|
Starting on July 1st, MDMA and psilocybin will be rescheduled and legalized in Australia for the treatment of PTSD and treatment resistant depression respectively, making Australia the first country in the world to officially recognize and regulate the medical use of these psychedelic drugs. The announcement was made on February 3rd by the Australian government’s Therapeutic Goods Administration (TGA) which is equivalent to the European Medicines Agency. The decision acknowledges the lack of options for patients with treatment-resistant mental illnesses and specifies that “prescribing will be limited to psychiatrists, given their specialised qualifications and expertise to diagnose and treat patients with serious mental health conditions, with therapies that are not yet well established”. The TGA also states that clinical trials with psychedelics have shown promise when they are used in combination with psychotherapy conducted in strictly controlled medical settings. The two indications for which psychiatrists will be able to prescribe these two psychedelics align with the most mature clinical research for each: MDMA for treatment-resistant PTSD and psilocybin for treatment-resistant depression. If “sufficient new evidence” emerges regarding the efficacy and safety of these two drugs in other conditions, the agency will consider applications to make further amendments. The move will also reduce the regulatory burden on researchers looking to conduct clinical trials in these conditions. One year earlier, the Australian government announced a $15 million grant to support psychedelic research through seven clinical trials testing the use of potential breakthrough combination therapies to treat debilitating mental illnesses. See the links to the TGA’s announcement and related materials here: The TGA announcement took place soon after the PAREA’s Chair Prof. David Nutt 3-week visit in Australia in November 2022 during which he advocated for the use of psychedelic-assisted therapies. Prof. Nutt gave numerous talks around the country and met with the TGA and federal Health Minister. The TGA specifically mentioned Prof. Nutt's presentation from November in their materials supporting the decision to allow medical use of psychedelic drugs. Mental health problems, such as depression and anxiety disorders affect
more than one in six people across the EU in any given year, with an annual cost of €600 billion – or more than 4% of GDP. 32 million (7%) affected people suffer from chronic depression and the majority of them don’t respond to existing treatments. PTSD affects 8 million Europeans.
|
