Question Period Note: Drug shortages

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

KEY MESSAGES
• 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 four Interim Orders 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.
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 June 8, we have been able to de-escalate 34 shortages from critical status, out of a total of 51 that have been deemed in critical shortage since the onset of the pandemic. Active monitoring continues and we will apply the lessons learned throughout the pandemic to strengthen our response going forward.
IF PRESSED ON POTENTIAL SHORTAGES OF ARTHRITIS DRUGS USED TO TREAT COVID-19 PATIENTS (Tocilizumab)
• The Government of Canada is taking steps to ensure Canadians have access to promising, safe and effective COVID-19 therapies, which are essential to saving lives, reducing suffering and alleviating the burden on health systems.
• The Government of Canada has secured access to some additional supplies of key drugs being used to treat COVID-19 patients, including drugs also used to treat arthritis such as Tocilizumab, to help protect supplies for all patients who rely on these drugs. These drugs are being directed to where they are needed most in Canada and are making a difference.
• The Government of Canada will continue to closely monitor supplies of all drugs being used to treat COVID-19 patients, and will take action with our partners to help mitigate the impact of any shortages.
SI L’ON INSISTE SUR LES PÉNURIES ÉVENTUELLES DE MÉDICAMENTS CONTRE L’ARTHRITE UTILISÉS POUR TRAITER DES PATIENTS ATTEINTS DE LA COVID-19 (Tocilizumab)
• Le gouvernement du Canada prend les mesures nécessaires afin que la population canadienne ait accès à des traitements prometteurs, sécuritaires et efficaces contre la COVID-19, lesquels sont essentiels pour sauver des vies, réduire la souffrance et réduire la pression sur nos systèmes de santé.
• Le gouvernement du Canada a réservé l’accès à un approvisionnement supplémentaire de médicaments clés utilisés pour traiter les patients atteints de la COVID-19, y compris certains médicaments aussi utilisés pour traiter l’arthrite, comme la Tocilizumab, afin d’aider à protéger les provisions pour tous les patients qui dépendent de ces médicaments. Ceux-ci sont dirigés là où le besoin est le plus grand au Canada et ils font une différence.
• Le gouvernement du Canada surveille de près les provisions de tous les médicaments utilisés pour traiter les patients atteints de COVID-19 et prendra les mesures nécessaires auprès de nos partenaires afin d’atténuer l’impact de toute pénurie.
IF PRESSED ON THE CRITICAL DRUG RESERVE…
• Working with provinces and territories and other partners, Health Canada has established a COVID-19 Critical Drug Reserve.
• Based on Canada’s experience to date, analyses, discussions with provinces and territories, as well as the advice of health care experts, the Critical Drug Reserve holds twelve drugs used in hospitals to support patients with COVID-19, including sedatives, pain relievers, antibiotics, and neuromuscular blockers.
• The Critical Drug Reserve complements other federal, provincial and territorial drug shortage management efforts, and is a safety that has augmented the supply of key drugs used in treating patients with COVID-19 in Canada.

IF PRESSED ON THE POTENTIAL FOR SUPPLY DISRUPTIONS AS A RESULT OF THE SITUATION IN INDIA…

• Early outreach by Health Canada to Market Authorization Holders did not uncover signals of imminent shortages likely to result from the situation in India.
• Health Canada is continuing to work with its partners, including key industry associations, to closely monitor the situation in India for any signals of drug supply disruptions and will take action to help prevent and mitigate any potential shortages as required.

BACKGROUND
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.
Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19
This interim order was made on March 1, 2021 to help prevent and alleviate shortages by permitting the exceptional importation of specified drugs, biocides, medical devices, and foods for a special dietary purpose that may not fully meet Canadian regulatory requirements, but are manufactured according to comparable standards. This interim order repeals and replaces the Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 that the Minister of Health made on March 30, 2020.
The Interim Order Respecting the Prevention and Alleviation of Shortages of Drugs in Relation to COVID-19
This 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.
This 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 made by the Minister of Health on November 27, 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 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. Through FPT collaboration, a process for the allocation of imported critical drugs is now in place to facilitate the distribution of critical products. The process allows companies the opportunity to work with Health Canada and provincial and territorial governments in allocating supply where it is needed most.
A COVID-19 Critical Drug Reserve has been established, working closely with provinces and territories and other partners, to complement other drug shortage mitigation efforts and includes 12 drugs used to support 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.

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