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Regulator Performance Framework: Self-assessment Report, July 2016 to June 2017

26 April 2018

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

KPI met Our self-assessment rating of met is based on improvements in our stakeholder survey results, implementation of better consultation practices, finalisation of two regulatory impact statements and continued collaboration with key stakeholders, including Australian Border Force for compliance purposes.
External validation Our external validators view the TGA as committed to continuous improvement, particularly through the implementation of the MMDR recommendations and subsequent regulatory improvements. We continue to work closely with sponsors to continue to improve the regulatory framework.
KPI 6.1 Regulators establish cooperative and collaborative relationships with stakeholders to promote trust and improve the efficiency and effectiveness of the regulatory framework.

Evidence

Stakeholder survey results indicate improved satisfaction with TGA performance.

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.

Finalisation of two Regulatory Impact Statements, following significant consultation with industry.

Reduction in compliance costs for industry through introduction of electronic forms/assessments.

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.

Cooperation within the Department of Health to align evidence requirements where possible.

Cooperation and collaboration with Commonwealth, state and territory entities to ensure the efficacy of our regulatory functions, notably with Australian Border Force for compliance purposes.

Continuous improvement 2017-18

Cooperation across the department as well as with other agencies will continue, as will consultation through Regulatory Impact Statements.

KPI 6.1 Regulators establish cooperative and collaborative relationships with stakeholders to promote trust and improve the efficiency and effectiveness of the regulatory framework

6.1a Market research conducted on an annual basis to measure consumer, health professional and industry trust in - and engagement with - the regulatory framework.

We annually survey our stakeholders to ascertain their views about our performance as a regulator of therapeutic goods and publish the full survey results on our website. We use the information collected from our market survey to help our stakeholders make more informed decisions about therapeutic goods and comply with our regulatory requirements.

For 2016-17 we invited 21,214 participants to complete our survey to gauge:

  • level of awareness of therapeutic goods regulation, the TGA and specific regulatory activities
  • support and perceptions of us
  • preferred sources of information about the regulatory system
  • previous contact with us and use of existing information services.

We collected information from 2,535 respondents. Survey participants identified as health professionals (220) and medical products industry members (1,344), which includes product sponsors (766) and product manufacturers (398). Other groups included consumers and community members (13) or 'others' (570) such as retailers, academics, media and government. 388 respondents did not make a selection. Generally we report on the three major stakeholder groups of health professionals, industry and consumers, however with only 13 respondents identifying as consumers in the 2017 survey, we are unable to report those findings.

This survey is particularly informative in the context of our self-assessment against the Framework as it provides direct insight into the views of regulated entities. Key findings in relation to trust in the regulator, based on cooperative and collaborative relationships, for two of the major stakeholder groups are provided in the following tables.

Trust in the TGA to perform ethically and with integrity increased among all stakeholder groups by an average of 3%. Only 6% of health professionals and 4% of industry respondents disagreed that the TGA can be trusted to perform ethically and with integrity, and 95% of both groups either agreed or were neutral in their responses when asked whether they believe the TGA provides safeguards for the health of Australians.

Health professionals 2017 Health professionals 2016 Industry 2017 Industry 2016
Trust to perform role ethically and with integrity 84% 83% 90% 87%
Provide safeguards for the health of Australians 67% 74% 73% 77%

Across all surveyed groups, satisfaction with the experience of communicating with the TGA was observed at 69%, with 12% highlighting some level of dissatisfaction. This was an improvement on 2016 satisfaction and dissatisfaction levels of 63% and 15% respectively.

In 2017-18, we will be placing greater emphasis on communicating what the MMDR reforms mean for industry as well as health professionals and consumers. With respect to key decisions, such as those relating to strong opiates and medicinal cannabis we will be proactively engaging with affected groups, through meetings, seminars and educational materials. Our 2017-18 stakeholder survey will look to target feedback from consumer groups to ensure that we continue to improve our consultation and education approach to regulatory reform and decision making.

Health professionals 2017 Health professionals 2016 Industry 2017 Industry 2016
Satisfaction with communicating with the TGA 70% 57% 70% 64%
Dissatisfaction with communicating with the TGA 10% 18% 11% 15%

More than half of industry respondents found TGA consultations very useful.

Health professionals 2017 Health professionals 2016 Industry 2017 Industry 2016
TGA consultations very useful 42% 40% 54% 49%
TGA consultations slightly useful 20% 22% 14% 17%

6.1b Stakeholder engagement and satisfaction with TGA consultative processes.

Our annual program of market research described under KPI 6.1b found that more than half of respondents either agreed or strongly agreed that the TGA undertakes effective collaboration, consultation and feedback processes, while 24% were neutral.

2017 2016
Percentage of stakeholders who agree or strongly agree that the TGA collaborates, consults and provides opportunities for feedback effectively 54% 48%
Percentage of stakeholders who disagree or strongly disagree that the TGA collaborates, consults and provides opportunities for feedback effectively 14% 19%

In response to the results from the 2015-16 annual survey, we expanded the membership of the TGA Industry Consultative Committee to include health professional and consumer bodies. The first meeting of the newly established TGA Consultative Committee was held in March 2017 where a range of issues were discussed, including progress of MMDR reforms.

The Government's response to the review of MMDR initiated a significant program of work, including stakeholder consultation to inform implementation of the recommendations. Thirteen MMDR-related public consultations were undertaken in 2016-17 in addition to targeted consultations. These included:

  • receiving broad support to proposed implementation of reform projects in response to external consultation on assessment pathways for complementary medicines. A public consultation paper was released in February 2017 and 60 submissions were received.
  • conducting two workshops, one with industry and the other with industry, health professionals and consumers as part of the development of the Priority Review and Provisional Approval pathways. These workshops were well-attended and we received informal positive feedback from participants on the format and opportunity to provide feedback.
  • receiving 30 responses to the public consultation paper on the Provisional Approval pathway and 33 responses to the public consultation paper on the expedited pathways for prescription medicines, demonstrating interest and engagement from stakeholders.

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

6.2a Evidence of continuous compliance with our practice of engagement with industry before a RIS is finalised.

Please refer to KPI 1.2a for information on the two RISs finalised during 2016-17. We also engage with regulated entities prior to minor or machinery changes that may not require a RIS, such as updates to guidelines, and improvements to forms and systems used to conduct business. These consultative processes are consistent with our commitment to minimise the potential for unintended financial or resource impacts on industry. Refer to KPI 2.2a and our website for information about our formal consultations.

6.2b Progress of business improvements and other projects aimed at reducing compliance costs.

We aim to reduce compliance costs to regulated entities by regularly engaging with our stakeholders and maintaining a cycle of continuous business improvements. Please refer to KPI 1.3b for further information.

Reform of Medicines and Medical Devices Regulation

The Government's response to the Review of Medicines and Medical Devices Regulation was released in September 2016, initiating a significant program of work, including stakeholder consultation, legislative changes and business improvement projects. The Review identified ways we can streamline our existing regulatory framework to improve consumers' access to new therapeutic goods, while still ensuring their safety and effectiveness.

Seven areas of work were agreed:

  1. Increasing flexibility for registration and post-market processes for medicines
  2. Increasing flexibility for approval and enhanced post-market monitoring of medical devices
  3. Increasing flexibility for pre-market approval and increased evidence of efficacy of complementary medicines for consumers
  4. Simplified and more effective regulation of advertising of therapeutic products
  5. Streamlined regulation of patient-specific access to therapeutic products
  6. Further reviews
  7. Rationalisation of TGA statutory advisory committees.

Overarching principals for regulatory reform include maintaining Australia's capacity to undertake assessments of therapeutic goods for safety, quality and efficacy, and for approving the inclusion of therapeutic goods in the ARTG; introducing greater flexibility in approval pathways for both medicines and medical devices; and aligning the level of regulation with product risk.

The first tranche of legislative changes to implement the reforms, the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017, was enacted in June 2017. Supporting regulations – the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017 were also endorsed by the Governor-General in June 2017.

The number of TGA statutory advisory committees was reduced from 11 to 7 from 1 January 2017. The Review has reduced red tape for companies importing or manufacturing new medicines, medical devices or complementary medicines, while maintaining the confidence of Australian consumers in the safety, quality, and performance of therapeutic products available to them.

The implementation of regulatory reform that commenced in 2016-17 will continue in 2017-18 in a staged approach to allow for continuity of our routine regulatory business.

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

6.3a Information on cooperation and collaboration with policy areas of our Department.

As part of the Department of Health, we work collaboratively with policy areas in the Department to promote and protect the health and wellbeing of Australians. We have worked with:

  • Medical Benefits Division to streamline the regulation and reimbursement of medical devices; support the activities of the Prostheses List Advisory Committee; and utilise datasets for effective post-market monitoring
  • Tobacco Control Branch, Office of Drug Control, National Industrial Chemicals Notification and Assessment Scheme and National Integrity of Sport Unit regarding scheduling proposals
  • Pharmaceutical Benefits Division to discuss reforms to regulation of Orphan Drugs, Provisional and Priority pathways and address alignment with reimbursement policies
  • Immunisation Branch to support the approval of vaccinations in response to increased rates of meningitis in children
  • Jurisdictional Blood Committee to keep them appraised on the progress of relevant medicines approvals.

6.3b Information on interactions with other Australian government departments, regulators and statutory authorities.

We work closely with related Australian Government departments, regulators and statutory authorities to ensure the effectiveness of our regulatory functions, including interactions with:

  • Office of Best Practice Regulation in accordance with the requirements provided in the Australian Government Guide to Regulation
  • Australian Pesticides and Veterinary Medicines Authority, Food Standards Australia New Zealand and state and territory health departments regarding scheduling proposals
  • National Health and Medical Research Council and Department of Health and Human Services Victoria on clinical trials
  • HealthPACT on new and innovative medical devices
  • Australian Commission on Safety and Quality in Health Care and state and territory health departments on post-market monitoring and vigilance activities for medical devices
  • Department of Industry, Innovation and Science on designating medical device conformity assessment bodies under the EU-Australia Mutual Recognition Agreement as assisting with developing the SME Assist program
  • other regulators such as the Australian Competition and Consumer Commission and the Australian Health Practitioner Regulation Agency to share information on compliance interests and priorities in relation to investigation and enforcement activities
  • Australian Border Force to prevent therapeutic goods or counterfeit goods entering the country
  • Department of Environment to understand ingredients which are included in an appendix to the Convention on International Trade in Endangered Species of Wild Fauna and Flora.

We conducted a pilot study with the Department of Foreign Affairs and Trade in March/April 2017 to determine the need for laboratory testing of medicines in four Pacific Island countries. The conclusions of this study were that these countries do not have the capacity to undertake the full range of regulatory activities required to assure the quality, safety and efficacy of priority medicines such as antibiotics and those used to treat non-communicable diseases. The Australian Government is exploring options to provide Pacific Island countries with access to the Australian medicines quality assurance laboratory testing program.

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