Health minister Dr David Clark has invited professionals, the public, businesses and other interested parties to have their say an exposure draft of the Therapeutic Products Bill and an associated consultation document. He says the proposed new regime aims to ensure the safety, quality and efficacy/performance of therapeutic products accessed by New Zealanders.
“The Therapeutic Products Bill will replace the Medicines Act 1981 and establish a new regulatory scheme for therapeutic products,” Dr Clark said.
“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.
“The bill sets up the main controls on things like clinical trials, product approvals, and prescribing. Importantly it also defines what we mean by ‘therapeutic product’. While that is obvious for many products, for others such as sunscreen, it’s not so clear and people may want to comment on those kinds of details as well.
“The new regulatory scheme will cover medicines including cell and tissue products but natural health products, including rongoā Māori, will be excluded, as far as possible, as the government is considering how these could be regulated separately.
“We are also looking for feedback on particular things like the ownership rules for pharmacies and direct-to-consumer advertising of named prescription medicines.
“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.
“It’s about providing New Zealanders with the assurances they expect about the quality of products used in our health system and sold to the public. I hope the sector and the public will take the opportunity to engage with this and future consultations on this scheme,” Dr Clark said.
Due to the complexity of the Bill, and the impact of the holiday period, the consultation period will run for four months, ending 18 April 2019.
The consultation material can be found on the ministry's website.