Experts interrogate the need for flexible harm reduction regulatory frameworks to support public health globally
Industry players and harm reduction experts have emphasised the need for a regulatory framework that encourages more innovative smokeless tobacco products, ensuring consumers’ safety and promoting public health.
This was during the just-ended Global Tobacco Nicotine Forum (GTNF) which took place at the end of September 2024 in Athens, Greece.
The GTNF 2024 ended with stakeholders emphasising the need for regulators and industry players to engage with each other to ensure that regulation does not block innovations that are in the best interest of public health.
The forum held under the theme, “Innovation in a regulated environment,” ended with stakeholders emphasising the need to balance regulation and innovation among other key takeaways, as a means to promote public health globally.
During a panel discussion exploring the interconnectedness between innovation and the regulatory environment, panelists emphasised that instead of stifling tobacco harm reduction strategies, regulation should be active in guiding the industry and not shutting them out, as scientific data has already proven to be in the best interest of public health by promoting less harmful products.
The panel discussion was moderated by British American Tobacco (BAT) Head of Scientific Affairs for Tobacco Harm Reduction, Valerie Solomon.
During the discussion, Regulatory Consultant and Strategist Lillian Ortega indicated that with the primary goal of the regulator being to achieve voluntary compliance from the industry as much as possible, it must endeavour to strike a balance by guiding the industry as best as it can so that players know what is expected.
Ortega says collaboration and dialogue between the regulators and industry players is key in tobacco harm reduction efforts, and the two players need to understand the needs of each other.
She says, ” to achieve compliance, there is a balance that the regulator needs to provide. And the balance is to guide the industry as best as possible so that they know what is expected from them, they know where the guard ends, where the framework lands, what they should do and what they shouldn’t do.”
She explains that collaboration with the industry and an open door policy by the regulator is needed so that they can learn from the industry that harm reduction innovations have been scientifically proven to improve public health by producing less harmful alternatives to smoking tobacco, instead of the belief that it is a danger.
“The regulator needs to learn from the industry. They need to ask themselves, what are we missing. What new things are happening and what don’t we know? The confusion and misunderstandings around harm reduction may be because the harm reduction products are new, and the regulator needs to have an open dialogue with the industry to understand that the products are safe,” she says adding, “There is a lot of room for growth in the regulatory environment, both on the industry side and the regulator’s side, to help promote innovation.”
Ortega says there are many opportunities to enhance consumer safety and promote public health through a more conducive regulatory environment, but that this cannot happen unless there is collaboration from both players to learn from each other. She says the stage should not be a black hall where information goes in and does not come out.
She explains that while enforcement is necessary for a fair and responsible marketplace, it is important for a regulator to achieve a balance with the real needs of consumers on the market, provided the products being offered are safe.
And speaking earlier, Phillip Morris International (PMI) USA Head of Regulatory Affairs Laura Leigh Oyler, said that innovation has big opportunities for the industry in that it retains a reservoir of scientific knowledge of what works and what does not.
Oyler believes through innovation the industry will also know how best to tailor applications with the consumer in mind so that innovations are understood better.
She says, “And I think another opportunity that we have is to think about the end user of our submission which is the scientific reviewer. So making sure that applications are tailored with that audience in mind and making it as clear as possible in order to help them understand the applications of the product.”
She however says there have been improvements in engagements with the agency in the last six months.
“I would say we’ve had some challenges with engagements in the last couple of years as there was a time when no matter how many calls you made or how many emails you sent, there was just no information coming back to you. This has improved in the last six months and so I have hope that this will continue,” she says.
However, Oyler says the agency has also called on the industry to have open discussions with them about what their priorities are and move a little bit faster.
She says some success has been made in negotiating with the agency on market requirements which can be voluminous. She however says data exchange with the agency being the recipient has helped shift the thinking of the regulator on some things, adding that moving together is good for the purpose of ensuring products that not only benefit the consumer but also promote public health.
Oyler says this will require the regulator and the industry to put aside their distrust for each other and work together to ensure public health concerns are adequately addressed.
“Several companies have already worked together in this space to have a consortium-based approach where there is a centralised literature review with everyone planning with the same data. This year we were accorded an opportunity to have breakfast with the regulator and during that conversation, they helpfully suggested that we should come together as an industry and deliver a set of change management guidelines that we can all agree with because getting a product onto the market is a challenge if there are all these misunderstandings,” she said.
For Oyler, changes have to be made because of supply chain issues that need upscaled manufacturing of harm reduction products, and by working together to help the agency with the change management, all stakeholders which includes the industry, regulator and the consumer will benefit.
She emphasised the need to ensure innovation processes do not take years before developing a product, but at least a few months to ensure products that are relevant to the needs of the market.
Meanwhile, Jessica Zdinak, Chief Executive Officer of the Applied Research and Analysis Company, said balancing public health and consumer choices requires that stakeholders typically look at it from a global perspective because both are universal issues that need to be viewed as such.
She says, “These issues need to be looked at from a public health and consumer choices lens. We need to balance public health and standards while getting products onto the market. Scientific testing of products is required and so is protection of public health.”
Zdinak says the focus is for smokers to switch to safer alternatives and that this all starts with innovation which is the product development process.
She says continuous feedback among players is also critical adding that the need for safer alternatives cannot be overemphasised, with some smokers having kids or sick parents who may not respond well to tobacco smoke.
She says through feedback, there is also a need to find out from the consumers what their current options are so that their unmet needs can be catered for.
Recognising the risks associated with nicotine, delegates at the event also emphasised the importance of ensuring public health concerns are adequately addressed through regulation that minimises harm and does not focus on prohibiting harm reduction products. The need to protect public health globally through balanced regulation was also emphasised.
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