Ms Jackson asked the Minister representing the Minister for Health and Ageing, upon notice, on 13 May 2003:

(1) Is the Minister aware that Prominal, a drug used by epileptics, has been delisted from the Pharmaceutical Benefits Scheme (PBS); if not, why not.

(2) Why was Prominal delisted from the PBS.

(3) Is it the case that other drugs available on the PBS for the treatment of epilepsy can cause serious side effects forcing some people to purchase Prominal without the benefit of the PBS subsidy; if so, was this considered when Prominal was delisted and, if it was not considered, why was it not considered before Prominal was delisted.

(4) Given the lack of transparency in the process of delisting drugs from the PBS, will the Minister undertake to make the process of delisting drugs from the PBS more accountable and transparent or assure the House that he will give his full support to any steps designed to bring greater accountability to the system.

(5) Will the Minister ask the Pharmaceutical Benefits Advisory Committee (PBAC) to reconsider its decision to delist Prominal from the PBS.

Mr Andrews (Minister for Ageing) —The Minister for Health and Ageing has provided the following answer to the honourable member's question:

(1) Yes.

(2) In August 2001, the sponsor of Prominal 200 mg tablet, Sanofi-Synthelabo Australia Pty Limited, advised the Department of Health and Ageing that it had decided to discontinue the supply of this product in Australia. The company requested that this product be deleted from the PBS, effective from 1 February 2002. In addition, Prominal 60 mg tablet was deleted from the PBS, effective 1 February 2003, following advice from the sponsor that the supply of this medicine was also being discontinued. The Government cannot force a company to supply a product under the PBS, if the company is unable to continue supply or considers it not in its interests to do so.

(3) All medicines have the potential to cause side effects. Pharmaceutical manufacturers provide information to consumers on possible side effects and adverse reactions to their medicines and who to contact if they experience any reactions to their medicines. As Prominal was discontinued by the manufacturer, it is no longer available for sale in Australia. Patients are best advised to consult their doctors concerning the most suitable medications for the treatment of their epilepsy.

(4) Parliament is advised whenever a medicine is to be deleted from the Schedule of Pharmaceutical Benefits.

Advice from the Secretary of the Pharmaceutical Benefits Advisory Committee concerning the deletion of methylphenobarbitone (the active drug contained in Prominal) from the PBS was forwarded to Parliament on 2 January 2003. This notice was tabled in Parliament on 3 March 2003.

(5) The Pharmaceutical Benefits Advisory Committee agreed to the deletion of Prominal in the knowledge that the drug was being discontinued.