et des pratiques funéraires durant la période Ve-Ier siècles avant J.-C. ; elle contient vingt-deux contributions. Ce sujet a été abordé en privilégiant quelques axes de réflexion, de façon à faciliter les comparaisons entre régions. À travers des bilans synthétiques, le thème spécialisé du colloque est traité à l’échelle de la Gaule, avec les éclairages de plusieurs régions de l’Europe celtique.This is the publication of the proceedings of the 33rd AFEAF symposium held in Caen from the 20th to the 24th of May 2009. Like the symposium, this book is divided in two parts. The first part, with its 17 contributions, deals with the current knowledge about the Iron Age in Lower Normandy. An important renewal of the documentation concerning this region allows a better understanding of the occupational processes and territorial organization existing throughout Protohistory. This first part also includes several summary reports on rural settlements, fortified sites as well as finds. The second part of the book, with 22 contributions, deals with the subject of death and funerary practices during the 5th to 1st centuries BC. The subject was discussed focussing on a chosen number of thoughts as to make it easier to compare between different regions. Various summary reports allow an overview of this specialized topic throughout Gaul with perspectives from other regions of Celtic Europe