A new report published on April 3, by Transcrime, the Joint Research Centre on Transnational Crime, warns that policy options being considered by the European Commission as part of the revision of the Tobacco Products Directive (TPD) carry a significant risk of increasing crime and the illegal trade in tobacco.

The report by Transcrime uses a widely endorsed crime proofing methodology that assesses opportunities for crime inadvertently created by regulation.

Analyzing all the proposed policy options for the revision of the TPD, Transcrime found three major policy areas which are likely to increase crime: generic packaging for tobacco products, implementation of a “polluter pays principle” and a ban on the display of tobacco products at the point of sale.

“The crime proofing exercise we have conducted has shown that some of the policy options envisaged by the European Commission carry significant risks of creating unintended opportunities for the illicit trade in tobacco products.

In particular, there is a high risk that a measure such as generic packaging may increase the counterfeiting of tobacco products and make it difficult for consumers to distinguish legitimate products from illegitimate ones,” said the report’s author, Professor Ernesto Savona.

Available information on the currently on-going impact assessment for the revision of the TPD indicates that the Directorate General for Health and Consumer Protection (DG SANCO) paid almost no attention to the potential impacts on the illegal trade in tobacco products.

“Contrary to their own guidelines, European policymakers rarely consider the crime risk implications when drafting new legislation and the revision of the Tobacco Products Directive by DG SANCO seems to confirm this,” continued Professor Savona.

In the report, Transcrime emphasizes the need for further research and attention by policy makers to assess, among the many consequences, also the crime impact of proposed tobacco policy measures, something that has been systematically overlooked so far.

“Regulation should be thoroughly proofed against the risk of creating opportunities for criminals. We know that the EU tobacco market is already extremely vulnerable to illicit trade and so greater caution should be exercised when considering the introduction of new policy measures in the tobacco market,” concludes Professor Savona.

The report “Crime proofing of the policy options for the revision of the Tobacco Products Directive” is available online: http://www.transcrime.unitn.it/tc/664.php

About Transcrime:

Transcrime (http://www.transcrime.it) is the Joint Research Centre on Transnational Crime of the Universita Cattolica del Sacro Cuore of Milan and the Universita degli Study of Trento. Founded in 1994, its Director is Ernesto U. Savona, Professor of Criminology at the Universita Cattolica del Sacro Cuore in Milan.

Transcrime analyses criminal phenomena and strategies for preventing and combating crime and identifies innovative solutions for improving the efficacy and effectiveness of policies to prevent and combat criminal activities at local, national and international level.

Transcrime’s initiative to conduct crime proofing research on potential tobacco policy was welcomed by Philip Morris International who agreed to contribute financially to the research. Transcrime retained full control and stands guarantor for the independence of the research and its results.

About crime proofing of legislation:

Crime proofing is a scientific approach used to assess the impact of legislation on crime, a key element of which is Crime Risk Assessment.

The Crime Risk Assessment consists of three steps:

1) The Initial Screening based on a checklist of 7 risk indicators revealing

legislation requiring further assessment.

2) The Preliminary Crime Risk Assessment identifies crime risks unintentionally

created by regulation, focusing on the vulnerability of the market and the possible

risks arising from specific options

3) The Extended Crime Risk Assessment provides an analytical assessment based on

a set of indicators that assess the likely impact of the possible policy options on

the crimes, the perpetrators, the victims and the social costs.

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As required by the 2009 law granting the U.S. Food and Drug Administration authority over tobacco products, the Institute of Medicine issued a report regarding the type of scientific evidence and research the FDA should require of tobacco companies seeking to make “modified risk” claims about tobacco products.

Modified risk products are defined in the law as “any tobacco product that is sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products.” Given the industry’s long and deadly history of deception, the IOM calls for rigorous, comprehensive and independent scientific evidence before any tobacco company will be allowed to claim that any of its products are less dangerous than other products.

This report lays out a comprehensive scientific roadmap for the FDA to follow in reviewing applications for modified risk tobacco products. It demonstrates the need for rigorous science, conducted and evaluated independent of the tobacco industry, before the industry is allowed to market any modified risk products.

It underscores the importance of the FDA considering the broad public health impact of introducing such products and not just the impact on individual tobacco users. And it properly puts the burden on tobacco manufacturers to produce adequate scientific evidence before allowing them to claim that any tobacco product reduces the risk of disease.

The IOM report makes it clear that the FDA must set a high scientific bar for allowing such claims given the industry’s history of deception about its products and of falsifying science. Such a high bar is critical to preventing a repeat of the decades-long fraud in which tobacco companies marketed light and low-tar cigarettes as safer despite knowing from their own research that they were just as harmful as regular cigarettes. This deception discouraged smokers from quitting and encouraged others to start, with devastating results for public health.

Before allowing a modified risk claim, the law requires the FDA to determine based on the scientific evidence that the product “as it is actually used by consumers, will (A) significantly reduce harm and the risk of tobacco-related disease to individual tobacco users; and (B) benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco products.”

This requires the FDA to consider whether any reduction in harm to an individual tobacco user may be offset by marketing that encourages non-users, including kids, to start using tobacco or discourages current tobacco users from quitting.

To effectively carry out this analysis, the IOM report calls on the FDA to require a wide range of scientific evidence that includes not only evidence and studies about the product’s contents and health effects, but also evidence regarding whether the product will promote initiation and continuation of tobacco use and how its marketing will be perceived by consumers. These are all critical issues that the FDA must consider in order to effectively protect public health.

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