Complementary Medicine Regulation Reform Suggestions

My submission to the TGA Working Group on Complementary Medicine Regulation Reform as a representative of:

 

 

Problem

It is alleged that some sponsors are not aware of the regulatory issues concerning complementary medicines including the Therapeutic Goods Advertising Act 2007.

Solution

a) Sponsors to be licenced by Industry Associations; the licence to be given only after the sponsor has attended an appropriate educational course on the obligations of sponsor to comply with the Therapeutic Goods Act, Regulations and other relevant legislation.

b) The initial and ongoing licence will also be dependent upon the sponsor’s staff attending a TGACC advertising seminar once every 3 years. [1]

c)  A condition of listing on the ARTG will be acknowledgement by the sponsor of compliance with Therapeutic Goods Act, Regulations and other relevant legislation and acceptance of any orders of the Complaints Resolution Panel; failure to comply will result in substantial accumulating fines for each individual breach if those orders are disobeyed. [2]

Problem

The Electronic Listing Facility (ELF) is being abused with some sponsors incorrectly labelling ingredients, using inappropriate indications and placing information on the ARTG that is not capable of substantiation.

Many of these problems are obvious if the ARTG public summary record is scanned by an expert; others require more detailed analysis.

In addition, the ARTG Public Summary Record lacks important information required by health professionals and consumers, such as the medicine dose, known adverse effects and interactions with other medication.

The end result is that the ARTG Public Summary Record is not a reliable guide for the quality use of complementary medicines. Nor does the ARTG fulfil the promise given by the Parliamentary Secretary for Health and Ageing, the Hon Catherine King, MP,

“It is now easy for consumers to find a product name and the ingredients, details about the company, the date a product was approved for use in Australia and importantly any warnings about the use of the product.” [3]

Solution

a) Sponsors will be required to add to the ARTG record the dose of the medicine, known adverse effects, interactions with other medication and a list of the evidence on which indications / claims and other information is based.

b) Prior to issuing an AUST L number, all new listing applications will be sent to a monitoring panel of experts (at the sponsor’s expense) for a scan of obvious problems. If problems are found, the application will to be sent to the Office of Complimentary Medicine (OCM) for a more detailed review.

c) In addition, the OCM will continue to conduct a detailed random post-marketing audit of a proportion of all medicines listed in the ARTG as resources permit.

Problem

The Complaint Resolution Panel (CRP) is overloaded, their determinations are delayed, they have no power to enforce their determinations and the follow-up of non-compliance by both the CRP and the TGA is deficient, as are the sanctions available.

Solution

a)  Implement the 2002 recommendations of the, “Report of a review of advertising therapeutic products in Australia and New Zealand”:

  • A new Complaints Panel be established with powers derived from the regulator’s power to license, with a condition of the license being compliance with the single Code and acceptance of any orders of the Complaints Panel;
  • The powers to order both withdrawal and corrective advertising;
  • The powers backed by substantial accumulating fines for each individual breach if those orders are disobeyed.

b) In addition, a wider range of penalties should be instituted for non-compliance as listed in the reform options paper and the TGA advertising consultation: [4]

  • Strengthening relevant legislation to include civil penalties and enforceable undertakings for breaches of the advertising provisions and court-imposed remedial action for serious and/or repeated breaches.
  • The power to refuse to list a product that was substantially similar to one that had been cancelled unless and until the relevant remedial action had been taken);
  • Publication of regulatory decisions, such as cancellations (for whatever reason);
  • Mandatory retail-level recalls of all cancelled products, (even when there is not an obvious safety concern) and public notification of successful prosecutions.

c) In the interim, the CRP should follow-up all their determinations to check for compliance, refer all cases of non-compliance to the TGA and/or the ACCC as appropriate, and publish the outcomes and timelines.

d) Therapeutic Goods Regulation 42ZCAJ should be repealed as it as it currently encourages some sponsors to stifle legitimate debate or complaints about their products by issuing SLAPP writs (strategic litigation against public participation). This has the convenient effect of postponing the independent investigation of CRP into complaints.

e) In addition, the CRP should institute a promotional monitoring system encompassing a random selection of advertisements from relevant media, including the Internet, similar to that conducted by Medicines Australia.

f) The CRP should publish the results of all monitoring and complaint procedures including the outcomes and time taken.

Problem

There is no incentive for sponsors of complementary medicines to conduct research to produce evidence-based products and there is no way that consumers (and health professionals) can distinguish evidence-based products from those that rely merely on hype.

Solution

a) By default, all listed medicines should contain the following prominent statement on the ARTG Public Summary Document, the label and on all promotional material:

  • “This product has NOT been evaluated for efficacy by Australian Health Authorities”.

b) All statements about Aust L products on the TGA web site should state:

  • “Unlike higher risk ‘registered’ medicines, listed medicines are not evaluated for efficacy before entry on the Australian Register of Therapeutic Goods (ARTG) and consumers and health professionals should be aware that the TGA regulates these products for safety but cannot guarantee if they actually work”.

c) Claims based on limited evidence that contain the words, “may relieve…” should state “may or may not relieve… ”

d) Sponsors should only be allowed to use clinical trial evidence relating to other products where their own product has been shown to have an identical herbal preparation, extraction and standardisation process.

e) An independent, civil-society, non-TGA, opt-in, not for profit, user-pays system for the evaluation of listed complementary medicine and the dissemination of reliable information should be supported which:

  • Allows consumers to distinguish between effective high quality products and those that lack these properties by the use of a logo, similar in concept to that used by the National Heart Foundation;
  • Encourages rational and effective use of complementary medicines in relation to other medicinal products;
  • Provides incentives and rewards for companies which subject their products to high quality research; encouraging the transition by industry from listed to registered complementary medicines; and
  • Supports education of consumers and practitioners and encourages the dissemination of reliable information about complementary products.

f) The National Prescribing Service (NPS), health professional and consumer organisations should be asked to run an on-going educational campaign for their constituents on the above matters.

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About Dr Ken Harvey

Public Health Physician, Medical activitist
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