Earlier this year, Professor Les Toop hosted a webinar with College members to explain parts of the Ministry of Health’s Therapeutics Bill (which will replace the Medicines Act 1981) relevant to GPs: direct to consumer advertising (DTCA), off-label prescribing, and pharmacy ownership.

Read on for a summary.

Direct to consumer advertising

New Zealand and the United States are the only countries currently allowing DTCA - Les tells us this part of the Act hasn’t been looked at since the 1970s so we’re mostly playing catchup. 

“New Zealand never made a conscious decision to allow DTCA, but we never put a policy or regulation in place to prevent it…pretty much every other developed country did.” 

The last Labour Government wanted to ban DTCA in the early 2000s and we saw a number of submissions and public consultations, but there was insufficient coalition support, so it didn’t go ahead. 

“It fell over at the time because of a coalition problem agreeing on Trans-Tasman Harmonisation and proposals to regulate herbal medicines. Alternative and herbal medicine isn’t part of this current consultation and will be a separate piece of work.”

The draft Bill allows DTCA, but states that the Government is aware of widespread concern and invites opinions. Many criticising DTCA are calling for Government funding for more useful, independent consumer health information.

“The public still needs information to help them make informed decisions. Past consumer surveys have indicated the public would favour independent consumer information over DTCA.” 

Off-label prescribing

The new legislation proposes that a prescriber would need to be aware of and take extra steps when prescribing medicines '“off-label”, this will protect both the patient and the prescriber.

Prescribers may not be aware they’re prescribing off label so it will be a challenge to come up with a simple solution.

“Some GPs may not know they’ve been prescribing a medication for an unlicensed unapproved indication  and in some patients, a medication will be used for more than one indication.

“A tick box might be a workable way to show that the prescriber is aware a medication is being used for an unapproved indication. The Government and Ministry of Health are aware this section needs further work.”

Pharmacy ownership 

Les says this part of the Bill will be relevant and of interest to pharmacists and also those looking to open new healthcare centres.

In the current rules, at least 51 percent of a pharmacy has to be owned by a pharmacist, and a pharmacist can own a small number of pharmacies.

Health centres across the country are increasingly including pharmacies and/or clinical pharmacists – the discussion document invites opinions on whether to preserve rules or deregulate.

“Technology is changing the role of pharmacists – internationally, more and more people are getting their regular prescriptions couriered to them and there is increasing robotic dispensing in New Zealand. 

“This, together with the growth of pharmacy chains, necessitates a review of the pharmacy ownership rules.”

What’s happening now? 

The College made a submission to Ministry of Health following member feedback. 

Overall, the College supports updating the legislation, but we do have concerns about controlled activities and, along with all the other medical colleges, we strongly oppose DTCA.

There will be a further opportunity to have input into the proposed legislation during the select committee phase.