HOW WOULD CONDITIONAL RELEASE WORK IN CANADA?(1)

New drugs would receive a conditional Notice of Compliance (NOC) based on a designated minimum of efficacy and safety data that could be less than the current requirement and would, therefore, be approved for marketing earlier than at present. It may be possible to implement such a scheme under the recent NOC with Conditions Policy, but most likely, legislative changes would be required because there appears to be no formal procedure to revoke an NOC.

Following conditional approval by the federal government, a drug could be prescribed in the usual manner. When the drug achieved the level of effectiveness and safety specified for it, the product would be guaranteed a full NOC, but a drug failing to achieve the criteria would have its conditional NOC withdrawn.

For conditional release to work, drugs given conditional approval by the federal government would have to be listed on all provincial and private insurer formularies in the conditional phase. During this time, drugs could be prescribed and patients could receive financial benefits under the prevailing regulations of the relevant systems. Because the would be marketed under a conditional NOC from the federal government, all drug costs, except dispensing fees and applicable copayments, in the conditional phase should be paid by the federal government. The funding of drugs under conditional release by the federal government would be a step toward the implementation of a national pharmacare program and a national core formulary.