A compassionate (if desperate) move from New South Wales on World AIDS Day yesterday showcased why even hidden interactions must be included in the push to dump unhelpful bureaucratic ways.
In this case, the hidden interactions are the drug approval processes of the Therapeutic Goods Administration that have lagged behind commonplace customer improvements seen in other parts of government.
The cost of not improving its way of doing business is worn by many others, such as the states trying to bring down new HIV infections, and even blowing back on the helpless federal minister — who is left with the awkward task of blaming the customer for government being unhelpful. So unhelpful in this case that the NSW government had to come up with a creatively legal way to route the TGA and act on behalf of its residents’ needs — threatening the compact between state and federal spheres.
Four years ago a United States drug manufacturer went public with its desire to make a transformational HIV prevention tool available for the Australian public. The method is called PrEP — pre-exposure prophylactic — and involves using existing HIV drugs on healthy people with high exposure risk to prevent the virus from taking hold in their system.
It had many successful peer-reviewed trials, approval from the equivalent body in the US, and public health policy experts eager to see an impact on local HIV rates. Logically, Australia should be seeing positive outcomes by now, but instead the TGA still does not even acknowledge it’s received the application.
The public is upset, state health agencies are frustrated, a few federal agencies are embarrassed — we’ll come to those examples later.
Federal Health Minister Sussan Ley (pictured) acknowledged the concerns at a World AIDS Day breakfast yesterday, telling anxious community members and HIV prevention practitioners:
“The TGA, which independently assesses new medications for safety and efficacy must be allowed to do its work without political pressure no matter how frustrating the process may seem. However, PrEP is a perfect example of an issue I highlighted earlier this year which is that drug companies wait until after the drug has been approved in the larger US market before submitting an application in Australia.
“If the drug company in this case had submitted an application for this drug to be used in HIV prophylaxis in Australia three years ago like it did in the US, perhaps we would be in a different situation now.”
Ley’s first point is an excellent one. It would be disastrous for good public policy if pharmaceutical companies felt they could lobby ministers directly for specific drug approvals.
A competent bureaucracy is also required for independent good public policy. Blaming the customer for a stagnant and unnecessarily repetitious approvals process is not encouraging. It is the opposite of what Prime Minister Malcolm Turnbull and reform voices he echoes have advocated, but there are signs of good leadership at the Department of Health and collaboration is on their radar.
Audit once, use many times
Independently assessing new goods or products for safety and efficacy is something many agencies do. TGA does not have a monopoly on regulating life-saving and potentially life-threatening products. Other agencies have found ways to balance rigour with efficiency and the needs of the communities they serve.
For instance, the Department of Defence has internal regulatory groups that audit the risk of “catastrophic” failure of purchased components for aircraft, vessels and weapons. If assessments have been completed by an equivalent competent regulator in another country then Defence does not repeat the same exercise. Reciprocation isn’t required; Australia can look at what the US found without the US having to agree to follow Australia’s lead. Equivalence is key: an aerospace electronics assessment from the US would meet local requirements, but an assessment from Venezuela would not.“The TGA has begun to turn its attention to the need for global collaboration.”
The TGA has begun to turn its attention to the need for global collaboration. The US is perhaps the only important player here, with a significantly larger approval program than any other country. Australia began its first meaningful reciprocal co-operation with the US Food and Drug Administration last year with a pilot called the Medical Device Single Audit Program. As the name implies, it is intended that manufacturers need only submit to a single audit for approval in all participating countries.
The single audit foray could not be considered a uniform success, with the mid-way pilot report revealing a poor response — a mere 1% of manufacturing sites have expressed an interest, far below the 10% minimum set target. Manufacturer participation is vital for the success of the program, the report insists. It looks like another case of government not listening to the customers or finding out how to make their services meet the customers’ needs.
Even if the MDSA pilot yet succeeds, medical devices cover only a fraction of the repetition that the TGA needlessly undertakes. New drugs and new applications for existing drugs aren’t covered by that program. But it also doesn’t need to. The TGA doesn’t need US consent or a global pilot program to decide if the FDA is an equivalent competent authority.
Vacuum of its own making
Four years of TGA silence and inaction has created a situation where at-risk men — wanting to safeguard their own health and avoid the stigma of HIV infection — are obtaining the drugs via mail order. The risks of misuse under these circumstances have galvanised every other player in the HIV prevention space; unifying people writing policy, clinicians, prevention practitioners, community organisations.
Peak bodies like the Australian Federation of AIDS Organisations and the Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine have urged expedited approval of PrEP in Australia, and filled the gap in advice to prescribing doctors and patients importing from overseas. That advice isn’t coming from government while the treatment is still “off book”.
Ensuring the proper supervision of people who want PrEP and have a high risk of exposure has vexed state health bodies. Trials set up in Queensland, NSW and most recently Victoria may have become de facto workarounds for HIV/AIDS prevention strategies to make PrEP available to those that most need it. Places were highly sought after — after all, US gay men were already taking it and it was having a profound impact on state of mind for those most at risk.
The Department of Defence, seeing the US approval and strong interest among gay men, approved its medical personnel to prescribe and obtain the treatment for ADF personnel. Two men would do so before the department realised it jumped TGA approval. While not technically required — Defence has an exemption — it was seen as embarrassing and the approval was revoked. It unsuccessfully tried to get the two personnel onto the oversubscribed state trials. Both men will lose access to the drug when their current supply runs out.
States’ solution of last resort
NSW Health noted in 2012, through its then-HIV strategy, that TGA was sole gatekeeper of the key component of future prevention. Yesterday, the new 2016-2020 HIV strategy was released and, despite no progress from TGA, laid out just how important PrEP still is by committing to:
“Assess all people attending public sexual health services and high caseload general practices for PrEP eligibility.”
Five of its eight prevention activities are based on PrEP. Without PrEP there isn’t much a prevention strategy left to implement. The strategy goes on:
“PrEP is the next critical addition to HIV prevention in NSW … Expanding PrEP access to people at a high risk for HIV infection, in the context of existing HIV prevention strategies and continuing high levels of HIV and STI testing and treatment, will allow NSW to harness the public health benefits of PrEP and prevent a significant number of new HIV infections in NSW.”
Unable to convince the TGA to play along, it’s gone it alone expanding the state’s trial program into a full-scale program that is a trial in name only. NSW Health Minister Jillian Skinner announced an additional 3700 places for “high-risk, mostly gay and bisexual men” starting early next year — a ten-fold increase. In effect, it has fully funded roughly the number of people that it expected would seek the drug through normal channels if it was approved by the TGA.
It was a desperate move. The cost is significant. But it really does matter to people’s lives.
The TGA now sits directly in the Department of Health. Since taking over as its secretary last year, Martin Bowles has initiated a reform agenda in the department based on collaboration and understanding each others’ point of view. There is much reason to be hopeful, if the TGA is part of that reform.
Blaming the customer for seeking approval only four years ago, instead of five or six, shows there is still much to be done convincing parts of government that aren’t highly visible to the community that they need to shape up too. The Mandarin and many other outlets contacted the TGA for comment yesterday, but were told confidentiality requirements restrict what information it can release. Such requirements do little to restore trust.
Bowles knows all too well how secrecy can hamper public good. In a piece published in The Mandarin yesterday, Bowles says that upon discovering his own department was unable to share valuable data with states and territories he ensured that was fixed. He may want to consider whether there is public good from doing the same with Health’s former fiefdoms, too.