The chance to create the world’s first prescription electronic cigarette

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What should we make of the Medicines and Healthcare products Regulatory Agency (MHRA) updating its guidance for licensing e-cigarettes as medicinal products?

The updated ‘Guidance for licensing electronic cigarettes and other inhaled nicotine-containing products as medicines’ (published on October 29, 2021) sets out with extra detail the steps needed to license e-cigarettes as medicinal products, meeting the quality, safety, and efficacy criteria demanded of other medicinal products.

Any medicinally licensed e-cigarette could potentially be prescribed to people who want to quit or cut down on smoking, meaning England would be the first country in the world to prescribe medicinally licensed e-cigarettes to help reduce smoking rates.

But hang on, it was already possible for e-cigarette manufacturers to submit their products for this regulatory approval process, so what’s going on?

Call to action

Dr June Raine, Chief Executive of the MHRA, said in a press release, “The MHRA will continue to support companies in the development of safe and effective e-cigarette products, to encourage the licensing of e-cigarette products as medicines in order to support patient-centred care and access.”

The MHRA’s announcement is a re-emphasis of its support of this product category’s role in smoking cessation and a call to action for the e-cigarette market. The update gives us cause to reflect that a commercially viable product hasn’t yet taken up this opportunity. Why?

The large companies in the tobacco space aren’t familiar with designing under the constraints of a medicinal product or going through regulatory approval for medicines. Smaller players are concerned about the funding required to go down the medicinal route.

There’s a perception that the medicinal pathway is complicated and costly. There’s no denying that the bar for regulatory approval as a medicinal product is set imposingly high as it seeks to ensure safety, quality, and efficacy for users.

KIND CONSUMER

Bringing a complex drug delivery device to market

A CE mark is required to sell a medicinal product in the European Union, indicating compliance with ISO 13485. This standard defines the quality management systems used to control the product’s design, manufacture, and post-market surveillance. Compared to consumer products, this places much greater emphasis on risk assessment and mitigation throughout the product lifecycle, along with robust documentation to demonstrate regulatory compliance.

If the MHRA’s announcement reflects its frustration at the lack of progress to meet the perceived demand for a prescription-based device, can manufacturers expect an easier route to a license as a result?

The requirements of ISO 13485 will still need to be met in full, but perhaps the MHRA will expedite engagement with the applicants, which could certainly help the process. The announcement is significant in reinforcing the prevailing UK public health policy that e-cigarettes can play a key role in smoking cessation, providing an ‘open door’ for a forward-thinking player to advance and elevate the product category.

Continuum of product stewardship

The reduced risk product market has been on a journey of increasing commitment to product stewardship, partly driven by increasing regulation, for example, Tobacco Products Directive (TPD) and Premarket Tobacco Product Application (PMTA), and the increasing sophistication of the major players.

CDP serves clients in consumer and regulated healthcare markets, so we’re familiar with the challenges of operating in these different regulatory frameworks. For those already invested in product stewardship, perhaps the leap to a medicinal product won’t be as challenging as they think.

While the MHRA’s announcement may not be ‘news’, it does perhaps signal a reappraisal of the opportunity to create the world’s first prescription e-cigarette.

To find out more, explore Reduced Risk Products.


References

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David Lewis

Partner, Head of RRP