Debate: Medicine shortages and strategic healthcare autonomy in the EU
Date: TUESDAY, 3 OCTOBER 2023
Speaker: Stella Kyriakides
Language: EN

The continued availability of safe and effective and affordable medicines for all European patients has been a top priority for many of us since the very beginning of this mandate. This is the foundation of a strong European Union in health that we have been building. Last winter was a strong reminder that we need to act to make Europe’s medicine supply chains more resilient. When EU action is necessary to manage critical shortages, the Commission steps in to support Member States, working closely with the European Medicines Agency. We use all tools available under the Agency’s extended mandate regulation to manage and mitigate those shortages and engage with the industry so that medicines can reach all those that need them across the EU. But we are also taking steps to prevent shortages. Our pharmaceutical reform aims to enhance security of supply and addresses shortages of medicines beyond crisis situations. Key elements include a new European alert system so that we have an earlier notification of shortages and withdrawals by companies, harmonised reporting criteria, shortage prevention plans and coordinated management of shortages by EMA. These measures will equip us better to anticipate and mitigate shortages, avoid national export restrictions, and ultimately achieve what we are all trying to do, and that is ensure that medicines are available for all patients. But they are more structural in nature and more for in the long term. This is why in the coming weeks, we will be putting forward a communication, including short- and mid-term actions, to enhance the security of supply and make the supply chains of medicines more resilient. This responds to calls from the public, from this House and from the Member States for more immediate actions on availability of medicines ahead of the winter seasons because we saw what we had to face last year. This communication will complement our regulatory efforts by encouraging Member States to anticipate the many relevant steps under the pharmaceutical reform. We will also adopt a Union list of critical medicines for the first time. We will institutionalise the voluntary cooperation and establish the European Solidarity Mechanism to support Member States to tackle the shortages of medicines this winter in a coordinated but also in a timely way. Finally, we are going to be building on the strategic relations with all our international partners to achieve supply chain diversity and global solidarity. In line with the Council recommendation, we are also stepping up the fight against AMR. One concrete example is the creation and implementation of a Union multi-country pool incentive scheme for antibiotics. Dear Members, I have stood here many times and we have discussed the issue of availability of medicines for all EU citizens, no matter where they live in the EU, and shared that this needs to be what we are working towards. This is our joint political responsibility. No matter where a citizen lives across the EU, whether it is in a big or small Member State, they need to have access to medicines. I assure you that this Commission will continue to take very concrete and collaborative steps to achieve these goals. But the success ultimately depends on all our joint efforts with the stakeholders, with the public authorities, at European level, at national level. And I will count on your strong support to move forward with the pharmaceutical reform in a rapid way and with other initiatives which aim to deliver medicines to all citizens.