Gerry Stimson | 13 October 2013
As the Telegraph put it, ‘The decision by MEPs to reject a European Commission proposal to treat electronic cigarettes as medicinal products was as sensible as it was unexpected’.
After months of politicking among MEPs in Brussels, the proposal in the Tobacco Products Directive to treat nicotine containing products (electronic cigarettes) under medicine regulations was thrown out when the European Parliament adopted - by 362 to 298 votes - to treat them as consumer products. This followed a major campaign by electronic cigarette users.
Other key points agreed by Parliament were:
- to continue the ban on the sale of snus (except in Sweden)
- the sale of cigarettes in packets of 10 to be banned by 2016
- all tobacco packs to carry a health warning covering 65% of their surface (down from a proposed 75% and up from 30-40% now)
- individual package markings on tobacco packs to aid traceability
- rejection of a ban on slim cigarettes
- rejection of an immediate ban on menthol, now to be postponed for 8 years
The adopted amendment on electronic cigarettes includes:
- medicines legislation applies where a health claim is made i.e. that the product can be used for treating or preventing disease
- a maximum limit of nicotine at 30mg/ml.
- a health warning that nicotine is addictive
- flavourings are allowed
- applying the directives on tobacco advertising – the products will be subject to many of the same advertising bans as normal cigarettes
- manufacturers and importers of nicotine-containing products submit to national authorities a list of ingredients and emissions
- a ban on sales to under 18s.
The vote on electronic cigarettes poses a problem for the UK Medicines and Healthcare Products Regulatory Agency, which had linked its policy - that all electronic cigarettes would need medicines license by 2016 – to the TPD. Following the vote on October 8, MHRA and the Department of Health said that it still believed that the products need to be regulated as medicines and will continue arguing for this in further negotiations.
It’s not over yet! This is only an early stage in the European legislative process. The European Parliament and the Council of Ministers (which favours medical licensing) now have different positions and compromise negotiations will now take place between Parliament, Council (the EU member states, led by the Presidency) and the European Commission – a process known as the trialogue) see if they can find common ground. The Council will then need to propose amendments (probably in December) that it hopes the Parliament accepts. The Directive does not pass unless the Parliament and Council agree.
Many of those involved in the TPD are concerned that the process will run over into January when the Greece takes over the Presidency from Lithuania, and May next year when the current Parliament dissolves.
Watch this space for more information as the EU decision-making process unfolds and the UK government's position becomes clear.