This report analyzes the tobacco carve-out clause (as well as the negotiations that led to its adoption) included in the final text of the Trans-Pacific Partnership Agreement, which permits the TPP Parties to deny investors that challenge their tobacco control measures access to the investor-state dispute settlement mechanism. The report also discusses the potential advantages and disadvantages of such a solution.

The field of robotics is remarkably wide, with many social settings now entailing and increasingly requiring the use of robots to support a variety of human activities. Unsurprisingly, robots’ form and shape, their level of intelligence and intended purpose can vary significantly depending on the relevant industry.1 Domestic robots are already a reality in a growing number of family homes. They include both humanoid robots which support those in need (such as the elderly, people with disabilities or children) and robots for household consumer markets, including domestic vacuum cleaners and grass-trimmers. Humanoid robots only account for a small fraction of the industry, with robotic arms for industrial automation being instead widespread.2

This article discusses the development of a more supranational EU approach to regulate risks of “serious cross-border threats to health” such as pandemic disease outbreaks. It argues that the EU’s public health measures to prevent and tackle pandemics could affect individual patients’ rights, because the rights of individual European citizens are balanced against the importance of protecting the European community as a whole. This results in a tension between public health and individual rights in the EU, especially with regard to the right to informed consent, a central right in health law. In response to the 2013–2016 Ebola outbreak in West Africa, the EU introduced several preventive and responsive measures in the Member States to prevent the pandemic from spreading to the EU. The case study analysis of Dutch pandemic policies established in reaction to this outbreak shows that national pandemic policies are substantially shaped by EU actions, which has implications for the protection of the individual right to informed consent in the Member States.

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.

One of the few certainties we have in dealing with corruption lies in its adaptive nature. Over time, corruption has in fact proved to be able to change, evolve and adapt within all political systems. Such an adaptive nature calls for close scrutiny of the setting or space where corruption spreads out. Therefore, this raises questions about the unappreciated risks and immeasurable opportunities for corruption in the ever-changing and interconnected world of techno-social systems we live in. This article aims to advance the policy and regulatory debate surrounding corruption by focusing on its complex and adaptive nature. In applying the main tenets of complexity theory, the analysis builds on the well-known Cynefin framework. This decision-aiding framework proves to be an insightful tool for shedding light on some critical features of corruption (eg its perception and the affected confidence).

The United States’ Food Safety Modernization Act (FSMA) revises the US Food and Drug Administration's regulatory authority. While expanding FDA's authority, the legislation replicates and relies on private systems of standards and third party audits, albeit with modifications. This article argues that public and private actors develop food safety regulations within multiple types of institutional venues, including private standards regimes, courts, congresses, and government regulatory agencies. It examines how interactions within each of these venues are shaped by stakeholders’ interests, and how the relevant subset of interactions within these venues ultimately shaped the FSMA. The article concludes by offering insights into what consequences these interactions and outcomes may have on the roles and capacities of affected stakeholders in food safety governance.

This article is a critical reflection on the manifoldness of the notion of “partnership” in Critical Infrastructure Protection. It is argued that the partnership arrangement can be a promising political approach to CIP if the details of public-private cooperation – that is: the participants, the duration, the responsibilities and duties, as well as possible financial compensation – are formalized. Illusionary ideas of a “partner-like” relationship between the public and the private, such as those laid down in the German “National Strategy for Critical Infrastructure Protection”, are, however, doomed to fail. State authorities have to actively offer binding regulatory arrangements to private CI firms in order to establish which companies genuinely agree to cooperate – and which do not. Due to the state's constitutional obligation to guarantee national security and protect the life and health of its citizens, introducing legal requirements is the only possible reaction to a company's refusal to cooperate. In order to avoid overly intrusive market intervention, the state's offer to private firms or their industry associations to conclude binding regulatory contracts on CIP matters may serve as a promising compromise between a laissez-faire approach and regulation.

In February 2016, the Feasibility Report on options for an EU ecolabel scheme for fishery and aquaculture products was published. The study did not make a strong case for the introduction of a seafood EU Ecolabel and it is unlikely that the European Commission will pursue this policy option. We argue that sustainability information on seafood should not be framed through the EU Ecolabel debate. The more pressing issue concerns self-declared sustainability claims on seafood products. As a possible solution, we propose to address these by re-invigorating the labelling rules on seafood information in the Regulation on the Common Organisation of the Markets in Fishery and Aquaculture Products.

In this article, we ask what the impact is of the role of the EU administration in responding to emergencies in terms of (changes to) the rule of law. A response to an emergency in some cases creates exceptions to rule of law guarantees that bind the authorities to procedural rules and fundamental rights. These exceptions can become more permanent and even change the constitutional order of the EU. We articulate the legal framework for health emergencies, and discuss how the EU court has interpreted and developed this framework in two key decisions. We then ask whether this framework offers adequate safeguards for upholding the rule of law in cases of major health emergencies. We conclude that public health emergencies can bend and even break rule of law requirements for the EU administration, and advocate for more legal guidance on proportionality, which may offer better safeguards suited for protecting the rights of affected parties.

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.

The EU has yet to develop definitive policies for the crypto-economy, and this article argues that policy development should follow a “systemic” and not “sectoral” approach. This is because the crypto-economy is not merely a financialised space and new productive activity is occurring that would benefit from more holistic policy development than regulation focused on securities and investments. This article proposes that the EU should develop policy for the crypto-economy based more broadly on innovation policy and perhaps feed into the Single Market project.

The article tackles the issue of personal data protection in case of tracing (looking for) individual persons who have been exposed to health risks pursuant to the EU Decision 1082/2013 on Serious, Cross-border Health Threats. This problem exemplifies just one among many challenges of the health-security nexus in the EU. That is, it regards a certain trade-off between the limitation of individual rights and securing populations’ safety. The text appraises the safeguards for the (lawful) limitation of the right to data protection after an in-depth examination of the provisions of the Health Threats Decision, its implementing measures, the reports on its operation, and in light of the general EU data protection laws. In conclusion, it claims that a number of improvements are needed because of the incompleteness, and the insufficient coherence and transparency of the EU regime for health threats. The established shortcomings are, at least in part, caused by the new EU “integrated approach” to health and security. In effect, an overall philosophy of reforms of public health policy in the name of “all-hazards security” applied in the Health Threats Decision can result in a reduction of the adequate level of protection of individuals’ personal data.

Critical infrastructure (CI) sees to assets that are essential for the functioning of a society and economy, as they provide public services, enhance quality of life, sustain private profits and spur economic growth. Assets of CI differ considerably, ranging from hardware such as cables and wires, through to networks for the generation and supply of energy sources. Critical infrastructures encompass many sectors of the economy, such as banking and finance, transport and distribution, energy, utilities, health, food supply and communications, aswell as key government services.

Former Soviet republics and other countries of the ex-Communist “block” may seem unlikely places to look for inspiration in “better regulation”. In fact, their experience in moving away (with varying degrees of success) from an approach based on “total control” and complete risk-aversion (an absolute RRR, as it were) may be an opportunity to get many insights. Data from surveys conducted by the World Bank Group allows to shed light on trends in regulatory delivery, and in particular in inspections, which is the primary way in which the RRR is felt by businesses. This paper describes the starting situation, analyses the reform processes and their outcomes, and attempts to draw some lessons – as well as some comparisons with situations and experiences in EU and OECD countries. Tentative conclusions suggest both that addressing the inspections and control issue (and not just regulations themselves) is crucial to success in reform, and that reducing the “pressure” from total control through a “risk-focused” approach leads to real improvements in the business climate without negatively affecting public safety.

This section aims at updating readers on the latest developments of risk-related aspects of food law at EU level, giving information on legislation and case law on various matters, such as food safety, new diseases, animal health and welfare and food labelling.

This article reports on and discusses the findings of the first systematic study on Regulatory Impact Assessment (RIA) reforms in developing and transition economies. The macro part of the study reveals that between 2001 and 2016 60 such reforms were launched in total, with 20 of them leading to functional RIA systems two years or more after they were initiated. Appropriate and complete reform design, analysed by measuring compliance with six internationally recognised “good practices”, is found to be a necessary but not sufficient condition for early success. To develop a better understanding of challenging factors for RIA reforms’ success the micro part of the investigation analyses four case studies (Botswana, Cambodia, Kenya and Uganda). Findings point to the importance of donor flexibility and patience and the need for building reform constituencies inside and outside government. The traditional orthodoxy of regulatory impact assessment reforms as an extension of red tape reduction is challenged. The article finally presents several possible policy implications of the findings.