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Covid-19 and the TGA - How has the pandemic changed the role of our medicines regulator? 

Every single Australian Government agency and department was changed by the Covid-19 pandemic. They all had to produce much more work than in normal times, many with static or even reduced headcounts. Business as usual was disrupted as they had to focus almost all their energies on responding to an unprecedented public health crisis. Others had to deal with a vastly expanded group of stakeholders, or increased attention paid to their work.


For the Therapeutic Goods Administration (TGA), it was all of the above. Although it was always important by virtue of being the nation’s main medicine and therapeutic regulatory agency, the TGA previously didn’t have a high profile beyond the medical community. The pandemic changed all this. Suddenly, the TGA had to contend with dramatically heightened public scrutiny of its work, particularly as Covid-19 vaccines progressed through clinical trials. In comments provided exclusively to HPG, a TGA spokesperson shed light on how the work of the regulator was changed by the pandemic.


Given the crucial role the TGA already played in Australia’s pre-pandemic landscape, it’s important to understand how the pressures of Covid-19 displaced its existing work. According to the TGA, “the diversion of resources to focus on COVID-19 products [including tests, vaccines, hand sanitiser, face masks, etc.] … have meant that review timeframes increased slightly for a number of other products.” More specifically, the average review time (in calendar days) for new active substances increased by 35 calendar days in 2021 compared to 2020.


In addition, review times for non-Covid related over-the-counter medicines and non-Covid in vitro diagnostic tests also increased. However, the TGA was quick to add that throughout the pandemic it had always met the legal maximum timeframes for reviews.


Beyond the increased workload, the biggest impact of the pandemic on the TGA was greater public scrutiny. Suddenly, the agency was thrust into the public eye like never before. Part of this was undoubtedly a result of its central role in the approval of Covid-19 vaccines. There is a small but vocal cohort of Australians who either believe that the vaccines were rushed through clinical trials and the approvals process, or that all vaccines are unsafe.


The TGA confirmed that there was a strong public focus on its pharmacovigilance activities, “particularly around vaccine safety”. This included a high volume of media requests and requests for information made under Freedom of Information laws. While it is legitimate to seek information about our government agencies, there is no doubt some of these requests were either frivolous or made in bad faith to slow down the TGA’s work or perhaps uncover a “scandal”.


Unsurprisingly, the pandemic had major impacts on staff. According to the TGA, “many staff have worked harder and much longer hours during the pandemic.” It was routine for senior management staff and product evaluators to work six or seven days a week throughout 2020 and 2021. Although such intense workloads were not unique to the TGA, very few institutions had to undertake work of such critical national importance.


Despite these and other issues, the TGA recognises there are also potential benefits to the increased public attention on its work. True, some of the increased attention it received was negative. However, most Australians were appreciative and grateful to the TGA for its work to approve Covid-19 vaccines as quickly as possible without compromising its standards.


Evidence for this positive sentiment comes in the form of recent recruitment rounds, which have provided “large and high-quality fields” of applicants “attracted to working at the TGA because they see that the work that we do touches the lives of all Australians.” Despite the extraordinary pressure on existing staff, retention has reportedly been high: a testament to the agency’s leaders and culture.


The pandemic is unlikely to have significantly altered the TGA’s long-term funding path. As the spokesperson says to HPG, although its budget is “overwhelmingly derived from industry cost recovery”, it is ultimately up to the government of the day to determine the agency’s overall funding. No doubt, the TGA’s leaders will be making the case to the new Australian Government that its performance throughout the pandemic merits greater future funding.


Public awareness of the TGA and its work is at an all-time high. The hope is that, as the pandemic falls off our front pages, the glare of scrutiny that’s been applied to the TGA over the past months begins to fade, leaving in its place an agency that’s more resilient, able to support its staff, and able to deliver for Australian consumers, regardless of the circumstances.


One thing is clear: this is a very interesting time to work for the nation’s highest-profile regulatory agency.