QUESTION PERIOD — Pediatric Health Care
Senator Gold, as of February 26, Health Canada is running a pilot for the next two years where they will accept pediatric data that manufacturers already have available and are already submitting to the European Union and to the United States. This will, in Health Canada’s words, increase access to safety, efficacy and quality information in pediatric populations and align them with international standards. Indeed, this policy should lead to a significant reduction of the 80% off-label drugs that are being used in pediatric care right now.
Health Canada is to be congratulated for making this move after two decades of lobbying from both myself and pediatric leaders across this country. Nevertheless, the devil is in the details. Senator Gold, what will be the indicators that Health Canada will use to examine whether or not this pilot is a success?
Thank you for your question. Indeed, Health Canada is taking these steps to increase the availability of data that will help our health care providers make the important decisions to which you alluded.
I do not have information about the specific indicators that will be used, but I can share with you, colleagues, the basic objectives of the pilot program. They are to encourage sponsors to submit, in a timely manner, the safety and efficacy information for drugs expected to be used in pediatric populations; and to provide more information on the safety, effectiveness and dosage of drugs used in pediatric populations to the health care providers, the patients and their families, all with an eye toward informing and improving future policy developments.
Senator Gold, will Health Canada, to your knowledge, commit to publishing data on the performance of the pilot at regular intervals so that Canadians and medical practitioners can see and understand how the pilot is progressing?