As I’m a software developer I love edge cases… well, when I don’t have to deal with them anyway. Over the years I’ve learnt about the various types of business that exist in New Zealand. It’s a bit esoteric, but interesting to me so I’m going to write about it!
The most common businesses are sole traders - a person, partnerships - several people, and limited liability companies - a legal entity that pretends to be a person until you try to put it in jail. So here are some examples of none of the above!
First, lets look at the AA (or the New Zealand Automobile Association, inc. Not Alcoholics Anonymous). The AA is an incorporated society, this is a type of member-owned business that has to operate for the benefit of its members. Everyone who pays for an AA membership ‘owns’ part of the AA while their membership lasts, and everything the AA does must be for the benefit of its members - in the AA’s charter this is providing roadside assistance and advocacy for motorists. In addition an incorporated society cannot make a profit, and can only retain surplus funds if there’s a justification. In reality the AA’s main business is selling its membership database, but this subsidises the roadside rescue. Which is contracted out to the lowest bidder…
OK. What next? Fonterra! Fonterra is a producer co-operative*! This is another type of membership-owned* business, with ownership of the company being granted in proportion to the member’s contribution*, in the case of Fonterra the amount of milk each farmer produces* defines their ownership*. Unlike an incorporated society, a co-operative does make a profit, but this must be distributed to its members. So Fonterra’s job is to make the most money for the milk produced as they can, which is then distributed back to the CEO’s pocket the farmer’s in proportion to their ownership*.
What’s with the *s? Fonterra is weird and has special laws that make it different to other co-operatives. But for other producer co-ops like Tatua (dairy), Zespri (the kiwifruit people!) and the co-operative I used to work at, Ion Technologies (software consulting), don’t have the *s, though the exact way contribution determines ownership varies.
Speaking of co-operatives, The Co-operative Bank is a co-operative. It’s in the name! However it’s a consumer co-operative - it’s owned by everyone who deposits money in the bank, and consequently all profits get distributed back to the account holders rather than siphoned off to Australia (For anyone who knows a bit about finance, this sounds a lot like a credit union… but the Co-operative Bank, or rather its predecessor PSIS, is specifically excluded from being a credit union by law). Farmlands is also a consumer co-operative, the members are farmers who use their collective buying to get better deals.
What’s next? Another sort of co-operative! They’re everywhere! Foodstuffs - New World, PAK’nSAVE, Four Square etc - is a co-operative. Actually it’s two, one for the North Island and one for the South Island. So are ITM and Mitre10, but these are all vendor co-operatives. Their co-operative combines bulk purchasing and centralises advertising and branding to get a better deal for the store owners - not the consumers!
One last one, Southern Cross Health Society. It’s not an incorporated society like the AA, and it’s not a for-profit company. It’s a Friendly Society, which is yet another kind of member-owned business, but for specific kinds of mutual insurance. Unlike a for-profit insurer whose goal is to take in more fees than it pays out, Southern Cross has a legal obligation to only take in exactly as much as it pays out each year (plus administrative overheads). This is significant as some people regard for-profit insurance as gambling, but a Friendly Society is mutual aid.
Friendly Societies are regulated by the Friendly Societies and Credit Unions Act 1982. Credit unions? Yes, this is the act that specifically says The Public Service Investment Society Limited, or PSIS, or now the Co-operative Bank, isn’t a credit union, despite walking and quacking like one. Why? Alas I’m not a lawyer.
After my last post I feel it’s a good idea to go over the dangers of doing DIY HRT. I’m sure most people are aware, but it’s one of the things that can’t be overstated. If you’re thinking about DIY then it pays to be aware.
The biggest risk is the product. Without proper certification you have no way of knowing what standards the product is made to, if the ingredients are pure, or if it’s safe to use at all. While they may be as good as licensed pharmaceutical companies you can’t be sure of this and they have no accountability for the product made. Despite what doctors here in New Zealand think, even compounding pharmacies have oversight.
If you have access to a commercial lab you can validate the products, and some people do this, but it’s an expensive option.
Secondly, if you’re taking medication without oversight from a medical professional they may unknowingly prescribe something with a bad interaction. This is unlikely with hormones but it’s definitely a risk.
And finally, it’s illegal, at least here in New Zealand. Possession of prescription medicines without a valid reason (eg a prescription for yourself or your dependant) is an offence, though I’ve never heard of anybody prosecuted for non-controlled substances. Same goes with importing them, though again if it’s not a controlled drug and it’s your first time it probably won’t be severe.
Of course if I do decide to get my own HRT I won’t write about it or where I get it from
Starting my transition journey was pretty easy everything considered, I started later in life and had no (recorded) mental health issues which eliminated a lot of the gate-keeping. It still took four months from telling my doctor I wanted to start HRT to getting it because of Process.
Living in Auckland the main clinic is Auckland Sexual Health Service (ASHS), and as most GPs are not familiar with transgender healthcare they often forward questions to ASHS. ASHS have a very particular view of what transitioning looks like, at least for transfeminine people - you will be binary transgender and aiming for gender-confirmation surgery (even though that’s essentially not available…). If you step outside that box the best you’ll get is “this is our recommended treatment” with no change, the worst is refusal to provide HRT.
Once I started HRT the problems started appearing. It was plain sailing for the first year, I didn’t encounter the problems I hear a lot. I started oestrogen and testosterone blockers at the same time - having no dominant sex hormone is a recipe for depression, and I stepped up to the full dose of oestrogen within a year. I even switched anti-androgens between cyproterone acetate and spironolactone a couple of times before settling on spironolactone without an issue.
Then I wanted to look at progesterone. I know progesterone is controversial, the scant research that has been done on trans women is inconclusive, but anecdotal reports said it has effects I was looking for and as bio-identical progesterone is now available the risk is minimal. The answer I always got was “there is no evidence it has any effect”, which is true but omits that there’s no evidence that it doesn’t. I eventually found a sympathetic GP who’d prescribe it to me, but it was a mission to get there and only oral progesterone is available in NZ (see my rant about Medsafe) which has far lower bioavailability (about 5%) compared to transdermal delivery. Synthetic progestins have better oral availability, but they have other problems.
As part of that I switched to oestrogen patches from pills to give more consistent, and hopefully higher, hormone levels. I was looking at switching to injected oestrogen for better absorption but it turns out that ASHS are using their position to force GPs away from prescribing injections rather than considering patient wishes. ASHS have also instituted an arbitrary limit of 500pmol/L of oestadiol even though many other countries consider 1000pmol/L the limit - or rather levels above this as supra-physiological. This is important as high oestrogen levels are clinically linked to blood clots. My level on patches is around 450pmol/L at the moment.
After a year on patches my skin is getting quite irritated though, and that coupled with the patch shortage has made me consider switching to injections again. Pills affected my liver, so I’d rather not go back on them.
It’s also notable that the only oestrogen for injection sold in New Zealand is oestradiol valerate, which requires twice-weekly injections and has a rather rapid release profile. Other esters like oestradiol cypionate and oestradiol enantate have much longer life and and only need injections fortnightly. See Medsafe again.
So that’s where I ended up. I can’t get the oestrogen levels I’d like on pills, the patches irritate my skin and aren’t available, and progesterone isn’t available in the form I’d like. I don’t want to DIY this, it’s far more risky than the approved medicines, but if they refuse to prescribe and the alternatives are not working what else can you do?
If the specialists who control HRT considered patient wishes rather than their own opinions we wouldn’t have as many people on DIY and I certainly wouldn’t be considering it. I don’t think they should be changing the standard regime, but when somebody asks for injected oestrogen or progesterone then they should follow the informed consent process - let us know the risks and alternatives and make our own decision about our bodies.
I’m going to start a series of blog posts here, hopefully with contributors to show the extent of the problems faced for transgender people in New Zealand. It’s far from the worst place in the world to transition, but we could do so much better.
I intend to cover:
Lack of access to medications with low risk profiles such as bio-identical progesterone.
Refusal to consider injected oestrogen even in the face of shortage of oestrogen patches.
Incorrect dosing of medications with high risk profiles at inappropriate doses, like prescribing 100mg of cyproterone acetate for over a year.
Requiring people to go on extended periods with no sex hormones.
Gatekeeping transition with mental health requirements.
Dismissal of non-binary transition goals.
Extended wait times for consultations.
The lack of medical autonomy granted to transgender people.
And what ever else comes my way.
Why?
Hopefully I can get enough voices to get some attention. It’s very hard to find out who makes the policies or give them feedback, so shaking the tree a bit might get us heard. My goal is to improve access to medication options so people aren’t forced to DIY to get the transition they desire.
Contributing to this series
I can’t just tell my own story - that would be boring. I would like to hear from others in the New Zealand community about the problems they’ve faced, or if they’ve opted out of the medical system and are doing DIY hormone therapy. All contributions will be held in confidence, I don’t need your real name if you don’t want to share it.
You can contact me via Mastodon (or other activitypub platforms), @sitharus@cloudisland.nz or @blog@thea.hutchings.gen.nz, via email at transgendernz at thea.hutchings.gen.nz, or via the comment form on this blog (just between you and me, it doesn’t check the name or email fields).
After a lot of swearing, grumbling, trial and error this blog is now an activitypub publisher!
So far you can follow and get new post notifications, but replies and anything else aren’t processed (including un-follows…). Next on the list? Maybe. I also need to add an avatar.
When I get replies working I think I’ll integrate them in to the comments if the note is set as public. Non-public replies won’t be shown of course.
And I need to automate the publish runs, right now it’s all manually triggered… And switch to tokio instead of async-std.
Anyway, you can check out the source at https://github.com/sitharus/blog if you want to see how the fediverse works, though I’m sure I’m totally not spec compliant.
Medsafe is New Zealand’s medication regulatory authority. Except in a few cases all the medications on sale in New Zealand, and certainly any you see on shelves or advertised, have Medsafe approval.
This is a very important role - Medsafe ensures medicines meet the quality and efficacy the manufacturers claim, is safe to use in the way the manufacturer has specified, has appropriate guidance for patients and prescribers, and has a secure distribution network.
So why is this a problem?
Medsafe is industry funded. That is, to sell a medication in New Zealand you first have to pay Medsafe for the privilege of approval, supply all the documentation that Medsafe require, and wait for Medsafe to process your application.
This process can cost from NZ$10,000 to over $100,000 depending on the category of medicine. Medsafe do not recognise any overseas approvals.
The end result is unless a manufacturer or importer can justify the cost of Medsafe approval they won’t apply for it. Medications that are perfectly usable are unavailable in New Zealand because the cost is too high. This can be seen with the current oestrogen patch shortage - two brands which are just as effective as the only approved one are being prescribed under Section 29 of the Medicines Act, but they’re unapproved because there isn’t the demand to pay for Medsafe approval.
What about Section 29?
Section 29 allows for registered doctors - not nurse practitioners, dentists, or other medical practitioners who could prescribe an approved medicine - to prescribe medicines without Medsafe approval.
However, when something is prescribed under S29 the name of the patient, prescriber, supplier, and the medicine have to be sent to the supplier, who must store this information and forward on information about the medicine supplied (but not patient details) to Medsafe.
This means any supplier of S29 medicines has to maintain a database of what they’ve supplied and who they sent it to. Which isn’t great for things like hormones…
Additionally doctors seem wary of prescribing under S29 unless they’re really familiar with the medication. I don’t know why.
How could we address this?
Make Medsafe work for the health of New Zealanders, either by funding its work or by recognising overseas authorities. We collaborate with Australia on food regulations, why not medication?
Of course these things take far too long. It was recommended that the maximum length for a prescription be increased from three months to six, and from one to three for controlled drugs. Only the latter has actually happened. At least they’ve dropped the $5 kick-in-the-teeth when you’re sick charge.
With the shortage of Estradot I’ve seen quite a few people wondering what all the different ways medication is described in New Zealand actually mean. What is an unapproved medication? What is a special authority? Hopefully I’ll answer that!
This isn’t an exhaustive list, just the ones you’re likely to see.
Funding (and Pharmac)
Lets start with the funding because it’s the easiest to understand, this comes from Pharmac - the buyer of most medication prescribed in New Zealand. There are four common funding states - unfunded, partially funded, fully funded, and special authority.
I’m only discussing the community schedule which you can handily search online - just put a medication brand or generic name in the search box to find out the funding status.
Pharmac have a set budget so fund the medications they believe will have the most impact for the amount they cost.
Unfunded
This is the easiest one - unfunded medications do not have any funding from Pharmac, you’ll pay the full market price.
Partially funded
Some less-common medications attract partial funding, for example some preparations of povidone-iodine are partially funded, so you’ll pay the market price less the Pharmac funding. For example Betadine Skin Prep attracts a $1.63 subsidy but the remainder has to be paid by the patient.
Fully funded
This is the most common state for medications prescribed in New Zealand. These are the ones that (from July 2023) are free to collect from the pharmacy as Pharmac pays the full cost of the medicine. However…
Funding restrictions
Sometimes there are funding restrictions, generally due to cost of medicine or likelihood of wastage. A great example is the Estradot oestradiol patch. These are funded for a maximum of two per week, or 8 per 28 days, so if you need 200mcg at a time you have to pick up the second pack yourself. Fortunately this is only around $18 per 8 patch box.
These restrictions are only on quantity supplied - either minimum, maximum, or only in whole packs.
For both partially and fully funded medications Pharmac will fund any use, they just pay the pharmacies. However there’s a case where they do care about the reason, so we have
Special Authority
Special Authority funding is for medications where Pharmac only fund for specific conditions or cases. These require a form to be filed with the pharmacy and Pharmac to get the subsidy - which may be full or partial - and a renewal of authority on a schedule. An example that comes to mind is the ADHD medication Concerta. Concerta is only available for patients who have some reason to not take the immediate-release versions, either addiction liability, lack of response, or an allergy to the ingredients (Ritalin IR contains wheat!).
Special Authority doesn’t prevent prescription, only Pharmac subsidy. The Utrogestan brand of micronised progesterone used to be special authority for funding (only specific cases of menopausal HRT) but could be freely prescribed, as long as patients would pay the full price (around $25 for 28 days if I recall).
So that’s funding. However funding isn’t the full picture, what about approved and unapproved? Section 29? These are nothing to do with Pharmac, so now we introduce the other half of the equation, Medsafe.
Approval (and Medsafe)
Medsafe are the regulator of medicines in New Zealand. Most medicines have MedSafe approval and approved indications, but practitioners can prescribe unapproved medicines. So lets look at these
Approved Medicines
Medsafe are an industry-funded government department, this means that if you want an approved medicine in New Zealand you have to pay the Medsafe fee. It costs between $50,000 and $110,000 to get a medication approved, plus the costs of getting the required data in to the format Medsafe need. This means that manufacturer or importer won’t apply for approval for medication unless they think they’ll be able to make their money back.
Unapproved indications
As an aside, Medsafe approval only covers conditions specified in the application for approval. However nothing stops an approved medication being prescribed for an unapproved indication - also known as “off label” - such as bupropion which is only approved as an aid to smoking cessation but is also used as an antidepressant.
Unapproved medications and Section 29 of the Medicines Act 1981
Because approval is industry-driven when they wrote the Medicines Act they realised that sometimes an unapproved medicine will be needed, for example with rare conditions or new medicines before approval is obtained. So Section 29 allows any doctor (specifically a doctor, not a nurse practitioner or pharmacist) to prescribe any unapproved medicine. However this must be reported to Medsafe by the supplier, Medsafe use this to monitor the use of unapproved medicines and direct practitioners to use approved ones where possible.
Section 29 prescriptions are for a named patient and a specific brand, so pharmacies can only supply the exact brand and quantity asked for (or an approved generic substitute, but in general that wouldn’t happen for an S29 prescription).
Additionally Section 25 allows a practitioner or pharmacist to import a medicine not otherwise available in New Zealand.
How this relates to Estradot
Estradot - and oestradiol patches in general - are in short supply worldwide. Estradot is the only patch that is approved for sale by Medsafe, and also fully funded (*with restriction to one pack per month 😞) by Pharmac.
Due to the shortage Pharmac have sourced alternate patches, Estraderm MX and Oestradiol TDP Mylan, but these are unapproved. This means there’s an odd situation where a doctor has to prescribe Estraderm MX under S29, but these are still fully funded because approval and funding aren’t linked. Pharmacies can legally substitute approved Estradot for unapproved Estraderm MX, but not the other way around.
I hope this makes things a little more clear…
An aside - controlled drugs
Completely unrelated to the above, controlled drugs are specified by the Misuse of Drugs Act 1975. There is no prohibition for prescribing controlled drugs - and in fact all classes of controlled drugs are available if hospital only use is considered. Medsafe and Pharmac do not consider the controlled status, only the medical utility. Controlled drugs can be prescribed under S29 if the prescriber can justify the use - this is how medicinal cannabis is currently managed.
Yep that’s right! You can now comment and read the posts on mobile! Technology! And still no Javascript!
For those interested the code is on github. I might write some instructions on how to build it, because you need to build the migrations first since the SQL library checks the SQL at compile time.
And yes the resulting binary is 5MB on my x64 machine, but no dependencies! It still runs pretty fast as well.
Now back to writing posts about things other than the blog…