Two Years Later: The Impact of the Health Canada Regulatory Changes

In the summer of 2015, Health Canada released an updated guidance for their name submission process. Almost two years later, found an impact that goes beyond the Canadian pharmaceutical market.

At Addison Whitney, it is a top priority to stay up to date on regulatory guidance and to adapt our processes accordingly. Due to our consistent communication with Health Canada, Addison Whitney has been able to update our name generation and testing process to continue to be fully compliant with the updated Health Canada guidelines.

One of the biggest impacts of this update is a push toward a very clear guidance; it is now very black and white for sponsors and manufacturers. It is expected to be adhered to more strictly than previous editions, and has in turn caused companies to take note and work with agencies who have a good understanding of the best practices to ensure adherence to these guidelines.

Also, and probably most importantly, the name submission timing has changed within Health Canada, which could have an impact about how companies go about creating and evaluating global brand names. A lot of companies, who may be looking at gaining both FDA and EMA approval, are trying to navigate the waters of two agencies that have annual name submission rejection rates between 35 and 50 percent and who also have very strict timelines for submission. If a brand is looking to create at truly global brand name, they must also submit to Health Canada, whose updated timing guidelines have changed how these organizations present their names to each of the global regulatory bodies. So starting early is something that a lot of companies have begun understand the importance around, which also helps when they understand the hurdles. For instance, it can take a year-and-a-half to two years just to get the trademark authorities to provide the registered trade name, after which the entire process time frame can begin, a time frame that has shifted with the updated guidelines.

But why are we here? Why did Health Canada make the decision to update their guidelines? It goes back to everyone’s end goal from a regulatory standpoint: to reduce medication errors. Patient safety is of the upmost importance from all of the health authorities, all of the markets and all of the regions who are doing name reviews. At the end of the day, they are doing what they need in order to eliminate name candidates that could be misleading, which could ultimately lead to a medication error, misuse or confusion with another product currently on the market. Around the world, typically 10 to 15 percent of medical error instances are connected to name confusion. So Health Canada, in addition to the other global bodies, is setting out to build a global, standardized and more predictable process, with the ability to better gauge whether a potential drug name could lead to medication error.

Another area which the new guidance touches on is to change the narrative that was out there in regards to the level of attention that was paid to Canadian name submissions. Previously, some thought that name evaluations done for FDA approval would automatically suffice for approval in Canada. The circumstances around Health Canada could lead to that mindset – it’s a country in close proximity to the United States with products that are marketed with the same active ingredient often under the same brand name, so obviously the expectation is it would work. Health Canada, looking to change that narrative, examined their process and the expectations are they had for sponsors and manufacturers. What they came up with is a thorough and robust process, but also a process that’s fairly easy to understand.

If done the right way, these guidelines increase the predictability of identifying a safe name. This will be assisted by repetition. A more robust process, combined with more innovation and more development that means more names are reviewed and submitted to the health authorities. This is essentially equal to practice for submissions, which will lead to names being developed with the Health Canada guidelines specifically in mind.

These changes largely go back to creating a more defined process, with the goal of having a more standardized process across the world. Now, there will be subtle differences between regions, but a drive for standardization, or something close to it, will touch on that mindset of increasing predictability for approval of names.

As for the guidelines themselves, they adopt a multi-step, multi-phase approach which lays out three different phases of development. The first is search – is something that should always be done when working on a new name. It’s fairly cost effective, a lot of it can be done internally and quickly, and it is an evaluation of the name candidates by any of a variety of online tools available, including database or internal searches.

The second phase of that is simulate, and that’s the step in which you are going out to your target audience, customers and prescribing dispensing handlers of the product to conduct primary market research. These are also called safety studies, amoeba studies, medication error prevention analysis, prescription simulation, etc., but in essence they’re all designed around going and getting real world input on the viability and the safety of your proposed name candidates.

The third step is synthesize, which is a failure mode effects analysis study, or “FMEA.” At its core, FMEA is about evaluating on a much more targeted comparison to determine if an error or breakdown in the prescribing dispensing handling administration process could occur, and identify where that breakdown could happen.

Although not necessarily listed in their top three categories, the fourth step is decide. After you’ve gone through all of those steps, put in a lot of due diligence, time and effort, you now must make sound decisions. Choose name candidates that are viable for approval but also won’t lead to medication errors. A question that is asked often is, what makes a good name versus a bad name? At a very high level, a good name is an approvable name that also never leads to a medication error. Yes, it is a goal to get your name approved globally through the health authorities. But it’s an even bigger goal to make sure it’s never reported in a medication error. This is the point where it is crucial to make good decisions and keep patient safety at the forefront of every decision, and then build a great brand from there. Keep in mind also that this evaluation can help you with potentially securing a global name with the other health authorities.

There are some important detail-oriented aspects to keep in mind for each of these phases.

For the search phase, a lot of the work that is required can be either done internally, through a trademark attorney or related counsel, or it can be driven by a branding agency. Whoever is contracted to work on this aspect, it is important to begin early in the development process. The earlier, the better, as the results from the search will drive the direction of many of the steps to follow. For instance, a clearly defined process use map, which depicts how a product gets from start to finish in the prescribing process, will lay out who and what is involved and where a breakdown in the product safety may occur. This will allow for the research that is to follow to clearly identify who should be interviewed and from who the data should be received.

The simulate phase can also be referred to as primary market research. With the updated guidelines, there are clear expectations from Health Canada in regards to sponsors submitting brand names for review and approval, for example submissions should include data from a simulation study with a minimum of 100 Canadian healthcare professionals involved. There is one caveat to this request; if a sponsor can prove or can show that meeting the 100 minimum criteria would not be impactful for their process, such as if the asset is designed for a rare disorder, has a low prevalence of patient disease or number of MDs treating that particular disease state, it is possible to petition to Health Canada that 100 respondents is an exorbitant number. But if it is something that is at retail setting or mass dispensed and could easily be confused with another product, the expectations should be set to interview a minimum of 100 respondents. Once again, the presence of a process use map will be highly beneficial in ensuring that all of the necessary and required interview participants are identified.

Another unique requirement in the updated regulation is at least 20 percent of respondents need to be French speaking. There are regions within Canada that are prone to speaking French Canadian and need to be considered due to the linguistic differences between French Canadian and English, which, in addition to the pronunciation differences, could conjure a variation of associations and reactions amongst the target audiences.

The goal in the primary market research study is two-fold. One is to evaluate the performance of the name, in particular the safety and clarity of the name when spoken, written, faxed, called-in or read, to ensure the name is interpreted correctly and not confusingly similar to other names. And then, most importantly, is to identify how distinct a name is compared to other products – medical terms, medical devices, acronyms, or anything else that could lead to the potential confusion in the marketplace.

The next step is synthesize, which includes a two-fold research study, a quantitative data research with fewer respondents than before, to again highlight any potential safety or name confusion issues. Some of the evaluations that done are to identify potential drugs that could be confused with the proposed drug names, a pharmacological opposite, or a product with a known interaction or allergy. Health Canada requests a perspective taken in this research from the patient point of view, if there is a medical error. What if the patient receives the wrong drug therapy, what are those consequences? What number of doses might the patient be administered to a point where when they receive the wrong drug harm? And then the combined drug therapy, what are the consequences if both drugs are prescribed and administered? Overall, it is a “worst case scenario” perspective to be researched that the guidance looks to clarify.

Overall, those are the three biggest steps in the updated process; all three of them being independently and conversely important. If one follows this process, hopefully data has been gained to be able to make sound decisions when submitting the name to the health authorities, including Health Canada. One of the requirements also from this process is that there are a lot of manufacturers who do a lot of due diligence around the name, but none of the health authorities except Health Canada require the manufacturer to submit the safety or prescription simulation data or POCA data. A report must be created and the data must be submitted if a name candidate is going to be submitted.

Also, the name submission timeline has changed and this is certainly one of the things has affected manufacturers, in that a lot of companies would try to align submission timing and dates to make sure they are giving themselves the absolute best chance of getting a global name. If submitting to Canada only, with little to no concern about a global name, then the impact is lessened, but for names being submitted to the global health authorities in which the same name is to be used, there will certainly be impacts. Prior to the update, pre-new drug submission, or NDS, reviews were allowed, which is no longer the case. Sponsors are now not allowed to submit a name candidate for review with Health Canada until the NDS is filed, which will impact many operating procedures of organizations working with Health Canada for submissions. A 90-day review, shorter than some other regulatory bodies, is now the standard, as is an abbreviated review which will happen 30 days prior to issuance of a NOC or DIN, munch in line with the FDA process.

Overall, one of the most important recommendations when working with the updated Health Canada guidelines is to give it the proper respect – they are out there to be followed, and if you give the attention necessary, your success level will be greater.

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