Committee Debates Repeal of Therapeutic Products Act 2023: Key Concerns and Clarifications

In a significant committee session on December 20, members debated Part 1 of the Therapeutic Products Act Repeal Bill, focusing on the repeal's implications for healthcare regulation. The discussion highlighted concerns about regulatory overreach and the necessity of a clear legislative direction.

Seeking Clarity in Legislative Change

Dr Lawrence Xu-Nan from the Green Party opened the debate by questioning the absence of a detailed alternative framework accompanying the repeal. He emphasized that dismantling an act with extensive clauses required careful consideration due to its substantial implications.

Associate Minister of Health Hon Casey Costello responded, explaining that concerns about over-regulation in the existing legislative framework prompted the decision to repeal rather than amend. She described the repeal as a strategic reset intended to avoid unnecessary expenditure on secondary legislation for an act perceived as overly complex and unsupported.

Addressing Regulatory Pathways for Medical Devices

Dr Tracey McLeLLan of Labour raised questions about how new regulatory pathways would manage complexities in regulating medical devices, specifically mentioning surgical mesh and pacemakers. Minister Costello reassured that current controls, such as guidelines and pauses on specific products like surgical mesh, remain unchanged post-repeal. She emphasized the importance of maintaining a balanced regulatory framework that is risk-proportionate.

Urgency Behind the Repeal

Tangi Utikere from Labour questioned the necessity for immediate repeal given the existing timeline until 2026, expressing concern for oversight issues like surgical mesh. Minister Costello justified the urgency by highlighting the need to prevent resource wastage and provide clear regulatory direction. She explained that continuing with an unsupported legislative framework could complicate future developments.

Future Regulatory Framework Considerations

Scott Willis of the Green Party sought details on the proposed modern regulatory regime, expressing concerns about proceeding without a comprehensive plan. Minister Costello acknowledged the complexity of developing future legislation but emphasized the need for immediate clarity to avoid prolonged uncertainty. She assured that detailed planning is ongoing, with a focus on providing clear guidance and resetting the regulatory framework.

Urgency and Amendments Discussed

Hon Willow-Jean Prime from Labour questioned why urgency was applied when amendments could have addressed existing issues with the act set for 2026. Minister Costello explained that urgency stemmed from a need to halt progress on legislation perceived as overly complex, allowing resources to be redirected towards developing a more effective regulatory framework.

Amendments Focused on Dietary Supplements

Dr Lawrence Xu-Nan revisited concerns about work done on secondary legislation and sought clarification on amendments related to dietary supplements. Minister Costello clarified that while preparatory work stopped post-election, the amendment aims to improve regulatory efficiency for exporters by updating outdated regulations from the repealed Food Act 1981 to align with the modern framework of 2014. This shift is intended to enhance international competitiveness.

Conclusion: Legislative Pathway Forward

The committee's deliberations on Part 1 concluded with votes affirming the repeal and its amendments, with Ayes totaling 68 (New Zealand National 49; ACT New Zealand 11; New Zealand First 8) versus Noes at 37 (New Zealand Labour 22; Green Party of Aotearoa New Zealand 15). The outcome reflects a legislative pivot towards redefining healthcare regulation in New Zealand, balancing regulatory rigor with innovation. As stakeholders await further developments, the debate highlights the complexities of overhauling longstanding legislation.

The decision sets the stage for future discussions on crafting a modern regulatory regime that addresses both domestic concerns and international standards, marking a significant moment in New Zealand's legislative landscape.