Restrictions lifted for abortion pill

IT will be made available on a very limited basis.

CHEMISTS will be able to stock the abortion pill RU486 after the medicines regulator approved it for wider use.

The drug's registration by the Therapeutic Goods Administration comes six years after it was allowed into the country under stringent conditions. Only 187 doctors were authorised by the TGA to use it for early-term abortions, when most elective terminations of pregnancy are performed.

The rollout of RU486 and a companion drug, misoprostol, will be through the country's biggest private abortion provider, Marie Stopes International Australia, which runs clinics in four states and the ACT.

The not-for-profit organisation would introduce the drugs "in a controlled way for the safe use of the medicines", the TGA said.

MSIA declined to say how many more women were expected to opt for RU486 instead of surgical abortions. However, 22,330 women have undergone medical terminations since historic conscience votes in federal parliament in 2006 cleared the way for limited importation of the drug, also known as mifepristone.

Right to Life Australia president John James said he was sceptical that the drug would be widely taken up by medical professionals. He said a death from complications of a medical abortion performed at an MSIA clinic in 2010 had reinforced concern about safety. Right to Life Australia would be seeking clarification from the TGA on the clinical guidelines. "We don't see this as a plus for women or a plus for the practice of medicine," the Sydney GP said.

MSIA chief executive Maria Daveson Crabbe said wider access to medical abortion was an important milestone for Australian women. The organisation has established a subsidiary, MS Health, to market and distribute the drugs.

RU486 previously had to be imported under provisions applying to experimental medicines while misoprostol was used off-label, as it was approved in Australia only for the treatment of acute stomach ulcers.

Typically, RU486 is administered as a tablet at a clinic and the woman takes misoprostol at home about 48 hours later to complete the abortion.

Under the new arrangements MSIA has been licensed to "sponsor" the drugs with doctors who have undertaken a course on how to use them. "This will mean that only medical practitioners recognised by Marie Stopes International Australia as having completed appropriate training will be able to prescribe the medicines," the regulator said.

Royal Australian and New Zealand College of Obstetricians and Gynaecologists president Rupert Sherwood said it would be up to pharmacists whether they stocked the drug but he doubted they would do so routinely.

Regarding the cost of the drug, the TGA said: "This is a commercial decision of the sponsor and is not presently known."

Dr Sherwood conceded there were risks with medical abortion but said they were in line with those of surgical procedures.

TGA figures show 792 cases of "adverse events" from use of RU486 over the past six years, including the reported death from sepsis.