Doodlebug
Postman
- Joined
- Sep 6, 2012
- Messages
- 126
Although somewhat overtaken by recent events, we did receive a response to our letter of 21st September 2012, and sent the following further letter on 9th October 2012:
Dear Dr Seychell,
Re: Revision of the Tobacco Products Directive 2001/37/EC
Thank you for your response, received today. I should like to take this opportunity to express my sincere gratitude to the Commission for its willingness to continue to engage with us in meaningful correspondence on these significant issues.
I confess, however, to feeling somewhat perplexed on a particular point, and write today to request clarification, if the Commission is able to provide same. Your letter states that the Commission is “considering a number of different policy options, from maintaining the status quo to subjecting all nicotine containing products to the medicinal products framework”, and you reference Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use.
My confusion centres on this question: by what mechanism can the Commission consider – even as one of a ‘number of different policy options’ – changing the classification of electronic cigarettes to subject them to the medicinal products framework as part of its current considerations of revising the Tobacco Products Directive?
Furthermore, since the legal definition of a medicinal product, under EU law, does not currently apply to electronic cigarette products (in the absence of medicinal claims), surely the Commission would be stepping quite some distance beyond its remit regarding revisions to the Tobacco Products Directive, if it sought to bring in new legislation for defining medicinal products, in order to capture electronic cigarettes?
Indeed, as we shall be explaining at the ‘Public Health: an update and way forward’ conference, to be held at the Barbican in London on 24th October 2012http://www.planetofthevapes.co.uk/forums/#_edn1, making electronic cigarettes medicinal would be to waste an opportunity. One of the main reasons why electronic cigarettes have become popular is the range of options available. Different smokers have different smoking patterns, and smoke different products, and electronic cigarettes allow a wide range of options to suit individual requirements. Since the core of medical regulation is a ‘per product’ licensing system, as well as rigorously-controlled dose delivery, this flexibility (and broader appeal) will be lost.
Electronic cigarettes are not well designed for controlled dosage any more than is a tobacco cigarette. Rather, electronic cigarettes are well designed to allow users to choose the amount of delivery they want – operating, as they do, as an almost exact ‘like-for-like’ alternative to tobacco smoking, but obviously, with a massively reduced risk factor. Introducing such medicinal/treatment controls will inevitably clash with users’ desires, reducing the effectiveness of electronic cigarettes as harm reduction alternatives to smoking.
One company left the electronic cigarette industry in early 2010 to join the pharmaceutical industry, and has voluntarily set out to obtain a Marketing Authorisation for their product as a smoking cessation device (instead of a non-medicinal, and thereby effective, harm reduction alternative). So far, they have spent in excess of £2 million, have not yet received an MA, and while the electronic cigarette industry has moved on to improved designs, are still using the same basic design they initially released in 2009. Of course, by following the medicinal route, they are stuck with having to have a limited product, by virtue of the limitations inherent in having controlled dosages, and attempting to achieve licensing. In contrast to the over 100 flavours in the electronic cigarette industry, the medicinal approach has limited this company to just 3.
In the course of our work, with both ECITA members, and vendors outside of our organisation, we have tested over 150 eliquids by Gas Chromatography and Mass Spectra analysis, for contamination. (Nicotine content is also checked by Isotope Dilution Analysis.) Across all these tests, we have not identified any significant toxic contamination at all. However, we have identified that there are quality control issues with some of the eliquids produced in China. As indicated above, this does not result in a ‘dangerous’ end product, but is something we would like to see improved. To this end, we are in the process of trying to source some more detailed and specific analysis, with a view to being able to complete our work on establishing a minimum quality standard for eliquid manufacture.
Suffice to say, the body of evidence is growing – from many different quarters, and indeed, many different agendas – and continues to demonstrate that electronic cigarettes are orders of magnitude safer than continuing to smoke. Any restriction on their availability to smokers who are unable or unwilling to quit, therefore, can only have a negative impact on the public health benefits which could be accrued. Reclassification of these general consumer products – admirably and robustly covered by the GPSR as they are – as medicinal products would clearly be a restriction on their wider availability, as well as restricting the usefulness and appeal of the products themselves.
Indeed, when it comes to questions of regulatory restrictions, there is a need for ‘appropriateness of control’. There is a legal requirement for regulators to demonstrate the clear risks of a product before restricting their free movement and access to those products for the public. This has been tested in Court within the EU, as the Commission is already aware, and must play its role in the Commission’s deliberations. Perhaps, however, a case which may have been overlooked sheds more light on this issue than those directly concerning electronic cigarettes:
In case C-319/05 (3) (Commission of the European Communities v Federal Republic of Germany, classification of a garlic preparation as a medicinal product[ii]), the European Court of Justice concluded, among other things, that the generic reference made to the risks that taking garlic may have for health in very specific circumstances, is not sufficient to justify a measure such as making the product subject to the particularly strict procedure for a marketing authorisation for a medicinal product. Furthermore, the ECJ concluded that such a restriction on the free movement of goods must therefore necessarily be based on a detailed assessment of the risk to public health. A detailed – and unbiased – assessment of the risk to public health posed by electronic cigarettes can only conclude that any necessary justification for such regulatory restrictions does not exist.
In tackling the issues surrounding the ‘Politics of Science’, it is important to realise why Tobacco Harm Reduction as a principle is so often overlooked, with much of the lobbying and ‘science’ motivated by anti-tobacco, rather than ‘pro-public health’ attitudes. We believe that the combination of the bad reputation of the tobacco industry, together with the vast sums pharmaceutical companies spend on promotion and lobbying, have negatively affected both THR policy, and thereby, public health as a whole.
I appreciate your seeking to assure us “that the impacts on all stakeholders are being carefully considered”, and I do believe that the Commission has the best of intentions. However, I urge you – particularly as you approach the conclusion to this impact assessment phase of the process – to be mindful of the fact that the many millions of vapers across Europe (and beyond) should also be considered stakeholders, and fully consider the impact on public health outcomes for them as individuals, as well as at the population level.
I shall certainly not publish your letter without your permission, but would like to have same, in order that I can keep the community informed as to our discussions, and far more importantly, the Commission’s progress with these difficult issues. Once again, I shall not publish my response until one week has elapsed, unless there is a good reason not to publish.
Thank you once again for your continued efforts. I trust you will be guided towards sensible decision-making which should result in the best possible public health outcomes for as many as possible.
http://www.planetofthevapes.co.uk/forums/#_ednref1 Conference – ‘Public Health: an update and way forward’, The Barbican, London, 24th October 2012. ECITA will be giving Masterclass 2, on ‘Technology and innovation’. http://www.publicserviceevents.co.uk/224/public-health[ii] Case C-319/05 Commission of the European Communities v Federal Republic of Germany, see also at (13/09/2012). See also the proposal of Advocate-General on the same matte, at http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:62005CC0319:ET:HTML(13/09/2012).
Whether or not the current revisions to the TPD have any ‘legs’ left remains to be seen, but whenever policy decisions are going to be made, the policy-makers MUST ensure they keep the emphasis on public health, with an absolute reliance on genuine scientific evidence.
More...
Dear Dr Seychell,
Re: Revision of the Tobacco Products Directive 2001/37/EC
Thank you for your response, received today. I should like to take this opportunity to express my sincere gratitude to the Commission for its willingness to continue to engage with us in meaningful correspondence on these significant issues.
I confess, however, to feeling somewhat perplexed on a particular point, and write today to request clarification, if the Commission is able to provide same. Your letter states that the Commission is “considering a number of different policy options, from maintaining the status quo to subjecting all nicotine containing products to the medicinal products framework”, and you reference Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use.
My confusion centres on this question: by what mechanism can the Commission consider – even as one of a ‘number of different policy options’ – changing the classification of electronic cigarettes to subject them to the medicinal products framework as part of its current considerations of revising the Tobacco Products Directive?
Furthermore, since the legal definition of a medicinal product, under EU law, does not currently apply to electronic cigarette products (in the absence of medicinal claims), surely the Commission would be stepping quite some distance beyond its remit regarding revisions to the Tobacco Products Directive, if it sought to bring in new legislation for defining medicinal products, in order to capture electronic cigarettes?
Indeed, as we shall be explaining at the ‘Public Health: an update and way forward’ conference, to be held at the Barbican in London on 24th October 2012http://www.planetofthevapes.co.uk/forums/#_edn1, making electronic cigarettes medicinal would be to waste an opportunity. One of the main reasons why electronic cigarettes have become popular is the range of options available. Different smokers have different smoking patterns, and smoke different products, and electronic cigarettes allow a wide range of options to suit individual requirements. Since the core of medical regulation is a ‘per product’ licensing system, as well as rigorously-controlled dose delivery, this flexibility (and broader appeal) will be lost.
Electronic cigarettes are not well designed for controlled dosage any more than is a tobacco cigarette. Rather, electronic cigarettes are well designed to allow users to choose the amount of delivery they want – operating, as they do, as an almost exact ‘like-for-like’ alternative to tobacco smoking, but obviously, with a massively reduced risk factor. Introducing such medicinal/treatment controls will inevitably clash with users’ desires, reducing the effectiveness of electronic cigarettes as harm reduction alternatives to smoking.
One company left the electronic cigarette industry in early 2010 to join the pharmaceutical industry, and has voluntarily set out to obtain a Marketing Authorisation for their product as a smoking cessation device (instead of a non-medicinal, and thereby effective, harm reduction alternative). So far, they have spent in excess of £2 million, have not yet received an MA, and while the electronic cigarette industry has moved on to improved designs, are still using the same basic design they initially released in 2009. Of course, by following the medicinal route, they are stuck with having to have a limited product, by virtue of the limitations inherent in having controlled dosages, and attempting to achieve licensing. In contrast to the over 100 flavours in the electronic cigarette industry, the medicinal approach has limited this company to just 3.
In the course of our work, with both ECITA members, and vendors outside of our organisation, we have tested over 150 eliquids by Gas Chromatography and Mass Spectra analysis, for contamination. (Nicotine content is also checked by Isotope Dilution Analysis.) Across all these tests, we have not identified any significant toxic contamination at all. However, we have identified that there are quality control issues with some of the eliquids produced in China. As indicated above, this does not result in a ‘dangerous’ end product, but is something we would like to see improved. To this end, we are in the process of trying to source some more detailed and specific analysis, with a view to being able to complete our work on establishing a minimum quality standard for eliquid manufacture.
Suffice to say, the body of evidence is growing – from many different quarters, and indeed, many different agendas – and continues to demonstrate that electronic cigarettes are orders of magnitude safer than continuing to smoke. Any restriction on their availability to smokers who are unable or unwilling to quit, therefore, can only have a negative impact on the public health benefits which could be accrued. Reclassification of these general consumer products – admirably and robustly covered by the GPSR as they are – as medicinal products would clearly be a restriction on their wider availability, as well as restricting the usefulness and appeal of the products themselves.
Indeed, when it comes to questions of regulatory restrictions, there is a need for ‘appropriateness of control’. There is a legal requirement for regulators to demonstrate the clear risks of a product before restricting their free movement and access to those products for the public. This has been tested in Court within the EU, as the Commission is already aware, and must play its role in the Commission’s deliberations. Perhaps, however, a case which may have been overlooked sheds more light on this issue than those directly concerning electronic cigarettes:
In case C-319/05 (3) (Commission of the European Communities v Federal Republic of Germany, classification of a garlic preparation as a medicinal product[ii]), the European Court of Justice concluded, among other things, that the generic reference made to the risks that taking garlic may have for health in very specific circumstances, is not sufficient to justify a measure such as making the product subject to the particularly strict procedure for a marketing authorisation for a medicinal product. Furthermore, the ECJ concluded that such a restriction on the free movement of goods must therefore necessarily be based on a detailed assessment of the risk to public health. A detailed – and unbiased – assessment of the risk to public health posed by electronic cigarettes can only conclude that any necessary justification for such regulatory restrictions does not exist.
In tackling the issues surrounding the ‘Politics of Science’, it is important to realise why Tobacco Harm Reduction as a principle is so often overlooked, with much of the lobbying and ‘science’ motivated by anti-tobacco, rather than ‘pro-public health’ attitudes. We believe that the combination of the bad reputation of the tobacco industry, together with the vast sums pharmaceutical companies spend on promotion and lobbying, have negatively affected both THR policy, and thereby, public health as a whole.
I appreciate your seeking to assure us “that the impacts on all stakeholders are being carefully considered”, and I do believe that the Commission has the best of intentions. However, I urge you – particularly as you approach the conclusion to this impact assessment phase of the process – to be mindful of the fact that the many millions of vapers across Europe (and beyond) should also be considered stakeholders, and fully consider the impact on public health outcomes for them as individuals, as well as at the population level.
I shall certainly not publish your letter without your permission, but would like to have same, in order that I can keep the community informed as to our discussions, and far more importantly, the Commission’s progress with these difficult issues. Once again, I shall not publish my response until one week has elapsed, unless there is a good reason not to publish.
Thank you once again for your continued efforts. I trust you will be guided towards sensible decision-making which should result in the best possible public health outcomes for as many as possible.
http://www.planetofthevapes.co.uk/forums/#_ednref1 Conference – ‘Public Health: an update and way forward’, The Barbican, London, 24th October 2012. ECITA will be giving Masterclass 2, on ‘Technology and innovation’. http://www.publicserviceevents.co.uk/224/public-health[ii] Case C-319/05 Commission of the European Communities v Federal Republic of Germany, see also at (13/09/2012). See also the proposal of Advocate-General on the same matte, at http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:62005CC0319:ET:HTML(13/09/2012).
Whether or not the current revisions to the TPD have any ‘legs’ left remains to be seen, but whenever policy decisions are going to be made, the policy-makers MUST ensure they keep the emphasis on public health, with an absolute reliance on genuine scientific evidence.
More...
