The Canadian government has published proposed amendments to the Food and Drug Regulations (Regulations) that will improve access to unauthorized human drugs through the Special Access Program (SAP) and unauthorized veterinary drugs through the Emergency Drug Release (EDR) Program.
What you need to know
- The proposed Regulations are not yet law. Stakeholders may provide comments on the proposed Regulations until July 12. Health Canada has also opened public consultations on a draft guidance document relating to the proposed Regulations, and will be accepting comments on the draft guidance document until July 19.
- The proposed Regulations will simplify the requests that practitioners make through the SAP or the EDR program. For example, patients will no longer need to be identified in the request. Additionally, in some circumstances, practitioners will be able to leverage: (i) a previous authorization under the SAP or the EDR program, and (ii) approvals that have been obtained in the United States or the European Union.
- Drug manufacturers will be able to pre-position a drug in Canada, which will help avoid any delays associated with importing the drug.
- The Certificate of Supplementary Protection Regulations (CSP Regulations) will also be amended to clarify that a sale of a drug under the SAP or EDR program will not impede a manufacturer’s ability to obtain patent term extension in relation to that drug.
- The proposed Regulations are forward looking. They will apply to requests made through the SAP and the EDR program after the date the proposed Regulations come into force.
Simplified requests under the SAP and the EDR program
The proposed Regulations will introduce several changes to the SAP and the EDR program, which will simplify the requests that practitioners must submit to gain access to the program.
First, in some circumstances, practitioners will be able to submit a request under the SAP or the EDR program without submitting data on the use, safety and efficacy of the unauthorized drug. This process will be allowed for an unauthorized drug that:
- has been previously authorized by Health Canada under the SAP or EDR program for the same medical emergency;
- is authorized for sale, without terms and conditions, in the United States or the European Union for the same medical emergency; and
- has not previously had a drug identification number or natural product number that was cancelled for safety reasons.
In a request, practitioners will still be required to provide: the name of the drug, details relating to the medical emergency, the quantity of the drug required and the address where the drug is to be shipped. Health Canada will also have the authority to request that additional information be provided relating to the medical emergency or the safety and efficacy of the drug in question. For example, Health Canada may request a copy of any report submitted to a foreign regulatory authority for the purpose of evaluating the safety, efficacy and quality of the drug.
Practitioners would no longer be required to provide information relating to the patient’s identity (human or animal) in a request through the SAP or the EDR program, if the patient’s identity is unknown at the time the request is made. This will allow practitioners to have the drugs readily available on site to treat patients in an emergency.
Moreover, requests made by practitioners through the SAP and the EDR program will no longer need to include the names of all institutions in which the drug is to be used. Instead, practitioners will only need to submit the address where the drug is to be shipped. This change will allow manufacturers to ship drugs to community pharmacies, so patients will no longer need to go to an institution, such as a practitioner’s office or hospital, to access the drug. The purpose of this change is to increase access to SAP and EDR program drugs in rural communities, and to avoid unnecessary delays in treating patients.
Ability for manufacturers to pre-position drugs
The draft Regulations will allow manufacturers to pre-position a drug in Canada in advance of a request for the drug under the SAP or the EDR program. Manufacturers will be able to file a request to Health Canada for a letter of authorization permitting a drug establishment license (DEL) holder to batch import the unauthorized drug to Canada. The DEL holder would then be required to store the drugs until a practitioner has received a letter of authorization under the SAP or the EDR program, allowing the sale of the drug to the practitioner.
This change will ensure drugs that are frequently requested by practitioners through the SAP and the EDR program will be readily available when they are required by a patient. In particular, it will help avoid any delays that may occur at the border when the drugs are imported into Canada.
Notably, this change will make the SAP and the EDR program for drugs more consistent with the current Medical Devices Special Access Programme. Under the Medical Devices Special Access Programme, batch importation is allowed for devices.
Exception under CSP Regulations
The Canadian government has also proposed changes to the CSP Regulations, which govern the process for obtaining a certificate of supplementary protection (CSP) in Canada.1 In general, a CSP can only be granted in relation to the first “authorization for sale” of a drug in Canada. The changes to the CSP Regulations will clarify that an authorization received pursuant to the SAP or the EDR program for a drug is not considered an “authorization for sale,” and therefore will not preclude a manufacturer from obtaining a CSP.
Stakeholders are encouraged to provide comments on the proposed Regulations before July 12.
1 For more information on CSPs, see “Finalizing patent term extension in Canada.”
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