In 2018 the Consumers Health Forum was contracted by the Therapeutic Goods Administration (TGA) for a 12-month consumer engagement project where CHF would provide input, advise and support for a range of TGA activies to enhace health literacy for all Australians.

The first phase of the project commenced in October 2018 and focused on the following services:

• Raise consumer awareness of the role of the TGA and Office of Drug Control
• Raise consumer awareness of TGA and ODC reforms, policy and legislation changes and key messages
• Provide consumer feedback on the design and functionality of various consumer focused materials, including TGA websites, fact sheets, webinars, eLearning modules and social media
• Develop and implement strategies for the dissemination of consultations, surveys, materials, information and leaflets
• Assist with the identification of consumers and test consumer views on the particulars of new products, designs and messages
• Provide advice on the design and strategy for a consumer-focused stakeholder survey
• Undertake activities that increase health literacy of Australians, by raising awareness and importance of reporting adverse events and other key regulatory touch points for consumers.

These specified several priority areas had been identified by the TGA through an internal consultation process, including a consumer stakeholder meeting in March 2018.

Following a Six Month Status Report in April 2019, the project was revised for a second phase focusing on the following:

• To develop a Consumer Engagement Strategy for the TGA, which would provide the TGA with ongoing guidance and direction on ‘best practice’ engagement with consumers, this would include for example when to consider communication with consumers and how
• To take an active role in the medical device consumer forum in August 2019, including assisting with ensuring the right people are in attendance, providing input into the planning of the day, working with ThinkPlace and delivering outcomes
• To assist in the implementation of the Medical Devices Action Plan through work with the medical devices branch.
• To provide education content and consumer outreach relating to two or three health literacy topics. One of these would be to increase consumer awareness of CMIs. The other one or two topics will be determined by agreement.
• To work with the Prescription Medicines Authorisation Branch to develop a suitable template for a half page summary of AusPARs designed for consumers.

As highlighted in the Six Month Status Report, Phase 1 of the project encountered key barriers to consumer engagement that prevented the original deliverables from being met. Consequently, the Phase 2 deliverables were developed in an effort to address these barriers- through a combination of high level internal consumer engagement strategy and specific, targeted activities that could be used as templates for other consumer engagement efforts that deliver more long-lasting and strategic improvements in the way TGA involves consumers in its work.

A Final Report was then submitted in October 2019 that summarised the final status of the specified deliverables from both phases of the project, the proposed next steps have been included to help guide future work the TGA may consider doing in those areas, the additional services provided by CHF outside of those deliverables and the barriers encountered in delivering these services to the TGA across the length of the contract.