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Regulator Performance Framework: Self-assessment Report, July 2018 to June 2019

2018-19 Performance Reporting

20 December 2019

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KPI 6 - Regulators actively contribute to the continuous improvement of regulatory frameworks

Measures/metrics Evidence (performance in 2018-19)

KPI 6.1

Regulators establish cooperative and collaborative relationships with stakeholders to promote trust and improve the efficiency and effectiveness of the regulatory framework.

Each July we undertake an annual stakeholder survey to measure our performance. In total, we received 4,069 responses to the 2019 stakeholder survey, which was up from 2,535 in2017–18. Health professionals and those working in the medical industry made up just under half of the responses (1,974).

83.7% of respondents agreed the TGA performs its role with integrity, showing that there is significant trust in our organisation from industry, health professionals and the general public. Full details of the survey will be published on our website.

SME Assist has systematically used a variety of methods to engage with target audiences. These have included providing online guidance and interactive decision tools, face-face training events as well as social media channels, the SME Assist subscription list, and exhibition booths at industry conferences.

The stakeholder survey indicated that one third of SME survey participants had heard of SME Assist, with 38% of that group having accessed the service. Eighty per cent of these users agreed or strongly agreed that the service was targeted to its audience, and 78% felt that the information was useful.

We held a one-day workshop with prescription medicine sponsors in March to better understand their use of the variations guidance documents so as to present a more effective and informative guide. The unanimous response of participants was that the experience was very valuable and they would participate in such a workshop again if available.

We held workshops with medical device sponsors and health professionals to discuss the proposed reforms for the reclassification of spinal implant devices, systems and procedures packs, and low risk devices. Participants provided positive feedback regarding the level of engagement offered by the TGA and with respect to the clear pathways established for future work in this space.

To support the reviews arising from the consultation Prescription strong (Schedule 8) opioid use and misuse in Australia - options for a regulatory response, TGA established the Opioids Regulatory Advisory Group (ORAG), comprising prescriber, palliative care, addiction medicine, pain medicine and consumer stakeholders. ORAG met in October 2018 and May 2019 and provided expert advice regarding the proposed amended indication for fentanyl patch products, the wording for inclusion within the boxed warning and class statement for opioids and the list of products in scope for additional smaller pack sizes. ORAG also provided advice on the Consumer Medicines Information (CMI) review. ORAG endorsed the interim findings of the TGA reviews and the various professional bodies undertook to work with TGA on guidelines and communication with their members.

The TGA coordinates the Medicinal Cannabis Access Working Group meetings, consisting of representatives from the TGA, the Office of Drug Control and each of the state and territory health departments, to promote collaboration between the Commonwealth Department of Health and state and territory health departments on issues relating to patient access to medicinal cannabis.

The Therapeutic Goods Advertising Consultative Committee meets quarterly and is the key consultative committee for the regulation of advertising. It consists of members representing consumers, health professionals, industry, media and government bodies. The Committee provides a forum for engagement on issues and policy relating to therapeutic goods advertising and assists with reviewing and shaping TGA reporting activities with respect to advertising compliance. It also provides input on the development of education and compliance priorities.

Self‑assessed rating: Met

KPI 6.2

Regulators engage stakeholders in the development of options to reduce compliance costs. This could include industry self‑regulation, changes to the overarching regulatory framework, or other strategies to streamline monitoring and compliance approaches.

By seeking out practical solutions, the TGA has identified and implemented a number of reforms to improve how we do our business, which has resulted in the removal of any unnecessary regulatory burden that had previously been imposed on affected stakeholders.

In addition to the 21 reform proposals that were considered by the Office of Best Practice Regulation (see KPI 1.2), approximately 13 reform proposals were considered minor in nature and a decision was made by the TGA to progress these streamlining processes. An example of is the re-classification of some Faecal Microbiota Transplant (FMT) products as Class 1 biologicals, when collected, manufactured and used in hospitals.

Each year we conduct meetings with industry bodies as part of our ongoing business improvements, with the aim of reducing compliance costs.

The TGA has continued to implement further reforms to streamline and simplify the regulation of low risk products to reduce the regulatory burden for those products that represent a very low safety risk to consumers.

A consultation paper on the proposed fees and charges for 2019–20 was released publicly to provide opportunity for wider industry and other stakeholders' comments. Based on stakeholder feedback, the TGA has enhanced the consultation process for the 2019–20 fees and charges.

We also brought forward the bilateral meetings to December 2018 to provide more opportunity for discussion of changes to sponsors. Industry bilateral meetings were offered to four additional peak bodies.

Self‑assessed rating: Met

KPI 6.3

Regulators regularly share feedback from stakeholders and performance information (including from inspections) with policy departments to improve the operation of the regulatory framework and administrative processes.

We work collaboratively with policy areas across the Department of Health to inform and improve operations in areas related to our regulatory framework.

We work closely with other Government Departments, regulators and statutory authorities to ensure effective and consistent regulatory functions.

For medical devices, we have worked collaboratively with states and territories within the context of our expert work group for acute care ventilators, breast implants and with the Australian Commission on Safety and Quality in Health Care on the safe introduction of neuraxial devices compliant with latest standards into Australia. We have also worked collaboratively with the ACCC on a number of issues, including button batteries in devices.

Self‑assessed rating: Met

Most external validators agreed that we actively contribute to the continued improvement of regulatory frameworks. Feedback noted that the TGA has undertaken significant regulatory reforms, and advocated for continuing international collaboration to keep abreast of regulation challenges associated with advances in medical technology. Stakeholder comments called for well considered singular major reforms when possible rather than a staggered implementation approach, as they contend that this would minimise impact on industry and reduce compliance costs and 'change fatigue'.

Identified opportunities for improvement

We will continue to provide ongoing support and education to stakeholders, and to work collaboratively with industry to minimise the burden of change, for example with the change to regulations for autologous cell and tissue products.

We will continue to seek and implement feedback from stakeholders, including conducting regular stakeholder surveys.

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