If approved by the TGA, an application to broaden prescribing powers would improve nationwide access overnight.
The TGA is expected to respond within the next few weeks to applications from MS Health that would allow any GP to prescribe medical abortion drugs mifepristone and misoprostol.
The applications, reported in The Saturday Paper and discussed in a parliamentary inquiry today, were lodged with the TGA in December and focused on enhancing prescribing powers.
The amendments put forward by MS Health include abandoning registration requirements for GPs and pharmacists, eliminating the need for GPs to retrain every three years and automating the authorisation process for scripts.
The proposed changes were a move in the right direction that would be welcomed by GPs, according to Professor of Practice at the University of Sydney’s Faculty of Medicine and Health Deborah Bateson.
“I think it’s very good news, because it’s another step [towards] removing unnecessary barriers to medical abortion,” she said.
Although GPs can now prescribe mifepristone and misoprostol (MS-2 step) over the phone after telehealth prescribing rules were changed in 2020, less than 10% meet the requirements to prescribe the drugs.
As of December 2022, only around 4000 GPs and obstetricians/gynaecologists were registered as active prescribers of mifepristone and misoprostol, while 5400 pharmacists were registered as active dispensers.
According to Professor Bateson, removing obstacles such as registration and recertification requirements would not only improve access to medical abortion by increasing the number of prescribers and dispensers, but it would also to allow GPs to feel more confident prescribing the drugs.
However, she also highlighted that more needs to be done to make abortion, and particularly surgical abortion, more widely available across the country.
MS Health is the only pharmaceutical provider importing and distributing mifepristone and misoprostol in Australia. It is also the subsidiary of MSI Australia, the only nationally accredited provider of abortion, contraception, and vasectomy and longest running provider of teleabortion.
Speaking at today’s hearing of the Senate committee inquiry into universal access to reproductive healthcare, MSI medical director Dr Philip Goldstone said the organisation planned future applications to extend the drugs’ range of use beyond the current cut-off at 63 days’ gestation, although this would be a much lengthier and more costly process. This application would cost the organisation more than $1.5 million, according to managing director Jamal Hakim.
“Mifepristone has been registered by the TGA since 2012 … the TGA took a very cautious approach with a risk management framework [for mifepristone] that has not been applied to any other drug,” he said.
“Changes to the risk management plan are much simpler and cheaper and that’s why we are recommending those changes now.”
Also at today’s hearing, RACGP president Dr Nicole Higgins said separating the religious beliefs of public hospital administrators from the hospital’s obligations to provide abortion services was vital to improving access in rural and regional Australia.
Answering a query from Queensland Greens Senator Larissa Waters, about whether publicly funded hospitals should be made to provide abortion services and training for the next generation of abortion providers, Dr Higgins said the problem of religious doctrine was not restricted to church-funded hospitals.
“In a state-funded hospital, if the director or administrator has a theological objection [that can affect access to abortion services],” she said.
“This has been a problem in Mackay, Rockhampton and Wagga, that I know of.
“We must improve access for women irrespective of their postcode, but also irrespective of the ethical or religious beliefs of the hospital administrator. We must separate those religious beliefs from the delivery of care.”
Multiple witnesses at the committee hearing called for the establishment of a national abortion hotline to provide women with information about their local providers, and with help accessing those providers.
If a woman’s GP is a conscientious objector to providing abortion services, many don’t know where to turn for help, said Professor Danielle Mazza, chair of the RACGP Guidelines for Preventative Activities in General Practice.
“The difficulty women face [when their GP is a conscientious objector] is the power differential in that relationship – they are not empowered to make a complaint,” said Professor Mazza.
“Women are often not aware of the option for telehealth for sexual health matters. Women just don’t know.”
A national hotline to help women navigate their options would be a step forward, she said, recommending a model similar to Victoria’s 1800 My Options service. Queensland’s Children by Choice mapping website also drew praise.
The UK, Ireland and Sweden all have national hotlines which have proved very successful, said Professor Mazza.