Tommy Broughan (Dublin Bay North, Independent)
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238. To ask the Minister for Health the way in which he plans to work to make orphan drugs more affordable and accessible for those who urgently need them; and if he will make a statement on the matter. [43141/18]

Simon Harris (Wicklow, Fine Gael)
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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. As Minister for Health, I do not have any statutory power or function in relation to the reimbursement of medicines.

The 2013 Act requires the HSE to have regard to both the clinical benefits and cost effectiveness but it does not include provision for a different ruleset when assessing orphan drugs. However, both the National Centre of Pharmacoeconomics (NCPE) and the HSE are mindful of the differences and challenges in terms of patient numbers when assessing this type of medicine.

The NCPE conducts health technology assessments (HTAs) for the HSE and makes recommendations on reimbursement to assist HSE decisions. The NCPE uses a decision framework to systematically assess whether a drug is cost-effective as a health intervention. These HTAs often allow the HSE to negotiate discounts on new medicines providing greater access to patients.

In line with the recommendations of the National Rare Diseases Plan 2014-2018, the HSE established a Rare Diseases Medicinal Products/Technology Review Committee in 2018, which is now operational.

This Committee is responsible for:

1. Reviewing proposals received from industry or expert groups in Ireland for funding of new products for rare diseases, or expanded indications for existing products for rare diseases and making recommendations as to the implementation of the relevant recommendations from the National Rare Diseases Plan 2011-2018; and

2. Providing contributions to the development of clinical guidelines for relevant Orphan Medicinal Products (OMPs) and supporting the implementation of guidelines in conjunction with the National Drugs Management Programme Office where applicable.

This Committee reports to the National Director of Acute Hospitals Division and makes recommendations regarding new treatments to the HSE Drugs Committee.

The challenge of securing affordable access to innovate medicines is not unique to Ireland. Over the past two years, I and officials have been engaging with 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 in an effort to identifying solutions to issues of medicine pricing, sustainability and supply.

On the 22 June 2018, I signed the Beneluxa Initiative on Pharmaceutical Policy to work with Austria, Belgium, the Netherlands and Luxembourg. This Agreement is in line with my objective to work with other European countries to identify workable solutions, in an increasingly challenging environment, to secure timely access for patients to new medicines in an affordable and sustainable way.

The Beneluxa Initiative on Pharmaceutical Policy will have an important role to play in securing faster access to innovative medicines and provide important platforms in which to strengthen the policy mix and deliver on the shared objective of securing access to high cost, innovative treatments at affordable prices. The patient is at the centre of this collaborative international approach.