This chapter examines trade rules and practices regarding technical standards on energy efficiency, carbon emissions and renewable energy. Such standards usually complement anti-pollution, decarbonization and subsidization measures discussed in the previous chapters. The active use and trade implications of these measures in the energy–environment context have intensified the pace of raising related trade concerns in the WTO. Often tensions arise because of regulatory divergence that stems from differences in domestic situations, conditions and preferences as reflected in national standardization policies. But the notion that regulatory convergence is important in cutting trade costs is widely recognized, with many jurisdictions being increasingly involved in regulatory cooperation. Clean energy products can be supplied together with the associated services. Yet international trade rules on service standards are nearly under-developed and lack substantive details, which gives leeway to national regulators. Besides ‘general’ markets, green goods and services find their use in the segment of government procurement where environmental aspects are made part of technical specifications.

The final empirical chapter turns to the international level in order to determine whether delegation to an international standard-setter alters the regulatory dynamics identified. Looking at the Codex Alimentarius Commission, the chapter asks whether this institution has been able to ameliorate the regulatory biases found domestically. In order to answer this, the chapter replicates the analysis conducted on agrochemical regulation in the United States, this time looking at changes to standards under Codex. The chapter shows that even though Codex standard-setters are substantially more removed from the domestic political process than regulators in the USA, the Codex Commission has shown as much of, if not a greater tendency to systematically impose stricter standards on out-of-patent agrochemical products. As such, the international standard-setter has ended up placing more onerous rules on more affordable products for reasons that are less based on science than they are based on the absence of scientific information. In addition to showing that international standards have been vulnerable to similar biases as domestic regulations, this chapter also explores how developing countries and generic producers have sought to combat the regulatory barriers that have arisen at the international level and how innovative firms have successfully blocked them.

Art. 325 TFEU aims to establish an effective and standardised protection of the European Union’s financial interests across all Member States, and in all of the EU’s institutions and bodies. This regime is underpinned by two key principles: assimilation and minimum protection. They require the Member States to take the same measures to counter fraud affecting the financial interests of the EU as they take to counter fraud affecting their own financial interests and to prevent and combat EU-fraud and other financial misconduct with effective, proportionate and dissuasive measures. National provision that is incompatible with this so-called ‘minimum trias’ is neutralized and rendered inapplicable. Moreover, the EU is empowered to adopt the necessary measures for the prevention of and fight against EU fraud. Arguably, this includes the right to enact legislation in the area of criminal law, to harmonise the respective national criminal laws of the Member States, and even to introduce directly applicable European criminal provisions. And yet, despite these sweeping powers, the EU has thus far proven reluctant to use them. Instead, it has generally opted for a restrictive interpretation of its anti-fraud competencies.

European Union criminal law as we know it is a product of intensive legal development on both legislative and judicial levels, accompanied by significant changes in the Treaty framework. In this chapter, we will discuss the emergence and nature of harmonisation efforts with an emphasis on especially substantive criminal law. Our claim is that whereas during the Amsterdam era, harmonisation of substantive criminal law was mainly regarded a competence issue, since entering of the Lisbon Treaty together with strengthening of the role of the fundamental rights and human rights in the law of the European Union, the debates concerning European criminal law take place mainly on the level of adjudication. Harmonisation relates not only to the cornerstone principle of mutual recognition but has a link as well to the debates on increased supranationalism as expressed by ‘Taricco saga’ and the establishment of the European Public Prosecutor’s Office.

From the long path through preclinical development, entering the regulatory field of interactions for human clinical trials can sometimes feel like you are walking into the lion’s den. This chapter guides you through an understanding of how to interact and how to prepare for FDA meetings so that they are on your side rather than fighting you. The common goals of companies and the FDA are highlighted here. Specific issues with identifying the appropriate regulatory approval pathway are discussed here with cautionary case studies. Complex new technologies which combine diagnostics and drugs, or devices and software, or AI-based dynamic software are reviewed here. The best approach to the appropriate regulatory pathway will be clear after reading this chapter. Case studies are used to show successful pathways taken by cutting-edge developments, such as cell-based therapy.

Exigencies of hyper-globalized, invariably transnational, trade have exerted immense pressure on the global legal infrastructure to produce a dispute resolution mechanism that attends to the needs of international commerce. In this chapter, it is argued that international commercial courts (ICommCs) possess structural features that allow them to fill in that lacuna. Furthermore, it is argued that ICommCs are predisposed to implement a new wave of harmonization of international commercial law, with English common law at the forefront of this effort. Harmonization of international commercial law is argued to be desirable both theoretically, but more importantly, from a practical standpoint of increasing efficiency. Through the perusal of the most recent and prominent examples of ICommCs, it is further posited that these courts, thanks to their jurisdictional reach, procedural laws, bench composition and judgment enforcement are substantially better positioned than domestic courts or arbitral tribunals to effect such harmonization.

Corruption is a current and complex problem with significant effects on trade. For example, at the time of writing the US Justice Department was intervening in a case against a large a pharmaceutical company. It was alleged that the company was responsible for a scheme of drug price increases in the US, as it “ … bribed doctors and their staffs to increase sales.” The price of the drug, addressing infant seizure disorder, had increased 97,000% since the year 2000. Also, many of the affected sales were driven by Medicare reimbursements.1 This case suggests that corruption may:Corruption is also a concern in a global perspective. The UN Secretary-General António Guterres, when addressing the UN Security Council on the issue of corruption in post-war territories, stated that “Corruption robs schools, hospitals and others of vitally needed funds,” with negative effects on people’s rights, foreign investment, and the economy. Based on the World Economic Forum, the cost of corruption is at least $2.6 trillion, or five percent of the global gross domestic product (GDP). According to the World Bank, businesses and individuals pay more than $1 trillion in bribes every year.2 Finally, the Organisation for Economic Co-operation and Development (OECD), through its Clean Government Initiative, has identified at least four negative effects of corruption, namely:The Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP) builds upon international instruments on corruption. It addresses them differently, by adhering to their principles, encouraging their observance, or mandating their ratification or accession. The list of instruments includes (Art. 26.6)

In today’s broader context of resistance to the expansion of international trade, particularly in the United States (with its rejection of the Trans-Pacific Partnership (TPP)) and the United Kingdom (with its rejection of the European Union), the regulatory coherence chapter of the TPP is highly relevant. Its cross-cutting sectoral approach and use of industry-specific annexes to reduce technical or regulatory barriers to trade is likely to serve as the model for all future multilateral trade treaties. Moreover, even though the TPP was rejected by the Trump administration, it later rose as the CPTPP. The United States may still participate in some form. Recently, the United Kingdom expressed an interest in becoming a party. Ambitious trade deals like the TPP sometimes take decades to finalize. In any case, both the substantive provisions and the architectural structure of a highly negotiated free trade agreement (FTA) like the TPP are quite enduring, so the TPP’s regulatory coherence mechanics are likely to re-surface in future FTAs. In other words, the current form of the TPP will serve as a model for any future TPP or similar mega-regional FTA.

Arbitration is a form of administration of justice that is distinguished from that administered by state courts fundamentally in that the basis of the arbitrators’ jurisdiction – at least in the case of voluntary arbitration – is the consent of the parties in dispute.

Philip Jessup’s ground-breaking work Transnational Law (1956) identifies the evolution of law as emerging from a concern with regulation of events confined within national boundaries to events “transcend[ing] national frontiers.” His identification of this new realm of interaction, absent the corresponding existence of a world state, has led to a useful analytic framework for a number of important issues extending Cardozo’s observation that “we must enlarge [law] until it is broad enough to answer to realities.” This framing has important implications for the study of developments in transnational dispute resolution and corresponding questions of adaptation, harmonization and diversity in global practice.

The international harmonization of intellectual property rules has tended on average to strengthen such rights, and to primarily benefit the leaders in international technology markets. The American patent system influenced policies in Britain, France, and such “follower countries” as Germany, Spain, Japan, and China, both individually and through multinational conventions. At the same time, these countries endogenously selected an array of standards and exemptions that varied on the basis of their social and economic needs. Developing countries that resisted exogenous political pressures to wholly harmonize their institutions arguably benefited from, or at least were not necessarily harmed by, their divergent intellectual property cultures. The historical record suggests that intellectual property institutions were most effective when they evolved in accordance with the underlying social and economic fundamentals of each nation.

The Spanish patent system in the twentieth century has been defined by the incorporation of technologies and regulations. Patents have been intermediaries, and their regulation has been subject to complaints, some of which came from abroad. To analyse this reality, I propose two case studies that suggest different patent cultures, subject to specific times and places. The first case, the arrival in Spain of the first North American patents to protect production of penicillins, shows the mediation role patents played. Patents connected practices, languages, and interests from different Spanish and North American professional communities – clinical, industrial, and political – at the end of the 1940s and beginning of the 1950s. The second case, the launch on the market of a Spanish patent for a DNA polymerase, product of research done in a Spanish laboratory and patented in the USA in 1988, shows rather local regulations and the limits on international harmonization. The political, social, and economic changes that protection systems demand differ from one place to another, and do not always coincide with voices calling for harmonization.

Agreements about reciprocal recognition of patent rights between nations were at the heart of discussions at the International Union for the Protection of Industrial Property held in Paris in 1883. Yet while some treat the so-called “Paris Union” as a starting point for the subsequent globalization in patent rights, the context of early attempts at patent law harmonization was international tension and disagreements. Divergences in patent laws have their roots in the strong heterogeneity manifest among national patent systems developing before 1883. The sheer diversity of patent systems available was indeed highlighted by those critics who sought the abolition of patents rights. The project of harmonization should thus be seen as a defensive response to critics of patenting per se, rather than as the advent of a natural process of legislative convergence. In looking at the 1883 Convention in this light, we see that negotiations there can only be understood in terms of a strong rivalry between the French and German models. Such rivalries continued to characterize the membership of the Paris Union even into the interwar period, raising major doubts about whether the project of harmonization could ever be completed.

Across the globe, modern patent laws and their early modern antecedents have served as policy instruments to reward and promote innovation. Best known are the first modern patent regimes in England, France, and the United States along with those systems adopted in the next wave of industrializing nations in Europe. Less examined are those patent systems and patenting cultures in late-developing countries, ranging from Eastern Europe to Latin America and beyond. This chapter examines one of these cases: the emergence of a modern patent system in Mexico between 1890 and 1910. There, new patent institutions drew partly on forms inherited from its colonial Spanish past, but were also shaped by the exigencies of responding to the international economy of the late-century Atlantic world. A partial outlier among other late industrializers, Mexico moved to harmonize its patent system with that of the United States in order to take full advantage of cross-border technology flows.

Expectations of the global harmonization of patent law are commonplace in legal literature. Historical writing on national patent systems, however, reveal their persistent specificities to national economic and cultural needs. These two narratives are not easy to reconcile, and the cessation in 2010 of the World Intellectual Property Office’s efforts to reconcile patent laws suggests that the diversity is the prevalent phenomenon. The reasons for this include the diverse rationales of patents in terms of: the “natural” rights of inventors; the social rewards for useful inventions; investments in the risky future of industrial progress; and the incentives required to encourage inventors to share private knowledge. Compounding this complexity is the way that historically libertarian cultures have privileged the rights of the inventor, whereas cultures cherishing strong government have focused on the needs of the state. While some systems have focused on the importance of novelty, others have focused on the utility of an invention – and not all national Patent Offices are formally required to examine patent applications for such qualities. The resilient diversity of patent systems can thus be understood as part of a multiplicity of contingent “social contracts” of protecting invention that are subject to local more than global forces.