Dear Minister Skinner,
Instead of being compulsorily required to wear a bicycle helmet, I do believe that my informed consent ought to be sought for the wearing of one which in and of itself fits the parameters of a medical device set out in Section 41BD(1)(a)(iii) in that a bicycle helmet contributes to modification of the anatomy.
However somewhat expediently, subsection 3 and section 7 mentioned within section 41BD grant special powers to the relevant minister who need not have any medical and/or biomechanical expertise but may declare in a specially devised political publication that certain medical devices are not medical devices.
I have included the relevant sections of the
Thereapeutic Goods Act 1989 (Cth) notwithstanding that they are easily available to you.
=========================================
Therapeutic Goods Act 1989 (Cth)
41BD What is a medical device
(1) A medical device is:
(a) any instrument, apparatus, appliance, material or other article (whether used alone or in combination, and including the software necessary for its proper application) intended, by the person under whose name it is or is to be supplied, to be used for human beings for the purpose of one or more of the following:
(i) diagnosis, prevention, monitoring, treatment or alleviation of disease;
(ii) diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability;
(iii) investigation, replacement or modification of the anatomy or of a physiological process;
(iv) control of conception;
and that does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but that may be assisted in its function by such means; or
(aa) any instrument, apparatus, appliance, material or other article specified under subsection (2A); or
(ab) any instrument, apparatus, appliance, material or other article that is included in a class of instruments, apparatus, appliances, materials or other articles specified under subsection (2B); or
(b) an accessory to an instrument, apparatus, appliance, material or other article covered by paragraph (a), (aa) or (ab).
Note: Declarations under subsection (3) exclude articles from the scope of this definition. Declarations under section 7 can also have this effect: see subsection 7(4).
=========================================
see below for subsection (3) and section (7)
subsection(3) The Secretary may, by order published in the Gazette, declare that a particular instrument, apparatus, appliance, material or other article, or that a particular class of instruments, apparatus, appliances, materials or other articles, are not, for the purposes of this Act, medical devices.
Note: A declaration under this section does not stop articles from being therapeutic goods.
section (7) Declaration that goods are/are not therapeutic goods
(1) Where the Secretary is satisfied that particular goods or classes of goods:
(a) are or are not therapeutic goods; or
(b) when used, advertised, or presented for supply in a particular way, are or are not therapeutic goods;
the Secretary may, by order published in the Gazette, declare that the goods, or the goods when used, advertised, or presented for supply in that way, are or are not, for the purposes of this Act, therapeutic goods.
(1A) In deciding whether particular goods or classes of goods:
(a) are therapeutic goods; or
(b) when used, advertised, or presented for supply in a particular way, are therapeutic goods;
the Secretary must disregard paragraphs (e) and (f) of the definition of therapeutic goods in subsection 3(1).
(2) The Secretary may exercise his or her powers under this section of his or her own motion or following an application made in writing to the Secretary.
(3) A declaration under this section takes effect on the day on which the declaration is published in the Gazette or on such later day as is specified in the order.
(4) If a declaration under this section:
(a) is a declaration that particular goods or classes of goods are not therapeutic goods; and
(b) applies wholly or partly to goods that, apart from this section, would be medical devices;
the goods are not medical devices, or are not medical devices when used, advertised, or presented for supply in the way specified in the declaration.
=========================================
How can an ordinary individual, albeit an elected politician, have powers bestowed upon him or her to declare that a medical device is not a medical device without the necessary knowledge to be considered an expert in this field?
I would like your thoughts on this question please because it is an area I intend to explore.
Yours sincerely,
Sue Abbott
Freedom Cyclist
