The Pharmaceutical Strategy for Europe (‘the Strategy’), published in November 2020, is part of a package of measures put in place to build a strong European Health Union. The other measures include the establishment of the European Health Emergency Preparedness and Response Authority (HERA), the launch of the European Health Data Space, and Europe’s Beating Cancer Plan.
The Strategy is fundamentally about ensuring safe affordable and accessible medicines for all citizens and patients. It will also look to balance this patient-centred approach with support to enable the competitiveness and innovative potential of the European pharmaceutical industry. The Strategy is based on 4 pillars, which include a range of legislative and non-legislative actions – further information can be found at https://health.ec.europa.eu/medicinal-products/pharmaceutical-strategy-europe_en#implementation .
One of the main actions of the Strategy has been the proposal to reform the EU’s general pharmaceutical legislation. To this end, on the 26 April 2023, the EU Commission published its legislative proposals. Further information can be accessed at Reform of the EU pharmaceutical legislation (europa.eu)
The Department of Health (DoH) is the lead Government Department tasked with considering the EU Commission’s legislative proposals and is engaging nationally as the proposals are negotiated by all EU Member States and progresses through the EU’s ordinary legislative process.
The Minister for Health established the Pharmaceutical Strategy Working Group as a vehicle to assist in ensuring a universal and coherent national approach and response to the Strategy and actions emanating from it.
The PSWG is currently focusing on supporting the development of Ireland’s position on the EU Commission’s legislative proposals, which will be coordinated by the Department of Health. The PSWG continues to meet on a regular basis to deliberate and inform the national position.
Representation on the PSWG includes Government Departments, and their Agencies as follows:
Following the publication of the EU Commission’s legislative package in April 2023, the DoH conducted an initial stakeholder event to inform a preliminary Irish position on the proposals. The Irish Pharmaceutical Healthcare Association (IPHA), Medicines for Ireland, the Irish Platform for Patient Organisations, Science, and Industry (IPPOSI) and Rare Diseases Ireland attended this engagement activity and shared their initial views with the PSWG on the EU Commission’s legislative package.
The PSWG is currently considering the measures and provisions included in the EU Commission’s legislative proposals specifically relating to the shortages and security of supply . Such considerations by the PSWG will help to inform the national position on this policy topic in the context of the EU Commission’s legislative package specifically.
The DoH is seeking to confirm the national position on this policy topic by the end of 2023.
Shortages/Security of Supply
To help in informing its deliberations on this policy topic, the Department of Health and PSWG are inviting interested stakeholders to provide submissions on this specific policy topic, shortages, and security of supply .
Identified stakeholders have already been contacted and the period for consultation will continue until 8 December 2023. To find out more about this consultation and / or should you wish to make a submission, please email the PSWG secretariat at EUpharmastrategy@health.gov.ie. , where you will be provided with a dedicated submission template.
This consultation has now concluded.
To help in informing its deliberations on the policy topic incentives, the Department of Health and PSWG are now conducting a consultation and are inviting interested stakeholders to provide submissions on this specific policy topic.
Identified stakeholders have already been contacted and the period for consultation will close on 16 February 2024.
To find out more about this consultation and / or should you wish to make a submission, please email the PSWG secretariat at EUpharmastrategy@health.gov.ie , where you will be provided with a dedicated submission template.
Ireland will continue to listen to the views of stakeholders in progressing the Pharmaceutical Strategy for Europe. The Department is also encouraging stakeholders to submit their opinions on the legislative proposal and feedback can be submitted to the Department at EUpharmastrategy@health.gov.ie .