Therapeutic Products Bill: Consultation

TINZ CEO, Julie Haggie

Julie Haggie

CEO, Transparency International New Zealand

Transparency International New Zealand (TINZ) recently commented on the Therapeutic Products Bill. The Government proposes this as a replacement for the Medicines Act 1981 and to enable a new regulatory scheme for therapeutic products. The Bill includes medicines (including cell and tissue products) and medical devices. But natural health products (including rongoā Māori) will be excluded as far as possible. This exclusion is because the Government is considering options for how these could be regulated as a separate process.

The Bill is a massive and complex piece of legislation. TINZ’s focus is on transparency issues.

TINZ approach

In forming the TINZ submission, we worked with two groups: TranspariMED is an international advocacy group working for transparency in clinical trials; Mesh Down Under is a New Zealand advocacy group that raises awareness, provides information and advocates on the topic of surgical mesh.

TINZ and Mesh Down Under met with the Health Research Council, to better understand the extent of transparency in clinical trial registration and reporting. They directed us to a very informative ‘The Clinical Trials Landscape in New Zealand 2006–2015’ report by the Australia and New Zealand Clinical Trials Registry.

TINZ then identified the following aims to:

We will also meet with the Ministry of Health.

Key points

The TINZ online submission addressed specific aspects of the new Bill. Our key points were:

  • Concern that there is insufficient balance in the principles of the new legislation for considering ‘benefit over risk’
  • NZ should sign up to the WHO joint statement on public disclosure of results from clinical trials
  • Strong advocacy for improved transparency in clinical trials, particularly: timely and more comprehensive registration; mandatory timely reporting of results including negative outcomes; and timely ethics approval for all trials including random control trials 
  • Opposition to the proposed continuation of direct-to-consumer advertising of prescribed medicines. Currently this is allowed only in USA and Poland. 
    There is growing opposition from medical professionals in New Zealand about the practice, as well as USA evidence about the risks of direct-to-consumer advertising for prescription medicines.
    Given the changing professional views, it would have been useful if the Ministry of Health had provided more considered justification for not restricting direct-to-consumer advertising for prescription medicines. At least the gap in evidence could be acknowledged with a plan on how to address that.

A copy of the relevant content of the TINZ submission: Therapeutic products regulatory consultation TINZ.