Editor’s Introduction to Cough, Cold & Allergy

Sneak peek at some highlights from Global OTC Cough, Cold & Allergy

With so much going on in the US allergy remedies category ­– from Allegra’s swift dash up the rankings to the switch of intranasal corticosteroid Nasacort, from new A+P campaigns to allergy extensions of blockbuster cough & cold brands Mucinex and Vicks – it is small wonder that it was the source of double-digit growth (+11%) in 2014. Not to mention 2015 developments like the February debut of Flonase and the planned launch of Rhinocort. Yet this was just one of a handful of strong performances around the globe in the past year, with the global CCA market responding positively to a spike in flu infections across several regions, switch activity, format innovation and other new launches.

A handful of highlights from around the globe include:

  • In Brazil the move to Rx status of vasoconstrictor-based nasal decongestants led to a significant downturn, but innovative launches subsequently revived topical decongestants sales
  • China’s cough and sore throat remedies benefited from A+P targeting smokers, both for treatment of respiratory conditions caused by smoking and for freshening breath
  • In France dereimbursement is gradually transforming CCA into a pure OTC market, with increasing numbers of semi-ethicals losing reimbursement and becoming pure OTCs – and so able to be advertised
  • CCA is Russia’s largest OTC category by a considerable margin, with over $400mn separating it from VMS (second largest category); CCA options are prominent on a proposed mass market list
  • In Turkey marketers are increasingly launching products classified as food supplements (particularly throat lozenges) and medical devices (notably saline topical decongestants) as these are less tightly controlled than registered medicines

For a comprehensive view of the Global OTC Cough, Cold & Allergy market, including in-depth coverage of the 15 leading CCA markets, check out our just-published report. For more information, download the brochure or contact Nino Hunter.

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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.

OTC INSIGHT North America Blog: Canada Unveils New OTC Regulations

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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.

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.

Scottish Independence: The Healthcare Aspect

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This week the people of Scotland will decide whether to end the country’s 300-year+ political union with England and the rest of the UK. As a Scot without a vote – owing to my residence in England – I’ve been watching from the sidelines while the debate has swirled around fundamental issues such as currency, the economy, EU membership and defence.

Healthcare – in particular, the NHS – has also been a key issue. This is despite the fact that, in the short-term at least, day-to-day healthcare provision will be unaffected, as the NHS and wider healthcare policy are already fully devolved to the Scottish Parliament. In addition, the Scottish Government intends to continue using the MHRA as medicines regulator, which should hopefully prevent a divergence in medicines regulation and access (imagine the absurdity of a medicine being deemed safe for OTC distribution in England but not Scotland …).

One can only guess how independence could affect health provision in Scotland in the long-term. Scotland currently enjoys higher NHS spending per head of population than England, while the Scottish Government has introduced flagship policies such as “free” prescriptions and personal care for the elderly (there’s nothing free about it of course, as patients pay for it through taxation), which it claims will be maintained if Scotland goes it alone. Opponents have questioned the affordability of such policies, casting doubt on the pro-independence camp’s estimates regarding the income it will receive through oil revenue and job creation.

What is clear, no matter which way the vote goes, is that Scotland will continue to face some strong public health challenges, with life expectancy remaining below that of the UK average for both men and women. For example, a report earlier in 2014 stated that Glasgow – Scotland’s largest city – has lower life expectancy than most of the developed world, with 25% of boys born there expected to die before the age of 65, owing mainly to poor lifestyle. Perhaps we’ll never find out how an independent Scotland would tackle these problems, but ultimately all that matters is that they are tackled.

What Causes the INNOVATION Slowdown in OTC from OTC INSIGHT Europe

Chris INSIGHT Header 2014The April edition of OTC INSIGHT Europe contains a full round-up from Nicholas Hall’s 25th European OTC Conference & Awards, held in the beautiful city of Luzern, Switzerland, last month. Innovation – or the lack of it – was the core theme, with the majority of delegates in agreement that a new approach is required in order to boost growth in our industry.

Several expert speakers reminded us that true innovation is about a whole lot more than traditional product line extensions or marketing campaigns; at its core is the desire to solve an unmet need and make a real difference to the consumer experience. How much successful innovation of this kind have we seen in the European OTC market over the past few years?

Frustrating regulatory issues undoubtedly play a part in limiting change of this kind, especially a risk-averse approach to Rx-to-OTC switch alongside a lack of incentives such as marketing exclusivity. As well as lobbying regulators and governments to explain the real public health and economic benefits offered by OTC, healthcare companies should also embrace problem solving, creative thinking and calculated risk-taking in order to have the best chance of nurturing game-changing innovation.

You can read more on about the the events within the OTC industry in Europe in our month OTC INSIGHT Europe periodical.

Big Growth for the New Year – Nicholas Hall’s OTC INSIGHT Latin America

Cath INSIGHT Header 2014We have just published the January / February issue of OTC INSIGHT Latin America. Our Market Report focuses on Gastrointestinals and it has been a good year for the industry with each Big 4 country and all sub-categories posting growth. Lots of activity has been seen in antacids & antiflatulents where a flurry of innovative launches and line extensions have increased competition. Marketers are expanding their consumer base by extending brands into niche segments, such as Bayer’s Alka-Seltzer Boost in Mexico, positioned to relieve hangovers, while on-the-go line extensions from GSK and Hypermarcas in Brazil offer consumers convenience.

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