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Medicinal Products Availability

Dáil Éireann Debate, Tuesday - 6 May 2014

Tuesday, 6 May 2014

Questions (433)

Billy Kelleher

Question:

433. Deputy Billy Kelleher asked the Minister for Health if there is a definitive list of areas of unmet medical need in terms of medicines either off-label or unlicensed; if not, if he will consider the compilation of such a list; and if he will make a statement on the matter. [20294/14]

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Written answers

It is not possible to identify unmet needs in terms of off-label and unauthorised medicines. Under European and Irish legislation, medicines must be authorised (licensed) before being placed on the market. The legislation provides that a medical practitioner may prescribe an unlicensed medicine for use by an individual patient under his direct personal responsibility. Off-label use of a medicine arises where a medicine which is authorised for use for a particular condition is used for the treatment of a different condition. Medicines shortages have become increasingly prevalent in recent years and off-label use and use of unlicensed medicines are two of a number of strategies used to ensure that the needs of patients are met. At EU level, initiatives have been put in place to promote the development of orphan (treatment of rare medical conditions) and paediatric medicines to address unmet need in those areas.

The Irish Medicines Board (IMB) operate a notification scheme whereby wholesalers and manufacturers are obliged to notify the IMB of requests to import authorised medicines. This notification scheme provides information on the use of unlicensed medicines. However, very little information is available on the off label use of medicines as a medical practitioner is not required to notify such usage to the IMB or HSE.

Question No. 434 answered with Question No. 432.
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