World Report

European Union adds teeth to its anti-tobacco legislation

A new European Union anti-tobacco directive presents some victories for health advocates but industry pressure has weakened the nal text, say campaigners. John Maurice reports.
The battle rages on. On one side, the tobacco industry. On the other, the public health community. Since the discovery in the mid-20th century of tobaccos devastating effects on health, the battle has been fought on many fronts, most visibly in the USA. At the turn of this century, the European Union (EU) joined the fray in earnest. In 2001, it introduced a tobacco products directive that put a clamp on how the tobacco industry makes and markets its products. This rst directive has since become outdated by new ways of consuming and marketing tobacco, new information about the damage it inicts on health, and new ways of limiting its use. A new EU directive has just been passed by the EU Parliament that aims to strengthen and update EU tobacco control policies. The numbers certainly make a strong case for a stronger directive. Every year, on average, 700 000 people in the EU die from tobacco-related causes. About a quarter of EU inhabitants smoke regularly. About 70% of them became hooked before the age of 18 years and about half of them will ultimately die prematurely from tobacco-related causes. under the previous directive. Pack sizes must be standardised and hold no less than 20 cigarettes (less aordable for young people than 10-cigarette packs). They must no longer be shaped and coloured to look like lipstick holders (more appealing to girls and young women). Labelling of cigarette packs as low-tar, light, mild, slim, and other terms suggesting, erroneously, a reduced risk to health, are banned. My aim with this legislation, Tonio Borg, EU Commissioner for Health, tells The Lancet, is to ensure directive, e-cigarettes will be regulated as consumer products and must comply with the same advertising and packaging restrictions as regular tobacco products. They must not contain nicotine in a concentration of more than 20 mg/mL. Member states, however, can classify them as medicinal products but have to prove that they help to cure or prevent tobacco addiction. What worries us about e-cigarettes, says Kristina Mauer-Stender, programme manager of the WHO Tobacco Control Programme at WHOs Regional Office for Europe, is that major tobacco companies are busily buying up e-cigarette manufacturers in order to enter the e-cigarette market and we are seeing an alarming unregulated expansion of these devices on the European market and beyond. There are now more than 250 types of e-cigarettes around and we dont know which are safe for health. That is why we wanted the directive to class e-cigarettes primarily as medicinal products that could be marketed only if drug regulatory authorities are convinced that they meet a given standard of health safety. Moreover, at this point in time, we dont even know if these devices could be a gateway to traditional cigarette smoking.
Published Online March 4, 2014 http://dx.doi.org/10.1016/ S0140-6736(14)60414-1 See Online for podcast

...There are now more than 250 types of e-cigarettes around and we dont know which are safe for health...
that prominent visual and text warnings effectively inform people about what smoking does to their health and thus help them make well-informed choices. It is also to ensure that tobacco products look and taste like tobacco products so as to discourage young people from starting to smoke.

E-cigarettes
One contentious issue is how to regulate e-cigarettes. Under the new

Stopping starting early

The main target of the new directive is young people. Among its provisions is a ban on avouring of tobacco to give it the taste of, say, vanilla, chocolate, or menthol, and thereby to enhance its appeal to youngsters. Manufacturers must report in detail all additives they put into their tobacco products. Additives claimed to enhance energy or vitality (such as caeine and taurine) are banned. Packaging of tobacco products will have to carry dissuasive text and images covering 65% of the total pack surface, versus 3040%
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Health warnings will have to cover 65% of the surface of tobacco packaging under the new directive

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Panel: Curiouser and curiouser One incident believed to have not only delayed but also threatened to halt work on the new European Union (EU) tobacco directive was the forced resignation, in October, 2012, of John Dalli, the Commissioner at the time responsible for bringing the new directive to fruition. The reason for this action by EU President Jos Manuel Barroso has not been made public but is alleged to be Dallis failure to report contacts he had with tobacco industry executives. He was replaced by Tonio Borg, but to this day the details of this so-called dalligate aair are unclear. A further incident that did little to allay rumours of impropriety occurred 2 days after Dallis resignation. The oces of three organisations battling the tobacco epidemic were burgled and robbed of several laptop computers. No other oces in the eight-storey building were broken into. Those who perpetrated or masterminded the operation remain unidentied.

They are freely used in hospitals, restaurants, and bars where vaping [inhaling nicotine vapour] has become commonplace. Were worried that this trend could undermine the tobacco control efforts many governments have made, such as banning smoking in public places.

raised questions about the integrity of some members of the European Parliament (panel). Industry pressure, in the view of many observers, clearly weakened the text. An early draft of the directive, for example, called for pictorial warnings to cover 75% of cigarette packs, front and back. The industry wanted 50%. Agreement was reached on 65%. In early drafts, the directive would have banned, simultaneously, all tobacco products with a strong flavour. In the latest version of the directive, menthol enjoys a stay of execution up to 2020. Industry pressure also contributed to the decision to class e-cigarettes as consumer goods rather than medical devices.

...the new directive will reduce the number of smokers in the EU by 24 million, thereby reducing tobacco consumption by around 2% over the next 5 years.
The massive lobbying eort by the tobacco industry is understandable, if not excusable. EU analysts estimate that the new directive will reduce the number of smokers in the EU by 24 million, thereby reducing tobacco consumption by around 2% over the next 5 years. As a result, tobacco manufacturers will suffer an estimated loss of 376 million in revenue. On the public health side of the coin is the annual saving in direct public health care costs of 506 million.

Tortuous process
Many observers wonder why the new directive took so long5 years to work its way from conception to adoption. Most fingers point at interference by the tobacco industry. Roberto Bertollini, WHO representative at the EU and chief scientist of the WHOs Regional Oce for Europe, was amazed: We had about 20 people working on the health side of the fence. The tobacco manufacturers had more than 160 lobbyists working aggressively to inuence and delay the process. One major tobacco manufacturer, he says, is believed to have spent well over 1 million in intensive lobbying over a year. Martin McKee, professor of European public health at the London School of Hygiene & Tropical Medicine, UK, also expresses dismay: It was a long-drawn-out, tortured process from the start and exposed the disproportionate power still wielded by the tobacco industry and the lobby groups they fund. It also
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Underground trade?
One argument often put forward by the tobacco industry in its efforts to weaken the directive was that its constraints on the industry will drive the market underground. In a press statement, Julie Soderlund, vicepresident of communications with Philip Morris International, the worlds largest tobacco manufacturer, warned that the new directive will force sales

out of legitimate corner shops onto unregulated street corners and other places where the products are illegal and the sellers are criminals who dont follow basic laws. This argument, says MauerStender, has no basis in fact. The illicit tobacco trade has existed for many years and has not increased in European countries that have adopted strong tobacco control policies. Recent evidence presented to European Parliament members by Anna Gilmore, professor of public health at the University of Bath, UK, suggests that the tobacco industry is itself actively involved in illicit tobacco trade in Europe. The tobacco industry is clearly involved in rampant smuggling, she tells The Lancet . Their claim that illicit tobacco use will increase is deeply awed. To curb illicit trading of tobacco products, which is depriving EU member states of an estimated 10 billion a year in lost tax revenues, according to European Commission estimates, the new directive called for the introduction of a high-tech track-and-trace system for use by EU member states and the EU Commission. Gilmore was dismayed at the successful attempt of the tobacco lobbyists to amend the new directive so as to enable the tobacco industry to implement its own track-and-trace system. Given industry involvement in smuggling, this amendment is incredibly nave, she says. The final step in the arduous journey of this directive will be its submission, on March 14, to the European Council. It will enter into force shortly afterwards and member states will have 2 years to incorporate it into their national laws. When all is said and done, the new directive, like many compromises, is not perfect. In the view of most public health observers, it is likely to reduce tobacco consumption in Europe. It will not, however, end the battle between the forces of health and those of wealth.

John Maurice
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