#NHOTC17: Day 2

OTCINACTION

This week we publish our second and final blog update on our 28th European OTC INSIGHT conference, which took place in Munich earlier this month and was centred on the theme of Making the Most of New Technology. Below is a quick round-up of proceedings on Day 2.

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Ed Rowland opens Day 2 proceedings

Ed Rowland opened the conference with an update on key drivers and dynamics in the US OTC strategic landscape. Akhil Chandra of Reckitt Benckiser led us into our final networking hour with a discussion on what makes an iconic brand in a world of biosimilar products. Chandra based his talk around the “iconicity” of Nurofen, insisting that when it comes to brands we should challenge the tendency to default, and instead create, identify and nurture iconic / symbolic elements.

Following an hour of networking with OTC peers, our delegates returned for our final session with Jesus Carrasco, Head of Healthcare at Société Générale, who discussed consolidation and the increasing attractiveness of the consumer healthcare industry from a corporate and investor perspective.

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Thornsten Umland from Bayer gave the final presentation on strategic growth and how to build OTC businesses and brands via well executed acquisition and true product innovation.

And finally, a personal message from Nicholas: “Thank you all for making a brilliantly successful conference, the array of speakers and topics covered have certainly left us all with food for thought on the OTC landscape in a world of digital!

As an official announcement, now the conference has ended, we hope to see you next year in… BARCELONA for our 29th European OTC conference #NHOTC18. Auf Wiedersehen or should I say… Adios!”

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Changing pharmacy for changing Germany

Germany is ageing, and fast – the UN puts the current average age at 46, second only to Japan, with the number of people over 60 set to reach 39% of the population by 2050. As younger Germans increasingly leave for the big cities, many small countryside towns are becoming depopulated, making it both hard for independent pharmacies to stay open and then to find replacements for them.

The small German town of Hüffenhardt – population 2,000 – is one such case, but luckily DocMorris has come up with an innovative solution to the problem – the telepharmacy, set to be opened as a pilot project in summer 2016. In the space of the old pharmacy, Hüffenhardt residents will be able to access a video screen linking them with a live pharmacist, with whom they can hold individual private discussions on health complaints, receive advice and product recommendations. At the end of the consultation, consumers can then choose to buy an OTC, or to hand in a GP prescription for checking, with the medicines then dispensed via a terminal controlled by the pharmacist. OTCs and Rx products which are not immediately needed can be delivered via DocMorris’ standard mail order service, or picked up at the neighbouring town at the next visit.

Hüffenhardt mayor Walter Neff commented: “The closure of our pharmacy affected our elderly and less mobile residents, who had to walk several kilometres to the next town to pick up medicines. Thanks to digital advances, Hüffenhardt residents can get personal face-to-face advice and pick up the most important medicines directly in the town”.

A longer version of this article will appear in the March 2016 issue of Nicholas Hall’s OTC INSIGHT Europe, a monthly publication reporting on OTC trends & developments throughout the region. For details on how to subscribe, contact melissa.lee@NicholasHall.com.

 

OTCs in Action Episode 59: Erasing painful memories in Russia

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“Our life is full of events, sometimes unintended and unpleasant. None of us are immune from falling, getting cut, being in an accident or having surgery. Fortunately, the modern level of medicine is that most of these situations are repairable. But the memory of the incident is likely to scar. Unfortunately, the scar does not always work carefully and quietly. If this happens to you, know that you are not alone. Pathological scars – a common problem. About 15% of people who have had any surgery or injury have unsightly scars. This means that over a million people are in need of treatment. Imoferaza cream will help you to adjust the appearance of the scar and make it inconspicuous.” (translated from Russian)

This week OTCs are in Action in Russia, where NPO Petrovax Pharm has launched Imoferaza to treat scarring with hyaluronidase enzyme technology. The product acts on the connective tissue that forms the basis of a scar. Applications described on the brand’s website include skin injuries, burns, tattoo removals, piercings, acne (post-acne) and make the preventive claim of “reduces the likelihood of unsightly scar”. The active ingredient is delivered in a cream formulation that soothes and softens skin while helping it retain moisture.

Although the technology is surely a benefit for Russian consumers, what caught OTCs in Action’s eye is the brand’s website graphics, which emphasise the emotional pain that can linger from scars:

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For more information on Nicholas Hall’s OTC INSIGHT regional journals, click the link below:

http://www.insight.nicholashall.com

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.

New transparency rules in Canada will affect OTC marketers

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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.

OTCs in Action Episode 15: E-Commerce excitement in China

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Online purchases of OTCs in China are in action, according to James Fan, CEO, JOWIN China Group and Nicholas Hall’s Network Partner.

In 2014, Alibaba issued the world’s largest IPO (raising funds of US$25bn), increased its investment in its pharma dispensing e-business and aggressively developed 
its online healthcare shopping arm. It also supported many cloud-based health projects and encouraged traditional distributors to develop their online businesses.

“Double-digit growth of OTCs online and a rise of 20% among big brand nutritionals and cosmeceuticals proves that Chinese consumers are convinced by e-healthcare product providers. Tmall – operated by Alibaba – reported the Top 3 brands purchased on its site last year were Dong-e E-Jiao (Dong-e E-Jiao Group), Caltrate-D (Pfizer) and Fupai E-Jiao (Shandong Fujiao), which grew on average by more than 30% vs 2013. All three products have numerous line extensions that meet a range of daily healthcare needs. Regulations are set to allow the online prescription market to open up, too. Meanwhile, we believe the next digital healthcare hotspot in China will be at-home devices that can be used alongside online and mobile technology.

OTC in Action Episode 2: Seducing voters with OTC oral contraceptives?

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OTCs are in action for political gain, with US Republican Senate candidates in four states proposing the oral contraceptives should be switched from Rx-to-OTC to expand access for consumers, whilst diverting free Rx OCs for consumers from mandated health insurance coverage, according to a Wall Street Journal article published on the 10th of September.

Under the Democrat-supported Affordable Care Act, Rx oral contraceptives are a preventive health service and, as such, are covered with no out-of-pocket cost to women. Many opponents of the ACA, including Republicans and health insurers, oppose this benefit. Of course, this opposition does not play well with some voters, including women who are eligible for the OC benefits. By calling for OCs to be switched to OTC, candidates are hoping to appease voters with more convenient access, while gratifying insurance companies by taking the Rx OCs off their benefits list.

Not so fast, though, says the American Congress of Obstetricians & Gynecologists. The candidates’ use of the respected medical group’s past endorsement of OTC OCs to justify the switch may backfire. Dr John C Jennings, President of the ACOG, rebuked the candidates, commenting: “We feel strongly … that OTC access to contraceptives should be part of a broader dialogue about improving women’s healthcare, preventing unintended pregnancies and increasing use of contraception, including long-acting reversible contraception (LARC). Over-the-counter access should not be used as a political tool by candidates or by elected officials.”

Ultimately, it’s a risk-benefit decision to be made by the FDA based on scientific and consumer studies, and there appears to be no such application on the docket. However, we at Nicholas Hall & Company believe OCs will switch eventually. Last spring, OTC INSIGHT Asia Pacific reported that the progressive Medicines Classification Committee in New Zealand, which often serves as a bellwether for Rx-to-OTC switches, said the proposed switch of several OCs to pharmacy-only classification “could work” if the applicant, Green Cross Health, included more collaboration with GPs in its proposal.