Róisín Shortall (Dublin North West, Social Democrats)
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212. To ask the Minister for Health the status of the commitment outlined in the programme for partnership Government to lower the cost of medicines and to examine opportunities to leverage the purchasing power of the State through national or European initiatives to make greater use of generic medicines; and if he will make a statement on the matter. [45155/17]

Simon Harris (Wicklow, Fine Gael)
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Medicines play a vital role in improving the overall health of Irish patients. Securing access to medicines in a timely manner is a key objective of the Irish Health Service. However, the challenge is delivering on this objective in an affordable and sustainable way.

The new four-year Framework Agreement on the Supply and Pricing of Medicines, signed in July 2016 is an agreement between the State and the Irish Pharmaceutical Healthcare Association (IPHA), and is expected to deliver approximately €600 million in savings over the lifetime of the Agreement from IPHA companies and €150 million in savings from non-IPHA companies. These savings have been taken into account in the 2017 HSE National Service Plan.

The new Agreement contains a number of features which represent clear additional value over the terms of the previous 2012 Agreement. The reference basket of countries used to set prices in Ireland has been expanded from 9 to 14 countries and, importantly, includes lower cost countries. For the first time, the Agreement provides for an annual price realignment, which will ensure that the prices of medicines in Ireland reduce in line with price reductions across the reference countries. This will ensure the State achieves better value for money on the cost of medicines as prices in other basket countries are adjusted downwards over time.

In addition, the Agreement secured a 30% reduction in the price of biologic medicines when a biosimilar medicine enters the market. The HSE included a savings target of €148m in the National Service Plan 2017 for drug related savings arising from the agreement and the launch of a biosimilar for Embrel in 2016.

My Department is currently developing a National Biosimilar Medicines Policy to promote the rational use of biosimilar medicines and to create a sustainable environment for biological medicines in Ireland. Biosimilar medicines provide an opportunity for long term sustainable savings on the public medicines bill, savings which can be then redirected into procuring approved new medicines. I expect this policy to be published in early 2018.

The Health (Pricing and Supply of Medical Goods) Act 2013 provided for the introduction of a system of generic substitution and reference pricing. The Act permits pharmacists to substitute medicines prescribed, provided they have been designated as safely interchangeable by the Health Products Regulatory Authority. Reference pricing involves the setting of a common reimbursement price, or reference price, for a group of interchangeable medicines, and this is the price that the HSE will reimburse to pharmacies for all medicines in this group, regardless of the individual medicines’ price.

My Department continues to examine new ways to achieve efficiencies in the cost of medicines. There is a major long term and strategic programme of work underway within the HSE Medicines Management Programme and the National Drugs Management Programme to maximise return from the investment in new medicines. The HSE has established the HSE Drugs Management Portfolio with the aim of ensuring equitable access to medicines for patients, value for the taxpayer and the cost-effective provision of medicines in Ireland.

Ireland is participating in a number of voluntary EU forums, including the Roundtable meetings with EU Health Ministers and the Pharmaceutical Industry, High Level Pharmaceutical Policy Meetings and the Valletta Technical Committee. These platforms are currently exploring possible areas for cooperation including information sharing, horizon scanning and possible price negotiations and joint procurement. Such platforms could also lead to faster access for patients for some treatments.