Health Select Committee’s report into the Therapeutic Products Bill
On Tuesday 14th of June, the Health Select Committee’s report into the Therapeutic Products Bill was released. It can be accessed here: Therapeutic Products Bill final report
This is what it means about the issues we had been highlighting:
1. Rongoā Māori will be excluded from the Bill, except for when Rongoā Māori is being commercialised or exported. It would appear that this will happen via regulations, as opposed to Rongoā Māori being excluded in the Bill itself.
2. Importation of prescribed medicines. This will remain as not being prohibited but with some potential guidelines that patients and clinicians must follow.
3. Advertisement of medicines. This has been further defined so that Givealittle pages and speaking publicly will not be within the definition of an advertisement.
4. The responsibility of clinical trials will still be transferred from the Health Select Committee to Medsafe with no timeframe given by which decisions have to be made. This provision remains unchanged.
5. There is no Section 29 equivalent in the new iteration of the Bill. It is very unclear how the Government intends to deal (or not) with patient access to unregistered medicines.
If you have had the chance to thoroughly review this report and have gained additional insights, please do to share your findings to: clladvocates@outlook.co.nz or via our CLL Advocates Facebook group: CLL Advocates Facebook group
We have a significant amount of information to cover, and we are particularly concerned about the future of New Zealand’s clinical trial framework, especially regarding the absence of an equivalent to Section 29.