Child Health Policy Accelerator 

Policy Objective

To ensure that regulatory protections for all nicotine-containing products, including those regulated under both the Food and Drugs Act (FDA) and the Tobacco and Vaping Products Act (TVPA), reflect global best practices in limiting youth exposure and addiction.

Background

Canada’s first synthetic nicotine pouch was approved in 2023 under the Natural Health Product (NHP) regulations of the Food and Drugs Act. As an NHP, the product was not subject to key safeguards—such as restrictions on point of sale, age of sale, advertising, and promotion—that apply to cigarettes and e-cigarettes regulated under the Tobacco and Vaping Products Act (TVPA). Recognizing the significant risk to young people, the Child Health Policy Accelerator successfully advocated for a federal Ministerial order to act as a stop-gap measure, preventing youth access to synthetic nicotine pouches. However, this action was a temporary stop-gap measure. Industry pressure to reverse the expanded regulatory authority is mounting, and a coordinated, evidence-informed advocacy campaign is urgently needed to ensure these protections are made permanent.
This work has been undertaken—and will continue—in close coalition with leading national health charities. Together, we are committed to ensuring that all effective federal strategies to reduce youth exposure to, and addiction from, nicotine-containing products are fully implemented.

Policy Objective

To advance comprehensive, child-focused federal online safety legislation that establishes an independent online safety regulator with strong enforcement powers and a clear mandate to address both content-related and design-based harms to young people associated with online platforms.

Background

Despite mounting evidence of harm, Canada continues to lag behind leading jurisdictions in protecting children online—a striking and unacceptable public policy faliure. At least 20% of Canadian children report experiencing negative impacts from online activity. These self-reported harms include compulsive internet use, feelings of decreased self-worth, body dysmorphia, engagement in self-harming behaviours, and cybervictimization. Younger children also experience harms unique to their developing brains, including emotional and behavioural dysregulation and impairment in acquisition of essential social skills.

Unlike other areas of children’s lives—such as television advertising or food labeling, both of which are governed by child-specific regulatory frameworks—Canada lacks comprehensive legislation aimed at safeguarding young people in digital environments. In contrast, leading jurisdictions have robust meaningful legislative and regulatory frameworks to keep children safe online.

Digital platforms that host user-uploaded content must not be allowed to facilitate or ignore harmful content. Effective parental controls, age-verification programs and age-appropriate terms of service must all be mandatory. Moreover, manipulative design features, such as algorithmically driven engagement tactics that exploit developmental vulnerabilities of young users, should be prohibited. To achieve this, Canada must establish an independent online safety regulator with the authority to enforce strong, evidence-informed protections for children and youth in digital spaces.

Policy Objective

To establish a complete exemption pathway for low-risk pediatric clinical trials investigating drugs routinely used in clinical practice, aligning Canada with peer jurisdictions while saving both valuable time and research dollars.

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Background

Currently, Health Canada regulates all pediatric clinical trials studying treatments that are not ‘on label’ for pediatric use – including routine treatments like oxygen, salt water, ibuprofen and acetaminophen. As a result, trials investigating commonly used therapies must adhere to the same regulatory standards as studies involving brand new molecules or novel gene-based or cellular therapies. These regulatory requirements increase trial costs by an average of 20%, create unnecessary bureaucratic requirements for researchers, and do not increase patient safety. A complete regulatory exemption would bring Canada in line with peer jurisdictions, including Australia, the United Kingdom and the United States, while saving both time and research dollars.

Policy Objective

To reform the Special Access Program to ensure that children with rare and life-threatening illness have access lifesaving treatments that are not available on the Canadian market, without unnecessary bureaucratic delays and without being routed through research pathways when the sole purpose of the therapy is clinical care.

Background

Pediatricians and pharmacists caring for seriously and critically ill children often require medications that are not available in Canada. Currently, clinicians must apply to Health Canada’s Special Access Program (SAP) and receive Health Canada approval before accessing these essential treatments. The SAP receives more than 16,000 applications annually, many of which involve therapies that are already proven to be safe and effective, and are approved for use in trusted foreign jurisdictions. For these routinely accessed therapies, the SAP serves no function other than delay and administrative burden. The program should be reformed to allow medical professionals to treat their patients first and notify Health Canada afterward.

For innovative therapies not available on the Canadian market, Health Canada currently requires clinicians to initiate a single-patient clinical trial (also known as an OLIP or SPS) to facilitate access. This process is complex, costly, resource-intensive, and most critically, it delays urgently needed care. When the intent is treatment, not research, Health Canada should establish streamlined application and monitoring requirements for accessing novel therapies from outside the country.

Policy Objective

To exercise existing reliance authorities under the Food and Drug Act (FDA) in order to expedite on-market, on-label access to medications and child-friendly formulations identified on the National Priority List of Pediatric Drug Act (NPLPD).

Background

In 2024, Health Canada released the draft National Priority List of Pediatric Drugs (NPLPD). Developed through a robust national consultation with Canada’s pediatric and pharmacy communities, and adjudicated by a multi-disciplinary panel of child health experts, the NPLPD identifies essential drugs that are unavailable in Canada, lack appropriate pediatric labelling or lack a child-friendly formulation, despite being accessible with appropriate labelling and formulations in the United States and European Union. Drugs that are not available in Canada must be imported through the pathway outlined above, while drugs that are available but not labelled or formulated for pediatric use are less safe, and often ineligible for reimbursement from provincial health plans.

Health Canada’s regulatory reliance mechanisms offer a promising opportunity to encourage manufacturers to bring these essential therapies to the Canadian market—making them eligible for review by the Canadian Drug Agency and, ultimately, for public coverage. Delays in using all available regulatory tools to secure access to NPLPD-listed products continue to compromise the safety, effectiveness, and equity of care for Canadian children.

Policy Objective

To mandate the submission of pediatric drug data with all new (NDS) and supplemental (SDS) drug submissions to Health Canada, when pediatric use can be expected or anticipated.

Background

Canada is more than three decades behind international best practice in mandating the submission of pediatric data with new and supplemental drug submissions. As a result, Canadian children are significantly more likely to receive “off-label” care than their peers in comparable countries around the world. In addition to the well documented risks of off-label prescribing, a critical lack of evidence-based pediatric-specific indications undermines child-focused health technology assessments and, by extension, limits public reimbursement for essential medications.

In February 2024, Health Canada launched a pilot program to encourage the voluntary submission of pediatric data. As expected, uptake has been limited. To align with trusted regulators around the world, Health Canada should make the current voluntary pediatric development plan (PDP) pilot mandatory and permanent. Without mandatory submission of pediatric data, Canada risks continuing a long-standing pattern of regulatory neglect for children.