New UK Pharmaceutical Packaging Warnings: Lucy In The Sky With Directions For Marketing Authorisation Holders

This client alert looks at the impact of a new drug driving offence in the UK which will come into effect during 2014 as part of The Crime and Courts Act 2013 (the "CCA 2013"). It is relevant for UK Marketing Authorisation Holders ("MAHs") with medicines containing specified controlled drugs.

Executive summary

The CCA 2013 introduces a new offence for driving under the influence of drugs, which will become enforceable later this year. This new offence is primarily intended to remedy the failings of section 4 of the Road Traffic Act 1988 (the "RTA 1988"). The RTA 1988 made it a criminal offence to drive under the influence of a controlled drug, but this was found to be difficult to prove. The new offence under the CCA 2013 addresses this issue and takes into account the fact that some specified controlled drugs may be taken by drivers legitimately.

In light of this, the Medicines and Healthcare Products Regulatory Agency (the "MHRA") has requested that all MAHs with medicines using specified controlled drugs update the Summary of Product Characteristic (the "SmPC"), the patient information leaflet and the product labelling of their medicines to include new warnings to notify prescribers and patients of the change. The MHRA has provided MAHs with wording for this purpose and set a deadline of 28 February for MAHs to provide their Type 1A notifications to the MHRA.

Background

On 10 December 2013, the MHRA wrote a letter to MAHs informing them of new compliance requirements for the packaging and labelling of their medicines following a new drug driving offence introduced as part of the CCA 2013. The MHRA stated that the Department of Transport has set a date of September 2014 as the anticipated date for the legislation to take effect, following a debate in Parliament due in early 2014, during which the regulations are expected to be finalised and after which the offence will become enforceable.

The offence

Before the CCA 2013 was introduced, regulations relating to drugs and driving were considered under the Misuse of Drugs Act 1971 (the "MDA 1971") and the RTA 1988.

The MDA 1971 prohibited the production, import, export, possession and supply of "controlled drugs" (a list of which can be found here), but stated that it was not a criminal offence to have a controlled drug in your body. Section 4 of the RTA 1988, on the other hand, made it a criminal offence to drive a vehicle when under the influence of drink or drugs. The difficulties involved...