Better Access Australia has slammed a federal government agency over its decision-making on the Opiate Dependence Treatment Program given it has known of its legal failings since 2019.
The program (ODTP) is how the government reimburses medicines through the PBS for people accessing treatment for opiate dependence. The ODTP pays the manufacturer of the medicines but explicitly removes the critical patient protections of co-payments and access to the PBS safety net. Community pharmacists are also denied dispensing fees. As a result, patients are forced to pay uncapped fees that can exceed $200 per month.
Three-quarters of the patients accessing treatments under the ODTP are dispensed their medicine through community pharmacy.
"Some 50,000 patients rely on the PBS to help them manage their chronic disease of opioid addiction. The majority of these patients became addicted as a result of government-subsidised pain medications," said Better Access Australia (BAA) in a statement.
The issue is confounded by the government's failure over an extended period of time to lawfully enforce the removal of these protections through a legislative instrument.
The government says the ODTP medicines are listed in a 'special arrangement' under Section 100 of the National Health Act 1953. There are over one dozen 'special arrangements' for medicines reimbursed under Section 100, including cancer medicines. The ODTP is the only 'special arrangement that has not been enforced through a legislative instrument. In other words, this denial of protections to PBS co-payments and the safety net does not exist in law.
Health minister Greg Hunt has argued he has the power to impose these arrangements without a legislative instrument. This would mean the minister has the lawful power to remove or vary PBS co-payments without reference to the parliament.
The issue was exposed during a Senate Estimates hearing in October last year with Department of Health officials moving quickly to enforce the ODTP arrangements through a legislative instrument.
A draft instrument was distributed to stakeholders for consultation in November last year. It has not progressed, potentially because it was proposing to enforce arrangements that are almost certainly and unlawfully discriminatory.
It was recently announced that the Pharmaceutical Benefits Advisory Committee (PBAC) would conduct a post-market review of the ODTP, including a focus on the impact of affordability. The review was announced on 25 March just hours before Department of Health officials were due to face further scrutiny on the issue at Senate Estimates.
The PBAC has a chance to at least partly address this issue at its meeting in November. Camurus has submitted for the reimbursement of its weekly and monthly forms of BUVIDAL (buprenorphine) through the ODTP. It has requested a 'general schedule' listing under Section 85 of the National Health Act 1953. This would ensure patients are able to access these treatments with standard co-payments and the safety net because the minister does not have the power to remove these protections for medicines listed on the PBS under Section 85.
BAA says medicines reimbursed through the ODTP should have a dual Section 100 and Section 85 listing.
In June, and in response to correspondence from BAA, a key Senate committee (Standing Committee for the Scrutiny of Delegated Legislation) intervened with correspondence to health minister Greg Hunt seeking an explanation for the failure to lawfully enforce the ODTP.
The committee, which is chaired by Liberal Senator Concetta Fierravanti-Wells, did not accept the first response and has again written to the minister.
Importantly, the minister did confirm the Department of Health was aware of the failure to lawfully enforce the ODTP arrangements since 2019 but did nothing until the issue was exposed under questioning at Senate Estimates in October 2020.
In his correspondence, Minister Hunt advised the committee led by Senator Fierravanti-Wells that his department made an undertaking to the Office of the Australian Information Commissioner (OAIC) in 2019 that the government would register a legislative instrument for the ODTP.
It has failed to deliver on this commitment for the past two years.
BAA submitted a Freedom of Information (FOI) request to the OAIC seeking a copy of the minister's undertaking. The OAIC, which is the federal agency responsible for oversight of the FOI law, has exempted the undertaking from release.
According to director David Mackay, “Better Access Australia sought access under FOI to the undertaking Minister Hunt’s department made to the OAIC to ‘register a special arrangement for the ODTP’ in 2019. It’s now August 2021 and the department has still failed to do so, and the OAIC refuses to release the details of this undertaking.”
In its response to the FOI request, the OAIC said, “The subject document is currently being considered by the Information Commissioner in performing an FOI function. As the matter is currently on foot, releasing the document at issue would have a substantial adverse effect on the OAIC’s process, as it would have the effect of circumventing the consideration of the matter.”
Mr Mackay continued, “The OAIC and Minister Hunt’s department have let this matter languish for two years. The decision not to release the requested documents seriously undervalues the public interest value of this information.
“Lives are being lost every day as a result of the Minister for Health’s intransigency on this issue and having yet another agency be part of the cover-up of this matter on the basis of maintaining good inter-departmental relations doesn’t meet the legal or pub test.
“We should expect better from the OAIC, the agency charged with stewardship of transparency and access to government decision-making for the community,” he said.
Mr Mackay said the minister is yet to "make good" on his undertaking and has only made the issue worse through the post-market review that could take around 18 months.
“In contrast, Minister Hunt announced this week that the entire National Medicines Policy is to be reviewed in just six months.”
“Unfortunately, the OAIC now joins the PBAC alongside the Minister and his department in the cover-up of this legally suspect instrument underpinning the ODT program.
“In doing so they help continue the discrimination against the 50,000 patients accessing the program and the thousands more not accessing it because they simply cannot afford the hundreds of dollars a month for their medicines. Enough is enough.
“Just as 'Robodebt' devastated so many vulnerable Australians, the Morrison Government’s refusal to take immediate action to end this discriminatory program is equally devastating.
“The Minister’s 18-month delaying tactic is unacceptable, while patients remain untreated and are dying as a result.
“We are grateful that the Parliament’s Senate Standing Committee for the Scrutiny of Delegated Legislation continues to pursue the legality of this matter. When everyone else is trying to cover things up, it is reassuring that our Parliament is trying to protect the rights of all in the Australian community."
