Frank Baeyens | 18 February 2016
Federal Minister of Health Maggie De Block recently (Jan 26th 2016) announced the completion of the highly anticipated royal decree regulating electronic cigarettes in Belgium. While the royal decree has not been signed and published yet, media reports allow for a preliminary and hence somewhat cautious review and evaluation of its main features.
The estimated 160,000 Belgian vapers in Belgium as of 2015, and the 1.65 million current smokers, some of whom might consider trying out e-cigs for tobacco harm reduction (THR) have good reasons to rejoice, but also to be angry.
The good news is that nicotine-containing e-cigarettes and e-liquids will soon be legalized, and that sales will be allowed wherever tobacco products can be acquired, including tobacco stores, supermarkets, newsagents and dedicated vape shops. The fear that - due to the ambiguities related to the "dual route" provisions in Tobacco Products Directive (TPD) 2014/40/EU - some public health bodies and/or political parties in Belgium would manoeuvre the decree in the direction of a requirement for all e-cigarettes to be regulated as medicines, has not proven to be true.
Unlike for tobacco cigarettes, flavour restrictions will not apply to e-cigarettes, nor will excise taxes be levied, but similar age restrictions will be applied as for tobacco cigarettes (no sales to under 16 year olds). The legislator may have missed an opportunity here to experiment with differential age of purchase limits , increasing the legal purchase age for tobacco cigarettes to 18 (as was recommended by the Superior Health Council (SHCBelgium) and setting it at 16 for e-cigarettes.
The decree ends the current legislation that only permitted sales in pharmacies of - until recently non-existent - medically licensed nicotine-containing e-cigarettes. Nevertheless the ban on nicotine-containing e-cigarettes has never been strictly enforced. Some of the small number (about 20) of vape shops in Belgium already sold nicotine-containing e-cigarettes, and cross-border internet imports from within Europe seldom met with difficulties or seizure at customs. But this new free and legal availability will finally provide e-cigarettes equal opportunities to compete with tobacco cigarettes.
The new legislation is both a reflection of, and in part the result of, the new recommendations of the Superior Health Council (SHC - Belgium) , which released its scientific advisory report on e-cigarettes in October 2015. In this document, on several key issues the SHC took a sharp turn in comparison with its recommendations in a first report (in December 2013) .
Less than two years ago, the SHC was invoking the precautionary principle as the major driving force behind its earlier recommendations - medicines regulation, pharma sales, no refillable e-cigarettes, flavour restrictions - and insisted upon avoiding theoretically possible but largely unproven risks - "gateway hypothesis" and the "renormalisation of smoking" - or more generally, on the inconclusive nature of available scientific knowledge concerning the health risks of e-cigarettes and their effectiveness as quit-smoking aids.
In its current report, SHC stresses several key elements of what could become a THR approach to smoking cessation, even though the report is somewhat reluctant to explicitly endorse the goals and benefits of THR. Key messages include that it is not "nicotine addiction" but tobacco smoking that is the main enemy that must be fought; that beyond any doubt e-cigarettes have a much lower health risk than smoking; that the use of e-cigarettes may help smokers to reduce or quit smoking; that continuing to use a highly-reduced-risk nicotine product (NRT/e-cigarette) in the long term is to be preferred over running the risk of returning to tobacco smoking; that currently there is no sound evidence confirming "gateway effects" or the "renormalization of smoking"; and that therefore "the e-cigarette is not a magic wand that can tackle the tobacco problem in our country, but does offer not to-be-missed opportunities as part of a powerful and revitalised anti-smoking policy".
First reactions on Dutch and French vaping fora, and from the recently established Belgian Federation of Vaping Professionals (BFVP) predominantly focused on less positive elements of the royal decree, namely those restrictions and regulations that directly follow from the fact that the decree also incorporates a quite strict implementation of the Tobacco Products Directive 2014/40/EU into Belgian law (maximum content of e-liquid bottles of 10 ml; maximum content of clearomizers/cartomizers of 2 ml; maximum nicotine concentration of 20 mg/ml; leak free filling; ban/restrictions on promotion and advertising; health warnings on the packaging; 6 month advance notification regime for new products, etc.).
Apart from the restrictions imposed by the TPD, Belgian vapers will have to deal with two other stumbling blocks. The first is the public vaping ban. Current bans on smoking in enclosed public places (including but not limited to bars, restaurants, public transportation, and the workplace) extend to the use of e-cigarettes. There are few signs that the royal decree will change this policy, or that the "minority position" expressed in the SHC report: "A general ban on the use of the e-cigarette in enclosed public spaces seems disproportionate to the minimal third party health risk, and if anything it appears counterproductive in pursuing the primary goal of reducing the prevalence of tobacco smoking. For that reason, the member does not support the general vaping ban in enclosed public areas, but selective restrictions" will translate into a relaxation of the public vaping ban.
Last but not least, just as in the Austrian proposals for the TPD implementation, the royal decree apparently will include a ban on online sales of electronic cigarettes. It is not yet clear whether this is intended to include the sale of e-cigarette hardware and components, nor whether it will extend to a ban on purchasing e-cigarettes and e-liquids at online shops abroad (nor if, and how this will be controlled and enforced).
None of the above represents the biggest obstacle to be removed to successfully implement an e-cigarette based THR strategy in Belgium, however. It is the opinions, attitudes and behaviour of many Public Health bodies, medical organisations, tobacco controllers, smoking cessation counsellors, and in particular those among the Belgian (and international) media and self-declared quality press, that are the greatest challenges.
What is currently lacking in Belgium is a an active and autonomous e-cigarette consumer association: the Flemish-speaking vaping advocates have associated with the Dutch Acvoda (and Dampforum) whereas the French-speaking vaping community has been incorporated in the French Aiduce. A Belgian association is needed to fight bias, prejudice, ignorance, and moral judgments about "nicotine addiction" with evidence-based, scientific arguments and a profound respect for the simple truth expressed by many vapers "I vape because I like it, it harms no one, and I'll live longer."