This special edition of the European Journal of Risk Regulation deals with a highly topical, complex and controversial subject matter – the reform of the regulation of medical devices in the European Union.

At first sight, and as further detailed in the following articles, there appears to be a general consensus about the need to improve the EU (and indeed the US) regulatory framework on medical devices, especially for high-risk categories of devices. Stakeholders including representatives of the industry, patient and consumer organizations, national authorities, healthcare professionals, agree that there is a need for change. However, opinions differ on what needs to be changed and how. Three alternatives for reform of the current EU systemof regulation have been debated over the past years: the adoption of a pharmastyle system of pre-market authorisation; maintaining the status quo but strengthening implementation and supervision in the Member States; or finally, introducing common technical specifications together with specific guidelines for certain high-risk devices.

The three Directives concerning medical devices are currently under revision and a long process that started with a consultation in 2008 seems to be nearing its conclusion with two Regulation proposals in the pipeline and at the time of writing under discussion in the European Parliament's Committee on the Environment, Public Health and Food Safety (ENVI Committee). In this article we examine if the proposed Regulation for medical devices will deliver on the promises. We will focus on what we know to be the hot topics for industry. Since the article is forward- looking about draft legislation currently in the legislative process, it is by necessity speculative on points and the proposals may have changed by the time this article is printed.

The Transatlantic Trade and Investment Partnership (“TTIP”) has been hailed as an opportunity for the world's two largest consumer markets to expand inter- regional trade, investment and jobs, and to secure greater regulatory convergence that could considerably reduce costly and market-distorting extra-territorial non-tariff regulatory trade barriers. As fears of potential adverse effects on the World Trade Organization’s multilateral trading system have abated after the Doha round stalled, the initiation of the TTIP has been welcomed by the business communities on both sides of the Atlantic.

Notwithstanding the anticipated benefits, questions arise with respect to both the way the negotiations are conducted and the topics covered. The TTIP negotiating mandate covers three main elements: (i) market access, (ii) regulatory convergence, and (iii) trade rules addressing shared global challenges.

The literature on the regulation of drugs at the FDA and the European Union is substantial, yet little research has provided comparative analyses and robust empirical data on the regulation of medical devices in the United States and the European Union. As medical and health markets become increasingly globalized, and the U.S. and the EU compete for leadership and recognition, salient domestic regulatory issues are becoming increasingly international and transnational policy issues. Building on Carpenter's (2010) work on drug regulation at the FDA, but taking a slightly narrower yet at the same time a broader approach by drawing on interdisciplinary studies instead of limiting ourselves to only the Political Science literature, this comparison focuses on key aspects of risk regulation and governance of medical devices in the U.S. and the EU, and shows how and why individual and organizational learning is imperative in each case.

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.

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.

Early initiation of gambling has been argued to be closely correlated with placing players at higher risk of developing problem gambling behaviour in the future. The vast majority of jurisdictions, including Great Britain, attempts to eliminate minors’ access to gambling by making it illegal and by requiring gambling providers to adopt strict age-verification procedures. Despite those measures minors continue to successfully access gambling. This paper demonstrates that British legal framework suffers from many statutory loopholes. It considers weaknesses in the regulatory offences as well as enforcement deficiencies. It further highlights how the differences between black letter law, political rhetoric and practical application undermine the strength of the prohibition of gambling by minors.

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.

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.

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.

On 13 August 2013, the Government of Indonesia requested a special meeting of the WTO Dispute Settlement Body (hereinafter, DSB) in order to obtain authorisation to suspend concessions or other obligations (i.e., to ‘retaliate’) against the United States (hereinafter, the US). This request stems from the US alleged failure to comply with the rulings and recommendations of the WTO DSB in the dispute US – Measures Affecting the Production and Sale of Clove Cigarettes (hereinafter, US – Clove Cigarettes). In that dispute, the WTO dispute settlement organs found that Section 907(a)(1)(A) of the Federal Food, Drug, and Cosmetic Act (hereinafter, the FFDCA), introduced by Section 101(b) of the Family Smoking Prevention and Tobacco Control Act discriminated against Indonesian clove cigarettes in favour of ‘like’ domestic menthol cigarettes, in a manner which was inconsistent with, inter alia, Article 2.1 of the WTO Agreement on Technical Barriers to Trade (hereinafter, TBT Agreement). The DSB recommended that the US bring its legislation relating to the ban on flavoured cigarettes into conformity with its obligations under the WTO. On 22 August 2013, the US objected to the level of suspension of concessions proposed by Indonesia and requested that the matter be referred to arbitration. Following such request from the US, the DSB agreed that the matter be referred to arbitration and informed WTO Members that arbitration would be carried out by the original panel.

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.