Bernard Durkan (Kildare North, Fine Gael)
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1388. To ask the Minister for Health the procedures in place to encourage manufacturers of medicines to make their products available for sale to the health services at a manageable cost with particular reference to top of the range new products; and if he will make a statement on the matter. [28201/17]

Simon Harris (Wicklow, Fine Gael)
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The 2016 Framework Agreement on the Supply and Pricing of Medicines provides for a new and more robust process for the reimbursement of medicines offering greater certainty to manufacturers regarding the reimbursement process.

The revised process now requires that each product seeking reimbursement under the community drugs schemes will undergo an assessment process by the National Centre for Pharmacoeconomics (NCPE). As part of this process the manufacturer must submit the price at which it is seeking reimbursement for its product.

Under Clause 6.2.1 of the Framework Agreement the maximum supplier proposedprice shall be no greater than the average of the currency-adjusted relevant price (being the ex- factory price or equivalent thereof and using the applicable exchange rate) applicable in such of the nominated states in which the medicine is available on the date of application. Under Clause 6.2.3 medicines are also subject to an annual price realignment so as to ensure that prices in Ireland fall in line with prices in other basket countries.

Once submitted to the NCPE the product will then be assessed in terms of its safety, clinical effectiveness and cost-effectiveness at the price submitted. The cost-effectiveness of the drug at the price submitted is factored into the NCPE's recommendation on whether or not the product should be reimbursed.

Following a recommendation from the NCPE, the HSE enters into negotiations with manufacturers, often seeking price reductions. The HSE frequently seeks to address what it may regard as excessive pricing demands around new medicines so as to bring those medicines within the range of affordability.

It is important to point out however that the HSE does not select the prices sought for patented medicines, that is determined by the pharmaceutical industry. Therefore I would urge all pharmaceutical companies to submit pricing proposals which are affordable and sustainable and which represent value for money for the Irish health service, patients and the taxpayer.

In May I attended the third Round Table meeting for European Health Ministers and CEO's/Heads of Europe-based pharmaceutical companies in Malta, where I signed the Valetta Declaration.

The Declaration is in line with my objectives since coming into office to work with other countries to make medicines available to patients at affordable prices.

A technical committee to be established shortly, will explore the possible areas for cooperation including information sharing, horizon scanning and possible price negotiations and joint procurement.