What is it?
The Therapeutics Products bill will see new regulations put in place when it comes to medicines, medical devices and natural health products – all in an effort to improve transparency of the products. The Ministry of Health says that while therapeutic products have several benefits, there are risks if they are not used for their intended purpose.
The Therapeutics Products Bill will affect many people – patients, consumers, health practitioners, and businesses. It will have an effect on all New Zealanders in some form. Whether you purchase medicines or natural health products over the counter, import medicines, or if you have a business that sells medicines or natural health products.
Medicines in New Zealand are already regulated under the Medicines Act 1981, but some products like natural health products are not.
Medical devices and natural health products, sometimes called complementary medicines, are regulated differently. The bill sets up the framework to regulate them all, but on the principle that lower-risk products will have lighter regulation.
What does the bill do?
It will regulate how therapeutic products are manufactured, tested, imported, promoted, supplied, and exported. It will regulate medicines, medical devices, active pharmaceutical ingredients and natural health products that are either produced in New Zealand for domestic use or export or are imported into New Zealand.
It will cover products ranging from highly sophisticated diagnostic equipment to lavender balms to assist with sleeping. The bill will also regulate blood products, advanced cell and tissue therapies, tissue grafts and whole organs.
CHPNZ concerns
CHPNZ has concerns with the bill at present, including the enormous quantity of work that will be put and the industry – which could lead to delays; no clear direction on the advertisement of medicines and acknowledging that advertising is a key component of the community’s health literacy; and regulations around exporting medications.
Bill report back
The Health Select Committee tabled its report back to Parliament in June 2023 and the government hopes to have it in law by the end of the Parliamentary term. CHPNZ remains concerned about the workload and resources of Medsafe, or the new yet-to-be formed regulator, from the bill and once it is enacted. This was not addressed in any significant way as part of the Select Committee report.
CHPNZ is currently in discussions with the government regarding this issue on behalf of its members and the consumers they serve.
Read the full CHPNZ submission here.
