# \[e-drug\] Unlicensed drug use in European countries (cont'd) **URL:** \ **Category:** e-drug\ **Created:** [January 22, 2000, 7:41am UTC](https://talk.edrugplus.org/t/e-drug-unlicensed-drug-use-in-european-countries-contd/7115 "2000-01-22T07:41:53Z")\ **Posts on this page:** 1\ **Page:** 1
**Author:** ![e-drug2](https://avatars.discourse-cdn.com/v4/letter/e/8dc957/32.png) [@e-drug2](https://talk.edrugplus.org/u/e-drug2)\ **Post date:** [January 22, 2000, 7:41am UTC](https://talk.edrugplus.org/t/e-drug-unlicensed-drug-use-in-european-countries-contd/7115/1 "2000-01-22T07:41:53Z")
E-drug: Unlicensed drug use in European countries (cont'd) --------------------------------------------------------------------------- ------------------ [The below reported action apparently follows a BMJ publication of only 2 weeks ago. The power of science! Should the bill be accepted, it would provide a wonderful opportunity to study the impact of this political intervention on unlicensed and off-label drug use. Distributed as fair use. Hilbrand Haak, E-drug co-moderator] BMJ 2000;320:208 (22 January) MP introduces bill to protect children from unlicensed medicines Gavin Yamey BMJ Andrew Love, Labour MP for Edmonton in north London, introduced a bill in the British parliament last week aimed at reducing the risk to children from unlicensed and untested medicines. The bill aims to strengthen the testing and licensing of medicines for children, giving them the same protection as adults afforded by the 1968 Medicines Act. It has all party support and is backed by the Consumers' Association and the Royal College of Nursing. An early day motion supporting the measure and calling for doctors to give more information to parents on drugs prescribed to their children was signed by over 100 MPs. In a recent Europe-wide survey, 67% of children received drugs prescribed in an unlicensed or "off label" manner (8 January, pp 79-82). In the United Kingdom, the Consumers' Association is concerned about the possibility of underdosing or overdosing of worthwhile treatments, and the underreporting of adverse reactions by doctors using drugs in this way. Mr Love's bill calls for there to be a statutory duty on the government to provide data on the use of medicines in children, particularly on adverse effects. It also recommends that new drugs should be tested on sick children in the context of rigorously designed clinical trials with adequate consent. The bill does not suggest testing drugs that are already in use. Mr Love said: "The lack of a system of proper testing and licensing means that doctors are left to sink or swim with their own knowledge and clinical judgment. A lot of doctors recognise the inadequacies of the system they are working in the dark. At the end of the day, they will get blamed if anything adverse happens." Recent EU guidance suggests that new drugs that are likely to benefit children should be studied in children themselves, though there is little evidence that this guidance is being followed (Br J Clin Pharmacol 1999;48:15-8). In the US, the Food and Drug Administration has offered an incentive to pharmaceutical companies to carry out such studies, which involves a six month extension to the drug patent. Professor Imti Choonara, of the academic division of child health at the University of Nottingham and one of the authors of the European survey, believes that such financial incentives will need to be offered to the European pharmaceutical industry to encourage the testing of new drugs in children. Regarding drugs already in use, Professor Choonara commented: "The only way to get old drugs studied is if the Department of Health and European Union say this is a problem area. The funding will have to come either from introducing a new tax on the pharmaceutical industry, which will be met with resistance, or by putting a portion of the licensing fees into a central fund." The Royal College of Paediatrics and Child Health broadly supports Mr Love's bill, though it is concerned about the proposal to establish trials of new drugs in children who are already ill. A spokesman from the College said: "This could involve having to give placebos, or at the very least a less efficacious treatment, to sick children. The other major concern is precisely how you get consent from a sick child." -- Send mail for the `E-Drug' conference to `e-drug@usa.healthnet.org'. Mail administrative requests to `majordomo@usa.healthnet.org'. For additional assistance, send mail to: `owner-e-drug@usa.healthnet.org'.