Results for 'EU Qualification Directive'

999 found
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  1.  14
    Is There a Need for Extension of Subsidiary Protection in the European Union Qualification Directive?Lyra Jakulevičienė - 2010 - Jurisprudencija: Mokslo darbu žurnalas 120 (2):215-232.
    The establishment of the Common European Asylum System by 2012 remains a key policy objective for the European Union. According to the Council of the European Union, the development of a Common Asylum Policy should be based on a full and inclusive application of the 1951 Geneva Convention Relating to the Status of Refugees and other relevant international treaties. In the European Pact on Immigration and Asylum attention is brought to the persistence of wide disparities amongst Member States in the (...)
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  2.  17
    Regulating Internal Protection Alternative as the Element of Refugee Definition in the EU Directive 2004/83/EC and its Recast Proposal (article in Lithuanian). [REVIEW]Laurynas Biekša - 2011 - Jurisprudencija: Mokslo darbu žurnalas 18 (3):871-882.
    Internal protection alternative (further—IPA) as the element of refugee definition is interpreted very differently in the practice of the State Parties to the 1951 Convention and the 1967 Protocol relating to the Status of Refugees (further—Geneva Convention). Thus it is important to regulate this concept clearly in the EC directive 2004/83/EB (further—Qualification directive) and its coming amendments. The definition of the IPA concept does not contain adequate criteria for assessing the level and effectiveness of protection required, in (...)
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  3.  11
    Licenced to Transplant: UK Overkill on EU Organ Directive Provides Golden Opportunity for Research.A. J. Cronin, J. Douglas & S. Sacks - 2012 - Journal of Medical Ethics 38 (10):593-595.
    Progress in transplantation outcomes depends on continuing research into both donor and recipient factors that may enhance graft and patient survival. A system of licencing for transplantation research, introduced by the Human Tissue Act 2004, which separates it from the transplantation process (then exempt from licencing), has damaged this vital activity by a combination of inflexible interpretation of the 2004 Act and fear of criminal liability on the part of researchers. Now, following the European Union (EU) Directive (2010) on (...)
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  4.  20
    New EU Standards of Consumer Protection? New Directive on Consumer Rights 2011/83/EU.Arndt Künnecke - 2013 - Jurisprudencija: Mokslo darbu žurnalas 20 (3):951-970.
    In recent years consumer law has come more and more into the focus of legislation within the EU. One of the EU’s key objectives, completing the final stage of the internal market, is to place consumer rights in the centre of it. Following the adaption of various consumer law measures for some decades, the EU has undertaken a thorough review of its consumer acquis. After years of consultations, the Consumer Rights Directive 2011/83/ EU, which was supposed to set new (...)
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  5.  18
    ‘Illegal Migrants’, Gender and Vulnerability: The Case of the EU’s Returns Directive[REVIEW]Heli Askola - 2010 - Feminist Legal Studies 18 (2):159-178.
    Feminist legal efforts to make sense of the external migration policies of the European Union (EU) have focused almost exclusively on the EU’s initiatives against trafficking in women. This article examines one of the more neglected areas of EU immigration policy—the return of ‘illegal immigrants’. It analyses the so-called 2008 Returns Directive in the light of the multidimensional inequalities experienced by migrant women, which affect their migration status and expose some of them to the threat of removal. Owing to (...)
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  6.  26
    Lessons of the First EU Court of Justice Judgments in Asylum Cases.Lyra Jakulevičienė - 2012 - Jurisprudencija: Mokslo darbu žurnalas 19 (2):477-505.
    Starting from 2009, national courts of the EU Member States for the first time gained a “real” right to request the EU Court of Justice for preliminary rulings in asylum matters. First judgments of this Court demonstrate equivocal tendencies: some are blaming the Court for incompetence in asylum matters, others believe that the adoption of authoritative decisions at the European level will assist in developing consistent practice of applying asylum law in the European Union, something that failed at international level (...)
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  7.  27
    '(More) Trials and Tribulations': The Effect of the EU Directive on Clinical Trials in Intensive Care and Emergency Medicine, Five Years After its Implementation.K. Robinson & P. J. D. Andrews - 2010 - Journal of Medical Ethics 36 (6):322-325.
    The European Clinical Trials Directive was issued in 2001 and aimed to simplify and harmonise the regulatory framework of clinical trials throughout Europe, thus stimulating European research. However, significant complexity and inconsistency remains due to disparate interpretation by EU member states. Critical care research has been particularly impacted due to variable and often restrictive consenting procedures for incapacitated subjects, with some countries requiring a court-appointed representative, while others recognise consent from family members and occasionally professional representatives. Furthermore, the absence (...)
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  8.  4
    Text and Data Mining in Directive 2019/790/EU Enhancing Web-Harvesting and Web-Archiving in Libraries and Archives.Μaria Bottis, Marinos Papadopoulos, Christos Zampakolas & Paraskevi Ganatsiou - 2019 - Open Journal of Philosophy 9 (3):369-395.
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  9.  16
    The New EU Directive on the Use of Animals for Research and the Value of Moral Consistency.Jan Deckers - 2012 - Journal of Bioethical Inquiry 9 (4):377-379.
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  10.  30
    Influence of the European Union Directive 2004/83/EC on the Interpretation of Definition of Refugee.Laurynas Biekša - 2009 - Jurisprudencija: Mokslo darbu žurnalas 117 (3):251-261.
    The 1951 Convention Relating to the Status of Refugees and the 1967 Protocol Relating to the Status of Refugees embody fundamental provisions of refugee law. However, since the adoption of these documents the world has changed dramatically and the laws are not developing fast enough in order to catch up with dynamically changing contemporary situations. The application and interpretation of definition of a refugee was developed through traditional practice of Western states, which was influenced by two world wars and the (...)
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  11.  20
    The Refugee Qualification Problems in LGBT Asylum Cases.Laurynas Biekša - 2011 - Jurisprudencija: Mokslo darbu žurnalas 18 (4):1555-1565.
    In 2011 there are 76 countries of the world still criminalising same-sex sexual acts between consenting adults. In seven of those countries homosexual acts are punishable with death penalty (i.e., Mauritania, Sudan, the northern states of Nigeria, the southern parts of Somalia, Iran, Saudi Arabia, Yemen). Homophobic (transphobic) attitudes are also frequent in many societies. However, the LGBT asylum seekers are frequently left outside the refugee definition due to many refugee qualification problems in LGBT cases. Therefore, in this article (...)
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  12.  7
    Reception Conditions Directive: Concerns of Transposition into Lithuanian Legislation and Implementation.Lyra Jakulevičienė & Laurynas Biekša - 2009 - Jurisprudencija: Mokslo darbu žurnalas 115 (1):313-333.
    The 6th of February 2005 marks the deadline of transposition of the EU Council Directive No. 2003/9/EC (Reception Conditions‘ Directive) into national legislation. This article is the second in a series of articles on transposition of the European Union Asylum Directives in Lithuania and remaining concerns. It analyses the transposition of the Reception Conditions Directive in the country, the impact of the directive‘s provisions on the development of the Lithuanian asylum law and draws attention to the (...)
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  13.  17
    The Rationality of Biofuel Certification: A Critical Examination of EU Biofuel Policy.A. J. K. Pols - 2015 - Journal of Agricultural and Environmental Ethics 28 (4):667-681.
    Certification for biofuels has been developed to ensure that biofuel production methods adhere to social and environmental sustainability standards. As such, requiring biofuel production to be certified has become part of EU policy through the 2009 renewable energy directive, that aims to promote energy security, reduce emissions and promote rural development. According to the EU RED, in 2020 10 % of our transport energy should come from renewable sources, most of which are expected to be biofuels. In this paper (...)
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  14.  9
    Criteria of the Implementation of the EU Directives and the Consequences of their Non-Compliance according to the European Union Law (article in German).Pavelas Ravluševičius - 2011 - Jurisprudencija: Mokslo darbu žurnalas 18 (3):883-904.
    This article investigates some special criteria of implementation of the EU directives into the national legal order and the consequences of their non-compliance, that could arise from the EU membership obligation to the European Union law. The most important acting form for the Institutions of European Union comes after the Reform treaty of Lisbon the form of the EU directive. The law-making practice of the Institution of the European Union set out with different levels of full or partial harmonization (...)
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  15.  7
    Implementation of EC Directive on Temporary Agency Work Into Lithuania Legislation.Tomas Bagdanskis - 2011 - Jurisprudencija: Mokslo darbu žurnalas 18 (3):1035-1053.
    On 19 May 2011, the Lithuanian Parliament adopted the Law on Temporary Agency Employment to implement the EU Directive on temporary agency work. Up to now there has been no special regulations for the so called “personnel lease”, although Lithuanian companies have been using such service since 2003. The law basically followed the recommendations of the Directive without setting additional restrictions. Temporary agency workers will be subject to the same conditions as permanent workers of employment agency clients are (...)
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  16.  4
    Multilingualism in the EU and Consistency of Private Enforcement of Competition Law: Two Examples From CEE Countries.Anna Piszcz - 2017 - Studies in Logic, Grammar and Rhetoric 52 (1):165-180.
    This paper attempts to address the question of how multilingualism in the EU might affect the consistency of private enforcement of competition law. In the literature, there have been concerns raised about the consistency of public enforcement of competition law, so in this paper attention has shifted to concerns about consistency of private enforcement. For the purposes of this paper, a distinction is drawn between rule-making and the application of competition law. The latter falls outside the scope of this paper. (...)
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  17.  39
    Procedural Problems in LGBT Asylum Cases.Lyra Jakulevičienė, Laurynas Biekša & Eglė Samuchovaitė - 2012 - Jurisprudencija: Mokslo darbu žurnalas 19 (1):195-207.
    In 2012 there are 76 countries of the world still criminalising same-sex sexual acts between consenting adults. In seven of those countries homosexual acts are punishable with death penalty (i. e., Mauritania, Sudan, the northern states of Nigeria, the southern parts of Somalia, Iran, Saudi Arabia and Yemen). Homophobic (transphobic) attitudes are also frequent in many societies. However, the LGBT asylum seekers are frequently left outside the refugee definition due to many refugee qualification and procedural problems in LGBT cases. (...)
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  18.  6
    Research Ethics Committees in Europe: Implementing the Directive, Respecting Diversity.A. Hedgecoe - 2006 - Journal of Medical Ethics 32 (8):483-486.
    With the recent Clinical Trials Directive, a degree of harmonisation into research ethics committees across Europe, including the time taken to assess a trial proposal and the kinds of issues a committee should take into account, has been introduced by the European Union . How four different member states—Hungary, Portugal, Sweden and the UK—have chosen to implement the directive is shown. Although this has resulted in four very different ways of structuring RECs, similar themes are present in all (...)
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  19.  72
    An Analysis of Moral Issues Affecting Patenting Inventions in the Life Sciences: A European Perspective.R. Stephen Crespi - 2000 - Science and Engineering Ethics 6 (2):157-180.
    Following the 1980 US Supreme Court decision to allow a patent on a living organism, debate has continued on the moral issues involved in biotechnology patents of many kinds and remains a contentious issue for those opposed to the use of biotechnology in industry and agriculture. Attitudes to patenting in the life sciences, including those of the research scientists themselves, are analysed. The relevance of morality to patent law is discussed here in an international context with particular reference to the (...)
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  20.  34
    The Structure of Rights in Directive 95/46/EC on the Protection of Individuals with Regard to the Processing of Personal Data and the Free Movement of Such Data. [REVIEW]Dag Elgesem - 1999 - Ethics and Information Technology 1 (4):283-293.
    The paper has three parts. First, a survey and analysis is given ofthe structure of individual rights in the recent EU Directive ondata protection. It is argued that at the core of this structure isan unexplicated notion of what the data subject can `reasonablyexpect' concerning the further processing of information about himor herself. In the second part of the paper it is argued thattheories of privacy popular among philosophers are not able to shed much light on the issues treated (...)
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  21.  69
    DO CHANGES TO THE EUROPEAN COMMISSION SHAREHOLDER RIGHTS DIRECTIVE ON CORPORATE PAY ALTER SHAREHOLDERS’ MORAL RESPONSIBILITES?Magdalena Smith - manuscript
    This paper looks at the specific proposed amendments to European directive 2007/36/EC and 2013/34/EU, and evaluates as to how such amendments alter shareholders’ moral responsibilities. To be responsible is here simply to be understood as being under an obligation, where an obligation is a requirement on an agent to either act or refrain from acting in a given way. In order to determine whether changes to the proposed directives alter shareholders’ moral responsibilities the following analysis argues that we need (...)
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  22.  3
    Impact of the European Clinical Trials Directive on Prospective Academic Clinical Trials Associated with BMT.L. J. Frewer, D. Coles, I. A. van der Lans, D. Schroeder, K. Champion & J. F. Apperley - unknown
    The European Clinical Trials Directive was introduced to improve the efficiency of commercial and academic clinical trials. Concerns have been raised by interested organizations and institutions regarding the potential for negative impact of the Directive on non-commercial European clinical research. Interested researchers within the European Group for Blood and Marrow Transplantation were surveyed to determine whether researcher experiences confirmed this view. Following a pilot study, an internet-based questionnaire was distributed to individuals in key research positions in the European (...)
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  23.  38
    Protection under the European Convention on Human Rights – Oasis for Asylum Seekers in Europe?Lyra Jakulevičienė & Vladimiras Siniovas - 2013 - Jurisprudencija: Mokslo darbu žurnalas 20 (3):855-899.
    Even though the Convention for the Protection of Human Rights and Fundamental Freedoms (ECHR) does not explicitly address the rights of asylum seekers and refugees, the case law of the European Human Rights Court (ECtHR) confirms that their rights can be successfully defended under this mechanism. In parallel, in its evolving jurisprudence on asylum the Court of Justice of the European Union (CJEU) refers to the Strasbourg case law, where there is a certain interrelationship between these two jurisdictions, in particular (...)
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  24.  28
    A European Consistency for Functioning of RECs? We Just Lost Our Chance.Marcin Waligora - 2013 - Journal of Medical Ethics 39 (6):408-409.
    On 17 July 2012, the European Commission formally adopted a proposal for a new European Union (EU) Directive regarding clinical trials, which will repeal and replace the existing Directive 2001/20/EC. The main reasons for the revision were: (1) the decreasing number of clinical trials in the region and (2) harsh criticism of the present version of the Directive. The proposed regulation could simplify the rules for conducting clinical trials and also rebuild the entire system of clinical trial (...)
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  25.  4
    Ist Die Arzneimittelforschung an Zwangsweise Untergebrachten Auf Basis Einer Forschungsverfügung Rechtlich Erlaubt?Is Drug Research on Compulsorily Accommodated Persons Legally Permitted on the Basis of a Research Directive?Gunnar Duttge & Melanie Steuer - 2019 - Ethik in der Medizin 31 (3):221-230.
    ZusammenfassungIn Umsetzung der EU-Verordnung Nr. 536/2014 hat der deutsche Gesetzgeber mit § 40b Abs. 4 AMG die gruppennützige Arzneimittelforschung mit Nichteinwilligungsfähigen zugelassen, sofern der Proband zuvor in einwilligungsfähigem Zustand nach den Regeln der Patientenverfügung darin eingewilligt hat. Die Anwendungsvoraussetzungen schließen forensische Psychiatriepatienten nicht aus, obgleich das kategorische Verbot für zwangsweise Untergebrachte formell-rechtlich unverändert geblieben ist. Damit stellt sich die praxisrelevante Frage nach dem rechtssystematischen Verhältnis der neuen Erlaubnis zum bisherigen Verbot – und letztlich zu den Perspektiven einer angemessenen Arzneimittelversorgung von (...)
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  26.  22
    Problems of Application of Detention of Asylum Seekers in the Practice of the Supreme Administrative Court of Lithuania.Laurynas Biekša & Eglė Samuchovaitė - 2012 - Jurisprudencija: Mokslo darbu žurnalas 19 (4):1407-1422.
    The question of detention of asylum seekers is specific due to the special situation of detainees (persons who have experienced human rights violations and apply for asylum in receiving country) and due to peculiarities of detention itself (persons have not committed crimes, but come or stay illegally because they have been forced to do so by fleeing from human rights violations). Therefore, lately it raises many discussions at the European level. Sooner or later, discussions influence national laws, as after adopting (...)
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  27.  29
    From Grand Policy to Targeted Destruction: Consumers as Victims of EU Satellite Television Policy. [REVIEW]Campbell McPherson - 2000 - Journal of Business Ethics 25 (2):129 - 141.
    In July 1997 the European Commission proposed a "Directive on the Legal protection of Service based on, or consisting of Conditional Access" (to various electronic systems).This paper considers the proposed Directive within the context of the European Union's failure to develop and maintain a coherent policy relating to satellite television broadcasts direct to the individual's home (DTH) within the nascent Single European Market (SEM), and the consequences of that policy failure for "ordinary" consumers who are highly unlikely to (...)
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  28.  14
    Changes of Legal Regulation on Natural Gas Market in the Context of the Third European Union Energy Package.Virginijus Kanapinskas & Algimantas Urmonas - 2011 - Jurisprudencija: Mokslo darbu žurnalas 18 (1):233-249.
    The article analyzes the changes of legal regulation on natural gas market in the context of the third European Union (EU) energy package. The paper consists of the introduction, two parts and conclusions. The first part analyses the main provisions on the natural gas market of the Third EU energy package. The second part of the paper focuses on the effect of the Third EU energy package on legal regulation of natural gas market in Lithuania. For this purpose, the author (...)
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  29.  18
    The Danish eID Case: Twenty Years of Delay. [REVIEW]Jens Hoff & Frederik Hoff - 2010 - Identity in the Information Society 3 (1):155-174.
    The focus of this article is to explain why there is still no qualified digital signature in Denmark as defined by the EU eSignatures Directive nor any other nationwide eID even though Denmark had an early start in eGovernment, and a high level of e-readiness compared to other nations. Laying out the technological, organizational and legal dimensions of eID in Denmark, and comparing these with a number of other European countries made it possible to explain this paradox. Thus, the (...)
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  30.  15
    From Local Product to Global Commodity.Mirja Mikkilä, Jussi Heinimö, Virgilio Panapanaan & Lassi Linnanen - 2008 - Proceedings of the International Association for Business and Society 19:421-431.
    This study was conducted with the aim of outlining a comprehensive picture of the coverage of various sustainability schemes or criteria sets related to the entire value-added chain of biomass and bioenergy and comparing them accordingly. Eight sustainability schemes and one draft directive were chosen for the qualitative comparison: two existing sets of criteria for agricultural biomass (RSPO, RTRS); two existing forest certification schemes (FSC, Finnish FFCS); two newly developed initiatives for biomass for energy raw material (WWF Meta standard, (...)
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  31. A Phenomenological Analysis of Bodily Self-Awareness in the Experience of Pain and Pleasure: On Dys-Appearance and Eu-Appearance. [REVIEW]Kristin Zeiler - 2010 - Medicine, Health Care and Philosophy 13 (4):333-342.
    The aim of this article is to explore nuances within the field of bodily self-awareness. My starting-point is phenomenological. I focus on how the subject experiences her or his body, i.e. how the body stands forth to the subject. I build on the phenomenologist Drew Leder’s distinction between bodily dis-appearance and dys-appearance. In bodily dis-appearance, I am only prereflectively aware of my body. My body is not a thematic object of my experience. Bodily dys-appearance takes place when the body appears (...)
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  32.  95
    How Far Does the European Union Reach? Foreign Land Acquisitions and the Boundaries of Political Communities.Torsten Menge - 2019 - Land 8 (3).
    The recent global surge in large-scale foreign land acquisitions marks a radical transformation of the global economic and political landscape. Since land that attracts capital often becomes the site of expulsions and displacement, it also leads to new forms of migration. In this paper, I explore this connection from the perspective of a political philosopher. I argue that changes in global land governance unsettle the congruence of political community and bounded territory that we often take for granted. As a case (...)
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  33.  16
    Anchoring European Governance: Two Versions of Responsible Research and Innovation and EU Fundamental Rights as ‘Normative Anchor Points’.Daniele Ruggiu - 2015 - NanoEthics 9 (3):217-235.
    Among the various experiments in ‘new governance’, the model of Responsible Research and Innovation is emerging in the European landscape as quite promising. Up to now, there have been two versions of RRI: a socio-empirical version which tends to underline the role of democratic processes aimed at identifying values on which governance needs to be anchored and a normative version which stresses the role of EU goals as ‘normative anchor points’ of both governance strategies and policy making. Both versions are (...)
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  34.  50
    Attitudes Towards and Barriers to Writing Advance Directives Amongst Cancer Patients, Healthy Controls, and Medical Staff.S. Sahm - 2005 - Journal of Medical Ethics 31 (8):437-440.
    Objectives: After years of public discussion too little is still known about willingness to accept the idea of writing an advance directive among various groups of people in EU countries. We investigated knowledge about and willingness to accept such a directive in cancer patients, healthy controls, physicians, and nursing staff in Germany.Methods: Cancer patients, healthy controls, nursing staff, and physicians were surveyed by means of a structured questionnaire.Results: Only 18% and 19% of the patients and healthy controls respectively, (...)
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  35.  14
    ODNI as an Analytic Ombudsman: Is Intelligence Community Directive 203 Up to the Task?Alexandru Marcoci, Ans Vercammen & Mark Burgman - forthcoming - Intelligence and National Security.
    In the wake of 9/11 and the assessment of Iraq's WMD, several inquiries placed the blame primarily on the Intelligence Community. Part of the reform that followed was a codification of analytic tradecraft standards into Intelligence Community Directive (ICD) 203 and the appointment of an analytic ombudsman in the newly created Office of the Director of National Intelligence charged with monitoring the quality of analytic products from across the intelligence community. In this paper we identify three assumptions behind ICD203: (...)
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  36.  90
    Promotion of LGBTI Rights Overseas: An Overview of EU and US Experiences.Artem Patalakh - 2017 - Janus.Net, E-Journal of International Relations 8 (2):70-87.
    The essay problematizes the incorporation of LGBTI rights promotion into the US and EU foreign policies. First, the paper examines the two actors’ key documents, speeches, and policies devoted to the promotion of LGBTI rights abroad, the similarities and differences between the two actors’ approaches, attending to the tendencies of their evolution and the ongoing development. Second, the article discusses the internal conditions in target countries that are conducive to the success and failure of international support of LGBTI rights. Finally, (...)
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  37.  8
    Contesting the Science/Ethics Distinction in the Review of Clinical Research.A. J. Dawson & S. M. Yentis - 2007 - Journal of Medical Ethics 33 (3):165-167.
    Recent policy in relation to clinical research proposals in the UK has distinguished between two types of review: scientific and ethical. This distinction has been formally enshrined in the recent changes to research ethics committee structure and operating procedures, introduced as the UK response to the EU Directive on clinical trials. Recent reviews and recommendations have confirmed the place of the distinction and the separate review processes. However, serious reservations can be mounted about the science/ethics distinction and the policy (...)
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  38. Global Ethics and Nanotechnology: A Comparison of the Nanoethics Environments of the EU and China. [REVIEW]Sally Dalton-Brown - 2012 - NanoEthics 6 (2):137-150.
    The following article offers a brief overview of current nanotechnology policy, regulation and ethics in Europe and The People’s Republic of China with the intent of noting (dis)similarities in approach, before focusing on the involvement of the public in science and technology policy (i.e. participatory Technology Assessment). The conclusions of this article are, that (a) in terms of nanosafety as expressed through policy and regulation, China PR and the EU have similar approaches towards, and concerns about, nanotoxicity—the official debate on (...)
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  39.  98
    Advancing an Advance Directive Debate.Christopher Buford - 2008 - Bioethics 22 (8):423-430.
    A challenge has recently been levelled against the legal and/or moral legitimacy of some advance directives. It has been argued that in certain cases an advance directive carries no weight in a decision on whether to withhold treatment, since the individual in the debilitating state is not the same person as the person who created the advance directive. In the first section of this paper, I examine two formulations of the argument against the moral legitimacy of the advance (...)
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  40.  7
    Argumentative Patterns in the European Union’s Directives.Corina Andone & Florin Coman-Kund - 2017 - Journal of Argumentation in Context 6 (1):76-96.
    This paper provides an account of the arguments advanced by the EU legislator in the preamble of directives adopted for harmonization in the internal market, and assesses them as to their potential at convincing the Member States to implement the directive at issue. We show what directives should argue for and how they do so in practice, by focussing in particular on Directive 2011/83/EU on consumer rights. Furthermore, this contribution moves beyond a purely academic discussion by linking the (...)
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  41.  34
    Strategic Corporate Social Responsibility and Orphan Drug Development: Insights From the US and the EU Biopharmaceutical Industry. [REVIEW]Olga Bruyaka, Hanko K. Zeitzmann, Isabelle Chalamon, Richard E. Wokutch & Pooja Thakur - 2013 - Journal of Business Ethics 117 (1):45-65.
    In recent years, the biopharmaceutical industry has seen an increase in the development of so-called orphan drugs for the treatment of rare and neglected diseases. This increase has been spurred on by legislation in the United States, Europe, and elsewhere designed to promote orphan drug development. In this article, we examine the drivers of corporate social responsibility (CSR) activities in orphan drug markets and the extent to which biopharmaceutical firms engage in these activities with a strategic orientation. The unique context (...)
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  42.  13
    Clinical Trial Application in Europe: What Will Change with the New Regulation?Viviana Giannuzzi, Annagrazia Altavilla, Lucia Ruggieri & Adriana Ceci - 2016 - Science and Engineering Ethics 22 (2):451-466.
    The European framework surrounding clinical trials on medicinal products for human use is going to change as demonstrated by the large debate at European institutional level. One of the major challenges is to overcome the lack of harmonisation of clinical trial procedures among countries. This aspect is gaining more and more importance, considering the increasing number of multicentre and multinational studies. In this work, the actual European rules governing the Clinical Trial Application have been analysed throughout the different steps including (...)
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  43.  11
    Case Study of R-1234yf Refrigerant: Implications for the Framework for Responsible Innovation.Rafał Wodzisz - 2015 - Science and Engineering Ethics 21 (6):1413-1433.
    Safety and care for the natural environment are two of the most important values that drive scientific enterprise in twentieth century. Researchers and innovators often develop new technologies aimed at pollution reduction, and therefore satisfy the strive for fulfilment of these values. This work is often incentivized by policy makers. According to EU directive 2006/40/EC on mobile air conditioning since 2013 all newly approved vehicles have to be filled with refrigerant with low global warming potential. Extensive and expensive research (...)
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  44.  7
    Punishing Non‐Conscientious Disobedience: Is the Military a Rogue Employer?Ned Dobos - 2015 - Philosophical Forum 46 (1):105-119.
    In many countries the military still threatens to punish personnel that disobey orders for the sake of self‐preservation. The Uniform Code of Military Justice (UCMJ) in the U.S., for instance, makes it a crime for a soldier to refuse a directive from a superior unless what that order requires is “patently unlawful”. This qualification is usually interpreted narrowly to cover orders to commit war crimes or to victimize civilians, not orders that would require sacrifice of life or limb. (...)
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  45.  3
    Data Protection and Sample Management in Biobanking - A Legal Dichotomy.Dolores Ibarreta, Daniele Paci & Tobias Schulte in den Bäumen - 2010 - Genomics, Society and Policy 6 (1):1-14.
    Biobanking in Europe has made major steps towards harmonization and shared standards for the collection and processing of data and samples stored in biobanks. Still, biobanks and researchers face substantial legal difficulties in the field of data protection and sample management. Data protection law was harmonized almost 15 years ago while rights in samples fall under the competence of the Member States of the EU. Despite the Data Protection Directive the field of data protection shows a substantial degree of (...)
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  46.  19
    Species Conservation and Minority Rights: The Case of Springtime Bird Hunting in Aland.E. Aaltola & M. Oksanen - 2002 - Environmental Values 11 (4):443-460.
    The article examines the case of springtime bird hunting in Åland from a moral point of view. In Åland springtime hunting has been a cultural practice for centuries but is now under investigation due to the EU Directive on the protection of birds. The main question of the article is whether restrictions on bird hunting have a sound basis. We approach this question by analysing three principles: The animal rights principle states that if hunting is not necessary for survival, (...)
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  47.  12
    Private Parts: A Global Analysis of Privacy Protection Schemes and a Proposed Innovation for Their Comparative Evaluation. [REVIEW]Laura B. Pincus & Roger Johns - 1997 - Journal of Business Ethics 16 (12-13):1237-1260.
    Given recent technological advances, we now are able to invade personal privacy as never before. The challenge in the business community is to make the most of the opportunities presented by the growth in communication technology while, at the same time, protecting what remains of individual privacy. The conflict between technological advances and privacy concerns is not new, but it has grown exponentially in recent years, and the development of a data protection scheme in the European Union lends a certain (...)
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  48.  40
    Ethics of Sustainable Development – a Study of Swedish Regulations for Genetically Modified Organisms.Mikael Karlsson - 2003 - Journal of Agricultural and Environmental Ethics 16 (1):51-62.
    In spite of stricter provisions inthe new EU directive on deliberate release ofgenetically modified organisms (GMOs), criticsstill advocate a moratorium on permits forcultivation of GMOs. However, in an attempt tomeet concerns raised by the public, thedirective explicitly gives Member States thepossibility to take into consideration ethicalaspects of GMOs in the decision-making. Thisarticle investigates the potential effects ofsuch formulation by means of an empiricalanalysis of experiences gained the last yearsfrom similar Swedish regulations for GMOs,aiming at promoting sustainable development.The faulty implementation (...)
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  49.  50
    When is the EU Charter of Fundamental Rights Applicable at National Level?Allan Rosas - 2012 - Jurisprudencija: Mokslo darbu žurnalas 19 (4):1269-1288.
    Whilst the Charter of Fundamental Rights of the European Union, which became part of binding primary EU law on 1 December 2009, constitutes an important codification and clarification of fundamental rights as they exist in the European Union, the field of application of the Charter is limited in a significant way: the Charter only applies when EU law is at stake. When national courts and authorities in the EU Member States are confronted with problems of purely national law, they are (...)
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  50.  8
    Multicentre Trials Review Process by Research Ethics Committees in Spain: Where Do They Stand Before Implementing the New European Regulation?R. Dal-Re - 2005 - Journal of Medical Ethics 31 (6):344-350.
    Objectives: To review the performance of research ethics committees in Spain in assessing multicentre clinical trial drug protocols, and to evaluate if they would comply with the requirements of the new EU Directive to be implemented by May 2004.Design and setting: Prospective study of applications of MCT submitted to RECs.Main measurements: Protocol related features and evaluation process dynamics.Results: 187 applications to be performed in 114 centres, were reviewed by 62 RECs. RECs had a median number of 14 members, of (...)
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