EU news in brief
- The EU Council of Ministers has supported in principle the funding of an Innovative Medicines Initiative (IMI) joint technology initiative from next year. They accepted that it should be a private-public consortium, able to spend e1bn of EU funds over 10 years. Following detailed final preparations, the formal go-ahead is expected in November (www.imi-europe.org).
- The EU Council of Ministers has supported in principle the funding of an Innovative Medicines Initiative (IMI) joint technology initiative from next year. They accepted that it should be a private-public consortium, able to spend e1bn of EU funds over 10 years. Following detailed final preparations, the formal go-ahead is expected in November (www.imi-europe.org).
- After postponing its vote three times, the European Parliament has finally approved the EU's acceptance of the WTO liberalisation agreement regarding generic medicine licensing for developing countries. "This is an historic victory and an extraordinary advance for the European Parliament," said Erika Mann, its socialist group spokesperson on trade policy.
- The ECJ has censured the Czech Republic and Ireland for failing to implement key recent EU regulations controlling the approval and testing of pharmaceuticals. The Czechs were found by the court to have failed to implement EU directive 2004/27/EC on the EU code relating to medicinal products for human use; and 2005/28/EC laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use. Meanwhile, the Ireland has failed to implement directive 2004/27/EC, said the court, which can order member states to comply with EU law, and levy fines if they do not obey.
- The European Medicines Agency (EMEA) has collated and published information on refusals of applications for pharmaceutical marketing authorisations within the EU (www.emea.europa.eu/htms/human/refusals/background.htm).
- EMEA has also published procedures for the co-ordination, preparation, conduct and reporting of good clinical practice inspections under EU centralised procedures (www.emea.europa.eu/Inspections/GCPproc.html).
- And it has released a guideline on the development of medicinal products for the treatment of post-traumatic stress disorder (www.emea.europa.eu/pdfs/human/ewp/35865006endraft.pdf
- Meanwhile, the European Commission has issued a report on current practice with regard to provision of information to patients on medicinal products (http://ec.europa.eu/enterprise/pharmaceuticals/pharmacos/docs/doc2007/2007_10/d-34327-summary-of-consultation-responses.pdf).