Reporting contributed by Kiran Sidhu
“There is definitely an opportunity to foster collaboration among all the different stakeholders in the industry, from the manufacturers and independent research companies, to build an evidence-based toolkit that can be utilised when facing regulators,” said Monica Andrade De Orbe.
De Orbe was hosting a panel titled, ‘Making evidence travel: a three region blueprint for market access’ with two leading figures involved in nicotine regulation.
Tim Phillips, managing director of Tamarind Intelligence, a global independent market and regulatory intelligence service providing data for businesses, said pouches were now the fastest growing safer nicotine products. Even in places where oral nicotine products had traditionally not been popular, such as Latin America, have seen a rise in the products. And with the rise in popularity the question inevitably turns to regulation. “How these countries regulate the products largely depends on what other countries do,” Philips said, noting that the Europe Tobacco Products Directive (TPD), a legislative framework that regulates tobacco and tobacco-related products, will be revealed by the end of the year.
Though countries may look to the European Union for clarity, Europe’s policy on pouches is fragmented. In the United Kingdom they are legal and soon to be regulated for the first in the Tobacco and Vapes Bill. In France they are banned and Spain’s ridiculously low strength cap equates to a de facto ban.
“The United Sates is more cohesive than Europe,” commented Dr Sydney Hiller, Director US Regulatory Operations at Inter Scientific. But the US has the FDA and the agency’s Premarket Tobacco Product Applications (PMTA) – a hugely expensive and time-consuming regulatory process. This means few brands can meet the onerous PMTA requirements. But Hiller said when launching a new product, manufacturers would do well to think outside the US. “There are things that overlap; chemistry, manufacturing: characteristics of the product,” she said. “There is foundational work that needs to be done – regardless of the market, adding that the initial cost might be hefty, but “it will cost you less in the end.”
But when it comes to showing data, much of the evidence exists with the large manufacturers who have had the funds to carry out the expensive studies. So there’s the inevitable question of why a comprehensive database, that collates all the evidence, doesn’t exist?
Simply put, Phillips said it wasn’t commercially viable for a manufacturer who has spent a vast amount of money on studies to then to share it. Manufacturers may have the common goal of creating a safer oral nicotine product that saves lives, but they are a business with competitors.
This needn’t be looked upon as negative, Hiller pointed out. “There is a stigma attached to data generated by tobacco companies,” she said. “Just seeing certain affiliations automatically discredits the data.” New brands should see this as an opportunity to conduct their own studies.
In an ideal world, if a database were to exist – who should be driving all the data?
“In the US all evidential evidence falls on the manufacturer,” Hiller said. “Many studies have already been done – the tests have been done – we have the data and we should leverage what we already have to save cost.”
Concluding, Hiller said when bringing a new product to the market, brands should think about building their own overall regulatory strategy at the very beginning – rather than it being an afterthought. She urged brands to think globally and not just country and market specific as well as looking at realistic timelines and the evidence that needs to be generated.
“Seeing where there’s an overlap, and building the strategy around that is probably the best place to start.’
