By Evelyn Ring
THE State’s drug policing body has welcomed plans for EU legislation next year that will result in drugs for children being tested before they go on the market.
The Irish Medicines Board (IMB) was responding to a British study that found that nine out of 10 medicines used on newborn babies have not been tested properly. The report also warns that around half of all prescription and over-the-counter drugs given to under-18s have not been put through suitable trials.
"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," the House of Lords select committee report said.
An IMB spokeswoman pointed out that between five and 10 clinical trials are carried out on children between the ages of two and 11 in Ireland every year. Such trials are approved by the IMB in consultation with hospitals’ ethics committees. It is understood that most of the trials are for cancer drugs.
New EU legislation, expected to become law next year, is being prepared for children’s medicines that would provide incentives for drug testing on children.
The proposed legislation will make it mandatory for drug companies to conduct clinical trials on children before a drug goes on the market. It will also require the companies to conduct trials on children before applying for a licence for drugs currently on the market in return for a lucrative six-month extension to their 20-year patent.
Most drug manufacturers are reluctant to carry out these trials because they cost on average an extra €3.97 million per product.
The IMB, which was involved in the initial drafting of the proposed legislation on medical products for children, has welcomed the planned measures.
"The fact that this legislation will stimulate paediatric clinical trials that will result in the provision of medicines that are geared specifically towards children will be of benefit to them," the spokeswoman said.
Some of the prescribed quantities are worked according to body mass but this is not considered the best method of calculating children’s doses.
The requirement for new drugs to be studied in children became law in the US in 2003 and since then the Food and Drug Authority has requested almost 700 studies. It is estimated about 70% of children and 90% of newborn babies in intensive care units will be given at least one unlicensed or ‘off-label’ medicine. Off-label use is when a drug is prescribed at a different dose or frequency, in a different age group or for a different condition than that recommended by the pharmaceutical company. The practice, which is not wrong or illegal, continues because there is no alternative and doctors know that the drugs are needed.