Hard News by Russell Brown


Greens drug policy 2: the animal testing problem

In an earlier post today, I've looked at what is undoubtedly the headline of the Green Party's new drug and alcohol policy: clear proposals for reform on both medical cannabis and cannabis law in general. But there's more there, including one important and tricky issue relating to drug law reform in general.

It's this: the policy refers repeatedly to the Psychoactive Substances Act – as a model – and would task the Psychoactive Substances Regulatory Authority, which was created by that Act, with helping to develop a law aimed at reducing "harm and cost to society and individuals from drug use and abuse" and enhancing "people's capacity for informed choice". It's a real relief to see a policy document that views the PSA in this way, rather than as part of some fevered Peter Dunne-centred conspiracy theory.

Further, the final paragraphs of the policy address the issue of new psychoactive substances:

The Green Party recognises that we have entered a new age in which specific, individuated regulation for new psychoactive substances cannot keep pace with the advancements and modifications made by producers. It is thus impractical to regulate individual substances by their specific chemical composition, and a more nuanced approach that utilises evidentiary licensing bodies like the Psychoactive Substances Regulatory Authority (PSRA) to measure actual harm is needed. In Government, the Green Party would:

  1. Require all manufacturers of recreational psychoactive substances to go through the PSRA’s licensing process and establish their harmfulness before deciding whether to allow their products to be sold in New Zealand.

  2. Task the PSRA with monitoring recreational drugs that have been approved for sale, so that reliable evidence can be collected about ongoing harm from drug use, and the wider social impact of a drug's availability can be counted in an evaluation of its harmfulness. 

Which is essentually what the Psychoactive Substances Act was designed to do.

But in a panicky amendment in May 2014, Parliament essentially disabled the PSA by foreclosing its interim product licensing period and, crucially, adding wording that stipulated that "the advisory committee must not have regard to the results of a trial that involves the use of an animal".

And that's a problem. From my November 2014 story on the fortunes of the Act for Matters of Substance:

“Our overarching assessment, not just in the offices of the Psychoactive Substances Regulatory Authority but also on our expert advisory committee, is that, at this point in time, it is not possible to have a product approved without animal testing,” says Stewart Jessamine, group manager at the clinical leadership and product regulation branch of the Ministry of Health and effectively the personal link between the Psychoactive Substances Regulatory Authority and its new neighbour, Medsafe.

“Obviously, that’s a major barrier to new products entering the market.”

Other interested parties speculated to Matters of Substance about possible workarounds, but as of now, the situation is this: the process created to approve and license psychoactive products – thus taking manufacture and sale out of the hands of the unregulated black market – cannot possibly approve or license any product.

And further:

Jessamine says that, in defining a standard for product approval, the authority and its advisory group have looked at existing manufacturing and safety standards, taking over-the-counter medicines as a starting point.

“That takes us into a series of international guidelines that say, ‘If you wish to introduce a new substance into an over-the-counter medicine, here is all the testing you have to do. It starts with simple stuff: how is it absorbed, how is it metabolised, how is it excreted? What is a toxic dose, what is a safe dose? Does it cause reproductive problems? Does it cause genotoxic problems?

“It then sets out a series of tests you can use to demonstrate those things. Those tests are set by boards of international regulators, which have animal welfare input as well. And some of the testing is still animal-based. There are a number of key issues where animal testing is still an essential part of the assurance of the safety of the substance.

“Our assessment here is that, whilst there’s a whole bunch of new technologies coming along that have been assessed and validated as accurate predictors of risk 
(as old-fashioned animal tests) and have been accepted into the standards required for medicines, foods and chemicals, there are some areas where there are no non-animal testing validated tests available at this point in time.”

Green MP Mojo Mathers helped champion the animal-testing amendment, and the party clearly isn't going to go back on that. But it appears that the ban hadn't been recognised as an issue until I put it to Julie Anne Genter this week. She confirmed the party's stance on animal testing and undertook to come back to me with a full answer on the issue, which she did:

Our policy states in Specific Policy Point 2: our intent is to use objective and health-centred legislation along the lines of the Psychoactive Substances Act 2013 to re-evaluate the relative harms and appropriate legal and regulatory status of psychoactive substances.

To that end, we will instruct the Ministry of Health to work alongside the Psychoactive Substances Regulatory Authority to develop integrated, effective legislation.

The PSA 2013 does have a review built in to it, and we would expect that review and additional work by officials to identify any shortcomings or problems with the existing regime, and evaluate potential solutions.

As I understand it there is disagreement amongst scientists about the suitability and availability of alternatives to animal testing. We supported the ban on animal testing after receiving robust scientific evidence that that are alternatives for each of the tests initially required for the purposes of testing the safety of recreational psychoactive substances. There is strong public support for banning animal testing on recreational drugs.

We would expect the evidence to be reviewed as part of our work on the new regulatory regime. The very thorough testing required for medicines (regulated under the Medicines Act) does require animal testing, and we support that where there is no alternative. However, it may not be appropriate or necessary for testing the safety of recreational drugs to undertake all the tests required for medicines, in which case we would expect the new legislation and regulation to reflect that. (As an example, alcohol almost certainly wouldn’t make it through the current testing regime for psychoactive substances.)

You might be able to get the public to buy into different standards of safety for therapeutic and recreational drugs, but it would be a far, far harder road through MedSafe. And Jessamine has a point: why would the standard of safety for a drug you expect people to take be different depending on their reasons for taking it?

On the other hand, is the overall goal of harm reduction fulfilled by a law whose standards are too high to meet? It's quite likely that if cannabis products went through such a process – and that's not a bad idea in itself – nothing intended to be smoked would pass muster (Jessamine suggested to me that “vapouriser-type solutions would have a much better show).

It's possible that technologies that fulfill all the risk-prediction roles currently represented in animal testing will be available in around five years. Maybe.

Genter did confirm to me that the Greens' proposed PSA-like law could be made applicable to drugs currently controlled under the Misuse of Drugs Act, which would fix probably the greatest problem with the original act: that being that in specically not applying to any already-controlled drugs it privileges the newest and weirdest drugs, the ones not captured even by the  very broad analogue provisions of the MoDA. That's a very counter-intuitive – and objectively bad – thing to do.

So, the Greens deserve real credit for for going into this space, especially given the political potential for being accused of wanting to legalise P, or something. But in doing so they've bought into something of a philosophical quandary.

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