Delayed legislation on children's medicines will hinder research, says pharmaceutical industry
The UK pharmaceutical industry has criticised the European Commission for delaying new European regulations on the development of medicine for children, saying that this could delay improvements to research and availability of medicines for children. 'Our biggest disappointment relates to the failure of the Commission to recommend a transition period whilst the discussions on the Regulation take place in the Parliament and Council. Companies should be encouraged to develop paediatric data as soon as possible and not have to wait for 18 months or more due to the Parliamentary process. This would definitely benefit the children of Europe and partially alleviate the outcomes of the continuing delays in the introduction of final legislation,' said Dr Richard Tiner, Director of Medicine at the Association of the British Pharmaceutical industry (ABPI). A consultation paper to improve the availability of medicines suitable for children was launched on the Internet by the Commission in March 2002. At the time, Erkki Liikanen, the European Commissioner for Enterprise and the Information Society, stated: 'To get the best and safest treatments for children across Europe, society must strike the right balance between incentives and regulatory obligations. We need to move forward on this important matter to ensure that both existing and new medicines are adapted to paediatric needs in the most resource-efficient manner for society as a whole.' Indeed, research shows that between 50 and 90 per cent of the medicines given to children have never been specifically evaluated for use in that age group. Pharmaceutical companies are often reluctant to invest in developing specific treatment or adapting existing medicines to meet the needs of children because the market for them is relatively small. However, in an enlarged EU, the paediatric population (0-19 years) will represent just over 100 million people. 'This is a vulnerable group with developmental, physiological and psychological differences from adults, which makes age and development related research particularly important' states a Commission report. However, despite launching the consultation process over two years ago, the Commission is unlikely to finalise the proposals for at least another 18 months. ABPI, which supports the need for new legislation to encourage further research, said in a statement: 'This will introduce further delays in the development of paediatric uses for medicines in Europe. [...] We are also disappointed that there will need to be further legislation introduced to promote the Community programme - Medicines Investigation for the Children of Europe (MICE) - as we believe this further delays research into much older medicines which are frequently used in children, and is work that is unlikely to be taken up by the industry.'