AusBiotech highlights clarity and transparency is key in recent submissions  


Clarity and transparency are highlighted in AusBiotech’s recent submissions, as it responds to the Department of Industry, Science, Energy and Resources’ R&D Tax Incentive Determination and the Department of Health’s Prostheses List (PL) Reform consultations.

As the national voice of the biotechnology industry, AusBiotech champions advocacy and regularly submits commentary on behalf of its members and the Australian life science industry. Read AusBiotech’s submissions here.

R&D Tax Incentive Determination

The Research and Development Tax Incentive (RDTI) is the most critical programme in supporting the Government’s stated policy objective – to improve Australia’s performance when it comes to the commercialisation of medical research; and the new Determination will offer certainty to the clinical trial sector, which already contributes around $1.4 billion to the economy each year, and enhance Australia as a globally-preferred location for clinical trials.

The Determination is a new instrument seeking to provide clarity on the types of clinical trials that will be accepted as core R&D activities, and thereby offer certainty in eligibility and reduce regulatory burden.

Clinical trials work in a highly-regulated environment and industry has become familiar with eligibility over the past 10 years; this Determination offers eligibility certainty and consistency and acts as a formal indicator to the national and international life sciences ecosystem that clinical trials are a recognised and eligible core activity under the RDTI.

AusBiotech was supportive of the Determination and recommended improvements for even greater certainty, including that definitions be added to the instrument and that guidance be released simultaneously and detailing what activities are included under each clinical trial phase and how decisions are made.

Prostheses List Reforms - A modernised fit-for-purpose listing process

AusBiotech has welcomed the opportunity to engage with the Department of Health on the redesign of the PL reforms’ listing pathways and has proposed five key principles to ensure improvements are in line with the Australian Government’s whole-of-government approach to innovation. 

These guiding principles include: Clarity and transparency; Maintaining safety and efficacy; Streamlining and efficiency; Rewarding innovation and effort; and Timeliness. While the consultation paper outlines pathway improvements that are aligned to these principles, AusBiotech’s response recommends opportunities to ensure that the proposals do not lead to unintended consequences, particularly for small and medium-sized Australian companies.

The Department has proposed a new three-tiered approach to listing pathways:

  1. (New) Tier 1 - Abbreviated pathway: where the device is medium or lower-risk, is a well-established technology, and is substantially similar in characteristics, intended use and clinical effectiveness to other devices listed on PL in the existing grouping with the benefit set up based on the reference pricing; assessments are largely undertaken by the Department with the relevant expertise and knowledge in medical devices;
  2. Tier 2 - Clinical/Focused health technology assessment (HTA) Pathway; and,
  3. Tier 3 - Full HTA Pathway (MSAC).

As an integral part of the PL Reform, the listing pathways must ensure fit-for-purpose processes to ensure timely access for private health insurance members to medical device innovation.

As well as containing cost, the PL Reform is an opportunity to reflect the Australian Government’s objectives to drive domestic innovation and effort in the medical device sector and to address the ongoing shortcomings of PL listing medical devices under private health insurance.

AusBiotech’s recommendations include:

  • Retain a standing consultative stakeholder mediating body, like the current Prostheses List Advisory Committee, to ensure a balance of interests for final decision making in all three proposed listing pathways by providing consistent and coherent PL listing advice to the Minister;
  • Implement a parallel process of TGA approval and PL submission assessment for all three listing pathways;
  • Remove the requirement for all Class III devices to go through a focused HTA, and determine the appropriate listing pathway based on the type of clinical and economic claims rather than TGA device classification;
  • Consistent with other Government policies and programs, reward local innovation by reducing or refunding cost recovery fees of all three listing pathways for PL applications of medical devices backed with Australian innovation;
  • Ensure the process is predictable through clear and mutually exclusive listing pathway criteria and guidelines for applications, as well as pre-listing consultations;
  • Increase transparency around listing decisions by publishing application summary documents;
  • Manage post-listing monitoring and PL de-listings via clear and transparent criteria; and,
  • Timelines and milestones for all three listing pathways must be clearly defined, predictable and reflective of the varying complexity of the three pathways to PL listing.