Firms to face high costs for RU486

05/07/06

ONE of the senators behind a push to make the abortion drug RU486 available believes the significant cost companies face to register it has put them off applying. Democrats leader Lyn Allison, one of four senators who forced a conscience vote on the issue in Federal Parliament almost five months ago, said the first drug company that applied would face significant costs. But subsequent applications from other drug companies may not incur that cost. ''There are not very high profits in this drug because it's not an innovative drug and it's not the first time it's come on the market, '' she said.

''The other problem is because it's generic, if a company from overseas goes through that process, another one could come along almost the next day and release it on the Australian market and not have to pay it. ''Since the conscience vote that stripped Health Minister Tony Abbott of his right to veto the drug, giving the power of approval to the Therapeutic Goods Administration, only one doctor has earned the right to prescribe the drug. No company has applied.

The delay in getting RU486 has prompted leading abortion provider Marie Stopes International to start a pilot program of early-stage abortions next month, using the cancer drug methotrexate.

It is using the drug off -label, meaning it is not licensed for that purpose but can still be legally used. Senator Allison said she was disappointed in the delay in getting RU486 and said people had become ''impatient'' waiting for it. She also accused Health Minister Tony Abbott of ''threatening the pharmaceutical industry not to get involved'' - a claim strongly denied by the Federal Government. But Prime Minister John Howard said he was not aware of any government pressure.

''I'm certainly not involved in applying any pressure, '' he told Southern Cross Broadcasting. Medicines Australia chief executive Kieran Schneemann said that, to his knowledge, the industry had not received any pressure from the Government or the minister. He said his members were companies that made only new, innovative medicine, not generic medicine that was off patent. A spokeswoman for the Therapeutic Goods Administration said it cost $185, 000 for a company to register a new drug.

''The first applicant does have to go through a lot more rigmarole to show that it suits the Australian market, '' she said. With AAP.