Pádraig O'Sullivan (Cork North Central, Fianna Fail)
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773. To ask the Minister for Health when the rare diseases technology review committee, RDTRC, is scheduled to meet in 2020; the frequency with which he expects the committee to meet in 2021; and if he will make a statement on the matter. [23895/20]

Stephen Donnelly (Wicklow, Fianna Fail)
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A Technology Review Committee for Rare Diseases (as recommended by the National Rare Disease Plan for Ireland) was appointed in late 2018 with responsibility for:

- 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

- 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.

The Rare Diseases Medicinal Products / Technology Review Committee meets in response to requests for assessment of new products for rare diseases or expanded indications for existing products for rare diseases. In 2020 no requests were received by the Committee until August when a request was received from the HSE Drugs Group to advise on two medicines.

The HSE has confirmed that the Committee will meet in the week commencing 21 September 2020 to provide the requested patient and clinician engagement that will facilitate the Drugs Group’s work. The frequency of subsequent meetings will relate directly to the number of requests received.

Pádraig O'Sullivan (Cork North Central, Fianna Fail)
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774. To ask the Minister for Health the timelines for assessment of medicines referred to the RDTRC; when recommendations will be made on referred therapies; and if he will make a statement on the matter. [23906/20]

Stephen Donnelly (Wicklow, Fianna Fail)
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The Rare Diseases Medicinal Products / Technology Review Committee is responsible for 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.

The Committee is also responsible for 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.

Assessment of medicines by the Committee are carried out in response to requests received. The HSE has advised that timelines for assessment are not defined in the Committee’s terms of reference, which are due for review this year.

In 2020 no requests were received by the Committee until August when a request was received from the HSE Drugs Group to advise on two medicines. The HSE has confirmed that the Committee will meet in the week commencing 21 September 2020 to provide the requested patient and clinician engagement that will facilitate the Drugs Group’s work.

Pádraig O'Sullivan (Cork North Central, Fianna Fail)
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775. To ask the Minister for Health when he expects the publication of a new national rare diseases plan; and if he will make a statement on the matter. [23907/20]

Stephen Donnelly (Wicklow, Fianna Fail)
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A National Rare Disease Plan for Ireland (2014 – 2018) was launched by the Minister for Health in July 2014. This is a generic policy framework for rare diseases. The scope of the plan is broad given that there are approximately 8,000 rare diseases affecting millions of EU citizens; and consequently, there can be a dearth of expertise and knowledge about some rare diseases, simply because they are so rare.

Many of the major recommendations of the plan have already been implemented and in December 2013 the National Clinical Programme for Rare Diseases was established as a joint initiative between the HSE and the Royal College of Physicians of Ireland. A Clinical Advisory Group was established to oversee the programme, a Clinical Lead and Programme Manager were appointed, and a multidisciplinary National Working Group was established to provide support to the programme workstreams and the National Plan was firmly embedded in the Programme.

The opening of the National Rare Disease Office, (NRDO) in 2015 was a significant milestone for people living with a rare disease, their families and their healthcare professionals. Prof Eileen Treacy is the Director of the National Rare Diseases Office, whose purpose it is to provide current and reliable information about genetic and rare diseases to patients, families and healthcare professionals.

On foot of the HSE Chief Clinical Officer’s (CCO), review of all the national clinical programmes in April 2019, it was recommended that the National Clinical Programme for Rare Diseases be operationalised and incorporated into the National Rare Disease Office. From 01 September 2020, the NRDO will be the main contact point and driver for national HSE rare disease projects and initiatives. The work of the NRDO will be overseen and governed by HSE Acute Operations. This means that the National Clinical Programme for Rare Diseases will be wound down and any outstanding projects will be transferred to the NRDO.

Building on the significant progress to date, themes for inclusion in a roadmap for the coming period have been agreed with the Rare Disease Task Force, which comprises the main rare disease advocacy groups; Rare Disease Ireland, the Medical Research Charities Group (MRCP), and the Irish Platform for Patient Organisations, Science and Industry (IPPPOSI).

Meetings, to ensure that the input and the voice of the patient is represented in the continuing work ongoing in relation to Rare Diseases will continue to take place at regular intervals with the Rare Disease Task Force, the HSE National Clinical Programme for Rare Diseases and the Rare Disease Office.

A number of key themes have now been identified for progression in the coming period, including: Patient Awareness; European Reference Networks; Research & Registries; Access to Services; Access to Medicines; Diagnosis; Education & Training and Legislation & Policy. This will form the basis for work in this area in the time ahead.