Category Archives: Health law

Drugs in Sport

ACT law, Commonwealth law, Health law, Sports law

Can I take it?

As a pharmacist, your patients may sometimes ask you about whether or not a particular medicine is permitted in sport. This might seem a trivial question, but to the person asking it is a very serious question. Professional sporting people stand to lose their livelihood if they make a wrong decision: amateurs can lose any chance of becoming professional.

The impact of a positive doping test affects so many people. It can be devastating news for the country, family and other team members, and can unfairly take the moment of glory of winning a medal away from clean athletes who competed without drugs. It is even more tragic when the athlete tests positive for a substance that they may have inadvertently taken — the rules of strict liability mean that the athlete is still sanctioned under the WADA rules.[1]

As the quote above says, athletes are strictly liable for what they put in their bodies. If they take a protein supplement which unbeknownst to them happens to contain a performance enhancing substance, they are liable and will be penalised. If they can prove that it was inadvertent and that there was no intent to improve their performance, it is possible that a penalty could be reduced, but there is no guarantee. The burden of proof is on the athlete: this is not an ‘innocent until proved guilty’ situation, but the other way around.

Sydney 2000 – the Romanian affair

There are many examples of banned substances being taken by athletes, and the consequences following discovery, but one example is sufficient to demonstrate the catastrophic effects of a mistake. In 2000, Sydney was the host city for the Olympic Games. Andreea Raducan was a gymnast from Romania who won the all-around gold medal in her sport. Just before the competition, the Romanian team doctor prescribed a cold remedy for her. Unfortunately it contained pseudoephedrine, a banned substance. She was tested, the pseudoephedrine was discovered and she lost her gold medal. The team doctor had his Olympic accreditation withdrawn, and also lost his Fédération International de Gymnastique accreditation for four years.

Ms Raducan was not to blame in any way: she was only 16 years old at the time, legally a child, and she was only doing what her doctor said she should do. But the rules are strict, so she lost her medal.

Danger for the health professional

The loss of potential earnings and reputation for the patient makes this a particularly dangerous area for a health professional to get wrong. As can be seen from the above example, your livelihood can be affected. If you don’t know the answer you need to know where to look to find it. One place to look for a quick answer is MIMS. However – it is not authoritative. MIMS is a secondary source.

Where to look

      

The primary authority is the World Anti-Doping Agency (WADA). It publishes the World Anti-Doping Code. The Code undergoes a major revision every few years with smaller amendments in the intervening years, so always look at the current version. Published under the Code is the Prohibited List, which again is often updated. The Code has legal force in Australia under the same Act that established the Australian Sports Anti-Doping Authority (ASADA) in 2006.

ASADA’s website is the best place to look for information local to Australia. You should be aware that individual sports may have rules additional to those of WADA and ASADA. The particular national sporting organising body should be consulted.

In the ACT there is separate legislation that applies to ACT competitors. It works in conjunction with ASADA’s powers.

[1] Mark Stuart The Pharmaceutical Journal 14 Mar 2016 http://www.pharmaceutical-journal.com/careers/career-qa/my-role-as-a-pharmacist-at-the-rio-2016-olympics/20200768.article DOI: 10.1211/PJ.2016.20200768.

National Therapeutic Poisons Law

ACT law, Commonwealth law, Constitutional law, Health law, New South Wales law, Northern Territory law, Pharmacy law, Queensland law, South Australia law, Tasmania law, Victoria law, Western Australia law

Introduction

We have in Australia six States that at federation in 1901 had separate and different legislation on almost every aspect of life, including therapeutic poisons[1]. The ACT and NT came into being later and then created their own poisons laws. On top of these eight, there is the Commonwealth. As a result there are now nine different varieties of poisons legislation.

This means that the nationally registered health practitioners who use poisons as everyday tools have to cope with the different rules in the various jurisdictions where they work. For some, who don’t change workplace often, it’s not a big problem. But for others who practise all over Australia, the differences can lead to a potentially career-ending legal error.

It’s not just health practitioners who suffer – even more importantly, patients can be detrimentally affected by the arcane differences between jurisdictions.

Why we don’t have a national poisons law

At federation, the States allowed the Commonwealth a list[2] of specific, limited powers – poisons were not in the list. What remained was the States’ responsibility. For twenty years it was thought that the States’ powers were reserved to them and difficult for the Commonwealth to impinge upon, but in 1920 the Commonwealth broke free[3] and ever since has gradually extended its legislative boundaries outwards at the expense of the States. However, the Commonwealth can only push so far: while it has constitutional power to create a system of paying for poisons[4] in the form of the Pharmaceutical Benefits Scheme, at present it has little power to control how poisons are stored, handled, used or disposed of. The main thrust of Commonwealth legislation in this area is to do with misuse,[5]  rather than therapeutic use and its power in this area is mainly derived from international treaties.

What has been done so far?

At the end of the last century, the Council of Australian Governments (COAG) commissioned a review, chaired by Rhonda Galbally, of the country’s many different poisons and therapeutics goods laws.[6] In 2000 the final report of this review was published[7] and in 2005 COAG accepted it. Many of the review’s recommendations have been acted upon, but recommendation 24 stands out as yet to be implemented – it is the call for a national poisons law to be adopted by reference by the States and Territories.

There has been some progress however. In a related recommendation, Galbally proposed that the Commonwealth’s Standard for the Uniform Scheduling of Medicines and Poisons[8] be adopted by the States and Territories – this has been done, with minor variations.[9]

Similarly,  the Review said that the Therapeutic Goods Act 1989 (Cth) should be adopted by all jurisdictions. This has been done except by Queensland and Western Australia. The former is considering it as part of the new legislation[10] currently before the Queensland parliament but the latter recently contemplated it as part of its recently commenced legislation,[11] then dropped it.[12]  It is to be hoped that Western Australia will eventually join its fellows.

What are poisons schedules?

Each poisons schedule from 1 to 10 applies a different degree of restriction upon use and possession. Schedule 2 medicines are available only from a pharmacy or in remote areas, a licensed retailer;  schedule 3 medicines are only available from a pharmacist or on prescription; schedule 4 contains medicines that are only available by prescription; schedule 8 substances are strictly controlled medicines such as morphine. Schedules 5, 6, and 7 contain things like weedkillers, insecticides and paints. Schedule 1 is empty; schedule 9 contains prohibited substances such as LSD that can be researched upon with a licence; schedule 10 contains poisons so dangerous that sale, supply, or use is prohibited.

The differences

Unfortunately, while the schedule a poison is in does not now vary from place to place, the same cannot be said of the restrictions attached to any particular poison. The Poisons Standard can be regarded as a base, from which no restrictions are taken away, but upon which States and Territories can build further constraints. It’s these differences which can cause problems.

The next few paragraphs illustrate some of the more common ones. Methylphenidate features a great deal as it has many extra restrictions placed on it and it is often prescribed for attention deficit hyperactivity disorder, a common condition of children in Australia. Methylphenidate is a schedule 8 medicine (controlled drug, controlled medicine).

It should be borne in mind that the main sufferer at the sharp end of the inefficiencies caused by the jurisdictional differences is the patient, with potential injuries to their health.

Prescribers and pharmacists have their time wasted trying to negotiate the red tape for their patients: and just sometimes, the knots in the tape are a real source of danger to their careers.

Everyday cross border inefficiencies

Methylphenidate

Consider a paediatrician who practises on the Gold Coast in Queensland. If he writes a prescription for methylphenidate to treat attention deficit disorder then he must write “Specified Condition” on the prescription,[13] but he doesn’t need to apply to the Queensland government for authority to prescribe it – he has that automatically.[14]  A Queensland pharmacist will have no trouble dispensing it.[15]

However, if the patient is from somewhere in northern New South Wales – Ballina perhaps – and goes home before getting the prescription dispensed, then a NSW pharmacist cannot legally dispense it. The reason being that prescriptions for methylphenidate must have written on them the prescriber’s NSW authority number (which must be applied for) to write prescriptions for this drug.[16]

The problem is the same in reverse – a Queensland pharmacist will not be able to legally dispense a NSW prescription for methylphenidate because although it will have a NSW authority number on it, it is very unlikely to also bear the words ‘Specified Condition” because NSW law does not require it.

Repeat prescriptions

With some exceptions, a prescription for a controlled drug[17] may be written with repeats. But in NSW,[18] Tas[19] and WA[20] the pharmacy at which such a prescription is first dispensed must retain the repeat forms (in NSW anabolic steroid prescription repeats must also be retained[21] – the only jurisdiction this is a requirement). This can be a problem if a family with a child on methylphenidate wants to go on holiday for any length of time. The repeats will be at their usual pharmacy and may not be moved easily to another pharmacy.

In WA, transfer between pharmacies is allowed but only with the permission of the Dept of Health – a slow process.[22] New South Wales law allows exemption from the retention clause, but this is not publicised, and would again require some notice to put into effect as it must be in writing. In Tasmania there is legislative provision for verbal permission from the Dept of Health to transfer repeats to another pharmacy, which is more practical.

But why should repeats be retained? The ACT, NT, Qld, SA, and Vic don’t seem to have a problem with patients looking after their own repeats.

Destroying controlled drugs

In all States and Territories except Queensland, a health professional can destroy unwanted controlled drugs with another health professional as witness (NSW only allows this in certain circumstances though, and prefers a police officer or poisons inspector as a witness in a retail pharmacy). In Queensland, controlled drugs must be sent to a government facility for destruction. Why is Queensland different?

Dispensing prescriptions from interstate

This is one of the most tangled areas of poisons law.

On the whole, there is little difficulty with unrestricted schedule 4 substances. When it comes to restricted schedule 4 substances (however they are named), and controlled drugs, life can get more difficult.

In Western Australia, it is legal to dispense a prescription for a controlled drug written in another jurisdiction (provided that it is written correctly), except for cannabis-based products, dexamfetamine, lisdexamfetamine, methylphenidate, flunitrazepam, alprazolam, methadone, or for opioid replacement therapy.[23]

There is a problem with scripts for controlled drugs written in the ACT, Tasmania, and Western Australia in that these jurisdictions do not require that the total quantity prescribed be written in words and figures e.g. 20 (twenty) tablets. If a person wants to get such a prescription dispensed outside the state, the other jurisdictions[24] have this requirement.

The Northern Territory does not normally allow any interstate prescriptions for controlled drugs or restricted schedule 4 substances.[25]  Provision exists to allow them in certain limited circumstances in cross-border areas.[26]

Tasmania goes further and does not allow interstate controlled drug, specified psychotropic substances[27] or declared restricted substances[28] prescriptions. This includes benzodiazepines, anabolic steroids, epoetin, and other drugs that are subject to abuse. Incidentally, the lists of specified psychotropic substances and of declared restricted substances are almost identical.

NSW allows prescriptions from other jurisdictions for all medicines, but as described above for methylphenidate, certain medicines must be prescribed by a NSW authorised prescriber – whose NSW authorisation must be on the prescription.

In Queensland most interstate prescriptions are allowed as long as the script is written correctly. Exceptions are stimulants such as methylphenidate as described above, and certain specified medications including clozapine, isotretinoin, and pseudoephedrine.[29]

The ACT, South Australia, and Victoria allow any scripts from interstate to be dispensed.

For a patient with little technical knowledge, it’s a lottery as to whether or not they’ll succeed in getting an interstate prescription dispensed for a S4R or S8.

Risk to health practitioners

It would be fairly easy for a locum health practitioner to make a mistake when practising in several different jurisdictions. What’s legal in one place might be illegal in another. It is also true that all the time the laws of two different jurisdictions must be taken into account – the Commonwealth and the law of the State or Territory of practice.

To continue an example from above, if a visiting specialist from the ACT, Tasmania or Western Australia writes a script for a controlled drug in one of the other jurisdictions and fails to write the quantity in word and figures because that’s what they’re used to doing, the penalty for doing so ranges from $2,000 to $15,400 depending on the jurisdiction. The risk to any pharmacist who dispensed such a prescription includes jail.

Methylphenidate in the NT

Methylphenidate is a very good example yet again. It has a standard PBS quantity of 100 x 10mg tablets, and a PBS authority will usually be given to a medical specialist for this amount. But in the Northern Territory, methylphenidate can only be prescribed and dispensed in lots of one month’s supply.[30] Visiting specialists sometimes don’t realise this and write prescriptions for a box of 100 tablets even if the dose is, for example, two tablets daily. The maximum penalty for writing the script is 100 penalty units (currently[31] $15,400) and is an offence of strict liability[32] – this means that if you did it then you’re liable, there are no mitigating circumstances. Disciplinary action would undoubtedly follow. Taking a very legalistic view, a pharmacist who dispensed such a script could face four years’ imprisonment or a fine in excess of $60,000.[33]

Penalties for dispensing an out of date S4 script

A prescription for a unrestricted schedule 4 substance expires one year after it was written in all jurisdictions. It is illegal to dispense it after the year is up. But even when the rules are the same in all jurisdictions, the maximum penalty for breaking the law can be wildly different. The list that follows illustrates the point. As can be seen, the fine for dispensing an out of date script in WA is 30 times greater than in NSW. Why is this acceptable? It’s certainly not rational.

ACT                             50 penalty units           $7,500 [34]

NT                                50 penalty units           $7,700 [35]

NSW                             15 penalty units           $1,500 [36]

Qld                               60 penalty units           $7,314 [37]

SA                                                   Cash           $5,000 [38]

Tas                               10 penalty units           $1,570 [39]

Vic                               50 penalty units           $7,773 [40]

WA                                                  Cash           $45,000 [41]

An additional layer of confusion – nomenclature

In spite of the fact that there’s a nationally accepted list of poisons in the the Poisons Standard, the names given to the various categories of substances can be remarkably different around the country. An example will suffice: any drug in schedule 4 of the Poisons Standard, depending on context and jurisdiction, is a member of the following legal categories:

 

●     Medicine ●     Regulated substance
●     Poison ●     S4 drug
●     Poison or controlled substance ●     S4 poison
●     Prescription drug ●     S4 substance
●     Prescription only medicine ●     Schedule 4 poison
●     Regulated good ●     Schedule 4 substance
●     Restricted drug ●     Scheduled medicine
●     Restricted substance ●     Scheduled substance

It’s as if all the jurisdictions have set out deliberately to use different terminology to each other. Subcategories also exist, but they are not listed here.

National registration of health practitioners

A strong argument for a national poisons law is that from 1 July 2010 pursuant to a decision by the Council of Australian Governments (COAG) in 2008, the various jurisdictions abolished their own registers of doctors, nurses, pharmacists etc and established the Australian Health Practitioner Regulation Agency to administer a national set of registers. All health practitioners now pay one annual fee to AHPRA and are held to a national standard for their respective profession.

Given that health practitioners now have national registration, it’s absurd that poisons used as tools every day by a whole range of health practitioners are still regulated differently in different parts of the country.

Calls for change

This article is by no means the first to make the point. In 2015 an article in the Medical Journal of Australia[42] highlighted the difficulties caused by differences in schedule 8 medicines regulations around the country; in 2016 a similar piece was published in the Journal of Pharmacy Practice and Research.[43]

COAG and poisons reform

The COAG commissioned Galbally Review does seem to have run out of steam in this area, but the Intergovernmental Agreement on Competition and Productivity-Enhancing Reforms[44] has some elements that could be used to push change (and resurrect Galbally’s recommendation 24), even if only five jurisdictions have signed up so far. Its objectives of improving standards of access, equity and quality, and and promoting efficient use of resources are particularly relevant. The resources in question are medicines for the community, which the Commonwealth pays a great deal of money for directly, and indirectly through the time taken to prescribe and dispense them. If patients can’t easily access their legitimately prescribed medicines because of State and Territory legal barriers, then the principles of equity and efficiency are not operating properly.

Also very much to the point: the first guiding principle for human services reform is ‘A better outcome for individuals who use human services should be at the heart of service delivery.’[45]

Misuse of drugs

A secondary point that needs to be addressed is that some jurisdictions have separate legislation for poisons misuse and therapeutic use:[46] others have the two mixed together.[47]

Misuse and therapeutic use of poisons deal with some of the same substances, but do not sit comfortably together. The two subjects should be dealt with separately as is the case in the Northern Territory. Not all poisons are subject to misuse, and not all misused substances are therapeutically used. Legislation gets somewhat byzantine when misuse and therapeutic use are regulated in the same Act.

Constitutional issue

Constitution s 117 Rights of residents in States

A subject of the Queen, resident in any State, shall not be subject in any other State to any disability or discrimination which would not be equally applicable to him if he were a subject of the Queen resident in such other State.

Does this make any difference? If as discussed above, a Queensland resident tries to get a Queensland paediatrician’s methylphenidate prescription dispensed in NSW and can’t, is that unconstitutional either from the paediatrician’s point of view or the patient’s?

Change the Queensland resident to a NSW resident – is that unconstitutional?

If the prescription is a PBS prescription (which most are), paid for by the Commonwealth, does that make any difference in either case?

These are interesting questions, to which currently there are no answers. S 117 was thought to be a dead letter since one of the earliest decisions of the High Court,[48] affirmed decades later by Henry v Boehm.[49] However, two more recent cases, Street v Queensland Bar Association [50] and Goryl v Greyhound Australia Pty Ltd [51]  have breathed a little life into it.

The most recent High Court case considering s 117 is Sweedman v Transport Accident Commission,[52] but nothing new was added to the law in this respect.

S 117 and the Commonwealth

In 1992 Leeth v Commonwealth [53] looked at s 117 with regard to Commonwealth law: the majority judgment stated that the question of whether or not s 117 applies to the Commonwealth has not been decided.[54] Further,

there can be no question, specific restrictions and implications arising from the federal structure apart, that the Commonwealth may give a varying application to its laws by reference to the laws of the States.[55]

This does seem to lend legitimacy to the differing treatment of PBS scripts in different jurisdictions.  However, against this obiter is:

While it has never been decided, there is no reason to doubt that s 117 of the Constitution applies to the Commonwealth as well as to the States.[56]

The point is that the Pharmaceutical Benefits Scheme is a universal system for all Australians – is it constitutional for a State law to impinge upon a person’s ability to access that system? The National Medicines Policy[57] states as one of its objectives

  • timely access to the medicines that Australians need, at a cost individuals and the community can afford;

It is arguable that in some circumstances, State and Territory law get in the way of this objective. While policy is not law, it can inform High Court judges in their decision-making.

S 117 as it stands is a weak section of the Constitution, but with the potential to be greater than it is at present. Time will tell if, in the absence of a national law, it can be used to improve access to the PBS.

For a discussion of s 117 see Section 117 Of The Constitution: The Unfinished Rehabilitation, by Michael Mathieson.[58] A later discussion, which includes consideration of Sweedman, can be found in the Melbourne University Law Review.[59]

Uniform laws already created

The States and Territories have already created national laws for subjects as diverse as electronic transactions, children’s education and care, business names, and evidence – to name but a few. Why not poisons?

Conclusion

It is clear that a national approach to poisons regulation is needed. COAG should begin work on a national poisons law and fulfill its commitment to the Galbally Review. The new law could be issued under the Therapeutic Goods Act 1989 (Cth), in a similar fashion to the current Poisons Standard. States and Territories could then adopt it, with those that need to do so moving their misuse of drugs provisions to separate legislation.

 

 

[1] From now on, unless otherwise stated, ‘poisons’ refers to therapeutic poisons.

[2] Constitution s 51.

[3] Amalgamated Society of Engineers v Adelaide Steamship Co Ltd [1920] HCA 54 (The Engineers Case).

[4] Constitution s 51(xxiiiA).

[5] Narcotic Drugs Act 1967 (Cth).

[6] https://www.tga.gov.au/review-drugs-poisons-and-controlled-substances-legislation-galbally-review .

[7] Rhonda Galbally, ‘National Competition Review of Drugs, Poisons and Controlled

Substances Legislation’ (Final Report, Council of Australian Governments, December 2000).

[8] Poisons Standard 2017 (Cth) – updated frequently – issued pursuant to Therapeutic Goods Act 1989 (Cth).

[9] For instance, Western Australia has added one thing – a local medicinal plant – to schedule 4, which seems a reasonable thing to do, but it would be better if it could have been done nationally.

[10] Medicines, Poisons and Therapeutic Goods Bill 2015 (Qld).

[11] Medicines, Poisons and Therapeutics Bill 2013 (WA).

[12] Medicines and Poisons Act 2014 (WA).

[13] Health (Drugs and Poisons) Regulation 1996 (Qld) s 79(4)(k).

[14] Health (Drugs and Poisons) Regulation 1996 (Qld) s 78(1)(ba).

[15] Health (Drugs and Poisons) Regulation 1996 (Qld) s 82(2)(h).

[16] Poisons and Therapeutic Goods Regulation 2008 (NSW) cl 90.

[17] A schedule 8 substance.

[18] Poisons and Therapeutic Goods Regulation 2008 (NSW) cl 89.

[19] Poisons Regulations 2008 (Tas) r 23.

[20] Medicines and Poisons Regulations 2016 (WA) rr 23(1)(e)(i), 24(2).

[21] Poisons and Therapeutic Goods Regulation 2008 (NSW) cl 42.

[22] Medicines and Poisons Regulations 2016 (WA) r 23(1)(e)(ii).

[23] Schedule 8 medicines prescribing code 2017 (WA).

[24] Medicines Poisons and Therapeutic Goods Regulations 2014 (NT) r 10(1)(b); Poisons and Therapeutic Goods Regulation 2008 (NSW) 80(1)(c); Health (Drugs and Poisons) Regulation 1996 (Qld) 79(4)(e); Controlled Substances (Poisons) Regulations 2011 (SA) r 34(1)(d)(ii); Drugs Poisons and Controlled Substances Regulations 2017 (Vic) r 24(3)(g)(iii).

[25] Medicines, Poisons and Therapeutic Goods Act 2012 (NT) ss 24, 57, 58 (there no restricted S4 meds at present in the NT, but provision exists for them to be declared).

[26] Medicines, Poisons and Therapeutic Goods Act 2012 (NT) s 253.

[27] Poisons Regulations 2008 (Tas) sch 4.

[28] Poisons (Declared Restricted Substances) Order 1990 (Tas).

[29] Health (Drugs and Poisons) Regulation 1996 (Qld) s 193A.

[30] Code of Practice Schedule 8 Substances Vol 1 2014 (NT) pt 3.8.

[31] Penalty Units Regulations 2010 (NT).

[32] Medicines, Poisons and Therapeutic Goods Act 2012 (NT) s 87.

[33] Medicines, Poisons and Therapeutic Goods Act 2012 (NT) s 50.

[34] Medicines, Poisons and Therapeutic Goods Act 2008 (ACT) s 27(1)(c)(v); Legislation Act 2001 (ACT)  s 133.

[35] Medicines, Poisons and Therapeutic Goods Act 2012 (NT) s 93; Penalty Units Regulations 2010 (NT).

[36] Poisons and Therapeutic Goods Regulation 2008 (NSW) cl 40(1)(g)(iii); Crimes (Sentencing Procedure) Act 1999 (NSW) s 17.

[37] Health (Drugs and Poisons) Regulation 1996 (Qld) s 193(2)(f); Penalties and Sentences Regulation 2015 (Qld).

[38] Controlled Substances (Poisons) Regulations 2011 (SA) r 35(7)(a)(i)(B).

[39] Poisons Regulations 2008 (Tas) r 17; Penalty Units and Other Penalties Act 1987 (Tas) ss 4, 4A.

[40] Drugs, Poisons and Controlled Substances Regulations 2006 (Vic) r 30(2)(a); Sentencing Act 1991 (Vic) s 110(1); Monetary Units Act 2004 (Vic) s 5(2).

[41] Medicines and Poisons Regulations 2016 (WA) r 23(3); Medicines and Poisons Act 2016 (WA) ss 14(1), 115.

[42] Andy Hua, Finna Shen, Xiaoting Ge, ‘State-based legal requirements for Schedule 8 prescriptions: why so complicated?’ (2015) 203(2) Medical Journal of Australia 64.

[43] Denise Hope et al, ‘Borderline health: jurisdictional variation in Australian medicines legislation poses potential risks to patients and healthcare practitioners’ (2016) 46 Journal of Pharmacy Practice and Research 201.

 

[44] Council of Australian Governments Intergovernmental Agreement on Competition and Productivity-Enhancing Reforms 9 Dec 2016.

[45] Council of Australian Governments Intergovernmental Agreement on Competition and Productivity-Enhancing Reforms 9 Dec 2016, app B s 2(a).

[46] E.g. Medicines, Poisons and Therapeutic Goods Act 2012 (NT); Misuse of Drugs Act 1990 (NT).

[47] E.g. Drugs, Poisons and Controlled Substances Act 1981 (Vic).

[48] Davies and Jones v Western Australia (1904) 2 CLR 29.

[49] (1973) 128 CLR 482.

[50] (1989) 168 CLR 461.

[51] (1994) 179 CLR 463.

[52] (2006) 226 CLR 362.

[53](1992) 174 CLR 455.

[54] Leeth v Commonwealth (1992) 174 CLR 455, 468.

[55] Leeth v Commonwealth (1992) 174 CLR 455, 468.

[56] Westlaw, The Laws of Australia (at 11 June 2017) 19 Government, ‘5 Federal Constitutional System’ [19.5.2870].

[57] Australian Government, Department of Health and Ageing, ‘National Medicines Policy’ (2000).

[58] Michael Mathieson, ‘Section 117 Of The Constitution: The Unfinished Rehabilitation’ (1999) 27(3) Federal Law Review. http://pandora.nla.gov.au/nph-wb/20001025130000/http://law.anu.edu.au/publications/flr/Vol27no3/MATHIESON.htm

[59] Amelia Simpson, ‘The (Limited) Significance of the Individual in Section 117 State Residence Discrimination’ (2008) 32(2) Melbourne University Law Review 639. http://www.austlii.edu.au/cgi-bin/sinodisp/au/journals/MelbULawRw/2008/19.html

 

 

Who Can Destroy Controlled Drugs?

ACT law, Health law, New South Wales law, Northern Territory law, Pharmacy law, Queensland law, South Australia law, Tasmania law, Victoria law, Western Australia law

Introduction

Controlled drugs are those substances that are found in Schedule 8 (S8) of the Poisons Standard 2017 (Cth) and thence incorporated into State and Territory law. In all jurisdictions, controlled drugs are subject to laws strictly regulating the way they can be handled. The process of destroying unwanted or expired controlled drugs is no exception. Each jurisdiction has a different approach to the process and this article aims to list the various laws involved.

The nomenclature of the S8 medications varies throughout Australia. The local name is provided at the beginning of each jurisdiction if needed.

In all cases involving health practitioners, the usual recording in the S8 register must occur – the details vary. But it is always wise to record as much about the destruction as possible.

ACT flag

Australian Capital Territory

Controlled medicine = controlled drug

It is an offence to discard a controlled medicine in a way that puts the health or safety of people at risk or is likely to cause damage to property or the environment.[1]

A controlled medicine may be discarded by a prescribed discarding witness in the presence of another prescribed discarding witness.[2] However, such a witness cannot be related to, a close friend of, employed by, the supervisor of, or supervised by the person discarding the controlled medicine.[3]

Prescribed discarding witnesses[4]

  • Ambulance officer (Territory, State or Commonwealth)
  • Approved analyst
  • Dentist
  • Doctor
  • Medicines and poisons inspector
  • Midwife
  • Registered nurse
  • Nurse practitioner
  • Pharmacist
  • Veterinary surgeon

The residue of a controlled medicine after it has been used may be discarded in the presence of someone who is not a prescribed discarding witness if no such person is available.[5]

There is no general prohibition on destroying a controlled medicine: so as a patient is not a prescribing discarding witness and is therefore not subject to the requirement to have a witness, he or she may lawfully discard a legitimately prescribed controlled medicine without a witness as long as it is rendered unable to be used.[6]

Northern Territory

Schedule 8 substance = controlled drug

A person has a duty to make sure they take reasonable care and precautions to ensure that anything in their possession that can endanger the life, safety or health of another does not do so.[7]

A person authorised under the Medicines, Poisons and Therapeutic Goods Act 2012 (NT) to possess a Schedule 8 substance may only destroy it with a witness who can be any one of an authorised officer,[8] a health practitioner or a veterinarian.[9]

The names[10] and signatures[11] of the destroyer and the witness must be entered into the S8 substance register.

There is no general prohibition on destroying a Schedule 8 substance so a patient who was legitimately prescribed a Schedule 8 substance is not caught by this law and may destroy it without a witness because he or she is not “authorised” in the sense used in the Act.

New South Wales

Drug of addiction = controlled drug

A person must not use or dispose of a poison in any place or in any manner likely to constitute a risk to the public.[12]

A person who is authorised to be in possession of a drug of addiction must not wilfully destroy the drug or allow the drug to be destroyed.[13]

Exceptions

The persons listed below may destroy drugs of addiction.

  • A police officer, inspector[14] or an authorised person can destroy or supervise destruction.[15]
  • A patient who was legitimately prescribed a drug of addiction.[16]
  • A retail pharmacist, either at his or her pharmacy or at the practitioner’s practice may, in the practitioner’s presence, destroy the unwanted drugs of addiction of a medical practitioner, dentist or veterinary practitioner. The fact of destruction; date, name, AHPRA number and signature of the pharmacist; name and signature of the medical practitioner, dentist or veterinary practitioner must all be recorded in the practice’s drug of addiction register.[17]
  • A retail pharmacist who supplies a nursing home or private health facility with drugs of addiction can destroy them in that place (not in the pharmacy), with either the director of nursing or the drugs of addiction licence holder. The fact of destruction, date, name, signature and AHPRA number of the pharmacist and the name and signature of the witness must be recorded.[18]
  • The director of pharmacy at a public hospital can destroy drugs of addiction with a witness who can be a pharmacist, medical practitioner, authorised midwife, authorised nurse[19] or a dentist. The fact of destruction and the date, names, signatures and AHPRA numbers of the two people must be recorded in the register. The director of pharmacy can delegate this power to another pharmacist. If there is no director of pharmacy at the public hospital, then the person in charge of controlling drugs of addiction has the same powers, including delegation to a pharmacist.[20]
  • A pharmacist can destroy drugs on a public hospital ward with a nurse or midwife as witness. The fact of destruction, date, name, signature and AHPRA number of the pharmacist and the name and signature of the nurse/midwife must be recorded.[21] The definition of nurse here can be taken to include an enrolled nurse,[22] but local policy may not allow this interpretation.

Queensland

Controlled drugs must not be disposed of or used in such a way as to endanger the life or safety of another person or an animal, risk contaminating food or other drugs, or allow access by persons not endorsed to possess them.[23]

A person endorsed to deal with controlled drugs may not destroy them unless also endorsed to do so.[24] The endorsement allowing destruction may also have conditions attached to it which must be followed.[25]

Exceptions

The persons listed below may destroy controlled drugs.

  • An inspector[26] may destroy a controlled drug in an emergency or disaster situation.[27]
  • A State analyst may destroy them or supervise the destruction by his or her trainee.[28]
  • The person in charge of a State forensic and scientific facility is authorised to destroy them – this power may be delegated to an appropriate person.[29]

NB Unlike other jurisdictions, health practitioners do not routinely have the power to destroy controlled drugs even with a witness. Unwanted controlled drugs must be sent to the State Forensic and Scientific Services for destruction. The form to accompany them is here.[30]

While health practitioners are explicitly not given the power of destruction, there is no general prohibition, therefore patients who have been legitimately prescribed controlled drugs may destroy them.

South Australia

Drug of dependence = S8 poison = controlled drug.

A person must not dispose of or use, or cause to be disposed of or used, a poison in any place or manner that constitutes, or is likely to constitute, a risk to public health or safety.[31]

A person must not destroy a drug of a dependence.[32]

Exceptions

The persons listed below may destroy drugs of dependence.

  • A patient who was legitimately prescribed a drug of dependence can destroy it.[33]
  • A police officer may destroy them.[34]
  • An authorised officer[35] may destroy them.[36]
  • Any person can destroy a drug of dependence provided the destruction is witnessed by any one of an authorised officer, a police officer, a registered health practitioner, a veterinary surgeon or a paramedic authorised to administer drugs of dependence.[37]

The remaining balance of the drug of dependence, and the names and signatures of the person and the witness must be recorded: also the date and time of the destruction.

Tasmania

Narcotic substance = controlled drug

It is the duty of every person who has anything in his charge or under his control, … which, in the absence of precaution or care in its use or management may endanger human life, to take reasonable precautions against, and to use reasonable care to avoid, such danger.[38]

A person who is licensed or authorised to be in possession of a narcotic substance must not wilfully destroy, or cause or permit that narcotic substance to be destroyed.[39]

Exceptions

The persons listed below may destroy narcotic substances.

  • A patient who was legitimately prescribed a narcotic substance.[40]
  • An inspector: he or she may also supervise destruction.
  • The Chief Pharmacist of the Department of Health and Human Services.
  • An [41]
  • A person authorised in writing by the Secretary of the Department of Health and Human Services.
  • Any two health professionals (dentist, medical practitioner, pharmacist, registered nurse, midwife, authorised nurse practitioner, veterinary surgeon) jointly.
  • An enrolled nurse working jointly with a health professional (see above).

The destruction must be correctly entered in the register.[42]

Victoria

S8 poison = controlled drug

The Environment Protection Act 1970 (Vic), the Crimes Act 1958 (Vic) or the Occupational Health and Safety Act 2004 (Vic) might be applicable in the case of unsafe disposal, depending on the circumstances.

A person must not wilfully destroy a Schedule 8 poison.[43]

Exceptions

The persons listed below may destroy Schedule 8 poisons.

  • An authorised officer can destroy them or supervise their destruction.[44]
  • A nurse practitioner or authorised registered midwife can destroy them if the destruction is witnessed by a registered medical practitioner, pharmacist, veterinary practitioner, dentist, nurse or registered midwife.[45]
  • A registered medical practitioner, pharmacist, veterinary practitioner or dentist can destroy them if the destruction is witnessed by a registered medical practitioner, pharmacist, veterinary practitioner, dentist, nurse or registered midwife.[46]
  • The unused part of a partially used ampoule or vial of injection can be destroyed without a witness by a registered medical practitioner, pharmacist, veterinary practitioner, dentist, nurse, registered midwife[47] or paramedic.[48]

As Victoria has a mixed misuse and therapeutic use Act, the police also have powers in this area.

The names of the person and witness carrying out the destruction must be recorded: also the method and place of destruction.

Western Australia

Schedule 8 poison = controlled drug

A Schedule 8 poison must not be wilfully destroyed.[49]

Exceptions

The persons listed below may destroy drugs of addiction.

  • Two qualified persons
  • A person acting on behalf of a qualified person with a qualified person as witness.

A qualified person is a health professional (does not include an enrolled nurse), a police officer or an investigator.[50]

The following information must be recorded in the register —

  • the name, contact details and signature of the person by or on behalf of whom the poison or medicine is destroyed;
  • details of the basis on which the person is authorised to destroy the medicine or poison or have it destroyed;
  • the date of destruction;
  • the name, quantity, strength and form of the poison or medicine destroyed;
  • the reason for destruction;
  • the method of destruction;
  • the name, contact details and signature of the witness to the destruction and details of the category under which the witness is a qualified person.[51]

One problem with the new law is that it seems that a person who was legitimately prescribed a controlled drug (as from 30 Jan 2017) can no longer legally destroy their unwanted medicine. Under the previous law, this was an allowed exception. [52] 

Conclusion

The different approaches to the legal controls in this one small area of the law are indicative of the problems faced by health practitioners who work in different jurisdictions on a regular basis. We need a national law for therapeutic poisons, separated from misuse laws. National legislation has already been worked out and implemented in many disparate areas of the law: electronic transactions, health practitioner registration, and education and childcare are just three. It’s time poisons law caught up.

[1] Medicines, Poisons and Therapeutic Goods Act 2008 (ACT) s 34(3).

[2] Medicines, Poisons and Therapeutic Goods Regulation 2008 (ACT) s 390.

[3] Medicines, Poisons and Therapeutic Goods Regulation 2008 (ACT) s 545(2).

[4] Medicines, Poisons and Therapeutic Goods Regulation 2008 (ACT) s 545.

[5] Medicines, Poisons and Therapeutic Goods Regulation 2008 (ACT) s 390(2).

[6] Medicines, Poisons and Therapeutic Goods Regulation 2008 (ACT) s 390(4).

[7] Criminal Code Act 1983 (NT) s 151.

[8] Medicines, Poisons and Therapeutic Goods Act 2012 (NT) s 274 (includes a police officer of sergeant rank or above).

[9] Medicines, Poisons and Therapeutic Goods Regulations 2014 (NT) r 19.

[10] Medicines, Poisons and Therapeutic Goods Regulations 2014 (NT) r 54(1)(h).

[11] Medicines, Poisons and Therapeutic Goods Regulations 2014 (NT) rr 67-69.

[12] Poisons and Therapeutic Goods Regulation 2008 (NSW) cl 25.

[13] Poisons and Therapeutic Goods Regulation 2008 (NSW) cl 125(1).

[14] Poisons and Therapeutic Goods Act 1966 (NSW) s 42.

[15] Poisons and Therapeutic Goods Regulation 2008 (NSW) cll 125(2)(a), 125(2)(b).

[16] Poisons and Therapeutic Goods Regulation 2008 (NSW) cl 125(2)(c).

[17] Poisons and Therapeutic Goods Regulation 2008 (NSW) cl 126.

[18] Poisons and Therapeutic Goods Regulation 2008 (NSW) cl 128.

[19] The registered nurse or midwife in charge of the ward at the time, or authorised to destroy drugs of addiction by the director of nursing.

[20] Poisons and Therapeutic Goods Regulation 2008 (NSW) cl 126A.

[21] Poisons and Therapeutic Goods Regulation 2008 (NSW) cl 127.

[22] Interpretation Act 1987 (NSW) s 21(1).

[23] Health (Drugs and Poisons) Regulation 1996 (Qld) s 130.

[24] Health (Drugs and Poisons) Regulation 1996 (Qld) s 51(5).

[25] Health (Drugs and Poisons) Regulation 1996 (Qld) s 51(8).

[26] Health Act 1937 (Qld) pt 4A div 2.

[27] Health (Drugs and Poisons) Regulation 1996 (Qld) s 60(c).

[28] Health (Drugs and Poisons) Regulation 1996 (Qld) s 70.

[29] Health (Drugs and Poisons) Regulation 1996 (Qld) s 70AA.

[30] https://www.health.qld.gov.au/__data/assets/pdf_file/0022/443614/drug-destruction-fm.pdf .

[31] Controlled Substances (Poisons) Regulations 2011 (SA) r 48.

[32] Controlled Substances (Poisons) Regulations 2011 (SA) r 45(1).

[33] Controlled Substances (Poisons) Regulations 2011 (SA) r 45(2)(a).

[34] Controlled Substances (Poisons) Regulations 2011 (SA) r 45(2)(b).

[35] Controlled Substances (Poisons) Act 1984 (SA) s 50.

[36] Controlled Substances (Poisons) Regulations 2011 (SA) r 45(2)(b).

[37] Controlled Substances (Poisons) Regulations 2011 (SA) r 45(1)(a).

[38] Criminal Code Act 1924 (Tas) s 150.

[39] Poisons Regulations 2008 (Tas) r 34(1).

[40] Poisons Regulations 2008 (Tas) r 34(2)(b).

[41] Poisons Act 1971 (Tas) s 19.

[42] Poisons Regulations 2008 (Tas) sch 2 (requirements of a register).

[43] Drugs, Poisons and Controlled Substances Regulations 2006 (Vic) r 50.

[44] Drugs, Poisons and Controlled Substances Regulations 2006 (Vic) r 51(1)(a).

[45] Drugs, Poisons and Controlled Substances Regulations 2006 (Vic) r 51(2).

[46] Drugs, Poisons and Controlled Substances Regulations 2006 (Vic) r 51(3).

[47] Drugs, Poisons and Controlled Substances Regulations 2006 (Vic) r 51(4).

[48] Drugs, Poisons and Controlled Substances Regulations 2006 (Vic) r 51(4A).

[49] Medicines and Poisons Regulations 2016 (WA) r 145(2).

[50] Medicines and Poisons Regulations 2016 (WA) r 145(1).

[51] Medicines and Poisons Regulations 2016 (WA) r 145(4).

[52] Poisons Regulations 1965 (WA) r 44A (now repealed).

Beware Insurance!

Health law, Insurance law

Pharmacist wins against insurance company

Madeyski_Pain

Although the outcome was good for the pharmacist in this case, it’s a warning to anyone contemplating taking out an income protection policy (or any kind of insurance for that matter) to make sure that all relevant material has been submitted to the insurer upon application.

Insurance contracts are conducted uberrimae fidei, ‘in utmost good faith’. The insurer is at a disadvantage, because only the prospective insured can possibly know all the details of their own circumstances: hence the need for utmost good faith. Because of this, if an insurer finds out something at a later date that should have been taken into account at the time of the application, the insurance policy can be avoided.

Summary

Ms Thereze Guirgis took out an income protection policy with Westpac Life Insurance Services Ltd (Westpac) in September 2007 and paid monthly premiums thereafter. In October 2011 she made a claim, saying that she had had to reduce her working hours because she now suffered fibromyalgia.

Westpac paid the claim until June 2012, at which point it alleged that Ms Guirgis had not properly disclosed her state of health in September 2007 and therefore Westpac was ceasing to pay.

In February 2013 Ms Guirgis took Westpac to court.[1] Westpac’s defence was that Ms Guirgis had fraudulently misrepresented that she did not have fibromyalgia at the time of application: further, they were claiming back the payments made under the claim from October 2011 to Jun 2012.

Westpac lost the case and sought leave to appeal. Leave was refused.[2]

Details

Ms Guirgis had told Westpac about various musculoskeletal problems but hadn’t mentioned fibromyalgia. In other respects her replies to the questions on the application form seemed truthful. She gave Westpac the contact details of her rheumatologist and her GP.

Westpac claimed that under the insurance underwriting guidelines in existence at the time of application, the insurance application would have been refused had fibromyalgia been mentioned.

From evidence adduced from some other specialists that Ms Guirgis had seen, it appeared that fibromyalgia could well have been mentioned as a possibility to her, but Ms Guirgis had no memory of being definitively told “You have fibromyalgia”. Importantly, her GP did not believe that she had fibromyalgia, and had never brought up the subject.

The judge at first instance found that while Ms Guirgis had almost certainly heard the word ‘fibromyalgia’ from at least one of her doctors, it didn’t register with her as a definitive diagnosis and was merely one of several possibilities. Her GP, the doctor whom she saw most often, never mentioned it. Ms Guirgis was not deliberately trying to deceive when she didn’t mention fibromyalgia, even though it had been mentioned to her. A strong indicator that this was the case was the fact that she gave Westpac the contact details of her rheumatologist, who if contacted by Westpac would have given it any relevant medical details requested.

The judge found that Westpac’s claim that they never would have offered the insurance in the first place didn’t hold water, because it couldn’t produce any evidence the guidelines it was relying on actually existed. If the putative guidelines said that fibromyalgia was so serious as to preclude insurance, then there should have been a question on the application form addressing fibromyalgia specifically.

Moral

It must have been an unpleasant experience for Ms Guirgis, but she won in the end. The fact that she disclosed her treating doctors’ contact details was a large factor in her win. After all, insurers ask for those contact details because people forget what doctors tell them, or misinterpret it, or just don’t understand it. Westpac also contributed by not being able to document its own policy – a basic flaw. Take note from Westpac’s failure – document everything.

[1] Guirgis v Westpac Life Insurance Services Ltd [2014] VCC 2039.

[2] Westpac Life Insurance Services Ltd v Guirgis [2015] VSCA 239.

Natural Justice?

Health law, Pharmacy law, Public law

Procedural fairness

BalancaJustica

Background

The locations of community pharmacies that can dispense Pharmaceutical Benefit Scheme (PBS) items are controlled under the National Health (Australian Community Pharmacy Authority Rules) Determination 2011 (Cth), issued by the Minster for Health under the National Health Act 1953 (Cth) s 99L. If someone wants to open a pharmacy that can dispense PBS items, there’s a fairly complicated set of criteria that must be met. For new pharmacies, an important one is that the new pharmacy must not be less than 1.5km in a straight line from any currently established one. Another set of criteria cover relocations – e.g. moving around the corner because the landlord decided to demolish the building the pharmacy is currently occupying. The Rules go on to cover several other scenarios.

A case last year[1] centred around an interesting point about procedural fairness. Normally when any sort of process involving the law or government is undertaken, the participants can expect to be treated fairly and with natural justice, unless this right is specifically removed by Parliament from the process. If procedural fairness is not forthcoming, there is often redress available on application to a court.

Facts of the case

Patrick and Lia Mahony applied to move their approval to dispense PBS items from their pharmacy in Tamworth NSW to a shop in Moree NSW. This application was turned down by the Secretary of the Department of Health on the grounds it didn’t fit the criteria in the Rules.

The Mahonys then applied to the Minister for Health to approve the move anyway. The National Health Act 1958 (Cth) s 90A(2) provides that the Minister can exercise her discretion to approve an application in circumstances where the Secretary has refused an application, where that refusal has resulted in a community being left without reasonable access to pharmaceutical benefits, and where the exercise of the discretion is in the public interest.

Timeline

Aug 2011        The Mahonys’ relocation application under the Rules was rejected by the Secretary of the Department of Health.

Sep 2011        The Mahonys submit a s 90A application for Ministerial reconsideration of the Secretary’s decision.

1 Nov 2011     Steven Kong, Bradley Coleman and Pannet Pok (KCP) purchased two PBS approved pharmacies in Moree.

29 Nov 2011   Nicola Roxon (then Minister for Health) decided to consider the Mahonys’ s 90A application, in accordance with s 90B(4).

27 Feb 2012    Tanya Plibersek (then Minister for Health) decided to approve the Mahonys’ relocation application.

KCP naturally were not happy about this, as they had just purchased two pharmacies in a town where the application for another, rival pharmacy had just been refused, and had reasonable expectations of the returns they could expect from their investment. But now, what they had purchased was suddenly perhaps not as valuable as it might have been. What was worse, they had not been notified (nor had the vendor of the pharmacies) of either the Mahonys’ s 90A request or the Minister’s decision to consider it, and therefore not had a chance to put their point of view to the Minister.

So they took the Minister and the Mahonys to court.

Main issue

KCP attacked the decision on the grounds that they should have been notified of either or both of the initial s 90A application and the decision by Nicola Roxon to consider it: the fact they did not receive notification denied them procedural fairness.

Result and reason

Unfortunately for them, KCP lost their case. Basically, procedural fairness did not apply in this case to them. They were not parties to the application for a ministerial review, and only had an economic interest in the result, which was not sufficient to engage an obligation on the Minister to accord procedural fairness to them. The full Federal Court applied the reasoning expressed in a previous full Federal Court case, Pharmacy Restructuring Authority v Martin.[2] The judges in that case said

… we do not know of any general principle to the effect that a statutory authority charged with the duty of considering an application is obliged by the principles of procedural fairness to notify and hear everybody whose economic interests may be damaged by an approval. To promulgate a general rule imposing such an obligation would be to visit upon statutory decision-makers a potentially massive task of indeterminate reference.

This reasoning held even though the Minister had the option under s 90D(1)(b) of advising any other person of the Mahonys’ request and inviting comment or information from the person advised. The section does not compel the Minister to advise, it merely allows the Minister to advise at her discretion. She chose not to do so.

So, the moral of the story is, buyer beware.

 

[1] Kong and Others v Minister for Health and Others (2014) 227 FCR 215.

[2] (1994) 53 FCR 589.

Euthanasia – Commonwealth and State

Constitutional law, Health law, Northern Territory law

Euthanasia prohibition

Potassium-chloride-unit-cell-3D-ionic   Potassium chloride (KCl)

For the sake of argument, if South Australia passed the (currently fictitious) Euthanasia Act 2015 (SA) allowing doctors to euthanase patients under strict conditions: assuming it was politically possible, how could the Commonwealth try to defeat it by legal means?

Firstly, through the use of Constitution s 51(xxiiiA) which gives the Commonwealth power to make laws with respect to the provision of medical services. The Commonwealth could pass a law stating that the medical service of euthanasia is criminal and tantamount to murder. Most criminal law is a State and Territory responsibility, but the Commonwealth can make criminal laws for areas within its constitutional limits. There would be an argument about whether or not euthanasia is a medical service but if the Commonwealth Parliament defines it as such and South Australia’s law says euthanasia can only be authorised and performed by medical practitioners, then it seems fairly clear that it would be a medical service. As further evidence, sections 6 and 7(1)(m) of the disallowed Rights of the Terminally Ill Act 1995 (NT) (ROTTIA) mention reasonable payment for medical services in connection with euthanasia.

Secondly, through the use of the trading corporations power in Constitution s 51(xx). This gives the Commonwealth power to prevent trading corporations from engaging in practices it disapproves of. A doctor employee of a practice that has a corporate structure of some kind would be caught by this. Even solo practice doctors often have some sort of corporate structure behind them, to protect their assets in case of a lawsuit.

What about hospital doctors? Is a State hospital a trading corporation? Quite probably: it’s a question of its activities[1] rather than its formal constitution. If an entity engages in trade of any kind, it’s likely to be a trading corporation within the meaning of Constitution s 51(xx). In E v Australian Red Cross Society[2] the Royal Prince Alfred Hospital in Sydney was found to be a trading corporation. On appeal[3] this part of the decision was not challenged and overall the appeal failed.

Thirdly, the Commonwealth could enact the International Covenant on Civil and Political Rights[4] as law or at least

Article 6.1     Every human being has the inherent right to life. This right shall be protected by law. No one shall be arbitrarily deprived of his life.

Currently the Covenant is Schedule 2 of the Australian Human Rights Commission Act 1986 (Cth), which gives the Australian Human Rights Commission (AHRC) the power to make a noise, but not much else. Granted, the AHRC cannot have any judicial function in itself because of the constitutional ban on anyone except Chapter III[5] judges having that power,[6] but the Act could have given the AHRC powers to refer matters to a court for determination. The Commonwealth could give the AHRC power to refer euthanasia cases to the Federal Court using Article 6.1.

But is voluntary, properly certified and consented euthanasia an arbitrary deprivation of life? It seems unlikely, given that the safeguards in ROTTIA are certainly going to be replicated (or even stronger ones possibly) in any future legislation that can be imagined. This could be the reason that the Covenant wasn’t even mentioned in the court case about ROTTIA, Wake and Gondarra v Northern Territory and Asche.[7] Justice Angel was of the opinion there is no such thing as a right to life[8] (and he was a dissenting judge who wanted to disallow ROTTIA).

Fourthly, the Poisons Standard 2015 (Cth) could be amended to include a caveat that no scheduled poison can be used for euthanasia purposes. However, this is easily got round by a State, as poisons law is within the States’ powers and the Poisons Standard 2015 (Cth) is only incorporated into State law by reference, meaning South Australia could simply remove that caveat.

Fifthly, there is a constitutional point. In Wake and Gondarra, the plaintiffs submitted that a panel of medical practitioners had acquired a degree of judicial authority: that by agreeing that someone should be euthanased, they were acting as judges and deciding a case. This failed completely, as the Chapter III separation of powers doesn’t apply in the Northern Territory.[9]  It would probably fail in South Australia too, as the separation of powers there is not as strict as the Commonwealth’s.[10] However, to be on the safe side, South Australia should add a provision to their hypothetical Act allowing a quick judicial review of a decision to euthanase a person on the application of an interested party. ROTTIA lacked this, which gave rise to the failed attack described above.

In conclusion, it seems likely that the Commonwealth could make ineffective a State law legalising euthanasia. There would have to be careful drafting of any such law, and no doubt a High Court case to follow. Whether it would be worth the political fight is another question – the Northern Territory only had one vote in the Commonwealth House of Representatives at the time of the disallowance of ROTTIA and only two votes in the Senate, so the political cost was low. States have far more votes in both Houses.

I should welcome comment – tell me my law is wrong or correct, I don’t mind. Just be polite…

[1] R v Judges of the Federal Court of Australia and Adamson; Ex parte Western Australian National Football League (Inc) and West Perth Football Club (1979) 23 ALR 439.

[2] (1991) 99 ALR 601.

[3] E v Australian Red Cross Society and Others (1991) 105 ALR 53.

[4] International Covenant on Civil and Political Rights, opened for signature 16 December 1966, [1980] ATS 23 (entered into force for Australia 13 November 1980, except Article 41 which entered into force for Australia 28 January 1993).

[5] Constitution ch III.

[6] Brandy v Human Rights and Equal Opportunity Commission and Others (1994) 183 CLR 245.

[7] (1996) 109 NTR 1.

[8] (1996) 109 NTR 1, [38] (Angel J).

[9] R v Bernasconi (1915) 19 CLR 629.

[10] Constitution Act 1934 (SA).

Codeine

Health law, Pharmacy law

This drug is available in pharmacies in various forms. As a pharmacy only or pharmacist only medication it’s one of the ingredients in such things as Codral® Cold & Flu tablets, Panadeine® or Nurofen Plus®.

Unfortunately, because it’s an opiate, related to morphine, it has the potential for addiction. Some people do get hooked on it, and start to shop around, buying multiple packets of, for example, Nurofen Plus® (or its generic equivalent ibuprofen + codeine) at various pharmacies. Each pharmacy is ignorant of the other purchases, and therefore can’t do much to help the addicted person. In a one-pharmacy town it becomes more obvious and something can be done – a contract with the person for instance.

Ideally, a real-time database should be set up to monitor sales of codeine products, in much the same way as Project Stop monitors pseudoephedrine sales. (If you’ve ever been asked for photo ID when buying cold medication, you have met Project Stop). The national e-Health record might do the job, but it is a slow process getting it rolled out effectively.

However, there is a another way of controlling codeine, and that is to make it prescription only, by moving it into schedule 4 of the Poisons Standard 2015 (Cth). The Advisory Committee on Medicines Scheduling has recommended that this happen, and has invited comment on its interim decision. Submissions close on 15 Oct 2015.

I can see both sides of the coin here. Codeine is addictive: the fact that it is only available easily to the public in combination with other drugs means that the risk of adverse effects is increased. I have seen an ibuprofen + codeine multiple purchaser end up in hospital with a gastric bleed – only after the event was it discovered that they were taking far in excess of the safe ibuprofen dose, shopping at many pharmacies. Gastric bleeding is a known adverse effect of ibuprofen.

On the other hand, when used properly as a temporary pain killer or cough suppressant, it is useful. But individuals have quite varied responses, with some being non-responders, and others being very sensitive and at risk of respiratory depression (especially children and breast-fed babies of very sensitive mothers). In small doses it’s a waste of time, and opiates generally aren’t great painkillers for headaches.

If the schedule 4 ruling is made definite, then doctors are probably going to have, at least at first, a lot of requests for prescriptions for these medicines. Add this to the proposed removal of over-the-counter pain killers from the PBS, and life will get interesting for pharmacies over the next year or so, and more expensive for the consumer.

The Difference between a State and a Territory

Constitutional law, Health law, Northern Territory law

Euthanasia in the Northern Territory

248px-Pentobarbital.svgPentobarbitone

This is an emotive subject, but one which needs to be discussed at least periodically. I started looking at the law involved in either preventing it or allowing it and quickly realised that this is not only a can of worms, it’s bigger than Ben Hur – and also very interesting. It throws up all sorts of legal questions to do with domestic and international law. Certainly more than one single blog article can cope with, so I’ll deal with it in chunks.

To start with, euthanasia law illustrates very well the difference between a Territory and a State.

In 1995, the Northern Territory passed the Rights of the Terminally Ill Act 1995 (NT) (ROTTIA), a law designed to allow euthanasia under certain prescribed circumstances. It commenced on 1st July 1996.

Less than a year later, on 27th March 1997, the Euthanasia Laws Act 1997 (Cth) came into force. This in turn immediately amended the Northern Territory (Self-Government) Act 1978 (Cth) to remove the ability of the Northern Territory’s Parliament (and those of other Territories too) to make laws on euthanasia. It also specifically nullified the Rights of the Terminally Ill Act 1995 (NT).

NB – ROTTIA is not repealed – it still exists on the statute book. The interesting question is “What happens if the Northern Territory becomes a State?” Other commentators seem to have assumed that ROTTIA is dead and buried, but I’m not so sure. If the Northern Territory becomes the State of Northern Australia, unless the legislation converting Territory to State specifically addresses the issue, it may be that ROTTIA will be reactivated – cue the High Court.

States’ laws cannot be overridden by the Commonwealth except in accordance with Constitution s 109, under which an inconsistency will be decided in favour of the Commonwealth. The Commonwealth law must also be within the powers granted to it by the Constitution.

On the other hand, under Constitution s 122, the Commonwealth can make whatever laws it likes regarding Territories. Which is how the Commonwealth could do what it did.

Must you save a life?

Health law, Northern Territory law

In the Northern Territory, must you use an Epipen® on a stranger when you see it is necessary to save that person’s life?

  • The short answer is “yes”, but not always.
  • At common law there is no duty to rescue:

The classic example of the absence of a legal duty to take positive action is where a grown person stands by while a young child drowns in a shallow pool. Another instance is where a person watches a nearby pedestrian stroll into the path of an oncoming vehicle. In both instances the callous bystander can foresee serious injury if he does nothing. … All that would be called for is the simplest exertion or a warning shout. Despite this, the recognised legal position is that the bystander does not owe the drowning child or the heedless pedestrian a duty to take steps to save him. Something more is required than being a bystander. There must be some additional reason why it is fair and reasonable that one person should be regarded as his brother’s keeper and have legal obligations in that regard.[1]

This was confirmed in 2009 by the High Court.[2]

  • However, the Criminal Code (NT) imposes a criminal penalty thus:

Any person who, being able to provide rescue, resuscitation, medical treatment, first aid or succour of any kind to a person urgently in need of it and whose life may be endangered if it is not provided, callously fails to do so is guilty of a crime and is liable to imprisonment for 7 years.[3]

  • There are defences:

A person is not guilty of an offence if any act, omission or event constituting that offence done, made or caused by him was authorized, justified or excused.[4]

and/or

Subject to the express provisions of this Code relating to self- defence and duress, a person is excused from criminal responsibility for an act or omission done or made under such circumstances of sudden and extraordinary emergency that an ordinary person similarly circumstanced would have acted in the same or a similar way; and he is excused from criminal responsibility for an event resulting from such act or omission.[5]

  • The good news is that If you act as a Good Samaritan, you will not be liable for any harm you might inadvertently cause (unless you were reckless or intoxicated).[6]

 

  • So in summary, you are unlikely to be sued successfully for a civil wrong if you have an Epipen® but don’t use it on someone to save their life, but you might go to jail.

 

[1] Stovin v Wise (1996) AC 923, 931 (Nicholls LJ).

[2] Stuart v Kirkland-Veenstra (2009) 237 CLR 215.

[3] Criminal Code Act 1983 (NT) sch 1 s 155.

[4] Criminal Code Act 1983 (NT) sch 1 s 23.

[5] Criminal Code Act 1983 (NT) sch 1 s 33.

[6] Personal Injuries (Liabilities and Damages) Act 2003 (NT) s 8.

Epipen®

Health law, Northern Territory law, Pharmacy law

Can a bystander in the Northern Territory with no connection to an afflicted person administer an Epipen® to that afflicted person to relieve an anaphylactic reaction?

Epipen Adult.1

  • The short answer is “yes”
  • Epipen® is a brand of adrenaline injection for emergency use when a person suffers a severe allergic reaction (anaphylaxis). It is a schedule 3 medication[1] which means it can only be legally supplied to the general public on their own authority by a health practitioner.[2] It can be administered by a health practitioner or an approved ambulance officer in the course of their duties.[3]
  • The good thing is that in the NT, anyone can administer a schedule 3 medication to anyone else in accordance with the instructions given by a health practitioner at the time it was supplied.[4]

Guidelines for adrenaline autoinjector prescription

How to give Epipen®

[1] Poisons Standard 2015 (Cth) incorporated into NT law by Medicines, Poisons and Therapeutic Goods Act 2012 (NT) ss 7, 16.

[2] Medicines, Poisons and Therapeutic Goods Act 2012 (NT) s 72.

[3] Medicines, Poisons and Therapeutic Goods Act 2012 (NT) s 64.

[4] Medicines, Poisons and Therapeutic Goods Act 2012 (NT) s 75.