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.

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Homeopathy under increasing scrutiny

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France is the latest country in recent years to call into question the role and efficacy of homeopathy, as governments look for savings in the healthcare budget. Last week’s announcement by France’s Minister for Solidarity & Health Agnes Buzyn that homeopathic medicines will be dereimbursed in France from 1st January 2021 is another blow to this consumer healthcare niche. In 2017, NHS England recommended that doctors no longer prescribe “ineffective, over-priced and low value treatments”, including homeopathy, which is said to have no clear or robust evidence to support use.

The French decision was based on a final recommendation by the Haute Autorité de Santé (HAS) stating that homeopathics have little proven efficacy and should not be covered by health insurance. In its assessment, which spanned 9 months, HAS evaluated close to 1,200 homeopathic products, many of which are currently reimbursed up to 30% when prescribed. In the interim, the level of reimbursement available for certain homeopathics will be cut from 30% to 15% on 1st January 2020, allowing consumers, manufacturers and prescribers time to prepare for eventual dereimbursement.

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Voicing its shock at the decision, key homeopathic player Boiron – which markets various leading OTCs in France, such as teething product Camilia – stated that around 1,000 jobs would be directly affected by the dereimbursement, given that 60% of the company’s business is in France and almost 70% of that is linked to reimbursed medicines. A November 2018 survey by Ipsos revealed that 77% of French people have used homeopathics.

In other countries, such as Spain and the USA, there has been a clampdown on homeopathic health claims. In November 2018, as part of a new marketing authorisation process for homeopathy, the AEMPS (Spanish Agency of Medicines & Medical Devices) indicated that homeopathics with no permitted therapeutic indication must state, “Sin indicaciones terapeuticas” (Without therapeutic indication) on packaging. Likewise, in May 2018, the American Association of Homeopathic Pharmacists announced that all homeopathic manufacturers will be encouraged to use the new disclaimer: “Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.”

Keep up to date with the latest in-depth reporting on homeopathy by subscribing to OTC INSIGHT! We have 4 title covering the latest developments in Europe, Asia-Pacific, Latin America and North America. Click here to find out what key features OTC INSIGHT includes. To receive a sample issue or for details of subscription rates, please contact melissa.lee@NicholasHall.com.

BMS to sell French subsidiary?

According to an exclusive report in Reuters, BMS is looking to sell its French OTC subsidiary, Upsa, in a potential deal which could exceed €1bn (US$1.2bn). Deutsche Bank and Jefferies are said to be preparing the auction process, which will begin after the summer. It is rumoured that potential bidders may include Stada, Zentiva, Mylan and P&G, while Recordati could also decide to make a play for the company.

Upsa has been in operation for over 80 years and the company itself is a well-established brand in France, by far BMS’s key OTC market. According to DB6, BMS generated global OTC sales of US$477mn in 2017, 60% of which were generated in France (US$285mn). BMS’ next two biggest OTC markets are Belgium and China.

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Upsa’s key brands are Dafalgan and Efferalgan analgesics (both paracetamol), as well as the paracetamol-based Fervex systemic cold & flu line. According to the latest OTC DASHBOARD trend report, Upsa is the No.2 OTC marketer in France behind Sanofi but sales there fell by 4.8% in 2017, with mid-single digit declines for Dafalgan and Efferalgan.

Price cuts for reimbursed semi-ethical painkillers like Dafalgan and Efferalgan have contributed to the decline in France, causing marketers like Upsa to shift focus from reimbursed options to pure OTCs; reimbursed Efferalgan SKUs were rebranded as Efferalganmed in October 2015. In December 2017, the marketer also rebranded Fervex medical device options as Les Élémentaires, in response to rising concerns about the use of umbrella branding which could confuse consumers.

With M&A activity in the CHC industry rapidly increasing, it might be the right time for your business to explore interesting and suitable growth opportunities coming from M&A. Our specialist M&A boutique is working with a number of strategic and financial partners to assess potential opportunities — for buyers and sellers — and is well placed to discuss the current business climate and possible synergies. To find out more, please contact ammar.basit@NicholasHall.com.

OTCs in Action Episode 34: One small step for French OTCs, a giant step for Greek

OTCinActionheaderThis week, OTCs are in Action in France, where 21 medicines have jumped over the pharmacy counter to retail shelves, where they can be selected by consumers. Famenpax homeopathic antinauseant, AsproFlash aspirin, Flustimex acetaminophen / chlorphenamine and MycoHydralin clotrimazole VYI treatments were among the brands leaping to freedom.

Earlier this year, regulators liberated Maalox Reflux (aluminum / magnesium hydroxide), as well as nicotine gums and lozenges from Nicorette and Nicotinell. To see the full list, click here: French OTCs by self-selection.

Although the move to front-of-store is a significant win for consumers, OTC sales are still restricted to pharmacies in France. This provides an interesting contrast to the recent bailout agreement which stipulates that Greece, with a similar distribution model, should go a leap further to liberate OTC from pharmacies and permit mass market sale of OTCs as part of the international economic rescue package.

For more international news, see OTC.Newsflash, published weekly by Nicholas Hall & Company every Friday.

OTCs in Action Episode 30: Kava kava, glucosamine shift status in Germany, France

OTCinActionheaderThis week’s OTCs in Action starts out in Philadelphia, where last week some Germans who came to visit me purchased the dietary supplement melatonin for personal use, because it’s only available on prescription at home. The German OTC sleep aids market is largely composed of natural products, such as valerian and homeopathic remedies, so it was somewhat surprising that melatonin is not available OTC.

In contrast, the Cologne Administrative Court overturned a ban on the calming herb, kava kava, last year. Owing to concerns about liver toxicity, the ingredient was withdrawn from most European markets in 2002, and the FDA issued a warning letter discouraging use of the product in the US. Subsequent research has indicated that the original studies were flawed, and the German court ruled that the risks did not outweigh the ingredient’s benefits.

Click on this link to access OTC INSIGHT Europe’s latest report on the German OTC sleep aids market.

Elsewhere in Europe, France has approved the Rx-to-OTC switch of Biocodex’s Dolenio (glucosamine 1,178mg, 30-tab pack), a slow-acting anti-arthritis medicine. This follows the dereimbursement of several anti-arthritis brands, which had been reimbursed at 15% when prescribed by a doctor. Affected brands included Piasclédine (Expanscience, avocado-soybean unsaponifiables), Chondrosulf (Genévrier / IBSA, chondroitin sulphate), Art 50 (Negma, diacerein) and Voltaflex (Novartis, glucosamine).

Piasclédine and Chondrosulf (in particular) used to command huge sales as semi-ethical brands in France, but now face a challenging, but potentially lucrative, new future in the self-medication sphere.

OTCs in Action Episode 11: Stigma, statutes and OTCs stub out smoking

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Q: What’s the difference between the 1960s and the 2000s?

A: In the 2000s, a guy goes into a chemist shop and shouts, “Give me a box of condoms!” … and then whispers to the shop assistant, “Oh, and slip in a packet of cigarettes, too.”

Although smoking is stigmatised in many countries in the new millennium, tobacco use still kills approximately 6mn people each year, according to the World Health Organization. It is the leading global cause of preventable death and OTC smoking cessation products can help people quit. This week, OTCs in Action takes a look at recent government initiatives to extinguish smoking – and spotlights nicotine replacement therapy* sales trends in those countries.

Brazil’s National Anti-Smoking Law will take effect this month, prohibiting smoking in enclosed spaces; banning the promotion of tobacco products and requiring warnings to cover a significant part of cigarette packs. Nicholas Hall’s Global OTC Database DB6 reports mid-year sales of NRTs increased by 14% to US$20mn (MAT June 2014) in Brazil.

China is considering raising cigarette prices and taxes and the State Council has issued a draft regulation to ban indoor smoking, limit outdoor smoking and end tobacco advertising. China has more than 300mn smokers and cigarettes are very inexpensive. OTC sales of NRTs increased by 8% to US$25mn.

France unveiled plans to require plain cigarette packaging, increase prices for tobacco and ban smoking in cars containing children. Although the Government more than doubled reimbursement rates for NRTs for those aged between 20 to 25, sales of OTC NRTs declined by 6% to US$82mn, owing to increased use of generics and rising use of e-cigarettes.

India announced that health warnings covering at least 85% of cigarette packs will be mandatory by April 2015. Sales of OTC smoking control products increased by 22% to US$12mn. The diminutive sales figure reflects that fact that most tobacco consumption in India is in the form of chewing tobacco and paan.

Russia’s ban on smoking in most public paces enacted in 2013 was extended to include transportation and leisure-oriented locations last summer. An estimated 40% of Russian adults smoked in 2011 and cigarette prices are among the cheapest in the world. Sales of OTC smoking control products were up by 38% to US$20mn in the mid-year results.

In the brilliant 2005 film, Thank You for Smoking, tobacco executive BR says: “We don’t sell Tic Tacs, we sell cigarettes. And they’re cool, available and *addictive*. The job is almost done for us.”

Maybe not so cool or available anymore.

For more info, Nicholas Hall’s OTC INSIGHT publications for Latin America, Europe, Asia-Pacific and North America have just published market reports on the smoking control trends in their regions. http://www.insight.nicholashall.com

*Does not include e-cigarettes

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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