• End game
• Harm Reduction
• Nicotine

Tobacco control essentially consists of a set of policy measures developed over 50 years.1 ,2 As these measures have not proved sufficient, we are now considering new ideas for what is being called the ‘endgame’. But there can be no single ‘endgame’. This is not chess, which is a complex game with a simple objective: to checkmate the king. Rather than a global game of chess, we are engaged in a multiplicity of battles and skirmishes, all aiming in the same general direction but with different rules and on different terrains.

Historically, tobacco control campaigners have had a triple goal: to end the death and disease caused by tobacco, to end nicotine addiction and to destroy the tobacco industry. Many still have these goals but in England, one of the original homes of the epidemic, our attitude to addiction has evolved. This is because while we have made great strides in reducing demand of late, it is clear that on its own, this will not be sufficient. Despite fulfilling most, if not all, the requirements of the WHO Framework Convention on Tobacco Control and even with plain standardised packaging under active consideration, it will still be decades before smoking disappears.

In 1976 the late Professor Michael Russell wrote: ‘People smoke for nicotine but they die from the tar’.3 Yet, over 35 years later, smoked tobacco is still the primary source of nicotine and by far the largest cause of avoidable death and disease. In England, it is now accepted by the public health community, the government and our medicine regulators that this conundrum is best resolved by allowing smokers access to safer sources of nicotine.4–7

There are potential risks. Providing smokers with safe, alternative nicotine products could see nicotine addiction begin to grow again, create a business opportunity for tobacco companies to continue to profit from addiction and possibly cause harm to smokers who might otherwise have quit completely. Young people might start with the harm reduction option, believing it to be safer, and then move to smoking. Former smokers might relapse to the harm reduction option and then go back to smoking.

However, there are significant potential benefits. Safer sources of nicotine reduce harm to people who otherwise would have continued as regular smokers. They reduce harm that arises more broadly from exposure to smoking. They act as a possible ‘halfway house’ to stopping smoking. They also create a market incentive for ever-better products to replace cigarettes. Even if significant numbers remained addicted to nicotine, the overall public health benefit in terms of lives saved would be enormous.

In England, there is recognition that concerns on both sides have merit and must be taken into account. The government's 2011 Tobacco Plan promised to ‘develop new approaches to encourage tobacco users who cannot quit to switch to safer sources of nicotine.’6 There is currently no regulatory framework for alternative nicotine products not designed for quitting. E-cigarettes, the only product of this kind currently in the market place, are marginal, almost entirely unregulated and have been banned in a number of jurisdictions. In England, that is not the case, as the medicine regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), has recognised that to do so could force e-cigarette users back to smoking.7 The medicine regulator is now working to end regulatory uncertainty and determine the most effective and proportionate form of regulation.

The National Institute for Health and Clinical Excellence is developing public health guidance on harm-reduction approaches to smoking in England.8 Guidance from the National Institute for Health and Clinical Excellence and the MHRA decision on regulation are due to be published in May 2013. Support is in place from the public health community, as long as such products are effectively and appropriately regulated by the medicine regulator.5

If an MHRA ‘light touch’ regulatory structure were in place by mid-2013 to ensure that products on the market are safe and effective, to prevent their promotion to youth and non-smokers, and to monitor the market as it develops, then we believe it would be a major step forward in winning the fight against smoking-related disease.

Regulation will need to be accompanied by a carefully considered surveillance and communication strategy. The former will set the agenda for tobacco harm reduction, address misperceptions about nicotine, include mass media campaigns aimed at smokers and, crucially, reinforce the government seal of approval for a harm-reduction policy. The latter will ensure that if the use of substitute products is found to be undermining tobacco control, the regulator will be made aware and can take action to strengthen regulation in an appropriate and timely manner.

It is for others to decide whether they wish to take this route but the UK has the regulatory structure in place to make it work. We have a medicine regulator with a statutory responsibility for promoting public health, the powers to control product advertising and promotion, and power to require effective monitoring and surveillance. Backing this up, we have a strong government lead on tobacco control, a comprehensive strategy in place and a long tradition of effective use of harm reduction strategies for public health.6 ,9

The death clock is still ticking. Over 80 000 people still die each year from smoking-related disease in England. One in five adults smoke and among the most disadvantaged in society, smoking rates are higher still. We believe that nicotine substitution is key to a successful endgame in our long struggle against tobacco use, while recognising that what is right for us may not be feasible or right for others.