Jim O'Callaghan (Dublin Bay South, Fianna Fail)
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471. To ask the Minister for Enterprise, Trade and Employment what assessments are taking place within his Department regarding the impact of the EU pharmaceutical strategy review on the Irish pharmaceutical sector; and if he will make a statement on the matter. [28488/23]

Simon Coveney (Cork South Central, Fine Gael)
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On 26 April, 2023 the European Commission published a proposal to revise and replace the existing general pharmaceutical legislation. The EU Pharmaceutical legislative package proposes a suite of measures with the purpose of assuring the quality and safety of medicines and ensuring their availability to health services across the EU. As such, consideration of the proposal is being led by Health Ministries at EU level, including for Ireland.

Since its publication, officials from my Department have been engaging with colleagues in the Department of Health to examine the proposal and analyse the impact of the proposed measure for the Irish pharmaceutical sector. We understand that regulation must ensure patient safety while acting as an enabler of bringing new products to market with certainty and predictability at its core. We are committed to collaborating across Government in analysing the proposal and working with all stakeholders to ensure this assessment is fully informed and based on all available data.

To inform the national deliberation of this proposal, the Minister for Health formally established the Pharmaceutical Strategy Working Group (PSWG) in April 2023 which is chaired by his Department and on which there is representation from my Department and our agencies. The PSWG will continue to meet at regular intervals to consider the Commission’s proposal in full. An initial structured stakeholder engagement exercise took place on 8th May at which key representative stakeholders were invited to share their perspectives. Government will continue to engage on the views of stakeholders in progressing the Pharmaceutical Strategy for Europe and in shaping a national, cross-Government position on this important package. For example, as Minister for Enterprise Trade and Employment, I am clear that a well-functioning intellectual property system is key in incentivising R&D of novel medicines and enabling the balance to facilitate equitable and adequate access to medicines alongside industry’s incentives to undertake long-term and expensive research and innovation costs. For new and innovative medicines, the goal of ensuring equitable and sustainable access must be balanced with the EU being at the centre of developing such medicines, supporting the good jobs and strong economic growth this sector brings to Europe.

I fully recognise the importance of the pharmaceutical sector in Ireland, and my Department will continually engage with key stakeholders throughout the course of the negotiations and will assess the impact of any interventions made. In keeping with our ongoing focus on maintaining Ireland’s reputation as an exceptional place to do business, we will continue to advocate for measures that ensure predictability, consistency, equity, sustainability, and transparency in the medicines legislative ecosystem across the EU.

Simon Coveney (Cork South Central, Fine Gael)
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In December of last year, my Department published the White Paper on Enterprise, which outlines the Government’s approach to enterprise policy for the period to 2030.

The White Paper sets out Governments vision for Irish-based enterprise to succeed through competitive advantage founded on sustainability, innovation and productivity as well as delivering rewarding jobs and livelihoods. The approach set out in the White Paper will ensure that Ireland continues to build on its economic strengths as an open economy with strong trade and foreign direct investment, internationally competitive Irish enterprises, a vibrant innovation hub, and a resilient and inclusive labour market.

The White Paper sets out the Government’s seven priority enterprise policy objectives for the period to 2030. These are:

- Integrating decarbonisation and net zero commitments where our targets are a 35% emissions reduction from Industry by 2030 and 45% emissions reduction from Commercial Built Environment by 2030.

- Placing digital transformation at the heart of enterprise policy where our target is that 90% of SMEs are at basic digital intensity by 2030.

- Advancing Ireland’s FDI and trade value proposition, including targets of a 20% increase in IDA client expenditure in Ireland by 2024, and at least half of all FDI investments between 2021 and 2024 to be located outside of Dublin. The White Paper further recognises that the Trade and Investment Strategy: Value for Ireland, Values for the World will be integral to our enterprise growth model, and the effective implementation of its actions will support Ireland to increase exports sustainably, deepen and extend our trade relationships, grow quality employment and build a more resilient economy.

- Strengthening the Irish-owned exporting sector where we are targeting 2.5% average annual growth in Irish-owned enterprise productivity by 2024, a 50% increase in the number of large Irish exporting companies by 2030, 2,000 additional Irish-owned exporters by 2030, and over two-thirds of Enterprise Ireland assisted new jobs between 2022 and 2024 will be created outside of Dublin. These measures alongside Enterprise Ireland’s wider strategic objectives will be vital in achieving an increase the number of new entrepreneurs and fast growing High-Potential Start-Ups (HPSUs) across the regions.

- Enabling locally trading sectors to thrive where our target is a 1% average annual increase in multifactor productivity growth in domestic sectors of the economy by 2025. This will include expanding existing supports of our Local Enterprise Offices to support more entrepreneurs and SME`s across Ireland, alongside wider efforts stipulated within the strategic national SME and Entrepreneurship Growth Plan.

- Stepping up enterprise innovation such that Gross Expenditure on R&D will increase to 2.5% of Gross National Income by 2030 and the Number of High-Potential Start-Ups is increased by 20% by 2024.

- Building on strengths and opportunities where our targets are five national cluster organisations funded under a new National Clustering Programme by 2025. Measures are also outlined to ensure Irish businesses are supported across our regions, particularly in the areas of green and digital. Commitments have also been made to ensure unemployment does not exceed one percentage point of national unemployment rate in any region.

The White Paper also addresses the key components of the competitive enterprise environment including infrastructure, cost of doing business, skills and talent, access to finance, taxation and regulation. Notably, we will work to ensure a more responsive, collaborative and properly resourced approach to skills development. This will include increased investment in horizontal and high-level digital skills and skills required for the green transition, as well ensuring barriers to workforce participation are appropriately addressed. Challenges around access to finance for Irish enterprise has also been highlighted, where Government will work to ensure Irish businesses are adequately supported through financing for starting-up and scaling-up.

The White Paper on Enterprise 2022-2030 commits to the development of consecutive two-year Implementation Plans of cross-government activity. The first of these Implementation Plan covering the period 2023-2024 was published in May.

This first Implementation Plan identifies a portfolio of 40 key initiatives and projects under each of the seven priority objectives. The initiatives and projects listed have been selected as reflective of the efforts underway to align enterprise policy interventions with the vision and ambition set out in the White Paper.

Progress on this first implementation will be reported on every six months to the Cabinet Committee on the Economy and Investment. The first update report to the Cabinet Committee will be delivered in Q3 of this year.