Demand high for cannabis, but its self-care future in Canada is uncertain

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Since Canada’s introduction of the Cannabis Act, which came into force on the stroke of midnight on 17th October 2018, government-operated websites and private retailer portals powered by Shopify are reporting “hundreds of thousands” of orders, according to the company’s VP, Loren Padelford. In addition, long queues have been reportedly forming outside licensed retailers across the country, leading to shortages in some areas.

Canada is now the second country after Uruguay to legalise cannabis for recreational use by adults, who can possess up to 30g of legal cannabis, dried or equivalent in non-dried form in public; share up to 30g with other adults; purchase cannabis products from a provincial or territorial retailer; and grow up to four plants per residence (not per person) for personal use from licensed seeds or seedlings.

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At the same time, however, Health Canada has shut down all possible direct pathways for companies to market any cannabis-derived ingredient for health purposes. This, according to the department, is because the safety (and efficacy) of cannabis “is currently insufficient” once a health claim is added to a product label. This means that all levels of THC and CBD sold without a label claim can be sold to any adult but those with a claim may not.

Health Canada also ruled that all phytocannabinoids will be required to make an application for an Rx-to-OTC switch before consumer health claims could be granted through a further amendment to the Prescription Drug List. Of course, this requires a company to make an application under the New Drug regulations and pay significant fees for the processing the application. Not surprisingly, this decision lands all cannabis health products in the most expensive pathway to market access, likely only affordable to the largest of players.

For an in-depth report on this breaking story, see the forthcoming issue of OTC INSIGHT North America. If you work outside of North America, we also have titles covering Asia, Europe and Latin America. Click here to find out what key features OTC INSIGHT includes! To receive a sample issue or for details of subscription rates, please contact melissa.lee@NicholasHall.com

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Self-care in Canada: Meandering Path to New Regulations

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Mathematically, the shortest distance between two points is a straight line. However, in public policy it is rare to chart such a clear direction. Reading through the “What was Heard” report from Health Canada’s public consultation on self-care regulation, which was conducted online in late 2016, there does not appear to be any real consensus over new proposals for an overhaul of all the regulations for non-prescription medicines, Natural Health Products (NHPs) and cosmetics.

Although the report was completed months ago, it was only released in late March this year, as a backgrounder to a series of town hall style discussions on a more detailed set of changes starting 4th April. While the government has developed a more detailed set of proposals that address some of the concerns set out in the report from last year’s consultation, it would appear that those attending the provincial feedback forums will not have the opportunity to digest these details prior to giving their advice. In fact, one of the key findings of the report was that all stakeholders felt that the original outline lacks enough specificity to make cogent comment.

Reading the report, it is interesting how what was heard may not actually be fully representative of what was said. For example, the report concludes that “many participants in the consultation see considerable value in the clarity that would be provided by a single regulatory approach to all three affected areas” (i.e. cosmetics, NHPs and OTCs). What the data show is that in virtually all stakeholder categories, the support across several key measures was only around 30%. Taken another way, roughly 70% or more of the stakeholders would not be more confident in these proposals.

The report notes that most of the concerns came from the NHP segment. This should not be a surprise since all previous consultations were only about moving OTCs out of the prescription drug regulations. For non-prescription medicines, this was round two of the discussions but for the NHP and cosmetics sectors this was novel territory. The visceral reaction was clear given that the NHP community spent years developing a set of regulations independent from drug classification and achieved it through a parliamentary process. They perceived that rolling all OTCs and NHPs into one single regulation was a step back in time, especially given the tone of the documents about claims-based barriers to market access.

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There weren’t many points where all stakeholders agreed. However, it seems there was a strong consensus that self-care products (OTCs, NHPs and cosmetics) “should not be regulated in the same manner as prescription drugs”. Far from an epiphany, this was the basis for the idea that OTCs should be granted their own regulations outside the prescription regulations, just as NHPs were granted such regulatory status. Cosmetics have never been in the prescription drug framework.

There was no consensus on the specific elements of the new framework. The risk-based approach was supported to the degree that most agreed that “products which pose a greater risk of harm should receive greater scrutiny and be subject to significant requirements”. Where the consensus fell into disarray was around the confusion between evaluating products for their individual risk and categorising products broadly into risk levels. The proposal seemed to set out a lower-risk category where claims would be limited and as such the government would not review and license them for sale. This type of product would be supported by pre-cleared information such as monographs.

The logic suffered in some stakeholders’ view since the model would seem to require lower-risk products to move into higher risk categorisation when clinical data would be provided to create greater confidence in the claims. The report notes that “there is no consensus that the proposed risk-based approach would create more confidence when purchasing self-care products”. In fact, 82% of consumers and healthcare professionals and 93% of cosmetics manufacturers said it would not give them more confidence.

The thought of requiring only “scientific” proof to justify health claims met with resistance from most stakeholders (except the five OTC drug companies). Only 30% of all respondents agreed with this notion and that was not highly differentiated across several segments. The support for stricter reliance on “science” (not defined but often assumed to be clinical trial data) was low with consumers (30%), healthcare professionals (33%), NHP companies (21%) and cosmetics manufacturers (30%). On the other side of the argument, academics and researchers were more supportive (60%).

A concept floated by government was that they would not evaluate and license certain types of products based on the types of claims being made. This was suggested to be accompanied by a disclaimer that Health Canada did not assess the claim. While cosmetics already enjoy a similar notification system, most stakeholders didn’t appear to support adopting a cosmetic-like system for OTCs and NHPs. The report notes that “participants are somewhat divided on the use of a disclaimer on products whose efficacy would not be reviewed”.

Despite the lack of consensus on a disclaimer, there would appear to be acceptance that changes could be made that would “facilitate informed consumer choice”. Some stakeholders have proposed adding labelling statements that would make it clearer when traditional evidence was used to support the claim. This, they feel, would add information that enhances consumer choice.

This consultation elicited a very strong response relative to most government consultations. Perhaps this was influenced by the fact that during the consultation period, Health Canada put out a very strong social media campaign and used traditional media stories to “clarify” some aspects of their proposals. With the communications efforts to ensure that the consultation garnered significant and reasoned responses, it should give some confidence in the results.

Perhaps one of the most telling observations related to the confidence stakeholders would have in the newly designed system. Consumers (78%), healthcare professionals (75%), NHP companies (80%) and cosmetics firms (63%) did not feel more confident with the new proposals. In a similar vein, 82% of consumers didn’t feel that the proposals adequately addressed their needs. The numbers were similar for healthcare professionals (78%), NHP companies (81%) and cosmetics businesses (74%). Only two OTC companies felt that their concerns were addressed.

The report concludes that “there is clearly a need for further detail on the proposed approach so that stakeholders may provide more specific feedback to Health Canada as the framework continues to be developed”. No doubt this is true and, as the government heads into the next phase of face-to face discussions, it would have been helpful to have that kind of detail available before asking stakeholders to respond.

British Columbia Pharmacists Could Provide Abortion Pills

The British Columbia College of Pharmacists has been working with Canada’s Department of Health to make the combination of mifepristone and misoprostol (for the termination of a developing intra-uterine pregnancy up to a gestational age of 49 days) available directly from a pharmacist.

The product, Mifegymiso (Linepharma International), was approved by Health Canada in 2015, and was placed on the Prescription Drug List (PDL). The provincial drug schedules also classified the two ingredients as prescription drugs (requiring a physician’s intervention).

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The College of Physicians and Surgeons of B.C. and the College of Pharmacists of B.C. have been working behind the scenes for months to find a way to circumvent the federal drug regulator’s plan for physician-only dispensing of Mifegymiso. Abortion advocates say that because most doctors’ offices are not equipped to act as miniature pharmacies, the dispensing requirement is likely to discourage physicians.

It seems that the intention may be to work around the regulations, though this may not be well received by federal regulators. Health Canada also advised that working around the regulations would have an impact on the liability of pharmacists.

Mifepristone has been approved in more than 60 countries, including the United States, where it has been available since 2000. Canada did not approve the drug until July 2015, and manufacturing issues have since delayed its sale.

Esomeprazole, Ibuprofen OTC Changes Take Effect In Canada

In February this year, Health Canada announced its intention to make two changes to the Prescription Drug List (PDL). Specifically, it was proposed that the PDL be amended to allow an OTC version of esomeprazole for heartburn and to make technical changes that would permit modified-release ibuprofen products available for self-care.

While this announcement was not a surprise as the six-month period for comment elapsed on 5th August, the delay in making the change effective (18th August) was more likely owing to administrative matters than anything therapeutic in nature. The two changes to the federal list are as follows:

  • Esomeprazole or its salts except when sold for the 14-day treatment for frequent heartburn at a daily dose of 20mg
  • Ibuprofen or its salts except:
    1. An oral dosage form that provides 400mg or less per dosage unit; or
    2. A modified-release oral dosage form that provides 600mg or less per dosage unit

While the Federal decision had no further restrictions attached, the provincial scheduling of these products do take on some further limitations as decided by the National Association of Pharmacy Regulatory Authorities (NAPRA).

Now that the federal switches are finalised, the interim decision made by NAPRA becomes effective. Specifically, the provincial decision on these two items were:

  • Ibuprofen or its salts, when sold in a modified-release oral dosage form that provides 600mg or less per dosage unit would be placed into Schedule III (sold only where a pharmacist is present)
  • Esomeprazole or its salts, when sold for the 14-day treatment for frequent heartburn at a daily dose of 20mg, in package sizes of no more than esomeprazole 280mg would be assigned to Schedule II (available only from a pharmacist directly)
  • Esomeprazole or its salts, EXCEPT when sold for the 14-day treatment for frequent heartburn at a daily dose of 20mg in package sizes of no more than esomeprazole 280mg will not be switched provincially (it will remain in Schedule I – Rx only)

The ibuprofen decision was notable since the regular dosage form is available as an unscheduled item (available through any outlet when sold in package sizes of up to 18,000mg) while the modified release product is restricted. The esomeprazole decision matched the decision made for omeprazole in 2014.