A European Parliament member involved in the drafting of the European Union’s new Tobacco Products Directive (TPD) has criticised the final adopted version, voted for in late February, as “hastily drafted and heavy-handed”.
UK Conservative Party politician Martin Callanan told ECigIntelligence that: “When the draft TPD first came to a vote in the European Parliament in October 2013, my political group played an instrumental role in the adoption of a text that set out what I consider to be the best possible regulatory framework for e-cigarettes.
According to Callanan, this text rejected medicines regulation and facilitated a simple market notification for electronic cigarettes, similar to that of conventional tobacco products.
“In order to account for concerns that these products may encourage young people to smoke tobacco, these provisions included a commitment from the Commission to compile a comprehensive study on the health impacts of and emerging markets for these products within five years. If necessary, the executive could then come forward with tailored legislation to limit their use.”
Callanan maintained that, as with conventional tobacco products, this initial parliamentary agreement stipulated that electronic cigarettes should also be subject to strict product safety laws and advertising restrictions.
“Despite the parliament’s endorsement however, the Commission and a handful of [members of the European parliament] then took it upon themselves to add a whole new article to the directive during late night closed-doors negotiations between the parliament and national governments seeking the agreement necessary to pass the proposals into law.”
“So much for evidence-based policy-making,” said Callanan.
Arguing against provisions in the TPD that could allow e-cigarettes to be classed as healthcare products he said this would “raise costs, reduce product diversity, slow down innovation, inhibit creativity and make the products less appealing to the very people we hope will switch to them”.
The TPD does not explicitly say that member states can adopt a pharmaceutical licensing regime if they wish – but nor does it prohibit that.
Callanan also said that restrictions on nicotine content, capped at 20mg/ml, would run the risk of “smokers going back to cigarettes in order to achieve the same nicotine hit.”
He said that “new manufacturing provisions for nicotine cartridges… go beyond the safety measures needed to make them childproof”.
What This Means: It is not really surprising that one of the more prominent advocates for e-cigarettes within the European Parliament is disappointed by the TPD.
Martin Callanan is unlikely to be the only one, and his concerns will surely be repeated by others – and perhaps tested in court; especially where the vagueness of the directive on the freedom of member states to take a pharmaceutical-style regulatory approach is concerned.
– Barnaby Page ECigIntelligence staff