The Medicines and Healthcare Products Regulatory Agency (MHRA) has opened a consultation on plans to simplify the information requirements for advertising of medicines to prescribers and suppliers.
The Agency wants to increase the number of ads which carry a “pointer” to where to find detailed prescribing information, rather than including this information within the ad. Currently, abbreviated ads which include a pointer rather than the prescribing information are only permitted for small-size ads appearing in journals and similar publications, but proposals put to the MHRA Red Tape Challenge in 2012 called for the abbreviated ad format to be more widely used.
The proposed changes - which would apply throughout the UK and not affect the requirements for advertising to the public - aim to reduce the costs to industry of keeping their ads current.
The Agency is consulting on the following three options put forward by industry:
- A: extending the use of the abbreviated ad format to all general sale list (GSL) medicines:
- B: extending use of the format to medicines that have been on retail sale through pharmacies for a minimum defined period; and
- C: authorisation of a link to the full Summary of Product Characteristics (SPC) in electronic ads as an alternative to the prescribing information.
When the prescribing information for a product changes, for example because of an updated safety warning, updating print ads costs the industry around £1,000 for a single product, and implementing proposals A and B would save at least £800 for each item, according to industry estimates.
The cost of updating digital ads for a single product is estimated at £4,800-£7,200, and implementing proposal C would save £5,000 per product, they add.
Also on proposal C, the MHRA points out that most SPCs are already available on the Internet and companies have established procedures for keeping them up to date. At present, the law requires a summary of this information to be accessible from the ad in the form of the prescribing information, while for an ad in a digital medium, such as on a website, this information is accessed by a single click.
Allowing a single-click link to the full SPC document as an alternative will be of benefit to companies marketing both prescription and over-the-counter medicines, while for healthcare professionals there will be no loss of information as the whole SPC will be available following a single click in the same way as the prescribing information is currently accessed, says the MHRA, which also points out that the full PSC may be considerably longer than the prescribing information.
The consultation runs until April 22.
