Embargo: 00:01 Thursday 2nd February 2006

Contact: Owen Williams 020 7219 8659


90% of the medicines used to treat newly born babies have not been tested to ensure their appropriateness and 50% of all medicines given to children of all ages are similarly untested.

These figures are highlighted in a House of Lords report published today on the European Commission's proposals for paediatric medicines.

The report by the Lords EU Sub-Committee on Social Policy and Consumer Affairs, praises the Commission for attempting to set up common EU-wide procedure for testing and approving medicines for use in children and incentives to encourage manufacturers to develop or adapt medicines specifically for children.

Baroness Thomas of Walliswood, Chair of the Committee, said:

"We are pleased that the European Commission has taken the lead on this important issue. It is worrying that so many of the medicinal products used by our children have not been properly tested to ensure the appropriateness of their use.

"Children are not simply small adults and it cannot be right that 90% of the medication given to new born babies has only ever been tested on adults. This will be a concern for all parents.

"We were satisfied that the basic framework proposed by the Commission was right and gave the Government the go-ahead to accept them, which they have done. But a lot of care has to be given to the guidelines that will be needed to carry out the procedures for testing and authorising drugs to make sure that ethical considerations are fully considered and clearly explained. The Government has promised to give us progress reports on this.

"While we accept that incentives are needed to encourage pharmaceutical companies to develop drugs specifically for children. The arrangements proposed are based on a system that seems to work well in the USA and is accepted by most professionals here. We've recommended that they should be rigorously examined in a few years' time to make sure they are working properly, giving drug companies fair rewards for their R&D, but ensuring that the cost to the NHS and the health services of other Member States is reasonable."

Conclusions of the report include:

  • Too many children's prescriptions and over-the-counter drugs have not been properly tested on children prior to launch.

  • Children are not simply small adults and their medication should not be treated as if they were. There is an overwhelming and urgent need to take action at a European level to promote and govern clinical trials of medicines on children.

  • Guidelines covering medical trials must take into account the vulnerability of children. They will need to consider ethical issues around consent to trials by children, the effects of different drugs on children of different ages and access to research databases.  

  • Medical products should be properly labelled to indicate their suitability for Children

  • It is impossible to judge at this stage how well the incentives designed to stimulate the development of drugs for children will work. The Government must press the Commission to carry out a full economic review of the incentive arrangements after a few years of operation. 

Notes to Editors     

1. The members of the European Union Sub-Committee G (Social Policy and Consumer Affairs) who conducted the inquiry were:

Baroness Thomas of Walliswood

Lord Colwyn

Earl of Dundee

Baroness Gale

Baroness Greengross

Lord Harrison

Baroness Howarth of Breckland

Baroness Massey of Darwin

Lord Moser

Baroness Neuberger

Lord Trefgarne

2. The report is published by The Stationary Office: Paediatric Medicines: Proposed EU Regulation, House of Lords, EU Sub-Committee on Social Policy and Consumer Affairs, 20th report of session 2005/06, HL paper 101, ISBN 010 400809 1, Price £15.50

3. The full report will available shortly after publication on the internet at:

4. The Committee received evidence from a wide variety of sources including the British Medical Association, Professor Sir Cyril Chantler, Chairman of Great Ormond Street Children's Hospital and The Royal College of Paediatrics and Child Health.

5. The report is a response to EU Commission Proposals for a Regulation on Medicinal Products for Paediatric Use.

For copies of the report or to request an interview with Baroness Thomas on either Wednesday 1st February (under embargo) or on Thursday 2nd please contact: Owen Williams, Press and Publicity Officer (Committees) on 020 7219 8659.