Category Archives: Medicine policy

TGA Consultation Submissions: Regulatory reform of complementary medicines and advertising

The regulatory framework for advertising therapeutic goods Reforms to the regulatory framework for complementary medicines – assessment pathways Options for the future regulation of “low-risk” products Draft List of Permitted Indications Therapeutic Goods Advertising Code See also: Australian patients vulnerable … Continue reading

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Concerns about the Exposure Draft of Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017

See the paper: “Concerns about the Exposure Draft of Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017” See also submissions to TGA Consultations on “regulatory reform”     by

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Letter to The Age 02/10/2017: Heed evidence

Consumer Affairs Victoria ordered Penguin to provide a “prominent warning” on all future books they publish about natural therapies (“Shining a spotlight on the self-help industry”, The Age, 30/9), explaining that the claims made are not evidence-based. A similar disclaimer … Continue reading

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Seminar Program, Papers and Presentations: The Advertising of Therapeutic Goods and Services (and its regulation)

Seminar program Papers Ken Harvey. Seminar Background Paper Sitesh Bhojani and Jodie Valadon. The multi-regulator model for Australian Consumer Law: effective or useless? Paul Lacaze & Jane Tiller. Online Direct-To-Consumer Genetic Testing in Australia: Concerns, Regulation and Recommendations Presentations delivered … Continue reading

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New TGA consultations relevant to Sept 8, 2017 Seminar

There were two new additions to the TGA web site yesterday that are relevant to next Friday’s seminar: Consultation on exposure draft Bills amending the Therapeutic Goods Act 1989 and the Therapeutic Goods (Charges) Act 1989. Closing date: 9am, 5 September 2017. Therapeutic … Continue reading

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Garvan Institute $6,400 genetic test

https://www.garvan.org.au/genome-one-news-australia2019s-first-whole-genome-and-health-assessment-service-to-provide-an-unprecedented-insight-into-our-current-and-future-health The Garvan Institute’s Sydney based Genome.One lab has launched a new ‘whole genome sequencing’ test which is claimed to provide genetic insight into a person’s propensity to develop a range of serious diseases including heart conditions and cancer. Costing … Continue reading

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Monash University SPHPM “Whack-a-mole” project 2017

Overview: The aim is to provide students with practical experience of the role of regulators in protecting the public from false and misleading therapeutic claims by product sponsors and health practitioners. Why “Whack-a-mole”: Because, given deficiencies in the current regulatory system, … Continue reading

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Order of Australia Honour

MEMBER (AM) IN THE GENERAL DIVISION OF THE ORDER OF AUSTRALIA Associate Professor Kenneth John HARVEY, Melbourne VIC 3004 For significant service to community health and the pharmaceutical industry through roles in developing guidelines for the ethical use of antibiotics. See … Continue reading

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Seminar: The Advertising of Therapeutic Goods and Services (and its regulation), Sept 8, 2017

In March 2016, a seminar on this topic attracted over 100 people to the Sydney University Health Law Centre. One outcome was a decision to hold a follow-up seminar in Melbourne in Sept-Oct 2017. The 2017 seminar is being organised … Continue reading

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HAIAP-PHM ISC Meeting, Bangladesh, 15-16 May 2017

Members of the HAIAP-PHM International Steering Committee (ISC) met at Gonoshasthaya PHA, Savar, Bangladesh during May 15-16, 2017 to discuss the planning and agenda of the proposed November meeting. Not all members of the ISC could attend due to problems … Continue reading

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