David Cullinane (Waterford, Sinn Fein)
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576. To ask the Minister for Health the status of the new framework agreement on the supply and pricing of medicines; the steps he has taken to help reduce the cost of medicines to the HSE and to patients; the timeline for negotiations for this agreement given the existing agreement is due to expire in July 2021; and if he will make a statement on the matter. [25677/21]

David Cullinane (Waterford, Sinn Fein)
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577. To ask the Minister for Health the organisations that he or his officials have met since July 2020 in relation to the process to agree a new framework agreement on the supply and pricing of medicines; his views on whether increased usage of generic medicines and biosimilars can help reduce the cost to the State; and if he will make a statement on the matter. [25678/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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I propose to take Questions Nos. 576 and 577 together.

Since the 1970s, the parameters of pricing mechanisms and supply arrangements for medicines in Ireland have been determined by the terms of successive agreements between the State and the respective representative bodies of the pharmaceutical industry in Ireland. The most recent agreement was the Framework Agreement on the Supply of Medicines to the Health Services 2016-2020(FASPM).

The HSE has statutory responsibility for medicine pricing and reimbursement decisions, in accordance with The Health (Pricing and Supply of Medical Goods) Act 2013. The Act specifies the criteria for decisions on the reimbursement of medicines, including provision for the existence of any framework agreements in place.

Savings generated from the powers afforded to the HSE under the Health Act 2013 relating to Reference Pricing and Interchangeability of generic medicines falls outside the remit of the FASPM. Similarly, HSE activities to optimise the use of biosimilars in Ireland are separate to this Agreement.

For example, the prescribing of Best Value Biologic medicines is leading to significant savings for the health service under the Gain-Share Initiative. By December 2020, almost 12,000 patients have switched to a best-value-biologic (BvB), almost 57% of the claims submitted to PCRS for payment was for the BvB alternative to the originator biologic and associated annual savings in excess of €46 million has been achieved.

The current FASPM was due to end in July 2020; however, due to COVID-19 it was necessary to implement an extension. The Department of Health, along with our partners in the Department of Public Expenditure and the HSE, agreed with the Irish Pharmaceutical Healthcare Association (IPHA) an extension on the terms of the existing 2016-2020. This remains in place until 31 July 2021 to facilitate preparatory work on the successor agreement within the context of the ongoing COVID-19 challenges.

My Department, the Department of Public Expenditure and Reform and the HSE are presently engaged in preparatory work with a view to initiating negotiations on a successor agreement later this year. My officials are considering all relevant stakeholders as part of this preparatory work.

David Cullinane (Waterford, Sinn Fein)
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578. To ask the Minister for Health if he has examined the policy proposals by an organisation (details supplied) which if implemented could help free up €1 billion in expenditure over the next five years; and if he will make a statement on the matter. [25679/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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The policy proposals mentioned have not been brought to my attention or to the attention of my officials in the Department. However, the matters raised are important objectives within the Department. Securing affordable access to existing and new 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. Expenditure on medicines represents one of the largest areas of expenditure across the health service and will continue to grow in the years ahead.

The Department of Health is fully supportive of domestic policies that maximise efficiency in our medicines usage. The HSE is actively engaged in implementing effective policy levers across a number of domains and under several initiatives, including those under the Acute Hospitals Drugs Management Programme (AHDMP), the Medicines Management Programme (MMP), and within the Primary Care Eligibility & Reimbursement Service (PCERS).

Foe example, in relation to biosimilar medicines, the AHDMP has a biosimilar strategy in place since 2017. This is making considerable progress using a collaborative approach to bring about changes in prescribing practice.  

The MMP completed an evaluation process in 2019 for the identification of the best-value biological (BVB) medicines for TNF-α inhibitors under the High-Tech Drug arrangements. In June 2019, a system of gain-share was introduced and is administered by the PCERS with the objective of encouraging the prescribing of the BVB medicines. This has been largely successful in increasing uptake of these medicines.

While progress has been positive, the Department of Health and HSE are continuously monitoring and evaluating the effectiveness of current levers to ensure that the State can capitalise on the most efficient policy approach.