EFA

The use of unlicensed and off-label medicine for children is widespread and it has been of increasing concern in recent years. In the EU, fifty per cent or more of medicines used for children have never been actually studied in this population. The EU Pediatric Medicines Initiative was initiated 2000. A resolution was adopted by the European Parliament on 07 September 2005 on the proposal for a regulation of the European Parliament and of the Council on Medicinal Products for Pediatric Use (you may recall the joint EFA/European Academy of Allergology and Clinical Immunology (EAACI) Position Paper on the Consultation on draft proposal by the Commission of the regulation in April 2004). The main point of debate involved the best way to give incentives to pharmaceutical companies to invest more money in pediatric medicine. The Commission proposed that companies should have an extra six months of protection under existing patents. A number of Members wanted to have a shorter additional period or one, which depended on the size of the company. The proposal has yet to be read by the European Council and we will keep you informed. Source: European Parliament Legislation Observatory For more information, visit the EU Pediatric Medicines Initiative website.