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Photo credit: Nancy Steward, Next Bikes in Berlin |
Dear Melinda,
I would like an exemption from wearing a bicycle helmet and here are the reasons why:
The provisions of regulation 256 state that:
(1) The rider of a bicycle must wear an approved bicycle helmet securely fitted and fastened on the rider’s head, unless the rider is exempt from wearing a bicycle helmet under another law of this jurisdiction.
I believe that the Therapeutic Goods Act 1989 supports my case for an exemption in that a bicycle helmet can be classified as a medical device meaning I need to provide informed consent or informed refusal before I adopt such a device or not.
The Therapeutic Goods Act 1989 is Federal legislation and therefore has jurisdiction over all state laws.
Inter alia section 41 BD (1) (a) ofthe Therapeutic Goods Act 1989 provides that:
(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;
(iii) investigation, replacement or modification of the anatomy or of a physiological process;
A bicycle helmet is an ‘apparatus’ that is used by ‘human beings’ for the purpose of ‘modification of the anatomy’ ostensibly to provide protection on Australian roads.
However section 41 BD (3) of the Therapeutic Goods Act 1989 provides that:
3) The Secretary may, by order published in the Gazette or on the Department's website, 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.
… though interestingly it is noted under sub-section (3) of the Therapeutic Goods Act 1989 that: A declaration under this section does not stop articles from being therapeutic goods.
Notwithstanding the note, the Therapeutic Goods (Excluded Goods) Order No.1 of 2011 specifically excludes non-sterile protective or safety apparel or equipment used in the home or for occupational or recreational use from regulation by the Therapeutic Goods Act 1989.
It would appear that bicycle helmets could be captured by this exclusion but only contingent with the dictated circumstances set out in Therapeutic Goods (Excluded Goods) Order No.1 of 2011.
I do not use a bicycle helmet in the home or for occupational use or recreational use because I do not use a bicycle in the home or for occupational use or recreational use. I only use a bicycle for transit purposes. ‘Non-sterile protective or safety apparel or equipment’ for this type of behaviour is not prescribed in the Therapeutic Goods (Excluded Goods) Order No.1 of 2011.
Prima facie a bicycle helmet in my circumstances is a medical device and not an excluded good, and therefore requires my informed consent or informed refusal with regard to whether I wear one or not.
Therefore the reason that you will accept that I should be granted an exemption to wearing a bicycle helmet is because section 41 BD (1)(a)(iii) of the Therapeutic Goods Act 1989 defines a bicycle helmet as a medical device, and also because of the way I use a bicycle cannot exclude a bicycle helmet from regulation by the Therapeutic Goods Act 1989 under the Therapeutic Goods (Excluded Goods) Order No.1 of 2011.
Using a bicycle for transit allows a bicycle helmet to come under the provisions of the Therapeutic Goods Act 1989 and therefore can be defined as a medical device.
To conclude whilst regulation 256 of the NSW Road Rules 2014 provides that the rider of a bicycle must wear an approved bicycle helmet securely fitted and fastened on the rider’s head, unless the rider is exempt from wearing a bicycle helmet under another law of this jurisdiction, in my interpretation of the law the Therapeutic Goods Act 1989 provides me with reasons for exemption from wearing a bicycle helmet.
Melinda, I have to say this is all so daft - I have a trial in Adelaide next Monday 17 July for bicycle helmet crime followed by two further bicycle helmet crime matters rolled into one in the Scone Local Court. I could end up with three more criminal convictions which will make a total of seven criminal convictions for the Australian crime of riding a bicycle without a helmet.
We are outliers in the world on this issue, and rapidly becoming outliers on many other issues too. The world is not impressed with us what with air pollution that breaches World Health Organisation standards, the prospect of Adani coal mine going ahead, the death of the Great Barrier Reef , motor vehicle traffic toll, obesity, inactivity. Yet for all this I am the one who is consistently punished for my very innocuous transport habits.
This particular request is about an exemption for me and I need an answer to that query.
When I wrote to you earlier this year asking for this, I received a very obtuse reply from your department stating and quoting the usual guff provided by the usual guff-producing academics that Australia so loves to engage with ... but nothing pertaining to the actual issue in hand which was 'can I have an exemption please?'
I rang your department and raised this issue with them, and was informed that the inference would have been that I did not get one. Notwithstanding I pointed out to your staff that there was nowhere in the letter that actually spelt that premise out. Once again I was informed by your staff that the presumption was I did not get one but yet again I pointed out there was no one part of the letter where either of us could see where the presumption might be at play and given that the bicycle helmet punitive system is so precise I actually do want it spelt out. The conversation finished with your staff member saying that they would hopefully get back to me the next day (I so wanted to say 'hopefully doth butter no parsnips' in true
Joe Lycett style but resisted the temptation).
Anyway that is several months ago now and in the meantime I have been cycling around the world sans helmet: London, Dublin, Paris, Torbole, Arco, Rive Del Garda, Berlin, and I might add Scone as well since I got home - the world has been mine and any available bicycle's oyster.
Please, Melinda, grant me an exemption so that I can tell Australian courts starting from next Monday what they would really like to hear.
Kind regards,
Sue Abbott (Scone)