Case C-195/14, Teek anne ECLI:EU:C:2015:361, not yet published

The labelling of a foodstuff must not mislead the consumer by giving the impression that a particular ingredient is present, even though it is not in fact present. The list of ingredients may, even though correct and comprehensive, not be capable of correcting sufficiently the consumer's erroneous or misleading impression that stems from such labelling (official headnote)

1. The concept of ‘monomer substances’ in Article 6 (3) of Regulation (EC) No. 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No. 793/93 and Commission Regulation (EC) No. 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC, relates only to reacted monomers which are integrated in polymers (official headnote).

2. Article 6 (3) of Regulation (EC) No. 1907/2006 infringes neither the principle of proportionality nor the principle of equal treatment (author's headnote).

On 17 January 2011, the European Commission launched , a monitoring exercise of patent settlements in the pharmaceutical sector for the second time after the Pharmaceutical sector inquiry of 2009. As was the case for the first monitoring exercise launched in January 2010, a number of pharmaceutical companies were asked to submit copies of their patent settlement agreements concluded in the European Economic Area (EEA), together with any relevant annex, amendment or related agreement.

The rationale for the monitoring exercise derives from some of the findings of the Pharmaceutical Sector Inquiry, which had highlighted the possibility that some of the agreements reached by originators and generics to settle IP-related disputes (generally believed to be efficiency-enhancing tools to save money on litigation costs), may in fact turn out to have anticompetitive effects on the market. This is particularly the case for so-called “reverse payment agreements”. These are settlements that involve a payment (in direct or indirect form) flowing in a direction that intuitively appears “reverse”, as money is paid by the patent holder (the originator) to the alleged infringer – a generic firm.

When reviewing a job application letter, going on a first date, or considering doing business with someone, the first thing many people do is entering the person's name in a search engine. A search engine can point searchers to information that would otherwise have remained obscure. If somebody searched for the name of Spanish lawyer Mario Costeja González, Google showed search results that included a link to a 1998 newspaper announcement implying he had financial troubles at the time. González wanted Google to stop showing those links and started a procedure in Spain. After some legal wrangling, the Spanish Audiencia Nacional (National High Court) asked the Court of Justice of the European Union (CJEU) for advice on the application of the Data Protection Directive, which led to the controversial judgment in Google Spain. In its judgment, the CJEU holds that people, under certain conditions, have the right to have search results for their name delisted. This right can also extend to lawfully published information.

The leak of confidential documents on 2 May 2016 by GreenpeaceNetherlands allows some preliminary conclusions on both the scope and success of the negotiations so far. As regards the pharmaceuticalmarket, the current state of affairs combines the promise of steps forward with the prospect of concerning standstills. This short opinion follows key points emerging from the leaked documents n.9 (“RegulatoryCooperation”) andn.16 (“TacticalState ofPlay”) that are directly relevant to the pharmaceutical market. The themes that will be briefly discussed are, first, the regulatory cooperation mechanisms emerging fromdoc. n.9 in comparison to current cooperation processes in pharmaceutical regulation. The leaked papers suggest positive and commendable (yet far from conclusive) developments towards amore transparent and regulated framework for cooperation, while perpetuating concerns regarding fundamental policy choices and prevalence ofmercantile imperatives over competing public interests.

Professor Lofstedt's article makes an important contribution to the growing scholarship on risk regulation. He focuses on one of Europe's key challenges – how to ensure that European law and regulation is “smart” in the sense that it strikes the right balance between a high level of protection for human health and the environment while not being overly burdensome and enabling us to maintain our competitiveness and standard of living. The EU has taken a leading global role in chemicals regulation, which is welcome. However, as Professor Lofstedt's study clearly illustrates, much work remains to be done to ensure transparency, legal certainty, and sound science-based regulatory outcomes.

The debate around risk versus hazard is an important one. As Professor Lofstedt notes, these are not contradictory concepts, but rather build on each other. Hazard and the intrinsic capacity of a substance to cause harm is the starting point. The debate then centers on to what extent a risk assessment (taking actual or potential exposure into account) should be made before the uses of the substance in question are regulated. Put simply, if there is no exposure, there will be no risk, even when the hazard is high. There are many examples of substances that have known intrinsic hazards, but that pose virtually no risk to human health given how and in what quantities they are used. Ordinary table salt is a well-known example.

A significant reform is currently under the scrutiny of EU institutions in the field of pharmaceutical risk regulation. With its proposal dated July 17th 2012, the Commission seeks to modernise the legal framework of clinical trials by addressing a series of shortcomings ascribed to the current regime governed by Directive 2001/20/EC (to be repealed by the new legislation). The iter of the reform is proving to be complex and lengthy, the first vote having been delayed to March 2014.While a comprehensive account of such a detailed proposal would defeat the scope of this short report, the analysis will focus on some of the most salient features of the proposed regulation, and attempt to situate them in the international context of pharmaceutical regulation.

By taking the EU Cyber Strategy as a case in point, this contribution examines how the distinction between external and internal security in contemporary EU law manifests itself in large-scale risk regulation and in particular, how the EU relies upon external norms to regulate risk. This article also maps the evolution of the rule-making processes themselves.

With the close of another round of United Nations Framework Convention on Climate Change (UNFCCC) treaty talks, this one held in Cancun from November 29–December 10, it is important to look at how green patents fared in the negotiations and the final agreement.

But first, some background is necessary to set the stage for Cancun.

Last year, when I became aware during the run up to the Copenhagen meeting that intellectual property IP) rights were being debated, the first question that popped into my mind was: why are IP rights even on the agenda in the climate change treaty discussions?

To me, IP seemed tangential at best to the problems of shaping policies to mitigate climate change, taking a back seat to a maximum temperature rise target, greenhouse gas emissions targets, carbon taxes, cap and trade, and other policy tools directed relating to climate change.

In the last twenty months, the Obama Administration has been taking an approach to regulation that is distinctive in three ways.

First, we have approached regulatory problems not with dogma or guesswork, but with the best available evidence of how people really behave.

Second, we have used cost-benefit analysis in a highly disciplined way, not to reduce difficult questions to problems of arithmetic, but as a pragmatic tool for cataloguing, assessing, reassessing, and publicizing the human consequences of regulation – and for obtaining public comment on our analysis. This emphasis on human consequences – on reducing or eliminating unjustified burdens on the private sector and on ensuring that high costs are justified by high benefits – is especially important in a period of economic difficulty. We have worked to put into place important safeguards while also making regulation compatible with the economic recovery, and while reducing the risk that costly regulations will have adverse effects on job creation, wages, prices, and economic growth as a whole.

In reviewing two similar cases, the CJEU clarified several essential elements of EU motor insurance law. First, the CJEU clarified the concept of “personal injury” as an insurable risk (another is damage to property) by holding that it also covers non–material damage and the concept of “injured party” by establishing that it also covers the next of kin of a person who died as a result of a road traffic accident. Second, the CJEU affirmed its previous case law that EU Member States are precluded from lowering the minimum insurance coverage as set in the amount of 350 000 euro by EU motor insurance law. In particular, the CJEU found that a Latvian national legal provision which provides fixed insurance redress in the amount of 142 (now 150) euro for non–material damage for the next of kin of a person who died in an accident is incompatible with EU motor insurance law (author's summary).

On 1May 2016,GreenpeaceNetherlands released 248 pages of TTIP negotiating texts stemming from previous negotiating rounds. Although it is not the first (and will not be the last) leak since the inception of the negotiation in 2013, this is the first to reveal the US negotiating position regarding 13 out of the 24 TTIP chapters.

As such, the TTIP leaks provide an unprecedented opportunity to not only analyse the contrasting positions of the EU and US on several issues in the ongoing negotiations, but also to test the veracity of the competing narratives devised by opponents and proponents of the agreement. To what extent do their respective storylines find support in the actual texts?

Supporters of TTIP have proposed fact-checking as an antidote against them is information around TTIP. Yet, having been predominantly advocated and provided for by the EU Commission rather than by the media, institutional fact-checking failed to counter the massive misinformation characterizing the public and political discourse surrounding the negotiations. Unfortunately, when it comes to public perception, the line between pedagogy and propaganda is fuzzy.

Towards the end of 2011, the Responsible Gambling Fund published a report which, inter alia, offers an overview of the research gaps in relation to the comparative effectiveness of gambling regulation. In the present article, the authors of the report provide a summary of the main findings. They conclude that hardly any empirical evidence is available that addresses, directly or indirectly, this subject. In view of further research, a set of recommendations is provided.

In order to secure their fishery products market share in the EU, third countries, especially the developing ones, tend to transplant EU requirements into their domestic legal order. In reality, theses transplanted laws do not correspond to measures to reach a level of protection needed by the country of destination. Based upon the case of Benin, this paper intends to show that when these legal transplants are adversely made, they can in some cases have disastrous effects. It can be argued that an unintended result of EU policy was that it contributed to the collapse of the shrimp industry in Benin. The paper moreover argues that despite the stringency of the EU requirements, the implementation of its control policy might inadequately protect European consumers of shrimp.

In rendering this decision, the Federal Supreme Court of Switzerland entered for the first time into a detailed analysis of questions relating to the cost-effectiveness of human healthcare. The decision, concerned with the availability of a drug for a rare genetic disease, makes it clear that the maximum amount available from a public health insurance provider for the medical treatment in a particular case has been reached once the amount requested by the individual patient cannot also be provided to all other persons in a comparable situation. It remains unclear, however, how cost-effectiveness is to be assessed below this maximum amount (author's headnote).