Similar to pharmaceutical products, medical devices play an increasingly important role in healthcare worldwide by contributing substantially to the prevention, diagnosis and treatment of diseases. From the patent law perspective both, pharmaceutical products and a medical apparatus, product or device can be patented if they meet the patentability requirements, which are novelty, inventiveness and entail industrial applicability. However, regulatory issues also impact on the whole cycle of the innovation. At a European level, enhancing competitiveness while ensuring public health and safety is one of the key objectives of the European Commission. This article undertakes literature review of the current and incoming regulatory framework governing medical devices with the aim of highlighting how these major changes would affect the industry at issue. The analysis is made in the framework of an on-going research work aimed to determine whether SPCs are needed for promoting innovation in the medical devices industry. A thorough analysis the aforementioned factors affecting medical device’s industry will allow the policymakers to understand the root cause of any optimal patent term and find appropriate solutions.

Text and Data Mining (hereinafter, TDM) issue for the purpose of scientific research or for any other purpose which is included in the provisions of the new EU Directive on Copyright in the Digital Single Market (hereinafter, DSM). TDM is a term that includes Web harvesting and Web Archiving activities. Web harvesting and archiving pertains to the processes of collecting from the web and archiving of works that reside on the Web. In the following analysis we will elaborate briefly upon provisions in EU Copyright law which were discussed during the proposal for a new Directive on Copyright in the DSM as well as provisions which are included in the text of art.3 and art.4 of the new Directive 2019/790/EU per TDM. In addition, the following analysis presents legislation in very few EU Member States which pertains to TDM and preceded the rulings of Directive 2019/790/EU. Digital legal deposit remarkable examples from EU Member States are also presented in this paper. The example of Australia is also presented below hereto because it is one of the oldest and most successful worldwide. The National Library of Australia’s digital legal deposit is state-of-the-art.

This article relies on the premise that to understand the significance of Open Access Repositories (OARs) it is necessary to know the context of the debate. Therefore, it is necessary to trace the historical development of the concept of copyright as a property right. The continued relevance of the rationales for copyright interests, both philosophical and pragmatic, will be assessed against the contemporary times of digital publishing. It follows then discussion about the rise of Open Access (OA) practice and its impact on conventional publishing methods. The present article argues about the proper equilibrium between self-interest and social good. In other words, there is a need to find a tool in order to balance individuals’ interests and common will. Therefore, there is examination of the concept of property that interrelates justice (Plato), private ownership (Aristotle), labour (Locke), growth of personality (Hegel) and a bundle of rights that constitute legal relations (Hohfeld). This examination sets the context for the argument.

This article describes the scope and contents of the newly adopted regulation governing regulatory impact analysis (RIA) and ex post evaluation of regulation (ExPER) in the Italian legal system. The article shows that this regulation has the potential to improve regulatory governance in Italy. Not only does it introduce innovations designed to increase transparency and participation, especially through strengthened consultation and communication mechanisms, but it also aims to improve the quality and effectiveness of regulatory analysis and evaluation activities. How the new regulation will be applied in practice, however, remains to be seen. In the meantime, the new set of rules are a welcome addition to Italy’s Better Regulation policy.

This study is focused on the evaluation of successes and failures of the Common Market of the South (Mercosur). This analysis of Mercosur’s integration seeks to identify the reasons why the bloc has stagnated in an incomplete customs union condition, although it was originally created to achieve a common market status. To understand the evolution of Mercosur, the study offers some thoughts about the role of the European Union (EU) as a model for regional integration. Although an EU-style integration has served as a model, it does not necessarily set the standards by which integration can be measured as we analyse other integration efforts. However, the case of Mercosur is emblematic: during its initial years, Mercosur specifically received EU technical assistance to promote integration according to EU-style integration. Its main original goal was to become a common market, but so far, almost thirty years after its creation, it remains an imperfect customs union.
The article demonstrates the extent to which almost thirty years of integration in South America could be considered a failure, which would be one more in a list of previous attempts of integration in Latin America, since the 1960s. Whether it is a failure or not, it is impossible to envisage EU-style economic and political integration in South America in the foreseeable future. So far, member states, including Brazil, which could supposedly become the engine of economic and political integration in South America, have remained sceptical about the possibility of integrating further politically and economically. As member states suffer political and economic turmoil, they have concentrated on domestic recovery before being able to dedicate sufficient time and energy to being at the forefront of integration.

As a result of the interconnectedness of the global economy, cross-border activities of economic operators are soaring. Their business practices are not governed by multilateral rules, but merely, if at all, by regional or national laws. As a result, they are potentially subject to over- or under-enforcement and -regulation or to conflicting rules. The resultant legal uncertainties and, therefore, potential lack of discipline for practices facilitates the development of dominant positions and anticompetitive behavior. This advances market distortions to the detriment of diverse offerings and the competitiveness of small market players, especially in economically weak developed countries. Such unfavorable developments could be reduced by preventing market concentration and disciplining anticompetitive behavior. I argue that multilateral rules alone would ensure that cross-border activities of economic operators are subject to uniform rules, irrespective of which country’s or region’s market is affected; and thus, provide legal certainty for current gaps. Moreover, in spite of the resistance of numerous countries to include competition disciplines within the World Trade Organization (WTO), rules aimed at dismantling barriers to trade created by private economic operators are not only theoretically desirable but indispensable in the long term to avoid an erosion of the WTO system by effectively replacing state-created barriers. The increasing role of supply chains and the rising volatility of international commodity prices should give all, albeit particularly the economically weak developed countries, reason to pause and revisit an issue that has significant implications for the competitiveness of their economic operators.

In May 2019, the Dutch senate adopted a private member’s bill introducing a due diligence obligation for companies bringing goods or services onto the Dutch market with respect to the use of child labour in their supply chains. The aim of this article is to place this Child Labour Due Diligence (CLDD) Act in the national and international legal context and to discuss its relevance for the broader debate on international responsible business conduct (IRBC) in global value chains. The article shows that the CLDD Act introduces a due diligence obligation in this context that is new to Dutch law, as is the public law supervisor that is to be tasked with its enforcement. However, it does nothing to broaden the possibilities for access to remedies for victims of child labour beyond those already in existence. The article also shows that when compared with 2017 the French Duty of Vigilance Law, which is the only other mandatory due diligence law to have been adopted so far, the CLDD Act stands out in several respects. It is overshadowed, however, by the European parliament’s recent adoption of an ambitious outline for a future EU due diligence directive. Nonetheless, in view of the fact that it remains unclear for now whether the future EU directive on this topic will display the same level of ambition as the current proposal, the CLDD Act will remain relevant from an international perspective also for some time to come.

As our economies continue to focus on growth, competition and maximisation of consumer choice, the global increase in consumption takes vast environmental and social costs and cause irreversible harm to our climate and environment. The urgency of reducing human footprint and to diminish one of the root causes of a declining climate and environment is irrefutable. In the shift that globally has to take place, a decentralised energy system relying on more distributed generation, energy storage and a more active involvement of consumers form a crucial component of renewable energy solutions. The move from a highly centralised to a more decentralised power system involves an increasing amount of small-scale (intermittent) generation from renewable energy which is located closer to the point of final consumption. In order to steer consumption towards sustainability national governments and supranational organisations have adopted policies and corresponding legislation that address individual consumers as rational and active choice-makers who make socially responsible choices when they receive the ‘right’ amount of information. By relying on insights from modern consumption theories with contributions from sociology, this article questions the effectiveness and legitimacy of these ‘consumer-centred’ policies and laws. First, the article argues that the single focus on individual consumer behaviour as a rational and utility maximising market actor fails to take into account the complexity of consumption, which is fundamentally influenced by social norms and its broader institutional setting. Although consumers are willing to consume more sustainably, they are often ‘locked in by circumstances’ and unable to engage in more sustainable consumption practices even if they want to. Second, by relying on evidence from sociological studies the article argues that individual consumers are not the most salient actors in support of sustainable consumption. Even though the urgency of the energy transition and the critical role consumers play in (un)sustainable energy consumption is acknowledged in both the EU and its Member States, their laws and policies remain grounded on goals of economic growth with competitive economies, the sovereignty of consumer choice and wealth maximisation, instead of aiming at slower economic growth or even degrowth, reducing overall resource use and consumption levels and introducing radically different ways of consumption.
Third, the role of law is underlined as a social institution both as a constraint on the autonomous acts of consumption, dictating the normative frameworks within which the role of consumer is defined, and as a facilitator which consumers might also employ, in order to determine for themselves particular normative parameters within which consumption can occur.
The Netherlands, which serves as a case study in this article, has reached important milestones in its energy transition policy since 2013. Still, it remains strongly focused on economic rationality and market competitiveness. Even though various models of consumer participation exist and local consumer energy initiatives are flourishing and are recognised as key actors in the energy transition, they remain embedded in institutional, structural and behavioural settings where consumers still face challenging sociocultural barriers to sustainable practices.
In light of these legal, political and social complexity of energy transition, the article offers a critical analysis of the current Dutch law in its broader legal context of EU law in order to answer the question what the role of (energy) law is in steering consumers towards sustainable energy consumption.

The EU-funded project Sustainable Market Actors for Responsible Trade (SMART, 2016-2020), undertook an interdisciplinary and multilevel regulatory analysis of the barriers and possibilities for securing the contribution of private and public market actors to a sustainable future. Jurisdiction-specific contributions were an essential part of this broad regulatory analysis. This afterword reflects on the Dutch contributions included in this Special Issue, emphasising the urgency of securing policy coherence for sustainable business. The afterword highlights how individual initiatives by national legislators such as those of the Netherlands can be inspiring examples, while they also bring with them challenges including questions of scope and of legal certainty for businesses, specifically with regard to cross-border operations and activities. This leaves business with the difficult task of figuring out the various requirements and expectations and may lead to regulatory competition between EU member states. The afterword therefore concludes with a call for EU harmonisation, to give sustainability-oriented business a level playing field and provide legal certainty both for decision-makers in business and for those affected by the conduct of business across global value chains.

The judicial landscape in Europe for commercial litigation is changing rapidly. Many EU countries are establishing international business courts or have done so recently. Unmistakably, the approaching Brexit has had an effect on this development. In the last decades England and Wales – more precise, the Commercial Court in London - has built up a leading position as the most popular jurisdiction for resolving commercial disputes. The central question for the coming years will be what effect the new commercial courts in practice will have on the current dominance of English law and the leading position of the London court. In this article I address this question by focusing on the development of a new commercial court in the Netherlands: the Netherlands Commercial Court (NCC).

The Singapore International Commercial Court (‘SICC’) was launched on 5 January 2015, at the Opening of Legal Year held at the Singapore Supreme Court. What prompted the creation of SICC? How is the SICC model of litigation different from litigation in the Singapore High Court? What is the SICC’s track record and what does it tell us about its future? This article seeks to answer these questions at greater depth than existing literature. Importantly, it examines these questions from the angle of reimagining access of justice for litigants embroiled in international commercial disputes. It argues that the SICC’s enduring contribution to improving access to justice is that it helps to change our frame of reference for international commercial litigation. Hybridisation, internationalisation, and party autonomy, the underpinning values of the SICC, are likely to be the values of the future of dispute resolution. International commercial dispute resolution frameworks – typically litigation frameworks – that unduly emphasise national boundaries and formalities need not and should not be the norm. Crucially, the SICC co-opts a refreshing public-private perspective to the resolution of international commercial disputes. It illuminates on the public interest element of the resolution of such disputes which have for some time fallen into the domain of international commercial arbitration; at the same time, it introduces greater scope for self-determination in international commercial litigation.

The Court of the Astana International Financial Center is a new dispute resolution initiative meant to attract investors in much the same way as it has been done in the case of the courts and arbitration mechanisms of similar financial centers in the Persian Gulf. This paper examines such initiatives from a comparative perspective, focusing on their Private International Law aspects such as jurisdiction, applicable law and recognition and enforcement of judgments and arbitration awards. The paper concludes that their success, especially in the case of the younger courts, will depend on the ability to build harmonious relationships with the domestic courts of each host country.

In 2018, in the wake of Brexit, the French legal profession took several important measures to strengthen the competitiveness of France and the French legal system, and to make Paris an attractive go-to-point for businesses when the latter have to deal with international commercial litigation. When taking a closer look at it, Brexit is only the top of the iceberg, and has mostly served as a catalyst. Reasons explaining the development of international commercial courts in France are manifold. They are consequences of long-standing efforts aimed at boosting the French judicial marketplace to adapt it to the requirements of globalization and to the expectations of multinational corporations. The setting-up of the French international business courts has made several procedural adjustments necessary. Although the latter undoubtedly represent clear innovations, they however do not constitute a full-blown revolution. France has indeed decided to maximize already-existing procedural rules, combined with a new organisational format inspired by the Common Law tradition. If it remains too early to draw clear conclusions on the impact of these new developments, it is essential to keep our ears to the ground, and to be forward-looking. We should carefully consider the possible side-effects on the French justice system considered as a whole, and in particular wonder whether these international commercial courts might in the future open the door to broader far-reaching evolutions within the judicial system. Finally, the multiplication of international business courts across Europe nowadays triggers some questions concerning the role and potential added value of an EU initiative in this domain.

France, Germany, Belgium, and the Netherlands have taken concrete steps to design and develop international commercial courts. Most of the projects claim to be building courts that match the preferences of court users. They also try to challenge England and Wales, which evidence suggests is the most attractive jurisdiction in the EU. For the success of these projects, it is important that their proposed courts corresponds with the expectations of the parties, but also manages to attract some of the litigants that go to London. This article argues that lawyers are the most important group of choice makers, and that their preferences are not sufficiently matched by the new courts. Lawyers have certain litigation service and court perception preferences. And while the new courts improve their litigation service, they do not sufficiently addressed these court perception preferences.

Online communication practices have become intrinsic to government work environments. Understanding the impact of these practices, whether they be general computer mediated communication (CMC) or specifically online dispute resolution (ODR) processes, is an essential step in supporting respectful and healthy work environments. ODR literature focuses almost exclusively on e-commerce, leaving large gaps in the body of knowledge as ODR applications diversify. Available ODR tools, which simply transpose traditional alternative dispute resolution (ADR) processes online through the use of office videoconferencing systems, are not mobile and do not utilize the full capabilities of the existing technology. This article explores the potential impacts mobile ODR (MODR) tools could have on the dispute interventions and prevention initiatives in government office settings. The study used an exploratory model to establish an understanding of the experiences and needs of Canadian and Australian government employees. Findings demonstrate an interest in the introduction of education-oriented MODR tools as supplementary support with the purposes of knowledge retention and further skill development following dispute prevention training. Findings suggest that workplace attitudes towards online communication and ODR have a significant impact on the extent to which individuals successfully develop and maintain relationships either fully or partially through the use of CMC.

The milestone provisions in the Outer Space Treaty designate outer space and celestial bodies as an area beyond national jurisdiction in which national jurisdiction extends only to space objects and persons in outer space. In view of upcoming commercial space mining activities and the recent national legal developments, it is of crucial importance to delineate the different levels of legal authority over space resource activities and to analyze them systematically. What is indisputable, in the first place, is that any national appropriation in outer space is prohibited by Article II OST, while the appropriation of resources is not explicitly mentioned. More specific provisions are formulated in the Moon Agreement. Its Article 11 prohibits the appropriation of resources on celestial bodies and states that such activities — as soon as they become feasible — must be regulated by the international community of States. While this moratorium on resource exploitation is binding only for the 18 ratifying State parties to the Moon Agreement, there is no doubt that the legal authority to regulate over outer space lies with the international community and not with single States. Unilateral legislative acts must conform to existing international provisions as outer space is an area beyond national jurisdiction. Where such explicit provisions are lacking – as is the case with the appropriation of space resources – the lawful scope of national authority must nevertheless be delineated through international regulation as States lack the national prescriptive authority to regulate over outer space and celestial bodies.

Entities enjoying international legal personality are generally regarded as the “subjects” of general international law and international space law and are considered to possess rights and obligations under international law. While States have historically been recognised as the principal subjects of international law, non-State actors, such as international organisations, non-governmental entities, multinational corporations, and (arguably) individuals, are increasingly empowered with rights and subjected to obligations on the international plane. International space law, although embedded in general international law, contains unique principles and rules that are in some cases different from those of general international law. With the changing nature of activities due to technological developments, and the proliferation of actors in the space domain, it is necessary to critically examine the issues as to what are considered the subjects of international space law. This question is important both from the doctrinal perspective, and as a matter of practical relevance, as space activities are increasingly being undertaken by non-State actors under the jurisdiction and control of, or having a nexus with, several States.