Keen to improve the European Union's economic health, the Irish Presidency is due to carry out surgical operations on modernising rules on clinical trials, legislative proposals on medical devices and revision of the directive on tobacco products.
Against the backdrop of the economic crisis, Dublin has chosen to focus its work on issues that might deliver growth and does not plan to bring forward any Council conclusions in the area of health.
A priority is being placed on reforming rules on clinical trials since this could contribute to creating growth and jobs. The directive in force has been heavily criticised by all stakeholders and is accused of having led to clinical trials moving out of Europe. They fell by 25% between 2007 and 2011 because of a regulatory framework that is too heavy, say critics. The proposed reform aims to remedy this and the draft regulation, which was presented to the 27 EU member states meeting in a working group on 24 July 2012, was well received. The Irish want to come to a general approach at least before July. As far as the European Parliament is concerned, work is only just beginning. Presentation of the draft report is planned to take place at the end of February.
Ireland is due to pursue the discussion on the draft regulation on medical devices and on in vitro diagnostic medical devices, which began under the Cyprus Presidency. This new legal framework, presented on 26 September, is designed to prevent a repeat mammary implant scandal', which had led to the sale of implants produced with adulterated industrial gel instead of normal medical silicon.
Work on revising the directive on tobacco products is due to start without delay after the Commission...