The Precautionary Principle and Harm Reduction
What the European Commission Continues to Get so Badly Wrong on Risk Management
Precaution is common sense. We don’t run blindly into a busy street or touch a hot flame. When a toddler learns to walk, the hands automatically come up to protect themselves should they take a hard landing. Rational people don’t willfully want to hurt themselves (even ultra trail runners) so part of the reasoning process is how to limit harm, reduce exposures to hazards and manage uncertainties. But once these rational, natural, common sense reactions get translated into regulatory concepts, strange things happen. What the European Commission defines as the precautionary principle has become incompatible with harm reduction and unworkable in the real world. This is a serious problem as they begin their revision of the EU Tobacco Products Directive.
I have written volumes on the precautionary principle, EU policy and regulatory risk management over the last three decades, as well as a bit on tobacco harm reduction. I expect to be busy as activists, regulators and the media spread lies and disinformation over the coming policy cycle.
Defining Precaution
There are many definitions of precaution and the precautionary principle. The term first started to become part of the policy lexicon in the early 1990s around the time of the Earth Summit in Rio in 1992. In the Rio Declaration, the precautionary principle was defined in a triple negative: Just because we are not 100% certain of the information, is not a reason to not take preventative action?
Climate change was the issue of the day then, so precaution here was translated as: Just because we are not certain about the warming effects on the planet being due to CO2 emissions, is not a reason (given the potential catastrophic consequences) to not take precautionary measures and reduce reliance on fossil fuels. This is a harm reduction approach to risk management (lower exposures to reduce harm, even if the consequences are uncertain).
The European Commission does not use this concept. It relies on another definition of the precautionary principle articulated by David Gee when he was the science director at the European Environment Agency (EEA). The Gee Definition declares that unless you can prove that a product, substance or process is safe, with certainty, then the precautionary principle must be applied.
This approach reverses the burden of proof in the regulatory process, no longer providing sufficient evidence that something is harmful, but rather proving that something is safe. This is not risk management (reducing exposures to as low as reasonably achievable), but rather uncertainty management (until you can deliver certainty of safety, your product or process cannot enter the market). This definition had its regulatory debute during the EU’s REACH chemical regulation process where producers had to prove their substances were safe to have the right to market them.
Take the case of EU regulations on genetically modified organisms (GMOs) or other new seed breeding technologies:
Under the Gee definition of precaution, these seed technologies are not allowed on the EU market because there is no certainty of safety (even though the evidence is strong). Indeed, because of this, GMOs for human consumption are still not allowed on the European market.
Under the Rio triple negative definition of precaution, GMOs would be imperative. Just because we are not certain on the complete safety of GMOs is not a reason to ban them (given how serious the threats to food security, public health and biodiversity from older farming practices).
The same can be said about tobacco harm reduction products (vaping and nicotine pouches).
The European Commission / Gee approach would find some activists claiming we cannot be certain vaping is safe (or some ill-informed Health Commissioner posting on X that nicotine is a carcinogen).
The Rio (triple negative) definition would come up with the opposite result. Even if we are not certain about the long-term effects of vaping, that is not a reason (given the high level of deaths from tobacco use) to not promote vaping as an alternative to combustible tobacco products. The only difference is that there are very low uncertainties on the safety of tobacco harm reduction products.
The Gee definition of precaution is neither rational nor practical in any real world situation. It could easily be used to ban coffee, 5G, vaccines and electric vehicles. Why then does the European Commission rely on it so much in its regulatory process? The European Commission invokes the precautionary principle only on issues where activist groups make a lot of inconvenient noise and kick up a lot of dust (chemicals, pesticides, plastics and fossil fuels). The food industry is being pulled deeper into the dustbowl of EU stakeholder dialogue with the recent ultra-processed food activism.
Precaution is the magic wand European civil servants can easily use to make the issue, and the activists, disappear (and the problems won’t be evident until after their next career posting). Under these conditions, with no noise from consumer groups or health advocates and industry excluded from the dialogue, vaping will be banned or severely restricted in the EU.
Safe and Safer
The main problem with the Gee definition of the precautionary principle, that the European Commission relies on, is that it sets the permission bar for any product or substance around the concept of “safe”. Safe is measured emotionally - what is considered safe for one person may not be the same for the next. Is our food safe? Is our air safe? What is safe? What is safe enough? For whom?
The more important question is not asked in this policy approach. Can it be safer? How can we reduce exposures to potentially hazardous toxins (in food, air, nicotine…) to make it safer (to a reasonable level). This is risk management: reduce exposures to hazards to as low as reasonably achievable. Harm reduction is clearly in line with this strategy – vaping is safer than tobacco use and it is thus more reasonable to promote pro-vaping policies.
An important related issue is that risk management aims to reduce exposure to hazardous substances (harm reduction strategies is a key element here). The Gee definition of precaution takes any level of exposure as a risk (unsafe), thus takes what has been called the hazard-based approach. This undermines risk management. If, for example, any exposure to a hazardous chemical is detected, precaution must be invoked and that chemical will be taken off the market.
Activists have pushed the hazard-based approach in regulations like the Sustainable Use of Pesticides Directive. (It should be noted that before David Gee took an influential position in the European Environment Agency, he was a lobbyist for the environmental NGO, Friends of the Earth, so he knew exactly what he was doing.)
In the EU’s upcoming revision of the Tobacco Products Directive, anti-nicotine activists will be lobbying hard for the hazard-based approach to be used in assessing the safety of tobacco harm reduction products like vaping or nicotine pouches. If any potentially hazardous substances are detected, no matter the exposure levels, these products will be banned. The negative regulatory outcomes are already baked in (via this half-baked policy approach). Under the EU’s use of precaution, more people will continue to be smoking tobacco products than if we had a reasonable approach.
Consequences of a Bad Policy Approach
The Gee definition of precaution (Do not allow a substance on the market unless you can prove it is safe) is frankly unworkable as it has become standard practice for some interest group to systematically pronounce some level of uncertainty on their targeted issues.
This misunderstanding of basic risk management tools was evident during the COVID-19 pandemic. Faced with uncertainty about the scope and severity of the virus, European regulators quickly locked down populations at regular intervals for at least 18 months (precaution). People were restricted to their homes until the authorities could be certain it was safe to go out. But who was defining safe, and for which populations?
Couldn’t we have found a better way to manage exposures during COVID-19 (especially for vulnerable populations) without imposing so much hardship on the wider public? I discovered during this period how little our policymakers understood about risk management. They had thought that the precautionary lockdown approach was risk management when, in reality, the were merely trying to avoid uncertainties regardless of the overall cost to society.
The Need for a White Paper on Risk Management
What we have seen from the juvenile misuse of precaution, the irresponsible lockdown of citizens during the coronavirus pandemic and the ignorance of basic common sense harm reduction practices is that the European Commission has no idea on how the risk management process works. Before they do any more damage to consumers, manufacturers or trading partners, it is imperative for officials, perhaps in the Joint Research Centre, to organize a consultation and prepare a White Paper on risk management. I have argued for this elsewhere.
The White Paper should include:
when the precautionary principle should be used
the different stages of the issue management process
what exactly the risk management process entails (eg, harm reduction, exposure reduction and benefit assessment) and
how exposures to hazards should be measured.
European Commission policymakers need to understand the difference between “safe” (something ideal, emotionally variable and impossible) and “safer” (a risk management target). The White Paper needs to codify a clear risk management process: from information gathering to scenario building to risk assessments to risk communication to exposure weighting to risk reduction measures, mitigation and only then, if necessary, to taking precautionary measures.
The European Commission confuses invoking the precautionary principle and the hazard-based approach with risk management. Risk management is very different from this useless form of uncertainty management. This confusion means they cannot understand how harm reduction alternatives (like non-combustible nicotine products) are useful risk management tools. They still see possible harm and therefore cannot consider tobacco harm reduction products as “safe”. Their stupidity would be funny if so many people were not still dying from smoking tobacco.
As we approach the messy business of a revision of the European Union Tobacco Products Directive, the European Commission desperately needs to learn how to implement some basic risk management concepts into the policy process.
But this won’t happen any time soon.
Hurry Up and Die Already
The problem is generational. The European Commission and the DG Santé activists leading the debate on the Tobacco Products Directive discussions are caught in an anti-tobacco industry warrior bias. Like the stubborn Karens in the WHO’s Framework Convention on Tobacco Control (FCTC), they cannot rationally accept tobacco harm reduction products because they are blinded by past combats with Big Tobacco.
Millennials don’t see the issue through such a narrow-minded lens and are quite happy to transition into tobacco harm reduction products like vaping and nicotine pouches. If properly informed by science and evidence, the consumer will continue to make rational choices even if the policymaker and regulator remain blocked by bias. The problem is that these old warriors are confusing the smoking public with disinformation against safer alternatives to tobacco.
In countries like Australia and certain states in the US, black markets have filled the gap of bad or absent regulations on smoke-free nicotine products. Will the same happen in the EU? Consumers fighting for access to less harmful products exhibit more knowledge than the regulators. Consequences like black markets, street violence and quality and safety concerns though don’t matter to prohibitionist zealots.
These moralizing old warriors, caught in a 1980s time warp, won’t change their tactics. They won’t retire, stop their campaigning or allow the next generation the chance to lead (especially if they might veer into more rational policy directions). The only hope for the tobacco harm reduction debate to become more rational is for these activist scientists, regulators and NGOs (handsomely funded by princely philanthropists) to die off and be forgotten.
Maybe we could offer them some tobacco?