5. Legal concerns
In the future there may be consumer products
which require implantation of non‑therapeutic
BCIs involving a medical procedure (e.g. surgery to
insert an implant into the brain). This will require
a surgeon to obtain informed consent regarding
the procedure to insert the device, but not the
operation and terms and conditions relating to
the device once it has been implanted. In these
circumstances consumers will need to be aware of
key issues in deciding to implant a device – including
service life, the availability of spare parts, changes
in company ownership, retention, ownership and
security of neural data and what will happen if
the company responsible for the device has been
deregistered. Significant decisions, such as this,
ought not be left to template consumer‑oriented
contracts with fine print terms.
Medical regulation
There are already medical/therapeutic regulations
which could usefully be applied to the development,
testing and use of neurotechnologies in medical
applications.
In Australia the Therapeutic Goods Act 1989 (Cth)
governs products defined as therapeutic goods,
which can include medicines, medical devices and
biologicals in Australia. The Therapeutic Goods
Regulations 2002 (Cth) intend to regulate medical
devices from the perspective of the physical safety
of a user. The Therapeutic Goods Administration
(TGA) is the authority responsible for evaluating,
assessing and monitoring products that are defined
as therapeutic goods. The TGA regulate medicines,
medical devices and biologicals to help Australians
stay healthy and safe.234
It is possible that many neurotechnologies will start
as medical products which hopefully fall within
the ambit of Australia’s medical regulations laws.
However, questions remain about what happens
which such products are pivoted away from medical
applications to consumer markets (where less
protection exists).
There certainly appears to be a regulatory gap
between the protections applied to medical and
consumer neurotechnological products which must
be addressed.
Australian Consumer Law
The Australian Consumer Law (ACL) is contained
in schedule 2 of the Competition and Consumer
Act 2010 (Cth) and will likely apply to consumer
neurotechnologies not otherwise captured by
specialist product safety regimes that regulate
medical devices and therapeutic goods.
Certain protections of the ACL are only applicable
to conduct in respect of ‘consumers’.235 Where
an individual purchases neurotechnological
product they may meet the statutory definition of
‘consumer’ provided the price of which is less than
$100,000 AUD.236
The ACL includes consumer guarantees which
are basic rights that businesses must meet when
they sell products or services. These basic rights
include ensuring a product sold to a consumer is of
acceptable quality and fit for purpose.237
Acceptable quality means that a neurotechnological
product:
is safe, durable and free from defects
has an acceptable appearance and finish
does everything that similar products are
commonly used for.238
However there are no set rules for deciding whether
a neurotechnological product is of acceptable
quality, or how long it should last.
To determine if a neurotechnological product meets
acceptable quality, the following factors need to be
considered:
What kind of product is it, and how does it
compare to similar products?
What is it made of and how was it made, and how
does this compare to similar products?
How much did it cost, and how does it compare
to products of a similar price?
What maintenance may be needed to keep the
product operating?
Did the business or manufacturer make any
claims about quality, or how long the product
could last for?
Did the business warn the consumer about any
defects, or warn against the product’s use in a
certain manner?
Australian Human Rights Commission
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