MHRA Regulation of Electronic Cigarettes

Recently the UK Medicines and Healthcare Regulation Authority (MHRA) moved to regulate electronic cigarettes as medicines, so that "people using these products have the confidence that they are safe, are of the right quality and work".

In response to this, Professor Peter Hajek, Head of the Tobacco Dependence Research Unit, Wolfson Institute of Preventive Medicine, Queen Mary University of London, UK writes;

"MHRA, the UK drug licensing authority, announced recently that electronic cigarettes will be licensed as a medicinal product. MHRA normally has a liberal and enlightened attitude to harm reduction and nicotine, but this time they got it wrong.

A good summary of what is wrong with medicinal licensing of e-cigarettes can be found on http://www.clivebates.com/?p=1252

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 will 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.

Another thing the ruling will do is to drive EC into the arms of the tobacco industry who are likely to be the only player able to afford these costs. Tobacco industry will end up with a monopoly for both conventional and electronic cigarettes and will be unlikely to want to develop EC and kill cigarettes. Agile innovative companies that would otherwise drive cigarettes out will be bought by big tobacco or go out of business. Indeed the tobacco industry has welcomed the MHRA ruling enthusiastically. EC will become more expensive than cigarettes, will be sold in packaging emphasizing unlikely dangers, and made into a product far less attractive than cigarettes.

I am not sure that the financial implications were thought out. It will be difficult to carry on prescribing NRT but not EC which are likely to be more effective. The NHS may potentially pay large amounts of money to buy smokers a product they are perfectly happy to purchase themselves.

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."

For information about taking part in research testing new treatments for smokers, call us on 0207 882 8225, or email smokers-clinic@qmul.ac.uk