Therapeutic Products for Children

The Minister of Health, on behalf of Health Canada, has asked the Council of Canadian Academies to provide an evidence-based and authoritative assessment on the state of therapeutic products for children, in Canada and abroad. This assessment will be relevant to the ethical development of safe and effective pharmaceuticals and biologics labeled as therapies for infants, children and youth.

Progress Report

The Expert Panel on Therapeutic Products for Infants, Children, and Youth held its second meeting on February 19-20 in Ottawa. A report outline was established, and a first draft of the report will be prepared for the Panel’s third meeting, scheduled for July 11-12.

Background

In the past, it was assumed that the pharmacological effects of drugs on children were similar to the effects on adults. Treatment decisions on how to use drugs in infants, children and adolescents were drawn from available adult drug study data. However, research has since shown that with age there are physiological changes in the functioning of tissues and organ systems. As a result, developing safe and effective drug therapies for the youngest age groups presents a particular challenge. The majority (up to 75 per cent) of drugs used to treat infants, children and adolescents have not been systematically evaluated by drug manufacturers[i].

Due to this science data gap, infants, children and adolescents are at higher risk than adults of experiencing an adverse drug event, which is an unintended or unwanted event linked to the use of drugs[ii].

Once complete, the Council’s expert panel assessment will provide an in-depth and authoritative report of the state of knowledge regarding the relationship between clinical pharmacology and the current understanding of the human developmental process to inform pediatric drug investigations.

The full assessment process is expected to take 18 to 24 months and will include a rigorous peer review exercise to ensure the report is objective, balanced and evidence-based. Following the review and approval of the completed assessment by the Council’s Board of Governors, the full report will be made available on the Council’s website in both official languages. More information about the Council’s process can be found here.

Question

What is the state of clinical pharmacology, in Canada and abroad, that can be applied to the ethical development of safe and effective pharmaceuticals and biologics labeled as therapies for infants, children and youth?

Expert Panel

The Expert Panel on the State of Therapeutic Products for Children is chaired by Dr. Stuart MacLeod, Professor of pediatrics at the University of British Columbia in Vancouver.  For a complete list of panel members visit the Expert Panel on the State of Therapeutic Products for Children page.

For further information, please contact:

Andrew Taylor, Program Director at 613-567-5000 ext. 263 or andrew.taylor@scienceadvice.ca

[i] Rieder, Michael J. Drug research and treatment for children in Canada: A challenge, Canadian Pediatric Society  http://www.cps.ca/english/statements/DT/DT11-01.htm

[ii] Canadian Pediatric Society, http://www.cps.ca/English/surveillance/cpsp/Resources/ADR.htm