What sort of winter for CHC is coming?

With the northern hemisphere estimated to generate around 90% of sales in the global CHC market, the impact of the coming cough & cold season is crucial to the market’s performance in Q4 2020. Recent indications from the southern hemisphere gave us some clues of what’s to come – according to a recent report by the CDC, from April to July (peak flu season in the southern hemisphere), there were only 51 positive flu tests out of more than 83,000 people tested in Australia, Chile and South Africa, for a positivity rate of 0.06%. In contrast, during April to July in the years 2017-19, nearly 14%, or 24,000 out of 178,000 people, tested positive for flu in those three countries.

Despite the expected low positivity rate of flu in the northern hemisphere in Q4 2020, as a result of improved hand hygiene and social distancing, the return to school in many countries is likely to lead to an uptick in cough & cold infections. According to Lucy Rigby, Senior Brand Manager of UK cough remedy Tixylix (in a quote to Wholesale Manager): “Going forward, we believe that parents will be much more conscious of their children’s health risks as schools and nurseries reopen, and are likely to stock up on OTC medicines prior to the peak winter months.” In addition, Paul Trethewy, Controller for Wholesale and Convenience at GSK, said: “With the NHS continuing to face overwhelming pressure and with GPs de-prescribing cold medication, we’re expecting the impulse channel to be an important provider of OTC cold & flu treatments.”

Source: Nicholas Hall’s upcoming Cough, Cold & Allergy Report

Whether any upcoming surge in demand for OTCs leads to the same constraints on supply seen in Q2 2020 remains an open question. Europe’s OTC industry body, AESGP, last week welcomed European Parliament plenary approval of the Report on shortages of medicines — how to address an emerging problem. AESGP agrees that shortages are of particular concern when they affect medicines for which no or limited alternatives are available, however in the case of OTC medicines, because substitution is possible and alternatives exist in most situations, it believes any shortage of a product will translate into little to no impact on the outcomes of self-care. Though the AESGP considers diversification of the supply chain to be a long-term strategic option, including greater independence brought by onshoring manufacturing and production of certain non-Rx medicines and APIs, it said this strategy was hardly actionable in the short-term.

One ingredient that remains under the spotlight is paracetamol (acetaminophen). India lifted restrictions on the export of APIs of paracetamol in late May 2020, but has continued to monitor usage of the ingredient in the domestic market. According to an article in Business Standard, OTC paracetamol sales have taken a hit in India over recent months owing to government legislation designed to monitor use of the ingredient, as well as CCA remedies, but these restrictions are now starting to ease and a spokesperson at GSK expects “sales to pick up in the coming months”. GSK’s Calpol and Crocin brands have been two of the products impacted by this extra vigilance over paracetamol use, but the short-term outlook for the ingredient and India’s OTC market is now improving.

With less than two weeks to go, register now for our new hot topics webinar! You will hear about key trends, including the impact of Covid-19, Distribution, e-Detailing and Sustainability. To find out more, or to register to join on 30 September, please contact elizabeth.bernos@NicholasHall.com.

How will CHC supply chains evolve in Covid-19’s wake?

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Supply chain issues are high on the agenda of consumer healthcare marketers in the wake of the Covid-19 pandemic. Bayer said in its Q1 results that its Consumer Health division was able to respond very flexibly to significantly higher volumes and shifts in the product mix thanks to its supply chain operation. In addition, RB last week appointed Sami Naffakh as Chief Supply Officer and member of the Executive Committee, effective 1st July 2020. RB CEO, Laxman Narasimhan, said: “Throughout the Covid-19 pandemic, the global supply chain teams have worked tirelessly to step up for our consumers and our customers. As we continue to ‘navigate our new normal’, we must also start to focus on our medium-to-longer-term supply needs across the entire, diverse portfolio.”

Novartis’ supply chain has also coped well during the pandemic, thanks to the extraordinary efforts of its staff – as outlined in this report – but some companies have been harder hit. In February 2020, Blackmores downgraded its FY2020 forecast saying that, while the outbreak has increased demand for key immunity products, this has been countered by supply chain disruptions that the company expected would continue to affect China sales for at least 2-3 months.

As our graphic below shows, China is a key producer of active ingredients (APIs), and absolutely vital to the world supply of ascorbic acid (vitamin C), for example. India, which imports most of its APIs from China, has been hit hard by disruptions in the supply chain, and in March 2020 the Government banned the export of 20+ APIs to protect the supply of essential medicines in the domestic market. This had knock-on effects around the globe, however last week India’s Directorate General of Foreign Trade lifted restrictions on the export of active pharmaceutical ingredients of paracetamol.

China, IndiaIn a recent report by the Economist Intelligence Unit (EIU), called “The Great Unwinding”, more and more companies are said to be moving parts of their supply chains away from China, a trend accelerated by Covid-19, with multinationals seeking to build “quasi-independent regional supply chains in the Americas and Europe”, to ensure future resilience. In addition, the report indicates that another long-lasting impact of Covid-19 will be companies looking to store inventory in “strategic locations from where it can be easily accessed and delivered to customers”.

The pharmaceutical industry is also facing rising prices of raw material. According to data from India’s Pharmaceutical Export Promotion Council (Pharmexcil), the cost of paracetamol went up up 50-60% at the start of the Covid-19 pandemic, and the prices of vitamins increased by 40-50%. As the EIU report indicates, companies will need to think strategically about pricing models, given that “both the regionalisation of supply chains and the build-up of strategic inventories will push up final goods prices, denting a product’s competitiveness”. However, one of the upsides to this change is that “a more regionalised supply chain will offer opportunities for companies to focus more on local tastes amid a greater capacity for product differentiation”.

Very soon we will be publishing the second edition of our hot topic review, Coronavirus 2020 and its potential impact on CHCThis report from our Competitive Intelligence & Market Analysis (CIMA) division explores the response to the pandemic from CHC brands and marketers as well as the overall impact on CHC to date. You will also be able to read about trends observed so far (key categories impacted, how consumer behaviour has changed etc), how key CHC players performed in Q1 and projections for the near and longer-term.  If you have purchased the original Coronavirus 2020 Review, you will receive the 2nd edition free of charge. For more information, or to purchase your copy, please contact Melissa.Lee@NicholasHall.com

Highlights from the Q4 update

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The latest quarterly report on the global CHC market is now available on the CHC DASHBOARD website, including data & trends on the market’s performance at a global, regional and country level (for all 63 markets) in the year to end-December 2019. Here we highlight some of the key topline trends from this update, selecting one major global development from each of our company, category and brand watch sections.

Company Watch: Stada enters the global Top 20

While the list of global Top 5 CHC marketers remains relatively stable, one company that shot up the global rankings in late 2019 thanks to M&A activity, and now claims the No.11 position worldwide, is Stada. The German marketer agreed two major deals in November 2019 that elevated it into the global Top 20. First, as part of Takeda’s goal to divest around US$10bn in non-core assets, Stada bought around 20 selected OTC and Rx products marketed in Russia, Georgia & CIS countries, for US$660mn. Secondly, Stada entered into an agreement to acquire Walmark from Mid Europa Partners for an undisclosed sum. With global No.9 Takeda reportedly now planning to sell its wholly owned OTC subsidiary, Takeda Consumer Healthcare, Stada may feature soon among the Top 10.

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Category Watch: Analgesics already accelerating before Q1

Driven by accelerating growth in North America and Europe in Q4, analgesics recorded an upturn of 4.7% in 2019, ensuring the category’s best performance in three years. This trend looks set to accelerate even further in Q1 2020, with various top marketers reporting very strong analgesics growth for their key brands in the latest quarterly results, as a result of the Covid-19 pandemic. In 2019, topical analgesics still grew faster than systemics, though the latter showed the strongest improvement in growth, powered in particular by upturns in USA, Brazil and Germany.

Brand Watch: Vicks and Tylenol race ahead

Only two CHC brands generate more than US$1bn in sales globally – P&G’s global No.1 Vicks and J&J’s global No.2 Tylenol – and both also grew more than twice as fast as the global CHC market overall in 2019. The latest company quarterly results indicate that both brands have shown further acceleration in Q1 2020, driven in particular by gains in North America.

Thank you to everybody who attended Nicholas’ CHC Trends Webinar! If you were unable to join live, you can now purchase a recording of the full discussion, and submit up to 3 questions via email. To find out more or to purchase your copy of the recording, please contact elizabeth.bernos@NicholasHall.com

CHC market forecast to hold up well in 2020

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Forecasts released by Nicholas Hall’s CHC sales database DB6 project that the global retail CHC market is expected to slow to 3.5% in 2020 amid the Covid-19 pandemic.

  • Analgesics are expected to increase to 6.1% driven by strong sales of paracetamol-based systemics, while topicals are forecast to slow to 3.3% in spite of the switch of Voltaren in USA
  • CCA is projected to be the fastest-growing category with an increase of 6.5% boosted by coronavirus and reports of a high incidence of seasonal cold & flu at the start of 2020
  • GIs (+0.4%) and Derma (+0.8%) are expected to remain static as consumers cut back on non-essential purchases amid the tougher economic environment
  • Antiseptics & disinfectants are forecast to buck the low-growth trend in derma with a double-digit increase
  • Lifestyle CHC sales are predicted to slow to 1.8%, with erectile dysfunction (+13.2%) and sedatives & sleep aids (+7.8%) bright spots in an otherwise challenging category
  • VMS sales are expected to maintain growth of 3.4% with anticipated gains in some subcategories — notably vitamins C & D, zinc and immune supplements, offset by a deceleration in some other subcategories

The market is expected to bounce back in the longer term with a forecast CAGR 24/19 of 4.3% and CAGR 29/24 of 4.7% driven by switch, most notably of erectile dysfunction and daily oral contraceptives. CBD is not included in these retail forecasts.

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DB6 VP, Celine Waller writes: The Covid-19 pandemic has prompted an unprecedented surge in sales of certain CHC products as consumers have stocked up on essential medicines and sought products to protect their health. However, latest data points suggest that this spike has been short-lived with the market now stabilising and in some cases receding. We expect this trend to continue over the next few months, leading to a slight slowdown in CHC retail sales across 2020 in its entirety, although of course the industry is expected to be far more resilient than many others.

However, this only tells part of the story – as consumers are unwilling or not permitted to leave their homes, we expect an acceleration of the channel shift from bricks & mortar to e-Commerce. CHC sales in the Internet & Mail Order channel are forecast to increase by 22.5% in 2020. This will boost growth of the holistic “all channels” view of the market, which also includes CBD, to 5.0% in 2020 (an improvement on 4.3% in 2019). Internet & Mail Order is expected to account for 19.2% of the total CHC market within next decade, more than doubling its share from 9.4% currently. 

We are pleased to announce the latest DB6 market forecasts are now available! With over 150,000 pieces of data across 63 markets, DB6 now includes topline data across all channels of distribution, including e-Commerce! To find out more about our extensive database or to set up a free demo, please contact Kate.Holdcroft@Nicholashall.com.

Covid-19: France advises against ibuprofen to treat symptoms

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France’s Health Minister Olivier Véran delivered a message via his Twitter account over the weekend, advising against taking anti-inflammatory medicines (ibuprofen, cortisone, etc) to treat Covid-19 symptoms, as they could be an aggravating factor for the infection. His advice for those with a fever was to take paracetamol instead. Patients already on anti-inflammatory drugs for other illnesses, or anyone with any questions, are advised to seek advice from their doctor.

Public health interventions like this, with directives specifically citing which OTC medicines to take or not take, are rare and so the story was picked up by major news outlets in the UK (Guardian), USA (New York Times) and elsewhere. According to a report in The Local, Véran’s tweet prompted several members of the public to ask for the source of his reasoning on not taking ibuprofen to treat Covid-19 symptoms. The main concern appears to be that anti-inflammatories have an “immunosuppressive effect“, plus the background in France is that medicines agency ANSM has already removed medicines containing paracetamol, ibuprofen and / or aspirin from the self-selection list in January 2020 to reinforce the advisory role of the pharmacist and guarantee safe use.

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Meanwhile, the effect of the Covid-19 pandemic on sales and availability of painkillers in other markets is already becoming evident, with UK retailer Boots imposing a limit of two items per customer on cough & cold and pain medicines and US marketer J&J reporting a spike in demand for its Tylenol range and other self-care products. In the wake of the Covid-19 outbreak, and India’s decision last week to restrict the export of some ingredients (including paracetamol), there have been fears of shortages and disruptions to supply chains, but J&J said it did not anticipate a shortage of Tylenol and that it was taking all possible measures to maximise availability of its consumer healthcare range.

The good news is that we have extended the campaign entry criteria and deadline for our 2020 Marketing Awards! Coinciding with the new event dates, the Awards will now be presented on 30 September during our 31st European Conference in Athens on 29 September–1 October 2020. If you’re proud of your latest campaign or brand, ensure that you enter before the new deadline of 14 August! For more information on entry criteria, contact jennifer.odonnell@NicholasHall.com without delay.

Combination OTC painkillers gaining ground

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Following the approved switch of Voltaren Arthritis Pain by the FDA in mid-February, there was more positive news for GSK’s US analgesics portfolio over the weekend with the FDA approval of Advil Dual Action. This is the first FDA-approved OTC combination of ibuprofen and paracetamol (acetaminophen) in the USA, and GSK is expected to launch the product later this year.

Franck Riot, Head of R&D at GSK Consumer Healthcare, said: “For decades, many consumers have been using ibuprofen and acetaminophen (paracetamol) to get the benefits of both active ingredients when safely treating their headaches, muscle aches, backaches, arthritis and other joint pain. Now Advil, the No. 1 selling OTC pain reliever, will offer US consumers the first-ever alternative option – a single, fixed-dose combination pain reliever.” According to the reported clinical research, this fixed-dose combination achieves superior efficacy compared to the individual monocomponents of ibuprofen (250mg) and acetaminophen (500mg) alone.

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Dolostop Plus, another recent combination launch

Another combination OTC painkiller we tracked recently, formulated with both ibuprofen and paracetamol, is Kern’s September 2019 launch of Dolostop Plus in Spain. Indicated to provide symptomatic relief from mild to moderate pain in adults, these film-coated tablets are formulated with paracetamol 500mg and ibuprofen 150mg, with a stated dose of 1-2 tablets every 6 hours, and claimed to be the first and only OTC paracetamol and ibuprofen combination available in Spain.

In several markets around the world, such as the UK, Russia, Japan and Indonesia, combination paracetamol + ibuprofen OTC remedies are already well-established, but these recent developments in the USA and Spain point to growing acceptance among global regulators about the safety of fixed-dose OTC analgesic combinations.

Where will NPD take the CHC market in the future? Find out in our upcoming report, Innovation in CHC: NPD & Innovation in CHC under the Spotlight! This report, drawing on Nicholas Hall’s CHC New Products Tracker, assesses the global picture of CHC innovation in 2019, featuring ingredient trends, delivery format trends, analysing innovation trends by region and by marketer, plus much more! To pre-order your copy and save with the pre-publication discount, or for more information, please contact melissa.lee@NicholasHall.com.

GSK and Alcon get FDA approval for US switches

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Following on from our recent blog highlighting the need for a new wave of Rx-to-OTC switches to kickstart growth in the global consumer healthcare industry, this week we cover the welcome news that the FDA has approved three drugs for non-prescription use. As well as GSK’s topical analgesic gel Voltaren Arthritis Pain (diclofenac sodium 1%), two Alcon eye care allergy products (available as solution / drops) have also switched to OTC status – Pataday Twice Daily Relief (olopatadine 0.1%) and Pataday Once Daily Relief (olopatadine 0.2%).

Karen Mahoney, Acting Deputy Director of the Office of Nonprescription Drugs at the FDA’s Center for Drug Evaluation & Research, said: “Approval of a wider range of non-prescription drugs has the potential to improve public health by increasing the types of drugs consumers can access and use that would otherwise only be available by prescription. This includes providing the millions of people that suffer with joint pain from arthritis daily over-the-counter access to another non-opioid treatment option.”

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Olopatadine is available OTC in a handful of other countries worldwide, but this is the first time it’s been switched in a major market. One of the countries where the ingredient can be purchased without a prescription is Singapore, which approved the Rx-to-OTC switch of olopatadine 0.1% and 0.2% in December 2016. More recently, Poland’s Office for Registration of Medicinal Products, Medical Devices & Biocidal Products (URPL) approved the Rx-to-OTC switch of Polfa Warszawa’s Starelltec Alergia eye drops (olopatadine 1mg / ml; 5ml bottle) in July 2019 and Adamed’s Oftahist eye drops (olopatadine 1mg / ml; 5ml bottle) in November 2019.

Voltaren currently ranks fifth among the world’s leading consumer healthcare brands, according to CHC DASHBOARD, and this switch could see it move up the rankings and even move ahead of its new GSK stablemate Advil into the No.3 position globally within the next few years. While the US switch of Voltaren has long been mooted, the news is all the more welcome at a time when the world’s No.1 CHC market is in desperate need of an injection of growth, and US arthritis sufferers are also in need of a wider pool of OTC non-opioid treatment options.

For the full story, be sure to read tomorrow’s edition of CHC.NewDirections, a weekly e-newsletter sent out every Tuesday. CHC.NewDirections focuses on innovation, science and regulation, and coverage spans Rx-to-OTC switch, CBD, relevant medical research, probiotics, medical devices, digital health / AI, e-cigarettes and much more! For more information, or to arrange a free trial, please contact Melissa.Lee@NicholasHall.com

Rx-to-OTC switch outlook for 2020

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One of the factors contributing to lower global consumer healthcare growth in recent years has been a falling-off in Rx-to-OTC switch activity in key markets like Japan and the USA. Looking ahead, however, there are reasons to be positive. In December 2019, Sanofi CEO Paul Hudson cited the company’s “plans to accelerate the over-the-counter switches for Cialis and Tamiflu” in order to fulfil its ambition of growing faster than the CHC market over the mid-term. In light of the current coronavirus epidemic, the benefits of wider OTC access to flu remedies is all the more evident.

Sexual health is another category with huge Rx-to-OTC switch potential, notably erectile dysfunction medicines and daily oral contraceptives. Though the switch of Cialis (tadalafil) has been stuck at the FDA for several years now since its submission, sildenafil (Viagra) is enjoying ever wider OTC availability, especially in Europe. After switching in Poland in 2016, sildenafil was launched as Viagra Connect (Pfizer) in the UK in 2018 and will be launched OTC as Viagra Reseptfri in Norwegian pharmacies in early 2020.

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There is also renewed interest in OTC triptans for migraine. A handful of switches took place in the mid-2000s but were held back by OTC purchase limits (a 2-tablet emergency pack). Over the past year, various countries have again began discussing triptan switches including Australia, Ireland and Germany (which is expected to expand the number of triptan molecules in the OTC sector), though major expansion of the segment is unlikely without larger pack sizes.

All that said, reverse-switch remains a threat and one OTC ingredient of ongoing concern is codeine. In late 2019, New Zealand’s Medicines Classification Committee, following Australia’s lead, recommended that all codeine-containing medicines should be reverse-switched from OTC to Rx. In January 2020, citing “widespread concern about the abuse of codeine-containing preparations nationally and globally”, the South African Health Products Regulatory Authority said it is reviewing the scheduling status of codeine and codeine-containing medicines which are available without a prescription.

CHC.NewDirections is an e-newsletter sent every Tuesday, with a focus on innovation, science and regulationCoverage spans Rx-to-OTC switch, CBD, relevant medical research, probiotics, medical devices and new delivery formats, digital health / AI, e-cigarettes and much more! For more information, or to arrange a free trial, please contact Melissa.Lee@NicholasHall.com

Time’s 100 Best Inventions of 2019

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Time magazine has just published its annual round-up of the 100 best innovations – based on key factors such as originality, creativity, influence, ambition and effectiveness – and healthcare was the best represented category with 10 innovations in 2019. Most have been designed for use in primary care settings, such as GE Healthcare’s new Senographe Pristina with Dueta mammogram, but there were several innovations designed for consumer use.

One of these is Tivic Health’s ClearUp, which was added to our OTC New Products Tracker database following its launch in September 2019. Positioned as a drug-free handheld device to treat sinus pain owing to allergic rhinitis, ClearUp delivers microcurrent waveforms to sinus nerves under the cheek, nose and brow bone. The medical device provides three intensity levels for personalised usage, and each treatment takes five minutes to perform and lasts for up to six hours.

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Tivic Health’s ClearUp for sinus pain

Also on the Time Best 100 Innovations of 2019 list were portable ultrasound device Butterfly iQ, Theranica’s drug-free migraine treatment Nerivio and handheld doctor examination kit TytoCare. The latter retails for US$299 and has been designed to eliminate the need for a doctor visit by examining the lungs, ears, skin and throat with special adapters and then video­conferencing a doctor to monitor the metrics in real time. According to TytoCare CEO Dedi Gilad: “It transforms primary care by putting health in the hands of consumers.”

As for Nerivio, it was described as the “first smartphone-controlled acute migraine-relief wearable device” when it gained de novo FDA approval in May 2019. The medical device, which is not suitable for people with chronic migraine, is placed on the upper arm and uses smartphone-controlled electronic pulses to create a Conditioned Pain Modulation (CPM) response. Alon Ironi, CEO and co-founder of Theranica, has said the product will be launched at an “affordable price” when it comes to market in 2020.

Don’t miss out on the chance to save 30% on a subscription to the ultimate tool for tracking consumer healthcare innovation, OTC New Products Tracker! We’ve recently hit over 20K entries and made some innovative improvements within the past year, including powerful new graphs, additional filter options, PowerPoint export, Save & Search options and monthly customised innovations reports. Until the end of 2019 we are offering an exclusive 30% discount off list price — please contact waisan.lee-gabell@nicholashall.com to find out more!

France clamps down on OTC painkillers

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First came a public consultation launched by French medicines agency, ANSM, in August 2018 on how to increase consumer awareness of the risks of paracetamol misuse or overdose. Then followed the decision in July 2019 that, within 9 months, all paracetamol-based medicines must carry a prominent warning on packaging, to inform consumers about risks associated with paracetamol overdose, particularly hepatotoxicity. Paracetamol is the most commonly prescribed and used medicine in France, and the change affects more than 200 medicines.

Now, the ANSM has decided that, to reinforce the advisory role of the pharmacist and guarantee safe use of medicines containing paracetamol, ibuprofen and / or aspirin (in particular to avoid the risk of overdose), such products should be removed from the OTC self-selection list from January 2020 and kept behind the counter in pharmacies. ANSM has launched a consultation period with marketers, who have one month to comment.

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According to our estimates, the decision (if implemented) could affect around 90 SKUs on the French market. This includes the trio of leading paracetamol-based brands – Doliprane, Dafalgan and Efferalgan – as well as the top OTC ibuprofen-based (Nurofen, Advil) and aspirin-based (Aspirine Upsa) analgesics. Various OTC generics from the likes of Biogaran, Sandoz and Mylan, as well as systemic cold & flu remedies (Fervex, HumexLib) and topical analgesics, could also be affected.

The true effect that this decision could have on sales of OTC systemic analgesics remains to be seen, but it would clearly not be welcome news for marketers active in a category that remains in persistent decline, in part because of another regulatory decision (reverse-switch of codeine in July 2017). Leading brands such as Doliprane (Sanofi) and Efferalgan (formerly BMS, now Taisho) are available in both semi-ethical (reimbursed) and pure OTC versions, the latter often backed by TV ads, and it’s these latter SKUs which marketers have invested in over recent years that are most at risk.

Rapid regulatory change will be one of the themes at Nicholas Hall’s upcoming OTC.NewDirections Executive ConferenceTaking place in London on 14 November, the meeting will ultimately focus on the latest CHC Innovations and Technologies, with presentations from RB, Mundipharma, J&J and many more experts from CHC and beyond. To book your place or find out more, please contact jennifer.odonnell@NicholasHall.com without delay.