The impact of European integration on the German system of pharmaceutical product authorization

The European Union has evolved since 1965 into an influential political player in the regulation of pharmaceutical safety standards. The objective of establishing a single European market for pharmaceuticals makes it necessary for member-states to adopt uniform safety standards and marketing authorization procedures. This article investigates the impact of the European integration process on the German marketing authorization system for pharmaceuticals. The analysis shows that the main focal points and objectives of European regulation of pharmaceutical safety have shifted since 1965. The initial phase saw the introduction of uniform European safety standards as a result of which Germany was obliged to undertake “catch-up” modernization. From the mid-1970s, these standards were extended and specified in greater detail. Since the mid-1990s, a process of reorientation has been under way. The formation of the European Agency for the Evaluation of Medicinal Products (EMEA) and the growing importance of the European authorization procedure, combined with intensified global competition on pharmaceutical markets, are exerting indirect pressure for EU member-states to adjust their medicines policies. Consequently, over the past few years Germany has been engaged in a competition-oriented reorganization of its pharmaceutical product authorization system the outcome of which will be to give higher priority to economic interests.Die Europäische Gemeinschaft ist in der Regulierung der Arzneimittelsicherheit seit 1965 zu einem einflussreichen politischen Akteur geworden. Das Ziel eines einheitlichen europäischen Marktes für Arzneimittel erfordert eine Vereinheitlichung der Sicherheitsstandards und Zulassungsverfahren in den Mitgliedstaaten. Im folgenden Beitrag wird der Frage nachgegangen, welche Auswirkungen der Prozess der Europäischen Integration auf das System der Arzneimittelzulassung in Deutschland hat. Es wird deutlich, dass sich die Schwerpunkte und Zielsetzungen der europäischen Regulierung der Arzneimittelsicherheit seit 1965 verschoben haben. Nach einer ersten Phase der Etablierung einheitlicher europäischer Sicherheitsstandards, die in Deutschland eine nachholende Modernisierung erforderlich machten, wurden diese Standards seit Mitte der 1970er Jahre ausgebaut und präzisiert. Seit Mitte der 1990er Jahre kommt es zu einer Neuausrichtung. Die Errichtung der europäischen Arzneimittelagentur EMEA und der Bedeutungsgewinn der europäischen Zulassungsverfahren erzeugen in Verbindung mit dem verschärften globalen Wettbewerb auf den Arzneimittelmärkten einen mittelbaren Anpassungsdruck auf die nationalen Arzneimittelpolitiken. In der Konsequenz wird in Deutschland seit einigen Jahren eine wettbewerbsorientierte Umgestaltung der Arzneimittelzulassung betrieben, die zu einer Aufwertung ökonomischer Interessen im Zulassungssystem führt

Wonders of Nature and Artifice

A stuffed blowfish, a meticulously-drawn insect, a ravishing lily, and a rhinoceros horn carved with scenes of plants and animals—these were among the wonders of nature and artifice, the marvels that fueled the Renaissance quest for knowledge. This exhibition explores the intellectual and aesthetic motivations of Renaissance naturalists and collectors, whose wonders of nature and artifice were displayed in elaborate gardens, illustrated books, and remarkable cabinets of curiosities. Collectors were driven by curiosity and a sense of wonder about what seemed to be an ever-expanding world. Students from Prof. Felicia Else’s upper-level art history course and Kay Etheridge’s First Year Seminar will draw connections between art and science, and curate a Renaissance-inspired “Chamber of Wonders” in Schmucker Art Gallery with resources from Gettysburg College’s Fine Arts and Special Collections, departments across campus, and individual loans. More informationhttps://cupola.gettysburg.edu/artcatalogs/1022/thumbnail.jp

Recent Acquisitions, 2007-2017: Selections from the Gettysburg College Fine Arts Collection

This exhibition reflects the breadth of Gettysburg College’s significant art collection and acknowledges the generosity of its donors. Major acquisitions have been made possible by The Michael J. Birkner \u2772 and Robin Wagner Art and Photography Acquisition Fund, which was established in 2013 to enhance the Gettysburg College curriculum, to offer curatorial opportunities for students, and to provide first-hand access to significant works of art. Purchases made possible by this endowment include works by prominent, internationally renowned artists Kara Walker, Wafaa Bilal, John Biggers, and Michael Scoggins. Other recent donations include important works by Andy Warhol, Glenn Ligon, Leonard Baskin, Raphael Soyer, Marion Greenwood, William Clutz, William Mason Brown, Sally Gall, and Jules Cheret’s Les Maîtres de l\u27Affiche lithographs. The Fine Arts Collection at Gettysburg College is comprised of over 500 museum-quality works, in addition to over 2000 Asian art objects that are featured routinely in Schmucker Art Gallery exhibitions and studied in Gettysburg College courses. The College has acquired over 200 fine art works in the past ten years, and this exhibition marks the first occasion to celebrate and view the scope of the collection. Some of the objects have been featured in recent exhibitions, while others, including large-scale color silkscreens by Andy Warhol and a rare print by MacArthur “Genius” Award recipient Carrie Mae Weems, have not yet been exhibited.https://cupola.gettysburg.edu/artcatalogs/1024/thumbnail.jp

The Effect of Medetomidine on the Burying Speed of Corbicula fluminea

A new anti-fouling drug, medetomidine, was tested to determine if it reduced the burying speed of a freshwater alien-invasive bivalve species, Corbicula fluminea. Corbicula are known to damage underwater structures and must be managed with chemical paints. The burying speeds of Corbicula were measured both before and after exposure to two different concentrations of medetomidine. The burying speed of Corbicula before exposure to a 1x10-6 M medetomidine solution was not significantly different from the burying speed after exposure (t=.55, df=21, p=.588). The burying speed of Corbicula was significantly slower after exposure to a 1x10-5 M medetomidine solution than before exposure (t=4.08, df=8, p\u3c.01). The results of this study indicated that medetomidine could be effective against Corbicula at concentrations higher than 1x10-5 M due to sedation of the foot muscles involved with burying. If so, medetomidine could be a superior chemical for anti-fouling applications compared to older, more toxic compounds

The Role of the Emerging Countries in the G20: Agenda-setter, Veto Player or Spectator? Bruges Regional Integration & Global Governance Paper 2/2011

In 2008, the G20 convened for the first time at leaders’ level, making emerging countries such as China, India and Brazil permanent members of an informal gathering at the highest political level. The aim of this paper is to refine previous assessments on the role of these emerging countries in the new G20. We first analyse the preferences of the United States and European members as a proxy for G8 positions and then juxtapose them with the preferences of China, India and Brazil as representatives of the emerging countries within the G20. We find that the latter share in particular the concern for more voice in global economic governance but – due to often heterogeneous preferences – do not generally act as a bloc. Moreover, by comparing their preferences with G20 outcomes, the paper investigates to what extent the emerging countries have agenda-setting or veto power, or whether they are taking a back-seat role among the G20 countries. We show that they are not mere spectators but have a certain agenda-setting power, especially when they are able to forge coalitions or hold the presidency

Flow processes in overexpanded chemical rocket nozzles. Part 3: Methods for the aimed flow separation and side load reduction

Methods aimed at reduction of overexpansion and side load resulting from asymmetric flow separation for rocket nozzles with a high opening ratio are described. The methods employ additional measures for nozzles with a fixed opening ratio. The flow separation can be controlled by several types of nozzle inserts, the properties of which are discussed. Side loads and overexpansion can be reduced by adapting the shape of the nozzle and taking other additional measures for controlled separation of the boundary layer, such as trip wires

Flow processes in overexpanded chemical rocket nozzles. Part 1: Flow separation

An investigation was made of published nozzle flow separation data in order to determine the parameters which affect the separation conditions. A comparison of experimental data with empirical and theoretical separation prediction methods leads to the selection of suitable equations for the separation criterion. The results were used to predict flow separation of the main space shuttle engine

Medicaid's Future: What Might ACA Repeal Mean?

Issue: Republicans in Congress are expected to repeal portions of the Affordable Care Act (ACA) using a fast-track process known as budget reconciliation.Goals: This issue brief examines how repeal legislation could affect Medicaid, the nation's health care safety net, which insured 70 million people in 2016.Findings and Conclusions: Partial-repeal legislation that passed Congress but was vetoed by President Obama in 2016 offers some insight but new legislation could go further. It could repeal the ACA's Medicaid eligibility expansions for adults and children but also roll back other provisions, such as simplified enrollment and improvements in long-term services and supports for beneficiaries with disabilities. Additionally, the Trump Administration could expand use of demonstration authority to introduce deeper structural changes into Medicaid, such as eligibility restrictions tied to work, required premium contributions and lock-out for nonpayment, annual enrollment periods, and coverage limits and exclusions. Together, these changes would have far-reaching implications for Medicaid's continued role as the nation's safety-net insurer

Die Regulierung der Arzneimittelsicherheit im Prozess der europäischen Integration

Hintergrund: Im vorzustellenden Projekt wird der Frage nachgegangen, welche Auswirkungen die Europäisierung der Arzneimittelpolitik auf die in Deutschland gültigen Sicherheitsstandards hat. Die Festlegung von Sicherheitsstandards geschieht einerseits hinsichtlich der Zulassung von Arzneimitteln (Nachweis von Qualität, Wirksamkeit und Unbedenklichkeit). Zudem wird das Nutzen-Risiko-Verhältnis bereits zugelassener Präparate in einem System der Nachmarktkontrolle (Pharmakovigilanz) beobachtet, um unerwünschte Arzneimittelwirkungen erfassen und gegebenenfalls darauf reagieren zu können. Die Europäische Kommission bemüht sich seit mehreren Jahrzehnten um eine Vereinheitlichung der Arzneimittelzulassung innerhalb der EU. Beabsichtigt ist die Herstellung eines einheitlichen europäischen Arzneimittelmarktes. Im Netzwerk europäischer Arzneimittelpolitik sind die pharmazeutischen Hersteller ein einflussreicher Akteur. Mit der Dominanz industrieller Interessen ist die Befürchtung verbunden, dass das Ziel der Arzneimittelsicherheit gegenüber ökonomischen Interessen in den Hintergrund tritt. Eine mögliche Konsequenz wäre die Aufweichung von Standards auf der nationalen Ebene. Material/Methoden: Die Auswirkungen der Europäisierung der Arzneimittelpolitik auf die Sicherheitsstandards werden mittels einer Dokumentenanalyse erfasst. Das untersuchte Material setzt sich einerseits aus den europäischen Rechtsetzungsakten (Verordnungen, Richtlinien, Leitlinien), andererseits aus den daraus abzuleitenden Veränderungen in deutschen Gesetzen und Verordnungen zusammen. Beginnend mit der ersten europäischen Verordnung im Jahr 1965 und ihren Konsequenzen für das deutsche Arzneimittelgesetz bis zur Etablierung und Revision europäischer Zulassungsverfahren wird anhand der relevanten Dokumente die Entwicklung der Sicherheitsstandards im Europäisierungsprozess nachvollzogen. Ergebnisse/Diskussion: Erste Untersuchungsergebnisse weisen darauf hin, dass die schrittweise Europäisierung der Arzneimittelregulierung für Deutschland in der Tendenz eine Erhöhung von Sicherheitsstandards zur Folge hatte. Der Prozess verlief in unterschiedlichen Phasen und bewirkte in seinen Anfängen seit Mitte der 1960er Jahre eine nachholende Einführung sowie eine kontinuierliche Weiterentwicklung regulativer Standards. Mit der Forcierung des europäischen Binnenmarktprojektes Mitte der 1980er Jahre zeichnet sich eine stärkere industriepolitische Akzentuierung ab. Die Arzneimittelzulassung wird zunehmend hinsichtlich ihrer Wirkung auf die globale Wettbewerbsfähigkeit der europäischen Hersteller bewertet. Jüngere Entwicklungen rücken die Beschleunigung und Entbürokratisierung der Verfahren in den Mittelpunkt

Einig und geschlossen? : Unternehmer in der politischen Öffentlichkeit

Neben dem alltagsbegrifflichen Verständnis der "Unternehmer", das deren Lagerbildung und Interessenhomogenität unterstellt, lassen sich bei genauerem Hinsehen immer schon interne Differenzierungen erkennen, erfassbar v.a. mit der Kategorie der "Kapitalfraktionen". Öffentliche politische Interventionen des "Unternehmerlagers" erscheinen wiederum auf den ersten Blick homogen. Rolf Schmucker zeigt empirisch, dass auch dieser Blick trügt