Traditionally, theories on regulation have suggested choosing the “right” regulatory tool for a given situation of desired behavioral steering, using a broad theoretical approach of understanding the factors involved in the regulatory realm and speculating from it toward the efficient choice.

By contrast, this paper will argue that the process of choosing the “right” regulatory tool should be guided by an opposite process, in which a searchable database of regulatory case studies (“Global-Regulation”) will be created. The institution (i.e., governments, regulation agencies, etc.) seeking to steer behavior using regulatory tools (“The Regulator”) will search Global-Regulation using the specific characters of its situation (i.e., industry, regulationmethod, country, etc.), to find relevant case-studies that will lead to the best regulatory solution.

It is assumed that this approach will establish regulation and regulatory tools as an empirical process of selection guided by a global accumulated body of knowledge, that will eventually create amore efficient and successful regulation and hence, desired behavior. The first part of this paper will provide an overview of regulatory learning. The second part will describe the Global-regulation database. The third partwill develop an example of the way in which case studies will be indexed into the Global-Regulation database. The fourth part will discuss the benefits of Global-Regulation to scholars and its symbiotic relationship with the research in the regulatory field. Finally, this paper will address possible problemswith the suggested system.

This report discusses the main provisions of the recently adopted WHO Protocol to Eliminate Illicit Trade in Tobacco Products. While recognizing the remarkable achievement of the global community in its efforts to curb illicit trade in tobacco products at the international level, the report also highlights those aspects of the Protocol that may undermine its effectiveness in the long–term perspective. In this context the enforcement capabilities of developing countries are cited as a main concern.

The recently published 5th edition of the Diagnostic and Statistical Manual of Mental Disorders has incorporated significant changes. This report aims to outline the changes that are most relevant for readers with an interest in lifestyle risks.

National rules of a EEA State, such as those at stake in the present judgment, under which a State monopoly on the retail sale of alcohol, may refuse to accept for sale alcoholic beverages that are lawfully produced and marketed in another EEA State on the grounds that the labelling of the products contains loaded or unrelated information, are in breach of Article 18 of Directive 2000/13/EC (‘the labelling Directive’ or ‘Directive’), and cannot be justified by a public health objective. Another rule requiring alcoholic beverages to carry stickers stating that their contents are alcoholic, in addition to the mandatory indication of the actual alcoholic strength by volume, ‘cannot be considered effective’ if it has been adopted without regard to the notification procedure laid down in Article 19 of the labelling Directive. However, individuals and economic operators who have been harmed by the incorrect application of the Directive may rely on the free movement of goods in order to render the State liable for the breach of EEA law, regardless of whether such a directive is being made or has been made part of the legal order of Iceland, since it has been incorporated in the EEA Agreement. Failure to notify the second rule in accordance with the Directive qualifies as a sufficiently serious breach of EEA law. Such a breach entails State liability if the national court finds a direct causal link between the breach of the obligation resting on the State and the damage sustained by the injured party (author's headnote).

The purpose of the paper is to discuss how to regulate the access to and use of biochemical and human genetic material currently considered as part of the market framework. Looking beyond the protection of traditional public goods (such as land or water), the paper emphasizes the debate around the progressive commodification of human genetic resources facilitated by an improper use of intellectual property rights. The discourse around commons is used to evaluate alternative tools and strategies to the issue of private appropriation of human genetic resources and natural compounds

In Fra.bo, it was held by the Court of Justice of the European Union (“CJEU”) that “Article 28 EC must be interpreted as meaning that it applies to standardisation and certification activities of a private-law body, where the national legislation considers the products certified by that body to be compliant with national law and that has the effect of restricting the marketing of products which are not certified by that body” (author's headnote).

A significant reform is currently under the scrutiny of EU institutions in the field of pharmaceutical risk regulation. With its proposal dated July 17th 2012, the Commission seeks to modernise the legal framework of clinical trials by addressing a series of shortcomings ascribed to the current regime governed by Directive 2001/20/EC (to be repealed by the new legislation). The iter of the reform is proving to be complex and lengthy, the first vote having been delayed to March 2014.While a comprehensive account of such a detailed proposal would defeat the scope of this short report, the analysis will focus on some of the most salient features of the proposed regulation, and attempt to situate them in the international context of pharmaceutical regulation.

Private law in Europe has undergone a significant transformation during the last two decades. From a branch of law that was scarcely affected by EU legislation, it has become the object of considerable harmonisation measures to facilitate free trade and protect European citizens. Simultaneously, there has been an increased attention for ‘better regulation’ in the EU. The efforts of the European Commission to improve regulatory quality and to reduce administrative burdens for industry have promoted a regulatory environment in which formal intervention is more limited and self–regulation and co–regulation have emerged as alternatives. The University of Maastricht organized a workshop on ‘Smart Regulation of European Private Law’ in January 2013 with the aim to assess how the Smart Regulation agenda has shaped/can shape European private law; investigate the contribution of different methodological approaches to achieve ‘smart regulation’; and explore opportunities and threats for European private law, in particular in respect with developments in self–regulation and co–regulation. This report shortly summarises the discussions.

In June 2013, the U.S. Supreme Court decided Association for Molecular Pathology et al. v. Myriad Genetics, Inc., et al., holding that “a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but cDNA is patent eligible because it is not naturally occurring”.

This case note gives an overview of the U.S. Supreme Court's decision, which is focused on the product of nature doctrine, and discusses its implications for the implementation of the criterion of isolation to DNA sequences and the United States Patent and Trademark Office's long-standing practice of granting patents on isolated DNA sequences (author's headnote).

On 08 October 2013, the General Court of the European Union (hereinafter General Court) delivered a judgment based on the Aarhus Regulation 1367/2006 on the access to information on substances under plant protection law, which attracted considerable attention among experts with conflicting response from environmental associations and industry. The judgment – still appealable at the time this article was written – would in case of becoming unappealable result in extensive limitations to the protection of commercial and industrial secrets under plant protection law, but additionally also generally under substance law. The following article analyses the content of the decision.