Government’s Medical Products Bill taking shape

The Medical Products Bill is planned to be introduced to Parliament next year. Photo / RNZ / Dom Thomas

Cabinet papers released this month show key government decisions around pharmacy ownership and advertising of medicines, which will be part of the upcoming Medical Products Bill.

“The new bill will remove restrictions on ownership of community pharmacies, allowing for more flexibility and innovation that will improve safe access to medicines and healthcare,” said Associate Health Minister Casey Costello.

Under the changes, pharmacies and companies that own pharmacies, will no longer need to be majority owned by registered pharmacists, Costello said.

“This is an antiquated and unnecessary law that companies have found complex ways of working around. We want to make sure pharmacists can concentrate on what matters – providing high-quality care to patients.

However, operation of pharmacies will continue to be strongly regulated to ensure patient safety, Costello said.

“Pharmacy activities such as dispensing will still be supervised by registered pharmacists, and pharmacists will still uphold professional standards and be expected to act in the best interests of their patients.”

New role

The Bill will introduce a new role of supervisory pharmacist, which will be required in all companies that operate more than one pharmacy.

The supervisory pharmacist will be responsible for compliance with pharmacy standards and regulation for the company as a whole, said Costello.

“These changes are about enabling different models for pharmacy ownership, allowing for more innovative and integrated healthcare that will improve safe access to medicines,” Costello said.

The Government would also make changes to the rules around advertising medicines and medical devices, allowing unapproved medicines to be advertised and promoted in some circumstances.

“The planned changes will enable access to information about medicines and medical devices, while still protecting consumer safety.”

Clearer definition

Costello said the Medical Products Bill would include a clearer definition of advertising, making it easier for manufacturers, health practitioners, and the public to understand. However, it would not regulate activities such as fundraising, news reporting and education as “advertising”.

“Under the current legislation, it is illegal to advertise the availability of a medicine which does not have Medsafe approval,” Costello said.

“This restriction on advertising of unapproved medicines is about protecting consumers from treatments which may not be safe or effective, but it’s also important that our legislation allows some common-sense exemptions.

“People raising money for their family members to access a promising new treatment overseas shouldn’t be at risk of a fine or jail just because the manufacturer of that medicine hasn’t yet applied to bring it to NZ.”

Unapproved products

Promotion of unapproved products would also be allowed under the Medical Products Bill if the Director-General of Health has approved the promotion, for example in response to a public health emergency.

The bill will continue to allow direct-to-consumer advertising of prescription medicines, with a power to make regulations restricting some kinds of advertising if necessary.

“Officials found no convincing evidence that direct-to-consumer advertising of prescription medicines has significant negative public health effects.

“Modernising medicines advertising regulations will ensure that the public has better access to information on medical products, the sector understand their responsibilities, and health practitioners are informed of innovative treatment options.”

The Medical Products Bill is planned to be introduced to Parliament next year. Natural health products are not part of the new bill.

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