Speech by Dr Philip Goldstone | The Road to Abortion Equity

The Federal Senate has established an Inquiry into universal access to reproductive healthcare. The Inquiry was called because the government has acknowledged we have a crisis of sexual and reproductive health access.

On Wednesday 9 November 2022, we hosted an online forum to explore what the inquiry terms mean, how it applies in practice and provided a submission template which you can download here to assist people in writing their own.

Dr Philip Goldstone gave the following speech at our webinar, which you can watch here.

For those of you who only know me as Medical Director for MSI Australia, I actually hold dual roles, I am also the Medical Director for MS Health.

We really encourage your submissions to the Senate Inquiry, and suggest they include something along the lines of:

We support amendments to the Risk Management Plan and regulatory reforms for medical abortion medications that will improve abortion access and equity.

I’d like to take just a few minutes of your time to explain why this is so important.

I commenced my role in 2010, this was early during our submission process with the Therapeutic Goods Administration (TGA) for registration of mifepristone and misoprostol, the medicines used for medical abortion.

Tragically, mid-way through that initial registration process we had what is the only death reported in Australia attributed to medical abortion.

This contributed to what was already an extremely cautious approach that the TGA was taking at the time.

It led to the development of a complex Risk Management Plan (RMP), and some of the additional layers of regulation that exist today.

The Risk Management Plan and other regulation of the medicines used for medical abortion were not sought by MS Health, rather they were the result of a protracted negotiation with the TGA with the intent to do exactly what the name suggests — that is to manage and mitigate risk.

The outcome of this process was that Australia became one of the few developed countries, at the time, to allow prescribing of medical abortion in primary care and dispensing of the medications through community pharmacies.

It significantly broadened access to medical abortion for people in Australia, particularly for those living in regional, rural and remote areas.

However, we are now 10 years down the track and in that that time, tens of thousands, if not hundreds of thousands of people in Australia have undergone a medical abortion, and the safety and efficacy of medical abortion is now very well established.

The Risk Management Plan is now viewed by many as a layer of over regulation.

MS Health has been working with key stakeholders to review several components that have been deemed to be unnecessary barriers to access.

This review is in its final stages of preparation and will be submitted to the TGA by the end of November.

We hope an outcome will be received without too much delay.

The revised RMP firstly proposes allowing medical and other healthcare practitioners to be prescribers of medical abortion.

This will remove any restriction by pharma and the TGA on who can prescribe MS-2 Step, allowing States and Territories to deem who can prescribe.

This could include nurses, midwives and Aboriginal and Torres Strait Islander healthcare workers.

With a potential broadening of the prescriber base, the need to certify and complete education where required will remain for now, but we’re hoping the requirement for recertification after 3 years will be removed.

In practical terms, what I hear as probably the greatest barrier has been the requirement for pharmacists to be registered to dispense MS-2 Step, especially as registration sits with the individual pharmacist and not the pharmacy.

Despite the fact that prescribers having access to an online database of dispensing pharmacists, this has been near impossible to maintain as pharmacists move on or only work certain days of the week.

Any of the prescribers amongst us will have experienced the frustration of trying to find a registered pharmacist, especially those who are providing telehealth services.

The revised RMP proposes removal of the requirement of pharmacists to be registered, meaning any pharmacist could simply place an order through their local wholesaler — like any other medicine.

Separate to changes to the RMP, MS Health has other submissions that are already under assessment by the TGA.

This includes updates to the Product Information, removing the requirement for Rhesus determination, and a change from Authority Required to Streamlined Authority.

For those of you asking why the authority can’t be removed altogether, there is no precedent for any medicine moving directly from Authority Required to general PBS.

The move to Streamlined Authority will remove the burden from prescribers to phone for authority or login via Proda to seek authority. We know this is really a bug bear for GPs.

The current approved indication for use to 63 days has also been challenged as a barrier to access.

This is a more difficult one and there are a number of considerations here.

The FDA in the USA, only in the last few years approved use of Mifeprex to 70 days.

But it remains the only developed country where a mifepristone product is registered for home use beyond 63 days.

Whilst we know there is widespread use in other countries to 70 days and even up to 84 days, such use is off-label in those countries as the sponsors haven’t sought applications to extend the approved indications.

Although there is evidence and guidelines to support such off-label use, we know the TGA is known as a conservative regulator and the risk of MS Health spending hundreds of thousands of dollars on such an application in Australia is not something we can justify presently as a not-for-profit pharma company.

However, if anyone knows of a donor happy to fund such an application, we’ll happily accept those details!

I hope that these few minutes have given you a clearer understanding of the current situation.

So again, when writing your submissions, please include something along the lines of:

We support amendments to the Risk Management Plan and regulatory reforms for medical abortion medications that will improve abortion access and equity.

Thank you

Dr Philip Goldstone is the Medical Director of MSI Australia and MS Health.

Philip joined MSI Australia in 2005, where he first worked as a clinician in our Sydney clinics before being appointed to the role of Medical Director in 2010.

Philip is one of Australia’s leading practitioners in abortion and contraception care. He played a key role in bringing medical abortion to Australia and has been published widely on the topic.