Suchergebnisse

Introduction: The participation of Spain in clinical trials is a reliable proof of its development in I+D in the health sector and of trying to follow at the vanguard of medical research. The new Regulation of the European Parliament and of the Council on Clinical Trials on medicines for human use (EU Regulation 536/2014, 16th April) derogates the legislation currently in force (Directive 2001/20/EC, 4th April) and it obliges to modify the Spanish Royal Decree (RD 223/2004, 16th February) to develop those aspects that are left in the hands of national legislation. Objetives: To analyze the main changes introduced by the new RD in clinical research (RD 1090/2015, 4th December), which regulates clinical trials with medicines, the Committees on Ethics of Research with Medicines (CERm) and the Spanish Registry of Clinical Trials and to compare them with the previous legislation. Material and methods: RD 1090/2015, 4th December was analyzed against RD 223/2004, 16th February, and the most important differences between the two regulations were compared. Results: The new regulatory development introduces important innovations. It opens the option for the unification of the analysis of the applications, so that, together with the authorization of the clinical trial issued by the SAMHP, it is only necessary that an accredited CERm emits its positive opinion that it will be binding. It regulates new definitions, such as the low-level clinical trial, subject to less stringent standards. It differentiates between Research Ethics Committee (REC) and CERm, establishing additional requirements to move from being REC to CERm. It defines non-commercial clinical research (in which the sponsor is a university, hospital, public scientific organization, non-profit organization, patient organization or individual researcher without involvement of the pharmaceutical industry). It opens the option to contract a clinical trial prior to its authorization. It defines compensation for damages and how the evaluation of clinical trials is conducted. It incorporates the figure of the legally designated representative for incapable and minor subjects. It stipulates the conditions in situations of urgency, pregnant and periods of lactation as well as informed consent. The main novelty is the single dossier of the two-part clinical trial, one for European Union (Part I) and another one for National Documentation (Part II). All data must be sent to a database and a European public access web portal. Conclusions: The new regulation proposes to give an important impulse to the clinical research in Spain with medicines, simplifying the administrative obstacles and speeding up the realization of multicentric studies simultaneously in all Europe. It improves the delimitation of the responsibilities of the agents involved, it increases the safety of the test subjects, and at the same time, it increases the efficiency in the evaluation and communication processes involved. ; Introducción: La participación de España en ensayos clínicos es una prueba fehaciente de su desarrollo en I+D en el sector salud y de intentar seguir a la vanguardia en cuanto a investigación médica se refiere. El nuevo reglamento del Parlamento Europeo y del Consejo sobre ensayos clínicos de medicamentos de uso humano (Reglamento UE 536/2014, de 16 de abril) deroga la legislación hasta ahora vigente (Directiva 2001/20/CE, de 4 de abril) obligando a modificar el Real Decreto español (RD 223/2004, de 16 de febrero), desarrollando aquellos aspectos que se dejan en mano de la legislación nacional. Objetivo: Analizar las principales modificaciones introducidas por el nuevo RD en investigación clínica (RD 1090/2015, de 4 de diciembre) que regula los ensayos clínicos con medicamentos, los Comités de Ética de la Investigación con medicamentos (CEIm) y el Registro español de ensayos clínicos y compararlas respecto a la normativa anterior. Material y Métodos: Se revisaron los RD 1090/2015, de 4 de diciembre y 223/2004, de 16 de febrero y se compararon las diferencias más destacables entre ambas normativas. Resultados: El nuevo desarrollo normativo introduce novedades importantes. Se abre la opción para la unificación del análisis de las solicitudes, de manera que junto con la autorización del ensayo clínico emitida por la AEMPS, únicamente haga falta que un CEIm acreditado emita su dictamen positivo que será vinculante. Regula nuevas definiciones, como la de ensayo clínico de bajo nivel de intervención, sujeto a normas menos rigurosas. Diferencia entre Comité de ética de la investigación (CEI) y CEIm, estableciendo los requisitos adicionales para pasar de ser CEI a CEIm. Define investigación clínica sin ánimo comercial (en la que el promotor es una universidad, hospital, organización científica pública, organización sin ánimo de lucro, organización de pacientes o investigador individual sin participación de la industria farmacéutica). Abre la opción de contratar un ensayo clínico previamente a su autorización. Define las indemnizaciones por daños y cómo se lleva a cabo la evaluación de los ensayos clínicos. Incorpora la figura del representante legalmente designado para sujetos incapaces y menores. Estipula las condiciones en situaciones de urgencia, embarazadas y periodos de lactancia así como del consentimiento informado. La principal novedad es el expediente único del ensayo clínico con dos partes, una de documentación para la Unión Europea (parte I) y otra de documentación nacional (parte II). Todos los datos tienen que ser enviados a una base de datos y un portal web de la Unión Europea de acceso público. Conclusiones: La nueva normativa propone dar un importante impulso a la investigación clínica en España con medicamentos, simplificando las trabas administrativas y agilizando la realización de estudios multicéntricos simultáneos en toda Europa. Mejora la delimitación de responsabilidades de los agentes que participan, aumenta la seguridad de los sujetos del ensayo, y a la vez, incrementa la eficiencia en los procesos de evaluación y comunicación implicados.

Introducción: La participación de España en ensayos clínicos es una prueba fehaciente de su desarrollo en I+D en el sector salud y de intentar seguir a la vanguardia en cuanto a investigación médica se refiere. El nuevo reglamento del Parlamento Europeo y del Consejo sobre ensayos clínicos de medicamentos de uso humano (Reglamento UE 536/2014, de 16 de abril) deroga la legislación hasta ahora vigente (Directiva 2001/20/CE, de 4 de abril) obligando a modificar el Real Decreto español (RD 223/2004, de 16 de febrero), desarrollando aquellos aspectos que se dejan en mano de la legislación nacional. Objetivo: Analizar las principales modificaciones introducidas por el nuevo RD en investigación clínica (RD 1090/2015, de 4 de diciembre) que regula los ensayos clínicos con medicamentos, los Comités de Ética de la Investigación con medicamentos (CEIm) y el Registro español de ensayos clínicos y compararlas respecto a la normativa anterior. Material y Métodos: Se revisaron los RD 1090/2015, de 4 de diciembre y 223/2004, de 16 de febrero y se compararon las diferencias más destacables entre ambas normativas. Resultados: El nuevo desarrollo normativo introduce novedades importantes. Se abre la opción para la unificación del análisis de las solicitudes, de manera que junto con la autorización del ensayo clínico emitida por la AEMPS, únicamente haga falta que un CEIm acreditado emita su dictamen positivo que será vinculante. Regula nuevas definiciones, como la de ensayo clínico de bajo nivel de intervención, sujeto a normas menos rigurosas. Diferencia entre Comité de ética de la investigación (CEI) y CEIm, estableciendo los requisitos adicionales para pasar de ser CEI a CEIm. Define investigación clínica sin ánimo comercial (en la que el promotor es una universidad, hospital, organización científica pública, organización sin ánimo de lucro, organización de pacientes o investigador individual sin participación de la industria farmacéutica). Abre la opción de contratar un ensayo clínico previamente a su autorización. Define las indemnizaciones por daños y cómo se lleva a cabo la evaluación de los ensayos clínicos. Incorpora la figura del representante legalmente designado para sujetos incapaces y menores. Estipula las condiciones en situaciones de urgencia, embarazadas y periodos de lactancia así como del consentimiento informado. La principal novedad es el expediente único del ensayo clínico con dos partes, una de documentación para la Unión Europea (parte I) y otra de documentación nacional (parte II). Todos los datos tienen que ser enviados a una base de datos y un portal web de la Unión Europea de acceso público. Conclusiones: La nueva normativa propone dar un importante impulso a la investigación clínica en España con medicamentos, simplificando las trabas administrativas y agilizando la realización de estudios multicéntricos simultáneos en toda Europa. Mejora la delimitación de responsabilidades de los agentes que participan, aumenta la seguridad de los sujetos del ensayo, y a la vez, incrementa la eficiencia en los procesos de evaluación y comunicación implicados. ; Introduction: The participation of Spain in clinical trials is a reliable proof of its development in I+D in the health sector and of trying to follow at the vanguard of medical research. The new Regulation of the European Parliament and of the Council on Clinical Trials on medicines for human use (EU Regulation 536/2014, 16th April) derogates the legislation currently in force (Directive 2001/20/EC, 4th April) and it obliges to modify the Spanish Royal Decree (RD 223/2004, 16th February) to develop those aspects that are left in the hands of national legislation. Objetives: To analyze the main changes introduced by the new RD in clinical research (RD 1090/2015, 4th December), which regulates clinical trials with medicines, the Committees on Ethics of Research with Medicines (CERm) and the Spanish Registry of Clinical Trials and to compare them with the previous legislation. Material and methods: RD 1090/2015, 4th December was analyzed against RD 223/2004, 16th February, and the most important differences between the two regulations were compared. Results: The new regulatory development introduces important innovations. It opens the option for the unification of the analysis of the applications, so that, together with the authorization of the clinical trial issued by the SAMHP, it is only necessary that an accredited CERm emits its positive opinion that it will be binding. It regulates new definitions, such as the low-level clinical trial, subject to less stringent standards. It differentiates between Research Ethics Committee (REC) and CERm, establishing additional requirements to move from being REC to CERm. It defines non-commercial clinical research (in which the sponsor is a university, hospital, public scientific organization, non-profit organization, patient organization or individual researcher without involvement of the pharmaceutical industry). It opens the option to contract a clinical trial prior to its authorization. It defines compensation for damages and how the evaluation of clinical trials is conducted. It incorporates the figure of the legally designated representative for incapable and minor subjects. It stipulates the conditions in situations of urgency, pregnant and periods of lactation as well as informed consent. The main novelty is the single dossier of the two-part clinical trial, one for European Union (Part I) and another one for National Documentation (Part II). All data must be sent to a database and a European public access web portal. Conclusions: The new regulation proposes to give an important impulse to the clinical research in Spain with medicines, simplifying the administrative obstacles and speeding up the realization of multicentric studies simultaneously in all Europe. It improves the delimitation of the responsibilities of the agents involved, it increases the safety of the test subjects, and at the same time, it increases the efficiency in the evaluation and communication processes involved. ; Sin Financiación

The Agbiotech Bulletin Volume 3, Issue 6, June, 1995 Code Number: NL95024 Sizes of Files: Text: 50K No associated graphics Minding the Store: Regulating Agbiotech Agriculture and food regulators are often the 'man in the middle' castigated by interest groups for being too lenient and harangued by industry for being too slow and demanding. But over the years of minding the store, the regulatory system has definitely 'produced the goods'. News PGS International Announces Canadian Canola Approvals Plant Genetic Systems (PGS) International has announced that its new hybrid canola varieties have received environmental and feed safety clearance from Agriculture and Agri-Food Canada. This approval follows last year's clearance of the variety by Health Canada. Novel Beef-Breeding Strategy Explored at Brandon Biotech Developments at Guelph Artificial 'seeds' are being developed for the $500 million dollar herb industry in North America by University of Guelph researchers. New Ethanol Facilities Opening A 50 million litre per year ethanol plant will be built in Cornwall, Ontario by Seaway Valley Farmers Energy Co-op. Canada To Aid Rwandan Research Reconstruction Canada's International Development Research Centre (IDRC) has launched a two-year, $500,000 project to assist the national reconstruction of Rwanda in the wake of civil war. Fast Plants Developed A Brassica rapa variety developed by interbreeding the 'fastest' species of Brassica accessions in the USDA's National Germplasm System flowers in 14 days and completes seed production in 35 days. Delay on rbST Ends on Canada Day The one year voluntary delay on the sale of rbST in Canada ends on July 1 of this year, however, sale of the recombinant cattle hormone will not commence unless the product has been given official Notice of Compliance by Health Canada by that date. Biotech Institute Launched in Singapore The newly-established Institute of Molecular Agrobiology (IMA) in Singapore is intended as a focal point for world-class research at the genetic and molecular levels. Events Public Expectation and the Corporate Sector Biotech Commercialization in Developing Countries. American Plant Physiologists Annual Meeting Engineering Plants for Commercial Products AgBiotech International Conference (ABIC) in Saskatoon 4TH International Conference on Plant Genetic Resources Trends The Research University in the 21st Century Fundamental changes in the nature of world society, such as the end of the cold war, are redirecting the course of universities, according to Paul Schimmel of the Massachusetts Institute of Technology. Alliances Canada-Latin American Initiative on Biotech Take Some Canola and Call Me in the Morning Tech Transfer AgCanada Expanding TechTransfer Activities New Environment for Research Support Agricultural research today is subject to a new set of ground rules. More Business Savvy Needed The stronger market orientation of agricultural research today necessitates that scientists develop more business savvy, says Yassa. 'Scientists must learn to function in a market-driven economy. They have to understand current business principles and problems.' Plant Transformation by Gene Transfer into Pollen British Technology Group (BTG) USA is entertaining discussions with regard to the licensing of a technology that allows for the production of transformed plants from seeds that have been produced by pollination using transformed pollen. Finance Saskatchewan Backs R&D Initiatives Saskatchewan's economic development strategy is placing renewed emphasis on R&D initiatives, including biotechnology. Western Economic Development Initiatives A number of initiatives of interest to the biotech sector have emerged from the new approach to economic development in the West announced by Western Development (WD) Minister Lloyd Axworthy in response to the recent federal budget. Royal Facilitates Exporter's Collection Process An easy-to-use service provided by the Royal Bank helps Canadian exporters prepare direct collection orders. Foreign Affairs Launches Electronic Trade Service The Department of Foreign Affairs and International Trade has initiated a BBS project. New Contracting Process at CIDA The Canadian International Development Agency (CIDA) has established a new process aimed at allowing more Canadians an opportunity to apply for contracts involving international development activities. Issues Issues Around Patents Assessed People, Plants and Patents is a new book on the impact of intellectual property on trade, plant biodiversity and rural society. Attitudes Consultation on Biotechnology Proposed A major process of public consultation on biotechnology has been proposed by a stakeholders group convened by the federal government's interdepartmental working group on biotechnology. Industry Needs Strategy to Boost Acceptance of Biotech Canadians are generally unaware of biotechnology, according to Rick Walter of the Canadian Institute of Biotechnology. Legal Notes Plant Protection Regulations Amended Amendments being proposed for regulations under the federal Plant Protection Act would affect the import and export of biologicals, seeds, plants, grain and pests, among other products. Brown Bag Sales Clarified by US Court A recent US Supreme Court decision (Asgrow vs. Winterboer) will be of interest to plant breeders. European Patent Developments The European Parliament voted in March against a directive which would have allowed the patenting of genetically-altered organisms, according to a report in SeedTrade News. Resources Biotech Educational Materials Available Canadian Ed Centres in Asia Nearly 100,000 foreign students the majority from Asia choose to study in Canada each year. They contribute $3 billion to the Canadian economy and help to generate some 19,000 jobs within Canada. Report of the rBST Task Force The Review of the Potential Impact of Recombinant Bovine Somatatropin in Canada has been completed and is available for review. Biotech & Plant Cultures Reviewed Biotechnological Applications of Plant Cultures is a new publication which presents the most updated reviews on current techniques in plant cultures. Getting Ready to Go Global The Management Development Initiative (MDI) is part of Getting Ready to Go Global, a campaign to improve the competitiveness of Canadian food and beverage processors in domestic and export markets. Evaluating Traditional Environmental Knowledge The book Capturing Traditional Environmental Knowledge is a product of an unusual workshop held in the Northwest Territories. People Watch Copyright 1995 Agbiotech Bulletins

This article examines the provisions of the Law of the Republic of Lithuania on Compensation of Damage Resulting from the USSR Occupation (hereinafter -- the Law), which was adopted on 13 June 2000, in the light of customary rules of international law on state responsibility, as codified in the 2001 the UN International Law Commission's Draft Articles on Responsibility of States for Internationally Wrongful Acts (hereinafter -- the ILC Draft Articles). The main aim of the article is to deal with the international legal grounds of the responsibility of the Russian Federation for the Soviet occupation of the Republic of Lithuania and, against this background, to identify the role of the Law. The ground of Russia's responsibility is an internationally wrongful act committed as the aggression against the Republic of Lithuania, which was started by the 15 June 1940 incursion by the Soviet armed forces & subsequently continued in the form of the illegal occupation of Lithuania until the restoration of Lithuania's independence on 11 March 1990, however, the illegal presence of the foreign forces on Lithuania's soil ended only in 1993. The fact of the 1940 Soviet aggression & illegal occupation of the Baltic States has been widely recognized by the international community, it was even acknowledged by the USSR & Russia in 1989-1991. Therefore there is no doubt that under international law from 1940-1990 the Republic of Lithuania had been an occupied State. That is why the illegal occupation with its consequences, as the breach of an international obligation not to resort to aggression having a continuing character, constitutes an objective element of an internationally wrongful act being the ground for Russia's responsibility. That also explains why the title of the Law refers to the occupation. Meanwhile the specific feature of subjective element is addressed in the preamble of the Law. That is the continuity of the Russian State & the corresponding identity of its international legal personality with the Soviet Union, which was claimed by Russia & generally recognized by the international community. Therefore under international law the Russian Federation is the State continuing the rights & obligations of the former USSR (ie., it is the same international legal person). Consequently, internationally wrongful acts of the latter, including the Soviet occupation of Lithuania & the other two Baltic States, should be attributable to the Russian Federation. Apart from the ground for Russia's responsibility, the issue of reparation is addressed in the article. In accordance with international law (the ILC Draft Article), the principle of full reparation should be applied to realize responsibility for an internationally wrongful act. The full reparation for the injury can be provided in the form of restitution, compensation & satisfaction, while any financially assessable damage should be covered by compensation when restitution is not practically possible. Responsibility for the Soviet occupation is the latter case. Therefore in this sense the Law concretizes the claim of Lithuania as it lays down the obligations of the Government of Lithuania to calculate the damage & seek its compensation from Russia. In conformity with the principle of full reparation, the provisions of the Law require to calculate the damage for all period of the Soviet occupation as well as to cover all types of financially assessable damage. The third main issue addressed in this article is admissibility of a claim for reparation, ie., the procedural requirements to be observed by the injured State invoking an international responsibility of other State. The main requirement, as follows from Art. 43 of the ILC Draft Articles, is that the injured State should give a timely & proper notice of its claim to the State responsible for an internationally wrongful act; the claim is admissible when it is waived by the injured State or it can be inadmissible when it is not maintained. However, a mere lapse of time without a claim is being resolved, including delay in its prosecution due to refusal of the respondent State, cannot result in loss of the right of the injured State to invoke responsibility. In this regard the Law is a unilateral act of the State of Lithuania which formulates & concretizes the claim for Russia's responsibility. The form of this act was determined by Lithuanian national rather than international law as the former requires that any compulsory rules or instructions for the Government can be laid down by the Seimas (the Parliament) only in the form of (statutory) law. As it is clear from the preamble of the Law, in continuing & consolidating the previous Lithuanian acts invoking Russia's responsibility the Law demonstrates that the claim for responsibility has been raised without any unreasonable delay a long time ago (the first time Lithuania declared about its claim for reparation in 1991) & Russia is aware of that claim from the very beginning. In such a manner the Law also proves a consistent & unchanging position of Lithuania with regard to Russia's responsibility. Therefore, the Law evidences that the claim of Lithuania remains admissible although still being unresolved & notwithstanding that Russia is rejecting it. Under international law the injured State has the right to waive its claim for responsibility of another State. National law may, however, restrict that right in setting up appropriate duties for the authorities of the injured State. In this regard it follows from the preamble of the Law that under Lithuanian constitutional law no State organ or official can declare a waiver of the claim for Russia's responsibility because the Law is based on & aims at implementation of the corresponding decision by the 14 June 1992 national referendum that demanded to seek reparation for the Soviet occupation. Therefore, the waiver can be declared only by other referendum as well as without a referendum the Seimas cannot abolish the provisions of the Law requiring to seek a compensation (such kind of action could amount to the waiver in the sense of Art. 45(a) of the ILC Draft Articles). To keep the claim for responsibility of another State admissible & valid, when it is being unresolved a long time, the injured State should do everything it can reasonably do to maintain the claim. Otherwise it can be questioned, whether the right to invoke responsibility is lost due to conduct of the injured State in the sense of Art. 45(b) of the ILC Draft Articles. Therefore, to avoid similar doubts the Law obliged the Government to seek constantly the compensation for the damage caused by the Soviet occupation. Since Russia used to reject Lithuania's initiatives to conduct negotiations on the matter & any other way of settlement is not available without Russia's consent, it can be stated that as yet, in particular due to the Law, the conduct of Lithuania has not raised any serious doubts with regard to validity of its claim for compensation. Obviously such doubts would be serious if any kind of moratorium on the claim had been announced. To sum it up, it can be concluded that the Law is based on & is consistent with the rules of international law. It also implements the international legal requirements for the proper declaration & maintenance of the claim for reparation. Therefore both under international law & under Lithuanian constitutional law the Law has been necessary to consolidate & consistently maintain the claim to Russia for the compensation of the damages caused by the Soviet occupation. Lastly, it should be noted that a proper settlement of the problem of Russia's responsibility for the Soviet occupation of Lithuania is not a question of self-interest for Lithuania & it should pursue the claim for compensation not only due to the decision by the 14 June 1992 referendum. Not accidentally Art. 1 of the ILC Draft Articles refers that "every internationally wrongful act of a State entails the international responsibility of that State." It is also not accidentally that the preamble of the 1991 Treaty between Lithuania & Russia states that mutual confidence between the people of both Parties is hard to achieve without elimination of the consequences of the Soviet annexation of Lithuania. Like for national law, rule of law & justice cannot be established without realization & inevitability of responsibility for grave breaches of international law. Therefore the realization of responsibility for the 1940 aggression against the Baltic States & its consequences would undoubtedly contribute to general prevention of such grave breaches as well as would assure that similar tragic events never happen again in the history of Lithuania. Such kind of prevention should be at the focus of attention of the whole international community rather than only Lithuania & the other two Baltic States, since a prohibition of aggression is a long-standing rule of jus cogens character & obligation erga omnes towards international community. Adapted from the source document.

This report seeks to inform the development of a framework for addressing governance reform in fragile and conflict affected environments through are view of international experiences. The report analyzes the experience both of countries that sustained a transition to peace and those that fell back into conflict. Pertinent lessons will be drawn selectively from a range of fragile and conflict affected countries, including Haiti, Cambodia, Bosnia and Herzegovina, Mozambique, Liberia, Timor-Leste, Afghanistan, Rwanda, Indonesia, Sierra Leone, and Angola. No specific typologies have been adopted or formed in order to assess these lessons, because typologies can be limiting and experiences can be better assessed based on the specificity of each country's context. The first section of the report sets out broadly accepted definitions of key terms such as governance, state building, and fragility. The second section reviews experiences with diverse governance dimensions and explores the objectives, opportunities, and constraints associated with each.

This evaluation assesses the performance of the Community Officer (CO) project, a trial community policing mechanism initiated by the Royal Solomon Islands Police Force (RSIPF) in late 2009, with assistance from the Participating Police Force (PPF) of the Regional Assistance to Solomon Islands (RAMSI). Current interest in community policing in Solomon Islands is occurring in the larger context of the rebuilding and reform of the RSIPF that has been taking place with the assistance of RAMSI. The Solomon Islands Government (SIG) and RSIPF are committed to introducing a viable form of community policing across the country.

This study is highly selective and organized into four thematic chapters. Specifically, chapter 1 provides a snapshot of Burundi's political and macroeconomic context, and reviews the evolution of the decentralization process to better understand how institutional, political, and bureaucratic dynamics have shaped the historical trajectory of decentralization and generated the outcomes observed today. Chapter 2 provides a systematic investigation of the status of fiscal decentralization in Burundi, and identifies key policy issues to be considered to ensure the medium-term sustainability of the reform process while at the same time addressing the short-term financial needs of communes. Chapter 3 provides an in-depth diagnostic of a key service delivery responsibility recently devolved to communes—the provision of land registration services—and discusses the challenges and opportunities related to ongoing efforts to scale up access to these land services across 116 rural communes and Bujumbura. Chapter 4 shifts the focus to the nature of statecitizen relations in an effort to better understand how citizen engagement in the decision-making process may be improved and local authorities held accountable for the provision of basic services.

In recent decades, established political parties across Europe have become increasingly challenged by a new party family: the radical right. In terms of how mainstream parties respond to this challenge, Sweden has been a puzzling case both in a comparative European perspective and in light of established theories of party competition. Rather than co-opting the restrictive immigration policies of the radical right party the Sweden Democrats, the Swedish mainstream parties jointly converged on liberal policies. In addition, rather than being included as a coalition partner or support party to the government, the Sweden Democrats have been excluded from government formation despite a pivotal position between the established left and right blocs in the parliament. In order to explain these puzzling outcomes, this dissertation combines two bodies of scholarly literature that have tended not to communicate much: coalition theory and research on mainstream party reactions to the radical right. It uses a multi-method research design to analyse party behaviour at both the local and the national level, and in both the electoral and the parliamentary arena. In doing so, it identifies aspects of established theories and concepts in need of refinement. The dissertation argues that despite the apparently puzzling nature of the Swedish case, the isolation of the Sweden Democrats can be explained in terms of the strategic pursuit of policy, office, and votes. The key to the strategic explanation lies in considering three things: first, that different kinds of party strategies interact, within and across arenas; second, that the choice of strategy is constrained, between different levels of a party and over time; and third, that we need to reconsider how some commonly used concepts – such as anti-pacts, winning coalitions, and policy dimensions – are operationalised. Rather than relying on the idea of qualitatively different 'pariah' or 'anti-system' parties, the findings of this thesis show how the isolation of a radical right party can be explained in terms of the strategic incentives of rival parties. The results also show that the transition from isolation to cooperation can, under certain conditions, be a rapid process. The dissertation is a contribution to research on coalition formation, spatial party competition, and mainstream party reactions to the radical right. ; Den här avhandlingen behandlar frågan om hur etablerade politiska partier agerar när de utmanas av nya partier från den högerradikala partifamiljen. Studien fokuserar på Sverige och hur de svenska etablerade partierna har bemött det högerradikala partiet Sverigedemokraterna. Sverige har varit ett avvikande fall i jämförelse med många andra länder i Europa, där etablerade partier har tenderat både att bilda regeringar med stöd av högerradikala partier, och att ta över deras politiska positioner – framförallt i invandringsfrågan – för att försöka vinna tillbaka väljare. I Sverige valde de etablerade partierna istället (inledningsvis) att förflytta sina positioner bort från Sverigedemokraternas politik. Vidare har partiet trots sin starka position i riksdagen uteslutits från regeringssamarbete. I syfte att förklara det svenska fallet kombinerar denna avhandling teorier om regeringsbildning med teorier om hur etablerade partier bemöter högerradikala partier. Studien kombinerar kvalitativ och kvantitativ metod för att analysera partibeteende på både lokal och nationell nivå, samt på väljararenan och den parlamentariska arenan. Genom att analysera ett avvikande fall vidareutvecklar avhandlingen etablerade teorier och koncept. Analysen visar att det svenska fallet, trots att det delvis skiljer sig från andra länder, kan förklaras i termer av hur partierna försöker uppnå tre strategiska mål: att vinna röster, att få genomslag för sin politik, och att sitta i regeringsställning. Den strategiska förklaringen består av tre delar. För det första måste vi beakta att olika partistrategier – t.ex. valet av sakpolitiska positioner och valet att misskreditera ett annat parti – kan påverka varandra. För det andra måste vi ta hänsyn till att partier inte alltid är fria i sina val. De kan förhindras från att tillämpa en viss strategi, antingen på grund av meningsskiljaktigheter inom partiet eller på grund av att det kan vara väljarmässigt riskabelt att alltför snabbt byta strategi. För det tredje behöver vi ompröva vissa av de koncept som vanligen används inom koalitionsforskningen – t.ex. vad som gör en koalition "vinnande", vilka politiska konfliktdimensioner som är de viktigaste, och hur vi bäst mäter förekomsten av "anti-pakter" mellan partier. Det strategiska perspektiv som presenteras i avhandlingen visar att isoleringen av högerradikala partier kan förklaras utan att hänvisa till att vissa partier är väsensskilda "paria"- eller "anti-system"-partier. Resultaten visar också att ett skifte från isolering till samarbete kan ske snabbt, givet att de strategiska förutsättningarna förändras. Avhandlingen är ett bidrag till koalitionsforskning, till forskning om partibeteende på väljararenan, samt till forskning om hur etablerade partier bemöter högerradikala partier. ; From the margins to the mainstream: Populist radical right parties and government formation in Europe

This thesis studies the link between institutions, gender and politics. Three questions are studied: can institutions undo gender norms? Would institutions be more gender-egalitarian if they were headed by women? Why are women absent from positions of power?The first chapter of this thesis tests whether institutions can undo gender. In particular, we study the consequences of institutions on the perpetuation of gender norms. We study the norm according to which a woman should earn less than her husband. Using the German division as a natural experiment, we show that East German institutions have undone gender. East German women can earn more than their husband without increasing their number of housework hours, put their marriage at risk, or withdraw from the labor market. By contrast, the norm of higher male income and its consequences are still prevalent in the West.The second chapter studies whether institutions would be more gender-egalitarian if more women were heading them. In particular, I test whether female politicians have the same priorities than their male counterparts. The context studied is the French Parliament from 2001 to 2017. Using text analysis and quasi-experimental variations to randomize legislators' gender, this chapter shows that women are twice more likely to initiate women-related amendments in the Lower House. Women's issues constitute the key topic on which women are more active, followed by health and childhood issues whereas men are more active on military issues. I provide supporting evidence that these results are driven by the individual interest of legislators. Finally, I replicate these results in the Upper House by exploiting the introduction of a gender quota.The third chapter studies the reasons behind the underrepresentation of women in positions of power. I investigate whether the persistence of incumbents hinders female access to political positions when incumbents are predominantly men. I exploit regression discontinuity from close electoral races in French municipalities to randomize the eligibility of incumbent mayors for reelection. Despite a context increasingly favorable to the election of women, I find that the persistence of incumbents does not block female access to the position of mayor. I investigate the mechanisms and show that it is more difficult for a woman to replace a female incumbent than a male one. ; Cette thèse vise à étudier le lien entre institutions, genre et politique. Elle cherche à répondre à trois questions: les institutions peuvent-elles défaire les normes de genre ? Les institutions seraient-elles plus égalitaires si elles étaient dirigées par des femmes ? Pourquoi les femmes sont-elles absentes des positions de pouvoir ? Le premier chapitre de cette thèse vise à étudier le rôle des institutions dans la création des normes de genre. La norme étudiée est celle selon laquelle une femme doit gagner moins que son mari. En utilisant, la division de l'Allemagne comme une expérience naturelle, nous montrons que les institutions égalitaires est-allemandes ont défait le genre. Après la réunification, une femme est-allemande peut gagner plus que son mari sans augmenter son nombre d'heures de travail domestique, risquer de divorcer ou de se retirer du marché du travail. A l'opposé, en Allemagne de l'Ouest, ces comportements sont toujours observables.Le deuxième chapitre étudie si les institutions seraient plus égalitaires avec des femmes à leur tête. En particulier, nous cherchons à déterminer si les femmes politiciennes ont les mêmes priorités que leurs collègues masculins. Le contexte étudié est celui du Parlement Français durant la période 2001-2017. En combinant des méthodes d'analyse de texte avec des variations exogènes dans le sexe des politiciens, ce chapitre montre que, relativement à leurs collègues masculins, les femmes politiciennes à l'Assemblée Nationale défendent plus les intérêts des femmes dans la population. Le thème où les différences sexuées d'activité parlementaire sont les plus marquées est précisément celui de l'égalité femmes-hommes, suivi des thématiques liées à l'enfance et à la santé. Les hommes sont plus actifs sur les thématiques militaires. Nous montrons que ces différences proviennent de l'intérêt individuel des législateurs. Enfin, nous répliquons ces résultats au Sénat en exploitant l'introduction d'une réforme qui a imposé la parité.Le troisième chapitre s'intéresse aux raisons derrière la sous-représentation des femmes dans les positions de pouvoir. Il cherche à déterminer si dans un contexte où les politiciens sont majoritairement des hommes, la "prime aux sortants" lors d'élections réduit le nombre de femmes élues. Le contexte étudié est celui des municipalités de moins de 1000 habitants en France. Nous montrons que contrairement à ce qu'on peut s'attendre, lorsque les politiciens ne sont pas éligibles à leur réélection, la part de femmes élus n'augmente pas. C'est parce qu'il est plus difficile pour une femme de remplacer une femme que de remplacer un homme.

This thesis studies the link between institutions, gender and politics. Three questions are studied: can institutions undo gender norms? Would institutions be more gender-egalitarian if they were headed by women? Why are women absent from positions of power?The first chapter of this thesis tests whether institutions can undo gender. In particular, we study the consequences of institutions on the perpetuation of gender norms. We study the norm according to which a woman should earn less than her husband. Using the German division as a natural experiment, we show that East German institutions have undone gender. East German women can earn more than their husband without increasing their number of housework hours, put their marriage at risk, or withdraw from the labor market. By contrast, the norm of higher male income and its consequences are still prevalent in the West.The second chapter studies whether institutions would be more gender-egalitarian if more women were heading them. In particular, I test whether female politicians have the same priorities than their male counterparts. The context studied is the French Parliament from 2001 to 2017. Using text analysis and quasi-experimental variations to randomize legislators' gender, this chapter shows that women are twice more likely to initiate women-related amendments in the Lower House. Women's issues constitute the key topic on which women are more active, followed by health and childhood issues whereas men are more active on military issues. I provide supporting evidence that these results are driven by the individual interest of legislators. Finally, I replicate these results in the Upper House by exploiting the introduction of a gender quota.The third chapter studies the reasons behind the underrepresentation of women in positions of power. I investigate whether the persistence of incumbents hinders female access to political positions when incumbents are predominantly men. I exploit regression discontinuity from close electoral races in French municipalities to randomize the eligibility of incumbent mayors for reelection. Despite a context increasingly favorable to the election of women, I find that the persistence of incumbents does not block female access to the position of mayor. I investigate the mechanisms and show that it is more difficult for a woman to replace a female incumbent than a male one. ; Cette thèse vise à étudier le lien entre institutions, genre et politique. Elle cherche à répondre à trois questions: les institutions peuvent-elles défaire les normes de genre ? Les institutions seraient-elles plus égalitaires si elles étaient dirigées par des femmes ? Pourquoi les femmes sont-elles absentes des positions de pouvoir ? Le premier chapitre de cette thèse vise à étudier le rôle des institutions dans la création des normes de genre. La norme étudiée est celle selon laquelle une femme doit gagner moins que son mari. En utilisant, la division de l'Allemagne comme une expérience naturelle, nous montrons que les institutions égalitaires est-allemandes ont défait le genre. Après la réunification, une femme est-allemande peut gagner plus que son mari sans augmenter son nombre d'heures de travail domestique, risquer de divorcer ou de se retirer du marché du travail. A l'opposé, en Allemagne de l'Ouest, ces comportements sont toujours observables.Le deuxième chapitre étudie si les institutions seraient plus égalitaires avec des femmes à leur tête. En particulier, nous cherchons à déterminer si les femmes politiciennes ont les mêmes priorités que leurs collègues masculins. Le contexte étudié est celui du Parlement Français durant la période 2001-2017. En combinant des méthodes d'analyse de texte avec des variations exogènes dans le sexe des politiciens, ce chapitre montre que, relativement à leurs collègues masculins, les femmes politiciennes à l'Assemblée Nationale défendent plus les intérêts des femmes dans la population. Le thème où les différences sexuées d'activité parlementaire sont les plus marquées est précisément celui de l'égalité femmes-hommes, suivi des thématiques liées à l'enfance et à la santé. Les hommes sont plus actifs sur les thématiques militaires. Nous montrons que ces différences proviennent de l'intérêt individuel des législateurs. Enfin, nous répliquons ces résultats au Sénat en exploitant l'introduction d'une réforme qui a imposé la parité.Le troisième chapitre s'intéresse aux raisons derrière la sous-représentation des femmes dans les positions de pouvoir. Il cherche à déterminer si dans un contexte où les politiciens sont majoritairement des hommes, la "prime aux sortants" lors d'élections réduit le nombre de femmes élues. Le contexte étudié est celui des municipalités de moins de 1000 habitants en France. Nous montrons que contrairement à ce qu'on peut s'attendre, lorsque les politiciens ne sont pas éligibles à leur réélection, la part de femmes élus n'augmente pas. C'est parce qu'il est plus difficile pour une femme de remplacer une femme que de remplacer un homme.