David Stanton (Cork East, Fine Gael)
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37. To ask the Minister for Health the State's position with respect to the EU revision of pharmaceutical legislation ahead of EU Parliamentary Committee votes expected in March 2024; if he supports proposals to reduce regulatory data protection for manufacturers; the impact that such a reduction will have on patients; and if he will make a statement on the matter. [9568/24]

James O'Connor (Cork East, Fianna Fail)
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47. To ask the Minister for Health the Government's position in respect of the European Union's revision of pharmaceutical legislation, given that EU Parliamentary Committee votes are expected in March 2024; if he supports proposals to reduce regulatory data protection for manufacturers; the impact that such a reduction will have on patients; and if he will make a statement on the matter. [8933/24]

Stephen Donnelly (Wicklow, Fianna Fail)
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I propose to take Questions Nos. 37 and 47 together.

On the 26 April 2023 the EU Commission published its proposal to revise the general pharmaceutical legislation - this is in the form of a Directive and a Regulation. This is the first full revision of the pharmaceutical legislation in over 20 years and is significant to all stakeholders involved in the medicines’ ecosystem.

The aim of the pharmaceutical revision is described as ensuring access to affordable, available medicines, while maintaining the competitiveness of the EU pharma industry sector, combating antimicrobial resistance, and providing for compliance measures which reinforce environmental protections ( the ‘3 A’s and 3C’s’).

Ireland is currently deliberating these legislative proposals with national stakeholders to inform the national position. My Department is the lead Government department tasked with responding and engaging nationally and at EU level, as the proposal is negotiated by all EU-27 and progresses through the ordinary legislative process.

Belgium, during its Presidency, have confirmed that they will focus their efforts in January and February on shortages/security of supply. They will then move to deliberate on the theme incentives during the planned Working Party meetings taking place in March.

To recognise the importance of this EU file, I established the Cross Government and Cross Agency Pharmaceutical Strategy Working Group (PSWG) to support the development of Ireland’s response to the proposal from a national perspective and facilitate this position to be informed by a whole of government view.

The PSWG continues to meet to discuss this package regularly and is actively involved in considering the detail of the proposed package of legislative measures, ensuring a well informed and balanced Irish position.

The Department of Health conducted a consultation exercise on shortages with key external stakeholders from various backgrounds at the end of 2023 to help in informing the national position and this will feed into the Irish negotiation mandate.

Furthermore ,the Department has just completed a consultation on incentives and again this information will feed into the preparation of an Irish position. RDP is included in this review. Officials in the Department have started reviewing and analyzing this data. It is vital that the Irish position is fully considered and a balance is found that ensures improved access to medicines to patients in Ireland while also addressing industry concerns.

I look forward to working collectively with all stakeholders as the package continues to be deliberated in Europe and I would like to thank key stakeholders for their continued engagement with this important file.