The implementation of Directive 2001/20/EC into Belgian law and the specific provisions on pediatric research

The European Clinical Trial Directive (2001/20/EC) was implemented into the Belgian legal system by the Law of 7 May 2004 concerning experiments on the human person (LEH). Apart from implementing the European Directive, this law also broadens the scope of the Directive from interventional clinical trials to all medical experiments involving human persons. This article offers an overview of the requirements for involving minors in medical experiments that are captured in the LEH, illustrates the process of protocol review by an ethics committee, and discusses the dissimilarities between the LEH and the European Directive.     

Research with minors in Greece and the EU Directive on clinical trials

This article describes the legal rules for research with minors in Greece in relation to the EU Directive on clinical trials and the Greek Code of Medical Ethics.     

Legislation and review of medical research with minors in The Netherlands

In The Netherlands medical research with minors is regulated in the Medical Research Involving Human Subjects Act. During the legislation process in the Houses of Parliament in the 1990s the issue of nontherapeutic research with minors and incapacitated subjects was heavily debated. Stringent regulations were formulated for this type of research and the Act became operational in December 1999. In order to implement the Clinical Trial Directive 2001/20/EG, the Act was modified on several issues. However, the Act was not modified on the issue of non-therapeutic research with minors and incapacitated subjects. As a result at present the Dutch law is more restrictive on non-therapeutic research with minors than the EU Directive. Currently, discussion is ongoing to adapt the Dutch law in order to harmonize it with the EU Directive.     

The Swiss regulatory framework for paediatric health research

Medical research on minors entails both risks and benefits. Under Swiss law, clinical trials on children, including nontherapeutic drug trials, are permissible. However, ethics committees must systematically verify that all clinical studies have a favorable risk-benefit profile. Additional safeguards are designed to ensure that children are not unnecessarily involved in research and that proper consent is always obtained. Federal Swiss law is undergoing revision to extend these protections beyond clinical trials to a broad array of health research. The Swiss drug agency also seeks to improve the incentives for pharmaceutical firms to develop new paediatric drugs and relevant paediatric drug labels.     

Using EHRs to design drug repositioning trials: A devolved approach to data protection

One area where the application of data protection law has proven complex is in relation to the secondary usage of health data in EHRs for medical research. Here the tension between the privacy interests of patients and the risk of harm if such sensitive data are compromised, and on the other side, the potential societal value of utilizing the data for the benefit of medical science, is especially striking. In this paper, we consider the applicable provisions of the EU Data Protection Directive, and outline a general approach to patient data handling for research, which we believe to be compatible with relevant legal and ethical requirements. We then illustrate and apply this by reference to a specific EU FP7 project, involving EHR data processing to select patients for clinical pharmaceutical trials. After introducing the project (PONTE), we explain the ‘devolved’ data protection architecture it employs and provide a legal evaluation.     

Limitation of medical research in German law.

In Germany, pharmaceutical trials and the testing of medical devices is regulated by statute. Any other kind of medical experimentation is handled according to the Declaration of Helsinki. Medical experimentation has to be reviewed by an ethics committee before the start and there has to be an elaborate research protocol, which provides for the protection of the experimental subject. In case of an accident, there is compulsory accident insurance as far as pharmaceutical trials and the testing of medical devices are concerned. The third party accident insurance just covers material loss, there is no provision paying and suffering. The sum paid by the insurance company is set off against damages for negligence. There is no strict liability for medical experimentation, but the German courts are expected to set very high standards for medical care in experimentation. The data protection and medical confidentiality have been lessened because of the European law that requires the experimental subject to give his consent to the inspection of the data or the file and if he takes part in the experimentation, that his data and some of his cells might be with the pharmaceutical company forever. In general, the German law seems to be adequate to the protection of experimental subjects.     

The new German Data Protection Act and its compatibility with the European Data Protection Directive

A substitution of the right to maintain mailing lists for marketing purposes (the so-called list privilege) by a strict opt-in requirement as proposed by the German Government for the amendment of the German Data Protection Act does not conform with European law. Making the use of relatively innocuous data like name and address for marketing purposes subject to the data subject's declaration of consent infringes upon the requirements of the European Data Protection Directive. The Directive allows for the use of personal data either on the basis of a data subject's declaration of consent or after a balancing of legally protected interests. Reducing this two-track model to a one-track model (based on the data subject's declaration of consent only) does not do justice to the idea of balancing of interests or free movement of goods and services which are a mandatory part of European law. The draft bill interferes drastically with the free movement of goods and services. A tightening of the opt-in requirements would be a severe burden for the German economy because it is impossible for businesses to distribute their goods and services without the help of marketing measures. The economic cycle would be hit at its weakest point, i.e. the link between businesses and consumers which is gaining more and more importance especially with a view to cross-border competition.     

Reconsidering the Premises of Labour Law: Prolegomena to an EU Regulation on the Protection of Employees' Personal Data

With its 1985 Directive on Data Protection, the European Union highlighted its commitment to the constitutionalisation of European law and, in particular, underlined its vision of the individual European as a rights-bearing individual; empowered through 'knowledge' and thus advantaged in communicative processes of political/social/legal bargaining. As such, the move to a data protection regime founded upon notions of individual empowerment, also mirrors a recent and fundamental re‐alignment in the guiding principles of regulative labour law, which has seen the paradigm of 'collective laissez‐faire' challenged, if not superseded, by a redirected emphasis upon the communicative empowerment of the individual employee rather than the representative function of employees' representatives. Accordingly, it is less than surprising that the field of labour law has seen increasing demands placed upon the Commission to fulfil its promise in the pre-amble to the 1985 Directive, and promulgate Regulations crafted to ensure data protection in line with the specific demands of individual societal sectors. This paper is a policy statement. It re-iterates the need for a Regulation on the protection of employees' data. Building on the comparative experience of the Member States, it outlines the nature, provisions and scope which such a regulation should entail so as to reflect, both the reality of the modern employment relationship, and a new normative vision of the workplace which aims to inject such relationships with a measure of communicative participation.     

European Union. Ethical considerations for clinical trials on medicinal products conducted with the paediatric population

This document has been developed by the ad hoc group for the development of implementing guidelines for Directive 2001/20/EC relating to good clinical practice in the conduct of clinical trials on medicinal products for human use, chaired by the European Commission. The document provides recommendations on various ethical aspects of clinical trials performed in children from birth up to the legal age of adulthood. This will contribute to the protection of all children who are the subject of clinical trials. As the approval of clinical trials, including ethical approval, is performed by the Member States, any recommendations on ethical aspects of clinical trials in children will also facilitate a harmonised approach to the application of the clinical trials directive across the EU, thereby facilitating the conduct of clinical trials in the EU and in whichever country the paediatric trial occurs. The protection against the risks of research in such a vulnerable population is paramount whilst this should not lead to denying them the benefits of research. Children are not small adults and there is a need to carry out specific trials that cannot be performed in adults. In general, children (minors) are unable to consent (in the legal sense) but their assent should be sought using age appropriate information. Ethics Committees need paediatric expertise to balance the benefits and risks of research in children. The lack of legal ability to consent has implications on the design, analysis and the choice of comparators used in trials, which should only be performed by trained investigators with paediatric experience. Pain, fear, distress and parental separation should be prevented and minimised when unavoidable. The neonate represents the most vulnerable of all paediatric age groups and requires even more careful review. Finally, various other aspects relating to the performance of trials in children are discussed.     

Restructuring "Germany Inc.": The Politics of Company and Takeover Law Reform in Germany and the European Union

The reform of German company law by the Control and Transparency Law (KonTraG) of 1998 reveals the politics of corporate governance liberalization. The reforms strengthened the supervisory board, shareholder rights, and shareholder equality, but left intra‐corporate power relations largely intact. Major German financial institutions supported the reform's contribution to the modernization of German finance, but blocked mandatory divestment of equity stakes and cross‐shareholding. Conversely, organized labor prevented any erosion of supervisory board codetermination. Paradoxically, by eliminating traditional takeover defenses, the KonTraG's liberalization of company law mobilized German political opposition to the European Union's (EU) draft Takeover Directive and limited further legal liberalization.     

Beyond European Labour Law? Reflections on the EU Racial Equality Directive

In June 2000, the Council adopted a directive forbidding discrimination on grounds of racial or ethnic origin in the areas of employment, social protection, education, goods and services, and housing. This is the first time the European Union has adopted binding legislation to combat racism. In this article, the Directive is placed within the context of European labour law, and its implications for the development of this area of law are considered. Specifically, it is proposed that a new category of European 'social law' is emerging, broader in scope than European 'labour law'. The Directive also reveals a new emphasis on effective enforcement of social law. Finally, this article considers the position of the Social Partners and non-governmental organisations in relation to the Directive. The prominence of NGOs is linked to wider trends in the wake of globalisation.     

An academic perspective on the copyright reform

The recently proposed new Copyright Directive was released on 14 September 2016. It has been described by EU law-makers as the pillar of the copyright package promised by the European Commission (EC), to be delivered before the end of Mr. Juncker's mandate. In its Communication of 6 May 2015, the EC had stressed “the importance to enhance cross-border access to copyright-protected content services, facilitate new uses in the fields of research and education, and clarify the role of online services in the distribution of works and other subject-matter.” The proposed Copyright Directive is thus a key measure aiming to address two of these three issues. However it is not without shortfalls.We have therefore decided to publicly express our concerns and send an open letter to the European Commission, the European Parliament and the Council to urge them to re-assess the new provisions dealing with mandatory filtering of user-generated content in the light of the CJEU case law and the Charter of Fundamental Rights of the European Union.In a more extended statement, we examine in details the text of both the explanatory memorandum and the Directive itself.Our conclusions are:1. A comprehensive re-assessment of Article 13 and Recital 39 in the light of the Charter of Fundamental Rights of the European Union and the E-commerce Directive (in particular Article 15) including CJEU case law is needed, as the proposed Copyright Directive does not expressly address the issue of its compatibility with both of these texts.2. Recital 38 does not clarify the domain and effect of Article 13. Rather, it creates confusion as it goes against settled CJEU case law (relating to Articles 14 and 15 of the E-commerce Directive and Article 3 of the Infosoc Directive). Recital 38 should therefore be deleted or substantially re-drafted/re-phrased. If the EU wants to introduce a change in this regard it should clearly justify its choice. In any case, a recital in the preamble to a directive is not an appropriate tool to achieve this effect.We hope that this exercise will prove useful for the debate that has now begun both in the European Parliament and in the Council.     

Towards the development of ethical practices in paediatric clinical trials: the special position of the terminally ill child

This article examines the emotive and vexing issue of the involvement of terminally children in paediatric clinical trials. Particular emphasis is placed on the participation of such children in Phase I clinical studies, as such studies do not yield any benefit to the individual child. It provides an historical overview of medical research involving children and examines the moral arguments surrounding the participation of children in clinical trials. The article examines the conflict between doctor-as-researcher and doctor-as-treater as well as the problems presented by proxy consent providers. The role played by the human research ethics committee in this area is examined, as is the regulatory framework established by the National Health and Medical Research Council. The article argues that the participation of terminally ill children in Phase I clinical trials is not morally repugnant provided that there is a total commitment to the protection of the child participant's well-being during the dying process. It is argued that the moral justification for such position derives from the utilitarian notion that participation in such studies aims to benefit future generations of ill children.     

Europeanization or National Specificity? Legal Approaches to Sexual Harassment in France, 2002–2012

This paper examines whether—and if so how—a 2002 European Directive on sexual harassment has changed the practice and content of sexual harassment law in France. It finds that the European Directive shaped how French courts address sexual harassment and informed the content of a new sexual harassment law France passed in 2012. Yet, its influence has been mediated by dominant national attitudes about: (1) the nature of sexual harassment, (2) which legal institutions are best suited to address it, and (3) the character of women who claim to have been harassed. This paper further suggests that news reporting on a 2011 arrest of a French politician for sexual assault led to more positive attitudes about sexual harassment victims.     

我国民法典视野下的数字内容瑕疵担保责任——基于欧盟背景下德国法的比较法考察

数字内容交易目前在全球数字化背景下蓬勃发展,其中,有关数字内容的瑕疵担保责任问题备受关注;立法上欧盟在新出台的《有关提供数字内容和服务的合同交易指令》中有三个条款对此作了专门规定,同时,德国也将此规定完全予以转化适用。基于现有欧盟背景下德国法有关数字内容瑕疵担保责任的比较分析,可知其不但能准确认定数字内容交易中的瑕疵形态与有效提供救济,而且有助于消费者保护。根据我国现有一般物之瑕疵担保规定并结合我国民法典编纂以及域外法经验,在解释论上,通过相关类案的比较分析,我国就此有借鉴适用的必要性;在立法论上,今后在我国《民法典》的解释与适用过程中,可先在《民法典(合同编)》司法解释中原则性地规定有关数字内容瑕疵担保责任,再另行制定具有针对性的单行法,从而有助于数字时代的我国消费者保护与数字经济发展。     

Compensation for Damage Caused by Defective Drugs: European Private Law between Safety Requirements and Free-Market Values

Abstract: Within the European Union, the success of private law harmonisation is based upon the fragile balance between legal integration and protection of national traditions. In this respect, a transversal analysis of the obligation of safety established by the Directive 374/85/CEE shows that harmonisation sometimes prevails over the potential protections granted to the victims of a damage caused by defective products. On the one hand, this reduction arises from the balance between objective and subjective criteria used in evaluating the defect as defined in the harmonised text. On the other hand, it results from problems of coordination between national laws and EC law remedies. This latter difficulty is illustrated by the 25 April 2002 European Court of Justice decisions on the French experience. The paradigmatic example of the pharmaceutical sector is a clear illustration of these tensions, since it heightens free‐market values at the same time as seeking to ensure compensation for breach of health and safety of consumers.     

Medical interpreting and the law in the European Union

In 2011, the Danish government announced that from June that year it would no longer cover the costs of medical interpreters for patients who had been living in Denmark for more than seven years. The Dutch Ministry of Health followed with an even more draconian approach; from 1 January 2012, the cost of translation and interpreting would no longer be covered by the state. These two announcements led to widespread concern about whether or not there is a legal foundation for interpreter provision in healthcare. This article considers United Nations treaties, conventions from the Council of Europe and European Union law. European Union member states have been slow to sign up to international agreements to protect the rights of migrant workers. The European Union itself has only recently moved into the area of discrimination and it is unclear if the Race Directive covers language. As a result, access to interpreters in healthcare, where it exists, is dependent on national anti-discrimination legislation or on positive action taken at national or local level rather than on European or international law.     

'We want you! But . . .' Recruiting Migrants and Encouraging Transnational Migration Through Progressive Inclusion

The article submits a proposal for outlining the present body of legal norms in the field of European migration and immigration law. To this end, it suggests understanding European migration and integration law as shaped by two principles: the principle of congruence between a state's territory, authority and citizenry and the principle of progressive inclusion. According to the established principle of congruence, the granting of rights to third‐country nationals (TCNs) is always geared to the ideal image that the persons permanently living on a territory are—in reality—part of the citizenry of that state and subject to the state's authority. According to the more recent principle of progressive inclusion, TCNs are to be gradually included into the host country's society by approximating their rights progressively to the rights of citizens. There are potential tensions between the two principles, which can be explained by the diverging philosophical and political concerns that they follow and the conceptions of migration that each uses. The article then goes on to explore the influence of both principles in current European migration and integration law. It brings forward the argument that current European migration and integration law is structured as much by the ‘older’ principle of congruence as by the principle of progressive inclusion. This assumption will be illustrated by the examples of the Long‐term Residents Directive (LTR Directive). Important provisions of the proposal for a framework directive intended to guarantee TCNs' equal treatment with EU citizens in social matters (Draft Framework Directive) and the directive on the highly skilled migrant workers (Blue Card Directive) will also be taken into account. Against the background of the highly contested legal field of migration and integration law, using the language of principles provides a useful tool not only for better grasping the current shape of this legal field, but even more for the legal discourse on the future development of European migration and integration law.     

德国国际私法渊源的新发展

在传统上,德国国际私法的渊源包括制定法、德国缔结或者参加的各种国际私法条约、习惯法和判例法,但是随着欧盟国际私法统一化的深入发展,尤其是欧洲共同体在公司法、合同法、物权法、知识产权法、破产法和国际民事诉讼程序法等领域的立法不断加强,欧盟法中的国际私法规范逐渐渗入德国国际私法,从而使德国国际私法的渊源突破了传统的范围,越来越多地打上了欧盟法的烙印,呈现出“欧盟化”倾向。