The EU Directive on Electronic Signatures--A Worldwide Model or a Fruitless Attempt to Regulate the Future?

The Directive on a Community Framework for Electronic Signatures is an essential and important new legal standard for the regulation of electronic signatures. The following article describes this Directive and assesses whether this new legal framework will be an effective and successful worldwide model or whether it will be rather fruitless. While doing this, I will consider the implementation of the Directive into UK and German law. This will also reveal some possibilities of how the legal status of electronic signatures can or cannot and should or should not be regulated. Furthermore, I will refer to other acts, for example, the UCITA and UETA of the US and the Model Law on Electronic Commerce and Draft Uniform Rules on Electronic Signatures of the UNCITRAL. My result is that the EU Directive is to be approved in general. Only if one said that in an ever-changing world every law was premature or even that in an imperfect world every law was either insufficient or unnecessary, would it be consequent to decline regulation of electronic signatures completely. However, regarding the details, some provisions, for example, the possibility of introducing a voluntary accreditation scheme, are open to criticism.     

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.     

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.     

The Transfer of Personal Data to Third Countries Under EU Directive 95/46/EC

The 1981 Council of Europe Convention 108 and EU Directive 95/46/ EC assert that data protection is privacy protection. Consequently, countries with data protection rules control trans-border data flows to protect the rights of their citizens. Under the Directive, but subject to some derogations, personal data may only be transferred to third countries with adequate protection. 'Adequacy' is to be assessed in the light of all the circumstances. Alternative safeguards can be provided by means such as contractual arrangements. The Data Protection Commissioners have tried to define 'adequacy' as the usual data protection principles plus an assurance of compliance. This can be delivered by self-regulation as well as formal law. The Directive has not made a radical break with the past. The usual principles are those found in Convention 108 and in the 1980 OECD Guidelines. Those instruments also dealt with the control of trans-border data flows because of fears of restrictions on the free flow of information. The flexibility of the effective current UK law, which permits flows whilst preventing those which would lead to a breach of data protection, would have prevented the acrimony of the current debate with third countries. National laws on transborder data flows long pre-date the Directive and data protection authorities can be expected to continue to promote pragmatic methods of protecting exported data such as the use of model contracts either as a basis for derogation from 'adequacy' or as part of a package to satisfy the adequacy test. Work is taking place to build bridges between those with formal law and others relying on self-regulation. In Ottawa last October OECD ministers reaffirmed the 1980 Guidelines and if practical privacy protection can be secured globally, transborder data-flow control is of much less concern.     

The new media landscape: Regulating the idiot boxes

The European Commission has proposed a modernization of the Directive 89/552/EEC, also known as the TV without Frontiers Directive (TVWF). The draft Audiovisual Media Services Directive suggests extending regulation to cover a broad range of new and emerging audiovisual media services. The proposal unleashed fierce opposition from all sectors. The most contentious issue concerns the distinction between the two types of audiovisual media services (linear and non-linear), which are distinguished from each other by the degree of user control. The Commission has failed to provide any convincing argument to prove the necessity of imposing a new regulation and the inadequacy of the current regulatory framework. This paper analyses the proposed Audiovisual Media Services Directive.     

Keywords,case law and the Court of Justice: the need for legislative intervention in modernising European trade mark law

Recent preliminary references to the CJEU on online keyword advertising and registered trade mark infringement have exposed the challenges facing EU registered trade mark law in its response to new technologies. These cases and the challenges they pose provide a timely prism through which to examine the European trade mark law-making process and the role of the CJEU within that process. This article will employ an analysis of the way in which the CJEU has developed certain key new aspects of the law on ‘infringing use’ to explore concerns over the CJEU's role and approach. It will be argued that, driven by policy considerations, the CJEU has acted creatively to develop the law of infringement in ways that cannot be sustained by the TMD and CTMR and which are likely to cause increasing uncertainties going forward. With the European Commission currently considering reform of Trade Marks Directive 2008/95/EC and Community Trade Mark Regulation 207/2009/EC, this paper will argue that there is a need for more comprehensive and forward-looking legislative intervention than has yet been proposed and that such intervention will be essential to restoring balance in the European trade mark law-making process.     

Is the European Medical Products Authorisation Regulation Equipped to Cope with the Challenges of Nanomedicines?

This article analyses the emerging European regulatory activities in relation to nanopharmaceuticals. The central question is whether the regulatory responses are appropriate to cope with the regulatory problems nanomedicinal development is posing. The article explores whether the medical product regulations are robust enough, whether there are certain regulatory gaps, and whether the competent bodies have the expertise to evaluate nanomedicinal products when approval is applied for. Based on a social‐constructive approach, the article identifies significant regulatory actors, their ideas on regulatory problems, and preliminary governance responses to them. It finds that the current dynamic regulatory structure appears robust enough to adapt to some of the technological challenges posed by nanomedicines. It concludes that regulators have not yet responded adequately to regulatory gaps related to definitions, classification and specific safety, quality, and efficacy standards that nanopharmaceutical development seems to require. As a consequence of these deficiencies legal certainty, a principle of high priority in European medical regulation policy, cannot be sufficiently provided.     

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.     

The Patients’ Rights Directive (2011/24/EU) – Providing (some) rights to EU residents seeking healthcare in other Member States

This article presents the main elements of Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare, commonly known as the Patient’s Rights Directive. It is the latest EU initiative with regard to European Health Care and the Single Market. The main elements of the Directive contain provisions related to the prior authorisation of health care in another Member State, the reimbursement of such health care and the removal of unjustified obstacles to achieving these aims.These provisions largely reflect the recent case law of the European Court of the Justice (ECJ). Amongst these are provisions involving the use of personal data. Such provisions will engage data protection issues and will have to be carried out according to the data protection directives. Alongside this primary aim of codifying ECJ case law the Patient’s Rights Directive also introduces novel initiatives aimed at fostering cross border cooperation between various elements of national healthcare systems.Part 1 of this contribution will describe the legal basis and the aims of the PRD, Part 2 will describe the principle obligations placed on the Member States with regard to reimbursement, Parts 3 and 4 will describe other informational and procedural requirements placed upon the Member States of Treatment and Affiliation. Finally Part 5 will outline some of the novel initiatives that have been included in the PRD.The increases in the frequency of cross border-treatment that this directive attempts to facilitate are likely to see a concurrent increase in cross-border patient information flows. Such data flows will be subject to the Union’s provisions on Data Protection. It remains uncertain whether the EU’s Data Protection regime will act as inhibitor to cross-border medical treatment or rather represent a gold standard that allows patients to engage in such activities with peace of mind. The Patient’s Rights Directive will form part of the EU’s future e-Health strategy which envisages a large increase in the fluidity of patient data. A discussion of this directive is therefore merited in this journal.     

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.     

The Takeover Directive: Is a Little Regulation Better Than No Regulation?

This article examines Directive 2004/25/EC on Takeover Bids through a regulatory lens in order to determine its effectiveness as a regulatory mechanism. A central regulatory problem for European legislators is to determine the optimal balance between harmonisation and diversity, and the directive reflects the balance which was struck. The article questions whether the resulting 'light regulatory touch' may have jeopardised the existing efficient self-regulatory regime which operates in the UK (the largest European takeover market), while simultaneously undermining the directive's goal of facilitating takeovers and yielding a level playing field.     

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.     

The regulatory pyramid meets the food pyramid: can regulatory theory improve controls on television food advertising to Australian children?

This article examines whether responsive regulation has potential to improve the regulatory framework which controls free-to-air television advertising to children, so that the regulatory scheme can be used more effectively as a tool for obesity prevention. It presents two apparently conflicting arguments, the first being that responsive regulation, particularly monitoring and enforcement measures, can be used to refine the regulation of children's food advertising. The second argument is that there are limits to the improvements that responsive regulation can achieve, since it is trying to achieve the wrong goal, namely placing controls on misleading or deceptive advertising techniques rather than diminishing the sheer volume of advertisements to which children are exposed. These two positions reflect a conflict between public health experts and governments regarding the role of industry in chronic disease prevention, as well as a broader debate about how best to regulate industry.     

Data processing by police and criminal justice authorities in Europe – The influence of the Commission's draft on the national police laws and laws of criminal procedure

The proposal for a fundamental reform of the European data protection law, published by the EU Commission on 25 January 2012 is composed of two elements. Apart from a General Data Protection Regulation, the Commission proposes a second regulatory instrument, namely a Directive with regard to data processing by police and criminal justice authorities that shall supersede the Council Framework Decision 2008/977/JHA. This paper seeks to analyse the draft Directive in the context of the entire reform approach and scrutinizes a number of specific issues in regard to the scope, the requirements of data processing, notification duties and data transfer to third countries.     

欧盟对分时度假及相关产品的法律规制

欧盟主要通过《分时度假指令》和《不正当商业做法指令》对分时度假产业进行法律规制,《分时度假指令》赋予消费者对购买分时度假产品合同的撤销权,《不正当商业做法指令》则禁止销售商在销售分时度假产品及相关产品时的不正当商业做法。由于《分时度假指令》的适用范围过于狭窄,欧盟已提出了对其的修改建议。总结欧盟规制分时度假产业的经验,我国应对分时度假产业进行法律规制并结合行业自治。     

论司法行政机关与律师自律组织之关系

我国的律师监管体制经历了从单一司法行政管理阶段到行政管理和行业管理相结合的阶段.在不断加强和规范律师协会的行业自律管理的同时,我们必须看到律师协会行业管理的不足.为了克服律师协会自律管理的不足和缺陷,司法行政机关应该把管理重点从直接管理律师转变到管理律师自律组织上来,这样才能够形成行政管理和自治管理良性互动的律师管理模式.     

Restriction of Hazardous Substances: On the Need for and the Limits of Comitology

This article demonstrates the need for and the limits of the so-called comitology procedure in the area of European waste legislation, using the example of Directive 2002/95/ EC on the restriction of the use of certain hazardous substances in electrical and electronic equipment (the RoHS Directive). The RoHS Directive prohibits the use of six hazardous substances in certain electrical and electronic equipment. The Annex to the RoHS Directive, which contains the exemptions from this prohibition, can be amended through the comitology procedure. This procedure is a widely used method in European Community law for the delegation of legislative power from the Council and the European Parliament to the executive branch, i.e. the European Commission. The authors conclude that the use of comitology is indispensable for highly technical issues for which the co-legislators are lacking the time, as well as the resources, to carry out the adaptation of the legislative acts. However, the Commission needs to handle comitology with care; otherwise it runs the risk that its decisions lack legitimacy.     

Business Responses to the Regulation of Health and Safety in England*

The material in this article is extracted from an empirical study of industrial and agricultural businesses' responses to regulation of health and safety in the workplace. The study critically assesses the philosophy of self-regulation which underpins the regulatory framework in England and within the context of the expectations of employers built into that philosophy, attempts to distinguish between different models of employers in relation to their levels of motivation toward health and safety issues; their knowledge and comprehension of the law; their general approach to compliance with regulations; and their response to inspectors' enforcement activities. The article concludes that self-regulation is only capable of operating under very narrow conditions. It is at its most successful within the largest and most hazardous companies, despite the fact that the inspectorates devote the greatest concentration of enforcement and advisory resources to these sites. Companies which do not have a natural interest in safety require considerable advice, encouragement and coercion. In some situations deterrent penalties may be required in order to achieve a sustained improvement in standards. The research suggests that greater attention should be paid to the variety of employers and their compliance strategies, and to the potential for better targeting of regulatory efforts.     

The Data Protection (Amendment) Act, 2003: the Data Protection Directive and its implications for medical research in Ireland

Directive 95/46/EC on the Protection of Individuals with regard to the Processing of Personal Data and on the Free Movement of Such Data has been transposed into national law and is now the Data Protection (Amendment) Act, 2003. The Directive and the transposing Act provide for new obligations to those processing data. The new obligation of primary concern is the necessity to obtain consent prior to the processing of data (Article 7, Directive 95/46/EC). This has caused much concern especially in relation to 'secondary data' or 'archived data'. There exist, what seem to be in the minds of the medical research community, two competing interests: (i) that of the need to obtain consent prior to processing data and (ii) the need to protect and foster medical research. At the same time as the introduction of the Act, other prior legislation, i.e. the Freedom of Information Act, 1997-2003, has encouraged candour within the doctor-patient relationship and the High Court in Ireland, in the case of Geoghegan v. Harris, has promulgated the 'reasonable-patient test' as being the correct law in relation to the disclosure of risks to patients. The court stated that doctors have a duty to disclose all material risks to patients. The case demonstrates an example of a move toward a more open medical relationship. An example of this rationale was also recently seen in the United Kingdom in the House of Lords decision in Chester v. Afshar. Within the medical research community in Ireland, the need to respect the autonomy of patients and research participants by providing information to such parties has also been observed (Sheikh A. A., 2000 and Irish Council for Bioethics, 2005). Disquiet has been expressed in Ireland and other jurisdictions by the medical research communities in relation to the exact working and meaning of the Directive and therefore the transposing Acts (Strobl et al). This may be due to the fact that, as observed by Beyleveld "The Directive makes no specific mention of medical research and, consequently, it contains no provisions for medical research as an explicitly delineated category." (Beyleveld D., 2004) This paper examines the Irish Act and discusses whether the concerns expressed are well-founded and if the Act is open to interpretation such that it would not hamper medical research and public health work.