The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
Introduction
This report provides a summary of findings from the 2018 Therapeutic Goods Administration stakeholder survey.
Executive summary
An online survey was conducted amongst TGA stakeholders in June and July 2018. The survey replicated those conducted in 2016 and 2017 and provided opportunities for feedback across a range of service and activity areas.
A total of 2,274 valid responses to the survey were received during the survey period, a response rate of 12%. Respondents include a broad range of groupings, including strong representation from the Medical products industry, Health professionals, Academics and Government stakeholders and Industry association representatives. In order to ensure a range of community views were captured, the 2018 survey was complemented by a separate community focussed survey. Results from the community survey are detailed in separate reporting.
Trust and balancing the risks
The TGA is trusted by the vast majority of key stakeholders surveyed. More than 85% trust the TGA to perform its role ethically and with integrity and only 6% expressed negative sentiment (disagreement) in relation to the statement. This result maintains the positive outcomes on this question seen in the survey since 2016 (2018 86%; 2017 88%; 2016 85%). Importantly, high levels of trust are recorded across all major stakeholder groupings.
Just under 7 in 10 respondents (69%) feel that the TGA gets the balance right between risks and benefits of therapeutic goods. Whilst representing a strong overall outcome, the level of disagreement on this statement (15%) highlights an opportunity for the TGA to improve its reputation in this area. Key potential groups to engage with in relation to this issue include Health professionals (particularly Complementary healthcare practitioners and Medical practitioners), Retailers and those in the Medical products industry.
Confidence in the TGA
Across a range of measures identifying the confidence levels of stakeholders in relation to a range of TGA focus areas there is broad variation in outcomes. Just under half of respondents highlight high or full confidence that the TGA clearly articulates reasons for its decisions (with a further 35% highlighting moderate confidence that this is the case). Similar outcomes are evident for measures of TGA transparency (50% High or full confidence; 33% Moderate confidence) and accountability (54% High or full confidence; 30% Moderate confidence). In each of these cases, between 16% and 17% highlight Low or No confidence. Measures relating to confidence that the TGA makes decisions based on scientific evidence (62% High or Full confidence; 29% Moderate Confidence; 9% Low or No confidence) and that the TGA is trustworthy (69% High or Full confidence; 24% Moderate; 6% Low or No confidence) show generally stronger outcomes.
Among the key stakeholder groupings identified in the survey, there is generally higher confidence expressed by Medical products industry and Government stakeholders across the range of measures. In contrast, Health professionals and Retailers tend to express lower levels of confidence. The lower confidence observed amongst Health professionals reflects a general trend across the range of health professional categories, with particularly low confidence expressed amongst Complementary healthcare practitioners.
The outcomes here highlight ongoing opportunities to focus on improvements in perceptions of accountability, transparency and clear articulation of decisions. In particular, a focus on clear, timely open communication and engagement with the range of stakeholders on key issues and decisions is likely to have positive impacts.
Collaboration, consultation and feedback
The 2018 results relating to measures of collaboration, consultation and feedback highlight continued improvements across all measures observed since 2016. Across the five measures tracked, there have been sustained increases of between 9% and 12% Nett agreement. The ability to provide feedback represents the strongest area, with 74% of stakeholders agreeing that they are able to do so (up from 62% in 2016). Participants in 2018 are also more likely to agree that the TGA Consults on relevant issues (up 11% since 2016 to 62%) and facilitates Opportunities to provide input (58% Nett agreement, up from 46% in 2016). Despite sustained improvements, ongoing opportunities exist to improve perceptions and experiences in relation to Collaboration (Nett agreement 55%) and Listening to feedback (51%). Targeting engagement, collaboration and feedback mechanisms toward specific stakeholder groupings is likely to facilitate improvements here. In particular, focussing on strategies that proactively engage with Health professionals, Academics and Retailers are warranted given their tendency to express lower levels of agreement with the statements.
Communication and information services
TGA stakeholders continue to use a range of contact and information channels. The most commonly used channels continue to be the TGA website (with almost universal use amongst stakeholders in the survey) and the eBusiness services portal. While the website based channels are most broadly used, the survey highlights evidence that uptake of other channels is increasingly occurring amongst stakeholders, with increases in the level of identified use observed in relation to email subscription services, the consultation forecast, RSS feed and TGA Twitter feeds.
There are large variations in the perceived usefulness of various information sources offered. TGA Guidelines and TGA news and updates are most universally found to be useful, with TGA updates, Safety information and eBS notices all showing relatively high levels of usefulness. Consistent with their targeted nature, Prescription medicine NCE registrations, Medicines shortages alerts and SME assist show lower levels of overall usefulness, although commonly this varies across specific audiences, such as Health professionals. The variation across stakeholder groups in the survey highlights the ongoing need to be mindful of specific information and communication needs of key target audiences.
Contact with TGA
Most commonly, contact with the TGA occurs irregularly, with around 7 in 10 highlighting they are in contact once a month or less frequently. Contact is most frequent amongst Government and Medical products industry stakeholders, including regular contact with Product sponsors, Regulatory affairs consultants and Industry association representatives. Contact is most commonly made via phone or email channels, with website based contact also accounting for a substantial number of contacts. Contact via Fax and Letter formats continue to decline and represent a very small proportion of the channels used by stakeholders.
Reasons for contact strongly reflect the core business processes of the TGA, with application lodgements and checking on the progress of applications representing the two most common reasons for making contact. Information related to manufacturing products, product recalls and issues related to problems with devices or medicines also feature strongly in the top reasons for contact.
Satisfaction with the contact made across various channels shows generally high levels of satisfaction for phone, email and website based contacts and lower satisfaction amongst other less utilised channels. Overall satisfaction with communications shows Nett satisfaction in 2018 at 68% (Nett dissatisfaction 12%). This is consistent with the 2017 outcome and maintains the gains made in comparison to the 2016 Nett satisfaction level of 63%. Satisfaction is strongest for Medical products industry and Government stakeholders, with Health professionals, Retailers and Academics all showing slight lower levels of Nett satisfaction and in the case of Retailers, high levels of dissatisfaction.
The time taken to respond to contacts continues to vary across contact methods. Overall, response times are in line with those tracked across previous years of the survey. Importantly, shorter response times continue to be strongly related to higher overall ratings of satisfaction with communications.
TGA website
The TGA website provides a common channel for contact with the TGA. Reported usage in 2018 is consistent with the patterns reporting in both 2016 and 2017, with a total of 91% of responses highlighting some use of the website.
Regular use of the website is most common for Medical products industry and Government stakeholders, with just under one in three of these groups highlighting use of the site weekly or more often. Amongst industry stakeholders, there is particularly high use by Regulatory affairs consultants, 59% of whom highlight use of the site on a regular basis.
Access to the site occurs for a broad range of reasons. Most commonly this includes use of TGA databases, access to guidance documents, fees and charges information and information related to regulatory decisions and notices. Use of available tools on the site is also commonly identified, almost nine in ten highlighting use of the website search function, just under two thirds using downloadable fact sheets and one in four using interactive tools such as decision trees. Ratings of the use of these tools indicate that just under half of those who have accessed interactive tools, fact sheets and videos feel that they are Very useful with very few respondents highlighting that the tools are Not useful. Usefulness of the search function is perceived to be lower, with 37% finding this tool Very useful and 8% highlighting it is Not at all useful.
Satisfaction ratings highlight that the website is viewed positively in relation to the Language used (81% Nett satisfied) and Length of content (77%). The overall look and feel of the site is also generally positively received, with 65% of users satisfied with this aspect and only 5% expressing dissatisfaction. Navigation of the site is less favoured, with 55% satisfaction and almost one in five dissatisfied with this aspect of the site. Further investigation of the barriers to effective navigation coupled with efforts to address the potential effectiveness of the search function may assist to address this lower level of satisfaction.
Overall satisfaction with the website showed a Nett satisfaction rating of 73% of users. This is in line with the outcome observed in 2017. Nett satisfaction is generally higher among Medical products industry stakeholders (74%) – particularly Regulatory affairs consultants (81%) - and lower for Health professionals (62%) and Retailers (63%).
Ongoing monitoring, testing and capture of site visit based (intercept) feedback is recommended to further identify specific areas for development and enhancement of the user experience.
TGA business services portal
Use of the Business services portal has remained constant across the three years of the survey, with 83% of participants in this year's survey highlighting some use of this resource. Generally use of the site is infrequent, with half using the site monthly or less often. Use of the site is highest amongst Medical products industry and Government stakeholder categories with industry based stakeholders both more likely to use the site and to use it more frequently than others.
Reasons for use of the site are consistent across the three years of the survey and highlight that the most common reasons for access are related to the core functions of the site, namely to lodge applications, check the progress of applications and seek information available on the site.
Satisfaction with the portal is consistent with previous years, with 68% Nett satisfaction (2017 66%). Satisfaction is highest amongst Medical products industry stakeholders, particularly core user groups of Product sponsors and Regulatory affairs consultants.
TGA activities and events
Just under 700 participants in the survey were involved in activities conducted by the TGA in the last 12 months. Most commonly this includes involvement in consultative processes, information sessions or webinars.
Around seven in ten consultation participants express satisfaction with the experience. Across the range of consultation focussed measures there is marked variation, with strong satisfaction in relation to the information provided, procedures employed and ability to provide input and feedback and relatively low levels of satisfaction with follow up processes.
Overall satisfaction with TGA booths (Nett satisfaction 82%), Information sessions (78%) and Workshops (95%) is generally high. Satisfaction with Webinars is lower at 71%.
Recent reforms by the TGA
Three in four survey participants indicate some interest in one or more recent reforms. Most commonly this centres around reforms focussing on the establishment of a priority review pathway; however, there is also strong interest across the range of reforms identified, particularly the list of permitted indications, provisional approval pathway and category C notifications focussed reforms. Interest in the reforms varies markedly across stakeholder groups, providing opportunities for targeted engagement and communication strategies to be employed.
General perceptions of the reforms highlight a strong neutral (Neither agree nor disagree) response, representing the most common response outcome across the range of statements presented. Beyond this tendency for neutrality in relation to reforms, it is notable that participants are generally more likely to agree than disagree that the reforms are beneficial, that they were prepared for the changes and that they received adequate information. Despite this it is notable that there are some opportunities to respond to perceived lack of information about the reforms, and to manage perceptions in regards to their potential adverse impact, particularly amongst Product sponsors, Pharmacists and Complementary healthcare practitioners where the level of disagreement with the statements presented is relatively high.
Engaging with the TGA through Facebook
A mixed response to the potential to engage with the TGA through Facebook is identified in the survey. More than half of participants highlight that they would be Unlikely (18%) or Very unlikely (36%) to do so. Among the remainder, 16% indicate they would be Likely to engage, 6% Very likely and just under one in four suggest they would possibly engage or were not sure if they would engage.
SME Assist
One third of survey participants from small and medium sized enterprises (SMEs) have heard of SME Assist and a further 38% of those who have heard of the service have accessed it. There is slightly higher awareness of for medium sized enterprises (20-199 employees) compared to small enterprises (1-19 employees). Where use is evident there is generally strong sentiment towards the SME resource. Eighty percent of users Agree or Strongly agree that the information provided is Targeted and 78% feel that the information is Useful.