Where Innovation Meets Regulation

New Directions Executive Conference 2018

Nicholas Hall was joined by our OTC.NewDirections team, including Consulting Editor Nina Stimson, to lead our inaugural OTC.NewDirections Executive Conference.

This celebrated our weekly OTC.NewDirections newsletter, which focuses on Where innovation meets regulation. This gave us the core themes for the day –science, regulation, NPD, and niches / new innovations such as medical devices, Medical Cannabis and other emerging categories.

For his opening keynote session, Nicholas was joined on stage by our VP for Consultancy, Ekaterina Panteleeva, who took the audience through some of the trends in Probiotics, before Stefan Kulik of BeMyEye shared with us the all-new topline results of a survey amongst CHC marketers such as many of those in the audience, looking at attitudes towards Probiotics. 


Agnieszka Buksowicz of APC Instytut then took to the stage to explore the uncertainty surrounding the Brexit deal, and how exactly this will impact pharma. It’s an unprecedented event, and whether we have a hard or soft Brexit, it seems likely that there will be inevitable delays for the pharma market. The UK sends 45mn patient packs per month to the EU, while it receives back 37mn packs per month, so both parties will be impacted. In anticipation of this, marketers have already started to stockpile medicine supplies. As Agnieszka concluded, it’s a divorce. Divorce costs, and it hurts – and we have no idea who, if anyone, will win the battle!

James Hall then explored the Art of Switching, emphasising that the regulatory side is only half the battle, and no guarantee that a switched product will be a commercial success. We must ensure we have the right dose, right presentation, cost, concept and consumer management model. Engaging stakeholders is crucial when applying for switch, as the regulator’s decision is influenced by other people’s decisions.

Maikel Hendriks of Medical Brands explored the new medical device regulations wit the audience, reviewing whether these offer growth potential, or could lead to a big shake out in the market. While pointing out that the new regulations offer areas of innovation, with the updated regulation permitting their use for prediction and prognosis, Maikel bemoaned the lack of transparency in the decision making of competent authorities. The new regulations will also lead to additional time and costs for marketers who must alter the class of their medical devices, with Maikel warning that marketers may choose not to invest the time and money needed; 40% of substance-based medical devices will need to be reclassified, possibly leading to gaps in the market if products disappear.


Dr Alexis Roberts-McIntosh then urged the industry to be bolder in adopting digital, stressing that every part of our life is being touched by digital, so why not healthcare? The demand from consumers for digital health tools is evident, and we must do more as an industry to meet this, or risk being superseded by non-pharma players. As technology, AI and Big Data advance, they allow us to deliver new and improved health products, and we will see democratisation of services including telemedicine. AI offers huge potential in data analysis and discovery, with Alexis highlighting that this is not about replacing experts but augmenting the capabilities of our industry. For Alexis, partnerships are crucial, stressing that bringing in outside expertise can help us to deliver a clear digital vision and strategy.

Ralph Ahrbeck was next up, exploring whether a Consumer-centric approach drives innovation. He concluded that we need to shift the paradigm and put the consumer at the heart of innovation, using consumer insights to understand underlying behaviours, motivation and emotions, which allows us to generate meaningful innovation which will deliver sustainable growth, and build trust with our consumers.

Marco Fiorani highlighted the position and importance of supplements in the consumer healthcare market, with the rising number of nutraceuticals blurring the lines between food and pharma. With Italy the largest food supplements market in Western Europe, Marco explained how national regulations have been used to develop the market at a time when certain EU regulations on food supplements are still yet to be finalised. With significant increases in scientific evidence supporting supplements over the past decade, doctors and pharmacists in Italy are increasingly recommending supplements to consumers. Marco stressed that it is crucial to engage with HCPs to help the supplements category reach its potential, and help consumers stay healthy for as long as possible. 


Jennifer Cooper gave a thought-provoking presentation on the role of probiotics. There’s almost no scientific substantiation for most of the products currently in the market, and probiotics have enjoyed a very generous interpretation of safety, with Jennifer predicting there will be a backlash. On the positive side, we are close to overcoming manufacturing hurdles that have stopped us dosing probiotics that are indigenous to the gut, which could lead to significant health benefits. We currently market easily-accessible strains, such as those found in food. Jennifer stressed that there are huge potentials for innovation in the probiotics category, both in terms of ingredients, but also application, with categories such as asthma, ageing and skin health.

David Skinner gave a concise overview of the new Medical Cannabis legislation in Canada, which still has room for development for more cannabis products. There is a need to update Food Regulations to accommodate edibles, for example, while there must also be consistency across regulations for different products, such as OTCs, natural health products and foods.

He was then followed by Kanabo Research’s Avihu Tamir who took us on a journey across the Medical Cannabis competitive landscape. He noted 7 key growth drivers for the CBD industry:

1. The clinical research base for CBD is growing

2. Market potential has been proven to be very high, and parallels the growth of herbal dietary supplements reported above

3. Recreational cannabis smoking is a dying trend

4. Effective smart devices are appearing on the market

5. Microdosing and accuracy is improving

6. Medicated cannabis is in line with the latest lifestyle trends: the ageing population and women are the main demographics, and "natural" is an important buzzword

7. Political change is underway, partly driven by consumer activism; by 2020 300mn people will live in countries where medicated cannabis is approved

That concluded proceedings, with Nicholas wrapping up the day before we adjourned for a Drinks Reception and the chance to visit The Innovation Fair, a display of licensing opportunities brought to us by The CHC Innovation Connection.