Update on reform of Australian complementary …...Expert Review of Medicines and Medical Devices...

Skeptics Annual Convention, Melbourne, Nov 26, 2016

Dr Ken Harvey

Update on reform of Australian complementary medicines and advertising

regulation


Dr Ken Harvey MB BS, FRCPA

Adjunct Associate Professor, School of Public Health and Preventive Medicine

http://www.medreach.com.au

Talk outline

• Problems with Australian therapeutic goods regulation

• The latest review (17th) and the government's response

• Current consultation proposals

• Problems with a TGA takeover?

• Call for "Active Skepticism" and submissions to the government and TGA (submissions close 21 December 2016).

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Dr Ken Harvey

• The TGA uses a risk‐based pre‐market assessment of therapeutic goods.

• Registered medicines (labelled AUST R) are thoroughly evaluated for quality, safety and efficacy prior to market release (with the exception of some “grandfathered” products)

• All prescription medicines are AUST R.

• Listed medicines (labelled AUST L) are regarded as lower risk self‐medication products. They are required to meet quality and safety standards but are not accessed for efficacy.

• Most CMs are listed (AUST L) on the ARTG. 3

Problems with TGA regulation

• The lack of pre‐market evaluation of the efficacy of most CM; especially the lack of timely and significant penalties for breaches of the regulations, encourages unscrupulous sponsors to flood the market with shonky products and unethical claims.

• Research has shown that the public does not understand the difference between AUST R and AUST L labelled products; nor “traditional” versus “scientific” evidence.

• Thus, there is currently little incentive for CM sponsors to undertake expensive research, compile an extensive dossier and pay the higher fees required for TGA registration.

• A better return on investment comes from spending the money on celebrity endorsement and promotional hype.

Problems with TGA regulation


Dr Ken Harvey

http://www.youtube.com/watch?v=12ww26sQF7E&feature=youtu.be

Media perceptions

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Rules under review?

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Date Initiative2002 Report of a Review of Advertising Therapeutic Products in Australia and New Zealand

2003 Report of Expert Committee on Complementary Medicines in the Health System

2005 Description of the joint (Trans‐Tasman) regulatory scheme for the advertising of therapeutic products

2006Consultation (Draft) Regulation Impact Statement on the proposed amendments to the current regulatory system for herbal and homoeopathic medicines in Australia

2007 Consultation ‐ draft (Trans‐Tasman) advertising rule

2008 Regulation of homoeopathic and anthroposophic medicines in Australia

2009 Draft Guideline for Levels and Evidence for Listed Medicines with Indications & Claims for Weight Loss

2010 TGA Consultation: Improving advertising arrangements for therapeutic goods

2011

Consultation and Report of the Working Group on Promotion of Therapeutic ProductsReport of the Review to improve the transparency of the Therapeutic Goods AdministrationANAO Report. Therapeutic Goods Regulation: Complementary MedicinesTGA reforms: A blueprint for TGA's future

2012Delivering reforms ‐ Implementation plan for TGA ReformsTGA Advertising regulatory framework: Options for reform

2013TGA Consultation Regulation Impact Statement: Regulating the advertising of therapeutic goods to the general public

2014Expert Review of Medicines and Medical Devices Regulation (Government de‐regulation agenda)Australian and New Zealand Governments agreed to cease efforts to establish a joint therapeutic products regulator

2015 Expert Review of Medicines and Medical Devices Regulation: recommendations and public forum.


Dr Ken Harvey

• A regulatory system with teeth!

• Mandatory labelling, “This product has NOT been evaluated by Australian Health Authorities to see if it works”.

• A better resourced, more timely and effective complaint system.

• Legislation for timely and meaningful sanctions for advertising violations (civil penalties, enforceable undertakings).

• Increased and better targeted post‐marketing surveillance and transparent reporting of problems and cancellations.

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What did we want?

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Another bloody review!July 2015 - Sept 2016

What did we get?


Dr Ken Harvey

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TGA Listed medicine compliance reviews: 2015-16

https://www.tga.gov.au/performance-statistics-report-july-2015-june-2016

• TGA compliance activity more than doubled from 212 (2014‐15) to 473 (2015‐16).

• Medicines with verified compliance breaches increased from 73% (2014‐15) to 80% (2015‐16).

• Labelling, advertising and evidence continued to be the major compliance breaches for listed medicines.

• More products were found to have safety related issues; 0 in (2014‐15) compared to 13 (2015‐16).

• In addition, for 2015‐16, the TGACRP found 98% of 141 complaints justified (and a 40% non‐compliance with TGACRP “requests” for redress).

Meanwhile

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Outcome of complaints

https://www.youtube.com/watch?v=jaQyrLzjvRs (2.05 minutes in)

Meanwhile


Dr Ken Harvey

11http://www.chemistwarehouse.com.au/buy/60462/Sambucol-Cold-Flu-24-Capsules

942 days later

(September, 2016)

MeanwhileOutcome of complaints

In short:

• The failure of the TGA to bring the industry into check over many years has resulted in:

– Loss of trust in the TGA as a regulator.

– Ongoing harm to consumers: • Direct harm from poorly disclosed adverse events from complementary medicines and their interaction with conventional medicines.

• Indirect harm, by consumers forgoing more evidence‐based remedies (often to the detriment of their health) because they are sucked in by misleading and deceptive promotional hype. This also wastes their money which could be better spent.

• So, will the MMD review recommendations help?12


Dr Ken Harvey

MMD Recommendations:Government response

• Rejected by government:

– sponsors to include a prominent disclaimer that products have not been independently assessed (r.44); rejected for more “education”.

– sponsors to publish evidence supporting their claims (r.43); made optional.

– TGA given the power to refuse listing (r. 34).

• Accepted (but controversial)

– mandatory pre‐approval of certain advertisements to cease in favour of self‐regulation (r.55).

Federal Health Minister Hon Sussan Ley MP

15 Sept 2016

Pros and cons of pre‐approval

• Pros

– Reviews over 2000 advertisements per year with an average turnaround time of 7 days.

– The majority of new advertisements require changes to avoid Code breaches, sometimes wholesale revisions.

– Pre‐approval is the only defence between a misleading advertisement on prime‐time television and the unwitting consumer; complaints and post‐marketing reviews take a long time to remove bad advertisements.

– Some of the worst offenders are not members of industry associations so self‐regulation is unlikely to impact.

– Prevention is better than cure.http://www.doctorportal.com.au/mjainsight/2016/38/advertising-reform-watering-down-consumer-protection/


Dr Ken Harvey


• Cons

– The pre‐approval process is only directed at “specified media”, mainly television, radio and print advertisements, not the Internet.

– Delegated by TGA to two industry associations (ASMI & CMA); decisions are not always consistent.

– Delegates do not have the time to review the evidence supporting the claims in detail; thus some pre‐approved advertisements may still be found to breach the Code by the TGACRP (albeit said to be less than 0.5%).

15http://www.doctorportal.com.au/mjainsight/2016/38/advertising-reform-watering-down-consumer-protection/


• The government has agreed that removal of pre‐approval requirements is conditional on the implementation of other recommended consumer protections:

– advertising claims being consistent with Permitted or Approved Indications (r.38);

– strengthening of post‐market monitoring(r.49); and

– improving the complaints management process(r.56).

• However, many believe that it would be better to extend pre‐approval to all advertisements and delegate the function to a combined ASMI‐CMA pre‐approval office. Prevention is better than cure. 16


Dr Ken Harvey


• Accepted: but needs ongoing input on implementation

– “Free text” on ARTG to be replaced by a limited list of Permitted Indications (r.38).

– a new listing pathway (option 2) where the sponsor can provide evidence acceptable to the TGA to support the safety and efficacy of health claims that fall outside the list of Permitted Indications (r.39).

– improvements to the complaint process, post‐marketing surveillance and increased penalties for regulatory breaches (r.56, r.49, r.57). Federal Health Minister

Hon Sussan Ley MP

15 Sept 2016

The problem: Free text on the ARTG

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Effective date: 28/06/2016

Clinically trialled*to shorten your cold by 3 days

In a clinical trial, patients given Sambucol recovered on average 3 days faster compared to those given a placebo.

CLINICALLY TRIALLED*

Scientific studies have demonstrated that Sambucol reduces the severity of cold and flu symptoms and shortens the duration of a cold.


Dr Ken Harvey

The solution: List of Permitted Indications?

• 2013 TGA proposed list includes:

– To help in weight management by reducing carbohydrate cravings.

– Assists in the maintenance of normal healthy blood sugar/glucose levels in healthy individuals.

– Male support. Beneficial to men in satisfying physiological requirements of the male body.

– Relieves symptoms of hangover.

– Helps to reduce the time it takes to fall asleep.

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Where is the evidence supporting these indications?

• 2013 TGA proposed list includes:

– Used in Herbal medicine to help fight off infections, especially the upper respiratory tract.

– Used in Traditional Chinese Medicine (TCM) to tonify the spleen and augment the Qi for spleen deficiency presenting with a lack of appetite, fatigue, and diarrhoea.

– Traditionally used in Ayurveda for memory enhancement.

The solution: List of Permitted Indications?

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Will be subject to consultation with consumers, sponsors and health

professionals: Essential!


Dr Ken Harvey






Hon Sussan Ley MP

15 Sept 2016






Hon Sussan Ley MP

15 Sept 2016


Dr Ken Harvey

• TGA current priorities include:

– Listed medicines with blood glucose and cholesterol indications

• Many indications were found to be unsupported by the evidence provided by sponsors such as, “supports healthy blood sugar levels”.

• Future priorities include:

– Listed medicines with eye health indications• There is no evidence of benefit when these preparations are taken as a preventative measure in patients with no (or early) macular degeneration.

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Enhanced post‐marketing monitoring?

https://www.tga.gov.au/compliance-and-education-listed-medicines

TGA public consultation timetable

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Simplifying regulatory arrangements for advertising of medicines and

medical devices

Consultation on options for handling complaints about therapeutic

goods advertising and other changes to the advertising framework

This consultation closes on 21 December 2016.

November 2016

Complementary medicine regulatory reforms

Introduction of a new class of assessed complementary medicines January 2017

Mechanisms for establishing a list of permitted indications including the

criteria for what a permitted indication is and the initial lists of

permitted indications

January 2017

Appropriate criteria for publication of claims on promotional material

for complementary medicines

January 2017

Incentives for encouraging innovation in the complementary medicines

sector

March 2017

https://www.tga.gov.au/implementation-reforms-public-consultation-forecast


Dr Ken Harvey

Advertising consultation proposals

• Sanctions:

– Civil penalties (fines),

– infringement notices,

– Warning notices, injunctions, and

– enforceable undertakings as additional enforcement options: Crucial!

• Complaint handling options:

– TGA takes over?

– Independent statutory authority?

• The TGA seeks stakeholder views.

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https://www.tga.gov.au/consultation/consultation-regulatory-framework-advertising-therapeutic-goods-november-2016

Both complaint system options

• If provided with adequate resources, appropriate expertise and statutory powers offer:

– Simplified processes by replacing current multiple complaint handling arrangements with a single process.

– The benefits of improved consistency and timeliness in the consideration of complaints.

– Sanctions and penalties that provide an effective deterrent including, where justified by the risk to public health, the urgent removal of non‐compliant advertising.

– The ability to deal with potentially non‐compliant ads that are not the subject of an actual complaint but arise from post‐marketing or other surveillance. 26


Dr Ken Harvey

Perceived problems with a TGA takeover

• The TGA is seen to be taking over a role that was shared in the past with stakeholders:– The current Code Council and Complaint Panel have

industry, media, health professional and consumer representation (in addition to TGA staff) which allows a variety of considerations to be brought to revising the Code and making complaint determinations.

• The TGA has make bad decisions in isolation:– for example, approving an advertising restricted representation for the

homeopathic product, “Restless Legs Relief”.

• The TGA appears to too close to industry:– for example, when sent advertisements whose sponsors declined

compliance with Complaint Panel determinations, they sometimes negotiate softer outcomes that eliminate the retractions sought.

27http://www.medreach.com.au/?p=1661

Perceived problems with a TGA takeover

• The TGA has failed to target sponsors with post‐marketing reviews whom the Complaint Panel has found to repeatedly breach the Code.

• Nor have they addressed long‐standing problems that are the subject of numerous upheld complaints such as weight loss and sexual enhancement products.

• The TGA rarely ask sponsors to correct misleading indications / claims on their ARTG Public Summary documents despite the same claims being found to breach the Code on advertisements by the Complaint Panel.

• Finally, the TGA has consistently lacked transparency, both in the outcomes of advertisements submitted directly, and in many referred to them by the TGACRP for non‐compliance.

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Dr Ken Harvey

Preferred model

• Independent statutory authority– One option might be a new section of

the ACCC; this would have the consumer protection culture, regulatory expertise, and the investigative and enforcement tools required.

– It would need the additional resources offered to employ appropriate staff to work up complaints, determinations and advise on sanctions. This could include a paid panel of stakeholder expertise (including TGA officers).

– It would also conduct monitoring, recognising that complaints are merely the tip of the iceberg.

– An advisory council of stakeholders with appropriate expertise could be used to update the Therapeutic Goods Advertising Code from time to time, and review the authorities activities.

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Friends of Science in Medicine

The battle continues

• The TGA has stated that the current consultations will not address the government’s decisions, only how these decisions might be implemented.

• Yet, legislation is required to implement the new listing pathway, the new complaint system and increased penalties and sanctions – This will offer the possibility of opening up the

government’s decisions via parliamentary representation and committees.

• Meanwhile, we need submissions to the TGA and government (active skepticism).

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Dr Ken Harvey

Submission template

Will be available on Monday Nov 29, 2016 (as will these slides)

from http://www.medreach.com.au/

(blog posts)

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Closing date:21 December 2016

Further viewing:

• TGA regulation– https://www.youtube.com/watch?v=_vPha4usTtI

• Nurofen– http://www.medreach.com.au/?p=1661

• Swisse chlorophyll– https://www.youtube.com/watch?v=MTa_ccZBvEg

• Pharma Sutra– https://www.youtube.com/watch?v=FTcLpY3MWPk

• Snot rocket science– https://www.youtube.com/watch?v=xyDZLvMhuSI

• A special welcome to the ABC's new commercial partner, Swisse– https://www.youtube.com/watch?v=c0WHvFI2I20

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Update on reform of Australian complementary …...Expert Review of Medicines and Medical Devices...

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