I was having a conversation about this with my father-a retired pharmaceutical industry executive-a few weeks back, about why certain generic prescription medication formulations were unavailable in Australia yet sold in New Zealand. He explained to me that the Australian pharmaceutical regulator (the TGA) and its New Zealand equivalent (Medsafe) had very different regulatory philosophies. Medsafe, if a major international regulator (such as the US FDA or the EU’s EMA) had already approved something, they’ll just approve it too (“if it is good enough for them it is good enough for us”); the TGA’s attitude was very different, just because the FDA or EMA had approved it didn’t mean they automatically would, they wanted to analyse the safety data for themselves and make up their own mind. For blockbuster patented drugs, the extra regulatory cost of Australia was worth it, but for the long tail of miscellaneous generic formulations, the extra cost of dealing with the TGA could make some of them financially nonviable.

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tehjoker 6 hours ago | parent [-]

Medsafe's strategy only works so long as there is at least one stringent regulator though.

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AuryGlenz 5 hours ago | parent [-]

I would think for a country like Australia a more moderate approach would be to approve things that were approved by other countries and have been in use for some amount of time - say, 5 years or so - apart from the things they directly approve.

	▲	skissane 5 hours ago \| parent [-]
		The actual drug my father and I were discussing was clonidine. In the UK and New Zealand, they sell 25 microgram clonidine tablets; in Australia, the smallest dose on sale is 100 micrograms. Clonidine is a very old drug – it was released back in the 1960s. The risks involved are very well understood (arguably the biggest risk is fatal overdoses, but patient/parent education is the accepted mitigation strategy.) The issue is, in Australia, it is only approved for treating high blood pressure in adults. Paediatricians and child psychiatrists commonly prescribe it for ADHD, and for anxiety, aggression and insomnia (particularly but not exclusively in the context of ASD); in adults, it is prescribed to treat menopausal hot flushes and migraines – but all those indications are off-label. And this is the problem – given the doses involved, 25 microgram tablets only really make sense for those off-label indications, there isn't much demand for them for treating adult hypertension. So to get the TGA to approve 25 microgram clonidine tablets, you need to prove to them that clonidine is safe and effective for one of those currently off-label indications. And that will cost a lot of money, and given it is a generic medication long out of patent protection, it isn't worthwhile. Whereas Medsafe quite possibly just decided "the UK approved it for X so we will too". As a parent, both of whose children are prescribed clonidine, this annoys me – cutting tablets in half is no fun, and cutting them into quarters is even worse. Or I can get them compounded into liquid by a compounding pharmacist, which makes it easier to measure out smaller doses (I always get 25 microgram/ml), but that adds expense and time (the nearest compounding pharmacy is 15 minutes drive one way). I just wish I could get 25 microgram tablets, but they can't legally be sold in Australia–possibly I could ask our child psychiatrist to apply for special permission to import them from New Zealand, but the amount of bureaucracy involved probably isn't worth it, there's no guarantee the request would be approved, and it would be expensive (it wouldn't be covered by our national prescription drug insurance).