Department of Health officials struggled to answer questions on the federal government's Opiate Dependence Treatment Program at Friday's Senate Estimates hearing.
The day was an 'overflow' from the hearings held in June.
The hearing, which was held virtually, was dominated by questions about the COVID-19 national immunisation program.
There was limited discussion about the PBS and the proposed reform of medical device pricing with some focus on the recently announced post-market review of the Opiate Dependence Treatment Program (ODTP).
Greens Senator Rachel Siewert, who has been using Estimates to scrutinise the government on the ODTP since last year, asked officials about health minister Greg Hunt's recent responses to correspondence from a key parliamentary committee.
Senator Siewert highlighted apparent inconsistencies between statements in the minister's correspondence and evidence given by the officials at Senate Estimates in October last year.
"I wanted to go to the letter that Minister Hunt wrote to the Senate Standing Committee for the Scrutiny of Delegated Legislation on the 10th of May," said Senator Siewert.
She said the minister "made a commitment to the Office of the Australian Information Commissioner to progress work in 2020 to register a special arrangement for the ODTP program. When we were talking about this last year, you said that you did not have much information or knowledge of the program and its operations, when we first started talking about it, we subsequently had other discussions, how does that fit with what the minister was saying to the Scrutiny of Delegated Legislation Committee?"
First assistant secretary Adriana Platona defended the discrepancy with the claim Senator Siewert's questions in October last year were focused on any relationship between the ODTP and PBS staged supply arrangements under which pharmacists are paid to dispense a monthly prescription quantity in instalments.
"In the first encounter that we had, you asked me about the relationship between one of the community pharmacy programs, the staged supply program and how that works with ODTP, and I had to tell you at that point that I did not know about how the two programs work together to my embarrassment," said Ms Platona.
The 'embarrassment' is confounded by the fact that, at that point, Minister Hunt had already undertaken to address the failure to implement the arrangements through a legislative instrument. This fact, and confirmation the department was aware of the ODTP's non-enforcement through a legislative instrument, was not disclosed during the exchange with Senator Siewert in October last year.
The ODTP is considered a 'special arrangement' under Section 100 of the National Health Act 1953. However, it is the only one of over a dozen PBS special arrangements not enforced through a legislative instrument. Other enforced special arrangements cover chemotherapy, human growth hormone, medicines for assisted reproductive technology and supporting access to medicines for Aboriginal and Torres Strait Islanders.
The lack of a legislative instrument means the ODTP is not lawfully enforced and that raises serious questions about the legality of arrangements that remove the protection of PBS co-payments and the safety net.
Ms Platona said the department attempted to progress a legislative instrument in late 2020 but that stakeholders raised a number of concerns.
"We did not feel that proceeding with a legislative instrument at that point would actually enable those concerns to be worked through, hence the commencement of the post-market review to work through all the issues that have been raised with us," she said.
Ms Platona did not state the concerns raised by stakeholders that led to the decision not to proceed with the legislative instrument. However, BioPharmaDispatch is aware that stakeholders raised a number of concerns, including the discriminatory nature of the special arrangement and the legality of removing basic PBS protections for one group of patients who are considered in law to be living with a disability.
In its 2021-22 pre-Budget submission, the Pharmacy Guild highlighted the fact there are nearly 150 hospitalisations, 14 emergency department presentations and three deaths involving opiate harm every day.
Senator Siewert asked whether any consideration had been given to interim arrangements for patients accessing treatment through the ODTP given the post-market review will take up to two years to complete.
At that point, deputy secretary Penny Shakespeare intervened to defend government support for people recovering from drug dependence.
The officials also declined to answer questions on whether the Pharmaceutical Benefits Advisory Committee had sought legal advice to guide its own consideration of issues related to the ODTP, particularly given the potential for the existing arrangements to be discriminatory.
Officials confirmed that the department is in the process of forming a reference group to support the post-market review.
"The department has sent letters of invitation on 25th of August, and we are hoping to appoint 14 members to that reference group and one chair, and we are working to have those appointments finalised and host the first meeting of the reference group this month," said Ms Platona.
She continued, "There will be a representative from a member of the PBAC and one each from the PBAC sub-committees; one from the Economics Sub-Committee and one from the Drug Utilisation Sub-Committee.
"There is going to be an expert in addiction medicine, a general practitioner who practices in this field, a nurse practitioner with expertise in providing opiate dependence treatment. Through the consultation, we have broadened the scope of the reference group with the feedback from the initial draft terms of reference, to talk more about marginalised and at-risk populations in rural and remote people in the justice system, Aboriginal and Torres Strait Islander people.
"So, there will be consumer representation and we hope to have four consumer representatives, including people who have a lived experience. That again will include representatives from injecting and illicit drug users and Aboriginal and Torres Strait Islander people, pharmacy and then a number of researchers, leaders in the field of drug and alcohol research."
Public consultation on the ODTP post-market review and final terms of reference is open until 1 October 2021.