Drones represent a rapidly developing industry. Devices initially designed for military purposes have evolved into a new area with a plethora of commercial applications. One of the biggest hindrances in the commercial developments of drones is legal uncertainty concerning the legal regimes applicable to the multitude of issues that arises with this new technology. This is especially prevalent in situations concerning autonomous drones (ie drones operating without a pilot). This article provides an overview of some of these uncertainties. A scenario based on the fictitious but plausible event of an autonomous drone falling from the sky and injuring people on the ground is analysed from the perspectives of both German and English private law. This working scenario is used to illustrate the problem of legal uncertainty facing developers, and the article provides valuable knowledge by mapping real uncertainties that impede the development of autonomous drone technology alongside providing multidisciplinary insights from law as well as software electronic and computer engineering.

The regulatory literature has long been concerned with the challenges of technological innovation, yet it says relatively little about what we understand as “innovative” and how innovation “types” impact on regulation. This article unpacks the concept of “innovation” and analyses its significance for the development of regulatory strategy. It shows that innovation types – such as “incremental” and “radical” innovation – are not clear-cut, but involve differences of interpretation. This interpretive flexibility makes them powerful discursive resources in regulatory decision-making. Through a study of the EU’s regulation of nanotechnology, the article shows how arguments of “incremental” and “radical” innovation can be mobilised to very different effect. These different ways of conceptualising new technology affect decisions on: (i) the desirability of legislative reform; (ii) the evidence-base for regulation; and (iii) the use of the precautionary principle. The study also shows how the framing of technology as “incrementally” innovative can contribute to a strategy of “deliberate regulatory ignorance”. The article concludes by arguing that the incremental/radical distinction can be put to more positive use, so that regulatory choices take account of the different techno-scientific and socio-economic dimensions of innovation.

The article provides an inclusive outlook on artificial intelligence by introducing a three-legged design perspective that includes, but also moves beyond, ethical artificial systems design to stress the role of moral habituation of professionals and the general public. It is held that an inclusive ethical design perspective is essential for a flourishing future with artificial intelligence.

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.

Climate engineering in general and solar radiation management (SRM) in particular raise profound and complex political, legal, social, and ethical questions that go well beyond technical feasibility issues. We consider three such questions. First, can existing EU decision-making processes accommodate sufficient public engagement to ensure legitimate decisions on SRM? Second, does politics influence the choice of legislative procedure for SRM regulation? Third, does the choice of legislative procedure influence the likelihood of SRM implementation? Three main conclusions emerge from our analysis. First, existing EU decision-making processes can – given certain conditions – accommodate considerable public engagement and hence ensure legitimate decisions on SRM. Second, politics matters; indeed, the EU's choice of legislative procedure concerning SRM may well become subject to political negotiations. Finally, the choice of legislative procedure may substantially influence the likelihood of SRM implementation.

For many years, the EU's legislation on animal testing and marketing bans regarding cosmetic products and their ingredients has been giving rise to controversy. First, the bans were introduced under the regime of the Cosmetics Directive, which was subsequently replaced by Regulation (EC) No. 1223/2009 on cosmetic products (hereinafter “EU Cosmetics Regulation”). In this process, the animal testing and marketing bans of Article 4a of the Cosmetics Directive were transferred – with identical content and largely with the same wording – to Article 18 of the EU Cosmetics Regulation, so that the legal issues connected with the bans have basically remained the same. Since the transitional periods for the application of the bans ended on 11 March 2009 and 11 March 2013 (for details, see Article 18(2) of EU Cosmetics Regulation), and the bans as provided by Article 18(1) of the EU Cosmetics Regulation are binding and directly applicable in the EU Member States, they must be observed by the affected businesses as of now. Violations are to be sanctioned in the Member States in an effective, proportionate and dissuasive manner (Article 37 of EU Cosmetics Regulation).

The role of software in society has changed drastically since the start of the twenty-first century. Software can now partially or fully facilitate diagnosis and treatment of a disease, regardless of whether it is psychological or pathological. Consequently, software plays a role comparable to medical equipment with a physical footprint. Understanding when software as a medical device must comply with applicable rules is vital for both manufacturers and regulators. We therefore examine the Medical Device Regulation to expand on the notion of intention, as this is the key basis for the classification of medical devices. Finally, we develop objective criteria that software must fulfil to be considered a medical device under European Union law.

As parliamentarians it is our job to represent the people of Europe and to make laws that are in the people's best interest. This sounds simple at a first glance, but it is not as simple when you think about it twice. A law might be in the interest of the people now, because it has known positive effects in the short term. But sometimes the very same law might bear a risk in the long-term, especially for future generations, and sometimes we can't even tell yet how big that risk is. If we would follow a short-sighted approach which only aims at the expected positive effects without taking into account actual and potential adverse effects that might occur in the future, we would act irresponsibly towards the generations of our children and grandchildren. That is why risk governance and the precautionary principle rightfully play a major role in the daily work of the legislator.

The potential exposure to organisms and humans of pharmaceutical waste presents society with a wicked problem. The health benefits of pharmaceuticals are obvious, but the public awakening to the risks posed by pharmaceutical residues in the environment is in its early stages. Regulators in the US and the EU require an environmental risk assessment of a medicinal product before it can enter the market. This article compares the US and EU approach to assessing these risks, with the purpose of providing a different perspective on how to approach this delicate balancing act of risk and benefit and to reveal the different values underpinning the risk assessment.

Since the adoption of the World Health Organization (WHO) Framework Convention on Tobacco Control (FCTC) in 2003, public health professionals have debated similar conventions covering other health risks, including potentially a Framework Convention on Alcohol Control. Much of this debate has focused on the merits of binding versus non-binding instruments in terms of commitments at the international level. In this paper, I draw on lessons from the WHO FCTC to discuss instead what the difference between binding and non-binding international legal instruments might mean for domestic legal frameworks for implementing regulatory measures for alcohol control. The paper looks at possible impacts on the authority of various national authorities to implement new measures, the ability of civil society to bring cases compelling more comprehensive regulatory measures and the defence of litigation brought by commercial-sector actors to prevent, delay or weaken the implementation of laws and regulations. It reflects on what lessons these might have for alcohol control governance.

This paper deals with the debate on the methods to regulate hedge funds, with a particular focus on direct or indirect regulation. After having briefly examined the pros and the cons of directly regulating these investment schemes, it comes to the conclusion (largely shared by most scholars) that hedge funds should not be directly regulated, while regulation should concern their management companies and, most of all, their counterparts (lenders in the first place) with a view to managing systemic risk. In addition, regulation should also set precise thresholds for access which should aim at protecting unsophisticated investors from hazardous moves, without, however, falling into the trap of regulating hedge fund themselves.

The attention is then turned to the European Union and to its Alternative Investment Fund Managers Directive (AIFMD). An analysis is conducted on some of the most significant approaches to hedge fund regulation which have fuelled (and are partly still fuelling) the debate within EU institutions in its struggle to provide Member States with a valid response to the financial crisis, and on some key provisions of the first level AIFMD. In this light the author concludes that, despite the declared intent to regulated fund managers, the directive often seems to regulate hedge fund themselves. This does not seem to be in line with the thoughts of most scholars and market operators on hedge fund regulation and also looks at odds with other pieces of EU legislation (in particular with the so-called “Newcits”).

This paper argues that the EU Regulation of credit rating agencies is concurrently pursuing two objectives that conflict with and would undermine each other. One is the objective of enhancing rating accuracy, and the other is the objective of restoring market discipline in the wholesale investment markets for credit ratings as information goods. The Regulation places more emphasis on regulating for rating accuracy which has the effect of instituting a form of product regulation for credit ratings, raising the public interest profile of credit ratings. This paper argues that this is undesirable and is contrary to policy-makers’ endeavours to enhance market discipline for rating quality and the private accountability of credit rating agencies. EU policy-makers would eventually need to confront the underlying conflicting objectives in the Regulation so that a normatively coherent and consistent regulatory regime can be designed and implemented.

This article contributes to the discussion about proper product safety in the wake of disruptive digital technologies. By picking the example of 3D printing we analyse why incumbent product liability law does not incentivise optimal deterrence of harmful 3D printed products. We identify the new business models associated with 3D printing as the main trigger for the non-applicability of incumbent liability law. The new business models are characterised by making no strong reference to economies of scale. As a result, the informational content of specific producers and their products is scarce and the identification of tortfeasors becomes a challenge for the legal system. While there is yet no easy solution to the problem, we provide at the end of the article an inventory of institutions that may take the lead in finding new proper liability rules and safety regulations.

This report examines the pending Proposal for a directive on unfair trading practices in business-to-business relationships in the food supply chain, and its proposed amendments. It provides a general overview of the current content of the Proposal and analyses the proposed rules from a legal perspective. We find that: (1) the CAP legal basis may prove insufficient for regulation that covers the entire agri-food chain; and may (2) result in a strained relationship with the competition and consumer acquis; (3) the empirical basis for the prevalence of unfair trading practices, and the effect of their prohibition is relatively dire, which results in uncertainty with regard to the achievement of the future UTPD’s intended effect and effectiveness; (4) the choice for specific targeted prohibitions instead of general umbrella clauses may lead to ad hoc regulation that leaves large loopholes; (5) the institutional enforcement mechanism makes it likely that the Proposal contributes to the foundation for a new area of EU law, which will increasingly regulate practices in business-to-business relationships.

As a previously unknown virus, the spread of the coronavirus challenged not only medical science and public health systems, but also public governance in all countries. In order to tackle the COVID-19 crisis in China, public authorities at various levels have issued a large number of measures that have no legally binding force, but produce practical effects. A closer look at selected COVID-19 measures in China shows that both the advantages and drawbacks of soft law are brought to the fore by the pandemic. This contribution, focusing on Chinese experiences with COVID-19 soft law, argues that the lack of legal bindingness and consequently of legal enforcement does not make soft law measures ineffective. On the contrary, these “defects” ease the adoption of soft law and ensure its availability to both public authorities and citizens, hence increasing its effectiveness in combating the pandemic. Yet problems remain in realising participatory possibilities and ensuring respect for legality.

Attempts at suitable identification of a generally accepted definition of a ‘nanomaterial’ have been going on in Europe and worldwide for some time. Definitions are important from a regulatory perspective as “they assist in establishing the subject matter and scope of what is to be regulated”. However, considering the complexities associated with nanoscience and also the differing opinions on various definitions, this has not been an easy task. Reaching an agreement on fundamental terms and definitions such as ‘nanotechnology’, ‘nanoparticle’, ‘nanoscale’, and a ‘nanomaterial’ is both complex and contested. To date, there is no internationally recognised and accepted definition of a ‘nanomaterial’ even though several definitions have been discussed and proposed by national authorities, scientific committees, international organisations, and other bodies.