The European Union tried to establish a “coexistence” policy for the cultivation and processing of GM and non-GM products after the political agreement that put an end to the 1999-2004 moratorium.

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.

This article aims to analyse the role of law in the identification of the responsibility domain of ‘regulatory science’ (Jasanoff, 1990) within the risk regulatory process. The main research question is therefore,what kindof relationshipbetween science andpolicy-making lawshould design in risk regulation.

In order to address this issue, this contribution focuses on the recent verdict of the Tribunal of L’Aquila. After the earthquake occurred in L’Aquila on the 6th April 2009, six Italian scientists that had participated in the Major Risks Commission's meeting have been condemned for the multiple manslaughter of 29 people who were among the 309 victims of the earthquake, ‘for having assessed the risks related to seismic activity in the L’Aquila territory in an inaccurate, generic and ineffective way’ and for having provided ‘information which was imprecise, incomplete and contradictory as to the nature, the causes and the hazardousness and on the future development of the seismic activity’.

As far as risk assessment and risk communication are concerned, firstly the tasks of the Major Risks Commission under the Italian Civil Protection law will be analysed. Against this backdrop, the issues related to this expert body's responsibility will be addressed and the gaps in the current accountability regime will be pointed out.

In Europe, medicines can only be marketed once they have passed through a strict regulatory process, designed primarily to protect patient safety. It is only after in–depth testing on the targeted disease population, including three phases of clinical assessment and clinical trials, that a medicine will obtain a ‘marketing authorisation’. Given its primary goal of ensuring patient safety, EU law only allows a few narrow exceptions to the requirement of amarketing authorisation. Adrug can only be used “off–label”, meaning outside the limits of its marketing authorization, in authorised clinical trials or under one of the strictly defined exceptions, such as severe public health risk, compassionate use for groups of patients or for individual patients on a named patient basis.

However, in recent years, a trend has emerged Among Member States to push the boundaries of the existing regulatory system, and actively promote the off–label use of medicines on the ground that they are cheaper than the alternative, authorised medicine. It is questionable whether this trend is in line with EU law.

Council Decision 2008/633/JHA on access for consultation of the Visa Information System for the purposes of prevention, detection and investigation of terrorist offences and other serious criminal offences must be read as a development of the Schengen acquis and not merely as a measure as to police cooperation, preventing the United Kingdom and Ireland from participating in adopting the measure (author's headnote).

Case T-429/05 Artegodan GmbH v. Commission

The infringement of Article 11 of Directive 65/65/EEC and of the proportionality principle are not per se sufficient to require the Commission to provide the applicant with compensation for the damages suffered if they are the result of a decision on the withdrawal of a marketing authorisation should this authorisation be deemed illegitimate and subsequently annulled by the Court (author's headnote).

This section discusses issues related to risk communication across a range of publicly perceived highrisk industries (such as pharmaceuticals, nuclear, oil, etc.). It reports critically and provides analysis on risk communication as an outcome of risk research within these industries. Contributions are intended to include methods working towards the advancement of risk perception research and describe any lessons learned for successfully communicating to the public about risk.

This article discusses the legal remedies available for Competent Authorities, patients and healthcare professionals to prevent harmful incidents involving medical devices. It outlines a theoretical framework for ex-ante and ex-post regulation of medical devices. It then focuses on certain aspects of ex-post regulation. Participation by Competent Authorities with a supervisory role, healthcare professionals and patients in ex-post regulatory legal processes is analysed in the light of the current European Union legal framework and the revised framework proposed by the European Commission. It also discusses whether the proposed new legal framework enables the Competent Authorities, patients and healthcare professionals to prevent the harm caused by unsafe medical devices. Ex-ante regulation might prevent the entrance on the market of unsafe devices whereas ex-post regulation might dismiss the unsafe devices. The contribution concludes by suggesting a number of improvements to the supervisory system of medical devices in Europe.

The precautionary principle in public decision making concerns situations where following an assessment of the available scientific information, there are reasonable grounds for concern for the possibility of adverse effects on the environment or human health, but scientific uncertainty persists. In such cases provisional risk management measures may be adopted, without having to wait until the reality and seriousness of those adverse effects become fully apparent. This is the definition of the precautionary principle as operationalized under EU law. The precautionary principle is a deliberative principle. Its application involves deliberation on a range of normative dimensions which need to be taken into account while making the principle operational in the public policy context. Under EU law, any risk management measures to be adopted while implementing the precautionary principle, have to be proportionate to ensure the chosen high level of protection in the European Community.

This article will illustrate the established practice concerning the release of genetically modified organisms into the environment and how the principle is implemented under hard law. The article also provides an outlook on what this may imply for the relative new case of nanotechnology and the use of precautionary principle within the context of soft law (use of codes of conduct).

In May 2013, the U.S. Supreme Court decided in Vernon Hugh Bowman v. Monsanto Company et al. in favor of Monsanto Company, affirming the judgment of the U.S. Court of Appeals for the Federal Circuit and holding that patent exhaustion does not permit a farmer to reproduce patented seeds through planting and harvesting without the patent holder's permission.

This case note gives a brief overview of the U.S. Supreme Court's decision, in which the meaning and limits of the doctrine of patent exhaustion have been examined, and discusses its implications for farmers and seed companies.

A ‘clair-obscur’ normativity. In French, Historians of art use it when they refer to an abrupt association of zones made out of very dark shadows together with dazzling lights, like da Caravaggio used to paint. It applies successfully to nanotechnologies, which points out to this set of technologies that are being developed at a billionth of a meter. At this scale, matter shows new and unexpected properties, which could potentially lead the way to numerous applications but how do we regulate it? Lacour's edited volume should be of interest to lawyers and regulators interested in this subject. It borrows this formula of the clair-obscur to characterize a fluctuating normative environment which surrounds nanotechnologies’ development.

The Commission has proposed to legitimise the renationalization of the cultivation of GMOs (Genetically Modified Organisms) accepting the request of a group of Member States who raised concerns at the Environment Council of June 2009 regarding the EU-wide decisions on GMO2 cultivation.

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).

On 26 February 2014, the German Federal Court of Justice (Bundesgerichtshof, hereinafter, BGH) held, in the case Hipp v. Milupa, that trademarks can be health claims under Regulation (EC) No 1924/2006 on nutrition and health claims made on foods (hereinafter the Nutrition and Health Claims Regulation, NHCR). The BGH, therefore, confirmed the broad interpretation of the term ‘health claim’ and remanded the case back to the Frankfurt/Main Higher Regional Court (hereinafter, OLG Frankfurt). Products bearing trademarks that existed before 1 January 2005 and that do not comply with the NHCR may continue to be marketed until 19 January 2022. On 15 January 2015, the OLG Frankfurt handed down a new judgment in the proceedings between Hipp and Milupa, relating to the question as to whether a trademark had to be used with the identical and unchanged food product before January 2005 to fall under the transitional rule, or whether changes to the product were permissible.