Pharmaceuticals, Regulation: Commission prescribes remedy to make medicine easier to swallow for children
The European Commission has proposed new legislation to encourage drug firms to produce more medicines designed specifically for children, addressing the dearth of such medication in the market.
More than half the medicines used to treat children in the European Union were not designed specifically for them, and have never been tested or authorised for use by them. This alarming situation means that when doctors writes prescriptions for children, they cannot always be sure the medicine will be truly effective.
One reason for this is the lack of market incentives for developing medicines for kids. Another is the difficulty and potential risk of testing new drugs on children. The Commission’s new draft regulation – officially launched on 29 September 2004 – aims to lure pharmaceutical companies into pumping more resources into research in this field so as to boost the availability of such drugs.
“[This] proposal is a good example of the Commission actively working to improve life for European citizens,” observed acting Enterprise Commissioner Olli Rehn. Industry has reacted positively to the draft legislation. “The adoption of an EU legislative framework is an opportunity to improve public health and strengthen Europe's science base,” said Brian Ager, director-general of the European Federation of Pharmaceutical Industries and Associations (EFPIA).
To encourage pharmaceutical firms to make the necessary investments, the draft legislation proposes such incentives as patent extensions, ten-year data protection for the innovative use of off-paten drugs for paediatric purposes.
The United States already has similar legislation in place. However, the US regulation has drawn criticism for giving pharma companies a route to gaining extra patent protection for their drugs – even if their use in children is questionable. The Commission maintains that its initiative would avoid this, while rewarding companies for developing medicines that were safe and effective in children.
“I believe that our proposal achieves the right balance between these objectives and the need to strengthen the competitiveness of the pharmaceutical industry,” Mr Rehn noted. One way of ensuring that no one plays the system, the Commission proposes, is through the creation of a new expert committee within the European Medicines Agency which will be assigned the task of checking companies’ testing plans.
The Commission’s proposal has an important proviso – medicines for children should be developed and authorised without requiring unnecessary clinical trials in children and without delaying the authorisation of medicines for adults. The Commission also calls for the establishment of an EU paediatric study programme to fund research leading to an increase in the availability of off-patent products.
The proposed legislation could become law by 2006, but it must first receive the endorsement of the European Parliament and the Council of Ministers.
Source: EU sources
Commission press release