In an enlightening exchange, Mark Dickinson, owner of OTC medicines marketing consultancy Clarityse Ltd, and Ian Fearon, Chief Scientific Officer with McKinney Regulatory Science Advisors and member of the Scientific Advisory Board of Qnovia, an American venture-backed pharmaceutical company, shed light on the convoluted process of gaining regulatory approval for medicinal vaping products in the UK and the US. The road to obtaining a license is not only filled with scientific challenges, but it also demands significant financial investment and an unwavering commitment to the end goal, to use Ian's comment, "the common good".
Mark emphasizes that transitioning from traditional cigarettes to medical nicotine products requires a significant shift in mindset and operational processes for companies. The creation of a new supply chain model while maintaining rigorous safety and quality standards presents substantial hurdles. However, with the right discipline and innovation, these challenges can be overcome.
USA vs UK
Comparing the differences between the UK and the USA in their respective hurdles to obtain the necessary licenses to market e-cigarettes medically, Ian describes USA's regulations as being much more strict. "The FDA data requirements are the same as for any other new drug product and they're onerous. You have to conduct a lot of preclinical studies." Despite FDA and the US Surgeon General knowing that nicotine does not cause cancer, "manufacturers are still require to complete a two-year cancer study. It's expensive, it's time consuming, and it's a fairly large hurdle to jump." Ian tells us that, "in the UK, you don't need to do animal studies. You can do a desk-based risk assessment and support this with laboratory toxicity tests. So there's a huge difference in the testing requirements despite the outcome being the same."
Financial Cost
On the financial front, the costs of meeting the regulatory requirements can be hefty. According to Ian, there is a stark contrast between the investment needed for approval in the US and the UK. The UK requires only around 3-4 million pounds in a two-year time frame, while the US requires a staggering investment of potentially hundreds of millions of dollars over up to a decade, “you really have to raise external capital from investors to do all those studies”, said Ian. This difference plays a crucial role in determining a company’s strategy and market choice.
The high investment is not the only daunting aspect of the process; time is another significant factor. The ever-evolving nature of vaping technology means that, during the lengthy approval process for medicinal products, consumer-grade vape products could advance several generations.
UK Cases
Ian shared two case studies of two products that have undergone the UK medical licensing.
“The first one was called Voke, and this was a product developed by a company called Kind Consumer, which were then invested in by British American Tobacco. So it was essentially a British American Tobacco product that received a marketing authorization in the UK. But for reasons I'm unaware of, it did’t make it to the market, so it was never available in pharmacies or and doctors could’t prescribe it. And strictly speaking, Voke wasn't an electronic cigarette, it was a gas powered inhaler, similar to, for example, the ventolin inhaler which people use to treat their asthma."
“Around the same time, another product called Evoke obtained a medical license and that also didn't make it to the market purely because it was a disposable cigarette-like product. It was one of those old classic products that was the same shape as a cigarette, and had the brown bit on the mouth-end that looked like a cigarette filter. And it didn't deliver nicotine to a user very well. By the time the product got to the end of the licensing process, it had become out of date because the whole industry had moved on to tanks and modular systems.”
The Upside
Despite the considerable investment and time required for regulatory approval, there's light at the end of the tunnel. As Ian highlights, the first company to navigate these challenges successfully could pave the way for others. This achievement could simplify the process for future manufacturers, creating a domino effect in the industry. Mark and Ian both agree that medical vapes can sell at a higher price, but they are more affordable because US consumers can get reimbursement from their medical insurance. "And in the UK, where some people can get products for free on prescription, then that's a good thing for lower-income people", says Mark.
Ian pinpoints Qnovia as a potential pioneer in this space, given its unwavering focus on becoming the first novel nicotine replacement therapy in the United States for well over a decade. Its success could serve as a blueprint for other companies, paving the way for a robust medical vaping industry.
Finally, the promise of a burgeoning market cannot be overlooked. Bloomberg predicts a $100 billion market for NRT products by 2028. Such potential offers a lucrative return on the significant initial investment, underscoring the substantial opportunity that awaits those who dare to venture into this space.
Both Mark and Ian agree that the route to obtaining regulatory approval for medicinal vape products is challenging and costly. However, they firmly believe that the company that successfully navigates this path first will not only reap significant financial rewards and open the doors for others to follow suit, but they will undoubtedly contribute to improving public health.
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