Medicines may not be ready when abortion law comes in
MEDICINES that need to be given to women having a medical termination may not be ready for authorisation in January when the new abortion law comes in to force.
Elaine Breslin, of the medicines’ watchdog the Health Products Regulatory Authority, says all efforts are being made to expedite the process but a special exemption may need to be invoked if it is not complete.
“In the event that medicines for the medical termination of pregnancy are not authorised by the end of 2018, there is an exemption in law for the treatment of patients with medical conditions for which an authorised medicine is not available,” she said.
“This is known as the Exempt Medicines Scheme. Specifically, an unauthorised medicine is considered ‘exempt’ from authorisation when it is supplied under prescription from a registered doctor for treatment of their individual patients in order to fulfil an unmet medical need.”
The Department of Health said yesterday that “exempt medicinal products are often used in clinical practice in Ireland and this reflects the fact that there are not always sufficient approved medicines to address every medical need”.
Officials were unable to confirm if the use of these medicines under the exemption carry a liability for the doctor in the event of a patient suffering complications.
Obstetricians and GPs have already expressed concern about the need for the Department of Health to increase preparations to support the new law if the January deadline is to be met.
The first medicine used in a medical abortion is Mifepristone. It acts by blocking the effects of progesterone, a hormone which is needed for pregnancy to continue. The second medicine, Misoprostol, causes contraction of the womb.
Currently in Ireland, there are no medicines authorised for the termination of pregnancy.
The medicines are authorised in many European Union member states. Across the EU, only a small number of companies supply them.