The health sector is being asked for its feedback on a major revamp of medicines and therapeutic product regulation with the release of the long-awaited draft Therapeutic Products Bill.

A major rehaul and replacement of the much-amended Medicines Act 1981 has been on the card for most of this century but was put into the too-hard basket after the omnibus 2006 Therapeutic Products and Medicines Bill was shelved in 2007 by the then Labour Government as too controversial to get through the House.

The Government had attempted to split the 2006 bill in two so it could separate out updating the Medicines Act from the contentious proposal to create a trans-Tasman regulatory agency for  all medicines and therapeutic products – including currently unregulated natural and complementary health products ­­­– but that also failed.

Health Minister David Clark has now released a 150-plus page consultation document on the proposed Therapeutic Products Bill that proposes a new regulatory scheme for therapeutic products – particularly medicines and medical devices – but excluding ‘as far as possible’ natural health products (including rongoā Māori).

“The Medicines Act is old, hard to use, and doesn’t cover products adequately. There is a long history of reform attempts and it is time to finally get a new scheme in place, said Clark on releasing the consultation document on December 14.

He said the Bill sets up the main controls on things like clinical trials, product approvals and prescribing and also defines what it means by ‘therapeutic product’.  The bill also makes possible that when it is unclear whether something is a therapeutic product – for example sunscreen – for regulations to be used to declare something a therapeutic product.

The Bill proposes defining cell and tissue products used for therapeutic purposes and therapies as ‘medicines’ and for them to come under the new regulatory controls.

It also says that New Zealand is currently out of step with most other developed countries because not only therapeutic products like cell and tissue products largely unregulated here but also medical devices and radioactive medicines.

But the Government is not including natural health products (including traditional rongoā Māori medicine) under this  bill – it was the backlash from natural health product companies that helped see the last bill shelved – and is instead considering how to separately regulate natural health products

“We are also looking for feedback on particular things like the ownership rules for pharmacies and direct-to-consumer advertising of named prescription medicines,” said Clark.

He added that because of the complexity of the Bill, and the impact of the holiday period, the consultation period would run for four months, ending 18 April 2019.

“The Bill will set the framework, and alongside this we will be working and consulting on a raft of other details that need to be settled in order to get the whole scheme in place. That will include things like medicines labelling and product standards.

“This is a significant step towards a new more comprehensive, modern regulatory scheme for therapeutic products including medicines and medical devices.

The consultation material can be found on the Ministry of Health’s website.

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