Go-ahead for child drugs law

By Anna McLauchlin

Date: 24/05/06

MEPs are set to sign off a law aiming to increase the development of medicines for use in children, paving the way for its entry into force across the EU by the end of this year.

The regulation will establish a paediatric committee at the European Medicines Agency and increase safety-monitoring for children's medicines.

A controversial aspect of the regulation that will not be changed in the second-reading vote on 1 June is that pharmaceutical firms that carry out paediatric tests on drugs will be rewarded by a six-month extension to the length of patent protection.

A new amendment that would extend the actual patent by six months as well as the data protection was rejected by MEPs in the environment committee's vote on 4 May.

Manufacturers of generic drugs, already angry at the extension, which they claimed would add 2 billion euro annually to EU healthcare costs, are disappointed by another amendment that will give drug firms an extra 18 months to apply for the patent extension.

The Commission wanted companies to apply for the extension at least two years before the patent is to expire, but the Parliament's drafts-woman, French centre-right member Françoise Grossetête, cut this to six months in order to cover more products.

Both the Commission and the Council of Ministers rejected this amendment when it was narrowly backed at first reading by MEPs. But the EU executive and member states have now changed their minds.

"The generics industry is concerned that if products are suddenly subject to a six-month extension it will seriously disrupt their planning, as well as making it difficult for hospitals to manage their budgets," said Nadene McClay of the European Generics Association.

But the association is hopeful that a review planned after five years will highlight the disproportionate cost burden of the new legislation, McClay said. "The generics industry is looking forward to that," she added.

The European Federation of Pharmaceutical Industries Associations (EFPIA) welcomed the text. "The proposed measures should allow Europe to reclaim a central role in innovative drug development and catch up with other world regions where paediatric research has been given effective means to meet the needs of the paediatric population," a spokesman said.

The law will become binding once it is approved by the Council of Ministers, probably in October, and published in the Official Journal.

Article reports that Members of the European Parliament were expected to give their consent to a law aiming to increase the development of medicines for use in children, paving the way for its entry into force across the EU by the end of 2006. The Regulation would establish a paediatric committee at the European Medicines Agency and increase safety-monitoring for children's medicines.