Gerry Adams (Louth, Sinn Fein)
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254. To ask the Minister for Health his plans to address persistent shortages of epinephrine injectors for anaphylaxis, given his announcement on 15 October 2015 to make these medicines more widely available. [36881/15]

Gerry Adams (Louth, Sinn Fein)
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255. To ask the Minister for Health if he is aware of shortages of epinephrine injectors in any other European countries; and if he will explain the apparent ability in the North of Ireland to maintain stock at appropriate levels. [36882/15]

Leo Varadkar (Dublin West, Fine Gael)
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I propose to take Questions Nos. 254 and 255 together.

My Department does not have information on shortages in other markets nor am I aware of any specific shortages relating to adrenaline supply in other European countries. In terms of the North of Ireland, it is a very different market from the Republic’s in that it shares the large UK market for pharmaceuticals.

There are currently three adrenaline auto-injectors authorised and marketed in Ireland. Brands include Anapen®, Epipen® and Jext®. I am aware that at various times one or more of these products has been in short supply.

The Health Products Regulatory Authority (HPRA) has been working with the suppliers to try to restore continuity of supply. The HPRA employs a number of procedures which help to reduce the occurrence, impact and length of medicines shortages. One such mechanism, used in the case of adrenaline auto-injectors, is to facilitate Batch Specific Requests (BSRs). BSRs enable the company to temporarily supply, essentially identical, medicines from other countries to the Irish market to alleviate shortages. BSRs are typically processed within 24 hours of submission by a company to the HPRA. I understand that the HPRA is working with the companies concerned to facilitate the provision of further stock in the coming weeks.

Adrenaline auto-injectors are complex systems due to both the characteristics of the adrenaline active substance, which is chemically unstable, and of the delivery device, which is designed to be as patient friendly as possible. The manufacture of these products is also complex. For these reasons supply shortages can occur from time to time.

The availability is also impacted by the shelf-life of these 3 auto-injector products (which ranges from 18 to 24 months). This is short compared to some other medicinal products.

I can confirm that the HPRA has recently granted a Marketing Authorisation (MA) for a fourth adrenaline auto-injector, Emerade®. This has a 3 year shelf life. It is expected that supplies of Emerade® will arrive onto the Irish market in the coming days. This will help to alleviate the supply problems that patients have been experiencing recently.

Gerry Adams (Louth, Sinn Fein)
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256. To ask the Minister for Health if he is aware that a medication manufacturer (details supplied) is currently providing EpiPens free of charge to schools in the United States of America; and if a similar arrangement might be sought for Irish schools [36883/15]

Leo Varadkar (Dublin West, Fine Gael)
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I understand that the initiative the Deputy refers to involving the supply by a medication manufacturer of adrenaline auto-injectors to schools in the United States of America is part of a marketing strategy by that company.

In relation to the Statutory Instrument which I signed on 15 October 2015, making a number of rescue medicines available for use in emergency situations by lay persons, the arrangements that it permits are voluntary. No schools or other organisations are obliged to participate unless they wish to do so. Furthermore the Statutory Instrument makes it a condition of administration of the medications concerned by lay persons that such persons must have undergone appropriate training in this regard.

I wish to stress the importance of people continuing to carry the medicines that they need to manage their own health needs, as this initiative in no way diminishes any individual's responsibility in this regard.