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POISONS AMENDMENT REGULATION 2007 (NO 1) (NO 33 OF 2007)
THE LEGISLATIVE ASSEMBLY FOR
THE
AUSTRALIAN CAPITAL TERRITORY
POISONS
AMENDMENT REGULATION 2007 (No
1)
SL2007-33
EXPLANATORY
STATEMENT
Acting Minister for Health
POISONS AMENDMENT REGULATION 2007 (No 1)
Pseudoephedrine-based products are legally available over the counter in
pharmacies for the treatment of ailments such as colds and flu. However, a
significant and growing problem within Australia is the diversion of
pseudoephedrine for illegal manufacture into methamphetamines, such as
‘speed’ and ‘ice’. Pseudoephedrine is the key chemical
ingredient in the manufacture of methamphetamine.
Large quantities of
Pseudoephedrine-based products are needed for use in the illegal manufacture of
methamphetamines. As the purchase of large quantities from a single source is
of itself naturally suspicious and likely to be reported to law enforcement
authorities, a practice referred to as “pseudo running” has
resulted. “Pseudo runners” travel from pharmacy to pharmacy
accumulating enough pseudoephedrine-based products to manufacture a significant
quantity of methamphetamines. By spreading out purchases, the volume of
pseudoephedrine-based products being purchased by a single individual becomes
extremely difficult to detect.
In response to the growing trend of
“pseudo running” the Poisons Amendment Regulation 2007 (No 1) (the
Regulation) has been developed to require ACT pharmacists to record sales of
psuedoephedrine which will be accessible by law enforcement agencies to identify
and track suspicious sales.
In addition to imposing this requirement on
pharmacists, the Regulation will also give pharmacists the legal authority to
request and record personal information, and to refuse sales of pseudoephedrine
where required information is not provided. The provisions being inserted into
the Poisons Regulation 1933 also specifically enable members of the public
to access records relating to them, and to request corrections if necessary.
This is supported by a review mechanism should the pharmacy that created the
record refuse to change a record as requested by a member of the public. The
review mechanism created empowers the Chief Health Officer to consider written
positions from both the buyer and the seller, and to direct alterations to the
record if the Chief Health Officer considers it appropriate to do so.
A detailed explanation of each clause of the Regulation follows.
The first section of the Regulation specifies that the name of the regulation
is the Poisons Amendment Regulation 2007 (No 1). The Regulation amends the
Poisons Regulation 1933, which is subordinate law to the Poisons
Act 1933.
This section establishes that the Regulation commences on 2 October 2007.
This provision alerts the reader that this Regulation amends the Poisons
Regulation 1933. Accordingly, upon commencement this Regulation will alter
the Poisons Regulation 1933 in accordance with the provisions this
Regulation contains, and will then be immediately repealed. Consequentially, on
the date that this Regulation commences a new republication of the Poisons
Regulation 1993 will operate that contains the alterations made by this
Regulation.
Prior to commencement of this Regulation, section 2 of the Poisons
Regulation 1933 contained definitions for the Poisons Regulation 1933.
This provision replaces that provision with a new section 2 about the
operation of the Dictionary, and also inserts a section 3 into the Poisons
Regulation 1933.
The replacement section 2 of the Poisons
Regulation 1933 alerts the reader that the dictionary at the end of the
Regulation forms part of the Regulation. Generally a definition of a word or
phrase that appears in the dictionary applies throughout the Regulation.
However, this is not the case if the dictionary definition limits the meaning to
a specific section or part, or if a different meaning is specifically provided
for within a section. Sections 155 and 156(1) of the Legislation
Act 2001 provide additional instruction on the application of
dictionaries and definitions within legislation.
It is important to note
that the Dictionary, to which the replacement section 2 refers, is inserted
into the Poisons Regulation 1933 by Clause 6 of this Regulation.
Furthermore, the content of the previous section 2, definitions of
prescriber and recipient for the purposes of the Poisons
Regulation 1933 are included in the new Dictionary created by
clause 6.
This clause also inserts a section 3 into the Poisons
Regulation 1933, which prior to this Regulation did not contain a
section 3. The new section 3 informs the reader that notes appearing
in the Regulation are explanatory only, and do not form part of the Regulation.
Section 127 of the Legislation Act 2001 provides additional
instruction on material that does not form part of Acts or legislative
instruments, such as notes.
Clause 5 inserts into the Poisons Regulation 1933 new
sections 5A through to 5E.
New section 5A
New
section 5A applies if a seller proposes to sell, by retail, pseudoephedrine
to a customer, referred to within the sections as the buyer. The section
requires that before a sale can proceed the seller must inform the buyer of
certain information. Under section 5A the buyer must be informed that the
seller is required to make a record of the sale, and that if the buyer refuses
to or cannot provide the required information, the seller cannot sell the
customer pseudoephedrine. This requirement ensures that the customer knows that
the seller is legally obligated to make a record and legally obligated not to
sell pseudoephedrine unless the record is made.
Additionally, the
customer must be informed that the record may be made available to a limited
group of people, primarily law police officers, other pharmacists and the Chief
Health Officer and his staff. Additionally, a customer must be informed that
the Pharmacy Guild of Australia may also have access to the information
recorded.
The Pharmacy Guild of Australia developed and administers the
Project STOP database. Project STOP is a tool that pharmacies can elect to use
to record sales of pseudoephedrine. However, a seller does not need to utilise
the Project STOP system to comply with the requirements of this Regulation.
Furthermore, this Regulation should not be read in such a way as to infer that
it obligates or encourages the use of the Project STOP system. It is up to
individual sellers to determine how best to comply with the requirements of this
Regulation.
By informing the customer of these matters the customer is
made aware of the reason behind the record being made, and also assured that the
record cannot be used by any other persons or for any other reason. Finally,
under section 5A, the customer must be advised that they have the right to
access the record and have any mistake corrected.
A failure to inform
the buyer of any of the matters contained within section 5A at the time of
sale constitutes an offence. The offence applies if a person sells
pseudoephedrine by retail and prior to the sale the person fails to inform the
buyer of the matters in subsection 5A(2). Accordingly, a seller who
wilfully chooses not to inform the buyer of the required information commits an
offence, as does a seller who omits to inform the buyer of the required
information. The offence is a strict liability offence that carries a maximum
penalty of 10 penalty units.
Section 23 of the Criminal
Code 2002 provides that if an offence is a strict liability offence,
there are no fault elements for any of the physical elements of the offence.
Furthermore, pursuant to section 36 of the Criminal Code 2002
the defence of mistake of fact under applies to strict liability offences in
addition to other defences available under criminal law.
New
section 5B
The required information to be recorded is stated in
new section 5B. Records kept in accordance with this provision must be in
English and in writing. The records must also be made in such a way that the
records are easily retrievable. Under section 11 of the Electronic
Transactions Act 2001 records can be kept in an electronic format
provided certain criteria can be met. Accordingly, the requirement for records
to be in writing and the Project STOP system being an on-line system are not
incompatible.
Information to be recorded includes the date of sale and
the brand name, dosage form and quantity of pseudoephedrine sold. Information
about the buyer must also be recorded, including the buyer’s name and
address, the kind of identification produced and the unique identification
number from the identification shown. Through the range of information
collected in the record of sale enforcement authorities should be able to
identify persons who make, or attempt to make, an unusually high number of
purchases or quantities of pseudoephedrine.
In addition to requiring
that the record of the sale include the type of identification shown, the
section also prescribes what types of identification can be lawfully accepted.
In doing so the section distinguishes between a photo identification
document and a non-photo identification document.
The
provision permits a seller to accept only two types of non-photo identification.
The first is a person’s birth certificate provided that it identifies the
issuing jurisdiction and the date it was issued. Provided it meets these
criteria birth certificates issued by any Australian State or Territory can be
accepted, as can any foreign issued birth certificate. The other form of
non-photo identification that can be accepted is a seniors card issued by the
ACT, the Northern Territory or another Australian State.
Section 5B
also contains a strict liability offence with a maximum penalty of
10 penalty units. The offence applies if a person sells pseudoephedrine by
retail and fails to make a record of the sale in accordance with the section.
Accordingly, a seller who wilfully chooses not to make a record of a sale
commits an offence, as does a seller who omits to make the
record.
Section 23 of the Criminal Code 2002 provides
that if an offence is a strict liability offence, there are no fault elements
for any of the physical elements of the offence. Furthermore, pursuant to
section 36 of the Criminal Code 2002 the defence of mistake of
fact under applies to strict liability offences in addition to other defences
available under criminal law.
New section 5C
A buyer has
a right to see a record pertaining to them, which is provided for by new
section 5C. Under this provision a buyer may request to see a record
pertaining to them that was made by the seller. If such a request is made, the
seller must allow the buyer to see the record within a reasonable period.
It is important to note that in order to see a record made about them a
buyer must attend the seller’s business that made the record. A seller is
under no obligation to produce a record or to come to the buyer. Furthermore, a
buyer can only see records of sales made from that business, and a seller cannot
change a record made by a different seller.
What amounts to a reasonable
period is not specified by the legislation. As such, determining what a
reasonable period is will be dependent upon a common understanding of the phrase
applied in the individual circumstances of each situation. This approach
recognises that the nature of a seller’s business will limit when it is
reasonable to give a buyer access to a record. It would be an unreasonable
imposition upon a seller’s business if a buyer were entitled to immediate
access to a record. To do so would make no allowance for requests made during
peak periods of trade, or shortly before the close of trade for the business.
In determining what should amount to a reasonable period for the
purposes of section 5C, regard should also be had to the availability of
the buyer to return at a more appropriate time. In most circumstances a
reasonable period will be the earliest opportunity that is manageable for both
the seller and the buyer. To achieve this it is possible, as well as
appropriate, for the seller and buyer to agree upon a suitable time to arrange
for the buyer to see the record.
Having inspected a record a buyer may,
if they believe the record to be incorrect, request that the seller change the
record. If the seller agrees with the request, the seller can alter the record.
If the change requested is not disputed by the seller, the seller should not
refuse to alter the record. Possible examples could be minor spelling errors of
a person’s name or address. More often than not, a clear discrepancy
between details on a receipt for purchase and on the record made concerning the
purchase would warrant a correction of the record.
New
section 5D
Section 5D applies if a buyer has requested a
seller change a record under section 5C and the seller has refused the
request. If this situation arises, a buyer can write to the ACT Chief Health
Officer asking that the Chief Health Officer direct the seller to change the
record. An application to the Chief Health Officer must be in writing, and
should provide as much detail and supporting evidence as the buyer is able to
provide. For example, if the date of sale or quantity of pseudoephedrine
purchased is disputed, the buyer should attach a copy of the sales receipt to
support the application.
Having received a written application the
Chief Health Officer must give a copy of the application to the seller
identified in the application, and ask the seller for a written response. A
seller must then provide a written response detailing why they believe the
record should not be altered within 10 working days.
New
section 5E
Following 10 working days the Chief Health Officer
must consider the application received from the buyer and any response submitted
by the seller, and then make a decision. Under section 5E the Chief Health
Officer can direct the seller to change the record in accordance with the
application, or refuse the application.
Crucially, the Chief Health
Officer may also direct the seller to change the record in a way other than in
accordance with the application. This enables the Chief Health Officer to
determine that the information recorded about the sale should remain unchanged,
but that a notation be added to the record that the buyer disputes all or part
of the record. This approach may be necessary where a buyer disputes the
quantity purchased, or even the sale itself, but cannot provide evidence that
contradicts the record.
Psuedo runners may attempt to avoid
detection through the use of fake or stolen identification. As a result, there
is the possibility that a buyer may be able to show that they did not or could
not have made a sale to which their details are recorded. In such circumstances
it is possible that the buyer’s identify, or an identifying document, has
been stolen or reproduced by a psuedo runner. Should such a situation
occur, it would be necessary for records to remain unaltered despite the
provision of clear evidence by the buyer that they did not make the purchases
recorded.
This provision will insert into the Poisons Regulation 1933 a
Dictionary. The Dictionary contains definitions of a number of terms used
throughout the Regulation. The existing definitions of prescriber and
recipient that were formerly the content of section 2 have been
relocated, without alteration, to the Dictionary.
Definitions within the
Dictionary include Australian student identification card, birth
certificate, proof of age card and psuedoephedrine.
For
the purposes of the Regulation, the Dictionary directs that an external driver
licence has the same meaning is assigned to the term by the Dictionary of the
Road Transport (Driver Licensing) Act 1999.
Under the
Road Transport (Driver Licensing) Act 1999 an external driver
licence is one of two things. The first is a license to drive a motor vehicle
issued under the law of a foreign country, referred to as a foreign driver
licence. The other is a licence to drive a motor vehicle issued under the law
of an external territory. An external territory is a Territory of the
Commonwealth other than the ACT and the Northern Territory.