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In accordance with the EU-UK Withdrawal Agreement, Regulation (EC) No 726/2004 and Directive 2001/83/EC as well as the Commission acts based on them, apply to and in the UK in respect of Northern Ireland.
Despite the transition period provided for in the Withdrawal Agreement, it proved difficult for certain economic operators based in parts of the UK other than Northern Ireland to adapt and move relevant regulatory compliance functions to Northern Ireland or the Union in respect of nationally authorised medicines, as required by the Protocol.
To ensure the uninterrupted supply of medicines covered by UK national authorisations from Great Britain to Northern Ireland, as well as to other markets that have been historically dependent on supplies from the UK market, the Union adopted Directive (EU) 2022/642, which introduced derogations from certain obligations concerning certain medicinal products for human use made available in the UK in respect of Northern Ireland.
Despite the above-mentioned derogations, the UK and certain stakeholders based in the UK have raised concerns that the need for separate marketing authorisations for Great Britain and Northern Ireland in respect of novel medicines and the application of the Union unique identifier requirement for medicines subject to prescription impose unnecessary administrative burdens for medicines that are to be placed only on the Northern Ireland market and will not be made available in any Member State.
The Commission and the UK Government have thus reached a comprehensive set of joint solutions to address these concerns, while protecting the integrity of both the the EU's and the UK’s internal markets.
The Proposal reflects these joint solutions, to provide that:
New and innovative medicines lawfully placed on the market in Northern Ireland are to be only covered by a valid marketing authorisation issued by the UK according to the law of the UK. The placing on the market of these medicines will therefore not anymore be regulated by EU-wide authorisations granted by the Commission.
The EU safety features that must be displayed on packs of medicines subject to prescription in the Union should not appear on packs of medicines made available to patients in Northern Ireland.
These solutions are accompanied by safeguards to ensure that all medicines placed on the market in Northern Ireland will not be made available in any Member State.
Agrees that the provisions of the proposed regulation are appropriately limited to the relevant policy area and that no assessment of consistency with other Union policies is necessary.
Supports the adoption and early implementation of the proposed regulation, which would ensure continuity of supply of medicinal products for human use in Northern Ireland and enhance the prospects for implementation of the Protocol on Ireland/Northern Ireland, as well as contribute to the protection of the Belfast/Good Friday Agreement.
Agrees that it is essential that the proposed regulation contains a provision that enables suspension of the specific rules by the Commission in the event of the UK's non-compliance.
Encourages ongoing consultation with key stakeholders to help ensure timely implementation as well as monitoring for any future risks to the delivery of the objectives of the proposed regulation.
Recommends that the European institutions be updated periodically on the progress of implementation ahead of January 2025.