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Psychedelics import deal struck as activists move ahead of regulators

A deal that paves the way for Australia’s biggest importation of psychedelic drugs has been struck by a charity pushing the new therapy.

There are currently no approved products containing psilocybin, the active ingredient in magic mushrooms.
There are currently no approved products containing psilocybin, the active ingredient in magic mushrooms.

A deal that paves the way for Australia’s biggest importation of psychedelic drugs has been struck by a charity pushing the therapy, with a Canadian manufacturer pledging to “provide financial assistance to marginalised Australians” to help them access MDMA and psilocybin.

Pharmaceutical manufacturer Optimi Health has been granted a permit to export MDMA and psilo­cybin capsules to supply authorised prescriber psychiatrists after Australia became the first in the world to change its drugs’ scheduling to permit the prescribing of MDMA for the treatment of post-traumatic stress disorder and psilocybin for treatment-resistant depression.

The charity Mind Medicine Australia has an exclusive supply agreement with Optimi. About 160 doses of psychedelics will arrive in Australia imminently but there are currently no approved products containing psilocybin or MDMA, including these imports, that the Therapeutic Goods Administration has evaluated for quality, safety and efficacy.

Ten Australian psychiatrists have authorised prescriber status, with many more having completed training programs provided by MMA, which lobbied the TGA vigorously for the change in scheduling.

The first patients underwent psychedelic therapy this year.

The charity, headed by opera singer Tania de Jong and her investment banker husband Peter Hunt, has a small pharma subsidiary to underwrite the financial risks of importing the drugs in Australia, which are distributeddomestically to an MMA-created pharmacy network connected to Australian prescribers.

The moves towards commercialisation of psychedelic drugs by the charity’s founders has sparked controversy within the ranks of mainstream psychiatry.

Many are critical of such organisations attempting to control the import, distribution and sales of a single drug, as well as the professional training of clinicians. These trends are also firmly in the sights of medical regulators.

MMA has moved to establish a Patient Support Fund to assist people to access psychedelics, in the absence of any government subsidies for the therapy.

Optimi Health, which is the largest certified psychedelics manu­facturer in the world, says it will be contributing to the assistance fund, which will support those on low incomes and marginalised patients to access psychedelic therapy. It is planned that the fund will subsidise up to 50 per cent of the treatment of eligible patients.

A course of psychedelic treatment now costs between $10,000 and $15,000, with much of the cost associated with the requirement for two clinicians to be present for many hours over the therapy’s course of three all-day sessions, in which patients take psychedelics and then receive psychotherapy in an altered brain state.

Optimi said it was contractually obliged under its partnership with MMA to provide Australia with the lowest-cost psychedelic drugs. “Affordability and accessibility is the backbone of our partnership; we intend to deliver on that commitment by offering MDMA and psilocybin capsules at the most cost-effective price in the market,” Optimi chief executive Bill Ciprick said.

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Original URL: https://www.theaustralian.com.au/science/psychedelics-import-deal-struck-as-activists-move-ahead-of-regulators/news-story/792c424fda565279ff928563e3961e16