Summary

Final regulations that simplify the process to add or remove drugs with prescription status were published on June 19, 2013, although their date of implementation will be December 19, 2013 - six months from the coming into force of the particular statutory provision, included as part of the Jobs, Growth and Long-term Prosperity Act, that authorized the regulations.   In addition to establishing the new list, the regulations will allow pharmacy technicians to transfer prescriptions, in order to reflect provincial legislation and practice.

The regulations will hasten the implementation of certain changes in a drug’s status as either prescription or over-the-counter.  Changes will be made through changes to a Prescription Drug List (PDL) and such changes will be incorporated to the list by reference.  No longer will it be necessary to follow the regulatory process for adding products to the current list of drugs, as it is set out in and referred to as “Schedule F”.

The ability to proceed by adding/removing products to/from the PDL reflects an approach similar to that taken by the government with respect to the approval and listing of food additives, for example, to allow certain governmental decisions to be made by administrative action, thereby removing the ability, at least for some products, for the public to participate in the comment process required as part of the Canadian regulatory process.

Amendments

Under current regulations, those drugs for which a prescription is required are set out in Schedule F.  Amendments to “Schedule F” (which occur frequently) must  follow a regulatory process that can be time consuming and result in delays to a drug achieving prescription status (or a change to “over the counter”  status).  The proposed PDL will change this process.

The Regulatory Impact Analysis Statement accompanying the new Regulations state that they will:

  • Define prescription drug. This ensures that the prohibitions relating to the sale, import, and advertising of prescription drugs continue to apply to drugs with prescription status. Previously such drugs were subject to those prohibitions because they contained substances listed on Schedule F.
  • Define the Prescription Drug List. This is a Web-based list of drugs that the Minister is able to establish under the new section 29.1 of the Act. The PDL includes drugs or classes of drugs that have to be sold pursuant to a prescription from a licensed practitioner. This list contains all of the drugs that were previously listed in Schedule F, with some minor modifications for reasons of clarity.
  • Establish scientific basis for listing. Three scientific criteria are set out to determine whether a drug or class of drug should be sold pursuant to a prescription. These criteria support the prior Schedule F factors that are now publicly available in a guidance document: Determining Prescription Status for Human and Veterinary Drugs. To add to the PDL, the Minister of Health shall consider whether any of the scientific criteria apply to a drug. To remove a drug or class from the PDL, the Minister shall consider the criteria and must determine that none of them apply to the drug or class.
  • Allow for public consultation. The Minister is required to consult the public on any proposal to remove a drug from the PDL for a period of time sufficient to allow comments from external stakeholders that would also meet international obligations under the World Trade Organization’s Agreement on Technical Barriers to Trade.

Link to Regulations

http://www.gazette.gc.ca/rp-pr/p2/2013/2013-06-19/html/sor-dors122-eng.php