At a time of increasing recognition worldwide of the role of Chief Science Advisers as of critical importance in improving dialogue between science and policy, the European Union, notably the European Commission, is currently considering – under the pressure of civil society organisations – whether to maintain or scrap this recently–created position. After contextualizing this debate within the broader efforts undertaken by the Barroso Commission to strengthen science in EU policymaking, this article discusses what role, if any, a Chief Scientist may play within the EU systemof scientific advice. After denouncing the lack of a public debate about the merits of this post at the time of its creation, the article takes as a point of departure the criticisms made against this position and assesses them in the light of the mandate entrusted to the Chief Scientist Advisor. It argues that the major point of disagreement on this post revolves around the question of whether the Chief Scientist Advisor, as it currently stands, helps or hinders the EU incorporating the ‘best science’ into policy. After identifying the flaws of the actual mandate and the challenges faced by the first holder of the position, it argues that the burden of proof rests with the EU Commission to prove the merits, and more specifically, the rationale for having yet another source of scientific advice in the EU.

At the end of August 2014, scientists and policymakers from forty-eight countries gathered at the Heritage Hotel in Auckland, New Zealand to debate the science and art of scientific advice. Jointly hosted by Sir Peter Gluckman, chief scientific advisor to the PrimeMinister of NewZealand, and the International Council for Science (ICSU), the Auckland summit was the largest ever meeting of its kind, attracting science advisors, advisory bodies and academic experts fromAlbania to Zimbabwe, and a host of countries in between.

Over two days of intense discussion, participants debated structures and methods for the provision of scientific advice in emergency situations, across national and disciplinary boundaries, and on contested topics,where science, values and politics collide. The meeting ended with a call to strengthen collaboration between advisory systems, an agreement to formalize the network, and a commitment tomeet again in 2016. As Sir Peter Gluckman said afterwards: “Our goal was to start a global conversation on the practices and challenges of conveying science advice to governments…The meeting has highlighted a real thirst among practitioners to share models and lessons.”

Today,more than ever, citizens expect value formoney, not only from their elected representatives, but also from the laws and regulations passed to protect them. As the European economy faces continued challenges and limited economic growth, citizens rely on policy-makers to encourage innovation and stimulate growth and jobs. This requires flexible legislation which fosters start-ups, encourages SMEs during those early days, but which also simultaneously maintains the high levels of consumer health and safety that they have become accustomed to.

Public accountability is also increasing – and rightly so. Citizens don't just want legislation that delivers – they alsowant transparency and open dialogue. They want decision-makers to explain why certain policy choices weremade over others, and what benefits they can expect fromsuch choices. This requirement for information must also be seen against a backdrop of increasing demands on consumers’ time and a tendency to deal in “twitterati” style soundbites. This often results in consumers feeling the need for analysis and validation of information via a third party, sometimes a journalist, sometimes anNGOor government agency.

Collection and provision of scientific information for policy and decision-making is particularly important during emergencies or when uncertainty and ambiguity creates situation of fear and anxiety. This article offers two suggestions for addressing natural or technology risks, leveraging research by the International Risk Governance Council (IRGC) and project contributors. The first advice is that concepts and instruments for risk governance be recognised and used as intermediation between evidence and policy. The second is that the role of the Chief Scientific Adviser in public sector organisations includes those of the Chief Risk Officer. These suggestions could help address the challenge for policymakers to deal with uncertainty and emergency, when little or contradictory evidence is available.

The start of a new European Commission represents a unique opportunity to build on successful regulatory reforms and to create the institutional architecture needed to ensure that high quality scientific evidence is used effectively in EU decision–making. The appointment by President Barroso of a Chief Scientific Adviser (CSA) in 2011 constituted an important springboard in this respect. The CSA Office has made a considerable and positive difference to the regulatory environment. This article argues for embedding the CSA Office into the institutional and procedural arrangements of the Commission by re–defining its organisational role and responsibilities as well as the resources allocated to it. The institutionalisation of the CSA Office and the creation of a fully–fledged risk regulation regime would provide a robust element of the EU's response to the demands for better governance by its citizens, as expressed in the recent European elections.

Risk regulation is a major task of the EU. In this context, scientific knowledge and advice is critical to the preparation, formulation, legislation and later revision of EU risk regulation. However and with some notable exceptions (e.g. some EU Agencies, DG SANCO), there seems to be no systematic view, let alone, organisation for the ‘use of science’ for EU policy–making. It is in this light that the new function of Chief Scientific Advisor (CSA) to the President of the European Commission can best be appreciated. The authors first sketch how ‘science’ is used in the EU regulatory regime and what is or has become problematic about it. Subsequently, an informal SWOT analysis of the ‘use of science’ for EU policy is conducted. The contribution ends with an attempt to evaluate the CSA's accomplishments to date and how it can contribute to improving EU regulation. This is followed by a few recommendations on how the role of the CSA could be strengthened in the near future.

Before the Treaty of Lisbon, EU agencies were unknown in the EU's primary law defined procedural law. Today, following (i) the Treaty's entry into force, (ii) the Common Approach on Decentralised Agencies and (iii) the European Court of Justice's ruling in Short–selling it is interesting to take a look at the peculiar position of EU agencies under the EU's primary and secondary law defined procedural law.

With the New Approach for goods, the EU has created a regulatory framework for placing products on the market in which both public and private parties have an important role to play. The various cases which have been brought after the PIP breast implants scandal show the difficulties with trying to link this ex ante regulatory framework to potential liability for defective products. National courts have reached different conclusions about the scope of the obligations of certification bodies in the New Approach. Since these issues are about the fundaments of the construction of the New Approach, it would be desirable for the ECJ, and perhaps even the European legislator, to get involved.

Sweden has long been seen as a pioneer in the area of chemical control policy. In 1995 it put forward a so called “generation goal” which called for a phasing out of all human made chemicals within a 25 year period. The Swedish Government took up the challenge of how to best reach this goal by putting forward a number of environmental quality objectives, which were approved by the Swedish Parliament in 1999. What has happened since then? Will Sweden reach its proposed generation goal? This paper addresses these two questions.

This report provides an overview of the potential impact of the draft Trans–Pacific Partnership Agreement on public health and access to medicines, in light of a recent analysis conducted by UNITAID. The international organization observed that the increased intellectual property protection endorsed in the draft agreement,which calls for the adoption of TRIPSplus standards, is likely to severely impact generic competition, affecting the availability of medicines in developing countries, and reducing the ability of governments to set the appropriate balance between the protection of innovation and the safeguard of public health

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.

When reviewing a job application letter, going on a first date, or considering doing business with someone, the first thing many people do is entering the person's name in a search engine. A search engine can point searchers to information that would otherwise have remained obscure. If somebody searched for the name of Spanish lawyer Mario Costeja González, Google showed search results that included a link to a 1998 newspaper announcement implying he had financial troubles at the time. González wanted Google to stop showing those links and started a procedure in Spain. After some legal wrangling, the Spanish Audiencia Nacional (National High Court) asked the Court of Justice of the European Union (CJEU) for advice on the application of the Data Protection Directive, which led to the controversial judgment in Google Spain. In its judgment, the CJEU holds that people, under certain conditions, have the right to have search results for their name delisted. This right can also extend to lawfully published information.

In reviewing two similar cases, the CJEU clarified several essential elements of EU motor insurance law. First, the CJEU clarified the concept of “personal injury” as an insurable risk (another is damage to property) by holding that it also covers non–material damage and the concept of “injured party” by establishing that it also covers the next of kin of a person who died as a result of a road traffic accident. Second, the CJEU affirmed its previous case law that EU Member States are precluded from lowering the minimum insurance coverage as set in the amount of 350 000 euro by EU motor insurance law. In particular, the CJEU found that a Latvian national legal provision which provides fixed insurance redress in the amount of 142 (now 150) euro for non–material damage for the next of kin of a person who died in an accident is incompatible with EU motor insurance law (author's summary).

On March 10, 2014, the U.S. District Court of Utah, Central Division, decided in University of Utah Research Foundation, et al., v. Ambry Genetics Corporation, holding that “Plaintiffs are not entitled to a preliminary injunction”, as they “are unable to establish that they are likely to succeed on the merits of the claims” nor “that the equitable factors support issuance of the requested injunction”.

This case note gives an overview of the U.S. District Court's of Utah memorandum decision and order denying plaintiffs’ motion for preliminary injunction and discusses its implications for the implementation of the criterion of isolation to “synthetic” DNA sequences, such as primers and probes.