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Peaceful Protest Expected At 2010 UK Smoking Cessation Conference

A demonstration is being staged by Freedom to Choose (Scotland) at the 2010 UK Smoking Cessation Conference taking place on 14 and 15 June in Glasgow.

FOR IMMEDIATE RELEASE
PRLog (Press Release) – Jun 10, 2010 – The conference’s delegate list stands at 559, including smoking cessation advisers and consultants, and representatives from Action on Smoking & Health (ASH), ASH Scotland, and from pharmaceutical companies.

Tax-payers’ money will fund most of the attendees from throughout the UK, who will discuss ‘new indications for NRT, medication compliance, marketing and supporting tobacco control activity, and the impact of illicit tobacco’.(1) The bulk of the conference programme concerns smoking cessation treatments/programmes and smoking restrictions; illicit tobacco is dealt with twice.

The Scottish Government spends £11m annually on direct smoking cessation, yet its targets appear startlingly unambitious: ‘… to support, through smoking cessation services, 8 per cent of your smoking population in successfully quitting (at 1 month post quit) over the period 2008/9 to 2010/11’.(2)

‘This conference is a publicly funded opportunity for improving market conditions for smoking cessation treatments, most of which have a very limited success rate,’ says spokesman Michael Davidson. ‘Smoking cessation programmes are little more than a revolving door, designed to transfer smokers from the tobacco market to a reliance on nicotine lozenges and patches.’

A success rate of a mere 8% demonstrates that the true aim of the smoking cessation industry is not that people give up smoking entirely, but that they take up smoking cessation support. Both the public and private sector elements of the health service have high stakes in this market in terms of jobs and sales of treatments.

Foiled efforts to persuade smokers to take up smoking cessation services via the NHS are relentless. In 2007, ASH – a major player in the smoking cessation movement – was obliged to apologise to Allen Carr’s Easyway Organisation for suggesting its success rate of 53 per cent was a made-up figure; ASH also paid the Allen Carr organisation’s legal fees.(3) Yet both the NHS and ASH still promote only medical interventions manufactured by pharmaceutical companies, combined with NHS support.(4)

‘At a time when public spending cuts are inevitable it is complete madness to spend money on treatments that are known to have a low rate of success when better alternatives are available,’ continues Michael Davidson. ‘It is hard to escape the conclusion that promoting smoking cessation products is a much higher priority than concern to help smokers to stop smoking. Eleven million pounds may not be a large share of the health budget. But the money is public funding, and it is being used ineffectively and inappropriately.’

Conflicts of interest are an obvious issue. The conference has been organised by Exchange Supplies, a company normally concerned with hard drug abuse issues. The conference director holds a patent application for a nicotine delivery device, tendered in the name of Exchange Supplies.(5) Members of the UK Centre for Tobacco Control Studies, represented among the conference speakers, also hold personal financial interests in smoking cessation research.(6)

The participants at this conference have everything to gain from promoting smoke-free environments and increasing restrictions on smokers. This has extreme ramifications in institutions such as mental health settings and prisons where people are effectively forced to take treatments that they have not needed in the past.

The demonstration will take place outside the Radisson Hotel, Argyll Street, Glasgow, between 12 and 4pm (the closing hours of the conference) on Tuesday 15 June.

ORAL QUESTION for Question Time at the part-session in June 2010 pursuant to Rule 116 of the Rules of Procedure by Justas Vincas Paleckis to the Commission

Subject: Electronic cigarettes
Parents in a number of EU Member States are concerned that electronic cigarettes, also known as electronic nicotine inhalers, are apparently becoming increasingly available among schoolchildren. These cigarettes are particularly dangerous for children, who become addicted more quickly than adults do. Large doses of nicotine can be highly poisonous.
Children can easily get hold of these electronic cigarettes, which are sold online. On ordinary cigarette packets there are warnings about the health dangers of smoking and it is clearly stated that cigarettes can only be purchased by those over the age of 18. Other restrictions also apply, and this is not the case for electronic cigarettes.
Does the Commission think it is about time steps were taken to put an end to the distribution of these electronic cigarettes on the internet, and does it think other action should be taken to protect the health of minors?

Nicotine Containing Products: Meeting between MHRA and Importers/Distributors of Nicotine Containing Products


Friday 4 June 2010 at 2pm, CR1/2 19th Floor, Market Towers


Introduction

1. The MHRA welcomed those attending and introductions were made of MHRA staff present at the meeting.


Purpose of the meeting

1. The MHRA clarified the purpose of the meeting was to gain a better understanding of stakeholders’ views and to clarify any aspects of the consultation MLX 364 on The Regulation of Nicotine Containing Products (NCPs). The Group were informed that this was not a decision making meeting. The MHRA informed the Group they would also be engaging with other interested parties including lay people; smokers and non-smokers, other consumer groups and healthcare professionals. The MHRA stated this meeting was a key opportunity for those importing/distributing unlicensed NCPs to input their views on the proposals contained in the consultation.



Background to the consultation

1. The MHRA presented information on the role of the MHRA, the background to the consultation and the trigger for consultation – a review of the approach to the regulation of nicotine following the grant of an extended indication for Nicotine Replacement Therapy (NRT) products. This followed expert advice from the Commission on Human Medicines and its expert working group, as well as legal advice. The MHRA stressed it recognised the need for innovation in products to help people stop smoking and that this needed to be balanced against the need for adequate safeguards in terms of safety, quality and efficacy. The MHRA clarified the three options set out in the consultation letter. The consultation included an Impact Assessment (IA) of the options, giving an idea of the number of products affected and their costing but the MHRA stressed this was based on the limited knowledge of the market currently available, invited input from those present and that the IA would be revisited once further information was available.

1. In response to questions, the MHRA said that the results of consultation would require cross-government consideration and it was not possible to give exact timeframes for completion of this process. It was hoped that a decision would be reached by September and the Agency would communicate the outcome of the wider consultation.

1. The NCP importers asked whether Trading Standards had stated during the consultation they could not regulate the products. The MHRA confirmed a response has been received from Local Authorities Co-ordinators of Regulatory Services, which supported regulation of NCPs as medicinal products. The MHRA confirmed the intention to publish all responses to consultation along with a summary in due course.

1. The NCP Importers stated they were currently in the process of setting up a representative body. The MHRA welcomed the concept of such a representative body and spokespeople in this area. It was recognised this would be an advantage for further dialogue and make the process more efficient. It was agreed it would be helpful for the importers of unlicensed NCPs to provide the MHRA with contact points who are able to gather the perspectives of the Group.

Action: NCP companies

1. The NCP Importers asked if literature was available on the process of gaining a Marketing Authorisation. The MHRA confirmed they wish to be as transparent as possible and documents such as Public Assessment Reports were available on the MHRA’s website. Other aspects around safety and quality were more specific to different products and might be discussed during the licensing process for individual products. The MHRA had not published guidance on how to license NCPs as this could suggest the outcome of the consultation has been prejudged.

1. The NCP importers asked for clarity on the options available. They questioned whether there was a fourth option to bring NCPs under regulation outside the medicines licensing procedures. The MHRA confirmed the options available were the 3 presented in the consultation but within those, there might be scope for movement, e.g. on the timescales of any transitional period in option 2.

1. The NCP importers questioned whether the movement of NRT products from Prescription Only Medicines to General Sales List products is recognition that these products are not medicinal products but are consumer products. The MHRA clarified that the definition of the legal status of a medicine and confirmed all General Sales List products are still medicinal products, subject to quality, efficacy and safety standards. The legal status of a medicine concerns the sale and supply of medicinal products.

1. The NCP importers asked for clarity on the definition of a Marketing Authorisation. The MHRA clarified that a marketing authorisation is the permit for a medicinal product to be sold or supplied on the market, it is defined in UK and EU legislation and was commonly referred to as the ‘product licence’. It was confirmed that if NCPs are not considered to be a medicinal product then a Marketing Authorisation is not required. MHRA agreed to provide a glossary of commonly used terms to those attending the meeting.

Action:MHRA


Discussion points


Should we regulate? What alternatives are available?

1. Introducing the discussion, the MHRA suggested that regulation could be seen as an opportunity to create a level playing field, and a legal framework could be enabling for products and support innovation. The MHRA had a responsibility to enable the availability of medicines for which benefit/risk was favourable.

1. The NCP Importers asked the MHRA whether they had the remit to regulate NCPs and whether they would be regulated based on the delivery of nicotine or the physiological function of the product. The MHRA explained they had received legal advice and basis for regulation had been confirmed by European Commission advice. There was not a consistent approach internationally to the regulation of NCPs, perhaps reflecting the relatively recent development of the market. Some countries have banned e-cigarettes within their regulatory framework. By contrast, the UK Government approach provides a framework for quality, efficacy and safety for such products and to enable innovation.

1. The NCP importers stated that e-cigarettes were not medicinal products but rather recreational products containing low levels of nicotine without the high number of carcinogens contained within tobacco cigarettes. The NCP importers suggested their products were consumer products and as such should be covered by Trading Standards.

1. The NCP Importers agreed that Trading Standards Officers did not always take a consistent approach and suggested the development of a self regulatory code to underpin regulation by Trading Standards would strengthen the current position. It was noted that a number of the Importers of NCPs tested the nicotine levels in their products and had controls on the sale of products to under 18 year olds.

1. There were differing estimates as to how quickly a code of practice might be available (from one month to one year).


If we regulate what is the best way of achieving this?


1. An NCP Importer asked if NCPs are to be regulated by the MHRA, what clinical data would be required and how would smaller companies procure this data in a short time frame. The MHRA confirmed that if regulation was agreed, evidence from published literature could support an application. A company would be required to show that the nicotine levels within their product fell within the levels in published literature. Further advice on how this might be achieved could be discussed on a product by product basis. The NCP Importers reiterated their belief that e-cigarettes are not NRT products and so should not be compared against them.

1. The NCP Importers asked if the MHRA was to regulate these NCP by their physiological function, what nicotine levels would be required. MHRA suggested this would likely require a clinical judgement and be informed by literature references, depending on the blood levels of nicotine achieved by particular products.

1. An NCP Importer presented information from their perspective on the regulation of NCPs in the USA. His belief was that NCPs were not being banned because of nicotine levels but because of irresponsible people marketing the products inappropriately. The NCP importers present at the meeting wanted to create a set of standards for all importers to use; ensuring availability of e-cigarettes did not necessarily mean regulating them as medicinal products.

1. Those companies attending the meeting confirmed that they dealt only with electronic cigarettes and not other forms.


Impact on Industry

1. The NCP importers stated they faced two big pressure groups: the tobacco industry and the pharmaceutical industry. Importers could not afford the cost of licensing as they were small business holders and licensing fees were too high. The MHRA stated that the agency commonly works with small and medium enterprises. It is a mixed market and the MHRA makes adjustments in fees for smaller organisations. The MHRA wanted to see innovation and gear regulation for small innovative companies. In order to do this it is necessary to engage with stakeholders.

1. The NCP Importers were concerned that if the MHRA regulate these products it will be equivalent to a ban and the market will go underground. If the market goes underground there will be no safeguards in place, there will be a risk of contaminated products reaching the market.

1. The NCP Importers asserted that e-cigarettes were not dangerous; there was no evidence of harm. The products had been around for over seven years, millions of people were using them and no single incident of harm had been reported across the world.

1. NCP Importers stated that the market for e-cigarettes was increasing dramatically and regulation could not stop consumer demand. They asked the MHRA to recognise the risk regulating these products as medicines could have, in terms of potential impact on supply of products less harmful than tobacco cigarettes.


Next steps and timings

1. The NCP Importers asked about wider engagement with interested parties. The MHRA outlined that an independent research agency had been used by the MHRA to contact voluntary organisations, health professionals and consumer groups. The findings of this research would be published around the time a decision is made. The NCP Importers were concerned that only 7-10% of smokers had heard of e-cigarettes so it may be difficult for the research agency to contact these people. In addition, an NCP Importer present during one of the focus groups suggested the research was biased on the basis that the role of Trading Standards was not made sufficiently clear. The NCP Importers stated that they felt the market research to be flawed and would welcome the opportunity to challenge the findings before they are published.

1. The NCP Importers were concerned that the level of understanding of their products was low at the MHRA and with other bodies from which the MHRA was taking advice. They felt it important that misinformation regarding their products was not put into the public domain which was damaging to them.


Conclusion

1. MHRA thanked those attending and agreed to circulate a note of the meeting early the following week.

Action: MHRA

1. Further comments will be welcomed from the Group up until 9 June and should be directed to Amanda Bryan as the point of contact on email address.


8 June 2010