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European Commission’s proposal to reform pharmaceutical legislation and medicine shortages

By Irish Pharmacist - 31st May 2023

The IPU has welcomed the European Commission’s long-awaited proposal to reform the EU pharmaceutical legislation, in particular the important provisions to improve patients’ access to medicines regardless of where they live in the EU.

The proposal introduces useful tools to address medicines shortages, including earlier notification, monitoring and assessment, and the obligation for marketing authorisation holders to have in place shortages prevention plans for all medicines. These measures will help in mitigating the problem of shortages.

The IPU has said it is concerned, however, that there may be delays in implementation due to the European Parliament elections in 2024, the complexity of the discussions, the different interests at stake, and the fact that the new legislation will be implemented only 18 months after its entry into force. This means that Irish citizens will have to wait many years to see its impact in real life “and we simply cannot wait that long,” said the Union. “We cannot afford to have another crisis such as the one we experienced with the shortage of antibiotics during the winter.” Because of this, the IPU is calling for short-term actions to tackle drug shortages, including granting community pharmacists greater flexibility in finding alternatives when a medicine is not available, such as therapeutic substitution under a serious shortage protocol.

Commenting on the proposals, Chair of the IPU’s PCC Committee Ms Kathy Maher said: “Given the far-reaching consequences of this legislation for the citizens of Ireland, we are once again calling on the Minister for Health to immediately appoint a Chief Pharmaceutical Officer, to lead the constructive dialogue with the co-legislators, the European Parliament, and the Council, during the anticipated long discussions ahead, with a focus on accessibility and affordability of medicines for Irish citizens and our health systems.”

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