Tuesday, 7 January 2014

Heigh-Ho Heigh-Ho, It´s Off To Work We Go!

Best wishes for 2014! That being said it is time to leave behind the holidays' spirit and to update our dear readers on what is going on currently in Brussels. Not much, that's the good news for anyone who took a bit of a break - you didn't miss much. However, just before Christmas on the 20th of December the European Council agreed its position on two relevant for consumer protection draft laws.
 
The first one, concerns a draft directive that is to improve the transparency and comparability of information on fees related to payment accounts. (see our previous post Money, money, money...) Upon the Council establishing its position it will now be time to negotiate this directive's provisions with the Parliament. (Council sets out its position on payment accounts)
 
The second measure is a draft regulation to facilitate and speed up the authorisation procedure of clinical trials. The goal of the EU is to encourage more clinical trials (the number thereof decreased by 25% between 2007 and 2011) while at the same time not giving up the necessary standard of patients safety. The timeline for authorisation of clinical trials is to be set at 60 days, with a tacit agreement having been given if no decision is taken within this time (! - I wonder how this is going to play out if/when the administrative bodies will be overloadedCouncil confirms agreement on clinical trials)
). When a clinical trial requires a substantial modification the decision about it will need to be taken in 49 days (again with tacit agreement rule). One single application will suffice to conduct clinical trials in different Member States. The next step in the adoption of these rules lies with the European Parliament. (

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