On 22 January 2014, the Grand Chamber of the Court of Justice confirmed the validity of the powers entrusted to the European Securities Markets Agency under Article 28 of Regulation (EU) No 236/2012, upholding their compatibility with the principle of institutional balance, the Lisbon Treaty and established case law of the CJEU.

This case note gives an overview of the ruling and analyses its implications for ESMA and the broader Union institutional setting, with particular regard to the interplay between EU Institutions and agencies. It concludes by highlighting some reasons for potential constitutional concerns resulting from the combination of politically unchecked agencies and highly controlled Institutions.

This report analyses the outcome of the latest meeting of the Conference of the Parties to the Framework Convention on Tobacco Control. In this context, it concentrates on the adopted amendments to the partial guidelines for implementation of Articles 9 and 10 of the Framework Convention, recommendations on the regulation of e-cigarettes, and discussion on the interactions between international trade/investment obligations and implementation of the obligations of the Convention.

This section is devoted to giving readers an inside view of the crossing point between intellectual property (IP) law and risk regulation. In addition to updating readers on the latest developments in IP law and policies in technological fields (including chemicals, pharmaceuticals, biotechnology, agriculture and foodstuffs), the section aims at verifying whether such laws and policies really stimulate scientific and technical progress and are capable of minimising the risks posed by on-going industrial developments to individuals’ health and safety, inter alia.

The leaked TTIP documents reveal that the EU and US are discussing the introduction of a detailed set of procedural requirements for the adoption of regulatory measures. Default provisions are set forth in the chapter on regulatory cooperation, applicable to goods and services. More specific provisions are being negotiated in the chapters on technical barriers to trade and on sanitary and phytosanitary measures. If they conflict with the regulatory cooperation chapter, they prevail.

This article analyses the regulatory cooperation chapter insofar as it pertains to trade in goods but to the exclusion of SPS matters and anything provided in the TBT chapter itself. The questions this article examines are to what extent the TTIP proposals expand upon the obligations the two parties have already taken on under WTO law and to what extent the resulting regulatory coordination is consistent withWTO law. It will be shown that the US proposals on procedure may constrain substantive regulatory discretion beyond what applies under the GATT and TBT Agreement of the WTO. It will alsobe shown that the needs to conduct trade impact assessments and a detailed explanation of the necessity of measures anticipate a legal challenge to necessity and will provide information of much use to complainants in meeting their burden of proof.

This section is devoted to giving readers an inside view of the crossing point between intellectual property (IP) law and risk regulation. In addition to updating readers on the latest developments in IP law and policies in technological fields (including chemicals, pharmaceuticals, biotechnology, agriculture and foodstuffs), the section aims at verifying whether such laws and policies really stimulate scientific and technical progress and are capable of minimising the risks posed by on-going industrial developments to individuals’ health and safety, inter alia.

It is frequently suggested that the EU in general and Parliament in particular suffer from an addiction to making rules and regulations on all things from chemicals to chocolates and from buses to booze. Classically, this is the first repost of the critic who sees the EU as legal procurator dressing up the legislative Christmas tree. Firstly, it is important to note that there are legitimate concerns that regulations passed in Europe are not always based on the best available science and perhaps even the best scientists. It is up to those with responsibility for making regulation to make it according to best verifiable evidence at hand. When you consider how important the potential implications are for industry and consumers alike then it is clearly of great importance to increase the use of risk analysis tools.

When asked to explain the difference between risk and hazard it is perhaps helpful to consider the life of a zoo keeper in charge of the Lions’ den. The animals themselves can be seen as a “hazard”, when the animals are free and uncaged, people in the surrounding area are exposed to the risk that they may be attacked. However, when the animal is caged, we’re dealing with altogether different beasts as only the zoo keeper (who knows how to handle the risk) could be exposed to certain dangers. It may remain “hazardous” but while those around it are protected there is no exposure to attack, therefore there is no risk.

The rise of sharing economy platforms is ubiquitous throughout the world.1 Their success is attributed to the fact that they directly connect supply and demand by enabling individuals to share goods and personal services, with minimal initial barriers to entry. In addition, they outsource their workforce – making it less expensive and easier to expand internationally. Similar to other global supply chains, workers are mediated by a third party and technology is fundamental to that.2

The World Trade Organization (WTO) Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement) relies on scientific evidence as a conclusive risk assessment criterion, which ignores the inherent limitations of science. This article highlights certain trade-restrictive effects of scientific evidence and comments on the Agreement’s aversions to precautionary measures and the consumer concern of the harmful effects of biotech products that may be necessary to protect public health and biosecurity in many WTO Member States. These measures and concerns have become pressing issues due to surging consumer awareness and vigilance concerning environmental protection and food safety. The Agreement is yet to overcome the weaknesses of its endorsed international standardising bodies, the problematic definition of scientific evidence and treatment of justification for scientific risk assessment methods and the implementation difficulties faced by most developing states. This article analyses these issues under the provisions of the Agreement and the interpretations of the WTO Dispute Settlement Body in disputes involving SPS matters, which fall short of addressing scientific uncertainty surrounding biotech products and their associated risks.

The EC-Seal Products case raises a number of interesting issues for scholars researching in the broad area of risk regulation. This symposium addresses a selection of them through innovative, analytical contributions whose goals are to test central assumptions and question the logic of the findings and to bring fresh solutions to problems faced by the Appellate Body and the panel. In keeping with this analytical focus, this introduction to the symposium will not just present a summary of the key legal findings. Instead, it attempts to draw some further conclusions from the different contributions, to place the contributions in their broader legal context and to make connections between aspects (not) decided in Seals and scholarship on risk regulation, more generally.

On May 20th, Professor Daniel Gibson and his team at the J. Craig Venter Institute announced in a paper published in Science the creation of a “chemical synthesis of a living organism”. The researchers have constructed a bacterium's genetic software and transplanted it into a host cell. The resulting organism looked and behaved like the species ruled by the synthetic DNA. The main difference between this technique and traditional biotechnology is that, for the first time in history, scientists have not only manipulated existing DNA but have created synthetic DNA and introduced it into a host organism that had been rebooted previously.

Professor Ragnar Lofstedt has written a very interesting and thought provoking paper “Risk versus Hazard Assessment – How to Regulate in the 21st Century”. The paper reflects upon the advantages and disadvantages of using risk assessments compared to hazard assessments of chemical compounds. It investigates the debate that has been going on in recent years in Europe between regulators, politicians, NGOs and industry on the subject.

This commentary will discuss some of the assumptions that the analysis rests on as well as some of the conclusions that are presented in the paper.

First, the commentary will discuss the definition and critique of the “risk assessment” approach that Lofstedt presents. The commentary here concludes that Lofstedt's analysis of risk assessment does not take sufficiently into account the fact that risks can not always be calculated in an exact way because uncertainty rather than certainty is the condition when analysing chemicals.

Joined Cases C-471/07 and C-472/07 AGIM and Others [2010] ECR I-00000

1. 1. The Member States determine, in compliance with the objective of transparency pursued by Council Directive 89/105/EEC and the requirements laid down by Article 4(1) of that Directive, the criteria on the basis of which the review of macro-economic conditions which is referred to in that provision is to be carried out, provided that those criteria are based on objective and verifiable factors (author's headnote).

2. 2. Article 4(1) of Directive 89/105, so far as its subject matter is concerned, is not sufficiently precise to have direct effect for the purposes of the national legal systems of the Member States (author's headnote).

3. 3. Article 4(1) of Directive 89/105 must be interpreted as meaning that a Member State may, 18 months after the end of a general price freeze in respect of refundable medicinal products which lasted eight years, adopt a new measure freezing the prices of medicinal products without carrying out the review of macro-economic conditions which is provided for in that provision (official headnote).

This contribution evaluates whether European Union State aid policy could play a role in achieving deeper and more solidary integration in the area of public health. According to Article 107 TFEU, the powers of Member States to grant aid to help their economies are seriously limited. Exceptions to the general prohibition to grant State aid are authorised by the European Commission, which enjoys wide discretion in weighing national objectives against European integration goals. The area of public health has been shielded from the application of these rules, with activities such as the provision of health insurance failing to be considered of economic nature (see most recently the Dôvera judgment). The COVID-19 experience shows that, in cases of major health crises, State aid provisions are practically suspended, with interventions allowed in the name of the fight against the pandemic. The eventual creation of a Health Union will require the re-evaluation of the application of the State aid rules to healthcare. This paper questions whether these rules should evolve as a reflective function of strengthened competences in healthcare or whether existing regulatory powers are enough to determine the interaction between national spending policies, a solidary European Health Union and fair competition.

While it is a consumer’s prerogative to be offered all kinds of food products they can choose from, it is also a consumer’s own responsibility as to what kind of products they choose. It is still argued that free choice is only an illusion due to the general decline in food quality; in this context, the extent of free choice that the consumer has is considered, as well as the factors affecting it. These include fundamental European Union principles that demand strong science to prove safety, observe the lowest applicable quality standards and by extent offer a wide leniency range to food manufacturers when it comes to food quality. Another main factor stems from a food law that intensely focuses on securing food safety, while somehow disregarding quality. In addition to that, major efforts have been concentrated on strengthening food information for the purpose of enabling consumers to make healthier choices by both simplifying information on the front of packaging and increasing it on the back, while no direct changes targeting the composition of food have been proposed. As a result, what healthy food choices are left on the market and how accessible are they to consumers?

Case C-427/12 Commission v European Parliament and Council (not yet reported)

- Article 290 TFEU

- Article 291(2) TFEU

- Article 80(1) of Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products, OJ 2012 L 167/1

1. 1. The EU legislature has discretion when it decides to confer a delegated power on the Commission pursuant to Article 290(1) TFEU or an implementing power pursuant to Article 291(2) TFEU. Consequently, judicial reviewis limited tomanifest errors of assessment (official headnote)

2. 2. The Commission appears to have more liberty under Article 290 TFEU than Article 291(2) TFEU, however this may be misleading. The difference between adding “further details” (implementing act) and supplementing or amending non-essential elements to a basic act (delegated act) is difficult to gauge. Furthermore, the control foreseen to be exercised by the Member States and the Parliament and Councilmay not function as planned (author's headnote).

Rarely has international law been investigated from a Business to Agency (B2A) or even Agency to Agency (A2A) perspective. In recent years, the “mushrooming” of agencies at European level has triggered the importance of looking more closely into the relationship of the agencies towards each other. Is there a struggle over competences and regulatory objects, and would such competition lead to desirable outcomes? In this paper I will first show that, due to the historical development of administrative law in Europe and the USA, the perception of the desirability of agency competition differs. I will then contrast these findings with EU pharmaceutical law and show that it tends to avoid competition. Also, in practice, competition among agencies is still exceptional for European pharmaceutical regulation. Finally, I conclude these findings and hint at the limits of the desired process for further coherence. Although a move towards even greater convergence in European risk regulation is desirable, it does have its limits set by the principle of conferral in Article 5 (1, 2) EU read in conjunction with the areas of shared competence and the competence to support, coordinate and supplement.