Industry concern as Commission promotes paediatric blueprint

By Peter Chapman

Date: 16/09/04

DRUGS giants are worried that a European Commission proposal to boost the development of medicine for children could stall their efforts to get new products approved for use by adults.

Olli Rehn, the commissioner for industry, is expected to unveil the blueprint in two weeks' time - ending years of wrangling between interest groups and policymakers on the ideal formula.

Under the plan, drugs companies would be awarded an extra six months of intellectual property protection for their existing medicines if they develop and test a new "indication" of that drug for children.

The regulation would also oblige pharmaceuticals firms to present the results of clinical trials on new drugs at the same time as they forward adult test data to the European Medicines Agency (EMEA), when they seek approval for marketing their products on the EU market.

The process is meant to ensure that doctors know the effects the drugs have on children and the correct doses to apply as soon as the drugs are put on the market.

Michael Mann, spokesman for Rehn, said this clinical trials results requirement could be relaxed on the advice of EMEA's paediatric board, a group comprising national drugs experts.

In theory a referral could be granted if the board believes the testing process would slow down the approval of the drugs for adults.

For example, the board might conclude that the safety of children would be at risk if the trials were carried out too soon in the process - before the effects of the drugs on adults had been properly studied.

Industry usually tests new products on consenting 25-35-year-old adults several years before turning their attention to children.

This allows them to learn about any unexpected side effects before they conduct tests on paediatric patients.

However, drugs companies said they fear the paediatric board may take too strict an approach, ignoring the ethical and practical constraints faced by the industry in conducting trials on children.

In reality, they say, this could lead to delays in winning approval for their products, despite the Commission's best intentions.

"We are not happy with it at all. Under the proposals the paediatric board would be all powerful," said Louis-Nicolas Fortin, a legal expert with the European Federation of Pharmaceuticals Industries and Associations.

"It may be a nightmare," he added.

Experts say the proposed EU regime is similar to one in place at the US Federal Drugs Administration.

But in private, drugs companies say the crucial difference is the business-friendly approach taken by US bureaucracy.

"It is not so much a difference in the law. The difference is the climate in the US is pro-fast access and pro industry. In Europe, people think the paediatric board will ask for unrealistic things - the climate has got so bad," said an executive at Swiss firm Novartis.

Drugs companies are worried that a European Commission proposal to boost the development of medicine for children could stall their efforts to get new products approved for use by adults. Under the plan, drugs companies would be awarded an extra six months of intellectual property protection for their existing medicines if they develop and test a new 'indication' of that drug for children.