An overview of the Therapeutic Goods Advertising Code (No. 2) 2018 (the Code) followed by a detailed walkthrough of the Code with examples to illustrate the application of the key sections.
Presentation: Updates from the Therapeutic Goods Administration - For medicin...TGA Australia
The presentation outlines how the TGA’s new priority review pathway for prescription medicines works and how medicines might be deemed to be a priority for Australian patients. We discuss how the provisional approval pathway contributes to early access and how to judge when early data seems promising.
Presentation: Updates from the Therapeutic Goods Administration - For medicin...TGA Australia
The presentation outlines how the TGA’s new priority review pathway for prescription medicines works and how medicines might be deemed to be a priority for Australian patients. We discuss how the provisional approval pathway contributes to early access and how to judge when early data seems promising.
TGA Presentation: What’s happening in regulation?TGA Australia
This presentation provides an overview of the Government's response to the Expert Panel Review of Medicines and Medical Devices, with an emphasis on complementary medicines changes.
Pharmacovigilance and complementary medicines - Regulatory requirementsTGA Australia
Presentation on Pharmacovigilance basics – sponsor obligations, Complementary medicine safety – Regulatory perspective and Special considerations for complementary medicine pharmacovigilance
Spotlight on MMDR Further Reviews and Advertising ReformsTGA Australia
An overview of reform initiatives relating to low risk therapeutic goods and the scheduling policy framework arising from the Review of Medicines and Medical Devices Regulation.
Presentation Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TG...TGA Australia
This presentation highlights some of the changes in Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO 101) Order 2019, compared to the previous Order, Therapeutic Goods Order No. 78 – Standard for tablets and capsules.
Presentation: Therapeutic Goods Advertising Code (No. 2) 2018TGA Australia
An overview of the Therapeutic Goods Advertising Code (No. 2) 2018 (the Code) followed by a detailed walkthrough of the Code with examples to illustrate the application of the key sections.
Presentation: Spotlight on prescription medicine post-market reformsTGA Australia
An overview of reform initiatives relevant to prescription medicines pharmacovigilance arising from the Review of Medicines and Medical Devices Regulation.
Manufacturing Investigational Medicinal Products - Legislative and GMP requir...TGA Australia
Presentation on Legislative requirements, specific risks for IMP manufacturing, manufacturing authorisations, PIC/S Guide to GMP PE009-13 and common issues
This presentation provides an overview of proposals for implementation of several reform initiatives relevant to prescription medicines, including expedited pathways for registration, enhanced post-market monitoring, variations to registered medicines, work sharing with comparable overseas regulators, the use of overseas assessment reports, and reforms to the orphan drug programs. The information session was held ahead of formal public consultations to provide an early view of the reform proposals to those stakeholders who will be most directly involved in the design of the new regulatory arrangements.
The TGA Pharmacovigilance Inspection Pilot Program: 2015-2016TGA Australia
Firsthand overview of the TGA's Pharmacovigilance Inspection programme from the perspective of both the TGA and companies that have participated in the 'Pilot Inspection Programme'.
Presentation: Updates from the Pharmacovigilance and Special Access BranchTGA Australia
This presentation covers using new sources of data in Pharmacovigilance, Pharmacovigilance Inspection Program update, international collaboration activities and Adverse Event Management System.
Presentation: Pharmacovigilance requirements inspected and example findingsTGA Australia
Presentations given at the TGA information sessions cover the pharmacovigilance inspection guidelines, preparing for inspections, inspection process, and close out of inspections.
Presentation: Advertising compliance - Ensuring you are code compliantTGA Australia
This session will explain the new regulatory tools and enhanced penalties that may be used to address non-compliant advertising, the features of the new Therapeutic Goods Advertising Code, provide overviews of the TGA's new advertising complaints handling system and the educational resources available to assist advertisers in understanding their obligations.
TGA Presentation: What’s happening in regulation?TGA Australia
This presentation provides an overview of the Government's response to the Expert Panel Review of Medicines and Medical Devices, with an emphasis on complementary medicines changes.
Pharmacovigilance and complementary medicines - Regulatory requirementsTGA Australia
Presentation on Pharmacovigilance basics – sponsor obligations, Complementary medicine safety – Regulatory perspective and Special considerations for complementary medicine pharmacovigilance
Spotlight on MMDR Further Reviews and Advertising ReformsTGA Australia
An overview of reform initiatives relating to low risk therapeutic goods and the scheduling policy framework arising from the Review of Medicines and Medical Devices Regulation.
Presentation Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TG...TGA Australia
This presentation highlights some of the changes in Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO 101) Order 2019, compared to the previous Order, Therapeutic Goods Order No. 78 – Standard for tablets and capsules.
Presentation: Therapeutic Goods Advertising Code (No. 2) 2018TGA Australia
An overview of the Therapeutic Goods Advertising Code (No. 2) 2018 (the Code) followed by a detailed walkthrough of the Code with examples to illustrate the application of the key sections.
Presentation: Spotlight on prescription medicine post-market reformsTGA Australia
An overview of reform initiatives relevant to prescription medicines pharmacovigilance arising from the Review of Medicines and Medical Devices Regulation.
Manufacturing Investigational Medicinal Products - Legislative and GMP requir...TGA Australia
Presentation on Legislative requirements, specific risks for IMP manufacturing, manufacturing authorisations, PIC/S Guide to GMP PE009-13 and common issues
This presentation provides an overview of proposals for implementation of several reform initiatives relevant to prescription medicines, including expedited pathways for registration, enhanced post-market monitoring, variations to registered medicines, work sharing with comparable overseas regulators, the use of overseas assessment reports, and reforms to the orphan drug programs. The information session was held ahead of formal public consultations to provide an early view of the reform proposals to those stakeholders who will be most directly involved in the design of the new regulatory arrangements.
The TGA Pharmacovigilance Inspection Pilot Program: 2015-2016TGA Australia
Firsthand overview of the TGA's Pharmacovigilance Inspection programme from the perspective of both the TGA and companies that have participated in the 'Pilot Inspection Programme'.
Presentation: Updates from the Pharmacovigilance and Special Access BranchTGA Australia
This presentation covers using new sources of data in Pharmacovigilance, Pharmacovigilance Inspection Program update, international collaboration activities and Adverse Event Management System.
Presentation: Pharmacovigilance requirements inspected and example findingsTGA Australia
Presentations given at the TGA information sessions cover the pharmacovigilance inspection guidelines, preparing for inspections, inspection process, and close out of inspections.
Presentation: Advertising compliance - Ensuring you are code compliantTGA Australia
This session will explain the new regulatory tools and enhanced penalties that may be used to address non-compliant advertising, the features of the new Therapeutic Goods Advertising Code, provide overviews of the TGA's new advertising complaints handling system and the educational resources available to assist advertisers in understanding their obligations.
TGA presentation: What pharmacies need to know about advertising therapeutic ...TGA Australia
An overview of the legislative landscape for pharmacies wanting to advertise therapeutic goods in 2019. Includes a brief overview of the advertising legislation, followed by a summary of the TGA's new advertising complaints handling framework, tips for pharmacies to ensure compliant advertising and how to find more information.
Devices Sponsor Information Day: 5 - Post-market - Advertising therapeutic go...TGA Australia
Presentations by TGA and Industry (combined) to help sponsors and manufacturers better understand the regulation of medical devices and in-vitro diagnostic medical devices
TGA presentation: Therapeutic Goods Advertising Code (No. 2) 2018 - The Code ...TGA Australia
An overview of the Therapeutic Goods Advertising Code (No. 2) 2018 (the Code) followed by a detailed walkthrough of the Code with examples to illustrate the application of the key sections. Information about which version of the Code will apply to advertisements for the purposes of advertising pre-approval and complaints handling is also provided.
mHealth Israel_UK Healthcare, Retail and DTC Market OverviewLevi Shapiro
Overview of UK Healthcare, retail and direct to consumer market by Jeremy Cummin and Steve Hazelwood. Includes description of the NHS buying process, alternative market entry strategies and key considerations for success in the UK retail and consumer sectors.
TGA presentation: Therapeutic Goods Advertising Code (No. 2) 2018 - The Code ...TGA Australia
An overview of the Therapeutic Goods Advertising Code (No. 2) 2018 (the Code) followed by a detailed walkthrough of the Code with examples to illustrate the application of the key sections. Information about which version of the Code will apply to advertisements for the purposes of advertising pre-approval and complaints handling is also provided, along with information about the enforcement discretion policy the TGA will apply in 2019 for complaints about advertisements that do not comply with the Code.
TGA Presentation: Medicines scheduling and scheduling policy ad hoc working g...TGA Australia
TGA Scheduling Working Group Meeting One February 2018. Role of the Working Group including Reforms to the advertising of S3 pharmacist only medicines, Reviewing what current S3 substances should be advertised, Proactively identifying S4 medicine substances for consideration for down-scheduling, Adding a new appendix to the poison standard to provide additional safeguards when down-scheduling
The challenges of regulating direct to consumer digital medical devicesTGA Australia
Presentation on digital medical devices, the role of the regulator, challenges in applying the framework to digital devices, international approaches and what is the TGA doing
Updates from the Pharmacovigilance and Special Access Branch TGA Australia
Presentation on using new sources of data in Pharmacovigilance, Pharmacovigilance Inspection Program (PVIP) update, International collaboration activities, Adverse Event Management System (AEMS)
Q and A
Update on regulatory reforms from the Scientific Evaluation BranchTGA Australia
Presentation on the latest on variations, Generic Medicines Reform Program, Human cells and tissue regulation (excluded goods), Faecal Microbiota Transplantation and 2D DataMatrix codes for medicines
Update on regulatory reforms from the Scientific Evaluation BranchTGA Australia
Presentation on the latest on variations, Generic Medicines Reform Program, Human cells and tissue regulation (excluded goods), Faecal Microbiota Transplantation and 2D DataMatrix codes for medicines
Presentation on the background of medicine shortages, definitions, reporting requirements, assessment and management, Section 19A and the compliance framework
Regulatory updates from the TGA Medical Devices Branch - Part 1TGA Australia
Presentation on the review of medicines and medical devices regulation, proposed changes to some definitions and regulation of some products without a medical purpose, reclassification of medical devices (not IVD), Unique Device Identification System and post-market monitoring
Regulatory updates from the TGA Medical Devices Branch - Part 2TGA Australia
Presentation on the regulation of software including software as a medical device, proposed regulatory scheme for personalised medical devices, including 3D Printed Devices, proposed changes to the Essential Principles, Conformity Assessment Procedures, and the requirements for devices used in clinical trials, and clarifying the requirements for systems and procedure packs
SME Assist: Help to navigate the regulatory mazeTGA Australia
Presentation to provide information on TGA’s SME Assist and what the service offers, details on upcoming SME Assist events and information on where to find more help
This presentation highlights some of the changes in Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO 101) Order 2019, compared to the previous Order, Therapeutic Goods Order No. 78 – Standard for tablets and capsules.
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
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Basavarajeeyam is an important text for ayurvedic physician belonging to andhra pradehs. It is a popular compendium in various parts of our country as well as in andhra pradesh. The content of the text was presented in sanskrit and telugu language (Bilingual). One of the most famous book in ayurvedic pharmaceutics and therapeutics. This book contains 25 chapters called as prakaranas. Many rasaoushadis were explained, pioneer of dhatu druti, nadi pareeksha, mutra pareeksha etc. Belongs to the period of 15-16 century. New diseases like upadamsha, phiranga rogas are explained.
CDSCO and Phamacovigilance {Regulatory body in India}NEHA GUPTA
The Central Drugs Standard Control Organization (CDSCO) is India's national regulatory body for pharmaceuticals and medical devices. Operating under the Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India, the CDSCO is responsible for approving new drugs, conducting clinical trials, setting standards for drugs, controlling the quality of imported drugs, and coordinating the activities of State Drug Control Organizations by providing expert advice.
Pharmacovigilance, on the other hand, is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. The primary aim of pharmacovigilance is to ensure the safety and efficacy of medicines, thereby protecting public health.
In India, pharmacovigilance activities are monitored by the Pharmacovigilance Programme of India (PvPI), which works closely with CDSCO to collect, analyze, and act upon data regarding adverse drug reactions (ADRs). Together, they play a critical role in ensuring that the benefits of drugs outweigh their risks, maintaining high standards of patient safety, and promoting the rational use of medicines.
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
The Gram stain is a fundamental technique in microbiology used to classify bacteria based on their cell wall structure. It provides a quick and simple method to distinguish between Gram-positive and Gram-negative bacteria, which have different susceptibilities to antibiotics
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
New Drug Discovery and Development .....NEHA GUPTA
The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
Presentation: Advertising therapeutic goods to consumers
1. Advertising therapeutic goods to consumers
Complaints framework
Advertising Education and Assurance Section
Regulatory Education and Compliance Branch
Regulatory Practice and Support Division
1 May 2019
2. Complaints Resolution Panel
Complaints about advertising in specified
media (including internet) for goods that can
be advertised to public
If compliance not achieved -
referred to TGA
TGA
Complaints about advertising of S4s to
public, advertising in other mediums & CRP
referrals
Limited compliance tools
to gain compliance
Industry bodies
Complaints generally about advertising to
health professionals & public “below the
line” ads
Can impose fines on members and require
other actions to be taken
Other bodies
Some government based – ACCC, ACMA,
state/territory government
Some self-regulatory - e.g. Advertising
Standards Bureau
Previous
complaints
handling model
1
3. Issues under previous scheme
• Prior to 1 July 2018, complaints were made to the Complaints Resolution Panel (CRP) or TGA.
• CRP could refer complaints to TGA outright or recommend TGA order an advertiser to comply with
the CRP’s findings
• Three possible outcomes of the recommendations:
– the advertiser agreed to comply and publish a retraction or correction (where required)
– TGA ordered the advertiser to take an action, such as withdraw an advertisement or publish a
retraction or correction (Reg. 9)
Only useful where advertiser was also product sponsor as the penalty for failure to comply was
removal of the product from the ARTG
– the complaint was closed
• Significant effort required over a long period to negotiate compliance, lack of enforcement powers
• Advertising remains available to consumers – avg 200 (approx.) days to CRP decision
• Only the details of the complaint were investigated
• Advertising Code subjective, limited focus on education and assurance 2
4. New complaints handling model
• Single complaints handling body
• Streamlined complaints handling processes
• New and enhanced sanctions and penaltiesTGA
• Pre-approvals cease 1 July 2020
• Support member compliance through
education
Industry and
other bodies
3
5. Our approach to handling complaints
• Consultation was conducted on how we should handle advertising complaints
• See ‘Complaints handling for the advertising of therapeutic goods to the Australian public’ on our
website
• Principles:
– We provide tools & education resources to advertisers to aid them in managing their compliance
– We focus our resources on alleged non-compliance that has the highest public safety risks
– We consider the perceptions of & impact on ‘reasonable consumer’ when assessing advertising
– Our compliance and enforcement actions are evidence-based and depend on the types of
behaviours identified, including demonstrated willingness of the advertiser to be compliant
– Our processes support consistent compliance and enforcement outcomes and provide clarity for
the public and advertisers about what is and what is not acceptable in advertising.
4
7. Categorising complaints
• We consider a range of factors, including:
– Whether reliance on the claims are likely to result in harm or injury
– Safe and appropriate use of the good for their intended purpose
– Action taken by the advertiser, willingness to comply with requirements, and
their awareness of their obligations
– Advertiser prior history and conduct
• Complaints within jurisdiction are categorised as Low, Medium, High or Critical
• Some may be outside our jurisdiction, and may be referred to another regulator
• An assessment may not identify any advertising non-compliance
6
9. Low
Risk Likely action
• One off or isolated non-compliance
• Low risk of harm
• Advertiser has not previously come to the
TGA’s attention
• Obligations letter with education material
Example: Advertisement promotes therapeutic goods in a manner that is misleading as to
their proper use or effect, but the product has low to no risk of harm, and the advertiser is
unaware their claim is in breach
Outcome published: Yes. However for reasons of natural justice, TGA reporting of closed
low matters will not specify the details of the advertiser or the goods involved because
the TGA has not investigated nor made a formal finding in relation to the advertising.
8
10. Medium
Risk Actions
• Ongoing advertising breaches, or where
an advertiser has been made aware of
their obligations in the past
• Advertisement encourages unnecessary
use
• Warning
• Directions notice
• Infringement notice
• Guidance
• Education and training
Example: Where a Schedule 3 medicine is being advertised to the public in a way that
encourages unnecessary use but there are no other public health concerns
Outcome published: Yes
Including the name of the advertiser and goods involved
9
11. High
Risk Activity
• Continued non-compliance despite evidence that
the advertiser is aware of their obligations
• Non compliance that is more serious in nature
and may include prohibited or restricted
representations
• Advertising likely to lead to excessive use, or
impact on the ability to use the therapeutic goods
safely, in line with intended use
• Infringement notice
• Substantiation notice
• Directions notice
• Cancellation or suspension of the goods
• Civil or criminal court action may be considered
Example: Where a reference is made to a serious medical condition where choosing the
product over conventional medical treatment may have a significant effect on the
consumer’s prognosis
Outcome published: Yes
Including the name of the advertiser and goods involved 10
12. Critical
Risk Activity
• Involves advertising of therapeutic goods that claim to treat
serious or very serious conditions that require
diagnosis/ongoing treatment from a medical practitioner
• Advertising to vulnerable or disadvantaged consumers
• Risk that use may result in or is likely to result in harm or injury
• Advertising may cause harm to a large group of consumers or
particular individuals
• Undermining public health campaigns
• Investigate with view to prosecution of a civil or criminal
penalties provision
• Directions notice
• Apply to Federal Court for injunction
• Publish a public warning notice
• Enforceable undertaking
• Cancellation or suspension of the goods
Example: Advertising a product for the treatment of cancer where the product has not
been evaluated by the TGA, or is a listed complementary or registered over the counter
medicine
Outcome published: Yes
Including the name of the advertiser and goods involved
11
14. What’s in our compliance toolkit?
Voluntary compliance
• Education program (further information about this later in the afternoon)
• Enquiry services
• Advertising pre-approvals remain until June 2020
Assisted compliance
• Obligations Notice – informs advertisers that their advertising may not be
compliant and advises them of their obligations
• Warning - informs advertisers that their advertising is non-compliant and advises
them of regulatory action that may be taken if they fail to respond/comply –
requires a written response
13
15. What’s in our compliance toolkit? (2)
Regulatory Compliance
• Substantiation Notice
• Directions Notice
• Cancellation or suspension of the therapeutic good from the ARTG
• Public Warning Notice
• Injunction from the Federal Court or Federal Circuit Court
• Infringement Notice
• Enforceable Undertaking
• Prosecution of a civil penalty provision
• Referral to the Commonwealth Director of Public Prosecutions for criminal prosecution
14
16. Enforcement discretion
• Pragmatic approach taken to non-compliance where a complaint is received after
1 January 2019 about an advertisement that would have been compliant with the
2015 Code.
January – June 2019 June – December 2019
The action taken (in the absence of
other non-compliance) will be a
reminder about the advertising
requirements of the 2018 Code.
We will seek information about what is
being done to correct the advertising,
including the date corrective action
commenced before determining
whether to apply enforcement
discretion.
15
17. Obligations letter
• For addressing low priority complaints
using an education based approach
• If you receive one:
– read it carefully
– assess your advertising for compliance
– get help if you need it
• The TGA will generally only issue this
letter to an advertiser once
• Future complaints are likely to be given a
higher priority
16
18. Warning
• Often used for addressing medium priority
complaints in the first instance
• If you receive one:
– read it carefully
– get help if you need it
– assess your advertising for compliance
– respond within the required timeframe
– address compliance issues ASAP
• Failure to address advertising issues may
result in escalating action
17
19. Substantiation notice – s.42DR
• Used to obtain further information for
management of the case
• For example to identify:
– the advertiser responsible, or
– whether the advertising claims are
substantiated
• If you receive one, read it carefully and
respond as outlined in the notice
• Failing to reply or providing false or
misleading information is an offence
18
20. Directions – s.42DKB & s.42DV
• Generally won’t be issued without prior contact with advertiser
• Used to direct an advertiser to:
– cease using a particular claim or advertisement
– issue a retraction or correction, and/or
– destroy the advertisement and recover any ads still in circulation
• If you receive one:
– read it carefully and consider how you will address the notice
– respond to the notice within the specified timeframe
• Failing to comply with a direction is an offence
19
21. Publication of Directions
The TGA has published one Direction:
• Advertising of Gumby Gumby capsules
• Advertiser complied with the direction to:
Cease making claims or representations for Gumby Gumby
capsules outright or in the form of testimonials that:
– They have or may have an effect on cancer of any sort, location or
grade
– They have or may have an effect on arthritis, chronic fatigue
syndrome, or skin diseases
– They have or may have any other therapeutic use whatsoever
while ever the capsules are not included in the Australia Register of
Therapeutic Goods (ARTG)
– You can or are able to arrange the supply of these therapeutic
goods which are not included in the ARTG and not excluded or
exempted from that requirement 20
23. Direction notice reviews
• Direction notice includes consequences of non-compliance and rights for
review
• Advertiser may request a review of the ‘initial’ decision to issue a direction
• The initial decision remains in effect unless and until it is revoked or
substituted by a new decision
22
24. Public warning notice – s.42DY
• TGA may publish a notice to alert consumers to a suspected contravention of the
advertising requirements
• Must be in the public interest
• Key consideration - is there an imminent need to inform consumers so they can
avoid suffering detriment from advertisements about therapeutic goods?
– an actual or a perceived risk to public health from advertising non-compliance
– advertising from persons who persistently or deliberately operate outside the
TGA regulatory scheme
• Can also be issued if a person fails to respond to a substantiation notice and it is
in the public interest to alert the public
23
26. Infringement notices – Part 5A-2 of the Act
• Infringement notices are administrative fines - an alternative to:
– criminal prosecution for a strict liability criminal offence, or
– litigation for contravention of a civil penalty provision.
• TGA can now issue infringement notices for non-compliance with
– the advertising requirements, and
– other requirements in the Act
(wherever there is a strict liability offence)
• TGA will publish the details of infringement notices issued
25
27. Impact of infringement notices on advertisers
• Amount for an infringement notice:
– 12 penalty units (individual) or 60 penalty units (company)
– multiple notices can be issued (e.g. for multiple contraventions)
• Payment of an infringement notice:
– pay by the due date to prevent further legal action
– does not amount to an admission or finding that the advertiser has
contravened the Act
• Advertiser still needs to make advertising compliant - further instances
of non-compliance may escalate regulatory or legal action
26
28. ACCC infringement notices
Two retailers of adjustable
beds and mobility
products pay $20,400
each in penalties
See https://www.accc.gov.au/media-release/two-retailers-of-adjustable-beds-and-
mobility-products-pay-20400-in-penalties 27
29. Cancellation/suspension from ARTG
• Once a therapeutic good is cancelled or suspended from the ARTG, it cannot be
supplied
• The TGA may cancel or suspend goods from the ARTG where the sponsor of
those goods:
– fails to ensure compliant advertising, and
– does not adequately respond to other regulatory tools (such as directions)
• Cancellation or suspension may also occur to address other compliance issues
• Cancellations and suspensions are published on the TGA website
• There are different provisions for cancellation and suspension depending on the
type of good
28
30. Act provisions for cancellation/suspension
Type of good Suspension Immediate
cancellation
Cancellation
with notice
Medicine/OTG s.29D ss.30(1) ss.30(2)
Biologicals s.32FA s.32GA s.32GC
Medical device s.41GA s.41GL s.41GN
• Advance notice of suspension of goods is generally given unless there is potential for
death, serious illness or injury as a result of the goods
• Failure of a sponsor to comply with an advertising direction notice is grounds for
immediate cancellation
29
32. Injunctions – Part 5-4 of the Act
• The Secretary can approach the Federal Court for an injunction to:
– restrain a person from contravening the legislation, or
– to compel compliance with the legislation
• The injunction may be permanent or interim
• The injunction may be pursued in conjunction with other enforcement actions (e.g.
civil penalties)
31
33. Enforceable undertakings – Part 5A-3
• When dealing with a matter about non-compliant advertising, TGA may accept an
offer from an advertiser to enter into a written undertaking as an alternative to
court action
• If the TGA accepts the undertaking, the advertiser would be bound by the terms
agreed to in the undertaking
• Terms of undertakings may include training requirements, compliance
requirements
• A breach of the terms can result in the matter being referred to the Federal Court
who can order the advertiser to comply with the undertaking, pay damages
• Details of undertakings are published on the TGA website
32
34. Criminal and civil penalties
• Can only be imposed by a Court
• Such action would not be a surprise to an advertiser:
– the TGA would have tried other avenues to achieve compliance first
• Court action may be taken against:
– a recipient of a substantiation notice that has not responded to the notice or has
provided false/misleading information in a response
– a recipient of a direction/infringement notice that doesn’t comply with the notice
– advertisers that promote goods in a way that raises public safety concerns
and/or has been unwilling to comply with previous compliance actions
• TGA will not publish details of matters proceeding to court until after final outcome
33
35. Key advertising offence provisions
Type of good Requirement Criminal offence Civil penalty
Medicines, OTGs Prohibits promotion of off-label use ss.22(2), (3) & (5) ss.21B(4)
Biologicals Prohibits promotion of off-label use ss.32BJ(2A)-(4) s.32BL
Medical devices Prohibits promotion of off-label use s.42ML s.41MLB
All Pre-approval offences s.42C N/A
All General advertising offences s.42DL s.42DLB
All Non-compliance with Code s.42DM s.42DMA
All Failing to comply with/misleading info
in reply to a substantiation
s.42DS s.42DT
All Failing to comply with direction notice s.42DW s.42DX
34
36. Three-tier criminal offence provisions
Tier Condition Penalty
1 the use of the goods in reliance on the
advertisement has resulted in, will result
in, or is likely to result in, harm or injury
to any person
imprisonment for 5 years or 4,000*
penalty units or both
2 harm not necessarily demonstrable but
intent evident
imprisonment for 12 months or
1,000* penalty units, or both
3 Strict liability (intent doesn’t need to be
demonstrated)
100*+ penalty units
* As at 1 July 2017, 1 penalty unit = $210. Offences by body corporates attracts 5x
multiplier on penalty units
+ Infringement notices are an alternative to strict liability offences 35
37. New civil penalty provisions for advertising
• Corresponding civil penalties added to complement most criminal
offences applying to advertising non-compliance
– 5,000 penalty units – individual
– 50,000 penalty units – body corporate
• Lower burden of proof than criminal offences
36
39. Cooperating with other regulators
• TGA works cooperatively with state/territory and other Commonwealth
regulators
• If we receive a complaint outside our jurisdiction, we will refer it on
– practice issues – AHPRA or state/territory government
– pricing and unconscionable conduct issues – ACCC or state/territory
government
– sole traders operating intra-state - state/territory government
• We will collaborate with other regulators to achieve a better outcome
38
40. Be contactable by the TGA
If you receive correspondence from the TGA, read it
Reply to TGA correspondence within specified timeframe
Have robust procedures in your business for dealing with
correspondence and checking advertising compliance
Address compliance issues expeditiously
Don’t wait for a complaint to collate supporting evidence for ads
Top 5 tips to prevent compliance action
39
41. Further information
• We provide a range of tools to assist advertisers and in managing their compliance,
including:
– E-learning modules
– Advertising hub: https://www.tga.gov.au/advertising-hub
– Fact sheets
– Webinars
– Roadshows
– Subscribe to TGA website updates
– Facebook, Twitter
– Contact:
advertising.education@tga.gov.au
40
The TGA reviews all the material considered by the Panel and provides the advertiser the opportunity to make a submission as to why an order under regulation 9 should not be issued. This material is considered with a fresh pair of eyes and an independent decision is made. This provides for the admin law principle of ‘procedural fairness’ (or natural justice).
Through this process the TGA is primarily seeking resolution of the advertising complaint by achieving compliance and assurances of ongoing compliance from the Advertiser. Ongoing compliance with the Panel’s requests is also examined
Having considered the Panel’s findings and where the advertiser is still non-compliant, the delegate may decide under regulation 9 to order to the advertiser to withdraw the advertisement and publish a retraction or corrective statement, where required.
The formal notice also draws the advertiser’s attention to the consequences of failing to comply with the Reg 9 order. This may also include cancellation of the good from the ARTG.
The Advertising Standards Board also has a place in the complaints handling model – generally complaints about taste, community standards etc
Where there has been a contravention of the advertising requirements, the Panel can request advertiser in writing to -
withdraw an advertisement
withdraw claim or representation
publish a retraction or corrective statement
Where requests are made by the Panel in relation to an advertising complaint, the advertiser is required to comply within 14 days as set out under regulation 42ZCAI.
If an advertiser fails to reply or indicate a willingness to fully comply (100%) or ignores the requests in the Panel’s determination, this usually results in the Panel making a recommendation to the Secretary of the Department of Health under regulation 42ZCAI(3) of the TG Regulations
Therefore, if you have a complaint before the CRP, it is in your company’s best interests to co-operate and actively participate in the process so that you have an opportunity to be heard. ‘Opting out’ of the proceedings is really not an option.
39 out of 119 (33%) determinations made in FY 14/15 were referred to the TGA (ie 67% of advertisers complied fully with the Panel’s requests
An unusual system – quite unlike other regulatory compliance activities undertaken at the Federal level
Focus on non-compliance rather than enhancing voluntary compliance
Limited focus on education and assurance
Lack of efficiency
Significant effort over a long period of time to resolve an advertising complaint
Limited powers to enforce
Perceptions of advertising may be nuanced. With multiple bodies handling complaints, there was capacity for like cases to be treated differently by different complaints handling bodies.
Most significant power was Reg. 9 re advertiser – publish a retraction or withdraw and advertisement. Limited deterrence impact where the advertiser is not the sponsor. There are plenty of other products that they may sell.
Where product is the sponsor there was a power to remove the product from the ARTG.
There is a very strong policy foundation for the new complaints handling model – the health and safety of Australian consumers is at the heart of this change
TGA is now the single complaints handling body
This allows for a more streamlined complaints handling process. Both complainants and advertisers only have to deal with one entity and provides clarity to both parties about how complaints will be handled
Allows for a consistent policy approach to be taken to the handling of complaints
Brings our complaints handling process into line with other commonwealth regulators.
Trend towards decisions by delegates, expert advice sought where required. Gives greater certainty as the process moves quicker
Provides greater policy consistency, ensures like cases are treated alike, procedural fairness
New and enhanced sanctions and penalties are available to the TGA to pursue non-compliant advertising, which allows us to better protect the health and safety of Australian consumers.
This also helps to provide a level playing field for industry – all advertisers of therapeutic goods are subject to the same rules, being applied consistently and with the TGA having sufficient compliance and enforcement tools to appropriately sanction those who intentionally flout the rules
To ensure procedural transparency, we have published our approach to complaints handling
Document titled “Complaints handling for the advertising of therapeutic goods to the Australian public” is available on our website through the Advertising Hub. This document is essentially a framework for how we deal with advertising complaints (I’ll refer to this as the framework)
It outlines the set of principles that we apply in addressing advertising non compliance.
Think of the complaint as a signal. We are not limited to dealing with just the subject matter complained of.
Initiate risk based action – we have a number of administrative and regulatory actions that we may undertake based on the way we have categorised the complaint
The framework sets out the sorts of things we will consider in categorising a complaint.
Each case will turn on its own facts, based on what evidence is provided by the complainant and what evidence we identify
We articulate key factors and provide some examples in the framework
There are some factors that are particularly important:
Whether reliance on the claims are likely to result in harm or injury
Safe and appropriate use of the good for their intended purpose
Action taken by the advertiser, willingness to comply with requirements, and their awareness of their obligations
Advertiser prior history and conduct
This pyramid is our “Risk based activity model”
Published in the Framework – something we will examine in more detail
What is critical to remember: WE ASSESS THE RISK – CATEGORISE THE COMPLAINT – CATEGORY DICTATES THE ACTION AVAILABLE TO US
This is what ensures that like cases are treated alike (within our regulatory powers).
The case categorisations operate as guidance for how we will treat a case. There is a sliding scale of risk. Some cases may sit on the cusp
Categorisation will be informed by whether the advertising is misleading as to the content or proper use or identification of the therapeutic goods. An example of this category includes promotion of therapeutic goods in a manner that is misleading as to their proper use, but where the product is ineffectual in its use for a minor or self-limiting condition and therefore highly unlikely to cause harm.
Imagine a new multivitamin company – producing vitamin C products – claiming that the product is TGA approved. Only product they manufacture and advertise. Not come to the attention of the TGA before.
Dosage information is accurate. Claims are not misleading. Breach of the code but unlikely to pose a risk to consumer health and safety.
Will be categorised as low.
Advertiser is sent a letter, but not required to respond.
Can refute letter content if they wish to.
No adverse finding
These outcomes are not published. They are not published because they have not been investigated. No adverse finding is made. Not adverse action taken.
Categorisation will be informed by the likelihood of the advertisement encouraging excessive or inappropriate use of the therapeutic good being advertised, the type of therapeutic good and the condition the product purports to treat. Examples include where a Schedule 3 (pharmacist-only medicine) is being advertised to the public in a way that encourages unnecessary or excessive use.
Medium cases usually involve advertisers who have previously come to our attention through their conduct.
They may have received an obligations letter, and failed to rectify the advertising issue that it identified and we receive later complaints that signal to us to that the advertiser remains non-compliant
EG1. Our new vitamin C company – we have engaged with them, sent them a letter reminding them of their obligations, maybe we have advised them over the phone about their advertising breach. We receive a subsequent complaint about their facebook page, stating that the product is TGA approved.
EG2 – We see a fairly large number of cases where advertisers are targeting consumers who are often termed “the worried well”. Higher dosage forms of Vit D are schedule 3. A complaint about Vit D that included images where a consumer is pictured engaging in a range of outdoor/sun worshipping activities. This would may encourage unnecessary use, by a person whose lifestyle factors make it unlikely that they would be suffering a vit d deficiency (and where they had not sought advice from their doctor).
PUBLICATION
High category cases include alleged non-compliance that we consider more serious in nature such as advertising containing prohibited or restricted representations around the indications (conditions) that the product is claimed to treat or manage. This category could also include advertising that is likely to lead to excessive use, or impact on the ability of consumers to use the therapeutic goods safely or appropriately in line with the good’s intended therapeutic use.
These types of cases might involve continued non-compliance despite the TGA taking time to ensure that the advertiser is aware of their obligations
Or, the advertising may involve the unapproved use of restricted or prohibited representations.
I.e. a complementary medicine making claims that it assists in the treatment of a form of type 2 diabetes, leading that consumer to use the product rather than seek conventional medical treatment.
Treats plantar faciitis (and does not include the statement ‘medically diagnosed’)
PUBLISHED
This categorisation may also be assigned to advertising clearly directed to vulnerable or disadvantaged consumers with a risk that use may result in or is likely to result in harm or injury due to reliance on the claims made or because of the indications advertised. It may also be assigned where the advertising may cause harm or injury to a large group of consumers, or particular individuals.
These are the most serious cases – cases requiring urgent attention.
Sometimes they involve events where there is a time critical element. I.e. handing out of samples to a large group of consumers where there is no due diligence on their health concerns, the population may include children, the elderly.
PUBLISHED
Voluntary compliance – these are the advertisers who want to comply.
We want to help advertisers who want to comply to do so. The bulk of advertisers fit within this category.
This is why we are rolling out an advertising roadshow (and participating in a range of industry events)
Further events are planned until December. Further events to support embedding the new code are planned. Keep an eye on our website
Assisted compliance – where advertisers may be unaware of, or fail to understand how to comply with the advertising requirements, we inform and/or warn them of the consequences of failing to comply.
Regulatory compliance
Where we use the powers provided in the Act to ensure compliance. Large list of tools at our disposal to ensure advertiser compliance in more serious cases.
Compliance assurance
We undertake a compliance assurance program to ensure that advertisers who come to our attention maintain their compliance.
Advertisers are working hard to update systems and processes
For some companies, it the internal approval process goes through strong governance processes
Stakeholders have queried what action we will take in relation to advertising that complies with the 2015 Code but not the 2018 Code, particularly around the prominent display of mandatory information (such as health warnings)
PRE APPROVAL – any ad pre-approved based on the 2015 Code – any complaints will be considered against the 2015 Code.
COPY of this available on the website
42DKB Certain representations not to be advertised
(1) If a representation in an advertisement about therapeutic goods is false or misleading, the Secretary may, by notice given to a person apparently responsible for:
(a) advertising the therapeutic goods; or
(b) causing the advertising of the therapeutic goods;
prevent that person from advertising the therapeutic goods, or causing the advertising of the therapeutic goods, in circumstances where the advertisement contains that representation (whether in express terms or by necessary implication)
42DV Directions about advertisements or generic information
Advertisements
(1) If, in relation to the advertising of therapeutic goods, the Secretary is satisfied that there has been a contravention of this Act or the regulations, the Secretary may, in writing, direct a person apparently responsible for advertising the therapeutic goods, or for causing the advertising of the therapeutic goods, to do one or more of the following:
(a) cease the advertisement;
(b) make a retraction;
(c) make a correction;
(d) recover any advertisement that is still in circulation;
(e) destroy the advertisement;
(f) cease making a particular claim or representation made by the advertisement.
Generic information
(2) If, in relation to the dissemination of generic information about therapeutic goods to the public or a section of the public, the Secretary is satisfied that there has been a contravention of this Act or the regulations, the Secretary may, in writing, direct a person apparently responsible for the dissemination, or for causing the dissemination, to do one or more of the following:
(a) withdraw the generic information;
(b) make a retraction;
(c) make a correction;
(d) recover any generic information that is still in circulation;
(e) destroy the generic information;
cease making a particular claim or representation made by the generic information.
Conditions
(3) A direction under subsection (1) or (2) may be subject to conditions specified in the direction.
(4) Without limiting subsection (3), the conditions may relate to one or more of the following:
(a) the period for doing a thing the subject of the direction;
(b) in relation to the making of a retraction or correction, either or both of the following:
(i) the form and manner of the retraction or correction;
(ii) the period for which the retraction or correction must be made publicly available;
(c) the reporting to the Secretary of compliance with the direction.
The delegate making a direction MUST publish it
Directions are published in the Regulatory decisions and announcements section of the advertising hub
This is an example of a retraction ordered under the previous complaints handling arrangement for Invisible Zinc advertising.
Retractions under the new complaints system won’t be identical to this but there will be similarities – e.g. prominence
A direction is an “initial decision” under the TG legislation. Advertisers may request a review of the decision under section 60 of the Act
The decision remains in effect unless it is revoked by the Minister of their delegate as a result of a review under section 60, is set aside, varied or remitted by the Administrative Appeals Tribunal or is otherwise overturned by a court.
Where the advertiser fails to comply with the direction, there are a range of other regulatory tools that may be used to achieve compliance, including:
issuing a notice under s.30 (medicine) or s.41GN (devices) of the Act, proposing to cancel the registration and / or listing of the goods from the ARTG making further supply of the product unlawful
Infringement notices
Court proceedings to pursue civil or criminal action
Past experience has shown that it is generally only the minority of sponsors who end up with a direction/order, which is a direct result of their own business decisions.
A public warning notice may be issued if the TGA reasonably suspects non-compliant advertising or dissemination of generic information about therapeutic goods to the public or a section of the public and is satisfied it is in the public interest to issue that notice. A public warning notice may also be issued if a person who has been given a substantiation notice fails to comply with it and the TGA is satisfied that it is in the public interest to do so. An example includes where the advertiser fails to provide evidence in response to a substantiation notice, in circumstances where there is a public safety risk, a public warning notice may be issued.
EG – ADVERTISING ABOUT THE USE OF HUMAN PLACENTA INJESTION
There is currently no evidence to support the claims of health benefits associated with consuming human placenta, and the broader risks are unknown.
Human placenta is a biological material and is capable of containing and transmitting infectious agents, including bacteria and viruses. In addition, preparation may inadvertently introduce infectious agents. The risk of transmission may be even greater if your placenta is ingested by another person or you ingest another person's placenta.
This is an example of a consumer alert that was issued before the a specific power was added to the Act to enable
It provides an example of how public warning notices might look
The ACCC also issue similar alerts
An infringement notice may be issued where a person has, within 12 months contravened a strict liability offence or civil penalty provision of the Act. The person can choose to pay an amount to the Commonwealth as an alternative to having court proceedings brought against them in relation to the contravention.
1 penalty unit = 210 = 12600 for a company.
Can issue multiple. Adds up quickly.
The ACCC has (following TGA intervention) issued two infringement notices to retailers of adjustable beds as they made false or misleading representations about their adjustable beds and associated mobility equipment. Each paid $20,400 in penalties.
One of the retailers used the Commonwealth Coat of Arms accompanied by the words “Australian Government”, “Department of Health and Ageing” and “Therapeutic Goods Administration”. The words “TGA Approved products” were used elsewhere in the brochures. The other retailer claimed that their products had been awarded a certificate by the TGA.
The ACCC considered that the materials represented that the goods were sponsored or approved by the TGA, when this was not the case. Such false representations can mislead elderly or other vulnerable consumers when they are choosing to make what can be very significant purchases.
We may Cancel or Suspend the relevant therapeutic goods from the ARTG.
SensaSlim was cancelled from the ARTG from 1 December 2011 for failing to comply with advertising requirements following a review of the product by the (then) Office of Complementary Medicines.
This is one of the more interesting cases that the TGA has worked on. The product was said to help people lose weight without any change in diet or exercise.
The Complaints Resolution Panel received a number of complaints in 2011 about the product and the TGA also became involved in the matter.
The SensaSlim Solution Business model was problematic:
Involved Peter Foster (commonly described in the media as a ‘conman’ that has been jailed on 3 different continents).
Financed by “underworld” figure Mick Gatto.
used a non-existent Swiss research institute and non-existent research to back claims.
Retirees targeted to purchase $60,000 franchises but being ripped off.
Peter Foster, after a year on the run, was eventually arrested at Byron Bay and served a year in jail for a contempt charge relating to SensaSlim. In May 2016, Peter Foster was also fined $660,000.00 for his role in SensaSlim and permanently banned from being a company director or having any business in the diet or health industry.
The TGA may seek an injunction in the Federal Court or Federal Circuit Court to stop or prevent a person from contravening the Act or compel a person to comply with the Act. An example of the circumstances where the TGA would seek an injunction is where advertising is planned for a defined event (e.g. a promotion at a particular major rock concert), there is a risk to public health and safety posed and it is time critical.
An advertiser may choose to give an enforceable undertaking, a promise able to be enforced by a court. An example includes where the advertiser undertakes to establish, review or improve their advertising processes to be compliant with the requirements in the Act and to make regular reports to the TGA for the period of the undertaking.
The TGA may commence prosecution of a civil penalty provision. This can result in large fines being imposed and recovered. The most serious matters may be referred to the Commonwealth Director of Public Prosecutions for criminal prosecution of offences under the Act.
Not an exhaustive list of advertising related criminal offences (e.g. claiming to be able to supply provisions omitted).
This is an example of how a civil court action can turn out.
In March 2015, the ACCC brought a case in the Federal Court of Australia against Reckitt Benckiser Pty Ltd, the sponsor of Nurofen products, alleging it misled customers over claims its range of Nurofen “specific pain” products were each formulated to treat a specific kind of pain despite containing the same active ingredient (ibuprofen lysine 342mg). They are the same formulation, and have the same approved indications included on the ARTG. There are four products in the range: Nurofen Back Pain, Nurofen Period Pain, Nurofen Migraine Pain and Nurofen Tension Headache.
On 11 December 2015, the Federal Court declared by consent that Reckitt Benckiser’s conduct was, or was likely to be, misleading to consumers by claiming on the packaging and on its website that each product in the Nurofen "specific pain" range of products was specifically formulated to treat, and solely or specifically treated, the particular type of pain specified on the product packaging. As such, each product is equally effective as the others in the range in treating the types of pain described on the packaging.
The Federal Court ordered Reckitt Benckiser to cease any further distribution and sale of all Nurofen “specific pain” range products with this packaging within 4 weeks of the order, and to remove the products from retail shelves within 3 months.
The Court also ordered that Reckitt Benckiser publish website and newspaper corrective notices, implement a consumer protection compliance program, and pay the ACCC’s court costs. A hearing to resolve pecuniary penalties resulted in a $1.7 million fine, however, on 23 May 2016, the ACCC announced that they would be appealing this penalty as too lenient given the sales of 5.9 million units of the products. In December 2016, the Federal Court increased the fine to $6 million.
I’ve also listed the TGA’s Twitter handle. The TGA tweets summaries and links to website information on recalls, safety alerts, medicine shortages, consultations and information for new sponsors (including advertising aspects).
Before I ask for questions, I’ve included the email address for the Advertising Education on the slide if you have any questions in the future.