Research with minors in Germany

The European GCP Directive has been implemented into German law in sect. 40 ff. AMG (German pharmaceutical law). Unlike the Directive, German pharmaceutical law basically differentiates between three constellations of clinical trials on minors: clinical trials on healthy minors, clinical trials on ill minors with an individual benefit for the individual participant, and clinical trials on ill minors without direct benefit for the individual participant, but with a so-called "group benefit". Particularly the latter possibility of conducting clinical trials on minors even if no individual benefit can be expected is not a matter of course in Germany since due to historical experiences a sceptical attitude towards clinical research on humans prevailed for a long time. German legislature has availed itself of the option granted by Article 3 of the GCP Directive to establish a higher level of protection of clinical trial subjects than the European level.     

From International Ethics to European Union Policy: A Case Study on Biopiracy in the EU's Biotechnology Directive

This article explores how the question of biopiracy, and the rights of indigenous people in the context of patents over natural resources related to traditional knowledge became articulated within the European Union's law and policy process. It presents how this issue was first introduced into the EU during the negotiation on the Directive 98/44/EC, and which mechanisms transformed this ethical issue into a policy concern. Analyzing the history of this issue within that of Directive 98/44/EC offers significant opportunities for testing the appropriateness of multilevel governance and policy-network theories to empirical sociolegal research in the EU context.     

Sui generis database protection: a new start for the UK and Ireland?

LEGAL CONTEXT: The decisions of the ECJ in William Hill and Fixtures Marketingconstitute setbacks for rightholders seeking to protect thecontent of databases from unauthorised use by others. This developmentis keenly felt in Ireland and the UK because of the absenceof any overlapping protection in the form of unfair competitionrelief against parasitical activities by competitors. Ironically,post-Feist US copyright law, in the form of the Montgomery CountyRealtor case (1995), when contrasted with the recent Dutch ZAHdecision (2006), shows that US copyright law affords a greaterlevel of protection than is available in the EU under the DatabaseDirective. The ZAH decision also builds upon earlier Germancase law, virtually eliminating liability for linking to websitematerial made available to the public. KEY POINTS: In ZAH, the Dutch Court's interpretation of the Directive andcriteria to be met before content may be copyright protectedwas very restrictive, in stark contrast to the approach of mostCommon Law judges. The result is a very different one to thatintended by the drafters of the Directive, a point reinforcedby the European Commission's own 2005 assessment of the Directive. PRACTICAL SIGNIFICANCE: The Directive has been a disaster from every perspective. Lawmakersin the UK and Ireland may feel that the time is right to consideradopting national measures to produce a more balanced protectivemeasure in respect of commercial databases and an effectivemeans of stimulating investment by following unfair competitionprinciples, rather than the quasi-copyright model of the suigeneris right. ZAH demonstrates that until the European Commissiontackles the critical issue of a common originality standard(which is very unlikely) national differences will be inevitablewithin EU copyright law.     

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.     

Ireland and medical research with minors: some medico-legal aspects

The practice of medical research with minors in Ireland consist of practices pertaining to therapeutic and non-therapeutic medical research. Clinical trials (a category of therapeutic research), is governed by legislation. However, any other therapeutic research (non-clinical trials research) and non-therapeutic research, e.g. observational medical research such as a longitudinal study of children or non-therapeutic research such as blood sample collection for analysis of cause of disease, are unregulated by legislation. This, article will outline and describe some of the medico-legal issues involved in both types of research and will comment on matters such as what national law exists, how the directive on good clinical practice has been implemented, what guidelines, if any, exist.     

Medical data breaches: Notification delayed is notification denied

The EU and the United States have implemented data breach notification rules that cover the health sectors. Nevertheless, data breach incidents involving medical data continue to rise, especially in the US and the UK. The HITECH Act, Pub. L. 111-5 Title XIII is the first federal health breach notification law in the US to be characterized by less government intrusions, while the revised EU Privacy Directive, 2009/136/EC calls for tougher privacy protection for data held by electronic communication providers. While the EU law sets a global de facto standard, the law remains toothless without strong enforcement mechanisms.     

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 public interest dimension of the single market for data: Public undertakings as a model for regulating private data sharing

Data plays a crucial role for society. Accordingly, building a ‘single market for data’ by increasing the availability of public and private data ranks high on the EU policy agenda. But when advancing legal data sharing regimes, there is an inevitable need to balance public and private interests. While the European Commission continues to push for more binding rules on data sharing between private businesses, public undertakings are already covered by mandatory rules. Exploring how the law addresses their data offers valuable lessons on the reconciliation of market reasoning with the public interest. In particular, this article inquires into the recast Open Data and Public Sector Information Directive, the Data Governance Act, and different national rules which regulate access to and re-use of public undertakings' data. It identifies five striking characteristics and discusses their potential and limitations for regulating data sharing by private undertakings. The implications serve as a guidepost for advancing the wider debate on building a single market for data in the EU. Some of them are already reflected in the upcoming EU Data Act.     

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.     

Contract Governance in the EU: Conceptualising the Relationship between Investor Protection Regulation and Private Law

The instrumental use of private law, in particular contract law, by the EU raises a complex issue concerning the relationship between contract‐related regulation and traditional private law and underlines the need for conceptualising the interplay between the two from the contract governance perspective. The present article aims to apply this new analytical approach in the investment services field where there is considerable tension between the EU investor protection regulation embodied in the Markets in Financial Instruments Directive (MiFID I and MiFID II) and national private laws. The article explores various models of relationship between investor protection regulation and traditional private law within a multi‐level EU legal order, considering the strengths and weaknesses of each field in pursuing public and private interests involved in financial contracting. This analysis also offers some lessons for the broader narrative of how European integration in regulated areas dominated by public supervision and enforcement could proceed.     

欧盟统一的法定审计制度:挑战与改革

欧盟公司法的统一是不断向前推进的,有关法定审计的第8号公司法指令是欧盟公司法的组成部分.本世纪初在美国及欧盟发生的财务丑闻加快了欧盟强化法定审计独立性及法定审计责任的改革.以公司治理为背景,主要分析了欧盟修订法定审计指令的考量因素、对法定审计独立性的强化措施、有关法定审计的形式选择以及尚未解决的问题,指出欧盟法定审计的改革受到美国《萨班斯法案》以及欧盟成员国内法的影响,而且,这一改革还将持续进行,并且也影响着包括中国在内的其他国家的相关立法.     

Exhaustion and parallel importation of copyright goods under Turkish law

Legal context. Turkey undertook to align its domestic intellectualproperty legislation with that of the European Communities,although it is not currently a member of the European Union.Towards this goal, the Turkish Copyright Act was amended inaccordance with Decision 1/95 of the EC-Turkey Association Counciland Council Directive 92/100. This article sets out the arrangementsregarding the exhaustion and parallel import of copyright goodsunder Turkish intellectual property law. Key points. The territorial exhaustion rule has been acceptedunder Turkish intellectual property law. By the first sale orother transfer of ownership of copies of a work, within theborders of Turkey, the distribution right of the copyright owneris exhausted in these copies. Copyright owners have the exclusiveright to prevent parallel import of copies of their works whichwere manufactured and marketed abroad with their consent. Practical significance. The rule of regional exhaustion is notapplicable in trade relations between Turkey and the EU. Onthe assumption that the copies of a work which is protectedunder Turkish law are first sold within the borders of the EU,the copyright owner in Turkey may prevent the parallel importationfrom the EU to Turkey. In contrast, once the first sale of copiesoccurs in Turkey, the parallel importation from Turkey to theEU can be prevented by the copyright owner within the bordersof the EU.     

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.     

Monopoly defeating mechanisms: Will they function in the digital world?

History reveals that ‘copyright’ was originally monopolistic (in the early fifteenth century) and remained so until the enactment of the Statute of Anne in 1709. Since then copyright has striven to maintain a delicate balance between incentive to authors and avoiding monopolistic stagnation. To achieve these goals, certain monopoly-defeating mechanisms have been adopted such as: fair use, public domain, the idea/expression dichotomy and the exhaustion doctrine. Recently, however, with the implementation of new laws: for instance the Digital Millennium Copyright Act (1988), the EU Copyright Directive (2001), and the implementation of the EU Copyright and Related Rights Regulation amending the Copyright, Design and Patents Act 1988, there is a growing concern that the mechanisms which were enacted to defeat the monopoly will not work in the digital medium. With the provision of affixing technological measures to copyrighted works and the non-application of the exhaustion doctrine in the digital world, arguably the monopoly defeating mechanisms have been disabled. The aim of this paper is to demonstrate the way monopoly defeating mechanisms are becoming non-functional in the digital world. Furthermore, the study also demonstrates how the European Copyright Directive and the UK implementation of the Directive has transgressed the boundary of exclusive rights set by the two World Intellectual Property Organization (WIPO) treaties – the World Copyright Treaty (WCT) and the WIPO Performers and Phonograms Treaty (WPPT) – and copyright law, thereby strengthening the copyright owner's rights in a way that was never intended by the WIPO treaties or by copyright law. Consequently, the new laws have also shifted copyright's attention from commercial pirates to non-commercial individual users. The study aims to demonstrate how the shift took place and finally, trace the recurrence of the monopoly; giving rise to a situation where there is no fair use/dealing, no public domain, no idea/expression distinction and no exhaustion doctrine.     

Combatting those who intentionally access images depicting child sexual abuse on the Internet: A call for a new offence in England and Wales

In England and Wales, there are four main categories of offence surrounding images depicting child sexual abuse, those of making/taking, publishing, distributing and possession. Despite being in force for almost 40 years, it is argued that now, additional regulation is required. In response to technological provision such as private browsing, streaming and encryption which are providing investigative difficulties for digital forensic analysts, this article proposes the need to implement a fifth offence, one of ‘intentional accessing’ and debates the feasibility and justifications for doing so. Such an offence would also arguably support the effective transposition of Directive 2011/93/EU into English law. This proposal also coincides with the recent enactment of the Investigatory Powers Act 2016, which enforces new data retention requirements on Internet Service Providers allowing offender Internet connection records to be stored for up to 12 months and potentially retrospectively investigated.     

Taking fundamental rights seriously in the Digital Services Act's platform liability regime

This article highlights how the EU fundamental rights framework should inform the liability regime of platforms foreseen in secondary EU law, in particular with regard to the reform of the E-commerce directive by the Digital Services Act. In order to identify all possible tensions between the liability regime of platforms on the one hand, and fundamental rights on the other hand, and in order to contribute to a well-balanced and proportionate European legal instrument, this article addresses these potential conflicts from the standpoint of users (those who share content and those who access it), platforms, regulators and other stakeholders involved. Section 2 delves into the intricate landscape of online intermediary liability, interrogating how the E-Commerce Directive and the emerging Digital Services Act grapple with the delicate equilibrium between shielding intermediaries and upholding the competing rights of other stakeholders. The article then navigates in Section 3 the fraught terrain of fundamental rights as articulated by the European Court of Human Rights (ECtHR) and the Court of Justice of the European Union (CJEU) under the aegis of the European Convention on Human Rights and the EU Charter. This section poses an urgent inquiry: can the DSA's foundational principles reconcile these legal frameworks in a manner that fuels democracy rather than stifles it through inadvertent censorship? Section 4 then delves into the intricate relationship between fundamental rights and the DSA reform. This section conducts a comprehensive analysis of the key provisions of the DSA, emphasising how they underscore the importance of fundamental rights. In addition to mapping out the strengths of the framework the section also identifies existing limitations within the DSA and suggests potential pathways for further refinement and improvement. This article concludes by outlining key avenues for achieving a balanced and fundamental rights-compliant regulatory framework for platform liability within the EU.     

Parties’ legal capacity in electronic commerce transactions

The aim of this article is to scrutinise the uncertainty of the Iranian Electronic Commerce Law (IRI ECL 2004) provisions especially on the issue of capacity of parties. Issues of parties’ legal capacity have been resolved in traditional contracts but they are still debatable in electronic commerce transactions. Under UK law, contracts formed by minors for things other than necessities are unenforceable against the minor but enforceable against the merchant (seller) while according to US uniform commercial code in online contracts capacity is not recognized as a legal excuse to nullify a contract. At the mean time, contracts made by incapacitate person is considered null under Iranian law. In spite of technical developments such as digital signatures and smart cards used in verifying the identity and capacity of parties in electronic commerce transactions, the legal certainty on capacity of parties is still questionable. The article also examines the application of traditional contract general rules on parties’ legal capacity in Iran to electronic commerce with reference to EU law. The EU law which is already at an advance stage serves a guide for future development of e-commerce law in Iran.     

The new EU cybersecurity framework: The NIS Directive,ENISA's role and the General Data Protection Regulation

The NIS Directive is the first horizontal legislation undertaken at EU level for the protection of network and information systems across the Union. During the last decades e-services, new technologies, information systems and networks have become embedded in our daily lives. It is by now common knowledge that deliberate incidents causing disruption of IT services and critical infrastructures constitute a serious threat to their operation and consequently to the functioning of the Internal Market and the Union. This paper first discusses the Directive's addressees particularly with regard to their compliance obligations as well as Member States’ obligations as regards their respective national strategies and cooperation at EU level. Subsequently, the critical role of ENISA in implementing the Directive, as reinforced by the proposal for a new Regulation on ENISA (the EU Cybersecurity Act), is brought forward, before elaborating upon the, inevitable, relationship of the NIS Directive with EU's General Data Protection Regulation.     

The Cyprus and other EU court rulings on data retention: The Directive as a privacy bomb

This paper discusses the controversy surrounding the Data Retention Directive with an emphasis on the 2011 decision of the Cyprus Supreme Court which has annulled several district court orders that allowed the police access to telecommunications data relating to certain persons relevant to criminal investigations. The annulment has been on the ground that the legal provisions upon which the orders have been issued are unconstitutional. It will suggest that the decision does not entail a direct rejection of the EU Data Retention Directive and that in any event, Cyprus is not a Member State resisting the particular measure. This is because the legal provisions are deemed unconstitutional, though part of the law that has transposed the relevant Directive into national law are provisions that go beyond what the EU legislator intended to regulate through that Directive. Still, the particular Directive sits rather uneasily within the ‘human rights’ regime, in particular the one governing the individual right of privacy.     

Constitutional Principle,the Rule of Law and Political Reality: The European Union (Withdrawal) Act 2018

The European Union (Withdrawal) Act 2018 is the cornerstone of UK legislation designed to accomplish the legal dimension of Brexit. It brings the entire acquis of EU law into UK law in order to avoid regulatory black holes that would otherwise occur. The Act embodies a twofold legislative strategy: EU law brought into UK law thereby is to be made fit for purpose by exit day, with necessary changes being made by statutory instrument; Parliament can then decide at greater leisure thereafter whether it wishes to retain, amend or repeal this legislation. The burden placed on Parliament is unprecedented, all the more so given the exigencies of time in which the changes are to be made. This article explicates the principal provisions of the 2018 Act, and the concerns as to constitutional principle and the rule of law raised by the legislation. The tensions in the drafting process are made apparent, and uncertainties in the resulting text are revealed.