Ignoring the eu: mhra still want to move to regulate e-cigarettes as medicines
October 19, 2013
In a completely opposing statement to the recent vote in the EU on the Tobacco Products Directive, the Medicines and Healthcare products Regulatory Agency (MHRA) has stood firm in its stance that the UK should still regulate electronic cigarettes as pharmaceutical products.
In an interview with The Telegraph, the MHRA s Jeremy Mean reiterated its recommendations for medical classification stating
Our tests show that different products vary in how much nicotine they deliver. So some products may not help people regulate their nicotine cravings. This is precisely why they need regulating as medicines, so that they are not sold to under 18s or targeted at non smokers.
However, medical classification of electronic cigarettes is not the answer to sales to minors, universal industry standards or appeal to non smokers. In fact, according to research, the latter is not even a substantiated concern.
In a report on e cigarette use amongst adults and young people, Action on Smoking and Health (ASH) found that a minute 1% of non smokers surveyed had tried e cigarettes, and a flat out 0% currently used them with any kind of regularity.
E Cigs More Helpful Than NRT But Medical Regulation Needed
In a bizarre almost contradiction, the MHRA s Mr Mean then praised electronic cigarettes for their effectiveness for smokers looking to switch due to what he called the cigarette experience . He told The Telegraph
Rituals such as having something to hold are very important in addiction. E cigarettes may help some people more than standard NRT.
However, in the very same interview he went on to cite the promotion of nicotine addiction, renormalisation of smoking, varying nicotine concentrations and the need to stop sales to under 18s all as reasons why the UK should continue to unilaterally regulate electronic cigarettes as pharmaceutical products.
This is despite the majority vote in the EU this month against some of the proposed changes to the European Tobacco Products Directive (TPD), which many MEPs argued would unnecessarily restrict the sale of a safer alternative to tobacco cigarettes only serving to make the issues of public health and tobacco related deaths worse.
So, while the successful vote against many of the proposed changes to the TPD is a huge milestone in the fight against financial and regulatory throttling of the industry, the UK s MHRA and Department of Health could still move to have electronic cigarettes regulated as medicines exclusively on our shores.
Keep checking the VIP blog for further updates on the recent EU vote and developments in the situation on UK regulation we ll have any breaking news as soon as it happens.
News – european parliament gives vote of confidence to electronic cigarettes
There were mixed reactions to the European Parliament s handling of the commission s proposed new Tobacco Products Directive (TPD), which was voted on yesterday, but the electronic cigarette industry seemed full of praise for MEPs.
In a press note issued yesterday, XL Distributors, the electronic cigarette supplier, said the parliament had listened to reason in voting to reject plans that would have seen medical regulation applied to electronic cigarettes.
“We want to thank those MEPs who took the time to listen and to understand the industry s point of view as well as the views of many thousands of electronic cigarette smokers,” said Chief Executive Tony Scanlan.
“Electronic cigarettes have been described as potentially the greatest breakthrough for public health in decades. It would have been a sad day if our politicians had ignored the growing evidence that for many adult smokers these can be life changing products.”
Meanwhile, Taz Sheikh, co founder of XL Distributors, was already looking beyond the TPD to what might happen in the U.K. “We are in favour of an effective and well regulated market for our products, but we believe that applying onerous and costly medical regulation would be misguided and ill informed,” he said. “We hope that the U.K. government and the MHRA Medicines and Healthcare Products Regulatory Agency take note of today s vote and think again.”
There was much the same reaction from another electronic cigarette manufacturer and supplier, E Lites, which said that the EU Commission s plan to ban e cigarettes which were not licensed as medicines had been blocked by the parliament. MEPs had rejected the commission proposal, which had been backed by the Socialist Group s Linda McAvan.
Corporate Affairs Director Charles Hamshaw Thomas, described the parliamentary vote as a fantastic result for public health and the millions of smokers around Europe who were switching to e cigarettes. Without such a vote, he said, “We would have been in the absurd position of the EU making it much harder to make and sell e cigarettes than tobacco cigarettes which are vastly more harmful”.
“Common sense has prevailed and following this decision in the European Parliament, we now hope to work with the EU Commission and national governments to agree appropriate regulations for e cigarettes which reinforce existing consumer protection rules,” added Hamshaw Thomas. “The aim is to maximise the enormous health benefits of these products which are hugely popular with smokers seeking to reduce their tobacco dependency.”
The reaction from the traditional tobacco industry was more muted, however. “Today s vote in the European Parliament has introduced marginal improvement in some areas, but has still failed to take into account the views of millions of EU citizens, including our employees, retailers, tobacco growers and adult consumers who will be impacted by these measures,” said Philip Morris International EU Region President Drago Azinovic.
“It remains the case that members of the European Parliament have voted to ban an entire segment of the legal market despite the inevitable increase in illegal trade that this will fuel.
“They have failed to provide a workable framework for reduced harm products and have also continued to include oversized graphic health warnings and pack standardization even though the risks of smoking are already well known and without apparent concern for property rights that the EU Charter protects.
“There remain several important steps before this directive passes into law, and we hope that decision makers will take the opportunity to apply common sense and adopt a directive that is as any EU legislation must be necessary, proportionate and supported by credible evidence.”
According to a story in Malta Today, the vote was welcomed by the European health commissioner, Tonio Borg, of Malta, who said the amended TPD text would now go for negotiations between the European Council of ministers and MEPs.
Once the legislation is approved by the council and parliament, EU member states will have 18 months in which to translate the directive into their national laws.
U.K. based Forest (Freedom Organisation for the Right to Enjoy Smoking Tobacco) campaigners said consumers would have “mixed feelings” following the parliamentary vote.
“MEPs voted against a ban on slim cigarettes and rejected a ban on all smaller pouches of roll your own tobacco,” Forest said in a press note. (The European Commission wanted to ban pouches of 12.5 g and 25 g but MEPs voted to allow 20 g pouches.)
“The Parliament approved a ban on menthol cigarettes but voted to delay implementation for five years.”
“Consumers will have mixed feelings,” said Angela Harbutt, campaigns manager of Forest, which runs the No Thank EU campaign.
“We welcome the fact that some products have been reprieved while menthol cigarettes have been given a stay of execution, but consumers are still angry that the EU is trying to restrict or ban products they have purchased and enjoyed for many years.
“Prohibition doesn t work and banned products will almost certainly be available on the unregulated black market. Law abiding consumers will be at a serious disadvantage and it won t help children because criminal gangs don t care who they sell to.”
Harbutt came down hard on the parliament s decision to increase the size of the health warning to 65 percent of the pack.
“Increasing the size of the health warning is gesture politics,” she said. “It won t stop people smoking because everyone already knows about the health risks of smoking. It s incredibly patronising, even to teenagers, and the impact on smoking rates will be negligible.”
Harbutt accused the European Parliament of ignoring the concerns of consumers and retailers.
Forest, which is supported by British American Tobacco, Imperial Tobacco Limited and Gallaher Limited (a member of the Japan Tobacco Group of Companies), this week revealed that a letter writing campaign, opposing the Commission s revisions to the TPD, had generated almost 45,000 letters to MPs and MEPs in the U.K. alone.
Meanwhile, some of the harshest criticism of yesterday s vote came from within the parliament. According to another Malta Today story, the Greens blamed intense tobacco industry lobbying for the revisions made to the TPD.
“This is a shameful day for the European Parliament, as a centre right majority, led by the EPP group, has done the bidding of the tobacco industry and voted for weaker rules, which are totally at odds with citizens interests and public health,” said the Greens public health spokesperson Carl Schlyter. “It is scandalous that the centre right in this house seems to be more concerned about the profits of the tobacco industry than the health of EU citizens.”
