Therapeutic Products Regulatory Scheme: Online Consultation

Closed 18 Apr 2019

Opened 14 Dec 2018

Overview

Consultation

A Therapeutic Products Bill (the Bill) is being developed to replace the Medicines Act 1981 (and its associated regulations) and establish a new regulatory scheme for therapeutic products. This consultation document is intended to be read alongside an exposure draft of the Bill. It provides information on the policy and details contained in the exposure draft to help inform submissions on the draft Bill.

The purpose of this consultation document

Together with the exposure draft of the Bill, this document provides detail on the proposed regulatory scheme for therapeutic products that is; principles-based, risk-proportionate, reflects international norms, and is designed to be responsive to the challenges of emerging technologies and changes in the health care settings in which therapeutic products are used.

Even adopting a principles-based approach, the Bill is still long and technical. For this reason, the Government has agreed to release a draft of the Bill to get input from the sector before it is introduced to Parliament. We would like you to help us ensure this Bill is fit for purpose both now and into the future.

Layout of the consultation paper

This consultation paper is divided into three main chapters:

a.       Chapter A: Key features of the new regulatory scheme – describing the rationale for the Bill, what it covers and the main types of controls

b.       Chapter B: Content of the draft Bill – describing the parts within the Bill, providing additional explanation of particular provisions to assist understanding and highlighting the provisions that are different from the current regulatory approach

c.       Chapter C: What the new scheme would mean for different sectors and health practitioner groups – outlining how the regulatory tools within the Bill are intended to apply to different products, sectors or professions and what the relevant regulations, rules or notices are expected to cover. This includes a section focussed on the aspects of the Bill that are particularly relevant from a consumer perspective.

While these chapters overlap somewhat, we are aiming to cater both to those with an interest in the whole scheme and those with a specific area of interest.

Chapter B contains questions covering the sections (grouped by topic) in the draft Bill and provides an opportunity to comment on the policy, practical implications or detail of those sections.  These are grouped by topic.

To avoid repetition, Chapter C refers back to the questions in Chapter B when relevant. Chapter C then contains additional questions focused on particular policy issues where we are seeking feedback and also questions on specific issues that are only relevant for particular sectors. Each question is numbered once, so if the same question is asked in two topics within Chapter C, the question number is repeated. For example, question C6 is asked in both the topics for medicines and the wholesalers sectors. As such, the numbering of questions in Chapter C is often not sequential.

How to provide feedback

You can provide feedback by:

a.       using this online tool at by using "Online Survey" link below.  This is our preferred way to get feedback. 

Note, you can complete your submission over a number of sessions and save it as you go. If you select "Save and come back later" you will be sent an email with a unique link that will let you return to edit and submit your response. This link can be shared with your colleagues if you require their contribution, or review of, the submission. Once you have completed your submission you will be send a pdf copy for your records.

b.       sending an electronic submission to therapeuticproducts@moh.govt.nz

If you elect not to use the online tool for your submission, please:

  • ensure your electronic (email) submission includes the mandatory submitter information in the Therapeutic Products Consultation submitter form found on the website https://www.health.govt.nz/publication/therapeutic-products-regulatory-scheme-consultation-document
     
  • note that, your submission may be requested under the Official Information Act 1982.  If this happens, the Ministry will normally release your submission to the person who asks for it. If you consider there are good reasons to withhold it, please clearly indicate these in your submission.

The closing date for submission is 18 April 2019.  
We are also holding consultation sessions to provide richer information, and you are welcome to register your interest in attending - go to our website at
https://www.health.govt.nz/our-work/regulation-health-and-disability-system/therapeutic-products-regulatory-regime

Your feedback is important because it will help shape the final proposals, ensuring they are workable and that the purpose of the legislation is achieved. We appreciate you taking the time to make a submission.

Why We Are Consulting

The three main purposes of this companion paper to the exposure draft of the Therapeutic Products Bill are to:

a.       provide an overview of the draft Bill and describe in broad terms the regulatory scheme that would be established by regulations, rules and notices (while noting the detail of these instruments will be developed and consulted on later)

b.       obtain feedback on the draft Bill

c.       collect information from the sector on key policy issues.

What Happens Next

Next steps after the consultation

The Ministry will analyse the feedback and publish a summary of this analysis on its website.

The Ministry will provide advice to the Government on the overall outcomes of the consultation and seek approval for any major changes in policy identified. Then we will work with the Parliamentary Counsel Office to amend the Bill, as necessary. The Bill would then be introduced to Parliament.

Once introduced, the Bill would follow the standard parliamentary process. Following the first reading, it would be referred to a select committee (expected to be the Health Select Committee). The select committee normally invites public submissions on a Bill. It then holds public hearings to listen to some of the individuals or groups that have made submissions. After hearing submissions it works through the issues raised and decides what changes, if any, should be made to the Bill.

The Bill would then have second and third readings in the House. Then, after receiving the royal assent, it is referred to as an Act.

The Therapeutic Products Act would come into force on a specific date to be appointed by the Governor-General by Order in Council, or at the latest by a backstop date that would be inserted in the Bill. That date is likely to be around two years after royal assent. On the commencement date the new regulatory scheme would replace the current scheme in the Medicines Act 1981. For some aspects of the scheme, the Bill will include transition provisions to provide additional time for the sector to meet the new requirements. The transition period starts on the commencement date.

The regulations, rules and notices required to implement the scheme will need to have been developed before the commencement date. The Ministry would begin developing these while the Bill progresses through Parliament. It then would have around two years after the date of royal assent to consult and finalise them.

The key points to note from this process are:

a.       a lot of work remains to be done – the Bill sets out the legislative framework for the new regulatory scheme, but the detail of how this scheme will work in practice (ie, the regulations, rules and notices) still needs to be developed

b.       this consultation document does not offer your last chance to provide input into how the new scheme would work. Further consultation opportunities will follow during the select committee process and when the regulations, rules and notices are being developed.

Audiences

  • Members of the public
  • People affected by gambling harm
  • Health sector
  • Disability sector
  • Ministry staff
  • Gambling sector
  • Directors of Area Addiction Services
  • Pharmaceutical companies
  • Service providers

Interests

  • Therapeutic products
  • Assisted reproduction
  • Medical devices
  • Health information standards
  • Emerging Health Technologies
  • Gambling
  • Mental health
  • Substance use
  • Pharmacy
  • Research
  • Cancer services
  • Electives
  • Change programme
  • Technology
  • Accommodation
  • Travel
  • Nutrition and physical activity
  • Screening
  • Pacific health