Therapeutic Products Regulatory Scheme consultation

Submissions on this consultation have now closed.

Published online: 
14 December 2018
Therapeutic Products Regulatory Scheme: Consultation document.

The Therapeutic Products Bill would replace the Medicines Act 1981 and establish a new regulatory scheme for therapeutic products. This includes medicines (including cell and tissue products) and medical devices. Natural Health Products (including rongoā Māori) will be excluded, as far as possible, as the Government is considering options for how these could be regulated as a separate process.

As part of the development of the Therapeutic Products Bill, the Ministry of Health consulted on a draft of the Bill from December 2018 to April 2019.

Accompanying the Bill was the Therapeutic Products Regulatory Scheme: Consultation document. The purpose of this consultation document was to help stakeholders understand the draft Therapeutic Products Bill and to seek feedback on the provisions, and key policy matters, in the Bill.

Consultation closed on 18 April. We would like to thank the stakeholders who made a submission on the Bill.

Consultation period is closed

Submissions closed at 5.00 pm, Thursday 18 April 2019.

Submissions received

Four hundred and forty-two submissions were received from a variety of stakeholders including consumers, industry professionals, health practitioners and their organisations, and health sector organisations. Submissions covered all of the issues in the Bill and proposed regulatory scheme.

Stakeholders expressed general support for the purpose and principles of the Bill, recognising that successive governments have been working to enact reform in this area for nearly three decades. A summary of the key themes identified in the submissions is included below.

Ministry officials have analysed the submissions received and are using them to inform further development of the Bill and the scheme more broadly. In some cases we may engage with submitters to discuss specific issues they have raised.

We will seek Cabinet approval for any major changes in policy identified, and then work with the Parliamentary Counsel Office to amend the Bill, as necessary, before it enters the parliamentary process. We expect there will be further consultation as part of the parliamentary process.

Submissions release

Information forum

The Ministry held an information session to explain the draft Bill on 11 February. The focus of the session was to help those with an in-depth interest in the technical aspects of the new regulatory scheme to understand how the provisions in the draft Bill work.

The presentation, including an audio recording of the presentation, from this information session are available below

View presentation video featuring slides and audio

Listen to audio-only version of the presentation

Download audio-only version of the presentation (1 hr 14 minutes, mp3, 30 MB)

Information session slides (pptx, 486 KB)

Download a summary of the information session question and answers (Word, 17 KB)

Sector forums

In March the Ministry of Health held consultation forums on the draft Therapeutic Products Bill with the following sector groups: Medicines, Medical Device, Cell and Tissue, Research, Pharmacy, Consumers, and Health Practitioners. The Ministry also held a forum in Christchurch covering the draft Bill more generally. We would like to thank the stakeholders that attended these forums for their engagement and thoughtful questions. The questions and comments raised during these forums will be considered as part of the consultation analysis.

The presentations from these forums are available below.

Publishing information

  • Date of publication:
    14 December 2018
  • ISBN:
    978-1-98-856830-0 (online)
  • HP number:
  • Citation:
    Ministry of Health. 2018. Therapeutic Products Regulatory Scheme: Consultation document. Wellington: Ministry of Health.
  • Ordering information:
    Only soft copy available to download
  • Copyright status:

    Owned by the Ministry of Health and licensed for reuse under a Creative Commons Attribution 4.0 International Licence.

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