With the adoption of the C-17 bill (Vanessa’s Law), the Government of Canada took a major step towards the creation of reforms to the drug safety system. However, major challenges remain. Because they are old and often produced generically, many drugs we use every day have never been tested in children, thus doctors have little safety or efficacy data to guide prescribing.

This leads to a great deal of over- and under-dosing of kids. An important opportunity exists for the Federal Government to support Bill C-17 and ensure that medicines are tested for safety in children prior to use.

In alignment with European Union and USA legislation, the initiative we propose: KIDSCAN, will have a major impact across the whole Canadian child health sector, for patients and families as well as the pharmaceutical industry.

Critical issues around the development of better medicines for children have been reviewed in a recent report by the Council of Canadian Academies (CCA) which concludes:

  • Children take medications, many of which have not been proven safe and effective for their use.
  • Children respond to medications differently from adults; thus, medicines must be studied in children and formulated for children.
  • Studying medicines in children is always possible and in their best interests.
  • In the United States and the European Union, pediatric medicines research is encouraged, required and monitored in ways that offer lessons for Canada.
  • Pediatric medicines research is a Canadian strength, but it requires reinforcement and sustained capacity and infrastructure to realize its full potential.

We propose the creation of KIDSCAN, a national hub to coordinate research, training and knowledge transfer in the safe therapeutic use of medicines for children. KIDSCAN will address the guiding questions raised by the CCA report.

By federating all Academic Child Health Centres and their affiliated Research Institutes, KIDSCAN will encourage new processes and practices, new policy approaches and new ways of organizing care for children with the seminal goal to improve drug safety. It will catalyze the development of new research methods and new knowledge transfer tools and will foster collaboration among patients, families, child healthcare institutions, researchers, educators and regulators.

“Children take medications, many of which have not been proven safe and effective for their use.”

KIDSCAN will ultimately result in improved medication safety, better outcomes, and more efficient use of healthcare services. Successful examples of such initiatives in other jurisdictions (UK, EU, and USA) have shown that central support and coordination of applied pediatric clinical practice and knowledge transfer activities result in major benefits in quality and safety of care, accurate and complete labeling of therapeutic products for children, health outcomes based on appropriate knowledge transfer and application of evidence from exemplary clinical trials, satisfaction from patients and families related to improved patient experience, and supportive engagement of parents.

The Canadian Child and Youth Health Coalition — the umbrella of ten national organizations including the Canadian Association of Pediatric Health Centres, the Canadian Family Advisory Network, the Council of Canadian Child Health Research and the Canadian Paediatric Society — has endorsed KIDSCAN and made it its priority for 2015.

The time has come for Canada to join its international counterparts in facilitating studies to increase the availability of medicines authorized for use in children.