Consultation: Improved sharing of information about medical devices | Proposed amendments relating to transparency of disruptions to supply of a medical device

In 2019, the Therapeutic Goods Administration (TGA) released the An Action Plan for Medical Devices (Action Plan), a 3-part strategy designed to strengthen Australia’s regulatory framework for medical devices (including in vitro diagnostics). The plan emphasises the need for a patient-centred approach and increasing public confidence in the regulation of medical devices through greater transparency.

Section 61 of the Therapeutic Goods Act 1989 (the Act) facilitates the release of information in certain circumstances. This consultation seeks feedback on proposals to expand our ability to release information about medical devices lawfully to:

• aid in monitoring, assessing, and responding to potential and actual supply disruptions, and
• provide more information to the public following post-market reviews or investigations, particularly where review findings relate to the performance or use of the device.

Background

As a part of the Department of Health, Disability and Ageing, the TGA regulates therapeutic goods including medicines, medical devices and biologicals. We receive information about therapeutic goods from a wide range of sources to assist with assessing and monitoring the safety, quality and performance/effectiveness of therapeutic goods.

The primary source of information about medical devices are sponsors, who are required to provide us with access to certain documents and information to support our role in assessing, approving and monitoring the safety, quality and performance of the medical device. We also have powers to compel information about medical devices from sponsors, particularly when the information relates to the quality, safety and performance of the medical device. This information may be held by the sponsors, or they may obtain it from the manufacturer of the medical device.

In addition to the manufacturers and sponsors of medical devices, we receive information from other sources including:

• consumers and users of medical devices
• stakeholders involved in the supply and use of medical devices including health professionals and healthcare facilities
• other government authorities and entities who are engaged in healthcare sectors, and
• international regulators in other jurisdictions around the world.

Where there is a need to release information, including to the public, we typically do so under section 61 of the Act. Section 61 outlines the specific circumstances and information that can be released. Generally, these circumstances are connected to our role in securing positive public health outcomes for Australians.

Examples include releasing information to:

• the World Health Organization (WHO) for use in the development of policies relating to therapeutic goods regulation or (in confidence) for proceedings of committees
• other Australian government entities (including states and territories) that have functions relating to therapeutic goods to support those entities with the performance of their own functions
• other therapeutic goods regulators in other countries for the purposes of supporting them in their functions or furthering international co-operation in the regulation of therapeutic goods
• Australian and international law enforcement authorities
• the public where the information relates to the market authorisation status or safety of a therapeutic good.

The problem

Currently the circumstances where we can release information to external stakeholders that are not the manufacturer or the sponsor of a medical device are set out in various parts of the Act and more particularly under section 61. Limitations on the sharing of information under section 61 means information about medical devices generally can’t be shared unless:

• a legislative instrument has been made specifying the information that can be shared,
• a regulatory decision about a specific medical device has been made, or
• the information is required to facilitate the safe use of a medical device.

There are 2 further circumstances where the ability to share information about medical devices would enhance our existing ability to protect public health and safety:

1. Disruption to supply of a medical device
2. Device performance concerns.

This consultation paper only focuses on disruption to supply of a medical device. A further consultation paper will be released relating to device performance concerns.