The present Flash News Report sets outs recent EU regulatory law developments (as of 25 June 2012) which pharmaceutical companies should be aware of in the areas of Pharmacovigilance, Information on Medicines, Pricing and Reimbursement, EU Data Protection and Advanced Therapy Medicinal Products.

This section regularly examines Regulatory Impact Assessment (IA) at three levels: the EU, theMember States and internationally. Contributions aim to cover aspects such as the interface between IA and risk analysis, looking atmethodologies as well as legal and political science-related issues. Contributions are meant to report and critically assess recent developments in the field, develop strategic thinking, and make constructive recommendations for improving performance in IA processes.

This article focuses on the information requirements of public and private stakeholders engaged in critical infrastructure protection (CIP).With its emphasis on information management rather than information sharing, the article builds on existing research suggesting that the notion of information sharing inadvertently renders cooperation more difficult as it evokes impressions of information “dominance” rather than joint information ownership. The article proposes a joint public-private information management agenda based on core issues providing actionable information to tackle immediate threats and crosscutting issues looking at the long-term issues that are relevant to understand the overall context in which critical infrastructure development occurs.

C-547/14 Philip Morris Brands SARL and Others v Secretary of State for Health [2016] (not yet reported)

C-477/14 Pillbox 38 (UK) Ltd v Secretary of State for Health [2016] (not yet reported)

C-358/14 Poland v. Parliament and Council [2016] (not yet reported)

Article 114 TFEU provides an adequate legal basis for the adoption of the Tobacco Products Directive 2014 in full, including measures relating to flavoured tobacco, labelling and packaging, and electronic cigarettes. These measures also comply with the principles of proportionality, subsidiarity, legal certainty, equal treatment and free competition, and the rights of companies under the EU Charter. Member States may introduce further requirements in relation to packaging of tobacco products that are not harmonised by the Directive.

EU agencies, such as the European Food Safety Authority (EFSA), are usually created in an environment that is replete with other organizations, not only other European bodies and member state agencies, but also international organizations and third country agencies. Through their interactionwith EUagencies, these international organizations and third country agencies may affect policies, policymaking processes, institutions and behaviour in the EU and its member states. But EU agencies do not necessarily serve as passive channels for the interaction between international organizations and third country agencies, on the one hand, and the EU institutions, on the other hand. They often seem to play an active role as policy entrepreneurs,making use of the opportunities offered by the policies and policymaking processes of these organizations and agencies to influence institutions and behaviour in the EU and its member states. The above raises the question of what international role EFSA actually has performed: has it, despite the formal-legal restrictions put in place by the EU institutions, been able to act relatively autonomously at the international level? In order to address this question, this article examines EFSA's international relations, notably those with international organizations and third country agencies in its field of action. It adopts a dynamic perspective, describing these relations throughout the agency's development. The article demonstrates that EFSA has developed a considerable international role, despite the relatively limited scope of action allowed by its legal framework, and shows that this development has been driven by both functional needs and strategic motives.

This article looks back at the history and legacy of the Risk and Regulation Advisory Council in the UK. The Council was the first government body to explicitly challenge a culture of overreaction to ‘public risk’, one of a number of ways in which it was a unique and interesting experiment in addressing the political dimension of contemporary regulation. Whilst the RRAC was ultimately unsuccessful in bringing about a change in how risk is managed by government it has, at least, left a useful intellectual legacy and, more practically, its work is effectively being taken forward by the Risk and Responsibility programme of the Dutch government.

Ever more risky service activities are carried out across borders, creating spillovers and externalities. At the same time, if freedom to provide services is legally enabled, states can cooperate in multiple ways to mitigate the potential risks accruing from crossborder activities. Global Administrative Law Scholarship distinguishes five types of administrative regulation: “administration by formal international organizations; administrations based on collective action by transnational networks of governmental officials; distributed administration conducted by national regulators under treaty regimes, mutual recognition arrangements or cooperative standards; administration by hybrid intergovernmental–private arrangements; and administration by private institutions with regulatory functions. In practice many of these layers overlap or combine […]”. In the area of risky cross–border service provision, the EU has moved from a more decentralised version of networks and mutual recognition characterised by coordination and minimum harmonization of rules and standards to a more centralized commandand–control system with European authorities and supervision.

Case C-658/11, European Parliament v Council of the European Union [2014] (not yet reported)

CFSP acts can be challenged before the Courtwhen the arguments relate to procedural points outside of the CFSP articles in Title V TEU. The Court can annul Council CFSP acts when the proper notification procedures to the Parliament stemming from Article 218 TFEU have not been followed. The effects of CFSP acts can remain in place, even after the Court annuls them, until such a time when the act has been replaced.

This article discusses a number of pitfalls of the US-Tuna II Panel Report. This Report is interesting because it offers an occasion to reflect on some provisions of the Technical Barrier to Trade (TBT) Agreement, which may be crucial for the assessment of the legality of environmental labelling regimes. The most troubling part of the Report is the one dealing with the trade-restrictive nature of the measure. The Panel seems to have relied on a test by which if a measure does not reach its objectives perfectly, any other ineffective measures adopted with allegedly the same goals can be judged as a valid less-trade restrictive alternative. In other words, two wrongs seem to make a right in the view of the Panel; a conclusion that, for obvious reasons, will not be greeted with enthusiasm by environmentalists.

Despite the initial delay in Spain in the adoption and development of a better regulation policy compared to other OECD countries, in the last few years significant advances have taken place, as pointed out in the 2010 OECD report “Better Regulation in Europe. Spain”.

In this context, the initiatives promoted by the Autonomous Communities – Spanish subnational levels of government – are also very important, since they have wide powers for the development of their own public regulatory reform policies. In fact, the first Spanish experience of the introduction of regulatory impact assessment in the legal rulemaking process took place in Catalonia, which has been a pioneer in the integration of administrative simplification policies – applied since the early 90s – in addition to its administrative burden reduction strategy.

A vast body of scholarly articles and books has been devoted to the precautionary principle, making it one of the most studied principles of our time. This wealth of attention can be explained by the fact that the question of how to manage man-made risks remains an extremely divisive issue for contemporary societies and the precautionary principle is the only principle idiosyncratic to the field of risk law. The book by Zander contributes to this scholarship by presenting a rich comparative legal analysis that gives a clear illustration of how the principle is applied at the international and European level as well as the national level, where the Swedish, UK, and US legal frameworks are discussed. The central parts of the book (chapter 3 to 7) are devoted to these comparisons. For this comparison, Zander chooses two case studies: pesticide regulation and the regulation of base stations.