The Department of Health has failed to identify any law under which it denies the protection of PBS co-payment and safety-net arrangements to people accessing PBS reimbursed medicines for opiate dependence.
The legal status of the Opiate Dependence Treatment Program (ODTP) is now in serious doubt.
In response to a single question from BioPharmaDispatch, the Department of Health has failed over the last two days to identify the legislative instrument used to implement the program.
BioPharmaDispatch simply asked to be directed to the relevant published legislative instrument. No response.
There appears to be no relevant legislative instrument on the Federal Register of Legislation - meaning it has been unlawfully maintained and administered.
These patients have been unlawfully denied proper access to PBS-listed medicines and forced to pay private fees.
Thousands of patients will visit their pharmacy today to access their PBS-listed medicine for opiate dependence and be forced to pay an unlawful and discriminatory private fee.
Under the ODTP, medicines for opiate dependence are funded through the PBS but patients are denied the protection of PBS co-payment and safety-net arrangements. Patients with an opiate dependence, which as a result of a Federal Court ruling is considered a disability, are forced to pay as much as $200 per month for medicine the Pharmaceutical Benefits Advisory Committee (PBAC) has found to be cost-effective.
Importantly, in its consideration of one of these medicines, the PBAC explicitly identified the negative impact of administration fees on patient access to treatment for opiate dependence.
It said in a Public Summary Document from its November 2018 meeting there are patients who "currently choose not to be treated due to prohibitive private fees for existing treatments."
Several coronial inquests have found these 'prohibitive private fees' contributed to the deaths of multiple people.
The committee also recognised that patients are being forced into community pharmacy by the capping of patient numbers in state and territory public health systems - three quarters of patients access treatment via community pharmacy.
All this means these patients, some of whom are amongst the most vulnerable and marginalised members of the community, are denied protections every other Australian takes for granted.
Doubts over the legal standing of this program also put community pharmacy in a difficult situation. Under the ODTP, community pharmacists charge patients an 'administration' fee. However, the government's failure to properly regulate the program potentially exposes pharmacy.
The government might need to consider compensating patients for the payment of these fees over many years and community pharmacy for the loss of dispensing fees.
Patients might now focus their concern on ensuring the government does not simply move to resolve the lack of any legal basis for the program and entrench the arrangement through a new legislative instrument.
Yet this might be difficult given the impact would be to essentially regulate to impose a discriminatory outcome on a group of patients that are considered to have a disability.
