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The shock of the new - how government copes with innovation

The story of the EU’s tobacco products directive shows how difficult policy makers find it to cope with new things. If open policy making does anything, it should enable them to deal with innovation better.

It is very unusual to read a leader in the Daily Telegraph lauding MEPs for stopping a policy endorsed by the UK government. Yet this is what that newspaper did recently, hailing the revolt by Conservative and Lib Dem MEPs which threw a spanner in the works of an attempt by the Council and Commission to regulate e-cigarettes as medicines. This sounds a pretty obscure subject. And on the face of it, the government’s policy sounds harmless enough. After all cigarettes are very bad for you – and having let the smoking genie out of the bag, surely governments are right to be cautious about something that sounds very like them. But this is where the story gets interesting. Even after 50 years of throwing the policy book at cigarettes, around 20% of the population refuse to be priced, persuaded or regulated out of the habit – despite that fact that that habit will end up prematurely killing around half of them. Smoking is increasingly the domain of the poor and the vulnerable e.g. self-medicating schizophrenics. For years, those concerned about smoking have been seeking a safe(r) alternative – but they were badly bitten by their experience of low tar cigarettes – sounded good but offered few health benefits. E-cigarettes which offer the nicotine (relatively harmless fun, or so I am told) without the smoke (the cause of death and disease) have the potential to be just that breakthrough. If lots of smokers switched to e-cigarettes, there would be very substantial gains to public health. The market in the UK has taken off in a regulatory vacuum – which is where the argument starts. Within government, e-cigarettes were immediately characterised as a health issue – with Department of Health in the lead. So Department of Health referred the question of what to do about e-cigarettes to their expert committee on human medicines. Despite the fact that no maker had ever claimed the product was a medicine. Not surprisingly, the committee proposed that e-cigarettes should be regulated as medicines. Then along came the EU – with a proposal for ‘light touch medicines regulation’. But that is – sensibly enough – an oxymoron. Medicines regulation is very heavy duty indeed. And only big existing incumbents can possibly hope to comply. The small start-ups who are driving innovation would be driven instead out of business. But the impact on them was not considered. One group was completely ignored in the whole process: the estimated 1m plus former smokers who have switched wholly or partly to using e-cigarettes and are very passionate about the issue. They were a new interest group in town. When so-called ‘vapers’ discovered that their lifeline was about to be cut off in the name of health, they took to social media to campaign against the changes. The entrenched ‘health’ lobby was on the other side. But there was no argument on health impacts: everybody agrees that the risks from e-cigarettes are a tiny fraction of those from the conventional product. Instead they used their medical expertise and authority to opine on regulatory impacts and market consequences – issues not usually covered in medical training. So the forces of conservatism – the government, the EU Commission and Council and the health lobby locked themselves into protecting a status quo which privileges the most dangerous products – cigarettes – against potential competitors. The European Parliament proved its worth by forcing a rethink. There is now a new public health minister and this will be near the top of her in-tray. But government not only needs to take the chance to have another look at its stance towards e-cigarettes – but to look at how it copes with innovations. Open policy making could be the key: •Being open about how to frame an issue – rather than box it from the start in a way that almost predetermines the outcome •Involving innovators and not just incumbents •Consulting self-identified potential beneficiaries – as well as self-appointed ‘experts’ •Giving as much weight to potential dynamic benefits as to possibly hypothetical risks. The alternative is to stick not just with closed but ‘closed mind’ policy making.

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