The government has just announced its response to a series of reviews of the Therapeutic Goods Administration over the past 18 months. The announcement was brought forward after a summary of the reforms was accidentally emailed to about a dozen people yesterday.
Transparency review and devices
Most recommendations of the TGA Transparency Review will be implemented. These include the establishment of an Australian therapeutic goods advisory council for oversight of the implementation, ongoing monitoring, and evaluation of review recommendations over the next four years. A dedicated communications unit will also be created within the TGA to inform and educate the public.
Some positive moves regarding the regulation of medical devices include reclassifying the load bearing component of a hip, knee or shoulder joint replacement from medium-high risk to high-risk. This means such devices will require more assessment before entering the market.
The information on medical devices on the Australian Register of Therapeutic Goods (ATGR) will be amended so sponsors will nominate names for each product. This will make it easier for consumers and health professionals to find information about specific devices. The amount of available product information on the TGA website relating to medical devices will also be increased.
However, a key concern of the Working Group on Promotion of Therapeutic Goods (to health professionals) that compliance with an industry code should be a condition of including a product on the ATGR was not accepted. The government’s view was that this departs from their prefered self-regulatory model. However, group members noted that the worst perpetrators of unethical promotion were usually not members of industry associations and these cowboys would be unlikely to sign up to code compliance voluntarily.
Without addressing this problem, the likely outcome of “strengthening” and creating a “level playing field” for self-regulatory codes is that the good guys (industry association members who are code compliant) will increasingly be restrained while the bad guys (non-members of industry associations) will laugh all the way to the bank.
Not addressing this concern also perpetuates the difference between health professionals and industry. Health professionals now have government-mandated national registration and must comply with Australian Health Practitioner Regulation Agency (AHPRA) code while the latter (non-members of industry associations) have no controls placed on them at all.
The recommendation that the effectiveness of voluntary registration be evaluated annually required government acceptance of a number of other recommendations, such as creating an advisory group. But apparently “[the government] is not yet persuaded there is a need to establish a permanent advisory group” and “aspects of the Report which require either Government assistance or legislative amendments to move towards co-regulation have not been accepted by the Government at this time”.
Given this background, I cannot see how it’ll be possible to evaluate the impact of Working Group on Promotion of Therapeutic Goods recommendations or how “longer term changes will be considered if necessary”. But perhaps that was the aim of rejecting these key recommendations. So what was the point of setting up a broad-based stakeholder “Working Group on Promotion” and then ignoring their key concerns and recommendations?
There are positive measures for the regulation of complementary medicines and information provision, which include:
- amending the Therapeutic Goods Regulations with guidelines for the levels and kinds of evidence required to support claims;
- changing the way products are electronically listed so sponsors can’t just add free text; and
- working with stakeholders to create better labelling.
However, it’s disappointing that clear labelling requested by many has been assigned to further work with stakeholders. What’s required to assist consumers making decisions about complementary medicines is a clear statement on the label, on promotional material and above the shelves with complementary medicines that honestly reflects the regulatory reality.
Indeed, the TGA media spokesperson has recently been using an useful set of words, “The TGA does not evaluate the effectiveness of listed complementary medicines and cannot guarantee that these products work”. This labelling reform can and should be implemented now – why further delays?
Advertising reforms (promotion to consumers)
This was the most disappointing area of all. For the last decade, numerous reports to government and submissions from consumers and health professionals have highlighted the need to ensure that the Complaints Resolution Panel (CRP), on its own or along with the TGA, can readily apply escalating and effective sanctions on product sponsors who breach the Therapeutic Goods Advertising Code and Therapeutic Goods Act.
But the government response is – “changes to the approach of sanctions and penalties for advertising breaches, including civil penalty provisions which parallel offences and act as a deterrent, will be investigated.”
Currently, the CRP is under-resourced, overloaded and has no power to enforce sanctions. Sponsors are merely “requested to comply”. It takes between six and nine months for complaints to be heard and judgements to be made public. All this takes place while misleading promotion continues. The CRP also lacks resources to follow up its own decisions, which make them more easily ignored.
It often takes multiple complaints before non-compliance by a product sponsor is passed to the final regulator – the TGA. The TGA may write letters “ordering” compliance but, due to the low financial penalties available, it has never prepared a brief of evidence for consideration of prosecution (see ANAO report).
Industry knows that the CRP and TGA are paper tigers, so serial advertising offenders and conmen flood the market with dodgy products, undeterred by escalating (and ultimately ineffectual) complaints.
Recently, SensaSlim (and other shonky products) have been referred from the TGA to the Australian Competition and Consumer Commission (ACCC), but this has, as yet, failed to stop the continued sale of these products or their imitators, or their use.
We need legislation to give the CRP and TGA timely and meaningful sanctions for advertising violations (civil penalties, enforceable undertakings) now. I cannot see why “further investigation” and “further input by stakeholders” is needed apart from the sake of letting sections of industry profit by continuing to rip off consumers unchecked.
Like the Curate’s egg, the government’s reform blueprint appears to be good in parts. But it also displays a timidity to grapple with key issues, such as therapeutic goods advertising reform, and that seems to be a common failing of this Labor government.
I’ve been a card carrying member of the Labor Party for some time. I worked hard to get rid of the Howard government and get Labor elected and I’ve sat on a number of the working parties and consultations that have made the recommendations outlined above.
But I can no longer be a member of the party when a Labor government fails to implement unanimous recommendations from its own working parties, and continues to procrastinate after a decade of calls for effective sanctions on advertising violations. I have today submitted my resignation.