The year 2014 was aturning point for transparency in clinical research. Two regulatory innovations comprehensively changed the rules in the EU. For one thing, Regulation (EU) No.536/2014 on clinical trials of medicinal products for human use (Clinical Trials Regulation - CTR) came into force, and for another thing, Policy 0070 of the European Medicines Agency (EMA) on the publication of and access to clinical data was published. While the policy has been occupying the pharmaceutical industry in practice since 2015, the requirements of the CTR came into effect at the end of January 2022.The main innovation of the CTR is public access to the majority of documents and records that are created during the application process as well as during the course and after completion of aclinical trial. The special feature of Policy 0070 is the possibility for EU citizens to inspect the essential parts of amarketing authorisation application, such as the Clinical Study Report.This contribution to the discussion describes the completely new challenges in the area of transparency that the pharmaceutical industry is facing as aresult of the new requirements. In principle, transparency is to be welcomed in order to achieve the goals of the EU in the development and availability of medicines and vaccines. However, the protection of trade and business secrets of the pharmaceutical industry would be jeopardised. In the worst case, this could lead to adecline in investment in research and development within the scope of this regulation and to an international shift of clinical trials, including developing or emerging countries. Germany could lose more and more its leading role in conducting clinical trials in the EU.

AbstractHydropower is one of the oldest power generation technologies and the source of the largest power stations in the world. Despite a phenomenal rise of new renewable generation technologies, hydropower remains responsible for most of the renewable electricity generation around the globe. This chapter explores the economics of power generation from hydro and its advantages as well disadvantages. It describes the characteristics of the three hydropower generation types: run-of-river, hydro storage and pumped storage in detail and provides an outlook on the future role of hydropower in modern energy systems.

The World Trade Organization (WTO), with its tasks of dismantling trade barriers, liberalising international trade and settling trade disputes, has been badly hit. The organisation's 25-year history has led to countries with varying degrees of success despite identical rules. The emerging and industrialised countries who have shown ever stronger protectionist tendencies since the fi nancial crisis of 2008 are among the winners. The Corona crisis has exacerbated these tendencies. Multilateral agreements are becoming more meaningful. It is important for Europe to reduce its structural weaknesses and strengthen its negotiating position vis-a-vis China and the USA.

China is the panda in the room: its extensive foreign investment policy in recent years, whilst only incrementally opening its own internal market, serves as justification and yardstick for investment screening worldwide. But asymmetrical investment policies and the One Belt One Road initiative only provided the trigger for political action in Europe. The EU investment screening mechanism is justified by concerns that are mainly related to public security. This was overdue. However, the procedure set up does not provide sufficient legal certainty, given the various undefined and vague terms, including public order. The cooperation mechanism might therefore, contrary to its laudable intentions, become another element in the ongoing efforts by the EU Commission to politicize investment law, allowing for political horse-trading. It is further argued that economic statecraft demands a clear commitment to the rule of law and to the positive economic aspects of FDI. Investment screening should not become part of the overall negative stance that the EU took relating to investment protection as such. This approach has already undermined the trust of many investors in the integrity of the EU legal system. Attaching new regulatory hurdles to the free flow of capital should serve the purposes of the EU, which include free and fair trade, the integration of legal and economic systems, and a global level playing field.

ABSTRACTTitanium dioxide is a white colourant authorised as food additive E171 in the EU and is applied in a range of food products. Currently the EU specifications for E171 do not refer to the characterisation of particle size distribution; however, this may be requested in the near future. Only a few studies have been published to date reporting data on the size distribution of food grade titanium dioxide. The aim of this study was to characterise the size distribution of titanium dioxide particles contained in eight confectionery products and the pristine titanium dioxide samples used in each of the products. This allowed the direct comparison of the particle size distribution in both the pristine and the extracted materials. By using various analytical techniques, such as transmission electron microscopy, single particle inductively coupled plasma mass spectrometry (sp-ICPMS) and centrifuge liquid sedimentation (CLS) for the characterisation and quantification of the titanium dioxide particle sizes, the impact of the instrumentation on the results was systematically studied. The volume-specific surface area (VSSA) and crystalline structure were also determined for all additives.

Foreign direct investment (FDI) is a key economic driver for both developing and advanced economies. Direct investments promote the transfer of technology and know-how, thereby increasing productivity. German industry, which is heavily export oriented and globally positioned, has always actively sought to invest in foreign markets and attract FDI. This is especially true with regard to China. For more than two decades, China has been a central destination for German FDI. Around the years 2014 and 2015, we witnessed the start of a new era of Chinese companies going global. Since then, Germany has become an important destination for Chinese FDI, mostly in the form of shareholdings or full acquisitions. But if this new era of Chinese outward FDI is to be as successful as the old one of German inward FDI, we need the right framework conditions—not least given political developments in China in recent years. The hope for an alignment of economic systems—the thesis of “change through trade”—has become a distant prospect. Indeed, we are already locked in systemic competition with China. That competition must be taken into account in the current debate on how we conduct our investment relationship with China in the future.

The UK’s withdrawal from the EU will have far-reaching consequences on the European economy. However, the ultimate consequences of Brexit, especially for financial markets, depend on the final agreement, which is still under negotiation. Currently, regulated financial services can be provided across borders under simplified conditions. Without a special agreement, these EU passports cease to apply for business activities between both jurisdictions after Brexit. The EU third-country regimes for non-EEA companies are too few and too unsecure for intensive relations in trade and services. Knowing that London is the leading global financial center, an adequate agreement needs to be found, to ensure affordable and sufficient financial services for business, investors, and consumers. Unfortunately, it appears almost impossible to find solutions for the often contrary interests and various thematic areas in the remaining negotiating period—a no deal scenario becomes more likely. As a result, market participants have started to adapt structures and processes accordingly, by relocating certain functions to the EU27. Nevertheless, it is up to the negotiators to reach an agreement, which achieves the best possible outcome for all affected parties taking into account the opportunity costs of a failure in present Brexit negotiations.

At the outset of the Great Recession emerging in 2007, central banks of major-currency economies have adopted non-standard monetary policies. We examine whether and to what extent these measures pose a challenge to central banking in emerging and small open economies. In particular we assess how global liquidity spillovers caused by major central banks affect the economic dynamics of emerging and small open economies. In this respect, economies which are close to or even at the periphery of major-currency economies are particularly prone to “unbalanced” real exchange rate dynamics. In the short run, corresponding level and volatility effects in key relative prices may endanger financial stability in the recipient country. The long-term effects include a metamorphosis of the anchoring of private-sector inflation expectations into a perilous tightrope act in central banking of these economies.