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.

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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Key Trends around Gastrointestinals from OTC INSIGHT Europe

Chris INSIGHT Header 2014The latest issue of OTC INSIGHT Europe includes a round-up of the key trends & developments affecting the gastrointestinals category in France, Italy, Spain and the UK. It was a disappointing picture overall, with a significant decline in revenue for semi-ethicals in France dragging down the topline.

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OTC INSIGHT North America: Analysis of OTC Gastrointestinals market

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We start 2014 with good news for OTC INSIGHT subscribers; our new website offers an improved search facility, which will help readers navigate more easily through our archive going back to 2003 and offers an enhanced search function, making it easier than ever before to find the information or data that you need.

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