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The recent EU Directive on nonfinancial information (NFI) disclosure allows Member States some discretion regarding its implementation. More specifically, it allows countries to decide whether: (a) information assurance is compulsory; (b) companies can waive NFI disclosure because of possible competitive harms (safe harbor); and (c) fines can be imposed on companies not disclosing NFI. We empirically test the impact of different implementation strategies on NFI quantity and quality, and we find that regulations providing incentives ('carrots') are more effective than regulations imposing costs ('sticks'). More specifically, while mandatory assurance and safe harbor have a positive impact on NFI quantity, fines do not. Our results contribute to the literature on NFI disclosure and inform regulators on the effectiveness of different implementation strategies. [ABSTRACT FROM AUTHOR]

We present new evidence about the relationship between military conflict and city population growth in Europe from the fall of Charlemagne's empire to the start of the Industrial Revolution. Military conflict was a main feature of European history. We argue that cities were safe harbors from conflict threats. To test this argument, we construct a novel database that geocodes the locations of more than 800 conflicts between 800 and 1799. We find a significant, positive, and robust relationship that runs from conflict exposure to city population growth. Our analysis suggests that military conflict played a key role in the rise of urban Europe. [ABSTRACT FROM AUTHOR]

Both in the United States and in Europe, the patent laws contain a so-called Bolar provision, which provides safe harbor from patent infringement for certain activities related to obtaining marketing authorization for a drug product, whether it is a small molecule or a biologic drug. Recent court decisions and legislative initiatives on both sides of the Atlantic affect the drug safe harbor and invite a critical analysis of the Bolar provisions in the various jurisdictions.The safe harbor provision in the US differs significantly in scope from the safe harbor provision in the relevant EU Directive, and the national implementations of the EU Directive in individual member countries of the EU again differ significantly from each other. Main differences relate to the question whether the safe harbor extends to activities related to obtaining marketing approval for a new innovative drug, for a medical device, or for a drug outside of the respective jurisdiction, or to post-marketing approval activities. Unresolved questions regarding the scope of the Bolar provisions remain, and there seem to be distinct, in part opposing, trends. The recent Agreement on a Unified Patent Court (UPC) adds additional complexity to the drug safe harbor in the EU.The discussed issues affect drug or medical device companies’ decisions on aspects of patent infringement litigation strategy and the best location for pre- and post-marketing approval activities. Differences relating to safe harbor for post-marketing approval manufacturing and testing are of particular relevance for the emerging biosimilars industry. [ABSTRACT FROM AUTHOR]

Focuses on the international data protection compliance within the European Economic Area (EEA). Legal options for businesses wanting to transfer data outside the EEA; Provision of the standard contractual clauses for the transfer of personal data to third countries under Directive 95/46/EC; Principles of safe harbor that organizations must adhere to in order to continue to process personal data provided by the U.S. law.