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.
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.
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.
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 in proving driving impairment due to drugs meant that section 4 of the RTA 1988 was not often used in drug driving cases.
The offence under the CCA 2013 is similarly aimed at dangerous drivers who use drugs recreationally and drive under their influence. However, unlike section 4 of the RTA 1988, the offence under the CCA 2013 acknowledges that many controlled drugs are often used legitimately and that it can be difficult to distinguish therapeutic use from recreational use.
With this in mind, the offence under the CCA 2013 provides a statutory defence which states that it is a defence for a person to show that: (i) the specified controlled drug had been prescribed or supplied to them for medical or dental purposes; (ii) they took the drug in accordance with any directions given by the person who prescribed or supplied the drug, and with any accompanying instructions (so far as consistent with any such directions) given by the manufacturer or distributor of the drug; and (iii) their possession of the drug immediately before taking it was not unlawful under the MDA 1971.
Furthermore, the new offence provides that this defence is not available if the individual’s actions were: (i) contrary to any advice, given by the person by whom the drug was prescribed or supplied, about the amount of time that should elapse between taking the drug and driving a motor vehicle; or (ii) contrary to any accompanying instructions about that matter (so far as consistent with any such advice) given by the manufacturer or distributor of the drug.
Directions for MAHs
The letter from the MHRA to MAHs states that MAHs need to provide both health care professionals and patients with additional information where their medicines are considered controlled drugs under the new offence. The MHRA specifically reminds MAHs that the offence also includes medicines that are metabolised into a controlled drug.
The MHRA has requested that MAHs update the SmPC and patient information leaflet of their relevant medicines with new warnings. This includes updating packaging to draw patients’ attention to the new information with the addition of a “new warning” flash to the front of packets. The MHRA has provided MAHs with specific wording for these warnings, which can be found in the letter here in Annexes I and II respectively.
Furthermore, the MHRA has stated that the new warning flash on the front of packaging should not be removed until after September 2015. Before removing the warning flash, MAHs are required to complete a Better Recognition of Medicines Initiative notification (BROMI) informing the MHRA of the removal.
The MHRA has stated that the revised information will need to be included in labels and leaflets by September 2014. Variations should be sent to the MHRA as Type 1A notifications, stating the reason as “Addition of driving warnings in line with MHRA directions”.
MAHs are reminded that Type 1A notifications are variation applications which are accompanied by dedications and statements from the MAH and do not include information which requires assessment by the MHRA. There is also no fee for this type of submission.
Most importantly, MAHs must keep in mind that there is a 14 day acknowledgment period for a valid application using a Type 1A notification and the MAH should wait for confirmation from the MHRA before making any changes. This is especially pertinent as all variations are to be submitted to the MHRA by 28 February. MAHs should send in their Type 1A notifications as soon as possible for any products which are considered under the CCA 2013 offence.