欧盟转基因生物安全法评析

欧盟对转基因生物安全的管理在世界上一直是最严格的,因其严格,也遭到美国等现代生物技术产品出口大国的质疑.对欧盟管理转基因生物安全的指令和条例进行介绍,对新旧法律进行比较,从中可以看出欧盟这方面法律的一个发展轨迹,并介绍了欧盟及其成员国对这些指令和条例的执行情况.此外,还介绍了著名的美国等国家诉欧共体的转基因生物措施案,并对案件进行了简单的评议,从中可以了解世界贸易组织的争端解决专家对欧盟有关转基因生物的措施的一些意见.     

Applying Precaution in EU Authorisation of Genetically Modified Products—Challenges and Suggestions for Reform

In this article, I endeavour to examine concrete challenges that arise with regard to implementation of the precautionary principle in the field of European Union regulation of genetically modified organisms (GMOs). Developed by the European courts into a general legal principle, precaution requires EU regulators to strike a balance between scientific and political legitimacy when taking decisions on risk‐entailing products. Following this understanding, the current GMO legislation creates precautionary governance structures that allow for a broad input into the authorisation process, not only of scientific, but also of ‘other legitimate factors’. At the same time, it can be criticised for narrowly defining precaution as a decision rule, which, if applied correctly, will lead the decision maker to the ‘right’ decision. I argue that this misconception is one of the reasons why, in the current authorisation practice, the EU institutions fail to apply the principle in a balanced way, falling into the extremes of either purely science‐based decision making or a highly politicised precautionary rhetoric. I suggest that in order not to be paralysing, precaution should be understood as a procedural principle that provides for precautionary governance, thus enabling regulators to make appropriate risk choices.     

Risk Regulation and Deliberation in EU Administrative Governance—GMO Regulation and Its Reform

The article analyses the problems of EU risk regulation of genetically modified organisms (GMOs) through the lens of deliberative theories of EU law and governance, such as deliberative supranationalism and experimentalist governance. Previous research had suggested that the GMO issue is not conductive to deliberation within EU institutions because of its high politicisation. This article argues that another equally salient factor is the scientification of the GMO authorisation process. Scientification stands for the Commission's overreliance on epistemic legitimacy as the basis for risk management. Given the deadlock of comitology in this field, scientification is exacerbated by a reversion to top‐down regulation by the Commission. As a result, political responsibility for GMO authorisations gets lost. This article argues that both scientification and politicisation are mutually accelerative processes ultimately leading to a break down of dialogue at the EU level. This contradicts the assumption that deliberation is fostered by technocratic ‘behind closed door’ decision‐making. In the GMO case, the top‐down imposition of epistemic authority has only increased politicisation contributing to the de‐legitimation of all EU institutions involved in GMO regulation. The recent EU reform on national opt‐outs is not sufficient to address this problem. A successful reform should mitigate the negative effects of both politicisation and scientification.     

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.     

The proposed data protection Regulation replacing Directive 95/46/EC: A sound system for the protection of individuals

The recent release by the European Commission of the first drafts for the amendment of the EU data protection regulatory framework is the culmination of a consulting and preparation process that lasted more than two years. At the same time, it opens up a law-making process that is intended to take at least as much time. The Commission has undertaken the herculean task to amend the whole EU data protection edifice, through the introduction of a General Data Protection Regulation, intended to replace the EU Data Protection Directive 95/46/EC, and a Police and Criminal Justice Data Protection Directive, intended to replace the Framework Decision 2008/977/JHA. This paper shall focus at the replacement of the EU Data Protection Directive by the draft General Data Protection Regulation. Due to the fact that the draft Regulation is a long (and ambitious) text, a selection has been made, with the aim of highlighting its treatment of basic data protection principles and elements, in order to identify merits and shortcomings for the general data protection purposes.     

Data Protection: An Opening Door?

Swedish public law has incorporated a general rule of public access to documents, and to information in the wider sense, since the Freedom of the Press Act of 1766. On the Community level, the relationship between Regulation (EC) 45/2001 on data protection and Regulation (EC) 1049/2001 on public access to documents exemplifies the tension between the public's interest in scrutinising the administration carried on in its name, and the integrity of the individual. However, a similar tension exists between Sweden's Personal Data Act of 1998, implementing Directive 95/46, and the Freedom of the Press Act. A misuse model of data protection law, by seeking to concentrate on serious rather than technical infringements of privacy, might serve to ease the tension. The views expressed in this article are solely those of the author and are not attributable to any Community institution. This revised version was published online in August 2006 with corrections to the Cover Date.     

Are works communicated through television sets in hotel rooms a 'communication to the public'?

The European Court of Justice makes it clear that, while themere provision of physical facilities does not as such amountto a communication within the meaning of the Copyright Directive(2001/29/EC), the distribution of a signal by means of televisionsets by a hotel to customers staying in its rooms, whatevertechnique is used to transmit the signal, constitutes communicationto the public within the meaning of Article 3(1) of the Directive.     

An inquiry into the legal status of the ECOWAS cybercrime directive and the implications of its obligations for member states

On 19 August 2011, the ECOWAS Council of Ministers adopted Directive C/DIR.1/08/11 on Fighting Cybercrime at its Sixty Sixth Ordinary Session in Abuja, Nigeria. The adoption of the Directive at that time arose from the need to tackle the growing trend in cybercrime within the ECOWAS region, as some Member States were already gaining global notoriety as major sources of email scams and Internet fraud. Accordingly, the Directive established a legal framework for the control of cybercrime within the ECOWAS region, and also imposed obligations on Member States to establish the necessary legislative, regulatory and administrative measures to tackle cybercrime. In particular, the Directive required Member States to implement those obligations “not later than 1st January, 2014″. This article undertakes an inquiry into the legal status of the Directive as an ECOWAS regional instrument in the domestic legal systems of Member States.In this regard, the article examines whether the requirement regarding the superiority or direct applicability of ECOWAS Community laws such as ECOWAS Acts and Regulations in the domestic legal systems of Member States also apply to ECOWAS Directives such as the Cybercrime Directive. The article also examines the legal implications of the Directive's obligations for Member States. The article argues that while some Member States have not implemented the obligations under the Directive, that those obligations however provide a legal basis for holding Member States accountable, where the failure to implement has encouraged the perpetration of cybercrime that infringed fundamental rights guaranteed under human right instruments such as the African Charter on Human and Peoples’ Rights or under their national laws.     

Legal grounds to process personal data under Spanish legislation after the ECJ Judgment of 24 November 2011 (the ASNEF and FECEMD case)

Spanish law on personal data protection regulates (among other issues) the legal bases that permit the processing of data in a way that is similar to that set out in Directive 95/46/EC. Consent constitutes the general rule although data may be processed without it if necessary for administration functions, within the framework of a contractual relationship, in order to safeguard the vital interests of the data subject or if they are included in sources accessible to the public. However, unlike the Directive, legitimate interest is not recognised as an independent reason for processing data, whereas a legal ground that is not set out in community law is included, i.e., sources accessible to the public. This paper analyses these two cases, taking as its starting point consent, along with the consequences that the ECJ Judgment of 24 November 2011 regarding the interpretation of Article 7 of Directive 95/46/EC may have and giving attention to the revision of this Directive itself.     

Biotechnology and relevant aspects of the New Biosafety law]

On 24 March 2005, the President of the Federative Republic of Brazil approved the New Law on Biosecurity. This law has very diverse aspects, ranging from the genetically modified organisms to the genetic manipulation of human embryos or the liberalisation of the transgenic soy crops during 2004-2005. This article tries to analyse and criticise the content of the law, highlighting the genetic research and experimentation, the GMOs and their effect in the environment and the criminal responsibility derived from such actions. Likewise, it leaves rooms for the reader to reach his/her own conclusions. The author poses the moral dilemma on whether it is legitimate to make governmental decisions solely taking into account the economic and political interests, leaving aside the opinion of society.     

Employee Rights on Transfer of Undertakings: Italian Legislation and EC Law

Abstract:  The authors examine the conformity with Community law of the recent regulatory changes introduced to the Italian legal system regarding the safeguarding of employees' rights during transfers of undertakings. The investigation takes place on the assumption that the principle of primacy of Community law applies, which first and foremost means that it must be verified whether the domestic legislation in question complies with the interpretation given to the relative provisions of Community law. According to the authors' opinion, domestic law could be judged as non-conforming to the interpretation that has been given by the Court of Justice, so that the question may be brought before the Court of Justice ex Article 226 EC or by recourse to the preliminary ruling procedure under Article 234 EC, which reveal cases of incorrect implementation of the Directive.     

Nature Protection and the Introduction into the Environment of Genetically Modified Organisms: Risk Analysis in EC Multilevel Governance

Genetically modified organisms (GMOs) are usually introduced into the environment through experimental releases or extensive cultivation. The risks involved are controlled via both the authorization for deliberate release and the authorization for the placing on the market of a GMO. In these two steps, the core issues of legal protection are public health and the environment. GMO-free agriculture has been introduced as a third – economic – protected good. This has triggered coexistence measures keeping GM and non-GM agriculture separated. Given the fact that much has already been said about risks of GMOs to human health, this article will rather focus on the environmental dimension, and more precisely on aspects of nature protection. It will accordingly explore whether nature is adequately protected through the authorization for the release and the authorization for the market placement of GMOs. While these questions concern regimes aiming at preventing environmental damage, co-existence, if related to natural ecosystems (rather than to the protection of a variety of agriculture), raises the question of whether ecosystems can be considered as protectable goods even if no traditional damage is caused.     

Implementing the artist's resale right directive

Legal context: Directive 2001/84/EC, on the resale right for the benefit ofthe author of an original work of art, introduced the harmonisationof artist's resale right within the EU (and subsequently withinthe EEA). Resale right already existed in many EU States, butthe Directive also required its creation in others (such asthe UK) to which it was previously unknown. The implementationof the Directive in the UK was accordingly a matter of somecontroversy. Key points: This article concentrates on the legal difficulties involvedin that implementation, viewed against the background of theUK Government's stated general policy on the transposition ofEU Directives. From several points of view, the rules laid downin the Directive called for elaboration or clarification, andin a number of cases such an approach was appropriate. In othercases, however, this turned out not to be appropriate. Practical significance: As a result, although in the main it was possible to transposethe Directive into a clear and workable set of domestic rules,a number of issues had to remain unresolved. Among the mostimportant were: whether works of ‘applied art’ shouldattract resale right, and the territorial scope of the transactionscovered by the right.     

Data protection: The future of privacy

The Art. 29 Working Party (hereinafter “Art. 29 WP”) is an influential body comprised of representatives from the Member State Data Protection Authorities² established under the Data Protection Directive 95/46/EC, has recently issued an opinion with the Working Party on Police and Justice. This is quite significant, since the opinion sets out some of the issues that will need to be addressed in the lead up to the revision of the Data Protection Directive 95/46/EC.³ This comes at a time, when there have been discussions on the current application of the European Data Protection Directive to the internet,⁴ (such as social networking) and the recent European Commission’s consultation on the legal framework for the fundamental right to protection of personal data. Not least, there have been a number of cases brought before the European Court of Justice dealing with the partial implementation of the Data Protection Directive 95/46/EC.⁵The aim of this paper is to consider in detail the issues set out by the Art. 29 WP and the likely challenges in revising the Data Protection Directive 95/46/EC.     

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.     

How do GM/non GM coexistence regulations affect markets and welfare?

This paper presents a theoretical economic model assessing the effects of the level of mandatory genetically modified (GM) and non-GM coexistence regulations on market and welfare outcomes. We assume vertical differentiation of GM and non-GM goods on the consumer side. Producers of non-GM crops face a probability of having their harvest downgraded if gene flow from GM fields raises its content in genetically modified organisms (GMOs) above the labeling threshold. The government may impose on GMO producers mandatory ex ante isolation distances from non-GM fields in order to decrease the probability of non-GM harvest downgrading. It may also introduce an ex post compensation to non-GMO farmers for profit losses due to harvest downgrading, with a compensation fund financed by GMO producers and/or the state. Assuming endogenous crop choices and prices, we study the effects of ex ante regulation and ex post liability on four outcomes: market equilibrium, the achievement of coexistence, and both global and interest group welfare.     

Race Equality and TCNs, or How to Fight Discrimination with A Discriminatory Law

Two subjects often fit with difficulty in 'Fortress Europe': Equality and Third Country Nationals (TCNs). EC Law presents fundamental weaknesses with regard to TCNs in the intersections between race, religion and nationality discrimination. In particular for non-EU nationals, these three grounds of discrimination can be closely related, and difficult to distinguish. However, they are of great importance for the integration and fair treatment of migrants, which was one of the objectives of the Tampere Programme. This article analyses the extent to which the Race Equality Directive (43/2000/EC) and the Framework Equality Directive (78/2000/EC) provide an effective protection against 'racial related discrimination'. It suggests that the loopholes of both Directives, together with the current interpretation of Article 12 EC, have institutionalised not only a hierarchy of equalities, but also a hierarchy of peoples, and it explores possible interpretative solutions.     

Significant 2007 case law on the Community trade mark from the ECJ and the CFI

Legal context: This article looks at the important decisions of 2007 on theCommunity trade mark made by the Luxembourg courts. Key points: The cases discussed concern the application of Council Regulation(EC) No. 40/94 of 20 December 1993 on the Community trade mark(the ‘CTMR’), Commission Regulation (EC) No. 2868/95of 13 December 1995 implementing the CTMR (the ‘CTMIR’),and the Council Directive 89/104/EEC of 21 December 1988 (‘Directive89/104’). Practical significance: The purpose of this article is to give a quick overview of themost significant trade mark cases decided in 2007 by the Luxembourgcourts. The article has a practical bias and is aimed at readerswho wish to find quickly the key decisions of 2007.     

An Analysis of the Transfer of Undertakings (Protection of Employment) Regulations 2006

This article analyses the Transfer of Undertakings (Protectionof Employment) (TUPE) Regulations 2006, which revoke, entirely,the TUPE Regulations 1981. As well as comprising the UK Government’sresponse to the amending Acquired Rights Directive 1998/50/EC,they purport to fulfil a four-fold aim of increasing the coverageof TUPE in outsourcing situations; clarifying the law on transferconnected dismissals and when employees may agree transfer relatedchanges to employment conditions; providing for the supply bytransferors of employee liability information; and relaxingthe provisions of TUPE in insolvency situations to the extentpermitted by the Acquired Rights Directive 2001/23/EC. It isto be argued that some of these aims are realised in the newRegulations, and others not. And certain areas worthy of newregulation are ignored. What is ultimately apparent howeveris that the new Regulations cannot be taken to be an ‘employers’charter’. In some instances the new Regulations may breathenew life (and litigation) into the law.