Brussels, 09/12/2005 (Agence Europe) - As planned, EU health ministers reached a political agreement on Friday 9 December on the proposal for a regulation concerning paediatric medicines. The text of the common position must now be reviewed by jurist-linguists before it can be formally adopted and forwarded to the European Parliament with a view to its second reading in codecision procedure. On Friday, rumours continue to express concern about the delays that such a procedure could cause, mainly because of the heavy work overload on jurist-linguists at the end of the year. The German health minister, Ulla Schmidt, recalled with the British President, Patricia Hewitt, how important this dossier is for the health of children, and hoped that work would continue at a good rate under Austrian presidency. The text of the common position, adopted with the vote against from Poland, takes up the structure proposed by the Commission and already approved by Parliament during its vote on the report by the French UMP elected member, Françoise Grossetête. The Polish minister, Zbigniew Religa, said he shares the philosophy spelled out in the text but considers that the reward mechanism that it establishes is not in the interest either of Poland's citizens or its budget. At the heart of the mechanism, which institutes an obligation to carry out paediatric tests for the new medicines, appears attribution of a reward in the form of six-month extension of protection for the medicine when the laboratory carries out clinical testing on children with a view to determining the paediatric quality of using such a medicine. The mechanism is controlled by the European Agency for the Evaluation of Medicinal Products (EMEA) with contributions from national agencies. On several points, the Council has re-established the text of the Commission proposal and the initial balance between the rights of innovative laboratories and those of generic medicine producers. It is mainly a matter of time limits that the Parliament had made more favourable for patent holders. The Council was more in favour of transparency in clinical trials in order to avoid pointless duplication on children. It thus introduced a provision that should, during a new request for marketing approval, make it an obligation for laboratories to carry out tests for existing forms and indications of medicines. An additional obligation that could penalise the larger laboratories.
The Health Council also focused on mental health - after a presentation by Commissioner Markos Kyprianou of the Green Paper just adopted by the Commission on this subject and after having devoted most of the morning to Member States' preparedness to face up to a flu pandemic. The debate showed health ministers agreed with the principle of creating a Community stock of antiviral medicine. In the Presidency conclusions, ministers take a stance in favour of a feasibility study on various options including the creation of this strategic Community stock to provide a rapid response in the event of a flu pandemic. The text also calls on Member States to improve their state of preparedness and on the Commission to pursue the work of coordination. It stresses the progress that has still to be made to increase vaccine production capacity. The text, which could not be approved in the form of the Council conclusions due to the insistence of Italian Minister Francesco Storace to have it include the fact that poultry meat could be consumed without risk, the British Presidency and the Commission considered that this was not the appropriate place for such a declaration.