The New Zealand Government is working on a new and comprehensive regulatory regime to regulate therapeutic products in New Zealand, which will replace the Medicines Act 1981 and its Regulations.
Therapeutic product is an umbrella term for products that are intended to be used in or on human beings for a therapeutic purpose. Examples of therapeutic purposes include bringing about a physiological response to prevent, diagnose, monitor, alleviate, treat, or cure a disease, ailment, defect, or injury.
Therapeutic products can present serious risks of harm, especially if used inappropriately. Assuring that the benefits of therapeutic products outweigh possible risks of harm to consumers is fundamental to the delivery of high quality health and disability support services.
The Government is currently developing a new therapeutic products regulatory regime. This follows the cessation of the Australia New Zealand Therapeutic Products Agency (ANZTPA) project.
As well as replacing and modernising the regulatory arrangements for medicines, the regime will provide regulation of all therapeutic products. This includes medical devices and cell and tissue therapies which are currently not fully regulated in New Zealand.
The new regime will be flexible enough to ensure effective control over the quickly evolving technology used in therapeutic products, while also being as efficient and cost-effective as possible.
The new regime will also look to align with international standards where appropriate, and uphold the quality of regulation currently carried out by the Ministry of Health. This will help to:
- assure the safety of products used in health care delivery in New Zealand, and
- secure New Zealand producers a positive position in the global market place.
Update June 2017
Drafting of the Therapeutic Products Bill is underway with ongoing stakeholder engagement on specific aspects of the regulatory scheme. Consultation on an Exposure Draft of the Bill is expected before the end of 2017. This consultation is later than initially anticipated due to the number and complexity of the issues to be worked through.
Release of decisions on the regime (28 April 2016)
The Government has now made a series of decisions about the new regulatory regime that are being made publicly available through the below documents.
- Therapeutic Products Regulation Paper 1: Context and Overview (Word, 35 KB)
- Therapeutic Products Regulation Paper 2: Proposals for a Therapeutic Products Bill (Word, 157 KB)
- Regulatory Impact Statement 1 (for Cabinet Papers 1 and 2) (Word, 130 KB)
- Therapeutic Products Regulation Paper 3: Further Policy Approvals (Word, 46 KB)
- Appendix 1 for Cabinet Paper 3: A3 (PowerPoint, 68 KB)
- Regulatory Impact Statement 2 (for Cabinet Paper 3) (Word, 114 KB)
The decisions set the direction for the new regulatory regime and will be used as the basis for the drafting of the new legislation.
The documents are being released now to help stakeholders and the public understand the issues ahead of formal consultation.
The papers set out the Government’s intention that the new regulatory regime cover all therapeutic products and has controls that assess and manage the risks, which will vary between products. The Government is seeking a high-quality regime that is efficient and sustainable, positions New Zealand well on the international stage and is designed so that it can be kept up-to-date easily.
What are the papers?
The papers are those considered by Cabinet in November 2015 and in March 2016 and the Regulatory Impact Statements that accompanied those papers.
Update November 2016
Work continues on the development of the detail of the therapeutic products regulatory regime consistent with the decisions released in April 2016. Consultation on the Exposure Draft of the Therapeutic Products Bill was anticipated in 2016 however, due to the scale of this project and the large amount of detail that needs to be developed, consultation will now occur in 2017.
Ahead of formal consultation next year, engagement with stakeholders continues to inform the work.