October 8, 2013

expert reaction to EU vote on tobacco regulation

In a vote on tightening tobacco regulations, euro MPs rejected a European Commission proposal to treat electronic cigarettes as medicinal products.

Professor Robert West, CRUK Health Behaviour Research Centre, University College London, said:

“The decision is surprising to me at least because I thought there was strong support in member states for medicinal regulation. This would have restricted the market to large companies, including tobacco companies. This is because the cost of meeting medicinal manufacturing requirements would probably be pretty hefty and there would be a substantial cost just for getting the licence. On the other hand, it may now be difficult to prevent these products being designed and promoted in a way that indirectly promotes cigarette smoking, e.g. by marketing them in a way that could lead them to become a gateway to smoking or undermines quitting.”

Professor Peter Hajek, Wolfson Institute of Preventive Medicine, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, said:

“This is a victory of common sense, averting a decision which would have potentially serious negative consequences for public health.”

Further information provided by Professor Hajek following the MHRA announcements on e-cigarette regulation earlier this year:

“E-cigarettes (EC) are the best chance we had so far to end the tobacco epidemic – and to do it with no government expenditure. The product needs to develop further to give smokers exactly what they want, but it is on the way to remove tobacco related harm on the population scale. Medicinal licensing of EC would seriously undermine this opportunity.

“Medicinal licensing is a slow, conservative and very expensive process. Once a product is licensed, it is unlikely to develop further because any modification requires a new licensing application at prohibitive costs. This is the reason why nicotine replacement products such as nicotine chewing gum and patches hardly developed at all over the past 30 years. Medicinal licensing will freeze EC in their current ‘OK, but not yet very good’ format and prevent them from developing into a genuine competition to conventional cigarettes. Some essential developments such as improving EC taste are likely to be banned. Treating e-cigarettes as medicinal products may drive EC into the arms of the tobacco industry who are likely to be the only player able to afford these costs. Tobacco industry might then end up with a monopoly for both conventional and electronic cigarettes.

“Medicinal licensing has some merits but its disadvantages are much greater. Its rationale is weak because the product safety and quality can be ensured by consumer protection regulation (which also allows specific directives such as child-proof packaging and restrictions on advertising); and crucially, EC are not a medicine but a consumer product competing with cigarettes which do not have to jump through these hoops despite being famously unsafe.

“We have two products competing for smokers’ custom. One is seriously dangerous and the other one poses little risk. It makes no sense to cripple the safer one and to protect the market monopoly of conventional cigarettes.”