John Paul Phelan (Carlow-Kilkenny, Fine Gael)
Link to this: Individually | In context | Oireachtas source

297. To ask the Minister for Health if he intends to publish a successor to the now-expired National Rare Disease Plan; and if he will make a statement on the matter. [10710/23]

John Paul Phelan (Carlow-Kilkenny, Fine Gael)
Link to this: Individually | In context | Oireachtas source

298. To ask the Minister for Health the status of the recruitment process for a dedicated official within his Department to have oversight of rare disease policy; the timeframe for such a process; and if he will make a statement on the matter. [10711/23]

Stephen Donnelly (Wicklow, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

I propose to take Questions Nos. 297 and 298 together.

The Government and I are fully committed to doing everything possible to assist people living with a rare disease.

I intend to bring forward a successor plan to the National Rare Disease Plan 2014-2018. However, there is no doubt that the Covid-19 pandemic slowed our progress up until now.

Nonetheless, various actions have been implemented and significant resources invested in this area in recent years.

Principal among those actions was the establishment of the HSE National Clinical Programme for Rare Diseases and a National Rare Disease Office.

Last year the HSE was nominated as the National Competent Authority in an EU Joint Action of European Reference Networks for Rare Diseases, which enables greater coordination and sharing of best practices in key areas such as genetic testing.

As a result of this collaboration, we have entered in 18 European Reference Networks (ERNs) on Rare Diseases. These ERNs include representation from five academic hospitals and three universities and is coordinated by the National Rare Disease Office. This represents a significant achievement by the health service, to drive innovation, training and clinical research for highly specialised care. Through the European Reference Networks, the National Rare Disease Office is leading out on the development of optimal care pathways across a range of rare diseases.

My Department is seeking to appoint, through the usual recruitment channels, an official to progress the commitment in the Programme for Government to bring forward a new National Rare Diseases Plan.

In terms of medicines for rare diseases, I have during my term of office significantly increased the level of funding available for new innovative medicines including medicines for rare diseases; a combined €100 million in the last three Budgets. Over one hundred new medicines have been approved including thirty-four for orphan medicines that are used to treat rare diseases. However, I accept that a new Plan is needed.

John Paul Phelan (Carlow-Kilkenny, Fine Gael)
Link to this: Individually | In context | Oireachtas source

299. To ask the Minister for Health when he intends to publish the review of the Obesity Policy and Action Plan; and if he will make a statement on the matter. [10712/23]

Hildegarde Naughton (Galway West, Fine Gael)
Link to this: Individually | In context | Oireachtas source

A Healthy Weight for Ireland, the Obesity Policy and Action Plan (OPAP), was launched in September 2016 under the auspices of the Healthy Ireland Framework (Healthy Ireland: A Framework for Improved Health and Wellbeing 2013-2025).  It was developed in recognition of the growing need for a co-ordinated policy response to the increasing problem of obesity in Ireland and the increasing burden placed on individuals and society.

OPAP covers a 10-year period up to 2025 and aims to reverse obesity trends, prevent health complications, and reduce the overall burden for individuals, families, the health system, and the wider society and economy.  It recognises that obesity is a complex, multi-faceted problem and needs a multi-pronged solution, with every sector of society playing its part. Childhood obesity is a key priority under OPAP, as is reducing the inequalities seen in obesity rates, where children (and adults) from lower socioeconomic groups have higher levels of obesity.

In the context of preparing a review of the OPAP, UCC was commissioned to conduct an independent evaluation. This evaluation covers the period January 2016 to May 2021.

The Department of Health carried out a Review of the OPAP which provides an update as to the current status of some of the main deliverables in the Ten Steps to end October 2022. It also aligns the Ten Steps suite of population-health approaches in OPAP with the WHO European Regional Obesity Report 20225 and the policy options the WHO recommends on managing obesity throughout the life course, thus signposting key actions to consider out to 2025.

Both the independent evaluation of OPAP by UCC and the Review of OPAP by the Department of Health were published in November 2022 and can be found on the Healthy Ireland website at gov.ie - Healthy Ireland Policies (www.gov.ie).

John Paul Phelan (Carlow-Kilkenny, Fine Gael)
Link to this: Individually | In context | Oireachtas source

300. To ask the Minister for Health when the cross-departmental group on the EU Pharmaceutical Strategy last met; and if he will make a statement on the matter. [10713/23]

Stephen Donnelly (Wicklow, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

The Pharmaceutical Strategy for Europe, published on 25 November 2020 is the second major building block of the new EU Health Union, and is fundamentally about ensuring safe, affordable medicines for all citizens and patients.

The strategy has four key aims that are focussed on

- ensuring access to affordable therapies for patients, and addressing unmet medical needs (in the areas of antimicrobial resistance and rare diseases, for example)

- supporting competitiveness, innovation and sustainability of the EU’s pharmaceutical industry and the development of high quality, safe, effective and greener medicines

- enhancing crisis preparedness and response mechanisms, establishing diversified and secure supply chains and addressing medicines shortages

- ensuring a strong EU voice in the world, by promoting a high level of quality, efficacy and safety standards

Significant progress has been made to date on the delivery of actions laid out in the Implementation Plan, with some of the mechanisms of delivery addressing more than one of the desired actions. (55 outlined actions both legislative and non-legislative which will operationally realise the objectives of the strategy). This includes ongoing work on the revision of the General Pharmaceutical Legislation, Orphan and Paediatric legislation, work to define/set criteria for unmet need, creation of the Health Emergency Response Authority, Structured Dialogue Initiative, and Clinical Trials Regulation.

I understand that the European Commission intends to publish its proposal to update the general pharmaceutical legislation in March. Ireland welcomes and eagerly anticipates the actions that will emanate from and underpin the delivery on the aims of the Pharmaceutical Strategy for Europe, which is premised essentially on ensuring access to safe, affordable effective medicines for all European patients. Once the legislative proposal and Impact Assessment are available my Department will be participating as appropriate in the deliberative process. 

The Department of Health has established a Cross Departmental/Agency Group with key stakeholders, holding differing perspectives, which are shared so as to best inform national engagement as the implementation actions of the strategy progress. The Group has met on four occasions to date. The last meeting was on 17th January with a further meeting planned for later this month.  Views are shared at these meetings, and the learnings gleaned utilised as appropriate by my officials as we respond in accordance with the obligations derived from our membership of the EU.