The Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom has opened up the discussion about making all non tobacco nicotine products, including electronic cigarettes, a pharmaceutical. Specifically they are looking to make manufacturers of these nicotine products apply for a medicines Marketing Authorisation (MA) before marketing the products in the UK.
Obtaining the Marketing Authorisation (US: Authorization) from the MHRA in the UK is “generally submitted by the pharmaceutical industry, but anyone with the necessary supporting data may apply for a licence.” according to the MHRA website. It goes on to state, “The life cycle of a new medicine begins with discovery and laboratory studies carried out by the pharmaceutical company.”
It is pretty clear that forcing the electronic cigarette containing nicotine……who’s effects are well known, into this regulatory framework is no less than handing the pharmaceutical companies a new product to have a monopoly over. We at INSTEAD Electronic Cigarettes are against handing this industry over to the pharmaceutical industry.
So why is pharmaceutical control over the electronic cigarette a bad thing? Here’s why:
1) Giving any company or group of companies a monopoly is bad for the public. It means less options, higher cost to the consumer, and less recourse when consumer issues arise.
2) Not allowing electronic cigarettes to fairly compete with tobacco cigarettes means more people smoking and less people vaping. As a pharmaceutical, the electronic cigarette could be prescription only and even more likely to only be sold in pharmacies while tobacco is sold in many high traffic areas.
Even Philip Morris knows that making electronic cigarettes a pharmaceutical is good for them. They submitted “ Philip Morris Limited’s Reponse to the Department of Health’s Consulation on the Future of Tobacco Control” in September of 2008 and on page 46 they state, ‘…pharmaceutical regulation appears to be the only viable option for them [electronic cigarettes] today. The DH suggests, however, that such products would only be regulated as a medicinal product if sold with claims that the product “will help people quit smoking… However, if no such claims are made explicitly in the packaging or marketing, these products remain largely unregulated.” This is unacceptable.’ Of course this is unacceptable to the largest tobacco company in the world. Here is a product that directly competes with their product. Regulation is the best friend of big business….it keeps out competition. We should mention that PM also mentions the possibility of relaxing the pharmaceutical regulatory framework to accommodate tobacco harm reduction or create a new framework that encompasses both tobacco and reduced harm nicotine products. It’s too bad that they obviously didn’t push too hard for these ideas.
3) Since the electronic cigarette would now be a medicine, it would need to treat something. This is against what we have found; smokers like smoking. They just want to do it, recreationally, with the least possible risk. Marketing the electronic cigarette as a way to “quit smoking” and possibly even placing a stop usage date on it would undermine it’s ability to move people who enjoy smoking over to vaping. Giving the impression that electronic cigarettes gets people off of nicotine is misleading and could result in smokers continuing to smoke rather than trying an alternative.
We recommend all e-smokers in the UK ask for either a separate regulatory framework for this unique product or the creation of a subcategory as a reduced harm tobacco product. The bottom line is that if tobacco cigarettes, which are known to be deadly, are allowed to be freely sold on the market, then so should smoking alternatives such as the electronic cigarette.
Post time: Aug-24-2016