'Digital contraceptive' gets approval by Australian health authorities

A smartphone app can officially be used as a contraceptive tool by Australians after becoming the first to be approved by the nation’s drug and medical device watchdog, in a move that has health experts wary.

Natural Cycles, which is billed as a hormone-free birth control app, was added on November 26 to the Australian Register of Therapeutic Goods as a medical device to monitor fertility for preventing or planning a pregnancy, rather than specifically as a contraceptive. Natural Cycles is a fertility tracking app and so-described "digital contraception".The Swedish husband-and-wife founders of the seven-year-old app, which was previously sold in Australia as a fertility tracker, will now market it locally as a birth control option.

The decision made by the Therapeutic Goods Administration follows similar moves by health authorities in Europe and the US.

“Now that we’ve received regulatory listing approval [in Australia] … and are able to market it the way we do in our other top markets, we do expect our user base to grow quite substantially,” says co-founder Elina Berglund.

Dr Berglund, a physicist, says Natural Cycles has 1.8 million people using the app globally, of which three-quarters do so to prevent pregnancy.

The “digital contraceptive”, which costs $14 a month, involves women entering their daily basal body temperature and menstruation dates so an algorithm can identify their daily fertility status. Each day is marked either green, indicating it’s safe to have unprotected sex, or red, meaning it’s time to abstain or use condoms.

Natural Cycles is the first fertility monitoring app to brand itself as a contraceptive and publish clinical studies. It claims it is 93 per cent effective with typical use, similar to the oral contraceptive pill.

The app's rise has not been without controversy, having faced claims of women becoming pregnant unintentionally and of misleading marketing, which the founders have disputed. Dr Catriona Melville, deputy medical director of national family planning organisation Marie Stopes, says she welcomes any move that provides Australians with more choice but stresses people must be fully informed about the pros and cons.

“If having an unplanned pregnancy is a disaster for you, it may not be your first choice,” Dr Melville says. Natural Cycles is based on fertility awareness, which is one of the oldest forms of contraception and the only one approved by the Catholic Church.

“Digital technology does vastly improve things but ultimately we’re rewinding to a method that has been used for many, many years,” Dr Melville says.

The app relies on women being meticulous about recording their temperature around the same time each morning as soon as they wake up and about using condoms when in their fertile window. Dr Melville says the most effective contraceptives don't depend on user behaviour, such as the implant and the intrauterine devices (both hormonal and copper). She says the app will fit some lifestyles but may be unsuitable for many women, including those who are shift workers, have irregular menstrual cycles, are perimenopausal or are breastfeeding. Temperature can also be affected by factors such as illness and drinking alcohol.

“There is a lot of user motivation required ... [and] you have to really understand the intricacies,” Dr Melville says.

Dr Elizabeth Farrell, medical director of women's health organisation Jean Hailes, says the app's TGA approval “doesn’t mean that it’s fail-safe and it doesn’t mean that there aren’t risks”.

“It’s all very well using an app but you have to remember you’re the person who is responsible for your contraception, not the app,” she says. Dr Farrell is concerned about the growing perception that hormonal contraception is harmful despite its benefits for most women. Some women experience side-effects from the pill such as migraines and depression.

Dr Melville says there has been a noticeable rise in recent years of young people turning away from hormonal contraception and it's important they don't feel alienated. A 2017 Monash University survey of sexually active Australians found 15 per cent used hormone-free methods, such as withdrawal and fertility awareness, double the figure recorded in previous studies.

Dr Melville worries that people who want to use an app will avoid discussing contraception with a health professional. “My role is to help people make a decision they’re happy with.”

Dr Berglund says she understands that some medical practitioners are wary of a new contraceptive product and says the company hopes to work with health providers to help serve patient needs.

Natural Cycles is for people aged 18 and over and most users are 25-35.

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