Dáil debates

Thursday, 31 March 2022

Saincheisteanna Tráthúla - Topical Issue Debate

Medicinal Products

4:55 pm

Photo of Seán FlemingSeán Fleming (Laois-Offaly, Fianna Fail) | Oireachtas source

I thank Deputy Pádraig O’Sullivan for raising this matter, which is an area in which he has shown particular interest and knowledge. As he noted, having met people face-to-face, he understands the issue. It is important that the views of those who have first-hand experience of the need for orphan drugs are adequately reflected in Dáil Éireann.

All of us in this House fully appreciate how devastating a diagnosis of a rare disease can be for patients, families, and carers. I believe there is cross-party support for doing everything we can to help patients who live with these awful conditions on a daily basis. I know Deputy O'Sullivan has been a long-standing advocate in this area and I commend him on his recent orphan medicines Bill, which was widely supported in the House on its Second Reading. The Minister for Health looks forward to further positive engagements as this Bill progresses, as do I.

The Government's track record on both initiatives and funding for rare diseases speaks for itself. I will mention a few matters in the time available to me. Many of the recommendations of A National Rare Disease Plan for Ireland 2014–2018 have already been implemented, including the establishment of a national rare disease office incorporating the HSE national clinical programme for rare diseases. In 2021, the Minister met with all relevant stakeholders in this area, including the HSE, the national rare disease office and the rare diseases task force. The Minister secured the agreement of all parties for a number of priority areas for the coming period, including European reference networks, research and registries, access to services and medicines, diagnosis, and policy.

I am pleased to note that Governments have a long track record in supporting rare disease research through the Health Research Board, HRB. In the past ten years alone, the HRB has invested €14 million in rare disease research. On access to new medicines for the treatment of rare diseases, the Government has provided funding which has made a real and concrete difference. Budget 2021 allocated €50 million for the reimbursement of new drugs, enabling the HSE to approve 52 new medicines, 19 of which were for the treatment of rare diseases.

That includes a number of medicines that deal with innovative gene therapy treatments for spinal muscular atrophy following a joint assessment with Belgium and the Netherlands. Budget 2022 has allocated a further €30 million for the reimbursement of new medicines. I understand from the HSE that 27 new orphan drugs are currently undergoing a pricing and reimbursement assessment.

There is no getting away from the fact the overriding factor in medicines being approved for reimbursement is the availability of Exchequer resources. This is a challenge for all of us over the coming years as more and more of these medicines become available, though often at very high asking prices. It is estimated about 97 new medicinal indications, including treatments for rare diseases, will receive market authorisation in Europe over the next five years. These new medicines alone will have the potential to add hundreds of millions to the State's annual bill for medicines, which is already in the region of €2.5 billion per year.

On the assessment process, the Deputy will know the Health (Pricing and Supply of Medical Goods) Act 2013 introduced a robust statutory framework for pricing and reimbursement decisions. Under the Act, the HSE has statutory responsibility for decisions on pricing and reimbursement of medicines. The 2013 Act does not provide for a separate rule set for assessing orphan drugs. The EU health technology assessment, HTA, regulation of December 2021 will enable co-operation on clinical evidence requirements for HTAs in clinical trial design, thereby supporting innovation and addressing unmet medical needs.

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