Negative impact? Australian complementary healthcare practitioners reveal concerns over TGA reforms
The online survey, conducted in June and July last year and published in December, sought feedback on a number of areas, including TGA reforms, information, business services, and website
Respondents included industry professionals such as complementary healthcare practitioners, medical practitioners, pharmacists, medical product manufacturers, academics, regulatory affairs consultants, and industry association representatives.
Nearly half (47%) the complementary healthcare practitioners who participated in the survey disagreed that the TGA's reforms had been beneficial, though 57% agreed they had had an "adverse impact" on the industry.
At the same time, 41% disagreed that they had received adequate information on these reforms from the regulatory body, and 27% of the medical practitioners and 23% of the retailers who responded also disagreed that they had gotten sufficient relevant information from the TGA.
When it came to the question of whether or not the reforms had provided adequate preparation for change, 16% of the medical practitioners and 29% of the complementary healthcare practitioners disagreed.
In contrast, only 8% of the medical product manufacturers disagreed that the reforms had been beneficial, 20% disagreed that they had had an "adverse impact" on the industry, 8% disagreed that it had prepared them for changes, and 15% disagreed that they had received sufficient information on the reforms.
Reviewing the reforms
In addition to this, the survey respondents were also asked to name the areas of reform that most interested them, in order to help the TGA better assess how these industry professionals perceived recent reforms.
Respondents tended to be interested in multiple reform areas, with 40.9% expressing interest in two or more such areas — product sponsors, regulatory affairs consultants, industry association representatives, pharmacists, medical practitioners and complementary healthcare practitioners expressed the highest overall levels of interest.
Chief among these areas was establishing a priority review pathway for medicines and medical devices, in which 43% of the respondents indicated interest.
The TGA report on the survey also noted that this area was nearly twice as likely to be of interest to the respondents than the other areas, and was the "most commonly identified reform amongst all major stakeholder groups".
Other areas of reform that attracted significant interest included the list of permitted indications for listed medicines, the provisional approved pathway for certain medicines, and new Category C notifications for the Special Access Scheme (SAS).
The report further stated: "Most notably, (the small numbers of) pharmacists and regulatory affairs consultants express high levels of interest across the range of reform areas."
Additionally, pharmacists, complementary healthcare practitioners, regulatory affairs consultants and industry association representatives were most interested in permitted indications for listed medicines.
Pathways and permissions
The TGA's latest stakeholder survey was conducted after a series of regulatory reforms implemented throughout 2018.
From as early as February, a Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017 was passed under the Medicines and Medical Devices Review (MMDR), detailing amendments for the provision of a new approval pathway for listing complementary medicines that featured higher therapeutic indications and health claims.
This essentially created a middle ground between the low-risk listed classifications for complementary medicines and higher-level pharmaceutical classifications.
Other legislative changes included a new assessed pre-market pathway for listing complementary medicines on the Register of Therapeutic Goods, permitted indications for listed medicines, and the assessed listed evaluation pathway.
The TGA is also considering permitting claims that would allow manufacturers to commercially differentiate products that have had their efficacy assessed under the new listed pathway.
In the coming year, the regulator will address other potential changes under the MMDR, such as an enhanced post-market monitoring scheme for listed medicines, and a list of countries and jurisdictions from which it will accept reports under the government’s policy of accepting 'trusted international standards and products'.