BCAC has grave concerns about the potential impacts of the Therapeutic Products Bill as currently drafted and has written a submission to the Health Select Committee on this. Enactment of the Bill could result in adverse consequences for all diagnosed with breast cancer in Aotearoa, as well as many other New Zealanders with various health conditions.
BCAC identified three major concerns:
- Importation of Unregistered Medicines. The Bill fails to provide patients with access to unregistered medicines. Currently, private imports of medicines are permitted, as is importation of medicines that are not registered in New Zealand. There are many safe and effective medicines that can extend life and improve the quality of life of cancer patients that are not yet registered by Medsafe in New Zealand. Currently patients can import these under Section 29 of the Medicines Act. The new legislation provides no mechanism for this.
- Definition of “Advertising” of Unregistered Medicines. Under the Bill, advertising of unregistered products will be illegal and the definition of “advertisement” is far too broad. It covers any communication that could be deemed to promote any unregistered product. This would include advocacy by patient groups for new medicines, conference presentations about clinical trial results where a new medicine shows benefit, treatment guidelines, even journal publications, media articles and “Give A Little” pages. This clause would result in organisations such as BCAC being effectively gagged and our spokespeople potentially thrown in jail or fined for even talking about an unregistered product. This is completely inappropriate as it precludes dissemination of scientific information (for example at international conferences held in New Zealand or in local medical publications) and prevents open discussion about potentially useful medicines.
- Clinical Trials – Access and time limits for approval. The Bill proposes to make some changes to the regulation framework for clinical trials. The current framework, whilst not perfect, does allow some international clinical trials to be made available to New Zealand patients. For many patients, this is the best way for them to have access to the most up-to-date therapies being developed internationally. The proposed legislation contains no timeframe for a response to applications for approval of clinical trials, which will create uncertainty for multi-national trials and will deter international collaborators from undertaking clinical trials in New Zealand.
Public submissions to the Health Select Committee closed on 5 March 2023, and BCAC sincerely hopes that it will recommend changes to this Bill before it comes before Parliament.
15 March 2023
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