This is the second in a three-part series examining how Marie Stopes became the leading provider of abortion services in Australia, the sole provider of RU-486, concerns about its dominance, and what the future holds. Read part one here.
Mifepristone was a game-changer in the abortion industry. Previously known as RU-486, the drug relaxes the cervix and blocks the body’s receptor for the hormone progesterone, stopping gestation in its early stages. When taken with misoprostol, which causes contractions, the two pills cause the body to expel a pregnancy.
But mifepristone was — and still is — controversial. After years of conservative governments in Australia, pharmaceutical companies around the world were reluctant to step into the abortion market and supply the drug to the nation. Mifepristone is only available thanks to Marie Stopes International (MSI) Australia, which — after an investment from its UK parent company — set up MS Health to import and supply mifepristone.
But more than a decade later, it’s still the only supplier of mifepristone in Australia — with experts raising concerns around pricing, potential supply disruptions and lack of competition around the medication.
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How did we get here?
Mifepristone was developed in the 1980s by the French drug company Roussel-Uclaf (which is where the RU in RU-486 originates). Its inventor, French-Jewish scientist Étienne-Émile Baulieu, said he was encouraged to develop the pill to alleviate the “pain and punishment” associated with abortion. He had heard a surgeon tell his assistant to withhold anaesthesia during surgical abortion to “teach her a lesson she’ll remember”. Baulieu wanted to give women the option to end a pregnancy away from the harshness, sterility and masculinity of the medical industry.
It was brought to market in 1988 and used throughout Europe (despite condemnation from the pope). In 1999 in New Zealand, a group of doctors formed a not-for-profit pharmaceutical company to import mifepristone from France, and the drug was approved by the Federal Drug Administration in 2000 in the US.
But Australia was far behind. In 1996, then prime minister John Howard did a dirty deal, putting money above women’s rights. Behind closed doors, he made an agreement with anti-abortionist senator Brian Harradine to restrict the use of mifepristone in exchange for his support to privatise Telstra. For a decade, until this amendment to the Therapeutic Goods Act was overturned, the drug could be imported only with written approval from the federal health minister (who at one point was Tony Abbott).
Even after the Harradine amendment was overturned, mifepristone wasn’t readily available. It needed to be approved by the Therapeutic Goods Administration (TGA) — a costly process — but no pharmaceutical company applied for approval.
So MSI invested $6 million to build MS Health. MS Health told Crikey the investment didn’t need to be repaid. Using data from a Queensland GP who had managed to get around the laws to prescribe mifepristone, it was approved in 2009 and was added to the Pharmaceutical Benefits Scheme (PBS) in 2013.
The company sells mifepristone and misoprostol as MS-2 Step (with MS standing for Marie Stopes). Crikey understands the pills are imported from Linepharma in the UK, although MS Health told Crikey that questions about how many pills are imported and for what cost were commercial-in-confidence.
Medical practitioners who wish to prescribe mifepristone have to undergo a free training session lasting three to four hours that is conducted online and run by MSI Australia. They have to reregister as a prescriber every three years, as do pharmacists who wish to dispense the drug. Of the roughly 31,000 GPs in Australia, fewer than 3500 are actively registered to prescribe the pill.
How expensive is the drug?
The government pays pharmacies $353.84 for MS-2 Step; patients pay $42.50. Those without Medicare must pay the full amount. It’s not clear how much the drug alone costs (although research in 2013 found that costs for the pills alone were about $61.20).
MS Health told Crikey there were “significant additional costs” involved in the pills, “such as shipping, warehousing, distribution, regulatory costs, pharmacovigilance (safety), medical information (doctor, nurse, pharmacist information)”.
Emma Boucher, founder of Clinic 66, an abortion clinic, told Crikey she believed having just one supplier meant the Australian government paid more than was necessary: “They do have a stranglehold over the importation of the drugs … and if the government were open to sourcing cheaper generics in other ways, then it would save the taxpayer an enormous amount of money.”
Crikey asked a number of international pharmaceutical companies whether they had considered entering the mifepristone market, as well as anti-abortion organisations about whether they had attempted to block new pharmaceutical companies from applying to the TGA to sell mifepristone. As far as Crikey can ascertain, no other company has tried to enter the market.
Director of pharmaceutical company HL Pharma Matthew Hayward told Crikey that when a generic brand enters the market, drugs are generally 10% cheaper. But that given just a small number of mifepristone pills are sold each year — about 40,000 — there wasn’t much incentive for other companies to enter the market.
“I think it’s unlikely to make it that much cheaper because the volumes are so small and there are large costs involved in registering the product,” he said.
The TGA charges $258,000 in application and evaluation fees to have a standard prescription medicine registered, and annual charges. Hayward said the cost of adding a new drug to the market, combined with necessary clinical trials, could cost millions.
“You’ve got to balance the fact that you’ve got to try and recoup that money over a fairly small product in a small market,” he said. “Even though the drugs themselves as active ingredients are probably not that expensive, it’s all the other stuff behind that makes it quite expensive.”
Australia isn’t alone in the mifepristone monopoly: the US struggled with high prices until 2019 when a generic version was made available through GenBioPro. New Zealand also has just one brand available.
The drug is still controversial
Feminist researcher, biologist and former professor in family studies Dr Renate Klein has been highly critical of Marie Stopes’ provision of medical abortions, calling the company a “ruthless capitalist”. MSI Australia denies it has a monopoly.
Klein doesn’t believe medical abortions should be administered if surgical or suction abortions are an option. Medical abortions are slightly less effective than surgical abortions at 95%-97% compared with 99%, and 85% of patients have side effects ranging from nausea, vomiting, weakness, diarrhoea, headache, dizziness, fever and chills alongside the expected bleeding and cramping.
Complications with the drug are very rare (in one comparison, mifepristone is safer than Tylenol) although Klein pointed to failures in the initial rollout of the drugs: one woman died from sepsis in 2010, and when conducting clinical trials, MSI Australia lost contact with 16.6% of patients.
Prescribing the drug to women in regional and remote areas was also a major concern, she said, in case of complications requiring ongoing care.
As Klein writes in her book RU486: Misconceptions, Myths and Morals, Marie Stopes’ control over mifepristone put it in “a very powerful position”, with one doctor calling it an “abortion chain”. After MS Health got mifepristone approved by the TGA, she writes, MSI Australia was “quick to mail out brochures to local doctors suggesting they send women seeking abortions to an MSI clinic where they could avail themselves of ‘medical’ abortion”.
“Nobody can tell them that they shouldn’t [administer medical abortions] because they’re one of the only ones who offer it,” she said.
Professor of obstetrics and gynaecology at James Cook University Caroline De Costa was pivotal in making the abortion pill available in Australia and was the first GP to prescribe it before it was approved by the TGA. She told Crikey that private clinics charged a lot for medical and surgical abortions and she wasn’t sure how motivated MSI Australia was to change that. Having a sole supplier of mifepristone wasn’t “entirely satisfactory”.
But without MSI Australia’s application to the TGA, she said “it would have been much more difficult to make the drug available”.
MS Health told Crikey there have never been any mifepristone supply problems, even across COVID-19 when the supply of contraceptive pills was disrupted.
Next: as Australia moves to include abortion services in public hospitals, what does the future hold for Marie Stopes International Australia?