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Health Claims: CJEU confirms a claim can be refused on grounds of generally accepted nutrition and health principles despite scientific substantiation (Bird & Bird)

On 8 June 2017, the Court of Justice of the European Union (“CJEU”) confirmed that a number of health claims relating to glucose could not be authorised, even after having been found scientifically substantiated by the European Food Safety Authority (“EFSA”) [Case C-296/16 P]. The CJEU decision puts an end

2017-08-15T20:51:49+00:00 21 juni 2017|Categories: Pharma & lifesciences|Tags: , , , |

PSD2 and draft EBA RTS: a lot of issues remain unclear… (Bird & Bird)

PSD2 (i.e. the revision of the EEA Payment Services Directive, to be implemented within the laws of the EEA Members States by 13 January 2018 for most – but not all – of its provisions) raises a lot of questions of legal interpretation. Some of these questions have been answered

2017-05-10T14:06:00+00:00 10 mei 2017|Categories: Financieel recht|Tags: , , , |

Europese uitspraak over kosten van klantenservice. Duidelijkheid over maximale kosten (Bird & Bird)

Het Europese Hof van Justitie heeft op 2 maart 2017 een belangrijke uitspraak gedaan over de kosten van klantenservice. In deze uitspraak is bepaald dat de kosten van een oproep over een gesloten overeenkomst naar een door een handelaar opengestelde servicelijn niet meer mogen bedragen dan de kosten van een oproep

2017-03-09T13:26:27+00:00 9 maart 2017|Categories: Handelsrecht|Tags: , , |

Brexit: Competition law implications (Bird & Bird)

The full effects of Brexit in the field of competition enforcement will take some time to emerge.  There will be an immediate risk of parallel investigations in both antitrust and merger fields, with an increased burden to businesses as well as some risk of inconsistent outcomes, although EU case-law is

2017-02-10T07:35:52+00:00 10 februari 2017|Categories: Mededingingsrecht en antitrust|Tags: , , , , |

White Paper on Medical Devices & In Vitro Diagnostic Medical Devices Reform (Bird & Bird)

While many of the details of the Regulations remain to be decided via so-called secondary legislation, either through delegated or implementing acts, it is important for industry to already be aware of the challenges which may lie ahead. The timely adoption of these acts will be crucial to allow adequate

2017-02-09T11:42:14+00:00 9 februari 2017|Categories: Pharma & lifesciences|Tags: , |

Pharmaceutical companies outsourcing clinical trials to group companies may pay substantially more taxes (Bird & Bird)

A patent or innovation box is a type of tax incentive in the form of an exemption, deduction or reduced corporate income tax rate for certain income arising from the exploitation of IP. In most countries, the IP was limited to patents (hence, the “patent box”), but some countries also

Recent changes to the Orphan Drug guidelines (Bird & Bird)

The EU’s regulatory framework for orphan drugs is set out in Regulation (EC) No.141/2000 (the “Orphan Drug Regulation”, or ODR) and implementing Regulation (EC) No. 847/2000, and has been in force for a while now with relatively few changes. However, in recent years, a number of issues which challenge the

2017-01-11T08:49:22+00:00 11 januari 2017|Categories: Pharma & lifesciences|Tags: , , |

European Commission cracks down on codeshare agreement between TAP and Brussels Airlines (Bird & Bird)

The European Commission has announced that it has sent a so-called statement of objections (SO) to TAP and Brussels Airlines setting out its concerns that the codeshare arrangement between the two airlines infringes Article 101 of the Treaty on the Functioning of the European Union, which prohibits restrictive practices between

2016-12-28T13:29:19+00:00 28 december 2016|Categories: Mededingingsrecht en antitrust|Tags: , , |