Today’s correspondent says:
I was hoping you could clarify some points of concern for me. I have recently come across a post in the … Facebook group discussing pharmaceutical licensing by state governments. This in turn ignited a fierce debate in one of the private chat rooms about state health organisations getting around the TGA rules.
We, as a private provider in NSW have to apply to NSW Health Pharmaceutical unit to obtain a license and permits to purchase, store and administer various medications. I assume this system is very similar in other states. We can only request to have medications on license that have been approved for registration by the federal government’s TGA [Therapeutic Goods Administration].
It is my understanding that state health organisations do not have to abide by this rule and can use certain medications that are not approved by the TGA, intranasal fentanyl for example.
Now that our business is struggling due to CoVID19, I find it especially frustrating that government ambulance services can freely compete with small businesses for the same commercial contracts. In the case of NSW Ambulance for example, they have been given generous exemptions in every aspect of registration and licensing for medication and are also overly represented in the management of various industry groups and regulatory committees.
The questions I bring to you are two different aspects of this.
- Why are state ambulance services exempted from complying with these rules?
- What’s the point of rules and regulations if most of the industry does not have to comply with them?
- How can a publicly funded service, which enjoys these generous exemptions in various fields, bid for the same tenders and take commercial work away from small businesses? Is that not rather unethical?
We know that everyone needs an authority to possess, supply and/or administer a scheduled drug (The last word on scheduled drugs? (September 29, 2019)) and yes that scheme is consistent across Australia.
The Therapeutic Goods Act 1989 (Cth) makes provisions for how drugs are approved and listed for use. Drugs may be prescribed for ‘off label’ use. The TGA says:
Off-label prescribing refers to the use of a registered medicine outside of the indications, dose, route of administration or patient group set out in the TGA-approved Product Information (PI).
The TGA is responsible for ensuring that medicines available for supply in Australia are safe and fit for their intended purpose. The approved indications, as described in the medicine’s PI, have been evaluated for safety and efficacy by the TGA.
The TGA recognises that off-label prescribing may be clinically appropriate in some circumstances, but recommends that such use only be considered when other options are unavailable, exhausted, not tolerated or unsuitable.
Prescribers should discuss the risks and benefits of the proposed treatment with the patient and/or their carers so that they are capable of providing informed consent.
Additionally, the treatment, including its effectiveness and potential adverse events, should be monitored.
In situations where the PI for a medicine is updated in a way that makes continued use ‘off label’, the patient should be informed so they can participate in the decision regarding treatment options.
Intranasal Fentanyl does not appear to be something out of the ordinary; see
- https://pch.health.wa.gov.au/For-health-professionals/Emergency-Department-Guidelines/Fentanyl-Intranasal
- https://www.rch.org.au/clinicalguide/guideline_index/Intranasal_fentanyl/
- https://www.rch.org.au/uploadedFiles/Main/Content/comfortkids/Intranasal%20fentanyl%20%20Master%20presentation%202016%20PDF.pdf
- https://www.pbs.gov.au/pbs/industry/listing/elements/pbac-meetings/psd/2014-03/fentanyl-nasal-spray
Nor does it appear to be ‘off label’:
The NSW government, along with all Australian governments, has adopted the principles of competitive neutrality. They say (NSW Policy Statement on the Application of Competitive Neutrality (2002), p. 23):
The objective of competitive neutrality policy is the elimination of resource allocation distortions arising out of the public ownership of entities engaged in significant business activities: Government businesses should not enjoy any net competitive advantage simply as a result of their public sector ownership.
That policy statement sets out general pricing guidelines to ‘ensure that goods and services sold in contestable markets are costed and priced in a competitively neutral manner’ (p. 14).
Discussion
I can see nothing in the Therapeutic Goods Act and its various regulations nor state poisons laws that suggests that state ambulance services enjoy any exception to the rules.
There is however a clear difference between NSW Ambulance and private providers. First NSW Ambulance maintains a monopoly on responding to triple zero emergency calls. Therefore, NSW Ambulance has to have a capacity to respond to emergencies affecting the entire NSW community, people of all ages, of all backgrounds and all manner of emergencies. This may not be true of private providers depending on their area of operations. It may be that NSW Ambulance paramedics have a clinical need for some drugs that other providers do not.
NSW Paramedics can carry any drugs that the Secretary of Health authorises (Poisons and Therapeutic Goods Regulation 2008 (NSW) r 101 (with respect to schedule 8) and Appendix C, cl 7 with respect to schedule 2, 3 and 4 drugs). (Note that the Regulation refers to the Director-General of Health, but that title has been dropped and the relevant office is now the Health Secretary (Statute Law (Miscellaneous Provisions) Act (No 2) 2015 (NSW), Government Sector Employment Act 2013 (NSW) and Health Administration Act 1982 (NSW) s 8). A private provider also has to have the approval of the Health Secretary to be authorised to possess, supply or administer a scheduled drug (Poisons and Therapeutic Goods Regulation 2008 (NSW) r 170). The second major difference between NSW Ambulance and private providers is that the Health Secretary runs and is responsible for NSW Ambulance (Health Services Act 1997 (NSW) s 67A). No doubt that gives the CEO of NSW Ambulance direct access to the Health Secretary and to the relevant head of the pharmaceutical branch of NSW Health so it may be easier for NSW Ambulance to get approvals to allow NSW ambulance paramedics to carry drugs that the CEO has determined would better improve their service. But at the end of the day, everyone needs the Health Secretary’s approval. There is no exemption for NSW Ambulance.
Conclusion
I was asked:
- Why are state ambulance services exempted from complying with these rules?
- What’s the point of rules and regulations if most of the industry does not have to comply with them?
- How can a publicly funded service, which enjoys these generous exemptions in various fields, bid for the same tenders and take commercial work away from small businesses? Is that not rather unethical?
My answers are:
- I can see no evidence that state ambulance services are exempted from complying with the rules set by, or under, the Therapeutic Goods Act 1989 (Cth) or state poisons legislation.
- In light of my answer to question 1, question 2 is irrelevant.
- State government services are expected to bid for commercial work in a way that is consistent with the competitive neutrality principles that have been adopted by all Australian governments. I cannot say whether NSW Ambulance does that but there are complaint procedures if someone wants to allege that they have failed to do so.
Australian Emergency Law 
In response to my post, my correspondent said:
I want to note that NSW Ambulance enjoy a range of exemptions when it comes to paramedic registration and compliance. They can also access unregistered medicines through the NSW Health Drug and Therapeutics Committee. Neither of those are attainable for the private industry.
I do not know what is meant by ‘a range of exemptions when it comes to paramedic registration and compliance’. The Health Practitioner Regulation National Law applies to paramedics and is managed by the Paramedicine Board, not NSW Health.
As far as I can see there is no such thing as the NSW Health Drug and Therapeutics Committee. The NSW Health Policy Directive Approval Process of Medicines for Use in NSW Public Hospitals (10-Aug-2016) says:
All public hospitals in NSW must have a formally constituted, multidisciplinary Drug and Therapeutics Committee in place, or have access to a Local Health District or Speciality Health Network Drug and Therapeutics Committee. The Drug and Therapeutics Committee is responsible for governing the medication management system, and ensuring the appropriate, safe, effective and cost-effective use of medicines in the health facility, Local Health District or Speciality Health Network.
Notwithstanding the reference to public hospitals, the Directive is said to apply to the NSW Ambulance service. I infer that NSW Ambulance may have a Drug and Therapeutics Committee but as I say, I cannot see that there is a state committee. There is nothing in the directive that says that it applies to NSW institutions because they are exempt laws. It is a directive to allow institutions to comply with the laws. As noted ‘off label’ use is not illegal. There is nothing in that document to suggest a private provider could not have a similar policy save that they probably do not have the resources and are unlikely to be able to do the science required to verify for example whether a new drug, or a new use drug, is of therapeutic benefit.
‘a statement on Facebook, no matter how adamant the writer is, is proof of nothing. ‘. Where did this post say that a statement on Facebook was used as proof? I read this as saying it started a discussion.
Does the Ambulance Service of NSW not enjoy some special conditions to Paramedic Registration? Starting with having their Diploma recognised, paying application fees using tax payer funds, having their senior managers on the actual board, sub-committees and chairing the NSW state board?
A lot of us take what is written here are as the informed opinion of ‘the expert’ on law and ethics. I follow this blog almost weekly, however I must say I sometimes feel a sanctimonious and patronising tone in your comments. Not every emergency services worker or volunteer completed a PhD, and posts are often made out of frustration at an organisation. If more information or clarification is required, this could as well be obtained by asking the original poster.
Noted and thanks Zach; I have made some edits to the post and I apologise if I sometimes write with a ‘sanctimonious and patronising tone’. Important to make sure one is the right frame of mind before writing (as with everything).
Certainly NSW Ambulance does have the advantage that the Diploma of Paramedical Science issued by the Ambulance Service of New South Wales is accepted for registration as a paramedic (Health Practitioner Regulation National Law, s 312). That was a compromise to get NSW to come on board with paramedic registration. I suppose it is both a benefit and a cost to NSWAS. The benefit is that they can take people off the street and start training them and get them on the road to add to their workforce quickly and they get to train them as they want them trained. The cost is that they have to pay for that training, whereas employing someone who’s gone through uni means the student/employee has paid for their own training. Further if NSWAS employs someone and decides that they are not appropriate they have to go through the industrial processes required to terminate someone’s employment. Providing placements to uni students allows an ambulance service to observe them and they can then chose to offer them a job, or not. So the recognition of the Diploma comes with both costs and benefits.
If NSWAS is paying employees registration fees then it comes out of their budget and carries an opportunity cost. A private provider can also chose to pay its staff’s fees and the cost would be the same. When it comes to contracted services (the subject of this post) both services are looking to recover commercial fees.
As for having NSWAS on boards etc there is no question that the jurisdictional ambulance services set the standard that others are measured by and I’m sure that also gives them a competitive advantage if bidding for fee for service work. It is certainly not a free market as private providers not only need the Secretary’s approval for drugs, they need the Secretary’s approval to “(a) directly or indirectly provide or take part in the provision of transport for sick or injured persons for fee or reward, or (b) conduct for fee or reward any operations similar to the operations carried on by the Health Secretary under this Chapter’ (Health Services Act 1997 (NSW) s 67E).
I suppose there is no doubt that being part of NSW Health and therefore part of government does give NSWAS significant advantages but that is what the Competition Neutrality principles are meant to deal with.
I think the definition of “small business” needs to be questioned.
Are they really a small business.
Some own car parking stations, issue parking fines and run other government services.
Others such as Mayne Nickless Health were found out and had a name change to Affinity Health.
No these are not small businesses, but large corporations and in my opinion seeking to skim off the top tax payers money.
I suppose there are many players in the field. Some are small businesses, some are not.
Agree with what Prof Eburn has said. Two separate issues.
Regardless of whether you’re a clinician in private practice or the public health service, everyone has to comply with the federal and state legislation regarding the procurement & storage & prescription of controlled drugs. You can apply like everyone else to gain access to these medications, and ultimately it’s up to the Government to decide if you are allowed or not.
As far as I am aware, NSW Ambulance Service is the only statutory pre-hospital emergency ambulance service for the state. There currently is no need for another emergency ambulance service. I think there’s enough demand to justify engaging private companies for more non-emergency patient transport (NEPT) since a significant proportion of ambulance work is stable patient transfers, and for pre-hospital specialist aeromedical retrieval (CareFlight, Westpac, Toll) where it is more cost effective for the Government to contract private companies to look after helicopters (which the private companies in turn write off as charitable donations tax deductions). You’re welcome to put your bid in and compete other vendors including govenrment based services for NEPT or Aeromedical Retrieval.
My gut feeling is that the Government is disinclined to allow First Aid based or NEPT based private ambualnce companies carry drugs of addiction if there is no need for it given the nature of their work does not require it. Some may dispute this. But I think this is their mindset. Ironically if you want a work around, you could just have a doctor on payroll bring his ‘PBS Doctors Bag’ which would have all the basis resus and narcotics if you required it for that rare case. Maybe in the future Paramedics will be allowed to carry their own ‘bag’. Who knows.
If you have a look at the NSW Health Pharma website you will find a long list of private providers, large and small, that are licenced to carry ‘drugs of addiction’ up to ketamine. The issues we privates face is that NSW Ambulance does not have to play by the same rules as we do.
It’s true that ‘NSW Ambulance does not have to play by the same rules as’ private providers. It’s not a free market for ambulance services.