AESGP meeting 2018: Key learnings

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OTC INSIGHT Europe Editor Sarah Carter reports back from this year’s 54th AESGP Annual Meeting, which was held in Amsterdam and served as a farewell to Dr Hubertus Cranz, who retired as Director General after 30 years in the role.

Below are 8 key learnings from the meeting:

  1. Representatives from Pfizer and Hexal / Sandoz demonstrated how Rx-to-OTC switch can act as a growth driver for the consumer healthcare industry, with Nexium Control (EU Centralised Switch) and MometaHexal (Germany) given as case studies. Both asserted that the Rx heritage of the brands was instrumental in their successful switch, with both market leaders in their respective Rx spheres.
  2. However, while switch offers growth opportunities, several speakers stressed that the limited 1-year data exclusivity available with a switched product in the EU can deter marketers from making the timely and costly investment needed to switch their product.
  3. Digitalisation has transformed the rules of the healthcare industry and education. According to Google, search engines and online videos are the most important touch points for OTC purchasers, with one in 20 searches on Google related to health. In 2017, there were 40bn healthcare queries in EMEA alone.
  4. The global volume of healthcare data doubles every 18 months. It is crucial that we build trust with consumers regarding Big Data, ensuring that our industry uses this in a responsible manner, particularly salient given the introduction of the EU’s General Data Protection Regulation on 25 May 2018.
  5. Low levels of health literacy act as a barrier to self-care. We must empower consumers with the tools and knowledge necessary to play an active role in their health management, healthy ageing and prevention. Healthcare systems need conscious individuals who actively pursue a healthy lifestyle, and seek HCP advice where necessary.
  6. Technology such as wearables and apps has helped to raise health awareness and engagement among consumers, driving the trend for wellness and encouraging people to become key actors in their health management. In the industry, we see increasing purchases of long-term preventive products, rather than OTC treatments.
  7. It is vital that we understand the consumer at a much deeper level than we have done historically, as they no longer want to be sold to, but engaged with. The advent of Big Data and AI deliver us new tools to generate insights and ultimately create more meaningful connections and stronger relationships.
  8. There is little to report on regulations — still no decision on botanicals, and no real update on medical device regulations.

Only two weeks to go until the annual North American OTC Conference! Hosted by Nicholas Hall and Everything Health in Morristown, New Jersey, 20-21 June, this highly-anticipated meeting will review crucial topics impacting the competitive landscape around the central theme of The Future of Consumer Self-care: New OTC Solutions. With topics on the agenda including the e-commerce revolution, a presentation on “Magical Marketing in Healthcare” from Google and a look at the industry’s ‘Switch wish list’, this promises to be an event you can’t afford to miss. To receive a copy of the full meeting agenda or to reserve your place now, contact lianne.hill@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.

Trump To Roll Back E-cig Rules?

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As vaping has escalated in popularity over the past year, tobacco companies are focusing on new smoking products, which are potentially less harmful. With Trump now in his full role of presidency, the industry sees an opening for rolling back rules on these products.

In November, Trump’s surprise election victory, and his pledges to reduce federal regulations on business, led tobacco lobby groups to create a new plan of action. The immediate objective is to delay the implementation of new regulations on the current generation of e-cigarettes and other vaping devices. These devices produce a vapour from liquid nicotine rather than burning tobacco.

Longer-term, they are setting their sights on repealing the 2016 law that treats these devices like cigarettes. Lobbyists have described a wary optimism as they approach lawmakers with their plans for products that they say can help traditional smokers quit and avoid the well-known health threats caused by tobacco.

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With US sales of conventional cigarettes decreasing, Big Tobacco has made a major gamble in the past few years, flying the flag for the e-cigarette industry. Last week, British American Tobacco Plc announced a US$49bn deal to take over competitor Reynolds American, uniting two of the largest e-cigarette players in the United States and United Kingdom and becoming a huge rival to Philip Morris International and US partner Altria Group.

“Suddenly things that were not conceivable became something we thought we could do,” said Cynthia Cabrera, former president and executive director for the Smoke-Free Alternatives Trade Association (SFATA).

While the potential health risks and benefits of e-cigarettes are still being studied and debated, with regulators in different countries interpreting the evidence in different ways, some industry voices are saying that a change in US regulations could hurt the smaller companies there and cripple development and innovation in the country’s e-cigarette industry.

OTC Vending Machines in USA IN 2017?

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Vending machines are commonly used for distributing fizzy pop or a sugary / savoury snack to perhaps curb a period of waiting, quench thirst or eat on the go. Now that self-service is so available to us, why not use vending machines to offer other products?

In the US, a bill seeking to revise the current Pharmaceutical Affairs Law to allow OTC vending machines is currently under final review by the Ministry of Government Legislation, before being submitted to the National Congress for approval.

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Of course machines selling OTCs such as condoms, feminine hygiene products and tights are already a common feature in pubs, restaurants, clubs and cinemas but there are many possibilities to extend the product range beyond these common items.

The amendments are expected to be passed without difficulty and will come into effect on 1st January 2017. They will allow pharmacists to sell OTCs through vending machines located outside their premises after conducting a consultation with consumers via video call through the machine.

Jacksonville are already one step ahead as Jacksonville Memorial Hospital recently started offering prescription medicines through an “Rx-to-go” kiosk in its emergency room. At the start of this month, three Jacksonville pharmacists also launched medical vending machines of their own which provide OTC medicines and personal hygiene products.

OTCs in Action Episode 32: ED in NZ, not .com

OTCinActionheaderIllegal internet sales of Rx and OTC drugs, as well as adulterated dietary supplements, put consumers at great risk. “Tainted Sexual Enhancement Products”, published on the FDA’s website, warns consumers:

“The FDA has identified an emerging trend where over-the-counter products, frequently represented as dietary supplements, contain hidden active ingredients that could be harmful. Consumers may unknowingly take products laced with varying quantities of approved prescription drug ingredients, controlled substances, and untested and unstudied pharmaceutically active ingredients. These deceptive products can harm you! Hidden ingredients are increasingly becoming a problem in products promoted for sexual enhancement. Remember, FDA cannot test all products on the market that contain potentially harmful hidden ingredients. Enforcement actions and consumer advisories for tainted products only cover a small fraction of the tainted over-the-counter products on the market.”

Last week, this blog’s sister publication, OTC.NewDirections, reported that an international crackdown on  illegal internet trade of medical products yielded $81.8mn worth of items from 115 different countries, and 156 arrests. In the UK, a record $25.1mn worth of counterfeit and unlicensed medicines and 15,000 devices was seized, including potentially harmful slimming pills, erectile dysfunction, anaemia and narcolepsy tablets. The US FDA took action against 1,050+ websites that illegally sell potentially dangerous, unapproved Rx medicines and medical devices.

In fact, regulators around the world are playing a high stakes game of Whack-a-Mole, a popular arcade game in which players hit cheeky little moles with mallets, but as soon as one is knocked out another appears elsewhere.

WHACK A MOLE_0However, the risky business is driven by consumer demand, and now OTCs are in Action in New Zealand to satisfy those needs safely and legally. One of the more common unapproved ingredients in the FDA’s list of adulterated products is sildenafil, more commonly known by its legal Rx brand name, Viagra. The Rx-to-OTC switch of Silvasta (sildenafil) erectile dysfunction treatment in New Zealand was approved in late 2014. Men aged 35-70 years can purchase Silvasta without an Rx following a screening process with a trained pharmacist. This spring Nicholas Hall & Company awarded Douglas Pharma its top marketing award for the launch of Silvasta. A consumer campaign includes TV ads featuring an “everyday” man explaining that help is at hand from pharmacies without the need to see a doctor, while a pharmacy finder website directs men to the nearest outlet.

Another interesting development that will ensure consumer access to safer drugs is the UK’s new requirement that online medicine sellers must be registered with the Medicines & Healthcare products Regulatory Agency. They must display on every page of their website the new European common logo, which will be linked to their entry in the MHRA’s list of registered online sellers. The medicine being offered online must be licensed in the member state where the purchaser is based, and the seller must be legally entitled to sell medicine in accordance with UK legislation. Registered pharmacies can sell general sales list and pharmacy medicines or supply Rx-only medicines that they have dispensed against a prescription. Other retailers can only sell GSL (self-selection OTC) products. The penalty for disobeying the registration and logo rules is up to two years in prison, a fine or both.

In an somewhat related matter, as it affects consumer safety and appropriate use of OTC medicines by reducing illicit methamphetamine manufacture, Acura Pharmaceuticals has entered into an agreement with OTC cold remedy giant Bayer to license its IMPEDE technology. IMPEDE technology, which is available in the US in Acura’s Nexafed, has demonstrated significantly reduced yields of methamphetamine compared to traditional formulations in lab tests and has been associated with a reduction in meth labs in local markets of up to 90%. OTCs in Action covered the launch of Acura’s Nexafed Sinus Pressure + Pain (pseudoephedrine and acetaminophen) in February.

Episode 17: Outwitting meth manufacturers

OTCs in Action Episode 27: Regulation drives innovation

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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 in Action Episode 26: Honing in on homeopathy

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Last month, OTCs were in Action at a US FDA meeting, where eminent naturopathic physicians and captains of the homeopathy industry defended the current regulatory structures for the drugs, and a few sceptics were concerned with the lack of scientific-based evidence for compliance. This venerable segment of the market has long been ignored by the agency but the increasing popularity of homeopathy, the introduction of pseudo-homeopathic dietary supplements, as well as inappropriate treatment claims such as asthma, have put the alternative treatments in the spotlight.

Back in 1938, the Food, Drug & Cosmetic Act recognised the US Homeopathic Pharmacopeia as the official compendium containing monographs for homeopathic drugs. Fifty years later, The Compliance Policy Guide (CPG) gave the FDA authority to effectively police the homeopathic medicine trade for compliance in terms of appropriate OTC claims, product safety and GMP. The Federal Trade Commission helps regulate claims and advertising.

According to the CPG: The practice of homeopathy is based on the belief that disease symptoms can be cured by small doses of substances which produce similar symptoms in healthy people.

Although the efficacy of homeopathic drugs will be debated forever, the issue is further clouded by the fact that some  OTC “homeopathic drugs” are not prepared with homeopathic methods of dilution, but make a homeopathic drug claim based on having a plant source. This allows these pseudo-homeopathic products to avoid dietary supplement status and the required disclaimer: “These statements have not been evaluated by the Food & Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.” It also crosses the firm line stated by Paul Mittman, Southwest College of Naturopathic Medicine & Health Sciences: A homeopathic is a drug and a dietary supplement is a food.

This is just the beginning of the FDA’s evaluation of homeopathic products, with written comments accepted until 22nd June — and it’s likely there will be some harsh and sceptical comments on homeopathy received by the FDA. However, given the entrenched status of homeopathy as a viable alternative therapy practiced by medical professionals, as well as a relatively safe profile as a mass market OTC, will the FDA overhaul their regulation? Written comments are welcome here as well!

Full coverage of the meeting will be published in the May issue of OTC INSIGHT North America.