Lamb’s Letter

Posted 16th January 2019 by Dave Cross
The Science and Technology Committee released its report “E-cigarettes” back in August, and made recommendations. Two of these applied to the MHRA, and the committee chairman Rt Hon Norman Lamb MP wrote to it to urge a more rapid response to the issue of product licensing.

Addressing the letter to Dr Ian Hudson, Chief Executive of the MHRA, Lamb writes: “You will be aware that in August of this year my Committee published its Report on e-cigarettes. Two of our recommendations (those at paragraph 46 and 81) were directed to the MHRA. I hope that in due course the MHRA will respond to our Report directly or will feed into the Government’s response.”

The report’s recommendations:

  • Recommendation for Paragraph 46: “A medically licensed e-cigarette could assist smoking cessation efforts by making it easier for medical professionals to discuss and recommend them as a stop smoking treatment with patients. It would also make it easier for claims to be explicitly made about their harm-reduction relative to conventional smoking, which regulations currently prevent (Chapter 4). The Government should review with MHRA and the e-cigarette industry how its systems for approving stop smoking therapies could be streamlined; to be able to respond appropriately should manufacturers put forward a product for licensing.”

 

  • Recommendation for Paragraph 81: “Some aspects of the regulatory system for e-cigarettes appear to be holding back their use as a stop smoking measure. The limit on the strength of refills means that some users have to puff harder to get the nicotine they seek and may put some heavy smokers off persisting with e-cigarettes. The tank size restriction does not seem to be founded on any scientific rationale. A prohibition on making claims for the relative health benefits of switching to e-cigarettes from conventional cigarettes means that some who might switch are not getting that message. A ban on advertising ‘tobacco’ products, has prevented manufacturers putting ‘pack insert’ information about e-cigarettes in cigarette cartons. The Government, together with the ASA and the MHRA, should review all these regulatory anomalies and, to the extent that EU directives do not present barriers, publish a plan for addressing these in the next annual Tobacco Control Plan.”

Lamb is keen to press on with the first of the two recommendations: “While we await the formal response of Government and others I would be grateful if you could set out the MHRA’s response in particular to the recommendation at paragraph 46.”

Hudson responded: “To help address this recommendation, an Ad hoc working group will be set up under the sponsorship of the Commission on Human Medicines (CHM). A paper setting out the proposal was submitted by the MHRA and discussed by the CHM during their meeting on 6-7th December 2018. The CHM agreed that a group should be convened to advise, in the light of the further and emerging evidence, whether and if so, how the data requirements for the licensing of e-cigarettes as medicines could be further streamlined or simplified for companies applying to obtain a licence for e-cigarettes.”

Hudson has said that the MHRA has managed to discuss the draft terms of reference and membership of the group during the intervening months, although neither had been finalised.

He added: “We are hoping that the recommendation from the CHM will be received by July 2019 and after that the MHRA response incorporated in the Government response to the select committee.”

 

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 Dave Cross
Article by Dave Cross
Freelance writer, physicist, karateka, dog walker