Self-care in Canada: Meandering Path to New Regulations

OTCinActionheader

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.

o-HEALTH-CANADA-facebook.jpg

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.

Advertisements

Natural products tipping into mainstream

OTCinActionheader

A lollapalooza of healthy food, home care, beauty and health & wellness brands were promoted by 2,000 exhibitors at last week’s Natural Products Expo East, held in Baltimore, MD.

But which products are most relevant to mainstream consumers? Eric Pierce, Director, Strategy & Insights, New Hope Network, presented data from the NEXT Trend Concept Lab that used data to predict which natural product innovations are tipping into the mainstream consumer channel:

  • “Mission-based” brands
  • Pre/probiotics
  • Local sourcing
  • Paleo
  • “Hidden veggies”
  • Brain health
  • Compostable packaging
  • Grass-fed dairy

The partnership between Vitamin Angels, which supplies vitamins to undernourished people worldwide, and Walgreens, which donates vitamins based on consumer brand selection, is a great example of the tip towards “mission-based” brands. Walgreens is also donating immunisation to underserved communities when people get their flu shots in the pharmacy. Another trend that has tipped is probiotics, already a mainstream OTC category, and every week more scientific proof of their benefits is published.

60317_vitaminangels_withtext_466x148

But what about “hidden veggies” for parents trying to appease picky eaters? Can mainstream OTCs provide the nutritional benefits of greens? There were many drinks, sachets and capsules offering several servings of vegetables at the show.

Brain health has proven a challenging claim, in terms of demonstrable and clinical efficacy. Which consumer healthcare player (or start-up) will meet the brain claim challenge?

Compostable packaging may be the gold standard, but without a doubt mainstream marketers can adopt more eco-friendly attire for their brands. This will increasingly appeal to all consumers.

Local sourcing, grass-fed dairy and Paleo (based on the diet regimen) are of course trends in food, but the “clean” philosophy that underpins these trends is being adopted by consumers in all lifestyle segments, including supplements.

These trends are tipping to the mainstream now … will your brand meet consumer demand for healthy and sustainable healthcare products?

OTCs in Action Episode 27: Regulation drives innovation

OTCinActionheader

This week, OTCs are in Action in Indonesia. Last year, Indonesian regulators disallowed cough remedies containing only dextromethorphan as an active ingredient. Although this drug is considered safe and effective, it is widely abused because of its hallucinogenic and dissociative side-effects when taken in huge quantities, and tends to appeal to teenagers.

One of the products that was withdrawn is Komix DT, part of category-leading cough remedy Komix (Bintang Toedjoe / Kalbe). To bolster the brand after this withdrawal, the marketer launched Komix Herbal in 2014. It comes in the same packaging as the withdrawn version, and contains lagundi, liquorice and peppermint oil, among other ingredients. This year, Komix Luo Han Kuo+ was launched. The powders contain extract of luo han kuo fruit, honey and pelargonium, and are designed to be dissolved in water to create a warm drink that relieves symptoms of cough and associated heartburn.

Dextromethorphan is sold as an OTC in the US, but eight states have banned its sale to minors under 18 to discourage abuse by teens. It’s not very surprising that OTC INSIGHT North America’s US market report to be published later this month charts the meteoric rise of Zarbee’s honey-based natural cough medicine, launched about two years ago and now claiming fourth place in the category.

The trend towards naturals has been partly driven by regulation, but also by parents concerned about the safety of OTC medicines they give to their children, causing an inevitable rise in sales of homeopathic and herbal remedies across the globe that shows little sign of abating.

OTC INSIGHT North America Blog: Canada Unveils New OTC Regulations

Dave INSIGHT Header 2014

In June 2014, Federal Health Minister, Rona Ambrose, announced her intention to create a new set of regulations for OTC products. Now the Minister has released the framework for moving OTCs and disinfectants out of the regulations covering prescription drugs where these products currently reside.

The proposals are wide-ranging and designed to give the government more flexible tools to manage the licensing of products intended for self-care. New tools have been undergoing pilot testing and the results were positive to the extent that the new rules will allow the implementation of some key market access approaches. This would include the adoption of monographs, which could be used to grant a product licence when a manufacturer attests to those standards. The monographs would be incorporated into regulations by reference, making then easier to adapt to changes as needed.

There will be five pathways to market authorisation. Including the compendial approach described above, there will be a stream for non-compendial submissions (ingredients that are not found in the monographs), administrative changes (e.g. manufacturer’s name change), prescription drug status switch (removal of an ingredient from the prescription drug list) and innovative non-prescription drug filings (e.g. novel ingredients and perhaps some types of switches).

The proposals also make reference to incentives for innovation and data protection but fail to provide much detail on what this would look like. However, it does appear that there is an intention to encourage switch through some form of market incentive.

Some things won’t change much. The good manufacturing practice rules will stay largely as they are. This will facilitate the use of mutual recognition agreements for import and export that have been developed over the past several years. Evidence for safety, quality and efficacy will remain and the evaluation process will be driven by a relative risk assessment and mitigation approach.

Some aspects of the proposal may have broader implications. For example, there is a suggestion to remove the prohibition on sampling for OTCs and allow sampling under prescription conditions. Since natural health products regulations are not in the scope of this project, the sampling prohibition would continue to apply to natural health products. While natural health products companies do sample and this prohibition isn’t generally enforced by Health Canada’s Inspectorate, there could be some noise about a level playing field on this matter.

There are numerous Easter eggs in these proposals and they will become more apparent as the consultations evolve.

For updates on this story, make sure you subscribe to OTC.NewDirections. There will also be in-depth analysis of these regulations in the upcoming December issue of OTC INSIGHT North America.