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TGA stakeholder survey 2018

20 December 2018

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Recent reforms by the TGA

The 2018 survey included an additional module to gauge interest in and perceptions of recent reforms.

Reforms - stakeholder interest

Participants were asked to nominate those reform areas that are of interest to them. A total of 76% of responses indicated some level of interest in one or more reform areas (Figure 62 and Table 51). Interest in multiple reform areas is common, with an average of 2.2 selections amongst those who identified some interest and a substantial number of people indicating interest in 3 or more reform areas (Table 49). The highest overall levels of interest amongst stakeholder groups include Product sponsors, Regulatory affairs consultants, Industry association representatives, Pharmacists, Medical practitioners and Complementary healthcare practitioners. Most notably, (the small numbers of) Pharmacists and Regulatory affairs consultants express high levels of interest across the range of reform areas.

The reform area that generates the highest level of interest is 'Establishing a priority review pathway for medicines and medical devices' which is of interest to 43% of the stakeholder group who responded. This area is almost twice as likely to be of interest than other reform areas and is the most commonly identified reform amongst all major stakeholder groups (Table 50).

A range of other reform areas generate interest amongst the stakeholder groups, most notably the List of permitted indications for listed medicine (498 selections), Provisional approved pathway for certain medicines (458) and New Category C notifications for the Special Access Scheme (SAS) (391).

Figure 62: Interest in recent TGA reforms (%)
Bar chart - see Figure 62 in tabular format
Figure 62: Interest in recent TGA reforms (%)
Change area N
Establishing a priority review pathway for medicines and medical devices 966
List of permitted indications for listed medicines 498
Provisional approval pathway for certain medicines 458
New Category C notifications for the Special Access Scheme (SAS) 391
Efficacy assessed listed pathway 307
Black Triangle Scheme 246
None - I am not interested in these changes 550
Table 49: Interest in recent TGA reforms - number of selections (%)
Number of selections N
1 543
2 312
3 214
4 136
5 45
6 48
None 550
Total 1848

While the Priority review pathway is the most commonly selected area of interest across the broad stakeholder groupings, there are some notable patterns. These include high levels of interest in:

  • Provisional approval pathway for certain medicines among Regulatory affairs consultants, Pharmacists and Medical practitioners;
  • New Category C notifications for the SAS from Pharmacists, Academics, and regulatory affairs consultants;
  • Black triangle scheme reforms from Regulatory affairs consultants and Pharmacists;
  • Efficacy assessed listed pathway among Regulatory affairs consultants, Industry association representatives, Pharmacists and Complementary healthcare practitioners; and
  • Permitted indications for listed medicines among Pharmacists, Complementary healthcare practitioners, Regulatory affairs consultants and Industry association representatives.

Table 50: Interest in recent TGA reforms - By stakeholder group (%)

The TGA has recently made some changes to the regulation of medicines and medical devices. Please identify the changes that interest you.
Stakeholder group Priority review path Prov approv path New Cat C Black Tri Scheme Efficacy asses listed path Permit indic'ns list None N
Total 42.9 20.3 17.4 10.9 13.6 22.1 24.4 2252
Medical prod ind 50.0 21.7 18.7 12.9 14.2 20.6 21.4 1531
Health pro 30.6 22.2 18.1 6.5 13.4 25.5 21.8 216
Retailer 23.3 5.5 4.1 1.4 8.2 21.9 38.4 73
Government 25.4 13.4 14.9 7.5 7.5 13.4 32.8 67
Academic 36.5 20.6 27.0 9.5 12.7 30.2 36.5 63
Media 0.0 0.0 0.0 0.0 0.0 50.0 50.0 2
Other 26.1 17.2 12.0 7.2 13.7 27.8 34.0 291
Medical products industry
Product sponsor 55.3 24.6 20.7 15.7 14.3 20.5 18.9 932
Product manufacturer 37.7 10.9 14.0 5.0 10.7 16.4 29.1 422
Reg affairs consult 65.7 46.7 23.8 24.8 31.4 36.2 9.5 105
Ind assoc'n rep 18.2 9.1 18.2 18.2 27.3 36.4 9.1 11
Other 6.9 2.4 2.4 1.0 0.7 3.4 5.8 291
Health professional
Pharmacist 39.4 45.5 39.4 21.2 27.3 45.5 0.0 33
Medical practitioner 50.0 40.9 27.3 9.1 9.1 27.3 6.8 44
Nurse 8.3 8.3 8.3 0.0 4.2 4.2 37.5 24
Comp healthcare pract 23.1 12.8 0.0 0.0 33.3 53.8 15.4 39
Dental practitioner 11.1 11.1 22.2 0.0 0.0 11.1 33.3 9
Other 27.3 9.1 13.6 3.0 1.5 6.1 39.4 66

Perceptions of reforms

Perceptions of reforms highlight a strong level of neutral responses across the areas tested, with the neither responses the most selected answer across each of the statements presented (Table 51). Generally the neutral responses are more likely to be associated with Government and Academic stakeholders. In addition to this pattern, on all measures the level of positive response outweighed those who were not positive about the reforms.

Forty percent of all survey participants feel that the reforms are beneficial to them or their business compared to 8% who disagree (Table 51). Over one in three feel that their business is prepared for the changes compared to 9% who feel this is not the case (and 55% who selected the neutral Neither response). In terms of information provision regarding the reforms, 37% agree that the information provided was adequate. A substantial proportion (16%) feel that this is not the case and just under half Neither agree nor disagree on this statement.

There is substantial agreement on the statement focusing on adverse impacts of the reforms (18%), with those who disagree that there has been an adverse impact slightly higher at 23% (59% Neither agree nor disagree with this statement).

Table 51: Perceptions of reforms (%)

Please indicate your level of agreement with the following statements:
Statement Nett disagree Neither Nett agree N
The reforms are beneficial to my business/myself 8.2 51.5 40.3 1828
I am/my business is adversely impacted by the reforms 22.6 59.1 18.3 1809
I am/my business was prepared for the regulatory changes 8.6 55.4 36.0 1823
I received adequate information regarding the reforms 15.7 47.0 37.3 1825

Medical products industry respondents are most likely to highlight agreement in relation to the statement that the reforms are beneficial (Figure 63). Amongst this group, Product sponsors (48% Nett agree), Industry association representatives (63%) and Regulatory affairs consultants (53%) all show high levels of agreement with the statement and low levels of disagreement (Table 53).

Figure 63: Perceptions of reforms - The reforms are beneficial to my business/myself - by stakeholder group (%)
Column chart - see figure 63 in tabular format

Med prod ind: N=1,273; Health pro: N=151; Retailer: N=57; Gov: N=45; Academic: N=59; Media: N=2; Other: N=263.

Figure 63: Perceptions of reforms - The reforms are beneficial to my business/myself - by stakeholder group (%)
Stakeholder group Nett disagree Nett agree
Total 8 40
Medical products industry 7 45
Health professional 15 35
Retailer 19 32
Government 4 22
Academic 2 27
Other, please specify 8 29
No answer 40 40

Med prod ind: N=1,273; Health pro: N=151; Retailer: N=57; Gov: N=45; Academic: N=59; Media: N=2; Other: N=263.

Retailers (29%) and to a lesser extent Health professionals (25%) appear slightly more likely to agree that the reforms will have an adverse impact. These two groups show agreement levels on this question at slightly higher levels than disagreement. Within the Health professionals group, Complementary health practitioners (57% Nett agree), Pharmacists (29%) and Dental practitioners (33%) all commonly highlight that they have experienced adverse impact of the reforms (Table 52).

Figure 64: Perceptions of reforms - I am/my business is adversely impacted by the reforms - by stakeholder group (%)
Column chart - see figure 64 in tabular format

Med prod ind: N=1,259; Health pro: N=151; Retailer: N=56; Gov: N=44; Academic: N=57; Media: N=2; Other: N=235.

Figure 64: Perceptions of reforms - I am/my business is adversely impacted by the reforms - by stakeholder group (%)
Stakeholder group Nett disagree Nett agree
Total 23 18
Medical products industry 24 19
Health professional 23 25
Retailer 20 29
Government 16 5
Academic 21 7
Other, please specify 17 14
No answer 60 20

Med prod ind: N=1,259; Health pro: N=151; Retailer: N=56; Gov: N=44; Academic: N=57; Media: N=2; Other: N=235.

In terms of preparation for the reforms, those in the Medical products industry show the highest levels of agreement (40%) coupled with low disagreement (8%; Figure 65). There is generally strong consistency in responses across the range of industry stakeholder groups, although notably Regulatory affairs consultants are most likely to agree that they are prepared for the changes (Table 52).

Health professionals also appear to more commonly than not feel prepared; however, it is notable that almost one in three Complementary healthcare practitioners disagree that they are prepared (Table 52). Retailers also show a relatively high level of disagreement that they are prepared. These outcomes are consistent with those highlighted in relation to agreement levels relating to whether stakeholders received adequate information about the reforms (Figure 66 and Table 52). In response to this question, Retailers (Nett disagree 23%) and Complementary healthcare providers (41%), along with Medical Practitioners (27%), show a high likelihood to disagree that they received adequate information. The outcomes here highlight potential opportunities for further education and targeted information to Retailer, Complementary healthcare and Medical practitioner groups.

Figure 65: Perceptions of reforms - I am/my business was prepared for the regulatory changes - by stakeholder group (%)
Column chart - see Figure 65 in tabular format

Med prod ind: N=1,268; Health pro: N=152; Retailer: N=56; Gov: N=45; Academic: N=59; Media: N=2; Other: N=236.

Figure 65: Perceptions of reforms - I am/my business was prepared for the regulatory changes - by stakeholder group (%)
Stakeholder group Nett disagree Nett agree
Total 9 36
Medical products industry 8 40
Health professional 12 26
Retailer 23 23
Government 11 20
Academic 2 19
Other, please specify 9 31
No answer 20 40

Med prod ind: N=1,268; Health pro: N=152; Retailer: N=56; Gov: N=45; Academic: N=59; Media: N=2; Other: N=236.

Figure 66: Perceptions of reforms - I received adequate information regarding the reforms - by stakeholder group (%)
Column chart - see Figure 66 in tabular format

Med prod ind: N=1,273; Health pro: N=147; Retailer: N=56; Gov: N=46; Academic: N=60; Media: N=2; Other: N=236.

Figure 66: Perceptions of reforms - I received adequate information regarding the reforms - by stakeholder group (%)
Stakeholder group Nett disagree Nett agree
Total 16 37
Medical products industry 15 41
Health professional 20 31
Retailer 23 27
Government 9 24
Academic 22 18
Other, please specify 13 30
No answer 40 40

Med prod ind: N=1,273; Health pro: N=147; Retailer: N=56; Gov: N=46; Academic: N=60; Media: N=2; Other: N=236.

Table 52: Perceptions of reforms by Stakeholder group (%)

Please indicate your level of agreement with the following statements:
Stakeholder Reforms are beneficial Adverse impact Prepared for change Received adequate info
Nett disagree Nett agree Nett disagree Nett agree Nett disagree Nett agree Nett disagree Nett agree
Medical products industry
Product sponsor 7 48 25 20 8 41 16 43
Product manufacturer 8 36 20 17 8 35 15 33
Reg affairs consult 5 53 32 14 2 58 13 54
Ind assoc'n rep 13 63 13 50 25 38 13 63
Other 2 38 24 18 2 29 9 38
Health professionals
Pharmacist 5 67 23 29 0 38 0 57
Medical practitioner 6 47 19 9 16 16 27 27
Nurse 0 23 44 15 0 23 15 23
Compl health pract 47 23 8 57 29 35 41 21
Dental practitioner 17 50 13 33 17 50 17 50
Other 10 21 33 15 6 21 13 28

Sponsor: N=788-797; Manufacturer: N=326-330; Reg Affairs Con: N=88-91; Ind Assoc Rep: N=8; Other: N=45. Pharmacist: N=21; Med prac: N=30-32; Nurse: N=13; Comp health: N=29-31; Dental: N=6; Other: N=47-48.

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