In the last twenty months, the Obama Administration has been taking an approach to regulation that is distinctive in three ways.

First, we have approached regulatory problems not with dogma or guesswork, but with the best available evidence of how people really behave.

Second, we have used cost-benefit analysis in a highly disciplined way, not to reduce difficult questions to problems of arithmetic, but as a pragmatic tool for cataloguing, assessing, reassessing, and publicizing the human consequences of regulation – and for obtaining public comment on our analysis. This emphasis on human consequences – on reducing or eliminating unjustified burdens on the private sector and on ensuring that high costs are justified by high benefits – is especially important in a period of economic difficulty. We have worked to put into place important safeguards while also making regulation compatible with the economic recovery, and while reducing the risk that costly regulations will have adverse effects on job creation, wages, prices, and economic growth as a whole.

On 8 October 2010, the European Commission issued a communication paper on Smart Regulation in the European Union. The paper reports on progress made, future priorities and strategy in the field of regulatory reform, for the information of interested outsiders. It is the latest in a series of such communications, issued on a regular basis since the first major, systematic action plan in 2002.

However, this most recent communication comes at a time when the context has changed noticeably. First, the financial crisis sparked by the credit crunch has altered attitudes to regulation. More attention is now being paid to the effectiveness of regulation and its overall quality than before. The Communication acknowledges this and underlines that regulation is essential to ensure that markets deliver sustainable prosperity for all. Second, a number of the Commission’s tools have been in place for some time, allowing it to draw useful lessons from its own experiences as well as from those of other countries. Its impact assessment system recently underwent a major examination by the European Court of Auditors.

On Tuesday, January 18, 2011 President Obama issued a new executive order and two somewhat related memoranda which embody some of the principles discussed by the Office of Information and Regulatory Affairs (OIRA) Administrator Cass Sunstein in this Journal. Building on three decades worth of practice in the United States with regulatory review, the new order and memoranda maintain significant continuity with past experience, while emphasizing both “humanizing” and rationalizing elements in the practice of regulatory impact analysis.

We live at a time where Smart is better than Better, and Better was not Smart enough. This is not a dull pun. It actually reflects the status in which regulatory reform finds itself nowadays. To many observers, the switch from Better to Smart just reflects the attempt to instil renewed commitment and faith in an agenda, which in some (European) countries has maybe exhausted its thrust. The European Commission also admits candidly that the choice of the new term largely serves as a refreshing slogan. But limiting it to a branding change, with little consideration of its content, would be a mistake in appreciation. And a missed opportunity. We do need “Smart Regulation” – and not only in the Commission. Above all, we need smart regulators.

Parents of newborns and small children have recently been confronted with labels indicating that their purchases of a baby bottle, teethers or sippy cups are now ‘Bisphenol A-free’ (BPA). A synthetic chemical used in the production process of polycarbonate (plastics), Bisphenol A is currently making headline news in the US and the EU. Its questioned safety in food plastics, baby bottles and children's toys has turned plastics into a political issue as it is systematically framed as a risk in media coverage.

Apart from regulatory exposure limits (Tolerable Daily Intake levels (TDI), Bisphenol A is currently not subject to any restrictions in use yet (although BPA will be subject to a ban on the EU level from spring 2011 onwards). However, with the REACH framework (Registration, Evaluation, Authorisation of Chemicals), a new regulatory framework for EU's chemical policy in place since June 2007, these exposure limits may be reviewed and BPA may face regulatory action. This article aims to analyse the regulatory process of Bisphenol A in the EU as an example of an uncertain risk dossier. On the basis of document and media analysis and interviews, the main aim is to gain an understanding of how uncertain risks are being regulated in the European Union. To that end, the self-regulatory behavior of industry is also considered. On the basis of the current regulatory tools in place and the current state of affairs, as well as developments in the controversy around BPA, the paper concludes by presenting four scenarios that illustrate the dynamics of the case and its possible regulatory outcomes.

This article analyses the role played by standards of protection in the regulation of catastrophic risks. It examines how to protect people against the occurrence of catastrophic events, considering that the related risk is highly uncertain and difficult to predict using rational methodologies. In this perspective, the article focuses on environmental risks and terrorist threats affecting common goods – namely environment and security – areas where any damage is susceptible to producing ruinous effects and huge casualties. Both natural and man-made disasters are capable of altering the normal legal relations that States are institutionally to ensure to their citizens. Therefore, the severity of the consequences of catastrophic events cannot be ignored, despite the low probability of their occurrence. However, in the absence of emergencies, exceptional measures may be adopted as a means of altering the legal framework, and thus the enjoyment, of fundamental freedoms and priorities in the allocation of public resources. No precautionary approach can escape from rational reflections about the opportunity-cost of any action, the cost-benefit analysis of countermeasures and the proportionality of every regulatory decision. In order to understand how to face those “low probability – high cost” risks, the article considers a specific method of regulating risks by resorting to standards of protection. By using thresholds of alarm, public administrations can decide upon best-fit countermeasures that will correspond to specific risk characterisations. To this end, the article analyses the administrative process of formulating standards and how they enable uncertain risks to be managed, thus promoting the development of a sound and accountable administration.

The most remarkable recent development in EU administrative law is the widespread establishment of European agencies. Beginning in the early 1990s, EU agencies emerged as significant actors in a number of areas, including trademark law, pharmaceutical licensing and aviation safety. EU agencies are best understood, however, not as autonomous regulators at the federal level, but as the most recent expression of European governance through administrative networks. The regulatory intertwining of supranational and national authorities in the EU is significantly different from the division of authority between federal and state bureaucracies in the United States federal system Hence, the accountability of European agencies to the EU and to Member States has unique features that can be traced to the dynamics of European integration. Accountability is largely a function of networked institutional relations that link European administrative entities to both supranational and national forums of accountability This article concentrates on the second form of accountability through an in-depth exploration of the way Member States oversee EU agencies. Oversight, here, covers monitoring, hearings, budgetary reviews or judicial actions, as well as procedural constraints.

With the close of another round of United Nations Framework Convention on Climate Change (UNFCCC) treaty talks, this one held in Cancun from November 29–December 10, it is important to look at how green patents fared in the negotiations and the final agreement.

But first, some background is necessary to set the stage for Cancun.

Last year, when I became aware during the run up to the Copenhagen meeting that intellectual property IP) rights were being debated, the first question that popped into my mind was: why are IP rights even on the agenda in the climate change treaty discussions?

To me, IP seemed tangential at best to the problems of shaping policies to mitigate climate change, taking a back seat to a maximum temperature rise target, greenhouse gas emissions targets, carbon taxes, cap and trade, and other policy tools directed relating to climate change.

In this report, the author, an IP scholar and entrepreneur, analyses how nanotechnology will pervade all industries and therefore how important it is to find a proper method to valuate and especially evaluate nanotechnology-related inventions. Attaching a value or evaluating a technology is a fundamental task nowadays, especially when innovations are supposed to be licensed or assigned. The report focuses on the different valuation and evaluation techniques professionals usually employ, and then delves into the world of nanotechnology. It tries to develop a novel method that takes environmental and health-related issues into due consideration when attaching a value or evaluating a technology in the nano world. The novel tool envisioned in the article is particularly suitable for nanotech innovations, but it can be used for the evaluation of other technologies and patents as well. The innovative idea consists of introducing the concept of Present Value After Evaluation, which takes qualitative variables into consideration and provides a figure for the analyzed technology or patent. This method and the accompanying tool are perfectly suited for evaluation purposes when environmental and human safety concerns are at stake, because they take these variables into consideration and throughout technology's life cycle.

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.

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.

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.

“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.”

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.

Although the applicable standard of review under Articles 2.2/5.1 of the SPS Agreement is not de novo, an investigation of the WTO panel remains intrusive in terms of objectivity and coherence of risk assessment. Moreover, the panel's review does not end with a final conclusion reached by the WTO Member in the risk assessment. It also extends to the quality of the reasoning and the intermediate interferences that led to the conclusion. If a WTO Member exercises expert judgment in its risk assessment, this needs to be sufficiently transparent and well documented (author's headnote).

The obligations of Article 5.1 and 5.6 are distinctive and independent from each other. Therefore, a violation of the first provision does not imply infringement of the latter one (author's headnote).

The European Court of Justice (ECJ) rendered a decision regarding supplementary protection certificates (SPCs) for plant protection products and provisional marketing authorisation. The ECJ clarified that SPCs for patented plant protection products may also be based on provisional marketing authorizations pursuant to Article 8(1) Directive 91/114 (author's headnote).

The conditions of urgency for the granting of the interim suspension of a decision concerning the non-inclusion of an active substance in Annex I to Directive 91/414 should not be applied rigidly and mechanically and must be assessed in light of the specific circumstances of the case, in particular the progress of re-submission under Commission Regulation 33/2008, and be subject to a test of reasonableness (author's headnote).

The General Court annuls Decision C(2004) 1614 final, in which the Commission declared that the modified exemption to the aggregates levy in Northern Ireland, as notified by the United Kingdom, fell within the scope of Article 87(1) EC [107(1) TFEU] but was compatible with the common market on the basis of Article 87(3)(c) EC [107(3)(C) TFEU] (author's headnote).

The General Court reaffirms its traditional form-based approach to dominance (author's headnote).