EU Commission Pays Serious Heed To Critical Drug Shortages

The European Commission has gone on to take steps so as to tackle the issue of critical medicine shortages. These actions include putting up a unified strategy when it comes to stockpiling drugs and establishing a shortage alert system throughout the European Union. The aim is to prevent a recurrence of the situation that one went through in 2022.

According to a press release from the Commission dated October 24, a Communication went on to be published with the aim of preventing and mitigating critical medicine shortages at the EU level. The Communication is intended to address the issue not just for this winter but also for future winters.

During one of the recent press briefings, Stella Kyriakides, Health Commissioner, expressed her commitment to implementing collective actions when it came to the EU level. These actions aim to enhance the well-being of citizens for the medium and long term and not just the upcoming winter.

Kyriakides went on to express her disbelief at the current situation in Europe in 2023. She stressed that it is unacceptable for patients to be deprived of the necessary medications, particularly with regard to the efforts being made to set up a health union.

It is well to be noted that during last winter, many Europeans faced a harsh reality that was previously unthinkable. They had to deal with a surge of respiratory viruses along with ongoing COVID-19 infections. Additionally, there were challenges such as limited manufacturing capacity, a lack of raw materials, distribution issues, labour delays, and even natural disasters.

Kyriakides stated that medicine shortages cannot be resolved right away due to their long-standing and multifactorial causes.

In order to avoid a similar situation, the Commission has now put forth a proposal in terms of an operational response. This is needed because the actions outlined in the drug strategy cannot be implemented at the moment, as the dossier is still being reviewed by the Council and Parliament.

What does the communication consist of?

The proposed response from the Commission incorporates various aspects of pharmaceutical reform. These include asking companies to provide earlier notification of shortages, implementing shortage mitigation strategies for all medicines, and enhancing the sharing of information when it comes to shortages at the EU level.

The actions include the implementation of a European Voluntary Solidarity Mechanism for medicines, the establishment of a comprehensive list of critical medicines, the implementation of regulatory flexibilities, as well as the provision of EU guidance on purchasing.

The European Voluntary Solidarity Mechanism for Medicines has been established to promptly assist countries that experience shortages by allowing them to request support from countries that have an adequate supply.

Efforts to establish a comprehensive list of critical medicines, consisting of 100 to 350 essential medications, will be expedited. The aim is to offer an initial list by the end of this year. By April 2024, one will have analysed the supply chains of specific drugs and identified measures so as to address any shortages.

The Commission will develop a common strategic approach to medicines accumulating in the first half of 2024. This approach aims to avoid and minimise shortages in collaboration with member states.

Furthermore, the Commission plans to establish a Critical Medicines Alliance, which is expected to be working by early 2024. This initiative is referred to as an industrial policy pillar of the European Health Union.

Kyriakides stated that this alliance is an innovative approach for public authorities in the EU to collaborate with the industry. The aim is to provide effective solutions that ensure an uninterrupted supply of medicines.

The Commissioner has announced that the Alliance will have access to a range of actions. These measures will involve public procurement, strategic partnerships to broaden global supply chains, boosting Europe’s production capacity for medicines and ingredients, and coordinating EU and national funding.

Lastly, the Commission will set up a network of international partners with the aim of addressing supply chain resilience. Kyriakides emphasised the importance of global collaboration in the quest to achieve greater variety in supply chains.

The pressing issue at hand is being addressed by the health minister of Spain, Jose Manuel Minones, who currently chairs the EU Council presidency. He expressed his approval of the Commission’s announcement during a meeting of the Parliament’s health and environment committee, which took place on October 23. There is a need to examine the supply chain for medicines and take proactive measures to ensure its robustness and efficiency, and they also aim to enhance the security of supply and assess the overall state of medicine availability beyond times of crisis.

Before the announcement by the Commission, Emer Cooke, the chief of the European Medicines Agency, presented to Parliament the actions being taken by the agency. As per her, they have successfully obtained the demand data from the member states as well as the supply information from the manufacturer. Furthermore, this has enabled to effectively identify areas where shortages or shortfalls may occur, allowing to take proactive measures in a timely manner. EMA has developed a regulatory toolkit to effectively manage critical shortages by closely tracking contact with manufacturers. Cooke pointed out the importance of exploring alternative suppliers and allowing certain labelling flexibility. The debate on shortages continues to be a topic of discussion.