Suchergebnisse

El objeto de este trabajo consiste en un estudio comparado de las más recientes disposiciones sancionadoras del tráfico de órganos humanos incorporadas a la legislación de Chile y España. Para ello, se parte de la normativa que proclama el principio de gratuidad en materia de trasplantes, y se analizan las infracciones administrativas y penales previstas para sancionar, sobre todo, las conductas que se cometan en este ámbito con ánimo de lucro. Este estudio comparado permitirá conocer, por un lado, las principales notas comunes a ambos ordenamientos jurídicos, así como aquellas otras en las que divergen; y, por otro lado, los aspectos más problemáticos que plantea la aplicación de dichas normas sancionadoras. Tanto las discrepancias entre estas legislaciones como las dificultades que plantea su aplicación reflejan la complejidad para afrontar jurídicamente este problema de una forma satisfactoria. ; The objective of this paper consists of a compared study of the most recent penalty provisions about trafficking in human organs incorporated to the Chilean and Spanish legislations by assuming the regulations that proclaim the principle of free provision in the field of organ transplants, and analyzing administrative breaches and criminal offences provided in order to sanction above all the conducts committed in this area with the aim of getting economic benefit. This compared study will show, on the one hand, the main common aspects of both legal systems, as well as the divergent points; and, on the other hand, the most problematic aspects posed by the implementation of those penalty provisions. Not only the differences among those legislations but also the difficulties of their implementation reflect the complexity to satisfactorily deal with this problem from the legal point of view. ; Este trabajo se enmarca en el proyecto de investigación "Nuevos límites penales para la autonomía individual y la intimidad" (DER2011-26909/JURI) del Ministerio de Economía y Competitividad de España. La investigación se ha desarrollado gracias a una estancia de investigación en la Universidad Diego Portales de Santiago de Chile, financiada por la Beca Iberoamericana para Jóvenes Profesores e Investigadores (España 2013) del Banco de Santander (Santander Universidad).

Human experimentation at the intersections of biolaw and international criminal law : the case of unethical clinical trials in developing countries / Stefania Negri -- Are non-consensual medical interventions and therapies to change sexual orientation or gender identity a crime against humanity of persecution against the LGBTIQ population under the ICC statute? / Héctor Olasolo, Nicolás Eduardo Buitrago-Rey and Vanessa Bonilla-Tovar -- The case for decoupling unlawful experiments from the armed conflict nexus / Edwin Bikundo -- CRISPR / case technology : ending disease, designer babies, eternal youth, and 'crimes against the species' / Inez Braber -- Transplant tourism prohibition under transnational criminal law : a look at the human trafficking model / Terry Adido -- Systemic deprivation of access to essential medicine and medical care - a crime against humanity? / Sunčana Roksandić Vidlička -- Biolaw stakes, activist jurisprudence, and (presumed) limits for protected interests / Bronik Matwijkiw and Anja Matwijkiw -- Marketing body parts : morality, law, and public opinion / Michael Davis -- Bioethics, complementarity, and corporate criminal liability / Ryan Long -- Aspirational justice : achieving equity for children using the convention on the rights of the child and the international criminal court's policy on children / Susan E. Zinner -- Child soldiers, executive functions, and culpability / Tyler K. Fagan, William Hirstein and Katrina Sifferd -- Principles of bioethics and international criminal law in the light of philosophy of Islamic jurisprudence / Mehdi Zakerian and Farid Azadbakht -- From the martens clause to consent to human experimentations, the legal journey of the judges during the Nuremberg doctors' trial / Xavier Aurey -- Scope and limits of psychiatric evidence in international criminal law / Dragana Spencer -- Medical evidence at the International Criminal Court - dosage and contraindications / Caroline Fournet.

Editorial The first 11 articles in the first issue of 2014 deal with global legal topics ranging from outer space to domestic South African matters and legal challenges in other African countries, such as Uganda, Nigeria and Zimbabwe. Anél Ferreira-Snyman discusses legal challenges relating to the commercial use of outer space, with specific reference to space tourism. She points out that the current legal framework is outdated and no longer deals adequately with the rapidly developing space tourism industry. Further away from the moon, although it deals with creations of the mind and is just as mysterious for the average person, is the contribution of André van der Walt and Richard Shay, which analyses the South African Constitutional Court's treatment of intellectual property. They focus on the methodology that the Court has formulated to assess if state interference complies with constitutional provisions to determine if state intervention into property interests has been legitimate. The third contribution, by Joel Baloyi, also deals with a creation of the mind, namely copyright. He attempts through a comparative analysis to demystify the role of copyright as a tool for economic development in Africa and criticises the stifling effect the transferability principle has on the effectiveness of copyright in certain African countries. Bradley Slade discusses the differences between the concepts "public purpose" and "public interest" in the context of third party transfers as a result of property being expropriated for the realisation of public purposes in the fourth contribution. The influence of the Constitution of South Africa, 1996 on organ transplants is the topic of the fifth contribution, by Debbie Labuschagne and Pieter Carstens. They come to the conclusion that the South African government has failed to provide an effective legal framework to relieve the shortage of human organs available for transplantation. Sixthly, Lize Mills discusses recently proposed regulations prohibiting the advertising and promotion of infant formulae and other products marketed as being suitable for infants or young children with the purpose of promoting breast-feeding. The last five articles move further afield and deal with legal issues elsewhere in Africa. Dana van der Merwe gives a comparative overview of the relationship between digital information in certain legal fields in South Africa and Uganda. Nazreen Shaik-Premanov examines Zimbabwe's Marange conflict diamond situation and Lovemore Chiduza analyses the Zimbabwean constitutional provisions on judicial independence. Peter Obutte scrutinises ICT laws in Nigeria and the last two authors, Serges Kamga and Ogechukwu Ajoku, reflect on addressing human rights violations by extractive industries in both South Africa and Nigeria. Four notes are also published in this issue. The first one is an overview article by Christa Rautenbach dealing with the modern-day impact of cultural and religious diversity as reflected in the book on "Managing Family Justice in Diverse Societies". The other four notes are case discussions. The first one is a discussion of the case of Government of the Republic of Zimbabwe v Louis Karel Fick by Erika de Wet. The second one is a discussion of the case of Le Sueur v eThekwini Municipality by Warren Freedman, and the last one is a discussion of the case of Apollo Tyres v South Africa (Pty) Ltd v CCMA by Shamier Ebrahim.

La justicia transicional debe enfrentar la negación de las atrocidades. A pesar de la sofisticación del marco de derechos humanos presente en el sistema legal colombiano, el campo de la justicia transicional en Colombia adolece de un significativo grado de indeterminación normativa, como si dicho campo aconteciera en un vacío constitucional". Como consecuencia, ha sido objeto de uso estratégico por parte de distintos actores políticos dotados de intencionalidad en la fijación del sentido del arreglo institucional de la llamada justicia transicional. El uso estratégico gravita entre el acatamiento pleno del marco de derechos humanos o su elusión en distintos grados. La elusión niega las atrocidades. Para que el discurso de la justicia transicional en Colombia contribuya a hacer justicia por las atrocidades, debe dar viabilidad práctica a los derechos de las víctimas, no reducir esos estándares. Para ello, son necesarios dos requisitos: desde el punto de vista sustantivo, debe acatar las obligaciones en materia de verdad, justicia y reparación, que son parámetro de constitucionalidad, y respetar el núcleo esencial de tales derechos, sin perjuicio de la libertad de configuración legislativa y de la ponderación judicial. Desde el punto de vista procedimental, debe adoptar como metodología un enfoque contextualizado de análisis comparado que evite el trasplante acrítico de experiencias internacionales inaplicables. ; Transitional justice (TJ) must confront the denial of atrocities. Despite the sophistication of the national human rights legal framework in Colombia, a significant level of normative indeterminacy qualifies TJ, as if the field could work in a "constitutional vacuum." As a consequence, various political agents, who intentionally attempt to determine the content of the TJ scheme, have used the field strategically. The strategic use of the field ranges from total observance of the human rights framework all the way to attempts to circumvent human rights obligations. These attempts to dodge human rights obligations contribute to the denial of atrocities. If TJ rhetoric is to contribute to accountability in Colombia, it must contribute to the realization of victims' rights, not contribute to the devaluation of standards. In order to reach such a purpose, two requirements are necessary: from a substantive perspective, TJ must observe the essential core of international standards regarding truth, justice and reparation, which serve as constitutional parameters even in the context of legislative authority or judicial weighting; and from a procedural perspective, TJ must apply a sound methodology that considers a contextualized approach to comparative analysis, in order to avoid the non-reflexive transplantation of international experiences. ; A justiça transicional deve enfrentar a negociação das atrocidades. A pesar da sofisticação do marco de direitos humanos presente no sistema legal colombiano, o campo da justiça transicional na Colômbia adoece de um significativo grau de indeterminação normativa, como se este campo acontecera em um "vazio constitucional". Como consequência, tem sido objeto de uso estratégico por parte de distintos atores políticos dotados de intencionalidade na fixação do sentido do arranjo institucional da conhecida justiça transicional. O uso estratégico, gravita entre o acatamento pleno do marco dos direitos humanos ou sua esquiva em distintos graus. A esquiva nega as atrocidades. Para que o discurso da justiça transacional na Colômbia contribua a fazer justiça pelas atrocidades, deve dar viabilidade prática aos direitos das vitimas, não reduzir esses padrões. Para issi, são necessários dois requisitos: desde o ponto de vista substancial, deve acatar as obrigações em matéria de verdade, justiça e reparação, que são parâmetro de constitucionalidade e respeitar o núcleo essencial de tais direitos, sem prejuízo da liberdade de configuração legislativa e da ponderação judicial. Desde o ponto de vista procedimental, deve adotar como metodologia um enfoque contextualizado de análise comparado que evite o transplante acrítico de experiências internacionais inaplicáveis.

La justicia transicional debe enfrentar la negación de las atrocidades. A pesar de la sofisticación del marco de derechos humanos presente en el sistema legal colombiano, el campo de la justicia transicional en Colombia adolece de un significativo grado de indeterminación normativa, como si dicho campo aconteciera en un vacío constitucional". Como consecuencia, ha sido objeto de uso estratégico por parte de distintos actores políticos dotados de intencionalidad en la fijación del sentido del arreglo institucional de la llamada justicia transicional. El uso estratégico gravita entre el acatamiento pleno del marco de derechos humanos o su elusión en distintos grados. La elusión niega las atrocidades. Para que el discurso de la justicia transicional en Colombia contribuya a hacer justicia por las atrocidades, debe dar viabilidad práctica a los derechos de las víctimas, no reducir esos estándares. Para ello, son necesarios dos requisitos: desde el punto de vista sustantivo, debe acatar las obligaciones en materia de verdad, justicia y reparación, que son parámetro de constitucionalidad, y respetar el núcleo esencial de tales derechos, sin perjuicio de la libertad de configuración legislativa y de la ponderación judicial. Desde el punto de vista procedimental, debe adoptar como metodología un enfoque contextualizado de análisis comparado que evite el trasplante acrítico de experiencias internacionales inaplicables. ; A justiça transicional deve enfrentar a negociação das atrocidades. A pesar da sofisticação do marco de direitos humanos presente no sistema legal colombiano, o campo da justiça transicional na Colômbia adoece de um significativo grau de indeterminação normativa, como se este campo acontecera em um "vazio constitucional". Como consequência, tem sido objeto de uso estratégico por parte de distintos atores políticos dotados de intencionalidade na fixação do sentido do arranjo institucional da conhecida justiça transicional. O uso estratégico, gravita entre o acatamento pleno do marco dos direitos humanos ou sua esquiva em distintos graus. A esquiva nega as atrocidades. Para que o discurso da justiça transacional na Colômbia contribua a fazer justiça pelas atrocidades, deve dar viabilidade prática aos direitos das vitimas, não reduzir esses padrões. Para issi, são necessários dois requisitos: desde o ponto de vista substancial, deve acatar as obrigações em matéria de verdade, justiça e reparação, que são parâmetro de constitucionalidade e respeitar o núcleo essencial de tais direitos, sem prejuízo da liberdade de configuração legislativa e da ponderação judicial. Desde o ponto de vista procedimental, deve adotar como metodologia um enfoque contextualizado de análise comparado que evite o transplante acrítico de experiências internacionais inaplicáveis. ; Transitional justice (TJ) must confront the denial of atrocities. Despite the sophistication of the national human rights legal framework in Colombia, a significant level of normative indeterminacy qualifies TJ, as if the field could work in a "constitutional vacuum." As a consequence, various political agents, who intentionally attempt to determine the content of the TJ scheme, have used the field strategically. The strategic use of the field ranges from total observance of the human rights framework all the way to attempts to circumvent human rights obligations. These attempts to dodge human rights obligations contribute to the denial of atrocities. If TJ rhetoric is to contribute to accountability in Colombia, it must contribute to the realization of victims' rights, not contribute to the devaluation of standards. In order to reach such a purpose, two requirements are necessary: from a substantive perspective, TJ must observe the essential core of international standards regarding truth, justice and reparation, which serve as constitutional parameters even in the context of legislative authority or judicial weighting; and from a procedural perspective, TJ must apply a sound methodology that considers a contextualized approach to comparative analysis, in order to avoid the non-reflexive transplantation of international experiences.

This article reconstructs how Arab doctors, medical missionaries, British counterinsurgents, and Palestinian rebels negotiated and contested the legitimate role of medical workers and healthcare in times of colonial conflict. Drawing insight from a medical anthropological literature which challenges the notion of medical neutrality as normative, and setting mandate Palestine alongside other case studies of medicine in times of conflict from the interwar Middle East and North Africa, this article argues that while healthcare and medical authority could be put to work to support the colonial status quo, they could serve other, more radical ends too. To highlight the complexity of the political positioning of medical workers and healthcare, this article focuses on the town of Hebron during the great revolt which rocked the foundations of British rule in Palestine between 1936 and 1939, and relies on a range of colonial and missionary archival sources. The first part of the article uses the case study of an Egyptian medical doctor who took up political office in the town in moments of crisis to show how medical authority could be consciously transmuted into a force to uphold a besieged political order. The second part draws on the diary of a British mission doctor to reconstruct his efforts to assert medical neutrality during the great revolt, and-more strikingly still-how Palestinian insurgents participated actively in this attempt to transplant international legal protections to Hebron. The final part traces the incorporation of healthcare into the strategies of both British counterinsurgents and Palestinian rebels, with the British policy of collective punishment indirectly but appreciably degrading access to healthcare for Palestinians, and Palestinian counterstate ambitions extending to the establishment of insurgent medical services in the hills.

This research attempts to reconstruct the law enforcement issues related to the case of human organs trade in Indonesia. As we know, the rules of law related to the prohibition of the sale and purchase or illegal transplantation of organs has been issued by the government. But the fact does not make organized crime vanished. Therefore, it is necessary to have the latest reformulation that can realize to the root of the problem. One of them is by integrating between Islamic law in the form of the products fiqh and the Health Act (Act No. 36 of 2009). This research is normative juridical research. Its focus is directed on the study of theorem, principle, conception, legal doctrine and content rules of positive law. It is analyzed descriptively and qualitatively by reducing the data, presenting the data and draw conclusions. Both Islamic law and health law equally prohibits the practice of buying and selling of organs strictly in principle. It is because of the high risk of illegal actions against a person's health, due to the lack of health standards in the black market organ sales. Organs will no longer work when it is transplants for living donor. Interestingly, both Islamic law and the laws of health go hand in hand in an effort to prevent the practice of buying and selling of organs, especially the highly dynamic Islamic law to follow the development of humanity. This is evident from the birth of some of the Fatwa (a binding ruling in religious matters) issued by the Indonesian Mufti Council (MUI) that related to the issue of human organs. Similarly, Health Act is very appropriately referred to as human rights laws because many provide humanitarian protection in the field of health.

В статье анализируется законодательство Республики Казахстан в области трансплантологии органов, тканей и их компонентов. Данный вид правоотношений регламентируется Кодексом «О здоровье народа и системе здравоохранения» и представляется в форме социальных услуг. Определяются следующие направления правовой регламентации: 1. Основные проблемы законодательного регулирования пересадки органов их слагаемых, донорства крови, ее компонентов, половых, стволовых клеток. 2. Анализируется порядок предоставления таких медицинских услуг, проведения операций в Республике Казахстан и зарубежных государствах гражданам Казахстана. 3. Правовой статус доноров и рецепиентов. 4. Порядок транспортировки трансплантологического материала. 5. Направления международного сотрудничества. ; The article analyses the legislation of the Republic of Kazakhstan in the field of transplantation of organs, tissues and their components. This type of legal relations regulated by the Code "On people's health and healthcare system" and is presented in the form of social services. Identifies the following directions of legal regulation: 1. The main problems of legislative regulation of organ transplants their terms, donation of blood, its components, sexual, stem cells. 2. Analyses the procedure of provision of such health services, conducting operations in the Republic of Kazakhstan and foreign states, citizens of Kazakhstan. 3. The legal status of donors and reshepients. 4. Procedure of transportation of transplantation material. 5. Directions of international cooperation. The presence of gaps in the national legislation shall entail frequent use of citizens in need of data operations, the assistance of foreign clinics. It is often the criterion of choice is not the quality and skills of medical activities, and the availability of donor organs and low prices. So, for example, in Pakistan, the donors are waiting for the patients, and not vice versa, and the price of the transaction in some times below, than in other states. However, the quality of operations is very low. Until recently between the Republic of Kazakhstan and Pakistan was signed bilateral agreement, approved by the Governments of the countries, to conduct operations on transplantation of kidney, selection of donors, the organization of preoperative and postoperative care of the patients. However, in view of the fact that the mortality rate in the last two years amounted to almost one hundred per cent, this agreement was terminated. Other agreements of the republic of Kazakhstan on the issues of transplantation were not. There are no other international documents in this type of medical care. Thus, the direction of the legal regulation, in fact completely absent. None of the present day and common international standards in the field of transplantation of organs, tissues and their components. No less urgent is the problem of legal regulation of the supply of organs and tissues. Fantastic price in conjunction with a legal vacuum, entail criminal actions. These may be classified, such as the removal of organs or tissue from the dead, without the consent of the relatives, and also the traffic of citizens, including international, with the purpose of withdrawal of corresponding body material "illegal transplantation". Under Kazakhstan law, the legal status of the donor shall be determined subject principle. So, the donor germ cells can be only the citizens at the age from eighteen to thirty-five years of age, physically and mentally healthy, they do not have the right to information about the fate of their donor germ cells. They have no privileges. Donor blood and its components can be a person at the age of 18 years, passed the medical examination and has no contraindications, regardless of the mental state, and the donor tissues and organs of a man may be, the corpse of a man or an animal. With special requirements to donor status, the legislation does not clearly prescribes the procedure and the form of consent to this operation.

The Anti-Terrorism Proclamation of Ethiopia has a far-reaching effect on human rights, such as freedom of expression. The provisions of this law that impact freedom of expression are discussed in this article. The law gives leeway to criminalize innocent acts of individuals who are critical of government policies. It criminalizes in/direct encouragement to the preparation, instigation and commission of terrorism through the publication of statements. The law falls short of international standards that require only the criminalization of a speech intended and likely to incite terrorist acts. The Proclamation demands everyone including the media and journalists provide terrorism-related information to law enforcement agencies. The only way to be relieved of this obligation is showing the existence of a 'reasonable cause', a phrase that is not defined by the law. Moreover, the journalistic privilege of confidentiality of information and the protection of sources is not stipulated as an exception to the obligation of disclosure of information. Nor does the law provides the circumstances in which a journalist may be forced to divulge her information. Though surveillance and interception undermine democracy, a mere suspicion of terrorism gives the National Intelligence and Security Service a power to conduct surveillance or intercept any type of communications. The Proclamation failed to provide circumstances that a court should consider before permitting surveillance or interception. Surveillance and interception invade privacy and chill freedom of expression. However, the Proclamation failed to provide any safeguards that limit the misuse of executive power against freedom of expression. The legal ambiguity together with the nascent jurisprudence pose problems on freedom of expression. Hence, domestic courts should draw upon or transplant principles and their interpretations from jurisdictions like South Africa and Council of Europe to fill legal loopholes. Moreover, the "jurisprudential dearth" could be filled and the impact of the Proclamation on freedom of expression may be assuaged by incorporating the three-part test (prescribed by law, legitimate aims and necessary in a democratic society) from the well-developed jurisprudences of human rights bodies and regional courts, notably the European Court of Human Rights, which stands at the heart of the Council of Europe system.Keywords: encouragement of terrorism, freedom of expression, human rights, interception, journalistic privilege, terrorism, surveillance

A civil society and democracy in Tajikistan are being cultivated on local soil-they are not "alien transplants." The republic is ready to embrace the great transformation already going on, and the new phenomena have not weakened society's immunity: we are all eyewitnesses to the birth of a new statehood and stronger national identity that will determine cultural development in the broadest sense of the word. But we must keep in mind that cultural development is impossible without mutual integration of this new statehood and stronger national identity in the spirit of genuine democratization. However, from the dialectical viewpoint, the process is far from simple: a civil society ruled by law is coming into being by way of many contradictions, difficulties, meandering, and backtracking. As the road leading to a civil society ruled by law, democratization can be visualized as the sum total of numerous development vectors: some of them at times slow down the process, while others tend to miss certain seemingly logical stages by speeding things up. Talking of speeding up, it should be noted that Tajikistan, as a country at the crossroads between the secular and Oriental religion-intensive civilizations, has moved a long way along one of the vectors of the dialectical continuum. I have in mind the fact that a party of political Islam is functioning successfully in the legal context and is equally successfully integrating into the country's legal field. This part of the dialectics of the emergence of a civil society ruled by law has far outstripped all similar processes taking place in similar spheres in Tajikistan's Central Asian neighbors. There is the opinion that political parties do not belong to a civil society, yet the Islamic Revival Party of Tajikistan is not limited to its party structure-its impact on the civil consciousness sector and NGOs that represent the structures and norms of civil society is obvious and tangible. On the other hand, the establishment and functioning of the institution of ombudsman as a civil society phenomenon present in the Central Asian states (which are not considered democratic enough), but absent in Tajikistan, speak of the erratic nature of the process's manifestations in the country.

This is the final version. Available from Springer via the DOI in this record. ; This article reconstructs how Arab doctors, medical missionaries, British counterinsurgents, and Palestinian rebels negotiated and contested the legitimate role of medical workers and healthcare in times of colonial conflict. Drawing insight from a medical anthropological literature which challenges the notion of medical neutrality as normative, and setting mandate Palestine alongside other case studies of medicine in times of conflict from the interwar Middle East and North Africa, this article argues that while healthcare and medical authority could be put to work to support the colonial status quo, they could serve other, more radical ends too. To highlight the complexity of the political positioning of medical workers and healthcare, this article focuses on the town of Hebron during the great revolt which rocked the foundations of British rule in Palestine between 1936 and 1939, and relies on a range of colonial and missionary archival sources. The first part of the article uses the case study of an Egyptian medical doctor who took up political office in the town in moments of crisis to show how medical authority could be consciously transmuted into a force to uphold a besieged political order. The second part draws on the diary of a British mission doctor to reconstruct his efforts to assert medical neutrality during the great revolt, and—more strikingly still—how Palestinian insurgents participated actively in this attempt to transplant international legal protections to Hebron. The final part traces the incorporation of healthcare into the strategies of both British counterinsurgents and Palestinian rebels, with the British policy of collective punishment indirectly but appreciably degrading access to healthcare for Palestinians, and Palestinian counterstate ambitions extending to the establishment of insurgent medical services in the hills.

International audience ; To encourage and maximise the use of human biological material in Europe, the European Commission instigated a main Directive in 2004 (Directive 2004/23/EC), four technical ones in 2006 (Commission Directives 2006/17/EC and 2006/86/EC) and in 2015 (Commission Directives (EU) 2015/565 and (EU) 2015/566). They encourage the donation of tissues and cells for transplant purposes in the safeguard of public health. Another major aim of Directive 2004/23/EC is to guarantee recipients' safety in transplantation. Hence, measures for accreditation of establishments storing, preparing and distributing tissues and cells are required to be implemented in Members States' jurisdictions. In addition, adequate training is required for the personnel directly involved in such activities. Despite the adoption of a "full legislation, " the EU legal framework for cells cannot be seen as totally harmonized. In this article we first address the issues posed at the European level by the uses of human cells as therapeutic agent with regards to their qualification: body elements? Medicinal product? We study the ways to address these bioethical dilemmas at an EU level. Then we discuss the impact of this qualification in terms of safety through the definition of safety's measures and their limits regarding the directive's scope. We conclude with the emergence of an "ethical safety". ; Pour encourager et maximiser l'utilisation du matériel biologique humain en Europe, la Commission européenne a adopté une Directive mère en 2004 (Directive 2004/23/CE) et deux Directives techniques en 2006 (Directives 2006/17/CE et 2006/86/CE) complétées en 2015. Ce cadre encourage le don de tissus et de cellules à des fins de transplantation dans le respect de la protection de la santé publique. Un des objectifs de la Directive 2004/23/CE est de garantir un haut niveau de sécurité pour les donneurs et les receveurs en matière de transplantation. Par conséquent, ces directives visent à harmoniser les différentes mesures relatives à la ...

International audience ; To encourage and maximise the use of human biological material in Europe, the European Commission instigated a main Directive in 2004 (Directive 2004/23/EC), four technical ones in 2006 (Commission Directives 2006/17/EC and 2006/86/EC) and in 2015 (Commission Directives (EU) 2015/565 and (EU) 2015/566). They encourage the donation of tissues and cells for transplant purposes in the safeguard of public health. Another major aim of Directive 2004/23/EC is to guarantee recipients' safety in transplantation. Hence, measures for accreditation of establishments storing, preparing and distributing tissues and cells are required to be implemented in Members States' jurisdictions. In addition, adequate training is required for the personnel directly involved in such activities. Despite the adoption of a "full legislation, " the EU legal framework for cells cannot be seen as totally harmonized. In this article we first address the issues posed at the European level by the uses of human cells as therapeutic agent with regards to their qualification: body elements? Medicinal product? We study the ways to address these bioethical dilemmas at an EU level. Then we discuss the impact of this qualification in terms of safety through the definition of safety's measures and their limits regarding the directive's scope. We conclude with the emergence of an "ethical safety". ; Pour encourager et maximiser l'utilisation du matériel biologique humain en Europe, la Commission européenne a adopté une Directive mère en 2004 (Directive 2004/23/CE) et deux Directives techniques en 2006 (Directives 2006/17/CE et 2006/86/CE) complétées en 2015. Ce cadre encourage le don de tissus et de cellules à des fins de transplantation dans le respect de la protection de la santé publique. Un des objectifs de la Directive 2004/23/CE est de garantir un haut niveau de sécurité pour les donneurs et les receveurs en matière de transplantation. Par conséquent, ces directives visent à harmoniser les différentes mesures relatives à la ...

International audience ; To encourage and maximise the use of human biological material in Europe, the European Commission instigated a main Directive in 2004 (Directive 2004/23/EC), four technical ones in 2006 (Commission Directives 2006/17/EC and 2006/86/EC) and in 2015 (Commission Directives (EU) 2015/565 and (EU) 2015/566). They encourage the donation of tissues and cells for transplant purposes in the safeguard of public health. Another major aim of Directive 2004/23/EC is to guarantee recipients' safety in transplantation. Hence, measures for accreditation of establishments storing, preparing and distributing tissues and cells are required to be implemented in Members States' jurisdictions. In addition, adequate training is required for the personnel directly involved in such activities. Despite the adoption of a "full legislation, " the EU legal framework for cells cannot be seen as totally harmonized. In this article we first address the issues posed at the European level by the uses of human cells as therapeutic agent with regards to their qualification: body elements? Medicinal product? We study the ways to address these bioethical dilemmas at an EU level. Then we discuss the impact of this qualification in terms of safety through the definition of safety's measures and their limits regarding the directive's scope. We conclude with the emergence of an "ethical safety". ; Pour encourager et maximiser l'utilisation du matériel biologique humain en Europe, la Commission européenne a adopté une Directive mère en 2004 (Directive 2004/23/CE) et deux Directives techniques en 2006 (Directives 2006/17/CE et 2006/86/CE) complétées en 2015. Ce cadre encourage le don de tissus et de cellules à des fins de transplantation dans le respect de la protection de la santé publique. Un des objectifs de la Directive 2004/23/CE est de garantir un haut niveau de sécurité pour les donneurs et les receveurs en matière de transplantation. Par conséquent, ces directives visent à harmoniser les différentes mesures relatives à la ...

International audience ; To encourage and maximise the use of human biological material in Europe, the European Commission instigated a main Directive in 2004 (Directive 2004/23/EC), four technical ones in 2006 (Commission Directives 2006/17/EC and 2006/86/EC) and in 2015 (Commission Directives (EU) 2015/565 and (EU) 2015/566). They encourage the donation of tissues and cells for transplant purposes in the safeguard of public health. Another major aim of Directive 2004/23/EC is to guarantee recipients' safety in transplantation. Hence, measures for accreditation of establishments storing, preparing and distributing tissues and cells are required to be implemented in Members States' jurisdictions. In addition, adequate training is required for the personnel directly involved in such activities. Despite the adoption of a "full legislation, " the EU legal framework for cells cannot be seen as totally harmonized. In this article we first address the issues posed at the European level by the uses of human cells as therapeutic agent with regards to their qualification: body elements? Medicinal product? We study the ways to address these bioethical dilemmas at an EU level. Then we discuss the impact of this qualification in terms of safety through the definition of safety's measures and their limits regarding the directive's scope. We conclude with the emergence of an "ethical safety". ; Pour encourager et maximiser l'utilisation du matériel biologique humain en Europe, la Commission européenne a adopté une Directive mère en 2004 (Directive 2004/23/CE) et deux Directives techniques en 2006 (Directives 2006/17/CE et 2006/86/CE) complétées en 2015. Ce cadre encourage le don de tissus et de cellules à des fins de transplantation dans le respect de la protection de la santé publique. Un des objectifs de la Directive 2004/23/CE est de garantir un haut niveau de sécurité pour les donneurs et les receveurs en matière de transplantation. Par conséquent, ces directives visent à harmoniser les différentes mesures relatives à la ...