Therapeutic goods failures and the Rule of Law
Department of Health did not have the information requested.
From: B Bear
The Hon Susan Ley
Minister for Health MP
Dear Ms Ley and the Department of Health,
I am writing to you under the Freedom of Information Act 1982.
I want to know how many individuals have been injured by failed devices, such as hip replacements, which come under the TGA
AND the subsequent estimated cost to the Australian community through Medicare, Private Funds and Centrelink (disability payments) for replacing and repairing the damage to the individual which is caused by the failed device.
Goods which fail and injure people and which come under the Therapeutic Goods Act, provide no consumer protections for those injured by those goods. The Rule of Law: http://www.ruleoflaw.org.au/principles/, under which Australia's democracy should function, states that law shall be applied equally and fairly.Therefore those injured are unequally and unfairly treated by the consequences of this law.
From: TGA FOI
Dear Mr Bear,
I refer to your FOI request of 20 March 2016 to the Department of Health
Section 15 of the FOI Act requires that a request for documents meets
certain requirements. Your request, in its current form, does not
constitute a valid request. Please note that the Act provides for access
to documents and not to 'information'. In order for your request to be
processed under the provisions of the FOI Act you must provide us with
further information to enable us to identify the document or documents you
Please note that adverse event data can be accessed on the TGA website at
the following address
www.tga.gov.au/database-adverse-event-notifications-daen. All other
information sought in your request is not held by the TGA.
Please don't hesitate to contact our team should you have any further
Freedom of Information
Reporting & Collaborative Services Section
Regulatory Engagement & Planning Branch
Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [email address]