Health Canada has now finalized its Guidance Document for Industry – Review of Drug Brand Names, released July 2, 2014, outlining the rules to be followed by Sponsors when submitting product names for approval, and the approach of Health Canada in assessing whether a proposed name is misleading or could be confused with another product authorized for use in Canada. The policy aims to prevent medication errors that can occur in practice given similarity between product names. Although the Health Canada process is distinct from the registration process for trade-marks, it does have implications on a sponsor’s ability to use its chosen trade-mark in Canada, even if it has been registered through the Canadian Intellectual Property Office.
We had previously reported on the outcome of consultations in our Pharma-in-Brief in March of this year.
The new Guidance replaces a prior 2006 Guidance. The release of the new Guidance is but one element of the current Canadian government’s consumer safety focus, and coincides with the registration of the finalized Plain Language Labelling Regulations (formally known as the Regulations Amending the Food and Drug Regulations (Labelling, Packaging and Brand Names or Drugs for Human Use)), which are to be phased into effect. These regulations are directed to:
- requiring labels that are clear, understandable, and in plain language;
- providing for a standardized format for non-prescription drug labels;
- requiring mandatory contact information on labels so that users can report problems and adverse drug reactions;
- requiring manufacturers to provide mock-ups of labels and packages for Health Canada review; and
- requiring manufacturers to provide evidence that drug names will not be confused with other authorized products.
The Guidance notes that “full implementation” will commence 12 months after registration of the Plain Language Labelling Regulations, ie., July 2, 2015, although it can be expected that Health Canada will draw from the ground rules set in the Guidance in the interim when assessing brand names and whether there is potential for confusion with other names.
Application and scope of the guidance
The Guidance applies to drugs for human use (innovator and generic) in which a brand name is proposed, including:
- Pharmaceutical prescription drugs;
- Schedule D Products (e.g., biologics);
- Schedule C products (e.g. radiopharmaceuticals and kits);
- Drugs sold to the general public with the intervention of a healthcare professional (e.g., nitroglycerin and insulin); and
- Drugs that are sold directly to healthcare professionals and are intended for professional use (e.g. anaesthetics).
A separate brand name assessment framework will be developed for non-prescription (over-the-counter) products and natural health products.
While all names of products within the scope of the policy are subject to the review process (for misleading names), not all names will require a full LA/SA brand name assessment. For example, brand names that contain the proper or common name of the drug in combination with a modifier, such as the manufacturer name or abbreviation of the manufacturer name, do not require an LA/SA brand name assessment.
Steps in the name review process
Health Canada undertakes two types of review: (1) the initial band name review to screen for general safety criteria, as to whether the name is misleading; and (2) the LA/SA assessment (unless the product is exempt), which involves consideration of the sponsor’s detailed LA/SA brand name assessment as well Health Canada’s own searches of the name in three databases, namely, the Drug Product Database (DPD), the Licenced Natural Health Products Database (LNHPD), and the non-publicly available Drug Submission Tracking System (DSTS).
Sponsor requirements for LA/SA assessment
The new Guidance is more specific in terms of LA/SA Brand Assessment requirements than the prior 2006 Guidance for Industry – Drug Name Review: Look-alike Sound alike (LA/SA) Health Product Names.
When required, the LA/SA process requires companies to provide evidence following these steps:
Search: This step involves searching the relevant drug name databases, specifically, the DPD and the LNHPD using available search engines. The information retrieved during this step provides an initial list of drug names that merit further scrutiny, in particular, any name with a “similarity score” of 50% or above.
Simulate: This step involves assessing the confusability of a proposed name by inserting it into a variety of prescribing, transcribing, dispensing and administration scenarios and documenting the resulting failures. A process map must be developed outlining where and how the proposed brand name drug will be used; it is to be developed based upon indications and who in the medication use system will come into contact with the product.
Synthesize: At this stage, the database search results are reviewed together with the simulations to generate the information necessary to help make a decision about the likelihood of confusion with the proposed name. A “Failure Mode and Effects Analysis” (FMEA) is conducted based on the information gathered through the ”search” and “simulate” steps, to further identify potential confusion with the proposed name.
The results of the above process are to be included in a final report prepared by the Sponsor with a rationale and recommendation to Health Canada for approval. All raw data from the database searches must also be submitted.
Once the Sponsor’s regulatory submission is received, complete with the sponsor’s LA/SA assessment, Health Canada will use the Phonetic and Orthographic Computer Analysis (POCA) application to conduct its own searches, and make its own determination.
If the submission requires a review period of more than 180 days, Health Canada will conduct its assessment within 90 days of the date the submission is filed. However, Health Canada will also conduct a final assessment 30 days before product approval to ensure that no other names have been approved in the interim with a potentially confusing name.
Link to regulations