Denis Naughten (Roscommon-South Leitrim, Independent)
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737. To ask the Minister for Health when the Health Service Executive is to set a reference price for medicines or outline the mechanism to be employed for establishing such prices; if his attention has been drawn to the implications of such delays; the steps he is taking to address this situation; and if he will make a statement on the matter. [36649/13]

Alex White (Dublin South, Labour)
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The Health (Pricing and Supply of Medical Goods) Act 2013, which came into operation on the 24th of June, will introduce a system of generic substitution and reference pricing. Under the Act, the Irish Medicines Board (IMB) is responsible for the assessment for interchangeability of medicines. The IMB will review an initial 20 active substances, which equates to approximately 1,500 individual medicines. They include statins, proton pump inhibitors, angiotensin-converting-enzyme (ACE) inhibitors and angiotensin II receptor blockers.

It is expected that the first List of Interchangeable Medicines, containing groups of atorvastatin products, will be published in mid-August at which time generic prices will fall by 20%. The IMB will publish subsequent lists for other groups of medicines on an ongoing basis.

The Act also provides that the HSE may set a reference price for each group of interchangeable products published on the List of Interchangeable Products. Reference pricing involves the setting of a common reimbursement price, or reference price, for a group of interchangeable medicines. It means that one reference price is set for each group or list of interchangeable medicines, and this is the price that the HSE will reimburse to pharmacies for all medicines in the group, regardless of the individual medicine's prices.

The Act provides that when the HSE is setting a reference price for, or reviewing a reference price set for, a relevant group of interchangeable medicinal products it shall take into account the following criteria:

- the ability of suppliers to meet patient demand for the relevant item;

- the value for money afforded by the relevant item;

- the equivalent prices of the relevant item in all other Member States where the product is marketed;

- the prices of therapeutically similar items; and

- the resources available to the HSE.

Once the IMB publishes the first list of interchangeable products, the HSE will commence the process of setting a reference price for that group in accordance with the timeframes set out in the legislation. The first reference price is expected to be implemented by November.