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Market research: stage one - qualitative research report
Informing TGA education and communication activities
Awareness and understanding of the TGA and its role
All groups were able to identify the TGA as the regulator of therapeutic goods; the majority of participants had heard of the TGA, even if they had not had any direct contact with the organisation. However, the level of understanding of the TGA's role was low. Industry groups and pharmacists demonstrated the highest level of understanding, due to their knowledge of the Therapeutic Goods Act 1989, its regulatory and legislative requirements and either indirect or direct contact with the TGA.
In particular, there is considerable 'greyness' around the role of the TGA, including what the TGA actually does, the regulatory process, the complexity of getting goods approved and how the TGA is funded. The term 'therapeutic goods' caused a lot of 'distraction' in the consumer and health professional (GP, surgeon) groups with a lot of time being taken to clarify what is in scope for regulation as a therapeutic good.
'Perceptions' about the TGA are also hampering communication efforts, particularly negative media coverage, which is currently generating misinformation about the TGA and its role. Once participants were told the "TGA story" using language they understand, contextualised in terms of their own experiences and clearly addressing information gaps, there was much wider acceptance about what is reasonable in terms of resourcing, testing and getting products to market quickly and what the TGA can and cannot cover.
Consumers demonstrated the lowest level of awareness of the TGA, however many were able to name the TGA as the regulatory body for medicines and medical devices. Those with the highest level of awareness were older, had dealt with the TGA through its website to look up specific goods in response to a particular health issue or knew people in the health industry who have dealings with the TGA.
Even among those who could not name the TGA, there was an implicit understanding that therapeutic goods are regulated, and some defaulted instead to potentially better known organisations such as the US FDA and the Australian Sports Anti-Doping Authority (who were 'in the media' at the time of the study because of the peptides in sport issues). However, when prompted, many of these consumers reported that they had heard of the TGA before.
Many people were also unaware that the TGA provides information for consumers, or that they could contact the TGA directly to obtain information or to report an adverse event.
While its role was seen as complex and important, consumers do not believe it is well communicated and perceive the TGA as industry-orientated and characterised by 'too much red tape'.
The TGA is seen by some as over-regulating. These participants questioned delays in approvals and getting goods to market, and viewed recalls suspiciously - seeing them as evidence of a possible breakdown in the system. However, others found the delays reassuring and interpreted them as a sign that a thorough analysis is being done before products are released to the market.
Some of the specific issues about which there was uncertainty, included whether or not the TGA (we have used the language of the participants):
- does all its own testing of medicines
- controls doctors' incentives
- provides drug information packaging, including directions on how to take drugs
- makes recommendations about which products are the best or cheapest on the market
- subsidises expensive drugs and recommends which drugs should be subsidised
- tests alternative medicines and over-the-counter medicines, as well as prescription medicines
- deals directly with the general public or only deals with companies.
Consumers who want to supply therapeutic goods - such as health food retailers, beauticians and fitness trainers - had a slightly higher level of awareness that the TGA is the government body responsible for regulating therapeutic goods. Although few had had direct dealings with the TGA, some regularly used the TGA website to check ingredients and claims either in response to client questions or when looking to supply.
Understanding of the role of the TGA among this group was low. They tended to be more literal in their definition of a therapeutic good with the emphasis on therapeutic - e.g. relaxation therapy - although those in the fitness sector demonstrated a more in-depth understanding.
Some of the specific issues about which there were misconceptions, included whether or not:
- the TGA tested all ingredients, including herbal products
- products not yet tested by the TGA were available on the market and could be sold before claims were verified or the product recalled.
General awareness among health professionals of the TGA is high and primarily developed through product recalls disseminated through TGA alerts, information drawn from medical software and databases, and media coverage about recalls and court cases.
Understanding of the TGA's role is higher than in the consumer sector in terms of the TGA's legislative role as part of the Department of Health. However, overall knowledge is still superficial, with a level of confusion as to whether the TGA is also responsible for:
- identifying and subsidising certain medicines for PBS inclusion
- the regulation of products such as medical devices or complementary medicines
- testing of products, including complementary medicines
Other health professionals were generally aware that the TGA existed and had heard about the TGA through a variety of sources, including their university studies, the media or actual interaction with the TGA on specific issues.
For some there was a gap between their awareness of the TGA and their knowledge of the TGA's actual role and function. The greatest level of understanding was demonstrated by pharmacists. Within their professional and retail roles, as well as through their university studies, pharmacists had a sound understanding of the TGA's role and the checks and balances in place for therapeutic goods.
Pharmacists also had the most complete understanding of what was meant by a therapeutic good compared to others in the health sector, who were either uncertain or had an incomplete understanding.
Not surprisingly, industry awareness of the TGA and its core role is extremely high.
The industry sector demonstrated a thorough understanding of the TGA's role in relation to how they regulate the specific therapeutics good they wished to supply in Australia.
Industry has the greatest and most accurate knowledge when defining therapeutic goods due to the frequency of its dealings with the TGA.
The following perceptions from the research highlight how the TGA is currently positioned in people's minds and their 'gut reactions' to seeing a reference to the organisation without additional explanatory information. These reactions represent the sum total perceptions and experiences people have of the organisation, and which are built on:
- existing knowledge (whether accurate or inaccurate) of what the organisation does
- emotions associated with any relevant previous experiences
- interpretations of the images, values and beliefs embodied in the look, feel, tone and language used by the organisation.
The words provided in the table below are participants' 'gut reactions' to the TGA. This question was asked at the beginning of each group. The words are not shown in any particular order.
|Consumers (both groups)||Medical professionals||Other health professionals||Industry|
Lack of capacity
Lack of influence
Good but slow
Protection of people and health and safety
Quality and safety