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Medicinal Products

Dáil Éireann Debate, Wednesday - 13 July 2022

Wednesday, 13 July 2022

Questions (454, 456, 457, 500, 501, 503, 505, 567, 568, 569, 570, 571)

Colm Burke

Question:

454. Deputy Colm Burke asked the Minister for Health if his Department’s white paper on Enterprise Policy will be taken into account as part of Ireland’s position in respect of the European Union Pharmaceutical Strategy; and if he will make a statement on the matter. [38312/22]

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Colm Burke

Question:

456. Deputy Colm Burke asked the Minister for Health if he has engaged with the Department of Taoiseach and the Department of Enterprise, Trade and Employment in relation to formulating a Government position on the European Union Pharmaceutical Strategy. [38786/22]

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Colm Burke

Question:

457. Deputy Colm Burke asked the Minister for Health if he intends to set up a cross-Departmental working group to consider the European Union Pharmaceutical Strategy and its implications for biopharmaceutical innovation in Ireland. [38787/22]

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Colm Burke

Question:

500. Deputy Colm Burke asked the Minister for Health if he intends to set up a cross-Departmental working group to consider the European Union Pharmaceutical Strategy; and if he will make a statement on the matter. [38282/22]

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Colm Burke

Question:

501. Deputy Colm Burke asked the Minister for Health if he intends to launch a public consultation for industry and interested stakeholders to assist in developing Ireland’s position in relation to the European Union Pharmaceutical Strategy; and if he will make a statement on the matter. [38283/22]

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Colm Burke

Question:

503. Deputy Colm Burke asked the Minister for Health his views on whether the European Union Pharmaceutical Strategy could place at risk certain intellectual property rights, including those for orphan and paediatric medicines; if such a move could damage jobs, competitiveness and the development of new medicines; and if he will make a statement on the matter. [38285/22]

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Colm Burke

Question:

505. Deputy Colm Burke asked the Minister for Health his views on whether there is a role for Ireland, along with other economically advanced, similar-sized countries in supporting the protection of innovation in the European Union Pharmaceutical Strategy in order that Ireland remains competitive for new investments and raise standards of care; and if he will make a statement on the matter. [38287/22]

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Colm Burke

Question:

567. Deputy Colm Burke asked the Minister for Health if he will outline the Government’s position on the European Union Pharmaceutical Strategy as the European Commission finalises its proposal for December 2022; and if he will make a statement on the matter. [38788/22]

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Colm Burke

Question:

568. Deputy Colm Burke asked the Minister for Health the last time the European Union Pharmaceutical Strategy was discussed at an EPSCO Meeting; if Ireland contributed to that discussion; and if he will make a statement on the matter. [38789/22]

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Colm Burke

Question:

569. Deputy Colm Burke asked the Minister for Health if he has engaged with the Department of An Taoiseach in relation to formulating a Government position on the European Union Pharmaceutical Strategy; and if he will make a statement on the matter. [38790/22]

View answer

Colm Burke

Question:

570. Deputy Colm Burke asked the Minister for Health if he has engaged with the Department of Enterprise, Trade and Employment in relation to formulating a position on the European Union Pharmaceutical Strategy; and if he will make a statement on the matter. [38791/22]

View answer

Colm Burke

Question:

571. Deputy Colm Burke asked the Minister for Health if he has engaged with the Department of Further and Higher Education, Research, Innovation and Science in relation to formulating a Government position on the European Union Pharmaceutical Strategy; and if he will make a statement on the matter. [38792/22]

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Written answers

I propose to take Questions Nos. 454, 456, 457, 500, 501, 503, 505, 567, 568, 569, 570 and 571 together.

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

The Strategy identifies challenges and lays down high-level policy objectives to mitigate these, setting these out in a multi-year vision under a number of different work streams. It is also cognisant of the challenges that were highlighted and intensified at the early stages of the pandemic and seeks to learn from these experiences, including access to medicines.

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). These include revision of the General Pharmaceutical, 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.

A status report on the implementation actions is expected to be tabled at the next Pharmaceutical Committee meeting due to be held in October 2022.

Strategic considerations relating to issues around availability, accessibility and affordability of medicines, medicines shortages, the enhanced use of digitalisation in the context of its role and potential in facilitating market access, are of importance.

The Department of Health has established a Cross Departmental/Agency Group with key Stakeholders with differing perspectives so as to be best equipped and informed to react holistically from a national perspective as the implementation of the strategy progresses. Representatives from the Department of Enterprise Trade and Employment are members of this group. The Group has already held two meetings with a third one planned for early Autumn.

At a European level the Department of Health also attends Directorate General Sante meetings where Pharmaceutical Strategy Priorities are discussed with other Member States. Ireland is actively involved at these meetings ensuring Ireland’s views are expressed.

Finally, insofar as the White Paper on Enterprise is concerned, at the request of the Tanaiste and Minister for Enterprise Trade and Employment, the Government agreed in March this year to the development of this White Paper which is being led by the Department of Enterprise Trade and Employment. The White Paper will set out set out an ambitious medium- to long-term direction for enterprise policy in response to challenges, opportunities and new drivers of growth catalysed by the Covid-19 pandemic, new economic and geopolitical realities, and an increased urgency to accelerate the decarbonisation of industry. In so doing, the White Paper will articulate what needs to be done differently to realise this vision and to set out clearly the risks to be faced - such as energy, skills availability, technological change, etc. - and the policy choices and trade-offs that will arise in order to maintain high-quality jobs, to protect the elements which make Ireland’s economy globally attractive for investment and to ensure a competitive Irish economy into the future. The Tanaiste announced his Department’s public consultation on the White Paper on 3rd July and details are at www.enterprise.gov.ie Public consultation on the preparation of the White Paper on Enterprise - DETE

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