The scientific dimension of risk regulation is obvious. It is accepted that a measure banning a pesticide is to be based on toxicology studies and in particular on the data proving harmful effects for human health or the environment. A more subtle determinant of risk regulation is the ethical dimension of the decisions adopted to control the social risks emerging from new technologies. It is in this context that a document such as the Encyclical letter Laudato Si, on care of the common home of Pope Francis could offer important reflections on how public policy on science and technology could be enriched by including an ethical perspective. The Laudato Si encyclical letter has been accompanied by wide public attention, spurred on by both the huge popularity of Pope Francis and the announced choice of devoting, for the first time in the history of the Catholic Church, an entire document to environmental issues.

In U.S. patent cases, a factor for demonstrating that an invention is non–obvious is the commercial success of the product embodying that invention. There must also be a nexus or connection between the patented characteristics of the claimed product and its commercial success. One may presume that a nexus exists if the characteristics of a product that is shown to have commercial success are covered by the patent claims at issue. In Europe, “commercial success alone is not to be regarded as indicative of inventive step. The following requirements must first be met: a long–felt need must have been fulfilled, and the commercial success must derive from the technical features of the invention and not fro mother influences (e.g. selling techniques or advertising).” Based on my understanding of U.S. and European patent law relevant to the issue of commercial success, this paper addresses some of the economic issues and associated data to consider in assessing whether a patented pharmaceutical product is a commercial success.

Financial regulation is an issue where differences between the EU and US are highly sensitive. Indeed, EU and US apply in a different manner the financial standards adopted at international level by the Basel Committee and have different systems of financial supervision.

Due to these significant differences between the two systems, it is very difficult for the EU and US to reach an agreement on common financial standards within the TTIP negotiations. Actually, as the differences in regulation between the two systems are an obstacle to the access of the financial operators of each Party to the market of the other Party, the absence of common standards in this sector could nullify the efficacy of norms of market access that will be probably contained within the TTIP.

Moreover, in a risk regulation perspective, considering the weight that the US and EU financial relationship have on the global system and taking account of the effect of destabilization that could be generated by the divergent requirements imposed to the credit institutions on the two sides of the Atlantic, the lack of common financial standards between the EU and US could have a great impact on global financial stability.

Case C-82/10, European Commission v Ireland [2011] ECR I-00000

Article 4 of the First Council Directive 73/239/EEC of 24 July 1973 on the coordination of laws, regulations and administrative provisions relating to the taking-up and pursuit of the business of direct insurance other than life assurance, as amended and repealed by the Solvency II Directive, OJ L – 228, of 16.08.1973. pp. 3–19. [First non-life Directive].

Ireland was found to have failed to fulfil its obligations under the non-life insurance directives by not covering the Voluntary Health Insurance Board, the main health insurer in Ireland, with the supervisory scheme envisaged by those directives. The Court of Justice of the European Union judgment raises vital questions important for the existing exempted insurance institutions.

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.

The global obesity epidemic was in focus at the 7th Summer Academy on Global Food Law and Policy in Gexco/Bilbao in July 2015. It approached this accelerating public health concern from the angle of risk regulations as linked to processing, trade, marketing and choice/consumption of foodstuffs, addressing also risks of negative impacts on public health at the consumer end. A wealth of expertise enlightened participants about current developments regarding EU and US legislation on risk assessments and risk management.

This article reviews the policy process of setting maximum levels for aflatoxins by the European Union and the Codex Alimentarius Commission. The differences between the two regulatory organizations and the difficulties entailed in the alignment of the two standards are illustrative of the problems inherent in risk analysis in the food sector. This case is also instructive with respect to the way in which scientific evidence is used when deciding on appropriate food safety standards.

“And remember you’re in France: The customer is always wrong!”

Many years ago, there was intense debate about what the Precautionary Principle (“PP”) is, or is not. More recently, as the battle lines in that debate have ossified, academic attention seems to have shifted to a focus on the somewhat more subtle question of how the term PP, whatever it may mean, is used by different actors in different contexts. David Vogel’s recent book, The Politics of Precaution: Regulating the Environmental Risks in Europe and the United States (2012) (hereafter “Politics”), is a good recent example of such commentary. Vogel's approach recognizes the diversity of relevant developments, he seeks to impose a coherent narrative framework on those developments.

Given that cars have become icons for flexibility, individuality, and freedom, it comes as no surprise that the passenger car fleet in almost all of the EU Member States is constantly growing. In 2010 there were about 239 million heavy-duty vehicles and 35 million light-duty vehicles in the then 27 Member States, more than a quarter of the cars and trucks on the road worldwide. It is expected that this number will grow by 31%by 2030. Not only has the number of vehicles grown constantly over recent decades, but the distance travelled by each has increased as well. Cars, and the industries producing them, do however have significant impacts on the environment ranging from smog to climate change.

Over recent years there has been a growing concern for the tendency of modern Western public administrators and regulators to overregulate risk – also coined the risk-regulation-reflex (RRR). Too often public decision-makers react to instances of risk with knee-jerk interventions such as increased regulation and inspections. The underlying assumption behind this response is that fatalism, in the sense of accepting risk, is no longer tolerated by citizens and has no place in the current political discourse. This paper challenges that assumption and suggests, on the contrary, that political messages about accepting risk deserve a revival. A balanced perspective can help Western society avoid the pitfall of overreacting to risk.