This paper deals with the debate on the methods to regulate hedge funds, with a particular focus on direct or indirect regulation. After having briefly examined the pros and the cons of directly regulating these investment schemes, it comes to the conclusion (largely shared by most scholars) that hedge funds should not be directly regulated, while regulation should concern their management companies and, most of all, their counterparts (lenders in the first place) with a view to managing systemic risk. In addition, regulation should also set precise thresholds for access which should aim at protecting unsophisticated investors from hazardous moves, without, however, falling into the trap of regulating hedge fund themselves.

The attention is then turned to the European Union and to its Alternative Investment Fund Managers Directive (AIFMD). An analysis is conducted on some of the most significant approaches to hedge fund regulation which have fuelled (and are partly still fuelling) the debate within EU institutions in its struggle to provide Member States with a valid response to the financial crisis, and on some key provisions of the first level AIFMD. In this light the author concludes that, despite the declared intent to regulated fund managers, the directive often seems to regulate hedge fund themselves. This does not seem to be in line with the thoughts of most scholars and market operators on hedge fund regulation and also looks at odds with other pieces of EU legislation (in particular with the so-called “Newcits”).

This article assesses the impact of the global economic crisis on the European Union and analyzes the recently enacted and future legislative response to repair the EU financial sector. It closely discusses and critiques the main initial response legislation, the European Economic Recovery Plan, finding that the central regulation contained short-term measures, yet managed to remain within the EU's long-term goals. The article also closely examines the significant risk regulation considerations highlighted by the economic crisis, notably those considerations contained in the De Larosiere Report and the Basel III Framework, and discusses the importance of implementing financial risk regulations to stabilize and revitalize the EU financial sector. Ultimately, the article concludes that the EU's recently enacted legislative measures are consistent with, but also must continue in tandem with, the longterm policies of the EU, while including new and crucial financial risk regulatory measures.

The article depicts the general framework in which the regulatory bodies in financial sector have been operating. After an introductory outline of the financial system and its objectives, the analysis shifts to the framework of the financial business operators and of the regulatory bodies. The market is organised and fragmented in financial conglomerates, where cross activities take place and where potentially it is easier for the regulatory bodies to exercise their control. In this context, the different models of supervision will be scrutinised, together with the attempts, made at European level, to comply with the international standards. The final part is dedicated to the description of global dynamics and to the current situation to overcome the systemic crisis affecting the market. With some –bitter – concluding remarks we will try to prospect possible different solutions to the crisis, solutions that don't necessarily coincide with the actual decisions to reform the system taken at European level.

Counter-terrorist sanctions against private individuals adopted by the EU and by the UN are an exceptionally illustrative example of the executive’s power grasp, where the dangers of counter-terrorist policies and of externalized rulemaking have mutually reinforced each other. This article (re-)considers the role of the judiciary in the face of extreme exercise of externalized executive powers, demonstrates that multilayered governance has extended the powers of courts, shows that the justified exercise of judicial power has led the EU institutions and the Member States into a self-inflicted catch-22, and makes an argument that the extended powers of the executive and of the judiciary should be contained and guided by a principled choice of the constituent power. Constitutional law should require the judiciary to take a substantive approach to multilayered governance that reflects the principle of separation of powers.

According to the principle of risk analysis established by Regulation 178/2002, food safety measures in the EU and Member States must be based on scientific risk assessment. Apart from science, however, decision makers should take into account other legitimate factors, such as societal, ethical or traditional concerns. The extent to which risk managers can deviate from scientific evaluations in considering these factors depends on how much discretion is conferred on public authorities. This article compares the discretion at both national and Union levels of food safety regulation in the context of the internal market mechanism by analysing the standard review applied to food safety measures by the European judiciary.

The expression “risk regulation” conveys the idea of normalisation of the way in which the State deals with the problems raised by risk, through rules, institutions and procedures set up to either prevent risk or manage it once it materialises. It must be conceded, however, that there is a tension between risk regulation (understood as a means of bringing risk under control) and the fact that the emergence of new risks has persistently caused turmoil. For this reason, risk is proving to be a serious test of the State's ability to pursue the public interest when dealing with issues which are characteristically complex, both technically and socially.

The European Union has responded to the BSE and GMO crises by developing a truly European risk regulation system which has been a major driver of legal and institutional reform. Implementation has been far from homogeneous across the Member States, however, my premise being that the objective of normalisation has met perhaps unexpected obstacles in Southern European countries like Portugal, raising the question of the kind of local conditions which may either favour or hinder Europeanisation processes. This paper discusses the topic based on the analysis of three case studies illustrating the way the Portuguese state has tackled environmental and public health risks, and the impact of EU law and policy on the whole question.

Regulation n. 1107/2009 of the European Parliament and Council of 21 October 2009 concerning the placing of plant protection products on the market entered into force on 14 December 2009 and applies as of 14 June 2011, subject to some transitional measures set out in Article 80. It shall replace gradually the current legislation on plant protection products which is laid down in Council Directive 91/414/EEC and related implementing Regulations.

Broadly speaking, the harmonized authorization system for active substances used in plant protection products, as originally set out in Directive 91/414/ EEC, is maintained. Indeed, the placing on the market of plant protection products is still subject to a two-steps process whereby active substances are approved at the EU-level (with the inclusion into a “positive list” – Annex I to the new Regulation) while formulated products are authorised at the national level based on “Uniform Principles” laid down in a new implementing Regulation 546/2011. However, the criteria underlying each of these two steps have changed remarkably.

Article 14 of EU General Food Law Regulation1 178/2002 provides that a food product may not be placed on the market if it is unsafe. Article 19 of the Regulation imposes an obligation on food business operators to withdraw a product if they have reason to believe that it poses a health risk. Though it seems obvious that unsafe foods should be withdrawn from the market, the matter of when exactly a food product can be considered unsafe often leads to discussion. How much room is there for doubt as to the safety of a product and how many obligations do the provisions impose on food business operators? While it is ultimately always up to the courts to decide, on a day-to-day basis food business operators need to navigate within the interpretations of these provisions made by national authorities.

This report will discuss the topic in the light of two recent Danish cases that have highlighted the problems that can arise in this context – especially concerning the legal rights of the food business operators involved.

In 2006 the Hungarian system of food safety regulation was described as “chaotic” , fragmented and lacking accountability. Now, five years later and almost seven years after Hungary's accession to the European Union (EU) it is time to take stock again. Food safety regulation has undergone a “threefold change” and follows a separated model. Competences for risk assessment, risk management and risk communication are well distributed and the Hungarian Food Safety Office (HFSO)/Magyar Élelmiszer-biztonsági Hivatal (MÉBiH) fits into the overall structure now. But there are still problems concerning its legal position, weak status and especially insufficient independence.

This report shows the evolution of the Hungarian system and highlights the brand new developments and the current situation, challenges and organisation of the HFSO.

This article examines the issue of risk in research and development (R&D) pertaining to new pharmaceuticals, especially those aimed at neglected diseases and/ or relevant primarily to the developing world. In particular, the article considers the role of patent pools and other forms of non-proprietary models as alternatives to patents (and other types of intellectual property rights) in R&D for new pharmaceuticals. The article concludes that that these mechanisms still achieve very little output and can therefore not currently be considered as viable alternatives to the use of patents in pharmaceutical R&D. Another relevant finding is that many of the existing collaborative initiatives and partnerships for R&D in neglected diseases actually rely on different forms of intellectual property rights.

To discourage unhealthy eating and limit the population's intake of fatty foods, thereby alleviating the current obesity “epidemic”, an increasing number of countries across the industrialised world are considering levying taxes on unhealthy food. A “fat tax” may be defined as a tax or surcharge placed upon fattening foods, beverages or individuals with the aim to decrease consumption of foods that are linked to obesity. This is not an entirely new idea – some theorists, starting with Arthur Pigou, a 20th century English economist, have long presented the arguments for imposing special taxes on goods and services whose prices do not reflect the true social cost of their consumption. Examples of Pigouvian taxes are duties on cigarettes, alcohol, gambling and environmental emissions. Support for another such tax, a fat tax, is now spreading across the European Union. On 1 October 2011, Denmark introduced a tax on foods by targeting those products that are high in saturated fat. The Danish Act (hereinafter, Act) confirms the trend in various EU Member States to tax certain foods or consider taxing them in the future.

Nanomaterials have been the object of numerous public and private initiatives aiming to manage their risks and maximise their benefits. Proponents of nanotechnology programmes argue that their potential negative impacts need to be dealt with appropriately, and wish to integrate these concerns early in the industrial development of these substances. Science policy programmes do not provide a clear definition of the term “nanomaterials”. Defining nanomaterials, however, has become a central concern. It is called for by manufacturers who wish to sell the “nano” quality of their products as well as by associations who wish to classify products in order to facilitate consumer choice or introduce constraints on production.

This is more than an obscure technical and legal issue for specialists. Indeed, science and technology studies has shown that technical classifications perform social order, and that the creation of new entities destabilises the conduct of democratic life. For instance, Sheila Jasanoff demonstrates that the “ontological uncertainty” of biotechnological objects leads to the construction of different political forms in the United States and Europe. Building a legal and technical framework for biotechnology objects allocates public roles, defines expertise objectivity, and identifies public concerns – in short, it shapes political organisations at the same time as it constructs technological definitions.

The Swiss Federal Council (FC, the Swiss government) published a report on reducing administrative burdens on business in August 2011, in which it addressed also the performance of Regulatory Impact Analysis (RIA) at the federal level. The report reviews the measures undertaken by the FC since 2007 and sketches initiatives to be launched throughout the next four years. Administrative simplification and the reduction of regulatory costs have gained on relevance in the Swiss policy and political debate in the past few months – not least as a part of the campaign for the national political elections held in October 2011, with the economic crisis as a background. A national political party has launched a popular initiative against over-bureaucratisation, and the issue is brought forward by a number of stakeholders too.

The August 2011 report also fits into a wider debate about the legitimacy of RIA systems and the right balance between their effectiveness and efficiency. This brief note draws from a comprehensive evaluation of the system of in-depth RIAs in Switzerland, which supported the government's report and developed some avenues for further investigating those dimensions.

Since the North American Free Trade Agreement (hereinafter NAFTA) was successfully negotiated in 1993, the provisions for investor-state arbitration under its Chapter 11 have put pressure on the regulatory spaces of the State Parties. Under Chapter 11, any investor alleging a breach of the treaty norms by a host State can file an arbitration claim. This diagonal dispute settlement mechanism has determined a growing stream of arbitrations, focusing inter alia on the interplay between the regulation of toxic chemicals by the host State and the substantive provisions of Chapter 11. The arbitration claims filed by investors against host States regarding the regulation of toxic chemicals by the latter include those related to the adoption of discriminatory policies, the expropriation of investments and the violation of the fair and equitable standard (FET). In a nutshell, the question is how to reconcile environmental protection with the promotion of foreign direct investment (FDI). Can the host State adopt precautionary policies? To what extent can and should policy influence risk regulation? Should investors be compensated if their toxic chemicals are banned from the market? Which standard of review should arbitral tribunals adopt to assess scientific evidence? This note explores all of these issues through an analysis of the Chemtura award.

A visual display ban on tobacco products, imposed by national legislation of an EEA State, such as the one at issue in the case at hand, constitutes a measure having equivalent effect to a quantitative restriction on imports within the meaning of Article 11 EEA if, in fact, the ban affects the marketing of products imported from other EEA States to a greater degree than that of imported products which were, until recently, produced in Norway. It is for the national court to identify the aims which the legislation at issue is actually intended to pursue and to decide whether the public health objective of reducing tobacco use by the public in general can be achieved by measures less restrictive than a visual display ban on tobacco products (author's headnote).

In September 2011, the World Trade Organization (WTO) panel report in US – Clove Cigarettes was released. The report addressed a complaint brought by Indonesia concerning prohibitions on certain flavored tobacco products implemented by the United States (US). The dispute is one of a number of contemporary disputes under the WTO Agreement on Technical Barriers to Trade (TBT Agreement). Given that relatively few disputes have been resolved under the TBT Agreement, the outcome may have significant implications for interpretation of the agreement and risk regulation through technical regulations. The panel report may also have more specific implications for risk regulation in the context of tobacco products (author's headnote).

The EU has taken influence on the administrative laws of the Member States by introducing elements of public information, participation of stakeholders and private enforcement, and environmental law was the frontrunner of this development. The same tendency can be observed at the international level, culminating in the adoption of the Århus Convention in 1998. This has created tensions with traditional administrative law systems that have strongly relied on public authorities to produce the correct outcome whilst severely restricting private participation and private access to justice. The Trianel case, dealing with the protection of habitats against a coal power plant, demonstrates the need for fundamental adjustment of German administrative law, and it may lead to subsequent changes of the modalities of administrative procedural law in order to really allow the private enforcement of the public interest (authors’ headnote).

1. 1. The Commission is not entitled to assume that State resources constitute an advantage when it fails to examine whether: (i) the total amount of those resources exceeds the total amount of the net additional costs incurred by an undertaking providing an SGEI; (ii) that undertaking has other net additional costs associated with the provision of an SGEI for which it has the right to claim compensation.

2. 2. The use of a method different from that arising from Altmark Trans is justified only when the Commission is prevented, for objective reasons, from undertaking an examination of the information provided by a Member State.

3. 3. Even if the General Court is wrong in law when it examines information that was not subject to any analysis in the Commission’s decision, this did not affect the validity of its foregoing finding on the illegality of the contested decision (author’s headnotes).

Beneath the calm and measured prose of Dr. Caroline Foster lies a tsunami for the field of risk assessment in international adjudication.

Dr. Foster, a senior lecturer at the Faculty of Law, University of Auckland, looks boldly in the eye the difficult question of the influence of scientific evidence on international courts and tribunals. In an era where international law is endeavouring to come to terms with environmental protection, sustainable development, and public health and safety regulations and policies, international tribunals are called upon to adjudicate matters of extreme scientific complexity and, in this context, to understand the scientific approach to risk. One can no longer escape the realisation that judges and arbitrators on international tribunals rely on scientific expertise, and that this has a significant impact on their decision-making. This is one of the central tenets of Dr. Foster's book, and the basis for her analysis.