Uncertainty over implementation of generic drug scheme

Certain prescribed drugs could be substituted for cheaper version on interchangeable list

Minister for Health James Reilly: told Dáil the Bill aimed to achieve value for money while avoiding disruption in the availability of medicines on the Irish market.

Minister for Health James Reilly: told Dáil the Bill aimed to achieve value for money while avoiding disruption in the availability of medicines on the Irish market.

Thu, Apr 4, 2013, 06:00


There is uncertainty as to when a key healthcare reform that would allow pharmacists to substitute a cheaper generic drug for a branded product will be fully implemented.

Under proposed legislation, which passed committee stage in the Oireachtas last month, a prescribed drug could be substituted for a cheaper drug on an interchangeable list.

The Health (Pricing and Supply of Medical Goods) Bill 2012 is a key measure put forward by Minister for Health James Reilly to curb costs in the health sector, both for patients and for the Health Service Executive.

The review of medicines for inclusion on the list will be undertaken by the Irish Medicine’s Board (IMB). The department has given the board a priority list of 20 medicine groups for inclusion on the list, which are also those that incur the highest cost.

However, the IMB has said that, while it anticipates that one of the 20 priority medicine groups will be on the list within two to three months of the commencement of the legislation, it cannot provide a timeframe for the other 19 medicine groups.

A spokeswoman for the board said yesterday this depended on a number of factors, including when the legislation was enacted and any issues raised in mandatory consultations with pharmaceutical companies.

She said the other 19 medicines groups will be added to the list as and when these consultation periods come to an end but would not specify how long this might take.

The board was unable to say how long it would take for other drugs, understood to total some 300 groups, to be included. “The IMB’s current priority is the list of 20 medicines and therefore it is impractical to state when the IMB expects other groups to be included on the list,” the spokeswoman said.

She said a separate consultation is required for each group of medicines, adding that some consultations would run concurrently while others would take place consecutively.

Generic drugs are copies that can be made once the patent on the original branded drug expires.

Under the consultation process the relevant companies, known as marketing authorisation holders, have 28 days to comment. The board then reviews the comments and if there is no change to the group, the list will be published within 14 days.

“The list will be updated with further groups/medicines on a regular basis and this process will be conducted in an efficient manner in accordance with the legislation. The IMB is working with the Department of Health, the HSE and relevant stakeholders to ensure that appropriate processes are in place to implement this legislation,” the spokeswoman said.

Speaking in the Dáil last week, Mr Reilly said the Bill, which was passed at committee stage last month, aimed to achieve value for money while avoiding disruption in the availability of medicines on the Irish market.