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Focus on Regulation

Tag Archives: knowledge

No limits..? The limitation rules for cartel (damages) claims after the 9th reform of the German Competition Act (ARC)

At first glance, not a stone seems to be left standing. The new sec. 33h ARC hardly bears any resemblance with the old sec. 33 para. 5 ARC, the to date only special limitation rule applicable to cartel damages claims in the ARC. What appears tremendous – the new sec. 33h ARC comprises eight paragraphs in total – proves also on closer consideration quite far-reaching – even though perhaps not quite as far-reaching as the multiplication of the number of paragraphs by eight may suggest. The extension of the provision text is to a large extent due to the fact that a comprehensive special limitation regime for cartel (damages) claims has been introduced into the ARC which, while primarily meant to transpose the special requirements stemming from the cartel damages directive 2014/104/EU into national law, largely reconstructs the general limitation rules as contained in the German Civil Code previously applicable to cartel (damages) claims. In that regard, the German legislator aimed at attaining consistency with the general limitation rules, and quite successfully at that. As a result, the differences are in many ways hidden in the details – which by no means is to say that they weren’t fundamental. Apart from that, the newly introduced sec. 33h ARC brings some real novelties. One thing, however, is common to (almost) all changes: they strengthen private enforcement by cartel victims.

KNOWLEDGE ALONE ≠ INTENT: FDA Proposes To Trim One Basis for Determining “Intended Use” of Drugs and Devices

Last week, the U.S. Food and Drug Administration (FDA) published a proposed rule, 80 Fed. Reg. 57756 (Sept. 25, 2015), that at first blush is devoted to clarifying when a tobacco product may be subject to FDA’s regulation as a drug, device, or combination product vs. a tobacco product.  Slipped within this proposed rule, however,