Interim Order Respecting Drug Shortages (Safeguarding the Drug Supply): Guidance document

Date published: November 27, 2020

On this page

• Background
• Scope
• Details of the prohibition
• Determining the risk of a drug shortage
• About requests for information
• Guidance on requests for information

Background

The Interim Order Respecting Drug Shortages (Safeguarding the Drug Supply) was made on November 27, 2020. This interim order (IO) introduces new measures to help prevent bulk importation programs, such as the one recently established by the U.S., from causing or exacerbating a drug shortage in Canada. Under the IO, certain drugs intended for the Canadian market are prohibited from being sold for consumption outside of Canada if that sale could cause or exacerbate a drug shortage.

The IO also authorizes the Minister to require specific information from a manufacturer or drug establishment licence (DEL) holder to help Health Canada take steps to prevent or alleviate an existing or anticipated drug shortage.

Distribution of drugs intended for the Canadian market for consumption outside Canada will continue to be permitted if the seller determines that the distribution will not cause or exacerbate a shortage. Drugs manufactured in Canada solely for export are not in the scope of the IO.

On October 1, 2020, the U.S. Department of Health and Human Services published the final rule on the Importation of Prescription Drugs. The rule creates a pathway for licensed U.S. pharmacists or wholesalers to import, in bulk, certain prescription drugs intended for the Canadian market. Diversion of drugs from Canada to the U.S. or other countries would put extra pressure on our country’s drug supply and increase the risk of drug shortages harming Canadians.

Scope

The interpretation section of the IO defines the following terms:

• drug
• shortage
• manufacturer
• establishment licence
• drugs authorized under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (ISAD)

This IO applies to the following drugs for which a Drug Identification Number (DIN) has been assigned under the Food and Drug Regulations or under the ISAD IO:

• drugs that may be sold without a prescription, but are administered only under a practitioner’s supervision, also known as ‘ethical’ drugs (for example, hemodialysis solutions, pre-filled syringes with epinephrine for severe allergic reactions, MRI contrast agents)
• drugs on the Prescription Drug List
• drugs listed in Schedules D and C of the Food and Drugs Act
• drugs listed in Schedules I, II, III, IV or V of the Controlled Drugs and Substances Act

Natural health products, over-the-counter drugs and drugs for veterinary use are excluded from the scope of this IO.

The prohibition in the interim order does not apply in 3 different situations:

1. sales made by a person who is not required to hold a DEL (for example, a pharmacy selling drugs for personal use)
2. products that are imported for the sole purpose of export (transhipment)
3. products that are manufactured in Canada for the sole purpose of export

Under this interim order (IO), there is no prohibition on exporting certain drugs intended for consumption outside Canada if the seller determines this will not cause or exacerbate a drug shortage in Canada. In this case, the seller must create and retain a detailed record of the information they used to determine that the distribution of the drug is not prohibited by the IO.

The application of this IO extends to all drugs meeting the definition above, not just to drugs affected by the COVID-19 pandemic.

Details of the prohibition

Under this IO, certain drugs intended for the Canadian market may not be distributed for use outside Canada if that distribution would cause or exacerbate a shortage of the drug.

Drugs approved by Health Canada and labelled for sale in Canada are considered to be intended for the Canadian market. This prohibition applies to distribution conducted by DEL holders. The seller is required to determine whether the sale could cause or exacerbate a shortage before distribution outside of Canada. The seller must keep records showing how this was determined.

The distribution of drugs intended for the Canadian market for use outside of Canada is still permitted when the sale will not cause or exacerbate a drug shortage. This IO does not apply to drugs manufactured in Canada for export, such as drugs not labelled for the Canadian market or not approved for use in Canada.

Determining the risk of a drug shortage

DEL holders must have reasonable grounds to believe that distributing a drug for use outside Canada will not cause or exacerbate a drug shortage. This requires considering the quantity of drug to be exported in relation to demand.

When determining the likelihood that the distribution of a drug intended for the Canadian market outside Canada could cause or exacerbate a drug shortage in Canada, consider the following factors. These are based on the information available, at the time of distribution, and are not an exhaustive list:

• Is the product listed as a Tier 3 drug shortage?
  • Tier 3 drug shortages are the most severe shortages. Distributing a Tier 3 drug, in bulk, for export, would very likely cause or exacerbate a shortage.
• Are any companies listing any actual or anticipated shortages or discontinuations of the drug on the website for mandatory drug shortage reports? 
  • Is the shortage reporting for the same format and strength?
  • In general, the export of any sole-sourced drug with an actual or anticipated shortage would pose a risk of causing or exacerbating a shortage.
  • Extra attention should be given to any shortage being reported by a company (or companies) with significant market shares. 
• How many suppliers to the Canadian market are there of the drug? In other words, how many other marketed products are there in Canada with the same active pharmaceutical ingredient (API), same approved indication, same route of administration and similar strengths?
  • Special attention should be given to drugs that are provided by one supplier in Canada (sole-sourced drugs) and to products with a limited number of suppliers.
• Is the quantity of potential sales significant when compared to your historic sales or current inventory? Do you know if the quantity of drugs under consideration for sale represent a significant portion of the national demand for that drug?
  • Any sale of a significant quantity of drugs will require additional attention to ensure that the export will not cause or exacerbate a shortage. Companies should evaluate whether they can replace their stock through increased production and or resupplies. 
• Do any currently posted actual or anticipated shortages involve an alternative to the drug under consideration for export?
  • Alternative drugs may be different drugs with the same indication or different formats of the same drug.

Other factors to consider when determining whether a foreign drug sale may cause or exacerbate a shortage include:

• Is there a shortage of the drug in any markets other than Canada?
• Is the drug subject to any supply management actions such as allocation or other action that may restrict distribution?
• Do you have reasonable grounds to expect an increased demand in the near future for this format of drug (for example, pandemic, seasonal needs)?
• Are there issues that could limit production capacity and/or importation (for example, constraints on active pharmaceutical ingredients or raw materials for this drug)?
• Are there supply chain factors (for example, delays in shipping) affecting the availability of this drug?

Based on the answers to the questions (above) and the information available  DEL holders determine if there are reasonable grounds to believe that distribution outside Canada would cause or exacerbate a drug shortage. DEL holders must keep records of this decision-making as well as the supporting rationale, which need to be provided to Health Canada officials, upon request.

About requests for information

This IO also gives the Minister the authority to request specific information from drug manufacturers or establishment licence holders to assess existing and potential shortages. Manufacturers and licence holders may be obligated to provide this information if they fail to do so voluntarily.

When used in this guidance document, the term “requiring information to be provided” refers to this obligation, under section 4(2) of the IO. This authority will help assess the level of risks posed by a shortage or potential shortage of the drug.

Only the Minister of Health or designate can request information through this IO. The decision to exercise the authority relies upon the evaluation and recommendation of Health Canada officials.

The request for information is made to the person who holds a DEL or market authorization for a drug that is in shortage or that the Minister believes is at risk of being in shortage. A "person" may be an individual, research institution, corporation or authorization holder.

Guidance on requests for information

Voluntary responses

Prior to requiring the provision of information under this IO, information may be requested on a voluntary basis. Health Canada will notify a person that they may have information in their control that we believe is necessary in determining:

• whether a therapeutic product is at risk of going into a shortage or
• the information could help in prevent or alleviate a shortage

The notification should set out the rationale for this belief.

Health Canada will give the person enough time to respond. The timeframe for responding depends on how severe and immediate the risk of shortage is (24 hours, 2 business days, 7 days, and so on).

If a voluntary response to the notification isn’t received in the time given, the Minister may exercise authority under the IO to require the information.

Conditions for requiring information

Three conditions must be met for the Minister to use this authority under section 4(1)(a to c) of the IO:

1. there’s a shortage of the drug or the drug is at risk of going into shortage
2. the information is necessary to establish or assess:
   • the existence of a shortage or risk of shortage of the drug
   • the reasons for a shortage or risk of shortage of the drug
   • the effects or potential effects on human health of a shortage of the drug
   • measures that could be taken to prevent or alleviate a shortage of the drug
3. the manufacturer or person will not provide the information without a legal obligation to do so

When assessing the type of information that may be requested, Health Canada refers to a number of sources. These include:

• mandatory drug shortage reports
• environmental scans
• inspection reports or reports covering other quality issues
• signals generated internally or from patients, health care professionals, provincial and territorial partners, international regulatory agencies
• media reports
• consultations with clinicians
• academic literature

When determining who to send the request to, Health Canada relies on prior knowledge, experience or information stemming from other known activities or regulatory requirements.

Scope of the provisions

The Minister can only use the authority under this IO to obtain existing information from a person who holds a DEL or market authorization. The Minister can’t require a person to create new information, such as conducting new analysis or studies.

The request can only be made of the person holding the information. It can’t be used to require a person to obtain information not already under their control and which must be obtained from another source.

What a mandatory request for information looks like

The person will receive a set of instructions, decisions or directions for providing the information, which will be accompanied by an evidence-based rationale. This allows for more transparent decision-making.

A mandatory request for required information will include:

• the name of the person(s) it applies to
• the regulatory authority being relied upon
• the therapeutic product(s) in question
• a description of the information in the person's control that the Minister believes is necessary to determine if the product is at risk of a shortage and the shortage presents a risk to human health or the information could help prevent or alleviate the shortage
• the timeframe for providing the information
• the format for submitting the information

Health Canada may follow up with more information requests should the need arise.

The information must be submitted electronically by the deadline. The request will contain instructions for submitting the information, including the format for submitting that information.

If you have any questions, please contact us by email at hc.prsd-questionsdspr.sc@canada.ca.

Related links

• Explanatory note for the Interim Order Respecting Drug Shortages (Safeguarding the Drug Supply)