Council of Ministers
Research Council makes progress on Horizon 2020
On 10 October, the 27 research ministers approved the main elements of the regulation setting rules for financing rates for R&D projects eligible for Horozon2020, the future EU research framework programme. The new rules represent a considerable simplification compared with rules in force for the current EU R&D Framework Programme. Ministers amended the financing rates proposed by the Commission, setting the flat rate for reimbursement of indirect costs at 25% (instead of 20%). For direct costs, the reimbursement rate remains 100% for research projects and 70% for close-to-market innovation actions. The agreement allows the Council to start negotiations with Parliament on the Horizon 2020 package as a whole.
The ministers also agreed the launch of six new ‘KICs’ (Knowledge and innovation Communities) between 2014 and 2020, one of which will address innovation for healthy life and active ageing.
For more information: http://www.consilium.europa.eu/press/press-releases/competitiveness-(internal-market,-industry-and-research)?lang=en&BID=88
Ministers agree pharmacovigilance measures
At a Council meeting on 4 October, health ministers agreed the compromise on the new legislative measures aimed at strengthening the EU’s pharmacovigilance system. The new rules concern obligations on marketing authorisation holders in relation to reporting adverse reactions to medicinal products. They also clarify the procedures used by competent authorities to follow up on such reporting. The rules reinforce communication to the public by establishing a list of medicines subject to additional monitoring. Such products will have to be identified (by means of a black symbol to be defined by summer 2013) and the patient information leaflet must contain a detailed summary of the product characteristics. The majority of these measures will be applied within 12 months.
For more information:
http://ec.europa.eu/health/documents/latest_news/midday20121004.pdf
http://europa.eu/rapid/press-release_MEMO-12-737_en.htm?locale=en
