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For Oral Answer on : 29/02/2024
Question Number(s): 23 Question Reference(s): 9719/24
Department: Health
Asked by: David Stanton T.D.


To ask the Minister for Health if his Department has conducted a consultation with stakeholders on the policy topic incentives of the EU’s General Pharmaceutical legislation; the findings of same; and if he will make a statement on the matter.


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 recently completed a consultation on incentives and again this information will feed into the preparation of an Irish position.  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.