Transitional arrangements required after review missed legal problems

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The Albanese government is now racing to implement temporary transitional arrangements for non-PBS private clinics dispensing medicines for opiate dependence.

The new arrangements for patients accessing medicines under the Opiate Dependence Treatment (ODT) Program are scheduled to be implemented from 1 July.

Under these new arrangements, patients with opiate dependence will access their reimbursed treatment at official co-payment levels, with PBS-licensed pharmacists paid official remuneration, including staged supply.

The changes will be implemented through a Section 100 (National Health Act 1953) special arrangement.

Recent consultation has triggered alarm from private clinics dispensing PBS-listed medicines for opiate dependence.

The clinics, which currently dispense PBS-listed ODT medicines to around 5,000 patients, will be excluded from formal staged supply payments under the Section 100 special arrangement because they do not have the legal authority to dispense PBS-listed medicines.

Yet it also means that they have been inadvertantly unlawfully dispensing PBS-listed medicines over an extended period.

The Albanese government has announced a transitional arrangement involving the Commonwealth's direct procurement of ODT medicines for private clinics. It is planned to be in place until the end of November, but the information published by the Department of Health and Aged care suggests these patients could still face uncapped private dispensing fees.

The rush to develop and implement a transitional arrangement, barely days before the reform's implementation date, belies the key findings of the two-year post-market review.

The review's consultation processes, including focus groups with patients, consistently identified the important role of private clinics in the ODT Program.

The review's report identified private clinics as critical to any reform. It recommended against listing ODT medicines under Section 85 because it "would exclude many critical dispensing points currently providing ODT medicines, such as both private and public clinics, and correctional facilities."

It recommended a "revised" Section 100 special arrangement to "provide for access to ODT medicines from a range of settings, not just community pharmacy."

Yet it also seems that the review did not fully understand the legal ramifications of this recommendation, given that the recent development of the Section 100 special arrangement has triggered the anticipated demise of the private clinics and the need for a transitional arrangement.

There was some confusion over this issue at Budget Estimates in early June.

In response to questions from independent Senator David Pocock, a health department official said the private clinics could be covered by the new Section 100 special arrangement. However, deputy secretary Penny Shakespeare quickly corrected the official. She said that only an approved pharmacy is lawfully permitted to dispense PBS-listed medicines.

One consequence of the new program for private clinics is the requirement for suppliers and wholesaler-distributors to establish new systems.

In a statement, Aspen, which is a major supplier of methadone, said, "Aspen is endeavoring to contact private methadone clinics to inform them of the transitional arrangements in place. Should you have any questions relating to this, please call the Aspen Contact Centre on 1300 659 646."