Pangaea Express: Proposed Regulations for SAP
Canada Gazette, Part I regarding the Sale of a New Drug for Emergency Treatment (Special Access Program) was released along with the draft Guidance Document for Industry and Practitioners. In consultation with stakeholders, Health Canada identified challenges with the current regulatory framework, namely, i) the program can be burdensome for practitioners to submit necessary use, safety and efficacy data, even when such data has previously been submitted to secure authorization, ii) there is a time lag and barriers to access for patients, even for drugs that are frequently requested and iii) there is a lack of clarity and regulatory framework for foreign manufacturers on when they can bring drug into Canada in advance of a practitioner request (“pre-positioning” of drug).
The proposed regulations address these challenges by allowing:
i. practitioners to submit a request for access to an unauthorized drug without submitting data on the use, safety and efficacy of the drug for a specified emergency if:
a. the drug is authorized for sale without terms and conditions by the European Medicines Agency (EMA) or the U.S. FDA for the same medical emergency for which the drug is requested b. the drug was previously authorized through SAP for the same medical emergency (barring any restrictions e.g. no terms or conditions, identified by the EMA/FDA)
ii. drugs to be shipped directly to community pharmacies to facilitate access to these medicines, which is of particular importance in rural communities
iii. practitioners to submit for SAP without identifying a particular patient to enable future use scenarios where a patient’s identity is not known in advance, such as where a specific drug is needed for first responders or in emergency care settings
iv. “pre-positioning” so that drugs can be physically present in a warehouse in Canada in advance of a request from a practitioner. Upon authorization from SAP, the manufacturer may import and store an unauthorized drug by a Canadian drug establishment licence holder (DEL). However, the drug must not be distributed to a practitioner until a letter of authorization from SAP is issued for the sale of a specific quantity of the drug to a named practitioner. Pre-positioning will allow for much quicker access to drug supply once a request from a practitioner is authorized
Changes to Certificate of Supplementary Protection (CSP) In light of these proposed Regulations regarding the sale of a new drug for Emergency Treatment, Health Canada recognizes the need to amend the Certificate of Supplementary Protection Regulations (CSP Regulations) with respect to its current definition of “authorization for sale”. This definition would need to exclude drugs brought into Canada for emergency so that they could be considered for a CSP at a later time if and when the manufacturer seeks market authorization and receives an NOC.
Once a drug receives market authorization, access through the SAP would be limited to one final 90 day supply (exceptional circumstances may exist for continued supply).
These proposed amendments should remove some of the administrative burden set on practitioners to apply for SAP and increase timely access to these drugs for patients. As well, manufacturers will not be penalized for bringing a drug to Canada prior to NOC and inhibiting their future ability to apply for CSP.