We run long-term studies and monitor events linked to consumer use in order to track the long-term effects of smokers switching to our products.
The pre-market evidence collected so far on our smoke-free products is very promising, such is their potential to present less risk than continued smoking for smokers who switch completely. To see if our products fulfill their potential to have a positive impact on public health in the real world, it is important for us to follow the products even after they have been launched on the market. We collect information to verify whether smoking-related diseases are reduced and whether there are consequences unintended at the time of market launch.
We combine a number of approaches, including safety surveillance, clinical studies, and epidemiological studies, in order to progressively obtain a clearer picture of the risk-reduction potential of our products.
Safety surveillance to collect health-related information from consumers
We have set up a post-market safety surveillance program for consumers to report any health-related adverse events associated with the use of our smoke-free products.
We constantly monitor this information to identify potential safety concerns and to report them to the regulatory authorities if necessary.
Our first wave of studies
Our cross-sectional and cohort studies help us assess the prevalence and patterns of tobacco and nicotine use and provide signals on the health effects of our smoke-free products.
We have estimated the impact of smoke-free products' use on the health of the population
People’s smoking habits vary considerably and smoking-related diseases are complex and take decades to develop. How is it then possible to estimate the impact of RRP usage on overall population health before decades have elapsed?
In order to estimate the population-level health impact of RRPs, we have built an epidemiological model relying on mathematical simulations using publicly available real-life data, in line with the US FDA’s requirements.
We based our model — the Population Health Impact Model — on smoking prevalence, individual smoking histories, and the size of populations, using data gathered from different countries, such as the U.S., Germany, the U.K. and Japan. We combined this data with the mortality rates of smoking-related diseases determined by the World Health Organization.
The resulting Population Health Impact Model (PHIM) assists us in estimating a range of complex scenarios, including different assumptions about the risk reduction potential of our smoke-free products compared to continued smoking. The model also incorporates data on non-smokers, thereby providing an estimate of the population health impact as a whole.
The estimates are valuable because they are available today, before the actual long-term study results are obtained. So far, the modeling results suggest that our smoke-free products can reduce population harm caused by major smoking-related diseases.