Modernized programs will better meet the needs of patients and their healthcare professionals
OTTAWA, May 10, 2019 /CNW/ - Canadians want improved access to all available treatment options for themselves, their families and friends. At any point in their lives, Canadians could experience a serious medical condition or emergency requiring their healthcare provider to seek access to a treatment that has not yet been authorized in Canada. Similarly, veterinarians sometimes need to use treatments not yet available in Canada to provide urgent care to sick animals.
Today, the Honourable Ginette Petitpas Taylor, Minister of Health, announced the launch of consultations on proposed new regulations that would improve Canadians' access to the treatments they need by modernizing the programs that provide access to drugs in extreme situations.
For health products that are not currently available in Canada, the Special Access Program is used to provide access to human drugs, and the Emergency Drug Release program is used to provide access to veterinary drugs. These programs facilitate access for practitioners treating patients and animals with serious or life-threatening conditions when conventional therapies have failed, are unsuitable or are unavailable.
Health Canada is proposing changes to the Special Access Program and Emergency Drug Release program that would reduce the administrative burden for healthcare professionals trying to access treatments for their patients. These amendments would allow for a more efficient process for repeat requests. The proposal would also allow drug companies to bring some drugs into Canada in advance of anticipated requests, in order to speed up access to needed treatments.
In addition to these changes, public health officials would have the ability to request human drugs that are unauthorized in Canada for immediate use or to stockpile them in anticipation of a public or military health emergency, event or incident. Existing provisions for emergency access to unauthorized drugs do not permit advance stockpiling.
The proposed new regulations will be available for comment via the Canada Gazette, Part I, until July 19, 2019. Health Canada will consider the comments received and will revise the proposal as needed before publishing the final regulations in the Canada Gazette, Part II.
"When no other treatments are available or suitable, we need to make it easier for patients and their physicians to access drugs that are not yet approved in Canada. Canadians want and deserve access to treatments as soon as possible. The regulatory proposals we are putting forward today will accelerate access to treatments that can improve or save patients' lives."
The Honourable Ginette Petitpas Taylor
Minister of Health
- Each year, Health Canada approves more than 14,000 requests from practitioners treating patients with serious or life-threatening conditions through the Special Access Program.
- Under the Special Access Program, children with leukemia accessed the new chemotherapy drug pegaspargase before it was approved in Canada. Similarly, Canadians with serious parasitic infections have been able to access the drug ivermectin.
- Every year, Health Canada processes up to 1,000 requests for access to treatments under the Emergency Drug Release program for veterinary drugs.
SOURCE Health Canada
For further information: Thierry Bélair, Office of Ginette Petitpas Taylor, Minister of Health, 613-957-0200; Media Relations, Health Canada, 613-957-2983, email@example.com; Public Inquiries: 613-957-2991, 1-866-225-0709