TGA Consultation: Complaint handling and monitoring

Yet another TGA consultation; this one closing on 4 June 2018 for a new regulatory system that is meant to start on 1 July 2018! For the last one on the draft new Therapeutic Goods Advertising Code, see my comments here.

There are a number of concerns with the TGA proposal on their new complaint system (updated on 10/05/2018 after response from TGA):

Transparency:

A complainant who sends a valid complaint will receive an email with a case identification number. However, unlike the existing CRP system, it appears that the complainant:

  • Will NOT receive a detailed determination as to whether their allegations of specific Code breaches were agreed with or not (unlike what the CRP currently publishes),
  • Will NOT be told the priority level their complaint has been assigned to,
  • For a case the TGA regards as low priority, they may find some information about their complaint in bi-annually statistics the TGA propose to publish on the number, frequency and nature of complaints dealt with.
  • For cases the TGA regards as higher priority, it is said that complainants will be notified of a brief outcome posted on the TGA web site.

Low priority cases, the only details published appear to be the case identification number, date received, date completed and the outcome; that is, a “regulatory obligation notice” was sent. There apparently will be NO information published on:

  • The product involved;
  • What alleged Code breaches were determined by the TGA to be justified?
  • If the “notice” achieved compliance (the TGA says some target reviews may be done on such cases)?

Why should the complainant have to follow up if compliance has been achieved; why not the TGA in all cases?

Medium priority cases, where an acceptable response is received to a warning letter (which appears to be merely a statement from the sponsor that the alleged breach has been responded to), the details of the responsible entity along with the case identification number, date received, date completed, the therapeutic goods involved, compliance action/s taken (or proposed) and the outcome will be published. Once again, NO information is provided on:

  • The product involved;
  • What alleged Code breaches were determined by the TGA to be justified?
  • Whether the “response” achieved compliance or not?

Experience with the current CRP shows that many sponsors will assert they will fix the problem, but then don’t; alternatively, they may correct the breaches pointed out, but then create new ones!  In short, monitoring is essential; trusting sponsors is naive!

High priority and critical priority cases, a determination will be made as to the most appropriate regulatory tools to be used. Where these matters are resolved, the details of the responsible entity, the case identification number, date received, date completed, the therapeutic goods involved, the compliance action/s taken, and the outcome will be published.

It appears that these are the only cases in which the product involved may be identified. But apparently not if compliance is achieved by negotiation rather than administrative or regulatory action, such as cancellation or suspension of therapeutic goods from the ARTG, enforceable undertakings, infringement, directions and public warning notices, and court outcomes. Not good enough!

In conclusion, the proposed TGA complaint system provides much less transparency that the current CRP system; very convenient for industry and for the TGA!

Monitoring and trend analysis

There is considerable concern about the TGA’s ability to perform this task. My colleagues and I have previously asked that TGA post-marketing compliance data be broken down into targeted and random reviews. This breakdown is NOT found in the TGA’s annual performance statistics and half yearly performance snapshots.

Rather the TGA lumps data on compliance breaches for both targeted and random reviews together. This means that if the TGA targets a category of product (such as sunscreens) which have less compliance breaches than other categories (such as herbal or homeopathic products), then the overall compliance rate appears to improve as the latest TGA snapshot showed. This was reported by the media as, “Complementary Medicine Compliance Improves (80% non-compliance drops to 56%)”. TGA targets need to be reported publicly, not merely made available for industry to selectively report.

The latest data provided, “Listing Compliance Reviews FY2016-17” (attached) has the following problems:

  • It gives percentages but not absolute numbers. Good reporting practice means all percentages presented should be preceded by the numbers they represent.
  • It has added a new column to the table, Project” which is not present in the “Annual performance statistics report: July 2016 to June 2017 3.3.2 Compliance reviews”. What does this mean? If it’s projects mentioned in the annual report that targeted oral probiotics indicated for vaginal conditions and listed medicines with blood glucose and cholesterol indications, what other investigations comprise the “targeted” column?

It is also important to break down the results for the main categories of products targeted by random reviews: e.g. Vitamins and minerals, Fish oil, Western Herbal Medicine, Chinese Traditional medicine, Ayurveda (Indian) medicines, Homeopathic Medicines, Probiotics, Sunscreens and Aromatherapy products.

Finally, it’s crucial to report to consumers and health professionals the most non-compliant companies. This will help consumers to select products and health professionals to give advice. It will also provide a stimulus for the named companies to improve.

In the second Civil Society Seminar on, “The Advertising of Therapeutic Goods and Services (and its regulation)” held at Monash law Chambers on Sept 8, 2017, and attended by the TGA’s now departed Ross Hawkins, we heard a presentation by Suzanne Crowle, Director of Engagement and Complaints, of NSW Fair Trading.

The NSW Fair Trading Complaints Register provides information about businesses that are the subject of 10 or more complaints received by Fair Trading in a calendar month. It’s updated monthly and only includes complaints considered by Fair Trading to have been made by a real person, relating to a real interaction with a business. It provides information about the name of the business; the number of complaints NSW Fair Trading has received about the business in the last month and the product groups complained about.

If NSW Fair Trading can do this monthly, why can’t the TGA do it at least 6-monthly?

Finally, I reiterate the point made in other submissions; unless the TGA accepts that consumer protection is an equal objective to industry assistance, and gains the will to act, a revised Code and complaint system (including increased penalties and sanctions) will have no more impact than the current dysfunctional system.

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About Dr Ken Harvey

Public Health Physician, Medical activitist
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