Billy Kelleher (Cork North Central, Fianna Fail)
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432. To ask the Minister for Health the length of time for which he will monitor the progress of the early access to medicines scheme that was recently introduced in the UK before examining the possibility of introducing a similar scheme here; and if he will make a statement on the matter. [20293/14]

Billy Kelleher (Cork North Central, Fianna Fail)
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434. To ask the Minister for Health in advance of any decision regarding the possible introduction of an early access of medicines scheme here, if he will consider bringing the pharmaceutical industry together to have preliminary talks in relation to their possible participation; and if so how soon would he envisage these talks taking place; and if he will make a statement on the matter. [20295/14]

Alex White (Dublin South, Labour)
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I propose to take Questions Nos. 432 and 434 together.

On 14 March 2014, the UK Government announced the introduction of an Early Access to Medicines Scheme (EAMS) which aims to give patients with life threatening or seriously debilitating conditions access to medicines that have not yet obtained a marketing authorisation from the Medicines and Healthcare Products Regulatory Agency (MHRA). I understand that, under the EAMS, medicines will be provided to patients at no charge by the relevant pharmaceutical company until they are licensed by the MHRA. I also understand that the UK Government does not intend to establish a dedicated fund to support access to medicines under the Scheme. There is currently no equivalent scheme in place in Ireland. I will continue to closely monitor the implementation of the EAMS in the UK. At this stage, it is premature to consider the possibility of introducing a similar scheme in Ireland.

Billy Kelleher (Cork North Central, Fianna Fail)
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433. To ask 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]

Alex White (Dublin South, Labour)
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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.