The new codeine guidelines are legally questionable
ANYONE WHO has been to their pharmacy recently and asked for a packet of Solpadeine, Nurofen Plus or other painkiller containing codeine will have noticed that these products are no longer displayed where they used to be. They are also likely to have been asked about the symptoms they were looking to treat and may have been refused supply.
The Irish Medicines Board has licensed these products for sale in pharmacies over the counter (OTC) – in other words, without a prescription. However, the law requires chemists to ensure that codeine-containing products “are not accessible to the public for self-selection”.
Until recently, guidance issued by the Pharmaceutical Society of Ireland – the pharmacy regulator – required that such medicines be sited in an area inaccessible to customers and obliged pharmacists to ensure they were in a position to intervene in the decision to supply them. It has long been the practice to display such products behind the counter, so the customer would not have access but could see what was available.
So what has changed? While the law has remained the same, new guidance issued by the regulator, effective since August 1st, requires that medicines containing codeine be stored out of view and that they be sold only through the pharmacist. Effectively, such medicines – which have until now been available to the public to take on a self-medicating basis – are now being treated as prescription medicines.
The regulator has argued that these products must be kept out of view to ensure that they are not accessible. It has also indicated that displaying them constitutes an advertisement and that it is an offence to advertise medicines containing codeine, as they are controlled drugs. Both of these suggestions are legally questionable.
The removal of these products from view is not necessary to ensure their safe and rational use. A product which is visible but which cannot be physically accessed (as in the past) is not, according to ordinary canons of construction, “accessible to the public for self-selection”.
This interpretation is supported by the well-established presumption against unclear changes in the law. If the legislation intended to prohibit display, it was required to have done so in unambiguous language. An example of this can be seen in the legislation governing the sale of tobacco under which retailers must “ensure that tobacco products are kept in a closed container or dispenser that is not visible or accessible to any person other than the [retailer] or a person employed by him or her”.
Apart from providing a clearly worded prohibition on the visual display of tobacco products, the above supports the view that accessibility and visibility are distinct concepts.
While the regulator has certain defined statutory powers, it does not have the power to legislate. Codes of practice, guidelines and other “soft law” documents cannot displace established law. Their function is to regulate how things are to be done in a particular legal context.
The regulator’s guidance also flies in the face of community legislation and a 2003 decision of the European Court of Justice which held that a national law could not prohibit the advertising or sale by mail order of medicines not subject to prescription. As a result, Irish law was amended to allow the sale by mail order of OTC medicines containing codeine.
Thus, it is arguable, the regulator has exceeded its powers, rendering the guidance invalid and unenforceable.
Mark Ryan is a partner in Whitney Moore Solicitors, specialising in pharmaceutical regulation