GSCF publishes v2.0 of Self-Care Readiness Index

The Global Self-Care Federation has launched the second edition of the Self-Care Readiness Index, examining how self-care policies are being implemented across the world. Both editions, together covering 20 countries, demonstrate very clearly that there is a widespread lack of a coherent view of self-care and its benefits. The SCRI is a research and policymaking tool, which explores the key enablers of self-care in support of designing a better model for healthcare systems. It evaluates countries based on four self-care enablers – stakeholder support and adoption, consumer & patient empowerment, comprehensive self-care health policies, and the appropriate regulatory environment – supported by measurable indicators of self-care readiness. The new SCRI is available here.

This latest version of the SCRI report highlights the regulatory environment as one of the key enablers of self-care, advising countries to “focus on regulations and processes governing approval of new health products, from prescriptions to over-the-counter medications.” For example, the approval time for Rx-to-OTC switch applications can vary from as little as one month in Mexico to 11-13 months in Germany and 24-30 months in Canada.

Nicholas Hall Writes: The concept of self-care needs additional drive, which is why we support the excellent work of the Global Self-Care Federation. As GSCF Director General, Judy Stenmark, said when announcing the second edition of the Self-Care Readiness Index: “Self-care has to be a political priority for every single government across the world.”

In many respects we are pushing against an open door! The latest survey of US consumers shows that they want to live longer, but are unaware that their current lifestyles mean that the last lap of life will most likely be miserable. Our industry can help and prosper by meeting the needs of a growing and highly-demanding older population.

Trevor Gore, Founder of Maestro Consulting is part of the online presenting panel joining Nicholas for our upcoming Asia-Pacific e-Conference on 23 November, exploring Opportunities with Collaboration in the Self-Care space. For more information, or to register, please contact elizabeth.bernos@NicholasHall.com.

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

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.

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

Medical cannabis products legal in UK

Three hot topics we focus on at OTC DASHBOARD, in our blogs and infographics, are OTC adjacencies, e-commerce and new technology. Medical cannabis falls within the sphere of OTC adjacencies, and here at Nicholas Hall & Company we believe that this category will progressively become part of the consumer healthcare market.

Recent legislative moves show that government attitudes to cannabis use are becoming more and more liberal. Just last week, the UK Home Secretary made the decision to allow the legal prescription of cannabis-derived medicinal products by specialist doctors. The UK’s regulatory agency, MHRA, is now working on a clear definition of what constitutes a cannabis-derived medicinal product.

The UK has also been one of several markets that have seen the launch of innovative cannabidiol (CBD) products, such as CannaQIX (Precision Healthcare / Creso). Launched in April 2018, CannaQIX is formulated with CBD organic hemp extract, as well as vitamins and minerals. Available as lozenges, the product is positioned as a cognitive booster that maintains mental and nervous function, reduces fatigue and releases energy. The product is also available in Switzerland and being rolled out across Europe.

Other key countries for CBD products include Germany, Israel, Australia and the USA, with 45 products in the latter market already listed in our OTC New Products Tracker archive, in a variety of innovative formats including pens, vaporisers and gummy bears.

Canada is another country becoming more liberal in its approach to cannabis. In June 2018, legislation permitting Canadians to consume cannabis for recreational purposes was finalised, the final step that will pave the way for official legalisation in October 2018. The regulatory package is 390 pages long and provides details about how cannabis may be grown, harvested, processed and sold.

Looking ahead, Europe and North America are likely to be at the forefront of market development. According to a report from Prohibition Partners, the European cannabis market will be worth €115.7bn (US$135bn) by 2028, with the majority of European states expected to pass legislation to legalise medical cannabis programmes and recreational cannabis in that time.

Nicholas Hall’s upcoming OTC.NewDirections Executive Conference will reflect rising interest in the fast-developing cannabis market worldwide with two presentations on this key topic, from Canada and Israel. Being held on 12 September in London, this one-day meeting will explore Where Innovation Meets Regulation. For details of the full agenda or to reserve your place contact lianne.hill@NicholasHall.com

Self-care in Canada: Meandering Path to New Regulations

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.

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).

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.

OTCs in Action Episode 62: Countries claiming climbing CAGRs!

This week, OTCs are in Action all over the world as we post the top-performing markets in terms of compound annual growth rates. First, kudos to my colleagues on the DB6 OTC database team. Thanks to their amazing expertise and hard work, Nicholas Hall Companies has just published the DB6 global OTC database, which tracks sales at the brand level in 64 countries.

The leading OTC market in the world is the USA, with turnover of $31bn, while the smallest market is Slovenia, with OTC sales generating $61mn. Both are mature markets, with the US posting a CAGR of 3.3% from 2011-2015 — Slovenian OTCs were close behind, achieving growth of 3.2%.

Looking at the Emerging Markets, China’s performance was strong with CAGR of 7% and sales of $21.6bn last year. Russia’s CAGR was 12%, reaching $3.3bn in 2015. Brazil performed a point better with growth of 13% to achieve sales of $2.7bn, whilst India’s CAGR was significantly slower at 9% to generate sales of $2.6bn last year.

Turning to more mature markets, Japan’s OTC CAGR for the period was flat with sales of $7.1bn in 2015, while the $4.9bn Germany OTC cart sputtered forward with a CAGR of 2.3%. In France, CAGR was negative 1% to $3.9bn. The UK and Canada drifted equally with a 2.3% posted in both markets, with sales of $2.9bn and $2.1bn, respectively, in 2015.

Which markets were stimulated by Rx-to-OTC switches? Where in the Emerging Markets did Lifestyle OTCs outpace other categories? DB6 subscribers know the answers. Visit the DB6 OTC database 2016 website to learn more about this valuable service, used by leading OTC players around the world.

DB6 Global OTC Database

OTCs in Action Ep 55: Overdoses spur fast-track naloxone switch

Peter McKnight, of the School of Criminology at Simon Fraser University, wrote about the rising rates of fentanyl overdoses in the 13 August 2015 Toronto Globe & Mail, and observed:

“So, 45 years after US president Richard Nixon first declared what has become a worldwide war on drugs, opiates remain as easy as ever obtain.

But what if opiates aren’t your drug of choice? What if you’re looking instead for a drug that can reverse the deadly effects of opiates? Well – and here’s more irony – that drug is a lot harder to get. It’s called naloxone, a drug that blocks the effects of opioids in the brain, thereby reversing an overdose and preventing the loss of consciousness and cessation of breathing that often follow. A non-addictive, non-intoxicating, low-risk drug, naloxone has been used in Canadian emergency rooms for more than 40 years.

The trouble, of course, is that most people don’t shoot up in hospitals. People commonly use drugs – and overdose – at home, in a washroom or in an alleyway. And if we are to reduce the risk of death or brain damage, naloxone must be available wherever and whenever an overdose occurs.”

This week OTCs are in Action in Canada, where Health Canada announced its intention to make naloxone available for emergency use for opioid overdose without a prescription so that families can have emergency treatment kits at home and readily available, according to Nicholas Hall’s OTC.NewDirections. The agency is reviewing safety and efficacy data during a consultation period ending on 19th March, after which it intends to waive the usual six-month implementation period that follows such decisions so that the change in status can occur as quickly as possible.

To review a prior OTCs in Action on naloxone availability, click here:

nicholashallcompany.wordpress.com/2015/08/03/otcs-in-action-episode-36-naloxone-to-the-rescue/

To learn more about Nicholas Hall’s OTC.NewDirections, click here:

http://www.nicholashall.com/otc-newdirections

To read Mr. McKnight’s original editorial, click here:

http://www.theglobeandmail.com/opinion/why-is-an-opiate-antidoteharder-to-obtain-than-the-drug/article25959264/

OTCs in Action Episode 47: Natural Sucanon approved to treat Type II diabetes

Last week, OTCs were in Action in Canada, where Sucanon has been evaluated by regulatory authorities, and is now a licensed natural health product for treating Type 2 diabetes.

Marketed by PharmaRoth Laboratories, Sucanon is an insulin sensitiser, lowering a patient’s blood sugar by increasing the muscle, fat and liver’s sensitivity to the body’s own naturally produced insulin. The product is also available as an OTC in Mexico, but has Rx status in China and Peru.

Last year, the US FDA denied PharmaRoth’s New Dietary Ingredient application for Sucanon to be sold as a nutraceutical. According to the US agency, the active ingredients, derived from a dried root and a form of molybdenum, should be classified as a drug.

OTCs in Action will be watching with interest this product’s expansion to various countries as PharmaRoth seeks to give diabetics access to safe and effective treatment. The brand’s tagline is:

Sucanon … Diabetes is not curable but is treatable … enjoy life.

New transparency rules in Canada will affect OTC marketers

According to our industry contacts, there are some important issues to consider for marketers planning to launch OTC products in Canada. Over the past several months, the Minister of Health has been rolling out a number of initiatives designed to improve the department’s image concerning transparency. The most recent decision will require all drug approvals to be put into a publicly available database, whether these products are marketed or not. While this may or may not help improve the government’s reputation on transparency in some sectors, it is most likely that competitive interests will have the most to gain through this policy.

Until now, only those products that were on the Canadian market were entered into the Drug Product Database. The purpose of which is to allow stakeholders to know whether a product that is being sold in Canada has been approved or not. This database is an excellent tool for compliance officers at both the federal and provincial levels. The change this time is that the government will now place all approved drugs into the database even if the manufacturer has not yet commenced sale.

This new policy will likely change the way companies plan for and market their new products. In some cases a manufacturer will file applications for new products with the intent of rolling them out over a period of time. This allows the marketer some flexibility in planning for administrative delays in approval, seasonality or retail sell-through of older products. Since the products were not on the market, there was nothing for compliance officers to worry about. However, by making such registrations public, competitors will now know what products are coming to the market well in advance of new launches.

This policy has its genesis in the realm of prescription drugs but has been extended to all drug products. Yet there are significant differences between how companies approach the marketing of prescription and OTC products. New prescription drugs have regulatory provisions for protecting new products from competition through data protection or patent laws. Therefore, it could be argued that making competitors aware that a new prescription drug has been approved would not change the ability of those competitors to respond since they must wait for a statutory period anyway.

However, for OTC products, the only market advantage available to companies is usually through the opportunity to hit the market before store brands and other competitors can react with their own offerings. Now the lead time for brand innovators will be largely eliminated through this administrative tool. This is even more important for products being switched from Rx to OTC since there can often be a lag between product approval and final legal status of the new ingredient. Unless there is an offsetting regulation to encourage innovation, this new policy could give the advantage to subsequent entry products after the innovator takes on the burden of satisfying the requirements for a switch.

For monthly updates on the latest markets developments and trends in the US and Canada, make sure you subscribe to OTC INSIGHT North America.

OTC INSIGHT North America Blog: Canada Unveils New OTC Regulations

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.