News In Brief
The EU Council of Ministers has agreed that the EU should work with the Global Alliance for Vaccines and Immunisation to "increase commitments and actions to improve human resources for health in (its) work plans and financing". The pledge comes in a wide-ranging council policy statement on helping international health initiatives.
The EU Council of Ministers has agreed that the EU should work with the Global Alliance for Vaccines and Immunisation to "increase commitments and actions to improve human resources for health in (its) work plans and financing". The pledge comes in a wide-ranging council policy statement on helping international health initiatives.
The World Trade Organisation agreement allowing the waiving of patent rights to allow generic medicine production to tackle health emergencies in developing countries has been written into EU law. The Council of Ministers has approved a regulation that will allow member states to issue compulsory licences telling companies to produce copies of patented medicines for export to "countries in need" without sufficient capacity to produce them. This can take place only under set conditions, for instance that re-exporting cannot take place and that holders of patents for generic drugs can take legal action to protect their rights against such parallel importation.
The European Medicines Agency (EMEA) has released its 2005 annual report, covering its work last year - see http://www.emea.eu.int/pdfs/general/direct/emeaar/AnnualReport2005.pdf
Meanwhile, the European Commission has released detailed guidance on the collection, verification and presentation of adverse reaction reports during medicine clinical trials - see http://pharmacos.eudra.org/F2/pharmacos/docs/Doc2006/04_2006/susar_rev2_2006 _04_11.pdf. And it has published advice on drawing up clinical trials documentation - see http://pharmacos.eudra.org/F2/pharmacos/docs/Doc2006/04_2006/clinical_trial_ qa_april_2006.pdf
Pharmaceutical companies should not gain supplementary protection certificates within the European Union when devising a new means of delivering an old drug, the European Court of Justice has ruled. It rejected Massachusetts Institute of Technology's (MIT) case against the German Patent and Trademark Office, where the Americans called for more protection of the brain tumour drug Gliadel, because it had invented a tiny wafer implant, slowly releasing the medicine into a tumour. The court - unusually opposing its own advocate general - said supplementary certificates could not be issued for a "combination of two substances, only one of which has therapeutic effects of its own".