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Some reaction to the transparency review of the TGA

As previously reported, a review released today makes wide-ranging recommendations for improving the transparency and responsiveness of the Therapeutic Goods Administration.

Below is some reaction.

Dr Ken Harvey, Adjunct Senior Lecturer, School of Public Health at La Trobe University, was the CHOICE consumer representative for the review.

He writes:

During the consultations, and in some of the submissions made to the Review, stakeholders drew the Panel’s attention to a number of issues regarding the TGA or therapeutic goods that were not directly related to ‘transparency’.

When the Panel considered these issues, it determined that they were outside the scope of the Terms of Reference for the Review, and in some cases were policy matters for consideration by government.

However, the Panel agreed that these matters are important, and decided that each issue should be noted and/or drawn to the attention of either the TGA, or the most appropriate government agency. These are set out in Chapter 5 of the Review.

One key issue was the impact of the TGA’s current funding structure of 100% cost recovery from industry. Some consumers perceived that the funding structure limits the TGA’s capacity to provide public education and information.

Industry stakeholders understand, and in some cases are supportive of, consumers’ requests for the TGA to improve public education. However, they are also conscious that the TGA’s legislated funding structure does not necessarily provide for the level of engagement the community is seeking.

It was pointed out that, although full-cost recovery from industry may appeal to Governments, the consumer paid regardless. Either the cost of regulation was passed on by industry through higher priced products or, if the Government paid, through increased taxation. It was suggested that the latter was more equitable.

Another important issue was the assessment by the TGA of complementary medicines (such as vitamin and mineral supplements, herbal medicines and especially homeopathic products).

Contributors were concerned that the recognition of these products by the TGA, and the AUST L number on the label, provided the public with a perception that the claims made for these products had validity.

It was asserted that many therapeutic claims, or claims regarding efficacy and safety made for complementary medicines, cannot be supported from the limited scientific evidence available, while information about possible adverse effects, especially their interaction with conventional medicines, is often lacking.

It was accepted that the majority of complementary medicines are low-risk products, but low-risk does not mean no-risk. Submissions claimed that many complementary medicines are heavily promoted as ‘natural’ or ‘natural alternatives’, with the implication that they are harmless. It was said that this can result in consumers not advising their medical practitioner or pharmacist about their use, and that health practitioners often do not ask about them.

Some submissions sought not just greater transparency on what an AUST L number means with respect to the TGA’s risk-based assessment of safety, quality and efficacy. They asked for changes in labelling and legislation. Some suggested that all labels, promotion and ARTG Public Summary documents of AUST L products should contain the warning, “These products have not been evaluated for efficacy by Australian health authorities”.

Other submissions sought changes to the evidence-based requirements for listed medicines, to more clearly distinguish evidence-based complementary medicines from those that were not. Some submissions requested universal evaluation of all therapeutic goods for efficacy, arguing that there was no such thing as complementary medicines, only medicines with evidence of efficacy and those that lacked evidence.

In particular, many submissions strongly put the view that the inclusion of homeopathic products by the TGA be ceased, as it is perceived to provide an unwarranted or inappropriate endorsement of the products that may be no better than a placebo.

Finally, although not mentioned in the Review there are three other reports relevant to these matters sitting on the Parliamentary Secretary’s desk:

·         Working Group on Promotion of Therapeutic Products http://tinyurl.com/43nyyop (dealing with self-regulation of pharmaceutical promotion to health professionals – report finalised in March, yet to be released).

·         TGA Advertising Consultation http://www.tga.gov.au/newsroom/consult-advertising-arrangements-101028.htm (currently secret TGA business since 2010).

·         TGA Internal Working Group on Complementary Medicine Regulatory Reform (also TGA secret business).

***

Update, 22 July

More analysis from Susan Walters, Adjunct Associate Professor at the UNSW and a former TGA employee, is at The Conversation.

An extract:

It does not seem likely that the proposals could be implemented within the TGA’s present budget without a reduction in the functions presently being performed.

The panel is strongly of the view that the work of the TGA should not be diminished in any way. Accordingly, if the government is to accept and give effect to the Panel’s recommendations, it will be necessary for resources additional to those currently available to be found.

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Australian Palliative Care Conference
2018 conferences
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