Livestock drugs not currently available in Canada could become easier to access in emergencies, if proposals for amended federal drug regulations get on the books.
Health Canada, proposing to streamline the processes for emergency access to drugs for livestock as well as people and pets, on Friday announced a public comment period on its proposals, running until July 19.
Much like the Special Access Program for drugs for human use — which is up for similar amendments — the Emergency Drug Release (EDR) program is used to provide access to veterinary drugs to treat animals with serious or life-threatening conditions when conventional therapies have failed, are unsuitable or are unavailable.
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“Evolving disease patterns and global health incidents with a domestic impact have emerged, requiring new drugs, which are often not available in Canada, as manufacturers may not submit these drugs to the Canadian market due to its small size,” the department said in its regulatory impact statement.
“These conditions have reduced timely access to drugs for Canadian patients and animal owners.”
Proposed changes to the program “would reduce the administrative burden” and allow for a “more efficient process for repeat requests,” the department said.
Today, federal regulations require practitioners to submit data on the use, safety and efficacy of a drug to the EDR program, even if the program has previously authorized the same drug in the past for the same medical emergency.
The proposed amendments would allow practitioners to request a given drug that was previously EDR-authorized, under certain conditions, without having to submit the same data all over again.
The proposals would also more clearly allow drug companies to bring some drugs into Canada in advance of anticipated EDR requests, “in order to speed up access to needed treatments.”
That process, called “pre-positioning,” is today allowed only through an “exercise of enforcement discretion” by Health Canada on the current prohibition on imports on small individual shipments, so as to cut the time it takes to get an EDR-authorized drug from a manufacturer to a practitioner.
The proposals also call for an expansion of the antimicrobial sales reporting requirements already in place for drugs approved in Canada, to also cover veterinary drugs authorized under the EDR program.
The EDR program for veterinary drugs alone gets between 600 and 1,000 requests per year from up to 400 veterinarians for drugs for companion animals, food-producing livestock, wildlife species and fish. An average of 45 drugs have an active status in the EDR program, the department said.
EDR authorizations are meant for limited time, to meet specific emergency needs, and aren’t meant to promote or encourage early use of drugs, to conduct research, or to make an end-run around Canada’s clinical trial and drug review processes, the department emphasized.
EDR-authorized drugs don’t undergo comprehensive pre-market review and aren’t subject to the same manufacturing and post-market safety requirements as other drugs manufacturers take through the established approval process in Canada. — Glacier FarmMedia Network
