Question Period Note: DRUG SHORTAGES

• What action is the government taking to ensure the COVID-19 pandemic does not create drug shortages in Canada?

• Ensuring that Canadians have access to needed medication is a top priority for the Government of Canada.

• Significant efforts were made early in the pandemic to respond to drug supply disruptions. As a result, the supply situation for many key drugs has been stabilizing.

• I have signed three Interim Orders to allow for the exceptional importation of products to help prevent or alleviate the effects of shortages related to COVID-19 and to safeguard supply.

• We will continue to collaborate with provinces and territories, industry, healthcare and patient groups and international partners to closely monitor the situation and take necessary action to help prevent and minimize the impact of shortages.

Health Canada’s role

Health Canada recognizes that drug shortages can have a significant impact on patients and health care professionals, and is committed to doing its part to prevent shortages where possible and minimize their impact when they occur.

Addressing the complex issue of drug shortages is a multi-stakeholder responsibility requiring collaborative action from provinces and territories, manufacturers, distributors, practitioners, and the federal government. When national shortages occur, Health Canada works with provinces and territories and stakeholders across the drug supply chain to identify mitigation strategies, which may include regulatory measures and exploring access to alternative products available in other jurisdictions.

Factors such as whether the shortage is national in scope, whether alternative supplies are available and whether the product is considered medically necessary are all considered in determining the potential impact and any necessary actions by Health Canada.

Bill C-13, the COVID-19 Emergency Response Act

On March 25, 2020, the COVID-19 Emergency Response Act was brought into force to support the availability of drugs and medical devices by providing the Government with the authority to make regulations to address any future shortages of therapeutic products, including drugs and medical devices. This includes the importation of drugs and medical devices not authorized for sale in Canada to address certain shortages, such as for personal protective equipment or drugs required to treat COVID-19, and changes to the Patent Act to allow for compulsory licensing in health emergencies in the period up to September 30, 2020.

Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19

On March 30, 2020, the Minister of Health authorized an Interim Order which sets up a regulatory framework to help prevent and alleviate shortages of drugs, medical devices, and foods for a special dietary purpose.

It allows for the exceptional importation and sale of products that may not fully meet Canadian requirements, such as those related to licensing and labelling, but are manufactured according to comparable standards.

Through this work, Health Canada has been able to secure additional supplies of needed drugs and medical devices for Canada. For example, the department has worked with multiple companies to facilitate access to additional supplies of drugs such as muscle relaxants (e.g. cisatracurium), inhalers (e.g. salbutamol) and sedatives (e.g. propofol) to help support COVID-19 patients.

The Interim Order Respecting the Prevention and Alleviation of Shortages of Drugs in Relation to COVID-19

The Interim Order Respecting the Prevention and Alleviation of Shortages of Drugs in Relation to COVID-19 (the Interim Order), made by the Minister of Health on October 16, 2020 introduces new tools for the Minister to address drug shortages, or the risk of drug shortages, that may be caused or exacerbated, directly or indirectly, by COVID-19. The scope excludes shortages of veterinary or natural health products.

The Interim Order allows the Minister of Health to compel any person who sells a drug to provide information within the person’s control about a shortage or potential shortage of that drug related to COVID-19 under certain conditions. It also allows the Minister to impose or amend terms and conditions on authorizations to sell drugs for the purpose of preventing or alleviating a drug shortage related to COVID-19 under certain conditions.

Interim Order Respecting Drug Shortages (Safeguarding the Drug Supply).

This Interim Order was signed by the Minister of Health on November 27th, 2020. It introduces new measures to help safeguard the Canadian drug supply by ensuring that bulk importation frameworks, such as the one recently established by the United States, do not cause or exacerbate a drug shortage in Canada. The Interim Order also enables the Minister to require a seller to provide information that could help Health Canada take steps to assess or alleviate an existing or potential drug shortage.

Engagement with Provinces and Territories in Managing Drug Shortages

Drug shortage management requires a multi-stakeholder effort. Over the last number of years, capacity has been built up across governments, leading to a more coordinated and effective approach to mitigate the impacts of shortages.

Health Canada has strengthened existing mechanisms in place to manage drug shortages, and has leveraged existing FPT infrastructure and increased cooperation with multiple partners to identify shortage signals earlier, especially for critical drugs required for COVID-19.

The Government recently initiated a Request for Proposals process for critical drugs to treat patients with COVID-19 that have been in high demand or in shortage, including sedatives, muscle relaxants, and inhalers.

Health Canada officials continue to work with the provinces and territories, other international regulators and industry stakeholders to closely monitor Canada’s drug supply so that timely action can be taken to ensure Canadians have access to the drugs they need.

SYNOPSIS

• The onset of COVID-19 created global supply chain challenges and increased demand for drugs used in supporting patients with the disease. Drug shortages, particularly in the context of COVID-19 critical drugs, pose a risk to the health of Canadians.

• Health Canada collaborated with partners and took action early in the pandemic to supplement existing supply and in certain cases avoid critical drug shortages. While some pressures still exist, the supply and demand levels for many drugs are stabilizing.

• The need for vigilance in maintaining the national drug supply continues. Health Canada is continuing its surveillance activities and engagement with key supply chain players to mitigate impacts of any drug shortages.
IF PRESSED ON CURRENT DRUG SHORTAGES…

• Our government is taking proactive measures to mitigate the impact of any drug shortages related to COVID-19.

• Through this work, we have been able to secure additional supplies of needed drugs for Canada. For example, we have worked with multiple companies to facilitate access to additional supplies of drugs such as muscle relaxants, inhalers, and sedatives to support COVID-19 patients.

• While the supply and demand situation for many critical drugs is stabilizing, the need for vigilance continues. As of December 2, 2020, we have been able to de-escalate 22 shortages from critical
status, out of a total of 43 that have been deemed in critical shortage since March. Active monitoring continues and we will apply the lessons learned from early in the pandemic to strengthen our response going forward.
IF PRESSED ON REQUESTS FOR INFORMATION (RFIs) OR THE CRITICAL DRUG RESERVE…

• The RFIs were posted in the spring to identify additional supply that is not already earmarked to meet Canada’s current needs.

• The Government recently initiated a Request for Proposals process for critical drugs that have been in high demand or in shortage – drugs that have the greatest potential impact on the health care system. These drugs include sedatives, muscle relaxants and inhalers.

• Health Canada officials continue to work with the provinces and territories, other international regulators and industry stakeholders to closely monitor Canada’s drug supply so that timely action can
• be taken to ensure Canadians have access to the drugs they need.
• All options are being considered, including information gathering on drug pricing and the potential to secure additional drugs to function as a safety net by augmenting the supply of key drugs used in treating patients with symptoms of COVID-19