Hanna Schebesta

The European Union Court’s Advocate General’s Opinion and new plant breeding techniques

573 25. Medema, M.H. & Osbourn, A. Nat. Prod. Rep. 33, 951–962 (2016). 26. Yim, G., Wang, W., Thaker, M.N., Tan, S. & Wright, G.D. ACS Infect. Dis. 2, 642–650 (2016). 27. Wink, J. Microbiol. Aust. 32, 81–85 (2011). 23. Blin, K., Medema, M.H., Kottmann, R., Lee, S.Y. & Weber, T. Nucleic Acids Res. 45 D1, D555–D559 (2017). 24. Eisenhaber, B. et al. Methods Mol. Biol. 1415, 477– 506 (2016). product compounds against the bacterial enzyme sortase A was able to identify several hits active with IC50 < 30μM. In summary, we offer several complementary screening approaches to mine the 160K NOL for useful natural substances with a wide range of applications. As the library and its usage opportunities continue to expand, we invite interested academic and industrial parties to explore the BII NOL as a tool for their research and the NPDP for collaborations.

Liability and Automation: Issues and Challenges for Socio-technical Systems

Who is responsible for accidents in highly automated systems? How do we apportion liability among the various participants in complex socio-technical organisations? How can different liability regulations at different levels (supranational, national, local) be harmonized? How do we provide for accountability, while promoting safety? These and other questions are being addressed by the ALIAS (Addressing Liability Impact of Automated Systems) project. In this paper we present the outline framework of the project, its objectives, and some preliminary results: in particular, we present a framework for liability in aviation, an analysis of real accidents and of a hypothetical case involving UAS according to a methodology developed in the project, and finally, we introduce the Legal Case, that is a methodological tool (currently under development) aimed at identifying and addressing liability issues of automated ATM systems.

EU court casts new plant breeding techniques into regulatory limbo

799 To the Editor: We previously published a Correspondence in the June issue of Nature Biotechnology1 discussing the potential implications of the Court of Justice of the European Union (CJEU) Advocate General’s interpretation of how products generated by new plant breeding techniques (NBPTs) would be subject to regulation under European Union (EU; Brussels) law2. At that time, it appeared possible that the EU’s decision to exempt ‘mutagenesis’ from Directive 2001/18/ EC might also apply to all future mutagenic technology, regardless of the use of novel techniques. After the final ruling of the Grand Chamber of the CJEU on 25 July 2018 (ref. 3), it is now clear that that view is wrong. Europe is now on a course to take a much more sweeping and precautionary view of the NBPT products that fall under the remit of the directive than was first suggested by the Advocate General; indeed, only a very narrow set of products generated by conventional mutagenesis are now exempt from EU regulatory oversight. In a sense, the CJEU decision now puts the ball back squarely in the court of European legislators, who must decide whether they want to do nothing—except appease some environmentalists and other lobbyists—or change a European regulatory system that currently regulates mutagenized plant products that are completely indistinguishable from nonregulated mutagenized products. The CJEU decision is that any organism obtained through an NPBT that applies mutagenesis will be classified from now on with a retrospective effect from the day that the directive went into force as a genetically modified organism (GMO) within the scope of the EU court casts new plant breeding techniques into regulatory limbo

Case Study: The Netherlands

This chapter presents public procurement damages claims in the Netherlands, with a particular emphasis on jurisprudential developments. It covers the causes of action, in particular the constitutive criteria for pre-contractual liability and tort law, as well as the justiciability of claims. It further examines the quantification aspects of damages claims, notably the recoverable losses (bid costs, lost profits and the compensation for lost chances) and judges’ quantification methods.

The legal case

This paper presents the first release of the Legal Case, recently developed by the ALIAS Project and still under refinement. The Legal Case is a methodological tool intended to address liability issues of automated ATM systems: it provides for a legal risk management process that can be applied either proactively or retroactively. Used in a proactive way, the Legal Case aims to address the liability issues that may emerge in the design of new technologies. Used in a retroactive way, it is meant to assess liability issues pertaining to an existing piece of technology that has already reached the deployment stage. The Legal Case is mainly designed to be used by a Legal Analyst who is a member of an interdisciplinary project team dealing with the development of new automated technologies (in the case of the proactive approach) or with the accident investigation (in the case of the retroactive approach). Although not yet finalized, the Legal Case methodology is gathering great interest from the ATM community.

Empirical Legal Research - Necessity, Not Opportunity

The article proposes to use software supported content analysis in the legal discipline, because better empirical methods make research findings more scientifically robust, i.e. objective, reproducible and transparent. While there is some consensus on the need for engaging with empirical approaches, the methods to so are largely unexplored. Drawing on mainstream social sciences research, we show the opportunities in using software programmes that allow qualitative analysis with limited quantitative inquiry options for law and circumscribe the specific conditions for using qualitative assessment tools in legal research. The argument is supported by a proof of concept of legal research conducted using the software Atlas.ti. We conclude that qualitative analysis software is both accessible and useful for legal research, but that a specifically legal approach to the use of systematic content analysis is needed to accommodate particularities of the discipline.

Case Study: The United Kingdom

This chapter presents public procurement damages claims in the UK, with a particular emphasis on jurisprudential developments. It covers the relevant causes of action, namely breach of statutory duty, implied contract and public misfeasance, and discusses the justiciability of claims. It further examines the quantification aspects of damages claims, notably the recoverable losses (bid costs, lost profits and the compensation for lost chances) and judges’ quantification methods.

Case Study: Germany

This chapter presents public procurement damages claims in Germany. It covers the causes of action, in particular the constitutive criteria of the specific statutory legal basis §126 GWB, the doctrine of culpa in contrahendo, and general tort law, their respective constitutive criteria and the justiciability of damages claims. It further examines the quantification of damages claims, notably the recoverable losses (bid costs and lost profits) and quantification methods.

Case Study: France

This chapter presents public procurement damages claims in France. It covers the proceedings through which a damages claim can be brought in France, including their personal scope and time limits. The focus of the chapter is on the discussion of the extra-contractual liability of contracting authorities in public procurement as developed in case law. It further examines the quantification of damages claims, notably the recoverable losses (bid costs and lost profits) and quantification methods.

Issue Based Analysis of Public Procurement Damages

This chapter identifies and discusses systemic, institutional and constitutive factors that affect damages claims at the national level. In particular it considers the national policy making sphere, the institutional framework, the determination of the applicable law, various causes of action and the justiciability of public procurement norms (material conditions, standing, and prescription).