The fast development of technology and industrial processes during the last hundred years has caused increasing expectations by the public, customers and politics concerning the safety of operations and the risks of substances and activities related to production and consumption of goods. A highly differentiated and complex system of laws and regulations exists on the regional, national, and international level. In Germany alone, manufacturers are confronted with more than 10,000 regulations. Companies that trade all over the world are obliged to comply with a multitude of laws and regulations which partially are in conflict with each other.

In addition to the legal requirements, manufacturers of products and developers of technologies face increasing demands for more information and participation from the consumers, special stakeholder groups, and the public at large. The need for risk communication has been voiced since the late 1960s. The main targets have been large technical installations such as nuclear power plants or waste incinerators.

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.

While the introduction of GMOs in food is still being debated in many Member States of the European Union, a new field of discord just appeared around the issue of animal cloning.

E-commerce and information society services became part of the quotidian language of the European institutions in the mid-1990s, as the European institutions gazed into a crystal ball wherein electronic commerce would further the competitiveness of the internal market. Gradually increasing volumes of customers began to purchase goods and services via the internet, reflecting the development by undertakings of the internet as a sales channel and also due to the regulation of such transactions. Concurrently the internet can be characterised by its tendency to bring market actors closer together, and the case of DocMorris, concerning the sale of medicinal products via the internet, has been described as constituting an instance whereby the technological revolution which the internet embodies has “well and truly reached the doors” of the Court of Justice.

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.

On 13 April 2011 the Commission tabled a package of two legislative proposals implementing enhanced cooperation in the field of unitary patent protection and translation arrangements. Such proposals have subsequently been agreed upon by the EU ministers in an Extraordinary Competitiveness Council on 27 June 2011. Patent protection is indeed key to the European Union (EU) and constitutes a priority in EU institutions’ agenda, as it is capable of stimulating innovation and competitiveness.

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.

Attempts at suitable identification of a generally accepted definition of a ‘nanomaterial’ have been going on in Europe and worldwide for some time. Definitions are important from a regulatory perspective as “they assist in establishing the subject matter and scope of what is to be regulated”. However, considering the complexities associated with nanoscience and also the differing opinions on various definitions, this has not been an easy task. Reaching an agreement on fundamental terms and definitions such as ‘nanotechnology’, ‘nanoparticle’, ‘nanoscale’, and a ‘nanomaterial’ is both complex and contested. To date, there is no internationally recognised and accepted definition of a ‘nanomaterial’ even though several definitions have been discussed and proposed by national authorities, scientific committees, international organisations, and other bodies.

Nanosciences and nanotechnologies are a field of blooming technological applications, developed or manufactured at the nanoscale (a billionth of a meter). At this scale, matter shows new and unexpected properties. These may significantly differ from one case to the other, which results in a great diversity of different industrial applications, and eventually in very heterogeneous end-user products. As a matter of fact, the generic dimension of nanotechnologies, understood as a platform or enabling technology, drives their diversity, and potentially affects almost every industrial sector.

Professor Lofstedt presents a convincing illustration of the inconsistencies inherent in a European system of regulation where Member States choose whether to regulate based on assessments of risks or hazards depending on the product concerned. Particularly striking is the candid comment of a Swedish official who seems to marvel at the conflicting positions of his own government. The quote reminds this author of an official in the Swedish Ministry of Environment who in an interview stated that the application of regulation would be widely different if the precautionary principle as included in the Swedish Environmental Code or the precautionary principle as included in the Swedish Planning Code were to be employed.1 For a lawyer – or anyone else with an interest in the rule of law – such inconsistencies pose serious problems with regard to legal certainty. Unfortunately, those who could reasonably be expected to be most concerned with issues relating to the rule of law – national and European courts – have thus far proven reluctant to second-guess, or even criticise, decisions in the area of risk regulation.

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.

This report identifies the risk and regulatory factors that influence location decisions by research-based pharmaceutical/biotechnology companies. The primary data are from interviews with 34 senior executives representing 14 research-based pharmaceutical/biotechnology companies. These interviews provided qualitative information on the particular factors that matter and their relative importance in selecting a host country for an investment. The specific factors that influence the general willingness of companies to invest in a particular country are: industry history, the incremental nature of investments, stability, structure of the pharmaceutical marketplace, access to leading scientists and physicians, adequate supply of skilled workers, sufficient patient population for clinical trials, tax policy, and transport links both within the region served and to global headquarters.

Twenty five years on from Chernobyl, the tragic events in Japan of March 2011 seem to reaffirm the ‘risk society’ perspective which the 1986 nuclear accident in the former Soviet Union did so much to popularise. It was amidst widespread predictions of mass harm – projected both across Europe and into the future – that German sociologist Ulrich Beck’s book of the same name found such a receptive audience. Beck wrote of a new era defined by the greater risk posed by ‘manufactured’, technological risk than natural, ‘external’ ones. The way in which the possible, nuclear threat from the damaged Fukushima nuclear plant looms larger than the devastation and the thousands actually killed by the ‘natural’ earthquake and tsunami reminds us of Beck's distinction.

Cognitive neuroscience was born when the theories and methods of cognitive psychology and neuropsychology were combined after a long period of parallel development. Over the last few decades, neuroscientific studies have begun to meet the challenge of understanding cognitive functions, thereby identifying the causal chain of neural events that underlies cognition. The development of powerful brain imaging technologies is now likely to present a range of opportunities in many spheres of public life, such as the criminal and civil justice system, and the business world.

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.

“The Court considers that the Commission should give due consideration to the principles of clarity of objectives, simplification, realism, transparency and accountability when designing new and revising existing interventions.”

The SPS Agreement may apply to budgetary measures if they are motivated by SPS concerns. Equivalence-based measures are subject to regular disciplines of the SPS Agreement, including but not limited to Article 4. This means that WTO Members when engaging in the recognition process need to observe other SPS provisions such as requirement of scientific risk assessment (Articles 5.1–5.3) or quasi-consistency obligation of Article 5.5. An SPS measure which has been found inconsistent with certain provisions of the SPS Agreement (e.g. Articles 2 and 5), cannot be later justified under the general exception of Article XX(b) of the GATT 1994 (author's headnote).

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.

This article highlights the importance of unbiased scientific advice in the European Union's legal system. It then analyses and compares the policies in force throughout the European Food Safety Authority, European Medicines Agency and European Commission's Scientific Committees with the one implemented by the US Food and Drugs Administration. The author argues that at the present time the framework adopted and implemented by the European Food Safety Authority seems to be the most complete and stringent amongst those taken into account in the article and he advances some proposals for further improvement of the policies regulating conflict of interest.

Saturday, 18 December 2010 was the first of a two day complete closure of all London area airports due to freezing temperatures and approximately five inches of snow. A week later on December 26th, New York City area airports closed in a similar manner from the sixth largest snowstorm in NYC history, blanketing the city approximately twenty inches of snow. Both storms grounded flights for days, and resulted in severe delays long after the snow stopped falling. Both London and NYC area airports produced risk communications to explain the necessity for the closures and delays. This short flash news report examines, in turn, the risk communications presented during the airport closures. A background is provided to understand how the risk perceptions differ between London and NYC publics. Finally, it compares and contrasts the perceptions of the decision making process and outcomes of the closures, which continue to accumulate economic and social impacts.