Sanofi CHC on track to be standalone unit by end-2022

At Sanofi’s Capital Markets Day 2021, the company’s Head of Consumer Healthcare, Julie Van Ongevalle, shared her vision for the business: “With the ongoing implementation of our fully integrated standalone model, we look forward to being more agile and reducing the complexity of our portfolio to drive growth with our consumer-centric, data-driven marketing approach.” The aim is to divest around 150 brands (from the current 250) in the next two years to focus on “priority categories”, such as allergy, body pain, general pain and mental wellness – particularly sleep aids – via a “granular approach”.

Rx-to-OTC switch has already been a key factor in driving growth in one of Sanofi’s priority categories, allergy remedies, thanks to the successful global OTC rollout of Allegra (first available in the USA in 2011) and launch of Xyzal Allergy 24HR (USA, 2017). Josephine Fubara, Chief Science Officer at Sanofi CHC, noted that Sanofi continues to make progress in bringing two potential OTC switches to the market in the coming years, erectile dysfunction treatment Cialis and flu antiviral Tamiflu, presenting a blockbuster opportunity with a combined sales potential of €1bn in the US market alone.

Source: Sanofi Capital Markets Day 2021 presentation

Sanofi also stated that it is on track with its plans to be a standalone CHC business by end-2022. The company said that the overall planning for the transition was complete, and that the majority of its standalone CHC legal entities would be operational by end-2021. Among the benefits that Sanofi believes this transition will bring include the agility to reignite its innovation engine and reduce time-to-market by around 20%.

Looking ahead, Sanofi is targeting above average market growth, driven by its focus on priority categories and Rx-to-OTC switch, with a view to becoming the best-in-market CHC performer by 2024-25. Supporting this objective will be a focus on consumer insights, an emphasis on e-Commerce and digital channels and the operational independence provided by Sanofi’s standalone model.

Save up to GB£1,350 when you pre-order our forthcoming report from CHC New Products Tracker, Innovation in CHC: 2020’s NPD & Launch activity under the spotlight before 31 March. The report showcases the Top 100 innovations in 2020 and features major ingredient trends, delivery format trends, and much more. For further details, or to pre-order your copy, please contact melissa.lee@NicholasHall.com.

Allergy: NPD, switch & naturals power growth

While many of the leading CHC marketers reported declines for their cough & cold portfolios in Q3 2020, the performance of allergy remedies was more mixed, with notable variability by region. For example, Bayer reported rising sales for its Allergy & Cold portfolio in North America in Q3, partly driven by increasing sales for key allergy brand Claritin, which was boosted in early 2020 by the US launch of Claritin Non-Drowsy Chewables in a new cool mint flavour.

Likewise, Perrigo reported a strong performance for its Consumer Self-Care Americas unit in Q3, with increased OTC demand powered by allergy, pain and digestive health products. For Sanofi, while overall Allergy, Cough & Cold sales declined in Q3, portfolio sales were up in the USA, thanks to key allergy brands Allegra and Xyzal. Sanofi also launched its drug-free AllerLife range in the US market in early 2020, adding further fuel to the fast-growing naturals niche among allergy remedies.

Outside the USA, by far the world’s largest market for OTC allergy remedies, two countries that are performing very well are Germany and Brazil. Rx-to-OTC switch has been the driving factor in both markets, with various allergy ingredients – fexofenadine, ebastine and desloratadine – switched to OTC status in Brazil in recent years. As for Germany, after the switch of levocetirizine, which led to several OTC launches in April 2019, desloratadine was subsequently also approved for Rx-to-OTC switch in February 2020.

In October 2020, the EMA’s Committee for Medicinal Products for Human Use adopted a positive opinion recommending a change to the terms of the marketing authorisation for Ratiopharm’s desloratadine, potentially paving the way for an EU-centralised switch to non-Rx status for the allergy ingredient in the near future. Indications will be limited to adults only and the urticaria indication will be restricted to chronic idiopathic urticaria as initially diagnosed by a doctor.

Discover which marketers and brands stand out and how Covid-19 is impacting sales in our newly published Cough, Cold & Allergy report! Allergy remedies are just one of the many categories covered, alongside profiles of 10 major markets, forecasts and much more. For more information, or to order your copy, please contact melissa.lee@NicholasHall.com.

Digital strategy: Examples from China

In Sanofi’s recent Q3 earnings call, new head of Consumer Healthcare Julie Van Ongevalle said the company’s CH operation had “untapped potential”, and that her previous experience in the beauty industry would help with the strategy of leveraging consumer insights and maximising the digital and e-Commerce channel. In this week’s blog, we summarise three examples of innovative digital strategies by three companies (Alibaba, GSK and Bayer) operating in China.

Alibaba has kicked off its 11.11 Global Shopping Festival with new features to meet rapidly-changing consumer needs. These include the participation of Alipay’s digital lifestyle platform, broader consumer reach, as well as livestreaming technology creating more engagement for Chinese consumers, and with the largest international presence to date. A new sales window will be added from 1st-3rd November, ahead of the main event on 11th November, to provide merchants – specifically new brands and small businesses – the opportunity to showcase their products and tell their brand stories amid the pandemic. For many brands, 11.11 is the single biggest growth driver. This year, more than 2mn new products will be introduced, double the amount compared to last year.

OTC marketers are also building ties with local digital shopping platforms in China. GSK CH and Dingdang Kuaiyao have agreed a new strategic co-operation, which will utilise their R&D and data capabilities to drive growth and improve consumer access to healthcare products. Initially, the companies will focus on the concept of “Internet + Medicine” and work together to build brands and content, as well as consumer traffic and experiences. In 2021, the collaboration will cover brand awareness, global marketing, consumer trust and consumption scenarios. The news comes a month after GSK CH became an Alibaba “digital captain” after agreeing a joint business plan with its marketing technology platform, Alimama.

In addition, under a strategic co-operation agreement with digital shopping platform Meituan, Bayer CH aims to become a full-service healthcare solutions provider to help individuals better manage their own health. The businesses will work with 20+ chain pharmacies to integrate online and offline healthcare products and services by exploring digitalisation options, expanding consumer services and developing a new era of pharmaceutical retail. The co-operation aims to reach consumers more efficiently under the “new normal”, which has resulted in growing public awareness of healthcare issues, rising demand for healthcare products and a change in consumption habits, with online purchasing increasing significantly.

We are pleased to announce the next round of savings in our special Q4 promotional event, running until the end of the year! Plus, for November only we are offering a 25% discount on annual subscription rates for our combined CHC.Newsflash and CHC.NewDirections news service! If you would like additional information on any of our publications or subscriptions, or would like to place an order, please contact Melissa.Lee@NicholasHall.com

Q2 company results: Key trends & developments

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With all Top 6 CHC marketers and several important mid-tier companies having now reported their Q2 results, it’s a good time to analyse some of the key consumer health trends that have emerged in the second quarter of this turbulent year. Most notable is the downturn in Europe’s CHC market in Q2 2020, after an especially strong Q1, while North America’s CHC market has proven to be more robust so far. Also of note is the strong rise in e-Commerce sales for several CHC marketers.

Europe: Medicine cupboards already stocked

Marketers with well-developed CHC portfolios in Europe reported how “destocking” of medicine stores built up in Q1 had impacted regional OTC sales in Q2. GSK reported low single-digit decline for its pain portfolio in Q2, largely the result of this pantry unloading trend and the weak performance of Voltaren in Europe. Likewise, Sanofi reported a 13% decline in CHC sales in Europe in Q2, citing “consumer destocking” and low pharmacy traffic as key contributors to the regional fall.

Bayer, reporting on the wider EMEA geography, said regional sales fell 8.2% in Q2 after strong consumer stockpiling in Q1, with Allergy & Cold and Digestive Health the two categories most affected. Likewise, Mylan reported a 6% fall in its sales in Europe in Q2, as did several smaller CHC marketers, including Boiron, which recorded a 21% quarterly decline in sales in France owing to fewer doctors’ appointments and pharmacy visits.

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North America: J&J and P&G benefit from geographic mix

Bayer and GSK both reported dynamic VMS growth in the region in Q2, while Sanofi cited the “strong spring allergy season”, which boosted its Xyzal brand, as a factor in better Q2 sales in North America compared to Europe. Marketers with CHC portfolios more focused on the US market performed well, notably J&J, which reported a 10.7% rise in OTC sales in Q2 thanks to strong growth of Tylenol and Zarbee’s Naturals.

Like J&J, P&G benefits from a clear geographic focus on North America, and reported strong growth in the region in Q2 as a factor behind the double-digit rise in sales of its Personal Health Care portfolio, with Vicks and several other brands gaining share. Other CHC marketers with a particular focus on the region, including Perrigo and Church & Dwight, also reported stronger quarterly results in Q2 compared to competitors.

e-Commerce: RB and Nestlé report high growth

Another factor in rising organic CHC sales for Perrigo in North America in Q2 was continued robust growth in e-Commerce, more than offsetting category declines owing to lower brick & mortar foot traffic. Two other marketers that cited the impact of e-Commerce in their Q2 results were RB and Nestlé. For RB, e-Commerce sales rose by 50%+ and now represent 15% of total Health net revenue, while for Nestlé e-Commerce sales grew by 48.9%, reaching 12.4% of total sales.

Are the leading CHC marketers investing in e-Commerce? Do they have online platforms for their brands? Find out in our report Digital Marketing & e-Commerce: Tapping the Potential of Online Sales and Digital Promotion in Consumer Healthcare.  To order your copy, or to find out more, please contact melissa.lee@NicholasHall.com.

Market Movers Q1: CCA, VMS brands among fastest movers

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In this week’s blog, we take a closer look at our newly published Market Movers data for MAT Q1 2020, which highlights the brands that performed best and worst in terms of value sales growth or decline in that period. Certain marketers like RB, which last week reported a 12% rise in its OTC portfolio in Q2 2020, have found success from having a well-positioned portfolio of power brands in fast-growing, Covid-driven CHC categories, such as cough & cold remedies (Mucinex), immunity supplements (Airborne) and antiseptics & disinfectants (Dettol).

P&G also reported double-digit organic growth of its Personal Health Care portfolio in Q2 (fiscal Q4), powered by Vicks, which continues to gain share. Vicks NyQuil / DayQuil combo packs were among the six fastest-growing brands in MAT Q1 2020, along with one of China’s leading systemic cold & flu remedies, 999 Gan Mao Ling. VMS products also featured strongly among the Top 6 fastest-growing brands, with Olly and Emergen-C performing well in the US market thanks to their stress / immunity positioning, and Double Whale Vitamin D Drops achieving high growth in China. J&J’s Tylenol, the No.1 analgesic brand globally, also continues to produce dynamic Covid-driven growth.

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Asia-Pacific was the region that underperformed most in MAT Q1 2020 – achieving just 3.4% growth vs 6.3% for North America and Europe – so it is no surprise that five of the Top 6 worst-performing brands are from China or Japan. Tonics & cure alls was the subcategory most responsible for Asia-Pacific’s relatively low growth, with category sales down 25% in China, owing to issues with donkey breeding that have resulted in rising raw material costs and subsequent price rises, affecting two brands in particular – Dong-e E-jiao and Fu Fang E Jiao Jiang – while Hong Mao Medicated Wine was affected by negative claims.

OTC tonic drinks is another VMS subcategory hit by declining sales, with a continued downturn in Japan where the old, male consumer base is retiring and brands face competition from energy drinks. Takeda’s Alinamin EX was among the brands that declined fastest in MAT Q1 2020. Another CHC subcategory affected by weaker sales in Q1 was antacids, as a result of the withdrawal of ranitidine-based antacids from the market owing to concerns around NDMA in the formulation. Sanofi’s Zantac was among the key brands impacted, with Zantac 150 in sharp decline in the US market.

Today is the last chance to pre-order our upcoming Analgesics 2020: Assessing the Current & Future Self-Care Market for Pain Relief at the discounted rate and save up to GB£1,800! Contact melissa.lee@NicholasHall.com to order or find out about special discounts available on purchases of more than one report title!

Q4 update: Middle East & Africa highlights

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One key feature of your CHC DASHBOARD subscription is exclusive reporting on the consumer healthcare market in the Rest of World region, predominantly the Middle East & Africa. This dynamic region now accounts for almost 7% of the global CHC market, and produced continued strong growth in 2019, with sales up 7.0% to total US$9.6bn. Three countries in the region – South Africa, Turkey and Saudi Arabia – rank 20th, 24th and 25th respectively in terms of CHC market size.

Company Watch: Unsurprisingly, dominant global No.1 GSK is the leading CHC marketer in the region, as it is in all regions except Latin America. Multinationals Sanofi, Bayer and RB also feature in the regional Top 5, and each of these companies produced growth in 2019 in excess of the regional average of 7%. South Africa’s No.1 CHC marketer Adcock Ingram is the only local company to feature at the top of the rankings, while Abdi Ibrahim sits just outside the Top 5.

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Category Watch: Strong growth for analgesics (+8.1%) and Derma (+8.1%) helped ensure the region’s impressive rise in 2019. Three of the Top 5 regional analgesic brands – Panadol, Voltaren and Grand-Pa – are marketed by GSK, while RB markets another of the Top 5 regional CHC analgesic brands, Nurofen. As for Derma, a strong upturn for the leading dermatologicals category in the region, wound healers (+11.9%), was powered by Bayer’s Bepanthen / Bepanthol and Madecassol brands.

Brand Watch: Thanks to M&A activity in recent years, GSK now markets four of the Top 10 brands in the region, with No.3 Otrivin and No.8 Centrum added to the company’s existing key brands, Panadol and Voltaren. RB also markets multiple brands in the regional Top 10, with analgesic Nurofen, antacid Gaviscon and sore throat remedy Strepsils all featuring at the top of the rankings. However, the fastest-growing brand in the Top 10 in 2019 was Galderma / Nestle’s eczema & psoriasis treatment Cetaphil.

We are pleased to announce that Nicholas Hall’s CHC Yearbook 2020 is now published digitally, with print copies landing on desks next week! With the latest facts & figures, it offers the most up-to-date and fully-informed picture of the CHC industry around the world. To order or explore digital licence and multiple copy discount options, please contact melissa.lee@NicholasHall.com.

GSK and Sanofi seek to stand alone

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Structural reorganisation is on the agenda of two of the world’s leading CHC marketers in 2020. GSK’s consumer health tie-up with Pfizer in August 2019 was last year’s major M&A development and now the company’s next ambition is to list the new CHC business on the London Stock Exchange. As for Sanofi, the company unveiled a new strategy just before Christmas, including making Sanofi Consumer Healthcare a standalone business. In the meantime, both companies continue to trim their CHC portfolios.

In December 2019, Pfizer agreed to divest its topical pain management business, ThermaCare, to Italian-based Angelini for an undisclosed sum, reports apotheke.adhoc.de. In July 2019, the European Commission approved the consumer healthcare merger of GSK and Pfizer, conditional upon the global divestment of ThermaCare. The agreement follows Angelini’s acquisition of BoxaGrippal systemic cold & flu remedy and the Heumann herbal medicinal tea range from Sanofi in August 2019.

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Meanwhile, it was announced this month that BI is to sell Buscopan antispasmodic and Buscofem menstrual pain analgesic to Hypera Pharma in Brazil for Rs1.3bn (US$329mn). The deal, which is subject to approval by Administrative Council for Economic Defence (CADE), is in line with Hypera’s strategy of strengthening its portfolio with “established brands with high growth potential”. Under the terms of its 2017 business swap with BI, Sanofi has acquisition preference for the brands and could still pose a counteroffer. However, industry sources suggest that the company is unlikely to exercise this right.

In December 2019, Sanofi unveiled a new strategy to drive innovation and growth, focusing on three core global business units: Specialty Care, Vaccines and General Medicines. Consumer Healthcare will be a standalone business unit with integrated R&D and manufacturing functions. CEO Paul Hudson explained: “Our objective for the CH business is to unlock value and entrepreneurial energy by growing faster than the market over the mid-term. We believe the new standalone structure, coupled with plans to accelerate the OTC switches for Cialis and Tamiflu, will position the business well to accomplish this ambition.” Hudson added that the Rx erectile dysfunction treatment and flu remedy are expected to switch by 2026, adding around US$1bn to Sanofi’s top line.

Are you looking to make a strategic or bolt-on acquisition? If so, our Consultancy team would be happy to have a confidential discussion with you. Our specialist team can negotiate the successful acquisition of companies and brands, asset swaps, fostering and financing. We work with a number of strategic and financial partners to evaluate potential opportunities – for buyers and sellers – in the M&A, licensing and fundraising space. To find out more, please contact ekaterina.panteleeva@NicholasHall.com.

Ranitidine under regulatory spotlight

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Two weeks ago, the FDA put out a statement saying it had learned that some ranitidine medicines were found to contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels, which it classifies as a probable human carcinogen. In response, the FDA is conducting an ongoing investigation, working with international regulators and industry partners to determine the source of this impurity. Though the FDA made clear it is not calling for individuals to stop taking ranitidine, its advice to people taking OTC ranitidine was to consider using other OTC medicines approved for their condition.

Last week, the FDA alerted healthcare professionals and patients to a voluntary recall of OTC ranitidine tablets (75mg and 150mg) labelled by Walgreens, Walmart and Rite-Aid, and manufactured by Apotex. Sandoz (Novartis) also said it would no longer be distributing generic versions of ranitidine. This was followed by an announcement over the weekend that US retailer CVS is pulling the No.1 ranitidine-based OTC brand, Zantac (Sanofi), from its shelves over the possible links to cancer. CVS’ own generic ranitidine-based OTC products will also not be carried in the stores moving forward.

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Heartburn remedy Zantac is comfortably the No.1 ranitidine-based OTC brand, with global sales of around US$160mn (the vast majority of which are generated in North America). Chattem (Sanofi) markets Zantac in the USA in 75mg and 150mg OTC versions, while Aspen markets the brand in Australia and Perrigo is the UK marketer. In August 2018, Chattem extended its Zantac 150 line-up with two larger, value size 90-count SKUs, boosting sales significantly.

In a statement published in USA Today, Sanofi spokeswoman Ashleigh Koss said the company has no plans to halt shipments in the US market, adding: “The FDA reported that the levels of NDMA in ranitidine in preliminary tests barely exceed amounts found in common foods. We are working closely with the FDA and are conducting our own robust investigations to ensure we continue to meet the highest quality safety and quality standards.”

Take an in-depth exploration of the Lower GIs market in Nicholas Hall’s Lower GIs: Trends & Opportunities in Laxatives, Antidiarrhoeals, Probiotics, Antispasmodics & IBS remedies report. This key title includes dedicated case studies, NPD, innovative line extensions, coverage of 10 major markets, sales data and forecasts, plus much more! To find out more or to order your copy today, please contact melissa.lee@NicholasHall.com.

Lifestyle OTCs still the best hope for OTC switch revival

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2019 has been a slow year for Rx-to-OTC switch news, with activity dropping off markedly in the key US market in recent years, and Asia-Pacific (especially China, Japan and Indonesia) and Europe (Poland especially) the main source of developments. In this context, it was welcome news last week that Norway will become the second European market for OTC Viagra, after the Norwegian Medicines Agency approved the OTC sale of Viagra Reseptfri (Pfizer, sildenafil 50mg) erectile dysfunction treatment to men aged 18+ years, with this to be accompanied by pharmacist advice.

Pfizer plans to launch Viagra Reseptfri in pharmacies in early 2020, while Rx Viagra will remain available. The medicines agency recommends that men have a check-up with their doctor within six months of purchase so that any potential underlying conditions can be investigated. Viagra Reseptfri will be the first medicine available in Norway under the country’s new category of non-prescription medicine with guidance, and the Rx-to-OTC switch follows similar measures elsewhere in Europe. In Poland, sildenafil 25mg is available OTC from a number of domestic players, with initial launch from Adamed in May 2016, while Viagra Connect was launched in the UK in March 2018.

Of the 20 key markets covered by OTC New Products Tracker every month since the start of 2013, Poland has been the most active in terms of Rx-to-OTC switch activity, with 54 products reclassified to non-prescription status. A liberal switch environment has helped bring about a raft of Rx-to-OTC switches since 2014, including Europe’s first OTC erectile dysfunction brand and Poland’s first OTC systemic cold sore treatment.

Viagra Norway

Despite some notable failures (such as urinary product Flomax Relief), so-called “lifestyle” drugs remain the primary source of switch activity, helping to extend the reach of the OTC market into new categories such as contraception, erectile dysfunction and cardiovascular disease. A key switch development in 2019 was the downscheduling in Japan of Taisho’s hyperlipidaemia treatment Epadel T (ethyl eicosapentaenoate) to Class I OTC, where sales are permitted in pharmacies (and online) after professional consultation. Downscheduling may have come just in the nick of time – sales data suggest Epadel T had failed to make any noticeable impact on the OTC market in its almost six years as an Instruction-Required Drug.

There also remains hope that Sanofi may one day market Eli Lilly’s erectile dysfunction treatment Cialis as an OTC medicine (it owns the rights to market Cialis OTC in the USA, UK, Canada and Australia), but is switch application has been stuck at the FDA a full five years since its submission. In July 2019, Sanofi also signed a deal with Roche for the exclusive OTC rights to Tamiflu (oseltamivir 75mg capsules, Genentech / Roche Group) for flu prevention and treatment in the USA. Under the terms of the agreement, Sanofi will be responsible for leading negotiations with the US FDA for the OTC switch and subsequent exclusive marketing, scientific engagement and distribution of Tamiflu OTC in the USA. Let’s hope for the sake of OTC growth that its negotiations go smoothly.

Clear your diary for Nicholas Hall’s 31st European Conference, which will be held in Athens on 28-30 April 2020, on the theme of Advancing in CHC: The Must-Dos and  Reasons Behind Them. To register your interest in this event, or for more information on sponsorship opportunities, please contact jennifer.odonnell@NicholasHall.com.

Tamiflu to switch to OTC in USA?

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With 2018 a barren year for Rx-to-OTC switch, it is welcome news that Sanofi has signed a strategic deal with Roche for the exclusive OTC rights to Tamiflu (oseltamivir 75mg capsules, Genentech / Roche Group) for flu prevention and treatment in the USA. Under the terms of the agreement, Sanofi will be responsible for leading negotiations with the US FDA for the OTC switch and subsequent exclusive marketing, scientific engagement and distribution of Tamiflu OTC in the USA. Roche will continue to market Tamiflu in the rest of the world and Sanofi will retain the rights to first negotiations for switch rights in other selected markets. Sanofi’s Executive VP for Consumer Health, Alan Main, noted that: “A successful switch of Tamiflu to OTC would support our global cough and cold strategy by expanding into flu with a sustainable point of difference in the market.”

As Nina Stimson, OTC.NewDirections Consulting Editor, commented: “To some extent this was an unexpected development, but welcome insofar as (if approved), OTC Tamiflu will help expand the boundaries of consumer healthcare. Of course, in certain conditions (such as the swine flu pandemic in 2009-10) Tamiflu has sometimes been available from pharmacists without a prescription; New Zealand was one such country to permit OTC supply on a temporary basis.” 

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Tamiflu’s patent in the USA and some other markets expired in 2016 and, as the chart above indicates, this has led to a steady decline in sales over recent years, with US Tamiflu sales falling by 29% in 2018 to total CHF168mn (US$170mn). Generic competition intensified in the USA in 2017 and continues to grow, while Tamiflu brand sales are now also in decline in Japan and internationally. Roche is now focusing its efforts on Tamiflu’s successor, Xofluza, which was approved by the FDA in late 2018.

If Tamiflu can switch to OTC successfully in the USA, then similar reclassifications will likely follow elsewhere. In 2009, in the midst of the global swine flu pandemic, Australia’s State of Victoria issued a public health emergency order allowing pharmacists to supply Tamiflu (oseltamivir) without a prescription. There has also long been talk of Tamiflu switching to OTC in Europe – in 2008, at the AESGP meeting in Sweden, the EMA’s Executive Director Thomas Lonngren cited Tamiflu as a possible candidate for the EU’s then newly created centralised procedure for Rx-to-OTC switch.

Explore the latest CHC Innovations and Technologies at our OTC.NewDirections Executive Conferencetaking place in London on 14 November 2019. Nicholas Hall and Nina Stimson will be joined by experts from companies including Bayer, Mundipharma and J&J to review key issues impacting our industry and ensure that you are Keeping Consumers in the Spotlight. Book your place before 13 September to take advantage of our early bird booking discount and save GB£100! To find out more, or to reserve your place, please contact Elizabeth.Bernos@NicholasHall.com.