The UK Regulatory Policy Committee (RPC) has issued a withering criticism of the Medicines and Healthcare products Regulatory Agency (MHRA)’s consultation letter calling for the regulation of electronic cigarettes as a medicine, pointing out out that there is insufficient evidence that the electronic cigarette poses a risk to public health.
The MHRA, while acknowledging the device has the potential to save lives, has recently called for the regulation (by themselves!) of e-cigarettes in a move which is likely to lead to a de-facto ban on the device. (In contrast to MHRA claims that the devices are not regulated, Trading Standards currently oversees the safety and supply of these products in the UK.)
However, the RPC’s opinion issued on the letter criticised the MHRA on a number of grounds, including the following:
- there was insufficient evidence that the device poses any risk to health;
- the MHRA has failed to consider how their regulation will affect tobacco products;
- the MHRA has failed to provide a robust assessment of costs and benefits;
- the MHRA has failed to state the legal case for regulation;
- the MHRA has failed to estimate the impact upon competition, and the implications of raising new barriers to entry.
The RCP argues that the MHRA does not:
“provide sufficient evidence to suggest that there is a sufficient risk to public health from currently unlicensed NCPs which would justify the future regulation of these products.”
As we said in our own response, regulating e-cigarettes on the basis that they contain nicotine and affect the metabolism could affect tobacco. The RCP agrees, stating:
“…it is not clear from the consultation letter how this will affect tobacco products (e.g. cigarettes), which also contain nicotine and hence will be within the scope for these new regulations.”
Impact on Competition
The RCP stated that the consultation had failed to take into account the effect of the regulation on competition.
“The IA [Impact Assessment] does not provide an appropriate assessment of the impact of the proposed regulations on competition…”
“The regulations are likely to create additional barriers to entry…”
Who are the RCP?
The RCP (link) are a government advisory committee set up in 2009 to provide “strong and effective external scrutiny throughout the policy making process,” which they certainly seem to be doing so here.
For their full opinion on the MHRA consultation, see The Regulatory Policy Committee opinion: Consultation on regulation of nicotine containing products.
Thanks to Kate from Vapers Network for forwarding the RCP’s opinion to me!