The EU will have better crisis preparedness and management for medicinal products and medical devices. There will be a new EU platform to monitor and report medicine shortages, as well as increased transparency on shortages, clinical trials and marketing authorisations.

The European Parliament endorsed the provisional agreement reached with the Council last year on increasing the powers of the EU’s medicines regulator with 655 votes in favour, 31 against and 8 abstentions.

In a statement, Parliament said that the European Medicines Agency (EMA) will be better equipped to monitor and mitigate shortages of medicinal products and medical devices considered to be critical in order to address public health emergencies.

Two “shortages steering groups,” for medicines and medical devices respectively, will be created and the EMA will set up and manage the European Shortages Monitoring Platform to facilitate data collection.

All actors in the supply chain will be involved more closely, including expert advice from observers representing patients and medical professionals, as well as marketing authorisation holders, wholesale distributors or any other relevant healthcare stakeholders.

The agency will also set up a public webpage with information on shortages. Data related to clinical trials and product information on authorised medicinal products will be made available more timely and transparently.

Following the final vote in plenary, the text will be published in the EU Official Journal shortly after. The regulation will apply as of the 1st of March 2022.

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