Consultation guide on improving access to drugs and other health products in Canada: Why we are consulting

On this page

• A government priority
• Today's challenges
• Taking action

A government priority

Over the past decade, Health Canada has played a leadership role in bringing key stakeholders together and taking important steps so that people in Canada can access the drugs they need when they need them.

To address drug shortages, we:

• sped up the process to get drugs to the Canadian market by introducing flexibilities in regulatory requirements
• sped up approvals for new drugs or changes to existing drugs and
• allowed the importation of foreign-authorized drugs manufactured to similar standards as Canadian-authorized products

Health Canada also worked with provinces and territories to establish a time-limited Critical Drug Reserve. This reserve prevented or mitigated 12 shortages of key drugs that support patients hospitalized with COVID-19.

The Government of Canada has made significant progress on broader initiatives that will help to strengthen access to drugs by people in Canada.

As part of our $2.2 billion commitment to grow a strong, competitive domestic life sciences sector, we've made numerous investments to support domestic manufacturing. For example, we recently invested $80 million to strengthen Canada's biomedical sector and increase domestic production of critical drugs.

In 2020, we developed the Pediatric Drug Action Plan following significant engagement with stakeholders. Under this plan, Canada continues to work to ensure that children and youth in Canada can access the medicine they need.

To better support patients affected by rare diseases and their families and caregivers, we recently invested $1.5 billion through the National Strategy for Drugs for Rare Diseases. This will help provinces and territories improve access to new and emerging drugs, as well as existing ones, and promote early diagnosis and screening for rare diseases.

Canada's patchwork of drug coverage leaves many people in Canada facing barriers to get the prescription drugs they need. This is why we're working on a universal national pharmacare program to ensure drug coverage for everyone. The government will introduce related legislation with the intention of securing its passage by the end of 2023.

Finally, our regulatory system also needs to continue evolving to remain relevant in the current environment. We're creating new and more agile regulations to:

• better align with other regulators
• leverage foreign decisions to inform drug reviews based on risks
• remove outdated requirements for specific technology needs

Today's challenges

The Government of Canada has laid solid foundations to respond to drug shortages. However, we need to take additional action to build resilience in the supply chain for Canada's drugs, medical devices and life-sustaining foods. We're seeing an increase in the number of critical national shortages, and shortages are lasting longer. We're also seeing new shortages of different products like pediatric analgesics and infant formula.

Shortages are having real impacts on the lives of people in Canada. Recent public opinion research shows that 56% of the population is concerned about drug shortages. Most people want to know more about other choices that may be available. They also want to know the reason for a shortage and how long it's expected to last.

This consultation will focus on ways to improve the availability of drugs for everyone. We'll also consider other shortages. For example, recent shortages of epidural catheters and infant formula have shown that medical devices and life-sustaining foods are also vulnerable to supply disruptions.

Taking action

In November 2022, under the leadership of Minister Jean-Yves Duclos, Health Canada created a Drug Shortages Task Force to build on these foundations. This internal group will consider novel approaches to address shortages and improve the resilience of supply chains for drugs and other health products.

The task force has begun engaging provincial and territorial governments, industry stakeholders, healthcare system partners, patient groups and academia. These engagements have shown that stakeholders are poised for action to further improve our collective response and work to prevent shortages now and into the future. Many are already working to advance new practices, models and strategies so we can be better equipped to prevent and mitigate the impacts of shortages for patients.

Minister Duclos is seeking to develop a long-term strategy to improve the availability and accessibility of drugs and other health products for everyone. Our goal is to better prevent and manage shortages, and better inform patients and healthcare professionals. The strategy will be supported by the suggestions we receive from stakeholders, including families, patients, Indigenous communities, academics and supply chain actors.

To help us develop a strategy aimed at preventing drug and other health product shortages, and mitigating their impacts as much as possible, we need to hear from you. Over the spring and the summer of 2023, the Drug Shortages Task Force will continue engaging a wide range of stakeholders.

This consultation guide will help you provide direct input to help shape Canada's strategy moving forward. The consultation focuses on solutions that can be advanced by Health Canada as a federal regulator and by others who have a role to play in helping to prevent shortages.